实证医学之严格评读CriticalAppraisal
社会医学知识要点归纳

《社会医学》知识要点归纳【名词解释】1.社会医学(social medicine)是从社会的角度研究医学和健康问题的一门交叉学科。
它研究社会因素(social factor)与个体及群体健康和疾病之间相互作用就及其规律,制定相应的社会策略和措施,保护和增进个人及人群的身形健康和社会活动能力,提高生命质量,充分发挥健康的社会功能,提高人群的健康水平。
2.1848年,法国盖林第一次提出社会医学概念;德国格罗蒂扬提出整套理论和概念,并于1920年在柏林大学首次开设社会卫生学讲座。
3.医学模式(medical model)是人类与疾病抗争和认识自身生命过程的实践中得出的对健康观和疾病观等重要医学概念的本质概括。
4.亚健康状态是指人的机体虽然无明显的疾病,但呈现出活力降低,适应力呈现不同程度减退的一种生理状态,是由机体各系统的生理功能和代谢过程低下所致,是介于健康与疾病之间的一种生理功能降低的状态,亦称“第三状态”或“灰色状态”。
5.亚临床疾病是指没有临床症状、体征,但存在生理性代偿或病理性改变的临床检测证据,如无症状性缺血性心脏病患者可以无临床症状,但有心电图改变等诊断依据。
6.健康社会决定因素(social determinants of health,SDH)在那些直接导致疾病的因素之外,由人们的社会地位和所拥有的资源所决定的生活和工作环境及其他对健康产生影响的因素。
7.1978年9月,世卫组织和联合国儿童基金会在阿拉木图召开国际初级卫生保健会议,发布《阿拉木图宣言》,宣布2000年人人享有卫生保健的目标。
8.1986年11月,加拿大渥太华召开第一届国际健康促进大会,公布了《渥太华宪章》,列出8个健康的关键决定因素:安全、社会保障、教育、食品安全、收入、生态环境、可持续的资源、社会公正。
9.2000年9月,联合国大会提出“千年发展目标(millennium development goals,MDGs)”,与3个健康直接相关社会决定因素:降低儿童死亡率、改善孕产妇健康和对抗艾滋病、疟疾及其他疾病;5个健康间接相关社会决定因素:消除贫困和饥饿、普及初等教育、性别平等和提高妇女权益、保护环境资源可持续发展和建立全球发展的合作关系。
基于CRITIC法的医疗工作质量综合评价

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表1 2 0 0 6~2 0 1 1年医院 7项主要 医疗指标完成 情况
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从本研究 中可 以看 出 D M 合并心脑 血管 即大血 管并发症的患者 , 其猝死的机率要远高于合并其他死 亡 因素 。所 以对于 2型 D M 患者来说控制及预防大血
方法 , 选取 7项医疗工作指标 , 对某医院 2 0 0 6— 2 0 1 1 年 的医疗工作质量进行综 合评价 。结 果 评价结果 与医 院实 际情况 相符 , 评价指标 中出院人数 的权 重最大 , 2 0 1 1 年的 医疗工作质量最好 。结论 C R I T I C法在 医疗 工作 质量 综合评价 中具有 较好 的应用 价值。 【 关键词 】 C R I T I C法
将评价指标中的正指标门诊人次 、 出院人数 、 病床 使用率 、 病床周转次数 、 治愈好转率及住 院危重病人抢 救成功率 , 逆指标出院者平均住 院 日分别利用公式进
循证医学五步骤

Clinical Question (PICO)
MEDLINE
Disa JJ. Polvora VP. Pusic AL. Singh B. Cordeiro PG. Dextranrelated complications in head and neck microsurgery: do the benefits outweigh the risks? A prospective randomized analysis. [Clinical Trial. Journal Article. Randomized Controlled Trial] Plastic & Reconstructive Surgery. 112(6):1534-9, 2003 Nov.
