Pub Date : 2022-10-26DOI: 10.18203/2349-3259.ijct20222688
Rhiannon Dowla, C. Stubley, B. Murnion, E. Cayanan, Y. Mavros, Scarlett Hardy, K. Rooney
Background: Opioid use disorder has the lowest quality of life (QOL) and highest disease burden of all substance use disorders (SUD). While opioid treatment does lead to initial improvements in QOL it remains below that of the general population. The integration of exercise programs as an adjunct therapy for SUD is gaining popularity. Previous reviews have indicated that exercise offers significant benefits for QOL, however the evidence in an opioid treatment population is lacking. This study will investigate the impact of a 12-week exercise intervention on QOL and mood in a residential opioid treatment rehabilitation program.Methods: This is a 12-week single arm intervention with a natural history control. Participants will complete a baseline screening assessing QOL, mood and exercise habits and those who meet criteria for exercise participation will complete an exercise assessment. The exercise program will be delivered twice per week as part of the group therapy program. Exercise sessions will run for approximately 40 minutes and be at an intensity selected by each of the participants.Conclusions: A recent review indicated that two sessions of exercise for a minimum of 12 weeks leads to an improvement in QOL in general SUD, however, to date minimal studies have been completed in people receiving opioid agonist treatment. Hence, this will be the first study to our knowledge, assessing the role of exercise as an adjunct treatment for QOL in this population.Trial Registration: This trial has been registered with the Australian New Zealand clinical trials registry ACTRN12622000213741.
{"title":"Fitness in recovery: impact of exercise in people with substance use disorder in residential treatment","authors":"Rhiannon Dowla, C. Stubley, B. Murnion, E. Cayanan, Y. Mavros, Scarlett Hardy, K. Rooney","doi":"10.18203/2349-3259.ijct20222688","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222688","url":null,"abstract":"Background: Opioid use disorder has the lowest quality of life (QOL) and highest disease burden of all substance use disorders (SUD). While opioid treatment does lead to initial improvements in QOL it remains below that of the general population. The integration of exercise programs as an adjunct therapy for SUD is gaining popularity. Previous reviews have indicated that exercise offers significant benefits for QOL, however the evidence in an opioid treatment population is lacking. This study will investigate the impact of a 12-week exercise intervention on QOL and mood in a residential opioid treatment rehabilitation program.Methods: This is a 12-week single arm intervention with a natural history control. Participants will complete a baseline screening assessing QOL, mood and exercise habits and those who meet criteria for exercise participation will complete an exercise assessment. The exercise program will be delivered twice per week as part of the group therapy program. Exercise sessions will run for approximately 40 minutes and be at an intensity selected by each of the participants.Conclusions: A recent review indicated that two sessions of exercise for a minimum of 12 weeks leads to an improvement in QOL in general SUD, however, to date minimal studies have been completed in people receiving opioid agonist treatment. Hence, this will be the first study to our knowledge, assessing the role of exercise as an adjunct treatment for QOL in this population.Trial Registration: This trial has been registered with the Australian New Zealand clinical trials registry ACTRN12622000213741.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81463848","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}
Pub Date : 2022-10-10DOI: 10.18203/2349-3259.ijct20222626
L. Patel, Shreekant Sharma, D. Bunger
Background: To describe the patient characteristics and usage pattern of biosimilar bevacizumab for the treatment of metastatic colorectal cancer (mCRC) in India.Methods: This real-world, retrospective analysis included adult patients receiving biosimilar bevacizumab between April 2021 and March 2022.Results: A total of 1125 patients with mCRC who received biosimilar bevacizumab-based chemotherapy were included. The mean age at diagnosis was 57.8 years. Majority of the patients were males (71%) and belonged to the age groups of 41-76 years. The primary tumor site was right colon (52.6%) followed by left colon (29.2%) and rectum (17.3%), and the tumor grade was reported as high in most (88.7%) of the patients. Majority of patients received biosimilar bevacizumab-based chemotherapy as first-line therapy (61.3%), followed by second-line (31.9%) and third-line therapy (6.8%). In combination with biosimilar bevacizumab, FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin) was the most commonly administered regimen (42.9%), followed by CAPOX (capecitabine and oxaliplatin, 26.5%) and FOLFIRI (folinic acid, 5-fluorouracil, and irinotecan, 22.8%).Conclusions: Biosimilar bevacizumab-based chemotherapy is being widely used in real‑world clinical setting in India for the management of patients with mCRC.
