中国临床医209年6月第16卷第3期 389 子讨论 凹陷型病变诊断，其可清所显示结肠细微结构的变 种常见的消化道恶性肿痛，在我国， 发现相 内镜难以发现的一些早期 12%,排在恶性肿瘤中第5位，仅此干曾癌、食管席、 在其它周肠道疾病的诊断方面，FICE系统也 是示了其优越性。日本医学院 患者5年的生存率约0%，并能改患者预后 ，结果是示茶，在不使用放大功能时，通过下E 结肠黏膜息肉样病变分肿瘤样肉和非肿样 统可容易地辨别出48例(96% 患者的病变，当界 用原 鉴别诊新，有助于早阴治疗和改著患者的预后。而 统在不采用放大功能的情况下，有高强度的光源，可 非样息般不会支发生出持并发症 很容鼎地获得整个黏粮的清 据息肉的形、颜色、部位息肉的性质作出诊断，普 长，从面获得最佳成像，F1CE系统的第2,4,6色诺 选项可增 内镜诊断 色花样 准”，尽管CE系统不能替代组织学检在 肠黏膜细微变化，因此诊断肿瘤样息肉的阴性 研究结米看，FICE 系统可以 分析小凹形状是鉴别 病变的 状，为增生性病变：，型，管状或喝形（较正常小 参新文献 为州陷性肿：型状或团形教正大 oriat R.Ch ool fo oscope system]Stomscb .530.544 黏膜腺管开口特征进行Kud0分型。它可根据符列 et al.Com 流长组合不可颜 研究中纳人63例结肠病变忠 o CA.Teixe 者道过标准结 油大内镜和FC 与大内在别聚息肉和非腺指性影肉价值 本研究发现F10 成像结果优 1996 14 结果 值为9 3 FICE系统阴性预测值升高至5.7% 和 型按还有非息肉 wa M.YE H.ctal.Or mal hane 肿痛的32% …45% 对于这部分患者】 传统结既 s,672,2 镜检查，容易漏诊，而FICE系统有助于对平坦型和 第29页 万方数据 第21页
义 第 21 页
临床案例 阅读案例，通过上网检索文献，结合既往临床实践，讨论回答下述问题 患者男性，70岁，因进食梗阻感1月来院就诊。无反酸、烧心，无咳嗽、咳痰，无黑 便呕血，无发热、消瘦等症状。 1.临床上有哪些疾病可能引起进食梗阻感，有何特征？ 2.如果临床怀疑食管癌（可能性为50%），内镜检查（特异度为90%，灵敏度为60%）与食管吞 钡摄片（特异度为80%，灵敏度为70%，你认为如何选择进一步检查？为什么？ 3.如果患者胃镜检查发现食管中段距门齿30cm后壁见1.2cm轻度隆起病灶，表面糜烂，活 检病理提示粘膜内癌。你认为下一步需要做什么？ 4.如果可以接受超声胃镜检查，CT检查，PET-CT检查，你如何为该患者选择检查？选择的 依据是什么？ 5.如果胃癌检查中同时发现该患者胃底近责门口见1.5cm粘膜隆起病灶，超声胃镜检查结果 显示：食管30cm处病灶为早期食管癌（局限于粘膜层，T1期），胃底隆起处探及1.5cm占 位，位于胃壁外，与胃壁紧连，考虑淋巴结：增强CT食管壁未见异常，胃底资门处1.5m 林巴结可能：PET-CT食管3Om处恶性病灶可能，胃底责门未见恶性病灶。你会为忠者选 怪怎样的处理方式？ 6.对胃底责门降起，如果可以进行超声内镜引导下穿刺，其灵敏度为50%，特异度为99% 你在处理患者前选择吗？为什么？ 背景资料： 1、处理方式选择：分别处理食管早癌与胃底贲门隆起病灶 (1)内镜下粘膜剥离治疗早期食管癌：内镜下隆起病灶（粘膜下肿瘤）剥离术 (2)开胸手术切除食管癌+淋巴结清扫。 2、胃底贲门部降起病灶的诊断：包括很名情况，包括来自胃壁的占位（粘膜下肿腐如良性平活 肌瓶、 潜在恶性的间质瘤、 脂肪控 胃壁外压迹如肝、脾压迹， 胃壁外良性病灶如淋巴结 炎，胃壁外恶性病灶如肿淋巴结转移等。 3、食管癌切除+淋巴结清扫手术后生活质量影响很大：早癌内镜下手术不仅作为微创手术已 成为早期胃癌食管癌重要的治疗手段，目前在国内己成熟。 4、临床报道。讲展期合管璃，出现病什周围淋巴结转移的可能性90%以上，远处淋巴结转移 的可能性50%以上：早期食管癌，出现病灶周围淋巴结转移的可能性10%， 出现远处转移的 可能性不足5%。 5、假设两年内：早期食管癌，合并淋巴结转移，手术治疗的生存率85%，延迟手术治疗的生 存率65%。早期食管癌，无淋巴结转移，手术治疗的生存率90%（含生活质最），内镜治疗的生 存率95%（考虑复发再治疗因素和生活质量） 第西
ЈᑞḜ՟ 䯙䇏Ḝ՟ˈ䗮䖛Ϟ㔥Ẕ㋶᭛⤂ˈ㒧ড়᮶ᕔЈᑞᅲ䏉ˈ䅼䆎ಲㄨϟ䗄䯂乬 ᙷ㗙⬋ᗻˈ70 ቕˈ䖯亳ṫ䰏ᛳ 1 ᳜ᴹ䰶ህ䆞DŽ᮴ড䝌ǃ⚻ᖗˈ᮴ઇǃઇ⯄ˈ᮴咥ǃ ֓㸔ˈ᮴থ⛁ǃ⍜⯺ㄝ⮛⢊DŽ 1. ЈᑞϞ᳝ાѯ⮒⮙ৃ㛑ᓩ䍋䖯亳ṫ䰏ᛳˈ᳝ԩ⡍ᕕ˛ 2. བᵰЈᑞᗔ⭥亳ㅵⰠ(ৃ㛑ᗻЎ 50%)ˈݙ䬰Ẕᶹ(⡍ᓖᑺЎ 90%ˈ♉ᬣᑺЎ 60%)Ϣ亳ㅵ৲ 䩵ᨘ⠛(⡍ᓖᑺЎ 80%ˈ♉ᬣᑺЎ 70%)ˈԴ䅸Ўབԩ䗝ᢽ䖯ϔℹẔᶹ˛ЎҔМ˛ 3. བᵰᙷ㗙㚗䬰Ẕᶹথ⦄亳ㅵЁ↉䎱䮼啓 30cm ৢຕ㾕 1.2cm 䕏ᑺ䱚䍋⮙♊ˈ㸼䴶㊰⚖ˈ⌏ Ẕ⮙⧚ᦤ⼎㉬㝰ݙⰠDŽԴ䅸Ўϟϔℹ䳔㽕خҔМ˛ 4. བᵰৃҹফ䍙ໄ㚗䬰ẔᶹˈCT ẔᶹˈPET-CT ẔᶹˈԴབԩЎ䆹ᙷ㗙䗝ᢽẔᶹ˛䗝ᢽⱘ ձᰃҔМ˛ 5. བᵰ㚗ⰠẔᶹЁৠᯊথ⦄䆹ᙷ㗙㚗ᑩ䖥䌆䮼ষ㾕 1.5cm ㉬㝰䱚䍋⮙♊ˈ䍙ໄ㚗䬰Ẕᶹ㒧ᵰ ᰒ⼎˖亳ㅵ 30cm ໘⮙♊Ўᮽᳳ亳ㅵⰠ(ሔ䰤Ѣ㉬㝰ሖˈT1 ᳳ)ˈ㚗ᑩ䱚䍋໘ঞ 1.5cm ऴ ԡˈԡѢ㚗ຕˈϢ㚗ຕ㋻䖲ˈ㗗㰥⎟Ꮘ㒧˗ᔎ CT 亳ㅵຕ㾕ᓖᐌˈ㚗ᑩ䌆䮼໘ 