Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Clinical Study Design,Analysis,and Presentation,Yiqing Song,MD,ScD,Harvard Medical School,Boston,MA,USA,July,2009,临床研究设计分析和文章写作,宋一青,Clinical Study Design,Analysi,1,Study Design(,科研设计,),Why,（为什么要做科研？）,临床体会，经验是否正确；兴趣；等等。,What,（做什么,?,）,内容包括完整提出自己的假说，新理论、新方法或新模型？或者只是来验证别人的,How,（怎么做？,),方法的科学性和严格性,Study Design(科研设计)Why（为什么要做科,2,Overview,Clinical Study(definition):(,定义）,Clinical Study Purpose(,临床研究主要目的）,Etiology(,病因学）,Prediction,（疾病预测）,Treatment,（疾病治疗）,Study Direction,（侧重方向）,Genetics,（基因研究）,Biomarkers,（生物标记物）,Nutrition,（营养）,Pharmacological agents or surgery,（药物或外科手术）,Psychosocial factors,（社会心理学）,(,等等）,OverviewClinical Study(defini,3,Key issues in study Design(,研究设计的关键）,Knowledgement in your field,（本学科知识）,Literature search,（文献追踪）,Key issues in study Design(研,4,Fundamental Study Design(,基本研究设计类型）,Observational Study (,观察性临床研究）,Ecological Studies (,生态性研究）,Case report,（病例报告）,Cross-sectional Study,（横断面研究）,Case-Control Study,（病例对照研究）,Prospective Cohort Study(,前瞻性定群研究）,Retrospective Cohort Study(,回顾性定群研究）,Intervention Trial,（临床干预试验）,Open Trial,（开放性研究）,Randomized Trial,（随机干预试验）,Randomized double-blind Trial,（随机双盲干预试验）,Randomized single-blind Trial,（随机单盲干预试验）,Evidence-based Study,（循证医学研究）,Systemic Review,（系统性文献综述）,Meta-analysis(,荟萃分析）,Fundamental Study Design(基本研究,5,Any clinical study published in the Medical Journals,Study Design?,Study population?,Studies hypothesis or questions of testing?,.Title Abstract Introduction,How to read the literature,(,如何有效地阅读文献）,Main Analysis methods,Results?,研究问题？,研究类型？,研究人群？,主要分析方法？,研究结果？,Any clinical study published i,6,大气污染与糖尿病发生率的关系,出生体重与成人,II,型糖尿病的关系,糖尿病人合并,HIV,感染的特征分析,Examples,(,实例分析）,Case report or case-control study,Ecological study,Cohort study or Case-control study,空腹血糖水平与发生肿瘤的关系,Cohort study,；,case-control study,胰岛素治疗对糖尿病合并症的效果,Randomized trial,；,cohort study,？,新降糖药的疗效,Randomized trial,基因多态性与糖尿病的关系,Case-control study;cohort study;cross-sectional study,新检测方法对糖尿病预测的改善,Cohort study,血中几种检测标记物的相关性,Cross-sectional study,大气污染与糖尿病发生率的关系出生体重与成人II型糖尿病的关系,7,Summary,（总结）,Study Population,（,研究人群的建立最为关键,）,Representative,（代表性）,Sample Size,（数量）,Study Design,（研究设计类型）,Prospective,（前瞻性最优，其次，病例对照或横断面）,Longitudinal,（续贯性）,Data Collection(,数据收集齐备）,Basic characteristics(demographic,geographic,anthropometric,and lifestyle or psychosocial factors),Biological sample collection(blood,toenail,hair,and urine).,Accurate outcome ascertainment,(,疾病诊断准确）,Study Group,（研究团队）,Different Research Areas,（不同侧重点）,Multidisciplinary collaboration,（多学科协作）,Keep track of the latest information(,跟踪最新文献）,Summary（总结）Study Population,8,Study Population,Total population living in a specific area,(,一个范围明确的地区的全体或其样本）,High risk population,（高危人群）,Special populations,（特殊人群）：,e.g.Health Professionals,volunteers.,Study PopulationTotal populati,9,临床资料充分,人群特殊,横断面研究但是人群代表性,传统方法,阳性结果,临床资料充分人群特殊横断面研究但是人群代表性传统方法阳性结果,10,临床资料充分,人群特殊,同一人群,传统方法,阳性结果,临床资料充分人群特殊同一人群传统方法阳性结果,11,Common variants in KCNQ1 are associated with type 2 diabetes and impaired fasting glucose in a Chinese Han population.,Hum Mol Genet.2009,Plasma 25-hydroxyvitamin D concentration and metabolic syndrome among middle-aged and elderly Chinese individuals.,Diabetes Care.2009 Jul;32(7):1278-83.,RBP4 variants are significantly associated with plasma RBP4 levels and hypertriglyceridemia risk in Chinese Hans.,J Lipid Res.2009 Jul;50(7):1479-86.,Association of GCKR rs780094,alone or in combination with GCK rs1799884,with type 2 diabetes and related traits in a Han Chinese population.,Diabetologia.2009 May;52(5):834-43.,Associations of inflammatory factors with glycaemic status among middle-aged and older Chinese people.,Clin Endocrinol(Oxf).2009 Jun;70(6):854-62.Epub 2008 Sep 2.,Associations of resistin with inflammatory and fibrinolytic markers,insulin resistance,and metabolic syndrome in middle-aged and older Chinese.,Eur J Endocrinol.2008 Nov;159(5):585-93.,Common variants in CDKAL1,CDKN2A/B,IGF2BP2,SLC30A8,and HHEX/IDE genes are associated with type 2 diabetes and impaired fasting glucose in a Chinese Han population.,Diabetes.2008 Oct;57(10):2834-42.,Variants in the fat mass-and obesity-associated(FTO)gene are not associated with obesity in a Chinese Han population.,Diabetes.2008 Jan;57(1):264-8.,Elevated retinol-binding protein 4 levels are associated with metabolic syndrome in Chinese people.,J Clin Endocrinol Metab.2007 Dec;92(12):4827-34.,Common variants in KCNQ1 are a,12,Common Disease,（常见病的研究）,在有代表性的人群中从横断面研究做起，,样本要大，基线数据要齐备，生物样本注意正确采取和妥善长期保存,可包括前期疾病状态,资金及其它条件允许下，加入队列定群研究，或加做随机试验,Rare Disease,（临床少见病的研究）,建议做病例对照研究,注意对照组病人的正确选择,3.,数据收集要齐备，注意保存生物样本,Common Disease 在有代表性的人群中从横断面研究,13,小型病例对照研究,小型病例对照研究,14,ALS,（肌萎缩性脊髓侧索硬化症）,合适病例对照研究,ALS（肌萎缩性脊髓侧索硬化症）合适病例对照研究,15,Randomized Clinical Trial Design(,随机临床试验设计）,Study population,（研究人群）,Randomization,（随机化）,Blind method,（盲法）,Placebo,（安慰剂使用）,Dosage,（治疗剂量）,Sample size and power calculation,（样本量计算）,Duration,（治疗时间）,Compliance,（随访性）