{"title":"Real-world utilization and acceptance of biosimilar bevacizumab in metastatic colorectal cancer in India","authors":"L. Patel, Shreekant Sharma, D. Bunger","doi":"10.18203/2349-3259.ijct20222626","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222626","url":null,"abstract":"Background: To describe the patient characteristics and usage pattern of biosimilar bevacizumab for the treatment of metastatic colorectal cancer (mCRC) in India.Methods: This real-world, retrospective analysis included adult patients receiving biosimilar bevacizumab between April 2021 and March 2022.Results: A total of 1125 patients with mCRC who received biosimilar bevacizumab-based chemotherapy were included. The mean age at diagnosis was 57.8 years. Majority of the patients were males (71%) and belonged to the age groups of 41-76 years. The primary tumor site was right colon (52.6%) followed by left colon (29.2%) and rectum (17.3%), and the tumor grade was reported as high in most (88.7%) of the patients. Majority of patients received biosimilar bevacizumab-based chemotherapy as first-line therapy (61.3%), followed by second-line (31.9%) and third-line therapy (6.8%). In combination with biosimilar bevacizumab, FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin) was the most commonly administered regimen (42.9%), followed by CAPOX (capecitabine and oxaliplatin, 26.5%) and FOLFIRI (folinic acid, 5-fluorouracil, and irinotecan, 22.8%).Conclusions: Biosimilar bevacizumab-based chemotherapy is being widely used in real‑world clinical setting in India for the management of patients with mCRC.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77731727","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}
Pub Date : 2022-10-01DOI: 10.18203/2349-3259.ijct20222610
Shashikant Sharma, A. Chaturvedi, N. Dave, Ankita Shah
Background: To evaluate risk factors associated with retinal diseases and efficacy and safety of RazumabTM (biosimilar ranibizumab) in the management of retinal diseases in Indian patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).Methods: In the retrospective, observational REAR RD-2 study, all patients with retinal diseases who were treated with biosimilar ranibizumab were included from multiple Indian sites. The demographic parameters, disease characteristics and treatment details were recorded. Efficacy assessments included improvement in best corrected visual acuity (BCVA), and decrease in central subfield thickness (CSFT), intra-retinal fluid (IRF) and sub-retinal fluid (SRF) from baseline to week 48.Results: Data of 1422 patients (wet AMD-27.57%; DME-30.7%, RVO-33.47%; mCNV-5.48%), who were treated with biosimilar ranibizumab, was analyzed. The most common age group of patients was 61-70 years (36.6%). The most common ocular risk factor identified was glaucoma (24.90%). A total of 85.72% patients were treatment naïve and 14.28% were previously treated patients. Biosimilar ranibizumab treatment resulted in significant (p<0.05) improvements in the mean BCVA and CSFT, and the proportion of patients with IRF and SRF was significantly reduced throughout the treatment. No new safety concerns with biosimilar ranibizumab were observed.Conclusions: Retinal diseases are more common in the age group of 61-70 years. Glaucoma was the most common ocular risk factor identified for retinal diseases. Long-term treatment with biosimilar ranibizumab was effective and well-tolerated in retinal diseases including wAMD, DME, RVO and mCNV in real-world Indian scenario.
