流行病學(xué)試驗(yàn)ppt課件(編輯修改稿)
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【文章內(nèi)容簡介】 ers) of 24 or higher (22 or higher in Asians), and a plasma glucose concentration of 95 to 125 mg per deciliter ( to mmol per liter) in the fasting state (lessthan/equal) 125 mg per deciliter in the American Indian clinics) and 140 to 199 mg per deciliter ( to mmol per liter) two hours after a 75g oral glucose load. ? NEJM 2021 346(6): 393403 44 Participants 參與者的選取 ? Exclusion criteria (排除標(biāo)準(zhǔn) ) ? Subsets of people meeting inclusion criteria (potentially suitable for research question) except for characteristics that might interfere with quality of data etc. (排除對(duì)研究有干擾或不適于參加者 ) ? High likelihood of being lost to followup (容易流失 ) ? ., transients ? Inability to provide good data (不能提供好資料 ) ? ., language barrier or cognitive incapacitation ? High risk for side effects (對(duì)副作用敏感 ) ? ., pregnant, lactating ? Uhical to withhold study treatment (倫理上不宜 ) ? ., severe depression 45 Exclusion Criteriaexample ? Eligible persons were excluded if they were taking medicines known to alter glucose tolerance or if they had illnesses that could seriously reduce their life expectancy or their ability to participate in the trial. 46 Informed Consent ? To make informed decisions, patients need to hear and understand specific information about the research. 47 2. Informed Consent： 知情同意保護(hù)參與者 A Part of Human Subject Protection Objectives of Informed Consent 目的 To Ensure: ?Voluntariness 自愿 ?Comprehension 理解 ?Information 知情 To Demonstrate That: ?Person freely gave consent to participate 未壓逼下同意 ?Consent given by a petent person 有決定權(quán)者同意 ?Person has been given all information 充分知情 ?Person knows this is research – not treatment 知道是研究不是治療 48 Informed Consent ? Purpose ? Medicine to be studied ? Procedures and schedule ? Risks ? Potential benefits ? Alternatives to participation ? Confidentiality 49 6. Baseline data collection ? Need enough information to track subjects 聯(lián)絡(luò)信息 ? Contact persons。 Alberta Health Registry (to track deaths, moves from province, etc.) ? Description of participants (社會(huì)人口學(xué)特征 ) ? Aid in assessing generalizability (., gender, age, disease severity, etc.) ? Risk factors for oute or to define subgroups 危險(xiǎn)因素 ? ., smoking status, smoking status of spouse ? Measure of “oute” variable 結(jié)局變量指標(biāo) ? ., if pain is “oute”, need baseline pain 50 6. Baseline data collection 基線資料的用途 ? 描述研究對(duì)象特征，用于結(jié)果外推性的判斷 ? 判斷處理組間的可比性 ? 在組間可比性差時(shí)，用于控制混雜因素 ? 用于亞組分析或交互作用分析 51 7. Randomization Note ? Usually, sampling is not random ? Group Assignment is random 52 Randomization A A A A B B B B B Investigational Group Control Group 53 簡單隨機(jī)化法 (simple randomization) 區(qū)組隨機(jī)法 （ blocked randomization) 分層隨機(jī)法 (stratified randomization) 整群隨機(jī)法 (cluster randomization) 隨機(jī)化分組方法 54 The aims of randomization 目的 ? To get a unbiased parison of treatments 得到無偏倚的比較 ? To avoid any systematic difference in treatment groups 避免組間的系統(tǒng)誤差 Two key principles: 關(guān)鍵原則 ? Each patient has an equal chance of each treatment option 分組機(jī)會(huì)同等 ? Neither patient nor investigator can predict in advance which treatment they’ll get 受試者與研究者均不能預(yù)計(jì)將受到哪種干預(yù) 55 Advantages of Randomization 隨機(jī)分組的好處 Bradford Hill: 1. Eliminates bias from treatment assignment (排除人為分組所致的偏倚 ) 2. Balances known and unknown differences between groups on average (平衡組間已知及未知的差異 ) 3. More credible study 更加可信 RA Fisher: Assures validity of statistical tests 確保統(tǒng)計(jì)的有效性 56 Simple Randomization 簡單隨機(jī) The number and order of patients receiving treatments A and B is determined by chance. Example: Equal allocation ? Toss a coin(拋硬幣 ): A = head, B = tails (正反 ) ? Random number table: (隨機(jī)數(shù)字，奇數(shù)、偶數(shù) ) A = odd, B = even (Pocock, page 74) ? Uniform random number generator: (隨機(jī)數(shù)字大于或小于 ) A if B if 57 Timing of Randomization Usual Sequence of Events 什么時(shí)候隨機(jī)分組 1. Verify eligibility, informed consent, and pleteness of baseline data. 2. Complete patient accession log. 3. Obtain assignment. 4. Record assignment on log and data forms. 5. Initiate treatment as soon as possible after randomization. 58 問 題 ?隨機(jī)分組能消除哪些偏倚 ? 59 8. Blinding ? Randomization ? Controls for confounding bias at baseline ? Does not contro
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