文獻(xiàn)有效性分析

1、醫(yī)學(xué)文獻(xiàn)的有效應(yīng)用醫(yī)學(xué)文獻(xiàn)的有效應(yīng)用 Prepare students to make independent, balanced clinical decisions that contribute to optimal patient outcomes.Clinical Reasoning 的縱向目標(biāo):Clinical Reasoning 的縱向目標(biāo)By end of Year 2, students should be able to: Understand patient-centered outcomes and shared medical decision-making Syst

2、ematically analyze any clinical problem Make independent judgments on tests and treatments, based on published evidence Habitually seek and apply new knowledge from reliable sourcesCore Competencies Heath Professions Education: A Bridge to Quality Institute of Medicine 2003Provide patient-centered c

3、are Work in interdisciplinary teamsEmploy evidence-based practiceApply quality improvementUtilize informatics AAMC-HHMI 2009 Competency M8 Apply quantitative knowledge and reasoningincluding integration of data, modeling, computation, and analysisand informatics tools to diagnostic and therapeutic c

4、linical decision making.本次課的目標(biāo)本次課的目標(biāo)理解從文獻(xiàn)樣例中獲得的兩個(gè)關(guān)鍵概念：理解從文獻(xiàn)樣例中獲得的兩個(gè)關(guān)鍵概念：關(guān)注結(jié)果從病人角度考慮醫(yī)學(xué), （6 “requests” ） 理解醫(yī)學(xué)文獻(xiàn)及其有效性的評價(jià)標(biāo)準(zhǔn)理解醫(yī)學(xué)文獻(xiàn)及其有效性的評價(jià)標(biāo)準(zhǔn) What is it? Whats in it? Who creates it, how and why? What is clinical “evidence”? What are the criteria for validity of medical literature? Where to find the medic

5、al literature. Matching information sources to question types: what should an MS1 read? What are the best sources for PBL? PBL Learning issue sourcing matrix: how to use it醫(yī)學(xué)結(jié)果醫(yī)學(xué)結(jié)果 廣義定義廣義定義：results that matter to someone Patient-centered, clinical, satisfaction, cost, safety Individual and populatio

6、n outcomes 著眼于結(jié)果的各種器官系統(tǒng)及其相關(guān)狀況的方法。著眼于結(jié)果的各種器官系統(tǒng)及其相關(guān)狀況的方法。 “Input” focus: “How are iron chelating（螯合）agents used to treat complications of thalassemia(地中海貧血 ) ?” Outcome focus: “What outcomes do patients with thalassemia experience under different treatment approaches?”病人參照框病人參照框Dont kill me Do help me

7、Dont hurt meDont make me feel helplessDont keep me waitingDont waste resources, mine or anyone elsesProfessionalismOur duty to patientsKnow what to doDo what is knownUnderstand what is doneProvide ALL and ONLY the care patients needKnow what to do:3 sources of medical knowledge What we hear What we

8、see What we readThe Medical Literature: what is it?Definition: Experts systematically recorded observations relating to human illness and how to relieve it, published in generally accessible locations and forms Media: journals, books, web sites, audio, video Range: from single case reports to system

9、atic syntheses of large trials VERY LARGE!The Medical Literature: What kinds do clinicians use? 作為臨床醫(yī)生, 我們是 “信息不偏食者” We “consume” all different types of published information that help us care for patients But: we prefer some types to others, when available e.g., we prefer large clinical trials to c

10、ase series to guide choice of therapyWhat kinds of information does the medical literature contain? 用三條用三條“軸軸”簡單分類簡單分類 Biology (mechanism) vs. Outcomes Primary vs. Secondary Observational vs. Experimental Major clinical knowledge “Domains”: Biological knowledge: normal human biology and disease mech

11、anisms Outcomes knowledge: how tests and treatments perform in real patients Both types necessary, and complementary Major trend: clinicians increasingly favor outcomes information (when available) as a basis for specific clinical decisions But clinicians must judge outcome data in context of known

12、biology Based on the title, is this study an example of Outcomes or Biological clinical knowledge?Tropak MB, et al. Pharmacological enhancement of beta-hexosaminidase （已糖胺酶）activity in fibroblasts（纖維原細(xì)胞） from adult Tay-Sachs and Sandhoff Patients . J Biol Chem. 2004 Apr 2;279(14):13478-87The Medical

13、 Literature: Two main article types Primary studies: initial, first-hand report of observations from a (new) data set examples: case series, clinical trial Secondary literature: summaries or syntheses of primary studies examples: review article, textbook chapterBased on the title, is this study an e

14、xample of primary or secondary literature?Khoury MJ, McCabe LL, McCabe ER. Population screening in the age of genomic medicine. N Engl J Med. 2003 Jan 2;348(1):50-8 The Outcomes Literature: Two main classes of study designObservational: examples: case series, case control, cohortExperimental: exampl

15、es: Clinical Trials, RCTs Each has advantages and weaknesses General preference for experimental designs to answer clinical questionsWhat is “Clinical Evidence”? Inclusive definition: All systematically collected knowledge relating to illness and its treatment “Evidence-based” medicine: care that re

16、flects a good-faith effort to tie clinical decisions to current knowledge EBM: a method, and a movementClinical Evidence:Orthodox definition Clinical evidence comes from patient- centered clinical research which investigates the accuracy and precision of diagnostic tests, the efficacy and safety of

17、therapeutic regimes, and the reliability of prognostic indicators. DL Sackett, Evidence-based Medicine. How to Practice & Teach EBM, 2000 “Evidence alone is never enough” Evidence-based Medicine (EBM) combines individual clinical expertise with the best available clinical evidence from systematic re

18、search in making decisions about the care of individual patients. Clinical expertise is the proficiency and judgment that individual clinicians acquire through knowledge, clinical experience, and practice.DL Sackett, Evidence-based Medicine. How to Practice & Teach EBM, 2000Obtain current best evidence -文獻(xiàn)有效性分析文獻(xiàn)有效性分析臨床證據(jù)的質(zhì)量分級臨床證據(jù)的質(zhì)量分級 是指各種可以導(dǎo)致研究結(jié)果失真的系統(tǒng)性誤差。是指各種可以導(dǎo)致研究結(jié)果失真的系統(tǒng)性誤差。選擇偏倚（選擇偏倚（Selection bias)志愿者偏倚（志愿者偏倚（Volunteer bias）,也稱無應(yīng)答偏倚（也稱無應(yīng)答偏倚（Non-respondent bias）檢出偏