复旦大学：《循证医学》课程教学资源（教材教案）循证医学各章教案及相关文献

ACADEMIA AND CLINIC CONSORT2010 Statement memhers to contribute.A parallel rando intervention allocation,follow-up.and data analysis). CONSOR .That process informs the continually evolving apor岛 around the 0 the zed (n=) cated to interventio DEVELOPMENT OF CONSORT 2010 ed allo Pwgnen January 2007 ) reasons) min rringtochis b证norndddh5Ppbynnmioal ing thical review in their instructions for authors ilar topics reinforced earlier findings(15)and fed into the n of 2001(6-8).Subs against inclusion this point.The CONSORT 2010 CONSORT database (located on the CONSORT Wel ation gehich from these 8 group f元 drop or腰 ments and to producea p evidenc and the recc th hrst dr t of th dinicaltialists,staisti di.The CO kpidcmiologsniB8d D.G. researchers.The membership of the group is dynamic.A our work expands in response to emerging projects and from other members of the larger group.The substance of 728 1 June 2010 Annal of Internal Medicine Volume 152.Number 11 www.amnals.org 第26页

ilar topics reinforced earlier findings (15) and fed into the revision of 2001 (6 – 8). Subsequently, the expanding body of methodological research informed the refinement of CONSORT 2010. More than 700 studies comprise the CONSORT database (located on the CONSORT Web site), which provides the empirical evidence to underpin the CONSORT initiative. Indeed, CONSORT Group members continually monitor the literature. Information gleaned from these ef￾forts provides an evidence base on which to update the CONSORT statement. We add, drop, or modify items based on that evidence and the recommendations of the CONSORT Group, an international and eclectic group of clinical trialists, statisticians, epidemiologists, and biomed￾ical editors. The CONSORT Executive (K.F.S., D.G.A., D.M.) strives for a balance of established and emerging researchers. The membership of the group is dynamic. As our work expands in response to emerging projects and needed expertise, we invite new members to contribute. As such, CONSORT continually assimilates new ideas and perspectives. That process informs the continually evolving CONSORT statement. Over time, CONSORT has garnered much support. More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement. Many other health care journals support it without our knowledge. Moreover, thousands more have implicitly supported it with the endorsement of the CONSORT statement by the International Commit￾tee of Medical Journal Editors (www.icmje.org). Other prominent editorial groups, the Council of Science Editors and the World Association of Medical Editors, officially support CONSORT. That support seems warranted: When used by authors and journals, CONSORT seems to improve reporting (9). DEVELOPMENT OF CONSORT 2010 Thirty-one members of the CONSORT 2010 Group met in Montebello, Quebec, Canada, in January 2007 to update the 2001 CONSORT statement. In addition to the accumulating evidence relating to existing checklist items, several new issues had come to prominence since 2001. Some participants were given primary responsibility for ag￾gregating and synthesizing the relevant evidence on a par￾ticular checklist item of interest. Based on that evidence, the group deliberated the value of each item. As in prior CONSORT versions, we kept only those items deemed absolutely fundamental to reporting a randomized, con￾trolled trial. Moreover, an item may be fundamental to a trial but not included, such as approval by an institutional ethical review board, because funding bodies strictly en￾force ethical review and medical journals usually address reporting ethical review in their instructions for authors. Other items may seem desirable, such as reporting on whether on-site monitoring was done, but a lack of empir￾ical evidence or any consensus on their value cautions against inclusion at this point. The CONSORT 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other infor￾mation if they consider it important. After the meeting, the CONSORT Executive con￾vened teleconferences and meetings to revise the checklist. After 7 major iterations, a revised checklist was distributed to the larger group for feedback. With that feedback, the Executive met twice in person to consider all the com￾ments and to produce a penultimate version. That served as the basis for writing the first draft of this paper, which was then distributed to the group for feedback. After con￾sideration of their comments, the Executive finalized the statement. The CONSORT Executive then drafted an updated explanation and elaboration manuscript, with assistance from other members of the larger group. The substance of Figure. Flow diagram of the progress through the phases of a parallel randomized trial of 2 groups (that is, enrollment, intervention allocation, follow-up, and