{"title":"Long-term efficacy and safety of RazumabTM (biosimilar ranibizumab) in Indian patients with retinal diseases: results from retrospective REAR RD-2 study","authors":"Shashikant Sharma, A. Chaturvedi, N. Dave, Ankita Shah","doi":"10.18203/2349-3259.ijct20222610","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222610","url":null,"abstract":"Background: To evaluate risk factors associated with retinal diseases and efficacy and safety of RazumabTM (biosimilar ranibizumab) in the management of retinal diseases in Indian patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).Methods: In the retrospective, observational REAR RD-2 study, all patients with retinal diseases who were treated with biosimilar ranibizumab were included from multiple Indian sites. The demographic parameters, disease characteristics and treatment details were recorded. Efficacy assessments included improvement in best corrected visual acuity (BCVA), and decrease in central subfield thickness (CSFT), intra-retinal fluid (IRF) and sub-retinal fluid (SRF) from baseline to week 48.Results: Data of 1422 patients (wet AMD-27.57%; DME-30.7%, RVO-33.47%; mCNV-5.48%), who were treated with biosimilar ranibizumab, was analyzed. The most common age group of patients was 61-70 years (36.6%). The most common ocular risk factor identified was glaucoma (24.90%). A total of 85.72% patients were treatment naïve and 14.28% were previously treated patients. Biosimilar ranibizumab treatment resulted in significant (p<0.05) improvements in the mean BCVA and CSFT, and the proportion of patients with IRF and SRF was significantly reduced throughout the treatment. No new safety concerns with biosimilar ranibizumab were observed.Conclusions: Retinal diseases are more common in the age group of 61-70 years. Glaucoma was the most common ocular risk factor identified for retinal diseases. Long-term treatment with biosimilar ranibizumab was effective and well-tolerated in retinal diseases including wAMD, DME, RVO and mCNV in real-world Indian scenario. ","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"37 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79428508","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}
Pub Date : 2022-09-27DOI: 10.18203/2349-3259.ijct20222549
Shiba Roby, Z. Morse
Background: Ergonomics is a multidisciplinary science that studies how humans and other system elements interact and a profession that uses theory, concepts, data, and methodologies to improve human well-being and overall system performance. Oral health professionals need good working ergonomics to preserve their work competence, efficiency, and high clinical level of treatment throughout their careers. For various working practices, clinical procedures, and patient types, they must adjust and ensure proper working postures, adequate illumination, and easy access to essential apparatus and materials. Although some systematic studies and original research have been conducted about different aspects of “ergonomics in oral health professions,” no mapping review has been shown. The authors believe a broad overview of existing literature is required to map existing research, determine research gaps, and guide future research.Methods: The protocol for this mapping review has been designed by the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for scoping studies (PRISMA-SCR) and the Joanna Briggs Institute (JBI) guidelines. A comprehensive search strategy developed with an experienced liaison librarian for health will be used to search four databases and eight sources of unpublished literature. JBI’s proposed search approach will be used. A PRISMA-SCR flowchart will be used to track the number of recognised, screened, and excluded sources. A data extraction table will be used to collate critical information, supplemented with a narrative explanation, and presented in a tabular style.Conclusions: This mapping review will identify research gaps in this field and guide further studies.
{"title":"Ergonomics in oral health professions: a mapping review protocol","authors":"Shiba Roby, Z. Morse","doi":"10.18203/2349-3259.ijct20222549","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222549","url":null,"abstract":"Background: Ergonomics is a multidisciplinary science that studies how humans and other system elements interact and a profession that uses theory, concepts, data, and methodologies to improve human well-being and overall system performance. Oral health professionals need good working ergonomics to preserve their work competence, efficiency, and high clinical level of treatment throughout their careers. For various working practices, clinical procedures, and patient types, they must adjust and ensure proper working postures, adequate illumination, and easy access to essential apparatus and materials. Although some systematic studies and original research have been conducted about different aspects of “ergonomics in oral health professions,” no mapping review has been shown. The authors believe a broad overview of existing literature is required to map existing research, determine research gaps, and guide future research.Methods: The protocol for this mapping review has been designed by the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for scoping studies (PRISMA-SCR) and the Joanna Briggs Institute (JBI) guidelines. A comprehensive search strategy developed with an experienced liaison librarian for health will be used to search four databases and eight sources of unpublished literature. JBI’s proposed search approach will be used. A PRISMA-SCR flowchart will be used to track the number of recognised, screened, and excluded sources. A data extraction table will be used to collate critical information, supplemented with a narrative explanation, and presented in a tabular style.Conclusions: This mapping review will identify research gaps in this field and guide further studies.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"59 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85273664","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}
Pub Date : 2022-09-22DOI: 10.18203/2349-3259.ijct20222376
Smruti Divate, Z. Morse
Background: A universal method of dental home care regimen has been toothbrushing. It aids with dental biofilm and plaque removal in an attempt to prevent chronic oral diseases. Although many comparative studies have been conducted on toothbrushes and their efficacy in plaque removal, there has been no systematic mapping review focusing on toothbrush design, ease of use and safety. This mapping review aims to map key concepts, categorise existing themes and identify gaps in existing literature for future primary or scoping studies.Methods: The protocol for this mapping review has been designed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and the Joanna Briggs Institute (JBI) guidelines. Primary and secondary studies, guidelines, and reports about the design, ease of use and safety of toothbrushes will be considered for inclusion in this mapping review. Four databases (Dentistry and Oral Sciences Source, CINAHL, MEDLINE, and Scopus) and three sources of unpublished literature (Cochrane Library, Google, and Google Scholar) will be searched using the JBI proposed three-stage search strategy by reviewers independently. A PRISMA-ScR flowchart will be utilised to document the numbers of identified, screened, and excluded sources. Data will be extracted using a data extraction table designed by the reviewers. Extracted data will be summarised and presented in diagrammatic and tabular forms, accompanied by a narrative explanation.Conclusions: Examining the existing literature on toothbrush design is fundamental to guide future research, design innovations, and improve oral health.