循证医学五步骤
提出问题 (Question formulation)
搜寻证据 (Evidence search) 严格判读 (Critical appraisal) 恰当运用 (Evidence application) 评估结果 (Outcome evaluation)
Search terms & Strategy
(Disa JJ, Polvora VP, Pusic AL, Singh B, Cordeiro PG. Dextran-related complications in head and neck microsurgery: do the benefits outweigh the risks? A prospective randomized analysis. Plast Reconstr Surg. 2003 Nov;112(6):1534-9.)
critical review范文

IntroductionIn Man’s Search for Meaning, Viktor E. Frankl tells the very per sonal story of his experience as a prisoner in a concentration camp during the Holocaust. He presents this story in the form of an ess ay in which he shares his arguments and analysis as a doctor and psychologist as well as a former prisoner. This paper will review Fra nkl’s story as well as his main arguments, and will evaluate the qu ality of Frankl’s writing and focus on any areas of weakness within the story.SummaryThis section contains a summary of Man's Search. Frankl begins his book by stating that his purpose in writing the book is not to present facts and details of the Holocaust, but to provide a persona l account of the everyday life of a prisoner living in a concentration camp. He states, “This tale is not concerned with the great horror s, which have already been described often enough (though less oft en believed), but…it will try to answer this question: How was ever yday life in a concentration camp reflected in the mind of the aver age prisoner?”(21). Frankl then goes on to describe the three stag es of a prisoner’s psychological reactions to being held captive in a concentration camp.The first phase, which occurs just after the prisoner is admitted to the camp, is shock. The second phase, occurring once the priso ner has fallen into a routine within the camp, is one of apathy, or “the blunting of the emotions and the feeling that one could not anymore”(42). The third phase, which occurs after the prisoner ha s been liberated from the camp, is a period of “depersonalization”, in which “everything appears unreal, unlikely, as in a dream”(11 0). In this phase, released prisoners also feel a sense of “bitterness and disillusionment”when returning to their former lives (113). Fr ankl describes each of these phases using psychological theory and provides personal experiences to exemplify each of the stages.Author’s ArgumentsAs described above, Frankl’s main purpose for writing this book is to pr esent and analyze the average prisoner’s psychological reactions to the every day life of a concentration camp. His three main arguments are his presentat ion and analysis of each of the psychological stages that the average concent ration camp prisoner experiences: shock, apathy and depersonalization. He b ases his analyses of each of these stages on the actions of the prisoners and his own personal thoughts and reactions as he experienced life in a concent ration camp.For example, Frankl argues that the second phase of apathy forces “the prisoner’s life down to a primitive level”(47) in which “all efforts and all e motions were centered on one task: preserving one’s own life and that of t he other fellow”(47). He bases this theory on events he witnessed while livi ng in the camp himself, and states, “It was natural that the desire for food was the major primitive instinct around which mental life centered. Let us ob serve the majority of prisoners when they happened to work near each other and were, for once, not closely watched. They would immediately start discu ssing food”(48). Frankl continuously uses examples from his experiences in t he concentration camp to illustrate and strengthen his psychological argumen ts throughout the text.EvaluationThis section contains an evaluation of Frankl’s book. Firstly, the author i s a survivor of the Holocaust and was a prisoner of a concentration camp hi mself, which gives him the personal insight to be able to comment on the ps ychological conditions of an average prisoner. However, this also creates a bi as and because of his personal experience, he is unable to be entirely objecti ve in writing his analysis. Frankl acknowledges this bias in the beginning of his book, by stating, “Only the man inside knows. His judgments may not b e objective, his evaluations may be out of proportion. This is inevitable. An attempt must be made to avoid any personal bias, and