data analysis). Assessed for eligibility (n = ...) Enrollment Allocation Follow-up Randomized (n = ...) Excluded (n = ...) Not meeting inclusion criteria (n = ...) Declined to participate (n = ...) Other reasons (n = ...) Allocated to intervention (n = ...) Received allocated intervention (n = ...) Did not receive allocated intervention (give reasons) (n = ...) Allocated to intervention (n = ...) Received allocated intervention (n = ...) Did not receive allocated intervention (give reasons) (n = ...) Lost to follow-up (give reasons) (n = ...) Discontinued intervention (give reasons) (n = ...) Lost to follow-up (give reasons) (n = ...) Discontinued intervention (give reasons) (n = ...) Analysis Analyzed (n = ...) Excluded from analysis (give reasons) (n = ...) Analyzed (n = ...) Excluded from analysis (give reasons) (n = ...) Academia and Clinic CONSORT 2010 Statement 728 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 www.annals.org 第 26 页

CONSORT2010 ACADEMIA AND CLINIC rovided the material for vides information on all reporting guidelines in health research. oRmd ndards of Repo and in We do not wish to standardize the structure of repor should simply addres check That statd we think hat items undet their prev we added additional item 2o5 eadings within the major item numbe CONSORT UEE uthors ro suggested by the guidanc IMPUCATIONS AND LIMITATION cols,to We developed consOrT 2010 to assist authors in writing reports of randomized,controlled trials,editors and ing random did k Elaboration provide not ain any udgments on how t the author context t o the done. I hus,CON not and 2-group,paralk won the h ac Bax 1.Noteworthy general changes in the CONSORT 2010 the irems from the CONSORT 2010 Sra fied the such as in tems1 uld consult the CONSORT be relevant. ed pragma and h Sion,an a ndics8n.Tepliatgolofalheeinitiamvesisa y an nd settings. e development of reportin www.annals.org 1 June 2010 Annals of Medicine Volume 152.Number 11 729 第27页

the 2007 CONSORT meeting provided the material for the update. The updated explanation and elaboration manuscript was distributed to the entire group for addi￾tions, deletions, and changes. That final iterative process converged to the CONSORT 2010 Explanation and Elaboration (13). CHANGES IN CONSORT 2010 The revision process resulted in evolutionary, not rev￾olutionary, changes to the checklist (Table), and the flow diagram was not modified except for 1 word (Figure). Moreover, because other reporting guidelines augmenting the checklist refer to item numbers, we kept the existing items under their previous item numbers except for some renumbering of items 2 to 5. We added additional items either as a subitem under an existing item, an entirely new item number at the end of the checklist, or (with item 3) an interjected item into a renumbered segment. We have summarized the noteworthy general changes in Box 1 and specific changes in Box 2. The CONSORT Web site con￾tains a side-by-side comparison of the 2001 and 2010 versions. IMPLICATIONS AND LIMITATIONS We developed CONSORT 2010 to assist authors in writing reports of randomized, controlled trials, editors and peer reviewers in reviewing manuscripts for publication, and readers in critically appraising published articles. The CONSORT 2010 Explanation and Elaboration provides elucidation and context to the checklist items. We strongly recommend using the explanation and elaboration in con￾junction with the checklist to foster complete, clear, and transparent reporting and aid appraisal of published trial reports. CONSORT 2010 focuses predominantly on the 2-group, parallel randomized, controlled trial, which ac￾counts for over half of trials in the literature (2). Most of the items from the CONSORT 2010 Statement, however, pertain to all types of randomized trials. Nevertheless, some types of trials or trial situations dictate the need for additional information in the trial report. When in doubt, authors, editors, and readers should consult the CONSORT Web site for any CONSORT extensions, expansions (am￾plifications), implementations, or other guidance that may be relevant. The evidence-based approach we have used for CONSORT also served as a model for development of other reporting guidelines, such as for reporting systematic reviews and meta-analyses of studies evaluating interven￾tions (16), diagnostic studies (17), and observational studies (18). The explicit goal of all these initiatives is to improve reporting. The Enhancing the Quality and Transparency of Health Research (EQUATOR) Network will facilitate development of reporting guidelines and help disseminate the guidelines: www.equator-network.org pro￾vides information on all reporting guidelines in health research. With CONSORT 2010, we again intentionally de￾clined to produce a rigid structure for