背景:一种普遍的牙科家庭护理方法一直是刷牙。它有助于去除牙齿生物膜和牙菌斑，以预防慢性口腔疾病。虽然对牙刷及其去除牙菌斑的功效进行了许多比较研究，但尚未对牙刷的设计，易用性和安全性进行系统的绘图审查。这篇地图评论的目的是绘制关键概念，对现有主题进行分类，并确定现有文献中的差距，以便将来进行初级或范围研究。方法:本次地图评价的方案是按照系统评价和荟萃分析扩展范围评价的首选报告项目(PRISMA-ScR)和乔安娜布里格斯研究所(JBI)指南设计的。关于牙刷的设计、易用性和安全性的主要和次要研究、指南和报告将被纳入本次地图审查。4个数据库(Dentistry and Oral Sciences Source、CINAHL、MEDLINE和Scopus)和3个未发表文献来源(Cochrane Library、谷歌和谷歌Scholar)将由审稿人独立使用JBI提出的三阶段检索策略进行检索。将使用PRISMA-ScR流程图记录已识别、筛选和排除的来源的数量。使用审稿人设计的数据提取表提取数据。提取的数据将以图表和表格的形式加以总结和呈现，并附有叙述性解释。结论:检查现有的牙刷设计文献是指导未来研究、设计创新和改善口腔健康的基础。
{"title":"A mapping review protocol for toothbrush design","authors":"Smruti Divate, Z. Morse","doi":"10.18203/2349-3259.ijct20222376","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222376","url":null,"abstract":"Background: A universal method of dental home care regimen has been toothbrushing. It aids with dental biofilm and plaque removal in an attempt to prevent chronic oral diseases. Although many comparative studies have been conducted on toothbrushes and their efficacy in plaque removal, there has been no systematic mapping review focusing on toothbrush design, ease of use and safety. This mapping review aims to map key concepts, categorise existing themes and identify gaps in existing literature for future primary or scoping studies.Methods: The protocol for this mapping review has been designed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and the Joanna Briggs Institute (JBI) guidelines. Primary and secondary studies, guidelines, and reports about the design, ease of use and safety of toothbrushes will be considered for inclusion in this mapping review. Four databases (Dentistry and Oral Sciences Source, CINAHL, MEDLINE, and Scopus) and three sources of unpublished literature (Cochrane Library, Google, and Google Scholar) will be searched using the JBI proposed three-stage search strategy by reviewers independently. A PRISMA-ScR flowchart will be utilised to document the numbers of identified, screened, and excluded sources. Data will be extracted using a data extraction table designed by the reviewers. Extracted data will be summarised and presented in diagrammatic and tabular forms, accompanied by a narrative explanation.Conclusions: Examining the existing literature on toothbrush design is fundamental to guide future research, design innovations, and improve oral health.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"111 3S 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76772700","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}
Pub Date : 2022-08-05DOI: 10.18203/2349-3259.ijct20222070
Sucheta Gupta, V. Gupta
Background: Chronic suppurative otitis media (CSOM) is an important and a highly prevalent disease of the middle ear and poses serious health problem worldwide especially in developing countries. The objective of the current study was to evaluate the association between CSOM and sensorineural hearing loss (SNHL) and to study of pattern of hearing loss and clinical factors and demographic variables, if any, that might affect sensorineural component, in CSOM in North-Indian population.Methods: A randomized observational study was conducted on 120 patients, in the age-group of 1 to 50 years, divided into two groups of 60 each: who had safe CSOM and unsafe CSOM, over a period of 6 months, i.e., from: July 2021 to December 2021, in the department of otorhinolaryngology and head neck surgery, CHC, Chenani, Udhampur, J and K, India.Results: Out of 60 patients under safe CSOM, Male: Female ratio stood at 1:1.14 (i.e., 28:32). Mean duration ± SD of the disease stood at: 6.2±5.09 years. Incidence of hearing loss was observed in 93 (77.5%) patients of conductive type and 27 (22.5%) patients of mixed type and 19 patients (31.67%) were of unsafe mixed type. Maximum incidence of 35% was in the age group of 41-50 years and minimum in 11-20 years i.e., 7.32%. Total incidence of SNHL 16.67%.Conclusions: A significant association between SNHL and CSOM was found in this study, with incidence of SNHL increasing with advancing age, showing that age as a risk factor for sensorineural component of hearing loss in CSOM.