1.5cm ⎟Ꮘ㒧ৃ㛑˗PET-CT 亳ㅵ 30cm ໘ᙊᗻ⮙♊ৃ㛑ˈ㚗ᑩ䌆䮼㾕ᙊᗻ⮙♊DŽԴӮЎᙷ㗙䗝 ᢽᗢḋⱘ໘⧚ᮍᓣ˛ 6. ᇍ㚗ᑩ䌆䮼䱚䍋ˈབᵰৃҹ䖯㸠䍙ໄݙ䬰ᓩᇐϟこࠎ♉݊ˈᬣᑺЎ 50%ˈ⡍ᓖᑺЎ 99%ˈ Դ໘⧚ᙷ㗙ࠡ䗝ᢽ৫˛ЎҔМ˛ 㚠᱃䌘᭭˖ 1ǃ໘⧚ᮍᓣ䗝ᢽ˖߿ߚ໘⧚亳ㅵᮽⰠϢ㚗ᑩ䌆䮼䱚䍋⮙♊ (1) ݙ䬰ϟ㉬㝰࠹ᳳᮽ⭫⊐行亳ㅵⰠ˗ݙ䬰ϟ䱚䍋⮙♊(㉬㝰ϟ㚓⯸)࠹行ᴃ (2) ᓔ㛌ᴃߛ䰸亳ㅵⰠ+⎟Ꮘ㒧⏙ᠿDŽ 2ǃ㚗ᑩ䌆䮼䚼䱚䍋⮙♊ⱘ䆞ᮁ˖ࣙᣀᕜᚙމˈࣙᣀᴹ㞾㚗ຕⱘऴԡ(㉬㝰ϟ㚓⯸བ㡃ᗻᑇ⒥ 㙠⯸ǃ┰ᙊᗻⱘ䯈䋼⯸ǃ㛖㙾⯸ㄝ)ˈ㚗ຕय़䗍བ㙱ǃ㜒य़䗍ˈ㚗ຕ㡃ᗻ⮙♊བ⎟Ꮘ㒧 ♢ˈ㚗ຕᙊᗻ⮙♊བ㚓⯸⎟Ꮘ㒧䕀⿏ㄝDŽ 3ǃ亳ㅵⰠߛ䰸+⎟Ꮘ㒧⏙ᠿᴃৢ⫳⌏䋼䞣ᕅડᕜ˗ᮽⰠݙ䬰ϟᴃϡҙЎᖂ߯ᴃᏆ ៤Ўᮽᳳ㚗Ⱐ亳ㅵⰠ䞡㽕ⱘ⊏⭫↉ˈⳂࠡݙᏆ៤❳DŽ 4ǃЈᑞ䘧ˈ䖯ሩᳳ亳ㅵⰠˈߎ਼♊⮙⦃ೈ⎟Ꮘ㒧䕀⿏ⱘৃ㛑ᗻ 90%ҹϞˈ䖰໘⎟Ꮘ㒧䕀⿏ ⱘৃ㛑ᗻ 50%ҹϞ˗ᮽᳳ亳ㅵⰠˈߎ਼♊⮙⦃ೈ⎟Ꮘ㒧䕀⿏ⱘৃ㛑ᗻ 10%ˈߎ⦃䖰໘䕀⿏ⱘ ৃ㛑ᗻϡ䎇 5%DŽ 5ǃ؛䆒ϸᑈݙᳳᮽ˖亳ㅵⰠˈড়ᑊ⎟Ꮘ㒧䕀⿏ˈᴃ⊏⭫ⱘ⫳ᄬ⥛ 85%ˈᓊ䖳ᴃ⊏⭫ⱘ⫳ ᄬ⥛ 65%DŽᮽᳳ亳ㅵⰠˈ᮴⎟Ꮘ㒧䕀⿏ˈᴃ⊏⭫ⱘ⫳ᄬ⥛ 90%(⫳⌏䋼䞣)ˈݙ䬰⊏⭫ⱘ⫳ ᄬ⥛ 95%(㗗㰥থݡ⭫⊐㋴⫳⌏䋼䞣) 义 第 22 页
Unit4:疾病治疗证据的分析评价 主讲教师：刘天舒 助理教师：袁源智 一、教学目的：掌握和熟悉临床研究设计的类型及随机对照研究的设计和评价 二、教学内容： 1临床研究设计的类型 2.熟悉内容：随机对照研究的设计和评价 3. 了解内容：治疗决策和CONSORT评价标准 三、教学重点：随机对照研究的设计和评价 四、教学难点：临床研究的意义和设计要点 五、中文和英文关健词 临床试验 Clinical trial 随机对照临床试验，randomized controlled trial 选择/信息偏倚，selection/information bias 混杂，confounding 外部/内部效度（真实性）， external/internal validity 六、阅读文献： 1,Coombes RC.et al.A randomized trial....J Clin Oncol.1990 Aug:8(8):1362-9 2.Sakuramoto S,et al.Adjuvant chemotherapy....NEJM.2007 1:357:1810-20. 。计论思考题 1. RCT研究设计的特点及其意义？ 通过案例讨论和分析临床研究中常见的偏倚和混杂因素，RCT研究通过哪 些方法来减少偏倚和混杂因素。 2.从临床研究报告中如何评判该研究的价值？如何获取有用的信息和临床治 疗证据？ 通过分析临床研究报告，分别对其内部效度和外部效度进行评价：如何从报 告中获得可能有用的信息和临床治疗证据。 八、参考书及文献目录 1.《循证医学与临床实践》（第3版），王吉耀主编，科学出版社 2.The Lancet handbook of essential concepts in clinical research.Schulz KF,Grimes DA.Philadelphia,PA,USA:Elsevier,2006 elaboration.D.Altman.et al.Ann Intern Med.2001;134:663-694. 4.The CONSORT Statement.http://www.consort-statement.org/ 5.The James Lind Library.http://www.jameslindlibrary.org/ 第23页
Unit 4᧶⯴⯻⋱⯍䇷ᦤⲺ࠼᷆䇺ԭ ѱ䇨ᮏᐾ˖ࡈཙ㡂 ࣟ⨽ᮏᐾφ㺱ⓀᲪ жȽᮏᆜⴤⲺφᦼᨑ઼⟏ᚹѤᒺ⹄ウ䇮䇑Ⲵ㊫ර৺䲿ᵪሩ➗⹄ウⲴ䇮䇑઼䇴ԧ ӂȽᮏᆜᇯφ 1. Ѥᒺ⹄ウ䇮䇑Ⲵ㊫ර 2. ⟏ᚹᇩ˖䲿ᵪሩ➗⹄ウⲴ䇮䇑઼䇴ԧ 3. Ҷ䀓ᇩ˖⋫⯇ߣㆆ઼ CONSORT 䇴ԧḷ߶ пȽᮏᆜ䠃⛯φ 䲿ᵪሩ➗⹄ウⲴ䇮䇑઼䇴ԧ Ƚᮏᆜ䳴⛯φѤᒺ⹄ウⲴѹ઼䇮䇑㾱⛩ ӊȽѣᮽૂ㤧ᮽީ䭤䈃 Ѥᒺ䈅傼ˈClinical trial 䲿ᵪሩ➗Ѥᒺ䈅傼ˈrandomized controlled trial 䘹ᤙ/ؑ يٿ ˈselection/information bias ᵲˈconfounding ཆ䜘/䜘 ᭸ᓖ˄ⵏᇎᙗ˅ˈexternal/internal validity ޣȽ䰻䈱ᮽ⥤φ 1ǃCoombes RC, et al. A randomized trial…. J Clin Oncol. 1990 Aug;8(8):1362-9. 2ǃSakuramoto S, et al. Adjuvant chemotherapy….NEJM. 2007 1;357:1810-20. йȽ䇞䇰ᙓ㘹从φ 1. RCT ⹄ウ䇮䇑Ⲵ⢩⛩৺ަѹ˛ 䙊䗷Ṹֻ䇘䇪઼࠶᷀Ѥᒺ⹄ウѝᑨ㿱Ⲵيٿ઼ᵲഐ㍐ˈ RCT ⹄ウ䙊䗷ଚ Ӌᯩ⌅ᶕ߿ቁيٿ઼ᵲഐ㍐DŽ 2. ӾѤᒺ⹄ウᣕѝྲօ䇴ࡔ䈕⹄ウⲴԧ٬˛ྲօ㧧ਆᴹ⭘Ⲵ઼ؑѤᒺ⋫ ⯇䇱ᦞ˛ 䙊䗷࠶᷀Ѥᒺ⹄ウᣕˈ࡛࠶ሩަ䜘᭸ᓖ઼ཆ䜘᭸ᓖ䘋㹼䇴ԧ˗ྲօӾᣕ ѝ㧧ᗇਟ㜭ᴹ⭘Ⲵ઼ؑѤᒺ⋫⯇䇱ᦞDŽ ޡȽ৸㘹Ҝᮽ⥤ⴤᖋ 1. ljᗚ䇱५ᆖоѤᒺᇎ䐥NJ˄ㅜ 3 ⡸˅ˈ⦻ਹ㘰ѫ㕆ˈ、ᆖࠪ⡸⽮ 2. The Lancet handbook of essential concepts in clinical research. Schulz KF, Grimes DA. Philadelphia, PA, USA: Elsevier, 2006. 