that is the real difficu lty of a book of this kind”(24-25). Although he is aware of this bias, it crea tes a partiality that will sway the readers throughout his story and it serves a s a minor weakness in his writing style.A second weakness in Frankl’s writing is in the assumptions he sometim es makes to prove his point. He makes overarching generalizations several ti mes in his book, making statements that, although may have been true for hi mself and those around him, might not have been true for every prisoner in every concentration camp during the Holocaust. For example, in one instance, he says, “The prisoner of Auschwitz , in the first phase of shock, did not fear death”(37). It is very bold to say that no prisoner of Auschwitz, one of t he most well-known and deadly concentration camps of the Holocaust, did n ot fear death, as death was all around them and was a very real threat in th eir daily lives. Although he might have not feared death during his phase of shock, it is impossible for him to guarantee that no prisoner was at all fearf ul of death in this first psychological phase, and for him to make overarching assumptions like this is a weakness to the overall quality of his book.Finally, Frankl sometimes becomes too technical and verbose in his writin g style, which makes it very hard for the average reader to understand. One example of this is as follows. Frankl states, “I remember an incident when t here was an occasion for psychotherapeutic work on the inmates of a whole hut, due to an intensification of their receptiveness because of a certain exter nal situation”(102). This sentence, which is overly wordy and complicated, m akes it difficult for the average reader to understand exactly what he is sayin g. A reader can easily get frustrated when trying to decipher the author’s m eaning due to overly complicated language, and this is a third weakness of F rankl’s writing.ConclusionThis critical review has evaluated the book Man’s Search for Meaning by Viktor E. Frankl. The psychological theories that Frankl presents are very inte resting and he does a good job of illustrating these theories with his own pe rsonal experiences. However, his writing is weakened by the presence of bias, the overarching assumptions he occasionally makes, and his sometimes overl y technical and verbose language.。
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实证医学或循证医学

Evidence BasedMedicine實證醫學或循證醫學Se-Yuan LiuSurgeryPing-tung ChristianHospital實證醫學或循證醫學♦究竟是甚麼東東?♦為什麼我該了解這個東西?♦該怎麼做?♦很困難嗎?♦Evidence-based medicine (EBM) is the integration of–best research evidence with–clinical expertise and–patient values♦Evidence-based nursing (EBN)–nurses as important, active decision-makers♦Clinically relevant research, often from the basic sciences of medicine♦Especially from patient centered clinical research♦Power of prognostic markers, and the efficacy and safety of therapeutic,rehabilitative, and preventive regimens♦The ability to use our clinical skills and past experience♦To rapidly identify each patient’s unique health state and diagnosis, their individual risks and benefits of potential interventions, and their personal valuesand expectations♦The unique preferences, concerns and expectations each patient has♦Must be integrated into clinical decisions if they are to serve the patient♦Clinicians & patients form a diagnostic and therapeutic alliance, optimizesclinical outcomes and quality of life法國小鎮Why the Sudden Interest inEBM?♦These ideas have been around for a long time–post-revolutionary Paris–a much earlier origin in ancient Chinesemedicine♦Consolidated and named EBM in 1992 by a group led by Gordon Guyatt atMcMaster University in Canada4 Realizations♦Daily need for valid information about Dx, prognosis, therapy and prevention ♦The inadequacy of traditional sources for this information♦The disparity between diagnostic skills, judgment, knowledge, and performance♦Inadequate time for study and reading5 Developments♦Strategies to track & appraise evidence ♦Systematic reviews and concise summaries (Cochrane Collaboration)♦Creation of evidence-based journals of secondary publication♦Creation of information systems♦Strategies for life-long learningHow Do We Actually PracticeEBM?