the reporting of randomized trials. Indeed, Standards of Reporting Tri￾als (SORT) (19) tried a rigid format, and it failed in a pilot run with an editor and authors (20). Conse￾quently, the format of articles should abide by journal style; editorial directions; the traditions of the research field addressed; and, where possible, author preferences. We do not wish to standardize the structure of report￾ing. Authors should simply address checklist items somewhere in the article, with ample detail and lucidity. That stated, we think that manuscripts benefit from fre￾quent subheadings within the major sections, especially the methods and results sections. CONSORT urges completeness, clarity, and transpar￾ency of reporting, which simply reflects the actual trial design and conduct. However, as a potential drawback, a reporting guideline might encourage some authors to re￾port fictitiously the information suggested by the guidance rather than what was actually done. Authors, peer review￾ers, and editors should vigilantly guard against that poten￾tial drawback and refer, for example, to trial protocols, to information on trial registers, and to regulatory agency Web sites. Moreover, the CONSORT 2010 Statement does not include recommendations for designing and con￾ducting randomized trials. The items should elicit clear pronouncements of how and what the authors did, but do not contain any judgments on how and what the authors should have done. Thus, CONSORT 2010 is not in￾tended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist to construct a “quality score.” Box 1. Noteworthy general changes in the CONSORT 2010 Statement. We simplified and clarified the wording, such as in items 1, 8, 10, 13, 15, 16, 18, 19, and 21. We improved consistency of style across the items by removing the imperative verbs that were in the 2001 version. We enhanced specificity of appraisal by breaking some items into subitems. Many journals expect authors to complete a CONSORT checklist indicating where in the manuscript the items have been addressed. Experience with the checklist noted pragmatic difficulties when an item comprised multiple elements. For example, item 4 addresses eligibility of participants and the settings and locations of data collection. With the 2001 version, an author could provide a page number for that item on the checklist but might have reported only eligibility in the paper, for example, and not reported the settings and locations. CONSORT 2010 relieves obfuscations and forces authors to provide page numbers in the checklist for both eligibility and settings. CONSORT 2010 Statement Academia and Clinic www.annals.org 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 729 第 27 页

ACADEMIA AND CLINIC CONSORT2010 Statement 2.Noteworthy changes in the Statement nmary of trial design.methods.results,and conclusions and reference tem 2b (i tion)WVe added a ne ry item 5 in CONSORT 2001)on"Specific objectives or hypothes trial design (such as parallel group. et cluster)and th a new subitem that address s after tnial with a discussion of ets-forerly item 3 in CONSORT 2001. enobfepncoN5oT20o1.wencouagdatrpeccwys由tingthatdsotptonsofinr tions sh e that authors fre ile l 1 12a (statistical met Ve added that statistical methods should also be pn ovided for analysis of secondary outcom e to clari6 y that b: and clinical characteristics of each group are most cearly expressed in a tabl sed term.by a more ex cit request for informatl n of "For binary outcome e added a iated with estimated carchers begin trial 205.invcstiga2toshould understand the CONSOR adopton of CONSORT by jouas and editorial ign and conduct according to most authors should have to report transparently all impor rigorous standards 730 1 June 2010 Annal of Internal Medicine Volume 152.Number 11 ww.atnals. 第28页

Nevertheless, we suggest that researchers begin trials with their end publication in mind. Poor reporting allows authors, intentionally or inadvertently, to escape scrutiny of any weak aspects of their trials. However, with wide adoption of CONSORT by journals and editorial groups, most authors should have to report transparently all impor￾tant aspects of their trial. The ensuing scrutiny rewards well-conducted trials and penalizes poorly conducted trials. Thus, investigators should understand the CONSORT 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards. Box 2. Noteworthy specific changes in the CONSORT 2010 Statement. Item 1b (title and abstract)—We added a subitem on providing a structured summary of trial design, methods, results, and conclusions and referenced the CONSORT for abstracts article (21). Item 2b (introduction)—We added a new subitem (formerly item 5 in CONSORT 2001) on “Specific objectives or hypotheses.” Item 3a (trial design)—We added a new item including