{"title":"A randomized observational study into the pattern of hearing loss in chronic suppurative otitis media","authors":"Sucheta Gupta, V. Gupta","doi":"10.18203/2349-3259.ijct20222070","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222070","url":null,"abstract":"Background: Chronic suppurative otitis media (CSOM) is an important and a highly prevalent disease of the middle ear and poses serious health problem worldwide especially in developing countries. The objective of the current study was to evaluate the association between CSOM and sensorineural hearing loss (SNHL) and to study of pattern of hearing loss and clinical factors and demographic variables, if any, that might affect sensorineural component, in CSOM in North-Indian population.Methods: A randomized observational study was conducted on 120 patients, in the age-group of 1 to 50 years, divided into two groups of 60 each: who had safe CSOM and unsafe CSOM, over a period of 6 months, i.e., from: July 2021 to December 2021, in the department of otorhinolaryngology and head neck surgery, CHC, Chenani, Udhampur, J and K, India.Results: Out of 60 patients under safe CSOM, Male: Female ratio stood at 1:1.14 (i.e., 28:32). Mean duration ± SD of the disease stood at: 6.2±5.09 years. Incidence of hearing loss was observed in 93 (77.5%) patients of conductive type and 27 (22.5%) patients of mixed type and 19 patients (31.67%) were of unsafe mixed type. Maximum incidence of 35% was in the age group of 41-50 years and minimum in 11-20 years i.e., 7.32%. Total incidence of SNHL 16.67%.Conclusions: A significant association between SNHL and CSOM was found in this study, with incidence of SNHL increasing with advancing age, showing that age as a risk factor for sensorineural component of hearing loss in CSOM.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"129 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85747879","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}
Pub Date : 2022-07-26DOI: 10.18203/2349-3259.ijct20221869
Hyunjin Park, Z. Morse
Background: Removable orthodontic treatment corrects dental and skeletal malocclusion by utilising various types of removable appliances. Although removable orthodontic treatment has a reduced risk of dental caries compared to fixed orthodontic treatment, removable appliances create niches for cariogenic microorganisms to increase their numbers and lead to an ecological shift. However, there is insufficient information on caries prevention during removable orthodontic treatment. The protocol details the research for a scoping review of caries prevention during removable orthodontic treatment.Methods: This scoping review will be conducted according to the Preferred Reporting Items for Systemic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and Joanna Briggs Institute (JBI) Manual for Evidence Synthesis guidelines. Published primary and secondary research studies (including reviews), guidelines, websites, and reports that are written in English until April 2022 will be searched from seven databases, including Dentistry and Oral Sciences Source, CINAHL, MEDLINE, via EBSCOHost, Scopus, Cochrane, Google, and Google Scholar. Two reviewers (HP and ZM) will analyse the retrieved articles simultaneously using the parameters and three-step strategy recommended by JBI. Obtained numbers of included and excluded identified sources will be presented in a PRISMA flow diagram and the data extraction table will demonstrate the variables from included sources.Conclusions: The findings of this review will be summarised in a narrative description to facilitate guidance in clinical practice and research for health professionals.