♦Asking an answerable question♦Tracking down the best evidence♦Critically appraising that evidence for its validity, impact, and applicability♦Integrating appraisal, clinical expertise and patient’s values, circumstances♦Evaluating& seeking ways to improveAsk An Answerable Question: The PICO format♦P: Patient or population, a 50-year old lady recently diagnosed with breast cancer, or a 2-year old boy with bronchopneumonia♦I & C: Intervention & Compare, type of surgery, chemo or not, choice of antibiotics♦O: Outcome, survival or quality of life,recurrence rate, effect of treatmentDifferent “Modes”of Practice♦The “appraising”mode, all steps –For the conditions we encounter everyday–Very sure about what we are doing♦The “searching”mode, skip step 3–For the conditions we encounter less often ♦The “replicating”mode, doubtful–Authoritative or merely authoritarian?4S: Studies, Syntheses, Synopses, SystemsPractice EBM?♦Do full-time clinicians really recognize working in these modes?♦Can they actually get at the evidence quickly enough to consider it on a busy clinical service?♦Can clinicians actually provideevidence-based care to their patients?What Are The Limitations ofEBM?Limitations that are universal to science (whether basic or applied) and medicine–The shortage of coherent, consistentscientific evidence–Difficulties in applying any evidence to the care of individual patients–Barriers to any practice of high qualitymedicineWhat Are The Limitations ofEBM?Limitations that are unique to the practice of EBM–The need to develop new skills insearching and critical appraisal–Busy clinicians have limited time to master and apply these new skills–Evidence that EBM “works”has been lateand slow to come♦Denigrates clinical expertise♦Limited to clinical research♦Ignores patients’values & preferences ♦Promotes a “cookbook”medicine♦Cost-cutting tool♦An ivory tower concept♦Leads to therapeutic nihilism巴黎聖心堂Bill Clinton Awaits Heart SurgeryNext WeekNEW YORK (CNN)Bill Clinton said hefeels "a little scared,but not much" as hewaits to undergo heartbypass surgeryscheduled for earlynext weekSeptember 4, 2004Doctors Confirm Lee Teng-hui StillHealthy♦Lee has undergone twosurgeries, in 2001 & 2003♦The Taipei VGH didsurgery on Lee with theassistance from Dr.Kazuaki Mitsudo, whoalso performed Lee's firstoperation.Taipei Times 20040805♦兩位前任總統分別接受了不同的治療♦到底是開心手術好,還是心導管好呢?♦記住!你不只是閱讀新聞,看熱鬧而已,明天這就可能是病患或家屬對你提出的疑問♦你是根據甚麼來回答這個問題呢?♦Surgery is the bestintervention forsevere coronary artery♦David P Taggart,Professor ofCardiovascular Surgery,University of OxfordBMJ2005;330:785-6♦Most studies of percutaneous coronary intervention have been done on patients with single or double vessel disease and have limited follow up, being increasingly used to treat multivessel ischaemic heart disease♦Studies of coronary artery bypass grafting have established its safety & long term effectiveness ♦Patients must be given all the evidence to enablean informed choice about treatmentThe Coronary Artery Bypass Graft Surgery Trialists Collaboration (1994)—1♦Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration♦From National Heart, Lung, and Blood Institute, Bethesda, Maryland♦1324 patients: CABG surgery; 1325 medical management between 1972 and 1984♦Lancet. 1994 Aug 27;344(8922):563-70The Coronary Artery Bypass Graft Surgery Trialists Collaboration (1994)—2♦The CABG group had significantly lower mortality than the medical treatment group at 5 yrs (10.2 vs15.8%; OR0.61 [95% CI 0.48-0.77], p = 0.0001), 7 yrs (15.8 vs21.7%; 0.68 [0.56-0.83], p < 0.001), and 10 yrs (26.4 vs30.5%; 0.83 [0.70-0.98]; p = 0.03)♦The risk reduction was greater in patients with left main artery disease than in those with disease in three vessels or one or two vessels (OR at 5 years 0.32, 0.58, and 0.77)♦The absolute benefits of CABG surgery were mostpronounced in patients in the highest risk categoriesCABG vs PCI (2004)—1♦Propensity Analysis of Long-Term Survival After Surgical or Percutaneous Revascularization in Patients With Multivessel Coronary Artery Disease and High-Risk Features♦Cardiovascular Medicine and Cardiothoracic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio♦Circulation.2004;109:2290-2295CABG vs PCI (2004)—2♦Most randomized clinical trials have suggested that long-term survival rates after percutaneous coronary intervention (PCI) or surgical multivessel coronary revascularization(CABG) are equivalent♦Some post hoc analyses in high-risk groups and adjustment for severity of