this subitem to clarify the basic trial design (such as parallel group, crossover, cluster) and the allocation ratio. Item 3b (trial design)—We added a new subitem that addresses any important changes to methods after trial commencement, with a discussion of reasons. Item 4 (participants)—Formerly item 3 in CONSORT 2001. Item 5 (interventions)—Formerly item 4 in CONSORT 2001. We encouraged greater specificity by stating that descriptions of interventions should include “sufficient details to allow replication” (3). Item 6 (outcomes)—We added a subitem on identifying any changes to the primary and secondary outcome (end point) measures after the trial started. This followed from empirical evidence that authors frequently provide analyses of outcomes in their published papers that were not the prespecified primary and secondary outcomes in their protocols, while ignoring their prespecified outcomes (that is, selective outcome reporting) (4, 22). We eliminated text on any methods used to enhance the quality of measurements. Item 9 (allocation concealment mechanism)—We reworded this to include mechanism in both the report topic and the descriptor to reinforce that authors should report the actual steps taken to ensure allocation concealment rather than simply report imprecise, perhaps banal, assurances of concealment. Item 11 (blinding)—We added the specification of how blinding was done and, if relevant, a description of the similarity of interventions and procedures. We also eliminated text on “how the success of blinding (masking) was assessed” because of a lack of empirical evidence supporting the practice, as well as theoretical concerns about the validity of any such assessment (23, 24). Item 12a (statistical methods)—We added that statistical methods should also be provided for analysis of secondary outcomes. Subitem 14b (recruitment)—Based on empirical research, we added a subitem on “Why the trial ended or was stopped” (25). Item 15 (baseline data)—We specified “A table” to clarify that baseline and clinical characteristics of each group are most clearly expressed in a table. Item 16 (numbers analyzed)—We replaced mention of “intention to treat” analysis, a widely misused term, by a more explicit request for information about retaining participants in their original assigned groups (26). Subitem 17b (outcomes and estimation)—For appropriate clinical interpretability, prevailing experience suggested the addition of “For binary outcomes, presentation of both relative and absolute effect sizes is recommended” (27). Item 19 (harms)—We included a reference to the CONSORT paper on harms (28). Item 20 (limitations)—We changed the topic from “Interpretation” and supplanted the prior text with a sentence focusing on the reporting of sources of potential bias and imprecision. Item 22 (interpretation)—We changed the topic from “Overall evidence.” Indeed, we understand that authors should be allowed leeway for interpretation under this nebulous heading. However, the CONSORT Group expressed concerns that conclusions in papers frequently misrepresented the actual analytical results and that harms were ignored or marginalized. Therefore, we changed the checklist item to include the concepts of results matching interpretations and of benefits being balanced with harms. Item 23 (registration)—We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance (29). Item 24 (protocol)—We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol (4, 22). Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication. Item 25 (funding)—We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects (30). Academia and Clinic CONSORT 2010 Statement 730 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 www.annals.org 第 28 页

CONSORT2010 ACADEMIA AND CLINIC ic review of the s e We may d ons of A Ca the CONSORT 2010 Explanation and on(13 material can be ONSOR con We em hasize that CONSORT 2010 re isal and,if the CONSORT material ue DR.A DG.E CONSORT 地地oo o the CONSORTm IAMA 2006295115260.PMID Mohe BM 4.Sch M A.C ook D).Jd A. or Healt nd,Canadian of iou PP,Irwig LM ng o D rch Chair,and Dr. 2018404.m.1251304 (STROB ponlin 兰 MT. 18221781 DG.Er Referen ces Iani P. Altman DG. 爱.PD.15794971 scriptions of treatment in trials and reviews 25.M ms KE,Eggert CH,Briel M www.annals.org ine Volume 152.Number 11 731 第29页

