International Journal of Clinical Trials最新文献_第9页

Τhe effect of task oriented approach on gait of hemiplegic patients: a case series study Τhe任务导向方法对偏瘫患者步态的影响:一个病例系列研究

International Journal of Clinical Trials Pub Date : 2022-11-04 DOI: 10.18203/2349-3259.ijct20222960

Myrto Kesidou, Thomas Besios, G. Paras, Konstantinos Chandolias, G. M. Kyriakatis, Vasiliki Kouvelioti, E. Stefas

{"title":"Τhe effect of task oriented approach on gait of hemiplegic patients: a case series study","authors":"Myrto Kesidou, Thomas Besios, G. Paras, Konstantinos Chandolias, G. M. Kyriakatis, Vasiliki Kouvelioti, E. Stefas","doi":"10.18203/2349-3259.ijct20222960","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222960","url":null,"abstract":"The last few years, the main purpose of the treatment of the hemiplegic patient, is to regain his ability to execute functional activities of daily living independently. According to the latest studies, the effectiveness as well as the importance of task-oriented approach (TOA), is apparent and determining to reacquire the patient’s lost independency, through the practice of the specified functional activities. The aim of this study is to investigate a program of TOA on gait of hemiplegic patients. A sample of 5 post stroke patients was selected from according to the inclusion criteria. A TOA intervention was executed through the practice of 10 functional activities, related to gait, from Monday to Friday for 4 weeks. At the end of each week, gait and balance assessments were performed through the 10-meter walk test (10 MWT), the Berg balance scale (BBS), and the timed up and go test (TUG). The analysis indicates that TOA is extremely effective for stroke patients with mediocre and minor gait and balance deficits, as the difference was statistically significant (p<0.05). The statistically significant difference was from the first assessment T1 to the final assessment T5 and was proven through BBS, TUG and 10 MWT. In conclusion, TOA is a quite beneficial and a cost-effective intervention for the rehabilitation of gait and balance for stroke patients, while consequently improving the quality of their everyday life, independently from their original functional status.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85052971","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}

引用次数: 0

Takotsubo cardiomyopathy: a rare neuro-cardiological entity with its challenges Takotsubo心肌病:一种罕见的神经心脏病实体及其挑战

International Journal of Clinical Trials Pub Date : 2022-11-04 DOI: 10.18203/2349-3259.ijct20222963

Pugazhendi Inban, N. Venkatesh, Priyadarshi Prajjwal, M. Hassan, Mujtaba H. Shah, Rayyan Sunasra, Karan Gupta, Yamini Sharma

{"title":"Takotsubo cardiomyopathy: a rare neuro-cardiological entity with its challenges","authors":"Pugazhendi Inban, N. Venkatesh, Priyadarshi Prajjwal, M. Hassan, Mujtaba H. Shah, Rayyan Sunasra, Karan Gupta, Yamini Sharma","doi":"10.18203/2349-3259.ijct20222963","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222963","url":null,"abstract":"Takotsubo cardiomyopathy (TCM) is a type of neuro cardiological disorder that evince as acute but reversible heart failure. On the whole, it occurs by stress-related cardiomyopathy which illustrates the heart-brain connection. It was first discovered in 1990, by a Japanese cardiovascular specialist. That's the beginning of this heart disease in gaining worldwide acceptance as an independent disease entity. TCM is entirely different from acute myocardial infarction as usually occurs in postmenopausal elderly women due to emotional or physical stress. It is characterized by transient hypokinesis of the left ventricular apex. However, there are complications too that need to be addressed. Some reports of serious TCM include hypotension, thrombosis involving LV apex, heart failure, and ventricular rupture. It is also suggested that coronary spasms, myocarditis, and coronary microvascular dysfunction might contribute to the pathogenesis of TCM. But in total, its pathophysiology is unclear. In this review article, we review the pathogenesis and etiology of this rare complex disorder along with its clinical features, findings, challenges in diagnosis, and a comprehensive discussion on the same.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80044339","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}

引用次数: 0

Immunophenotype and genetic risk scores to improve autoantibody negative type 1 diabetes classification: study protocol 免疫表型和遗传风险评分改善自身抗体阴性的1型糖尿病分类:研究方案

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222690

Shivani K Patel, Cindy S. Ma, K. Bell, R. Oram, W. Hagopian, S. Fourlanos, J. Greenfield