3. The revised CONSORT Statement for reporting randomized trials: explanation and elaboration. D. Altman. et al. Ann Intern Med. 2001;134:663-694. 4. The CONSORT Statement . http://www.consort-statement.org/ 5. The James Lind Library. http://www.jameslindlibrary.org/ 第 23 页
ACADEMIA AND CLINIC Annals of Internal Medicine CONSORT 2010 Statement:Updated Guidelines for Reporting Parallel Group Randomized Trials Kenneth F.Schul,PhD,MBA:.Altman,DS and David Moher,PhD,for the CONSORT Group k)state deline basedon dix (av org) or March 210 Editor's note:in order to encoure CONSORT 2010 Statem ut focuses on the most commor PLOS Medicine andnoninfcriorirtrial qvarying of addi (11,12. nd cn-me ite (www.consor long with the trolled trials,when tely de th ed.rep gold ons月 weve lne if odological rigor (1).accurately,readers of Diligent herence byauthors to the checklist items a published nplete,clear, facilitate transparency of repor oted ass ause autho note that the consort That lack of ade dStandard nd 5 years later (6-8).While those statementsi wed the randomied,controlcd als trials,bu who tra parently report,should L ence has accumulated CONSORT result of that process,CONSORT 2010. signing their trial. INTENT OF CONSORT 2010 BACKGROUND TO CONSORT to improve the d.con research.Re archers had shown fo See also many years that autho conducted or poorly aspects of Web-Only ared with bi e).Tw Conversion of graphics into slides e the first CONSOR'T state ment in 1996(5).Further methodological research on sim- ww.amnals.org 第24页
CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials Kenneth F. Schulz, PhD, MBA; Douglas G. Altman, DSc; and David Moher, PhD, for the CONSORT Group* The CONSORT (Consolidated Standards of Reporting Trials) statement is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. Ann Intern Med. 2010;152:726-732. www.annals.org For author affiliations, see end of text. * For the CONSORT Group contributors to CONSORT 2010, see the Appendix (available at www.annals.org). This article was published at www.annals.org on 24 March 2010. Editor’s Note: In order to encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on www.annals.org and will also be published