coronary disease havesuggested higher mortality after PCICABG vs PCI (2004)—3♦6033 consecutive patients for revascularization in the late 1990s. PCI in 872; 5161 CABG♦Half the patients had significant left ventricular dysfunction or diabetes♦PCI was associated with an increased risk of death (propensity-adjusted hazard ratio, 2.3; 95% CI, 1.9 to 2.9; P<0.0001)♦In multivessel coronary artery disease & many high-risk factors, CABG with better survival thanPCI after adjustment for risk profileCochrane Reviews—1♦Percutaneous transluminal coronary angioplasty with stents versus coronary artery bypass grafting for people with stable angina or acute coronary syndromes (Cochrane Review)♦The Cochrane Database ofSystematic Reviews 2004, Issue 4Cochrane Reviews—2♦To examine evidence from randomised controlled trials (RCTs) on benefit of stents or CABG in reducing cardiac events in people with stable angina or acute coronary syndrome (ACS)♦Nine studies (3519 patients)♦Four RCTs included patients with multiple vessel disease, five focused onsingle vessel diseaseCochrane Reviews—3♦No statistical differences were observed between CABG and stenting for meta-analysis of mortality or AMI, but there was heterogeneity♦Composite cardiac event and revascularisation rates were lower for CABG than for stents♦Restenosis at 6 months (single vesseltrials) favoured CABGCochrane Reviews—4♦CABG is associated with reduced rates of major adverse cardiac events, mostly driven by reduced repeat revascularisation♦Limited by follow-up, unrepresentative samples and rapid development of both surgical techniques and stenting ♦Need further study at differentgroupings and risk factors♦QUESTION:Does screening for breast cancer by regular self examination or clinical examination (or both) reduce the incidence of breast cancer and death?♦Conclusions:The available evidence on breast self examination is limited.Based on 2 studies, regular breast examination does not reduce breast cancer mortality but increases the number ofwomen who have biopsies with benign results.♦QUESTION:In women with an increased risk of breast cancer, does tamoxifen reduce the risk of breast cancer and what are the associated harms?♦Conclusion: In women with an increased risk of breast cancer, tamoxifen reduced the risk of breast cancer but increased the risks of thromboembolic events and all cause mortality.♦From the International Breast CancerIntervention Study, first result (IBIS-I)♦PubMed/entrez/♦British Medical Journal (BMJ)/♦The Cochrane Library/♦Evidence Based Medicine or EBM Online/It’s free and a lot of fun!Topics in EBN Journal—1♦Review: adequately randomised trials showed that mammography screening did not significantly reduce breast cancer, cancer, or all cause mortality but increased breast surgeries♦Review: inhaled insulin provides better glycaemic control than oral hypoglycaemic agents but not better than subcutaneousinsulinTopics in EBN Journal—2♦Calcium reduced loss of bone mineral density but did not prevent fractures in healthy postmenopausal women♦Postoperative ibuprofen increased bleeding complications in hospital and did not improve pain or physical function at 6–12 months after total hipreplacementTopics in EBN Journal—3♦Review: exercise improves glycaemic control and reduces plasma triglycerides and visceral adipose tissue in type 2 diabetes♦Review: regular exercise improves quality of life and physical fitness inwomen with breast cancer。
CriticalAppraisalSkillsProgramme(CASP)

– Did the search terms cover the breath of the topic?
Yes No Can’t tell
– Were reference lists of articles looked at for additional references? Yes No Can’t tell
– Where clear and adequate criteria used to include and exclude studies from analysis? Describe:
– What study designs were included in this review? _______________________________________
Yes No Can’t tell
2. Was there a comprehensive and clearly described search for relevant studies?
Yes No Can’t tell
– Which bibliographic databases were used: ________________________________________________
___________________________________________________________________________________
– were p-value considered
Yes No Can’t tell
– sum up the bottom- line result of the review in one sentence:
治疗研究评析

• Narrow CI represents a precise reflection of the population value
“系統性回顧”的評析
• Are the results of the review valid (效度如何)?