{"title":"Immunophenotype and genetic risk scores to improve autoantibody negative type 1 diabetes classification: study protocol","authors":"Shivani K Patel, Cindy S. Ma, K. Bell, R. Oram, W. Hagopian, S. Fourlanos, J. Greenfield","doi":"10.18203/2349-3259.ijct20222690","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222690","url":null,"abstract":"Background: An estimated 10-30% of type 1 diabetes (T1D) individuals do not have detectable autoantibodies at diagnosis, thus are classified as “idiopathic” or “non-immune.” Given the non-pathogenic role of islet autoantibodies, the validity of excluding an immune basis for disease in such individuals needs to be questioned. The pan-autoantibody negative type 1 diabetes in adults (PANDA) study aims to characterise the immune, clinical and metabolic phenotype of autoantibody negative T1D individuals.Methods: This is a two-part, multi-centre study which is recruiting 100 participants: autoantibody positive T1D (N=25), autoantibody negative T1D (N=25), latent autoimmune diabetes in adults (N=25) and age- and sex-matched normoglycaemic control (N=25) individuals. Study 1 involves baseline pathology collection and high dimensional immune-phenotyping using flow cytometry. DNA will be extracted from saliva samples to calculate type 1 diabetes genetic risk scores (T1DGRS). Autoantibody negative individuals will undergo monogenic diabetes testing. Study 2 is a prospective, longitudinal sub-study of study 1 participants within 5 years of diagnosis. Beta cell function will be assessed using glucagon stimulated C-peptide at 0, 9 and 18 months. The primary outcome of study 1 is to determine the phenotype of immune cells in autoantibody positive and negative T1D compared to healthy controls. Secondary outcomes of study 1 include clinical and metabolic characteristics and the T1DGRS. The primary outcome of study 2 is the rate of decline of stimulated C-peptide over time. Conclusions: The PANDA study is the first study of its kind which aims to improve diagnosis and characterisation of autoantibody negative T1D.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"55 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80404643","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}

引用次数: 0

An exploratory, randomised, crossover study to investigate the effect of a nicotine containing electronic cigarette on appetite in healthy adult smokers, after a period of smoking abstinence: study protocol 一项探索性、随机、交叉研究，旨在调查含尼古丁电子烟对健康成年吸烟者在戒烟一段时间后食欲的影响:研究方案

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222692

O. O’Shea, H. Green, Helen L. Philpott, Nik Newland

{"title":"An exploratory, randomised, crossover study to investigate the effect of a nicotine containing electronic cigarette on appetite in healthy adult smokers, after a period of smoking abstinence: study protocol","authors":"O. O’Shea, H. Green, Helen L. Philpott, Nik Newland","doi":"10.18203/2349-3259.ijct20222692","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222692","url":null,"abstract":"Background: Many individuals continue to smoke despite the known harmful effects of cigarette smoking. Tobacco harm reduction (THR) is a public health strategy that seeks to reduce or prevent projected harm caused by cigarette smoke via encouraging smokers, who would otherwise continue to smoke, to switch to products with reduced risk profiles (such as e‑cigarettes). Research shows smoking can influence numerous physiological and psychological functions such as appetite, cognitive function and emotion. For some smokers, the loss of such effects upon cessation has been cited as an incentive to resume smoking. The effect of e‑cigarettes (and other non-combustible alternatives to cigarette smoking) on the above-described physiological and psychological functions has not been widely researched. Such information may be important for more thoroughly evaluating the proposition that smokers seeking alternatives may find e-cigarettes a satisfactory substitute for conventional cigarettes.Methods: This randomised, partially blinded, crossover study will test the hypothesis that use of a nicotine containing e-cigarette can influence appetite to the same extent as a combustible cigarette following a period of nicotine abstinence in current smokers. Up to 40 current smokers will be recruited into the study. Enrolment started in February 2021 and the results from the study are expected in 2022.Conclusions: The data from this study will be a valuable addition to the growing body of literature about the potential of e-cigarettes as a satisfactory and viable long-term alternative to cigarettes for existing smokers.Trial Registration: This study is registered with the ISRCTN registry, number ISRCTN72435551.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"2013 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86386639","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}

引用次数: 0

The effect of hydrotherapy according to Halliwick concept on children with cerebral palsy and the evaluation of their balance: a randomised clinical trial 哈里威克水疗法对脑瘫患儿的疗效及平衡性评价:一项随机临床试验