in BMJ, The Lancet, Obstetrics & Gynecology, PLoS Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials. The authors jointly hold the copyright of this article. For details on further use, see the CONSORT Web site (www.consort-statement.org). Randomized, controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating health care interventions. However, randomized trials can yield biased results if they lack methodological rigor (1). To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information (2– 4). That lack of adequate reporting fueled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 (5) and its revision 5 years later (6 – 8). While those statements improved the reporting quality for some randomized, controlled trials (9, 10), many trial reports still remain inadequate (2). Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organized a CONSORT Group meeting to update the 2001 statement (6 – 8). We introduce here the result of that process, CONSORT 2010. INTENT OF CONSORT 2010 The CONSORT 2010 Statement is this paper, including the 25-item checklist (Table) and the flow diagram (Figure). It provides guidance for reporting all randomized, controlled trials but focuses on the most common design type—individually randomized, 2-group, parallel trials. Other trial designs, such as cluster randomized trials and noninferiority trials, require varying amounts of additional information. CONSORT extensions for these designs (11, 12), and other CONSORT products, can be found through the CONSORT Web site (www.consortstatement.org). Along with the CONSORT statement, we have updated the explanation and elaboration article (13), which explains the inclusion of each checklist item, provides methodological background, and gives published examples of transparent reporting. Diligent adherence by authors to the checklist items facilitates clarity, completeness, and transparency of reporting. Explicit descriptions, not ambiguity or omission, best serve the interests of all readers. Note that the CONSORT 2010 Statement does not include recommendations for designing, conducting, and analyzing trials. It solely addresses the reporting of what was done and what was found. Nevertheless, CONSORT does indirectly affect design and conduct. Transparent reporting reveals deficiencies in research