背景:可移动正畸治疗通过使用各种类型的可移动矫治器纠正牙齿和骨骼错颌。虽然与固定正畸治疗相比，可移动正畸治疗降低了龋齿的风险，但可移动矫治器为致龋微生物创造了生态位，增加了它们的数量，导致了生态的转变。然而，在活动正畸治疗期间预防龋齿的信息不足。该协议详细介绍了在可移动正畸治疗期间预防龋齿的范围审查研究。方法:根据系统评价和荟萃分析扩展范围评价首选报告项目(PRISMA-ScR)和乔安娜布里格斯研究所(JBI)证据综合指南手册进行范围评价。截至2022年4月，已发表的初级和二级研究(包括综述)、指南、网站和英文报告将通过EBSCOHost、Scopus、Cochrane、谷歌和谷歌Scholar从七个数据库中检索，包括Dentistry and Oral Sciences Source、CINAHL、MEDLINE。两位审稿人(HP和ZM)将使用JBI推荐的参数和三步策略同时分析检索到的文章。已获得的已确定来源的包括和不包括的数量将在PRISMA流程图中显示，数据提取表将演示来自已确定来源的变量。结论:本综述的发现将以叙述性描述的形式进行总结，以促进临床实践和卫生专业人员研究的指导。
{"title":"Caries prevention during removable orthodontic treatment: a scoping review protocol","authors":"Hyunjin Park, Z. Morse","doi":"10.18203/2349-3259.ijct20221869","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20221869","url":null,"abstract":"Background: Removable orthodontic treatment corrects dental and skeletal malocclusion by utilising various types of removable appliances. Although removable orthodontic treatment has a reduced risk of dental caries compared to fixed orthodontic treatment, removable appliances create niches for cariogenic microorganisms to increase their numbers and lead to an ecological shift. However, there is insufficient information on caries prevention during removable orthodontic treatment. The protocol details the research for a scoping review of caries prevention during removable orthodontic treatment.Methods: This scoping review will be conducted according to the Preferred Reporting Items for Systemic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and Joanna Briggs Institute (JBI) Manual for Evidence Synthesis guidelines. Published primary and secondary research studies (including reviews), guidelines, websites, and reports that are written in English until April 2022 will be searched from seven databases, including Dentistry and Oral Sciences Source, CINAHL, MEDLINE, via EBSCOHost, Scopus, Cochrane, Google, and Google Scholar. Two reviewers (HP and ZM) will analyse the retrieved articles simultaneously using the parameters and three-step strategy recommended by JBI. Obtained numbers of included and excluded identified sources will be presented in a PRISMA flow diagram and the data extraction table will demonstrate the variables from included sources.Conclusions: The findings of this review will be summarised in a narrative description to facilitate guidance in clinical practice and research for health professionals.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"81 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80050534","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}
Pub Date : 2022-07-26DOI: 10.18203/2349-3259.ijct20221870
Olakunle I. Makinde, S. Aigere, N. Oyeyemi, A. Adesina
Background: Pain management post-caesarean section is a common source of exposure to opioids in women. To address the rising opioid addiction associated with peri-operative administration, trend in operative analgesia is moving towards opioid-free, multimodal analgesia. We present our protocol for this study so that it may be replicated in other settings and possibly modified for future studies.Methods: In a Single-centre, non-inferiority, parallel, randomized, controlled, clinical trial with balanced allocation [1:1] into two arms, we compared a peri-operative opioid-free analgesia regimen with a routine post-operative opioid-based analgesia regimen in women undergoing caesarean section under spinal anaesthesia. Primary outcome measures were post-operative pain intensity at 4, 8 and 24 hours (using Numerical Rating Scale) and post-operative pentazocine use. Secondary outcome measures were the incidence of adverse events and Apgar score. Results will be published in a peer-reviewed, open access journal.Conclusions: This protocol adopted the use of intravenous paracetamol and intravenous NSAID as baseline analgesics. Magnesium sulphate was introduced peri-operatively as part of our opioid-free multimodal analgesia regimen because of its established effect in decreasing post-operative pain and opioid use. We also relied on the preventive analgesic effect of administration of intravenous paracetamol and intravenous magnesium sulphate before surgical incision, continued intraoperatively and post-operatively. In addition, magnesium sulphate is a familiar drug to the obstetrician, readily available and affordable in most settings where comprehensive emergency obstetric care is offered, easy to administer and it has been well tolerated clinically.Trial registration: This protocol was registered with clinicaltrials.gov (Identifier: NCT04539249) on September 3, 2020, prospectively.