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222656

Konstantinos Chandolias, Evangelia Zarra, A. Chalkia, A. Hristara

{"title":"The effect of hydrotherapy according to Halliwick concept on children with cerebral palsy and the evaluation of their balance: a randomised clinical trial","authors":"Konstantinos Chandolias, Evangelia Zarra, A. Chalkia, A. Hristara","doi":"10.18203/2349-3259.ijct20222656","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222656","url":null,"abstract":"Background: Hydrotherapy according to Halliwick concept is a physiotherapeutic intervention technique for disabled patients and for children with neurodevelopmental disorders. Assessing the balance in children with cerebral palsy (CP) is an extremely complex process and more difficult to evaluate the results of some therapeutic interventions in these patients. The purpose of this study is to investigate the effect of Halliwick based Hydrotherapy on the support base in children with CP. Several studies have proven the beneficial effects of hydrotherapy in the respiratory system of children, but few are studies that report the effect on the balance of children with CP.Methods: The study involved 16 children diagnosed with CP. The 10 children were following a Halliwick Concept hydrotherapy program and the 6 children classical physiotherapy program for 3 months. Their balance was assessed with the Berg, GMFM, and footprint plate. The assessment was performed at the start of the program (pre-test) and after 3 months (post-test).Results: Τhere is a statistically significant change between the 1st and 2nd measurement with the BERG and GMFM tools and better for the water intervention group. The change in the support base between the 1st and 2nd measurement was better in the water intervention group but not statistically significant.Conclusions: The results of the study showed that hydrotherapy according to Halliwick has positive effects on gross mobility and the balance of children with CP. It also appears to have a positive effect on changing the support base compared to classical physiotherapy.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82793674","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}

引用次数: 1

The stigma of mental health, homelessness and intellectual disability, development of a national stigma survey with an intersectional gender perspective 心理健康、无家可归和智力残疾的耻辱，开展一项具有交叉性别观点的国家耻辱调查

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222689

Sara Zamorano, C. González-Sanguino, Iván Sánchez-Iglesias, J. Sáiz, María Salazar, C. Vaquero, Ana I. Guillén, Irene Muñoz-Lara, M. Muñoz

{"title":"The stigma of mental health, homelessness and intellectual disability, development of a national stigma survey with an intersectional gender perspective","authors":"Sara Zamorano, C. González-Sanguino, Iván Sánchez-Iglesias, J. Sáiz, María Salazar, C. Vaquero, Ana I. Guillén, Irene Muñoz-Lara, M. Muñoz","doi":"10.18203/2349-3259.ijct20222689","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222689","url":null,"abstract":"Background: Social stigma towards people with mental health problems, homeless people or people with intellectual disabilities leads to a significant restriction of their human rights. Such stigma, which is associated with different conditions of vulnerability, has been assessed over time through surveys. However, intersectional stigma due to gender is often not assessed in these studies as they only analyse the data for this variable separately. Therefore, presented here is the first national survey in Spain on the social stigma associated with mental health problems, homelessness and intellectual disability. This proposal considers the importance of gender and intersectional stigma.Methods: A qualitative-quantitative methodology is used by means of a computer assisted web interviewing survey. A gender perspective is proposed both in the development of the questions and in the measurement and analysis of the data. To this end, three versions of the questionnaire are developed: a neutral, a male and a female version.Conclusions: The results are intended to have an impact on social and equality policies for people with mental disorders, homeless people and people with intellectual disabilities.Trial Registration: The study has the approval of the deontological commission of the faculty of psychology and is registered in clinical trials.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82076716","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}

引用次数: 1

The effectiveness of a specialized hydrotherapy program based on Halliwick concept in the transition from supine to sitting of children with cerebral palsy: a randomised control trial 基于哈利威克概念的特殊水疗方案在脑瘫儿童从仰卧到坐的转变中的有效性:一项随机对照试验

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222657

Konstantinos Chandolias, Chrysoula Moscolouri, Paris Iakovidis, A. Hristara-Papadopoulou, Ilias Kallistratos

{"title":"The effectiveness of a specialized hydrotherapy program based on Halliwick concept in the transition from supine to sitting of children with cerebral palsy: a randomised control trial","authors":"Konstantinos Chandolias, Chrysoula Moscolouri, Paris Iakovidis, A. Hristara-Papadopoulou, Ilias Kallistratos","doi":"10.18203/2349-3259.ijct20222657","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222657","url":null,"abstract":"Background: Halliwick concept focus on people with disabilities, to participate in water activities and move independently. Many studies found a considerable improvement and positive outcomes in children that were included in hydrotherapy programs. The aim of this study was to investigate the Halliwick hydrotherapy in combination with on-land intervention, versus only on-land treatment, on the supine-sitting transition and head symmetry.Methods: 54 children with cerebral palsy (CP), two groups, the intervention group-water (N=28) (1 water and 1 on land treatment) and the control group-on land (N=26) (2 treatments on land). The duration was 3 months and the assessment via gross motor function measure (GMFM), parameter B, questions 18-37, and head angle via the Kinovea software.Results: In GMFM before intervention the mean value of the intervention group was 69.632 (±13.1269), while for the control group was 61.227 (±20.4681) and after for intervention group was 75.757 (±12.3766), 6.125% improvement, while for control group was 65.308 (±20.6663), 4.081% improvement. In the sitting head angle before intervention, the mean value of intervention group was 19.36 (±9.639) while for the control group was 20.15 (± 11.199) and after for the intervention group was 13.93 (±7.333), 5.43o improvement, while for control group was 16.46 (±9.205), 3.69o improvement.Conclusions: The addition of intervention in water in combination with intervention on land in the rehabilitation program of children with cerebral palsy can lead to a statistically significant increase in the effectiveness of the therapeutic program.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"47 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80122750","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}