– What question did the systematic review addressed (回答什麼問題)? – Is it unlikely that important, relevant studies were missed (沒有遺
“研究結果”中兩組實際接受 各項額外治療的種類與比例
□是
□否
□不清楚
評論:___________________
业精于勤荒于嬉 行成于思毁于随
4
→【医学生物PPT,欢迎收藏分享】
Were all patients who entered the trial accounted for and were they analysed in the groups to which they were randomised 所有進入試驗者皆列入統計,並依所分配的組別計算?
analysed in the groups to which they were randomised (所有進入試驗者 皆列入統計,並依所分配的組別計算)? – Were measures objective or were the patients and clinicians were blinded (結果的測量客觀,受試者及醫師都不知道所接受的治療為何)?
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What kind of this question ﹖
Etiology Diagnosis Therapy Prognosis 最佳文獻之研究方法為何﹖ Randomized controlled trial (RCT)
依問題性質選最佳的研究方法
不同研究設計的證據等級不同 依問題性質選最佳的研究方法
5
What is bias ?
Bias(偏差):
評估族群特色(特性)時所出現的系統性誤差 (error) 。
Origins of Bias
Study design(研究設計): failure to plan Study conduct(研究實施): Planned but not executed Study analysis(研究分析): planned but not executed Study reporting(研究報告): selective reporting of outcomes
Types of bias in analytical studies
Allocation(分派) Performance(執行) Placebo effect (安慰劑效果) Attrition(耗損) Detection(測量) Analytical(分析) Reporting(報告)
Check the table of baseline
Protection from allocation bias
Randomized allocation of treatment Restriction during enrollment Special analyses
Stratified multivariate
Performance bias
試驗過程中因不同的照護所出現的系統性差異
組別差異是因不同照護而非介入(intervention)不同 所產生。
Nursing and supportive care Monitoring for adverse effects
試驗過程中因不同的順從性所出現的系統性差 異。
Acceptable randomization methods
Computer-generated pseudo-random number Table of random numbers Physical processes
Coin toss Dice roll Draws from a bag
Frequency - Prevalence (case control), Incidence (cohort) Etiology / Harm - cohort Diagnosis – case control Prognosis - cohort Treatment / Intervention - RCT
Monitoring of treatment compliance
Hale Waihona Puke Placebo-effective bias
安慰劑作用: 效果來自受試者認為接受到有效 的治療。 對於未治療組( “no-treatment” arm)受試者認 為未接受到有效的治療,亦可能產生對結果的 干擾。
Protection from placebo-effect bias
Detection bias
對結果評估(outcome assessment)所出現系 統性的偏差。
measurement method Follow-up frequency for outcomes
介入不同副作用不同,所造成不同的順從性
Differential side-effect Differential perception of lack of effectiveness
Protection from performance bias
Blinding of caregivers
Blind the patient using placebo intervention
Placebo pills Sham operation (ethical?) Double dummies
If patient also assesses the outcome (e.g. QoL, feeling better), this blinding also serves to prevent detection bias
實證醫學
嘉義基督教醫院 外科部 黃國倉醫師 2010.12.03
實證醫學五步驟
步驟一: 形成出一個可回答的臨床問題 步驟二: 搜尋最佳證據 步驟三: 嚴格評讀證據 步驟四:應用證據於病患身上 步驟五: 評估執行效果及效用
臨床案例:
62 y/o男性,因慢性腎絲球腎炎併發尿毒症, 接受血液透析治療,抽菸每天兩包約15年,無 高血壓,無糖尿病,總膽固醇256 mg/dl,低 密度膽固醇125mg/dl,肝功能指數正常。 二週前,病人父親因急性心肌梗塞併發心衰竭 逝世,在一次血液透析中病人問腎臟科醫師: ” 我須要吃降膽固醇的藥來預防心肌梗塞嗎﹖” 他也擔心他的洗腎廔管會不會因為高膽固醇而 阻塞。
Allocation bias
任何分派組別的方法所造成組別中不同的特徵 系統性的出現在試驗之前。
Independent prognostic characteristics (confounders,干擾因子) Failure to plan e.g. non-randomized design Failure of execution(執行) e.g. unbalanced baseline
Randomization in clinical trials
Randomization procedure:
產生隨機且不可預測的分派。 為減少研究中評估者對分派組別的結果造成偏差所 作的預防措施。
Allocation concealment(隱藏):
Randomization method