if they exist. Thus, investigators who conduct inadequate trials, but who must transparently report, should not be able to pass through the publication process without revelation of their trials’ inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work. Moreover, CONSORT can help researchers in designing their trial. BACKGROUND TO CONSORT Efforts to improve the reporting of randomized, controlled trials accelerated in the mid-1990s, spurred partly by methodological research. Researchers had shown for many years that authors reported such trials poorly, and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias (14). Two initiatives aimed at developing reporting guidelines culminated in one of us (D.M.) and Drummond Rennie organizing the first CONSORT statement in 1996 (5). Further methodological research on simSee also: Web-Only Appendix Conversion of graphics into slides Academia and Clinic Annals of Internal Medicine 726 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 www.annals.org 第 24 页
CONSORT2010 ACADEMIA AND CLINIC ab/CONSORT 2010 Checklist of Information to Include When Reporting a Randomized Trial denmiietionsarnd guidance.se CONSOR o21. and condusions (for specific ntepotgioadadobrctnve gacbdeade2onolaoa ings and lo Interventions to allow replication yandcondhaye Sample女 10 nce.who enrolled participants.and Blinding 11a ceevant.dc Statistical method Becquitmeent 6 mes and sm ch group.an 176 18 Harms 9 ssing sources of potential bias:imprecision;and,if relevan onsdegonertantcaen and othe (32),herb extensions are fo 第25页
Table. CONSORT 2010 Checklist of Information to Include When Reporting a Randomized Trial* Section/Topic Item Number Checklist Item Reported on Page Number Title and abstract 1a Identification as a randomized trial in the title 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance, see CONSORT for abstracts [21, 31]) Introduction Background and objectives 2a Scientific background and explanation of rationale 2b Specific objectives or hypotheses Methods Trial design 3a Description of trial design (such as parallel, factorial), including allocation ratio 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 4b Settings and locations where the data were collected Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Outcomes 