{"title":"Single-centre, randomized, clinical trial of opioid-free analgesia versus routine opioid-based analgesia regimen for the management of acute post-operative pain following caesarean section: study protocol","authors":"Olakunle I. Makinde, S. Aigere, N. Oyeyemi, A. Adesina","doi":"10.18203/2349-3259.ijct20221870","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20221870","url":null,"abstract":"Background: Pain management post-caesarean section is a common source of exposure to opioids in women. To address the rising opioid addiction associated with peri-operative administration, trend in operative analgesia is moving towards opioid-free, multimodal analgesia. We present our protocol for this study so that it may be replicated in other settings and possibly modified for future studies.Methods: In a Single-centre, non-inferiority, parallel, randomized, controlled, clinical trial with balanced allocation [1:1] into two arms, we compared a peri-operative opioid-free analgesia regimen with a routine post-operative opioid-based analgesia regimen in women undergoing caesarean section under spinal anaesthesia. Primary outcome measures were post-operative pain intensity at 4, 8 and 24 hours (using Numerical Rating Scale) and post-operative pentazocine use. Secondary outcome measures were the incidence of adverse events and Apgar score. Results will be published in a peer-reviewed, open access journal.Conclusions: This protocol adopted the use of intravenous paracetamol and intravenous NSAID as baseline analgesics. Magnesium sulphate was introduced peri-operatively as part of our opioid-free multimodal analgesia regimen because of its established effect in decreasing post-operative pain and opioid use. We also relied on the preventive analgesic effect of administration of intravenous paracetamol and intravenous magnesium sulphate before surgical incision, continued intraoperatively and post-operatively. In addition, magnesium sulphate is a familiar drug to the obstetrician, readily available and affordable in most settings where comprehensive emergency obstetric care is offered, easy to administer and it has been well tolerated clinically.Trial registration: This protocol was registered with clinicaltrials.gov (Identifier: NCT04539249) on September 3, 2020, prospectively.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88209825","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}
Pub Date : 2022-07-26DOI: 10.18203/2349-3259.ijct20221868
A. Lescano, N. Atamañuk, G. Bortman, J. Cáneva, M. Diez, G. Giacomi, L. Lema, E. Perna
Background: Pulmonary hypertension (PH) is a chronic, progressive condition with high morbidity and mortality due to right heart (RH) failure. Prognosis depends on RH adaptability and remodelling in response to increased pulmonary arterial pressure. There is little information regarding risk variables and prognostic factors in the Argentinian population, current risk scores have not been validated, and its impact on free-event survival is still unknown. Prostacyclin analogues are the first-line treatment for high-risk patients. However, there is limited evidence on its clinical benefits, long-term effects, and impact on RH remodelling in the Argentinian population.Methods: The study was designed as a national, multicentre, prospective, observational, phase IV study including 100 patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension, treated with subcutaneous treprostinil and followed up for 48 months. The study will be conducted in parallel with the patients' standard management and treatment in each centre. The primary objective is to assess the long-term improvement or reversal of RH remodelling (RHRR) parameters obtained by echocardiography. Secondary objectives include the evaluation of the prognostic value of RHRR parameters and the rate of clinical events, the treatment effect in terms of pulmonary vascular resistance, right ventricle systolic function, morbidity and all-cause mortality, quality of life, and safety and tolerability.Conclusions: This study will help to determine the clinical benefits, long-term effects, and impact on RH remodelling of prostacyclin analogues in Argentina.Trial registration: The trial was registered at Registro Nacional de Investigaciones en Salud (RENIS) in Argentina (https://sisa.msal.gov.ar/sisa/#sisa; registration number IS003303).