引用次数: 0

Effect of addition of antispasmodic to local and systemic analgesics on pain perception during hysterosalpingography: a randomized controlled trial 局部和全身镇痛药加用抗痉挛药对子宫输卵管造影时疼痛感知的影响:一项随机对照试验

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222687

E. Kiridi, P. Oriji, A. Ubom, J. Ugwoegbu, Addah Abegnigo Ojanerohan, I. Abasi, Bosrotsi Panebi, Adesina Adedotun Daniel

{"title":"Effect of addition of antispasmodic to local and systemic analgesics on pain perception during hysterosalpingography: a randomized controlled trial","authors":"E. Kiridi, P. Oriji, A. Ubom, J. Ugwoegbu, Addah Abegnigo Ojanerohan, I. Abasi, Bosrotsi Panebi, Adesina Adedotun Daniel","doi":"10.18203/2349-3259.ijct20222687","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222687","url":null,"abstract":"Background: Tubal factor is responsible for most of the causes of infertility, especially in our environment, and hysterosalpingography (HSG) is the investigation of choice for assessing tubal patency. Objective of current study was to evaluate the effect of the addition of intramuscular hyoscine-N-butyl bromide (HBB) to local and systemic analgesics on pain perception during hysterosalpingography.Methods: This randomized controlled trial was conducted at the radiology departments and infertility clinics of four health institutions in Bayelsa State, Nigeria, from January 2020 to April 2022. One thousand and forty infertile women undergoing hysterosalpingography were randomized into four groups, and each group administered four different pain relief methods. Pain scores at different steps of the procedure were recorded. Data were analysed using the Statistical Product and Service Solutions for Windows®, version 25. Student’s t-test was used to compare sample means, while the chi-square test was used to compare the proportion of women in the two study groups, who expressed pain during the procedure.Results: The Paracervical block+HBB appeared to the most effective agent for pain relief in the study as women receiving this medication indicated the least pain intensity scores at all levels of the procedure except at the insertion of the speculum. The differences observed in the indicated pain intensity scores were also statistically significant (p<0.05).Conclusions: Our study revealed that adding HBB, an antispasmodic agent, to diclofenac and paracervical block significantly reduces pain perception during HSG compared to using diclofenac and paracervical block alone.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79373055","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}

引用次数: 0

Technology and its interventional value in patient-reported outcomes in cancer research, what is next? 技术及其对癌症研究中患者报告结果的介入价值，下一步是什么?

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222693

Luis Mendoza

引用次数: 0

Predicting antipsychotic-induced weight gain in first episode psychosis-a protocol for a field-wide systematic review of prognostic factor studies 预测首发精神病患者抗精神病药物引起的体重增加——一项对预后因素研究的全领域系统回顾的方案

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222691

Ita Fitzgerald, Erin K. Crowley, Amy Byrne, J. O’Connell, J. Ensor, Ciara Ní Dhubhlaing, S. O’Dwyer, L. Sahm

{"title":"Predicting antipsychotic-induced weight gain in first episode psychosis-a protocol for a field-wide systematic review of prognostic factor studies","authors":"Ita Fitzgerald, Erin K. Crowley, Amy Byrne, J. O’Connell, J. Ensor, Ciara Ní Dhubhlaing, S. O’Dwyer, L. Sahm","doi":"10.18203/2349-3259.ijct20222691","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222691","url":null,"abstract":"Background: One significant complexity associated with management of antipsychotic-induced weight gain (AIWG) is extensive interindividual variability amongst patients in initial susceptibility to AIWG, time to plateau of weight gain, and resultant final amount of weight gained. Prior to antipsychotic commencement, risk-stratified information highlighting those at increased risk of experiencing significant AIWG would allow tailored weight monitoring and subsequent management protocols to be developed.Methods: This protocol is for a planned systematic review to identify the current utility of baseline clinical, sociodemographic, and biological prognostic factors in predicting the likelihood of significant AIWG occurring prior to antipsychotic commencement. The cohort assessed will be antipsychotic-naïve adults with a first episode of psychosis. Searches for both randomised and prospective non-randomised studies will be undertaken by searching four electronic databases and two trial registers, followed by reference searching, forward citation searching and liaison with content experts. A meta-analysis of study results will be undertaken where study quality and homogeneity allow. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework modified for prognostic research will be used to assess evidence certainty. This protocol was prepared in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Protocols guideline and latest guidance from the Prognosis Methods Group of the Cochrane Collaboration.Results: This review will establish the current quantity, quality and clinical utility of evidence addressing the prognostic association of clinical, biological, and sociodemographic factors in prospectively identifying those more likely to experience significant AIWG.Registration details: PROSPERO registration number CRD42021258148.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"64 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87001228","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}

引用次数: 1