CONSORT 2010 supplants the prior version pub￾lished in 2001. Any support for the earlier version accu￾mulated from journals or editorial groups will automati￾cally extend to this newer version, unless specifically requested otherwise. Journals that do not currently support CONSORT may do so by registering on the CONSORT Web site. If a journal supports or endorses CONSORT 2010, it should cite one of the original versions of CONSORT 2010, the CONSORT 2010 Explanation and Elaboration, and the CONSORT Web site in their “in￾structions to authors.” We suggest that authors who wish to cite CONSORT should cite this or another of the orig￾inal journal versions of CONSORT 2010 Statement and, if appropriate, the CONSORT 2010 Explanation and Elaboration (13). All CONSORT material can be accessed through the original publishing journals or the CONSORT Web site. Groups or individuals who desire to translate the CONSORT 2010 Statement into other languages should first consult the CONSORT policy statement on the Web site. We emphasize that CONSORT 2010 represents an evolving guideline. It requires perpetual reappraisal and, if necessary, modifications. In the future, we will further revise the CONSORT material considering comments, criticisms, experiences, and accumulating new evidence. We invite read￾ers to submit recommendations via the CONSORT Web site. From Family Health International, Research Triangle Park, North Caro￾lina; Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford, United Kingdom; and Ottawa Methods Centre, Clin￾ical Epidemiology Program, Ottawa Hospital Research Institute, Univer￾sity of Ottawa, Ottawa, Ontario, Canada. Grant Support: From United Kingdom National Institute for Health Research and the Medical Research Council; Canadian Institutes of Health Research; Presidents Fund, Canadian Institutes of Health Re￾search; Johnson & Johnson; BMJ; and American Society for Clinical Oncology. Dr. Altman is supported by Cancer Research UK, Dr. Moher by a University of Ottawa Research Chair, and Dr. Schulz by Family Health International. None of the sponsors had any involvement in the planning, execution, or writing of the CONSORT documents. In addi￾tion, no funder played a role in drafting the manuscript. Potential Conflicts of Interest: Disclosures can be viewed at www.acponline .org/authors/icmje/ConflictOfInterestForms.do?msNumM10-0379. Corresponding Author: Kenneth F. Schulz, PhD, MBA, Family Health International, PO Box 13950, Research Triangle Park, NC 27709. Current author addresses and author contributions are available at www .annals.org. References 1. Ju¨ni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001;323:42-6. [PMID: 11440947] 2. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005;365:1159-62. [PMID: 15794971] 3. Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from de￾scriptions of treatment in trials and reviews? BMJ. 2008;336:1472-4. [PMID: 18583680] 4. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and out￾come reporting bias. PLoS One. 2008;3:e3081. [PMID: 18769481] 5. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT state￾ment. JAMA. 1996;276:637-9. [PMID: 8773637] 6. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised rec￾ommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191-4. [PMID: 11323066] 7. Moher D, Schulz KF, Altman DG; CONSORT GROUP (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommen￾dations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657-62. [PMID: 11304106] 8. Moher D, Schulz KF, Altman D; CONSORT Group (Consolidated Stan￾dards of Reporting Trials). The CONSORT statement: revised recommenda￾tions for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285:1987-91. [PMID: 11308435] 9. Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, et al. Does the CONSORT checklist improve the quality of reports of randomised con￾trolled trials? A systematic review. Med J Aust. 2006;185:263-7. [PMID: 16948622] 10. Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: a comparative study of articles indexed by PubMed. BMJ. 2010;340:c723. 11. Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328:702-8. [PMID: 15031246] 12. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an exten￾sion of the CONSORT statement. JAMA. 2006;295:1152-60. [PMID: 16522836] 13. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. 14. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment ef￾fects in controlled trials. JAMA. 1995;273:408-12. [PMID: 7823387] 15. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet. 1998;352:609-13. [PMID: 9746022] 16. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151:264-9, W64. [PMID: 19622511] 17. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al; Standards for Reporting of Diagnostic Accuracy. Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative. Ann Intern Med. 2003;138:40-4. [PMID: 12513043] 18. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbro￾ucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observa￾tional studies. Ann Intern Med. 2007;147:573-7. [PMID: 17938396] 19. The Standards of Reporting Trials Group. A proposal for structured report￾ing of randomized controlled trials. JAMA. 1994;272:1926-31. [PMID: 7990245] 20. Rennie D. Reporting randomized controlled trials. An experiment and a call for responses from readers [Editorial]. JAMA. 1995;273:1054-5. [PMID: 7897791] 21. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al; CONSORT Group. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008;371:281-3. [PMID: 18221781] 22. Chan AW, Hro´bjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Em￾pirical evidence for selective reporting of outcomes in randomized trials: compar￾ison of protocols to published articles. JAMA. 2004;291:2457-65. [PMID: 15161896] 23. Sackett DL. Commentary: Measuring the success of blinding in RCTs: don’t, must, can’t or needn’t? Int J Epidemiol. 2007;36:664-5. [PMID: 17675306] 24. Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet. 2002;359:696-700. [PMID: 11879884] 25. Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, CONSORT 2010 Statement Academia and Clinic www.annals.org 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 731 第 29 页

ACADEMIA AND CLINIC CONSORT2010 Statement 167.70MD:1275614 n DG NSO tids in 1.Moher D. 82151 n DG.Schulz KF,Rrvaud P:CONSORT 295-09.PMID1g283207 [PMID:CONSORT J,Boon H, A T.g mn DC. ANNALS OF INTERNAL INVESTIGATOR AWARDS b时a ●M s will consider the article's novelty tatio published in th the nan dwhen the ard,ando Physicians'annual meeting. 732 1 June 2010 Annal of Internal Medicine Volume 152.Number 11 第30页

et al. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294:2203-9. [PMID: 16264162] 26. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999;319:670-4. [PMID: 10480822] 27. Nuovo J, Melnikow J, Chang D. Reporting number needed to treat and absolute risk reduction in randomized controlled trials. JAMA. 2002;287:2813-4. [PMID: 12038920] 28. Ioannidis JP, Evans SJ, Gøtzsche PC, O’Neill RT, Altman DG, Schulz K, et al; CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141:781-8. [PMID: 15545678] 29. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al; International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [Edi￾torial]. Ann Intern Med. 2004;141:477-8. [PMID: 15355883] 30. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry spon￾sorship and research outcome and quality: systematic review. BMJ. 2003;326: 1167-70. [PMID: 12775614 31. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al; CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008;5:e20. [PMID: 18215107] 32. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Extending the CONSORT statement to randomized trials of nonphar￾macologic treatment: explanation and elaboration. Ann Intern Med. 2008;148: 295-309. [PMID: 18283207] 33. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C; CONSORT Group. Reporting randomized, controlled trials of herbal interven￾tions: an elaborated CONSORT statement. Ann Intern Med. 2006;144:364-7. [PMID: 16520478] 34. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al; CONSORT group. Improving the reporting of prag￾matic trials: an extension of the CONSORT statement. BMJ. 2008;337: a2390. [PMID: 19001484] ANNALS OF INTERNAL MEDICINE JUNIOR INVESTIGATOR AWARDS Beginning in 2010, Annals of Internal Medicine and the American Col￾lege of Physicians will recognize excellence among internal medicine trainees and junior investigators with annual awards for original research and scholarly review articles published in Annals in each of the following categories: ● Most outstanding article with a first author in an internal medicine residency program or a general medicine or internal medicine sub￾specialty fellowship program ● Most outstanding article with a first author within 3 years following completion of training in internal medicine or one of its subspecialties Selection of award winners will consider the article’s novelty, method￾ological rigor, clarity of presentation, and potential to influence practice, policy, or future research. Judges will include Annals Editors and repre￾sentatives from Annals’ Editorial Board and the American College of Physicians’ Education/Publication Committee. Papers published in the year following submission are eligible for the award in the year of publication. First author status at the time of manuscript submission will determine eligibility. Authors should indicate that they wish to have their papers considered for an award when they submit the manuscript, and they must be able to provide satisfactory documentation of their eligibility if selected for an award. Announcement of awards for a calendar year will occur in January of the subsequent year. We will provide award winners with a framed certificate, a letter documenting the award, and complimentary registration for the Ameri￾can College of Physicians’ annual meeting. Please refer questions to Mary Beth Schaeffer at mschaeffer@acponline .org. Academia and Clinic CONSORT 2010 Statement 732 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 www.annals.org 第 30 页