{"title":"Long-term effect of subcutaneous treprostinil in patients with pulmonary hypertension: rationale and design of the phase IV, multicentre, observational TREPAR-HP study","authors":"A. Lescano, N. Atamañuk, G. Bortman, J. Cáneva, M. Diez, G. Giacomi, L. Lema, E. Perna","doi":"10.18203/2349-3259.ijct20221868","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20221868","url":null,"abstract":"Background: Pulmonary hypertension (PH) is a chronic, progressive condition with high morbidity and mortality due to right heart (RH) failure. Prognosis depends on RH adaptability and remodelling in response to increased pulmonary arterial pressure. There is little information regarding risk variables and prognostic factors in the Argentinian population, current risk scores have not been validated, and its impact on free-event survival is still unknown. Prostacyclin analogues are the first-line treatment for high-risk patients. However, there is limited evidence on its clinical benefits, long-term effects, and impact on RH remodelling in the Argentinian population.Methods: The study was designed as a national, multicentre, prospective, observational, phase IV study including 100 patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension, treated with subcutaneous treprostinil and followed up for 48 months. The study will be conducted in parallel with the patients' standard management and treatment in each centre. The primary objective is to assess the long-term improvement or reversal of RH remodelling (RHRR) parameters obtained by echocardiography. Secondary objectives include the evaluation of the prognostic value of RHRR parameters and the rate of clinical events, the treatment effect in terms of pulmonary vascular resistance, right ventricle systolic function, morbidity and all-cause mortality, quality of life, and safety and tolerability.Conclusions: This study will help to determine the clinical benefits, long-term effects, and impact on RH remodelling of prostacyclin analogues in Argentina.Trial registration: The trial was registered at Registro Nacional de Investigaciones en Salud (RENIS) in Argentina (https://sisa.msal.gov.ar/sisa/#sisa; registration number IS003303).","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87445991","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}
Pub Date : 2022-07-26DOI: 10.18203/2349-3259.ijct20221876
Ashley S. Bae
Despite the United States’ (U.S.) longstanding history of promoting a melting pot nation of people from diverse racial and ethnic backgrounds all capable of achieving the American Dream, it is argued that the U.S. is failing to deliver high quality healthcare to all of its constituents equally. The widely seen health disparities of ethnic minority groups endure has extended into the parallel field of clinical research and clinical trials. There is a staggering gap between the percentage of White clinical trial participants compared to clinical trial participants of racially and ethnically diverse minority groups in U.S. clinical trials. Underrepresentation of minority groups in clinical trials dismisses opportunities to identify potential serious sub-group safety or efficacy signals, open doors to access life-saving treatments, and ultimately improve the standard of evidence-based medicine in the United States. Current literature on this issue frequently reiterates the following five key barriers underrepresented minority groups face against clinical trial participation: mistrust, lack of awareness and access, cultural and language barriers, investigator and provider bias, and financial burdens. A deeper dive into understanding each barrier will be critical in implementing changes with actions and in perspectives in order to address the issue of poor racial and ethnic representation in clinical trial populations.
{"title":"Key barriers against racial and ethnic minority participation in U.S. clinical trials","authors":"Ashley S. Bae","doi":"10.18203/2349-3259.ijct20221876","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20221876","url":null,"abstract":"Despite the United States’ (U.S.) longstanding history of promoting a melting pot nation of people from diverse racial and ethnic backgrounds all capable of achieving the American Dream, it is argued that the U.S. is failing to deliver high quality healthcare to all of its constituents equally. The widely seen health disparities of ethnic minority groups endure has extended into the parallel field of clinical research and clinical trials. There is a staggering gap between the percentage of White clinical trial participants compared to clinical trial participants of racially and ethnically diverse minority groups in U.S. clinical trials. Underrepresentation of minority groups in clinical trials dismisses opportunities to identify potential serious sub-group safety or efficacy signals, open doors to access life-saving treatments, and ultimately improve the standard of evidence-based medicine in the United States. Current literature on this issue frequently reiterates the following five key barriers underrepresented minority groups face against clinical trial participation: mistrust, lack of awareness and access, cultural and language barriers, investigator and provider bias, and financial burdens. A deeper dive into understanding each barrier will be critical in implementing changes with actions and in perspectives in order to address the issue of poor racial and ethnic representation in clinical trial populations.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"43 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90396785","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}
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