6a Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed 6b Any changes to trial outcomes after the trial commenced, with reasons Sample size 7a How sample size was determined 7b When applicable, explanation of any interim analyses and stopping guidelines Randomization Sequence generation 8a Method used to generate the random allocation sequence 8b Type of randomization; details of any restriction (such as blocking and block size) Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11b If relevant, description of the similarity of interventions Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses Results Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome 13b For each group, losses and exclusions after randomization, together with reasons Recruitment 14a Dates defining the periods of recruitment and follow-up 14b Why the trial ended or was stopped Baseline data 15 A table showing baseline demographic and clinical characteristics for each group Numbers analyzed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Outcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory Harms 19 All important harms or unintended effects in each group (for specific guidance, see CONSORT for harms [28]) Discussion Limitations 20 Trial limitations; addressing sources of potential bias; imprecision; and, if relevant, multiplicity of analyses Generalizability 21 Generalizability (external validity, applicability) of the trial findings Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Other information Registration 23 Registration number and name of trial registry Protocol 24 Where the full trial protocol can be accessed, if available Funding 25 Sources of funding and other support (such as supply of drugs), role of funders CONSORT Consolidated Standards of Reporting Trials. * We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration (13) for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomized trials (11), noninferiority and equivalence trials (12), nonpharmacologic treatments (32), herbal interventions (33), and pragmatic trials (34). Additional extensions are forthcoming: For those and for up-to-date references relevant to this checklist, see www.consort-statement.org. CONSORT 2010 Statement Academia and Clinic www.annals.org 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 727 第 25 页