This Article  • Abstract  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (782)  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Topic Collections  • Journalology/ Peer Review/ Authorship  • Quality of Care  • Quality of Care, Other  • Statistics and Research Methods  • Randomized Controlled Trial  • Alert me on articles by topic  Social Bookmarking   What's this?

David Moher, MSc; Kenneth F. Schulz, PhD,MBA; Douglas Altman, DSc; for the CONSORT Group

JAMA. 2001;285:1987-1991.

ABSTRACT
To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this article incorporates new evidence and addresses some criticisms of the original statement.

The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, according to each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis.

In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

INTRODUCTION

Jump to Section  • Top  • Introduction  • History of consort  • Revision of the consort...  • Changes to consort  • Comment  • Author information  • References

A report of a randomized controlled trial (RCT) should convey to the reader, in a transparent manner, why the study was undertaken and how it was conducted and analyzed. For example, a lack of adequately reported randomization has been associated with bias in estimating the effectiveness of interventions.^1-2 To assess the strengths and limitations of an RCT, readers need and deserve to know the quality of its methods. Despite several decades of educational efforts, RCTs still are not being reported adequately.^3-6 For example, a review of 122 recently published RCTs that evaluated the effectiveness of selective serotonin reuptake inhibitors as first-line management strategy for depression found that only 1 (0.8%) article described randomization adequately.⁵ Inadequate reporting makes the interpretation of RCT results difficult if not impossible. Moreover, inadequate reporting borders on unethical practice when biased results receive false credibility.

HISTORY OF CONSORT

Jump to Section  • Top  • Introduction  • History of consort  • Revision of the consort...  • Changes to consort  • Comment  • Author information  • References

In the mid 1990s, 2 independent initiatives to improve the quality of reports of RCTs led to the publication of the CONSORT (Consolidated Standards of Reporting Trials) statement,⁷ which was developed by an international group of clinical trialists, statisticians, epidemiologists, and biomedical editors. CONSORT has been supported by a growing number of medical and health care journals^8-11 and editorial groups, including the International Committee of Medical Journal Editors¹² (ICMJE, also known as the Vancouver Group), the Council of Science Editors (CSE), and the World Association of Medical Editors (WAME). CONSORT is also published in Dutch, English, French, German, Japanese, and Spanish. It can be accessed on the Internet, along with other information about the CONSORT group.¹³

The CONSORT statement comprises a checklist and flow diagram for reporting an RCT. For convenience, the checklist and diagram together are called simply CONSORT. They are primarily intended for use in writing, reviewing, or evaluating reports of simple 2-group parallel RCTs.

Preliminary data indicate that the use of CONSORT does indeed help to improve the quality of reports of RCTs.^14-15 In an evaluation of 71 published RCTs in 3 journals in 1994, allocation concealment was reported unclearly in 43 (61%) of the trials.¹⁴ Four years later, after these 3 journals required that authors reporting an RCT use CONSORT, the proportion of articles in which allocation concealment was reported unclearly had decreased to 30 of 77 (39%; mean difference, -22%; [95% confidence interval, -38% to -6%]).¹⁴

The usefulness of CONSORT is enhanced by continuous monitoring of the biomedical literature; this monitoring allows CONSORT to be modified depending on the merits of maintaining or dropping current items and including new items. For example, when Meinert¹⁶ observed that the flow diagram did not provide important information about the number of participants who entered each phase of an RCT (enrollment, treatment allocation, follow-up, and data analysis), the diagram was able to be modified to accommodate the information. The checklist is similarly flexible.

This iterative process makes the CONSORT statement a continually evolving instrument. While participants in the CONSORT group and their degree of involvement vary over time, members meet regularly to review the need to refine CONSORT. At the 1999 meeting, participants decided to revise the original statement. This report reflects changes determined by consensus of the CONSORT group, partly in response to emerging evidence on the importance of various elements of RCTs.

REVISION OF THE CONSORT STATEMENT

Jump to Section  • Top  • Introduction  • History of consort  • Revision of the consort...  • Changes to consort  • Comment  • Author information  • References

Thirteen members of the CONSORT group met in May 1999 with the primary objective of revising the original CONSORT checklist and flow diagram, as needed. The group discussed the merits of including each item in the light of current evidence. As in developing the original CONSORT statement, our intention was to keep only those items deemed fundamental to reporting standards for an RCT. Some items not considered essential may well be highly desirable and still should be included in an RCT report even though they are not included in CONSORT. Such items include approval of an institutional ethical review board, sources of funding for the trial, and a trial registry number (eg, the International Standard Randomized Controlled Trial Number [ISRCTN]) used to register the RCT at its inception.¹⁷

Shortly after the meeting, a revised version of the checklist was circulated to the group for additional comments and feedback. Revisions to the flow diagram were similarly made. All these changes were discussed when CONSORT participants met in May 2000, and the revised statement was finalized shortly afterward.

The revised CONSORT statement includes a 22-item checklist (Table 1) and a flow diagram (Figure 1). Its primary aim is to help authors improve the quality of reports of simple 2-group parallel RCTs. However, the basic philosophy underlying the development of the statement can be applied to any design. In this regard, additional statements for other designs will be forthcoming from the group.¹³ CONSORT can also be used by peer reviewers and editors to identify reports with inadequate description of trials and those with potentially biased results.^1-2

View this table: [in this window] [in a new window] Table. Checklist of Items to Include When Reporting a Randomized Trial

View larger version (46K): [in this window] [in a new window] Figure. Flow Diagram of Subject Progress Through the Phases of a Randomized Trial

During the 1999 meeting, the group also discussed the benefits of developing an explanatory document to enhance the use and dissemination of CONSORT. The document is patterned on reporting of statistical aspects of clinical research¹⁸ and was developed to help facilitate the recommendations of the ICMJE's Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Three members of the CONSORT group, with assistance from members on some checklist items, drafted an explanation and elaboration document. That document¹⁹ was circulated to the group for additions and revisions and was last revised after review at the latest CONSORT group meeting.

CHANGES TO CONSORT

Jump to Section  • Top  • Introduction  • History of consort  • Revision of the consort...  • Changes to consort  • Comment  • Author information  • References

(1) In the revised checklist, a new column for "paper section and topic" integrates information from the "subheading" column that was contained in the original statement.

(2) The "Was it reported?" column has been integrated into a "reported on page #" column, as requested by some journals.

(3) Each item of the checklist is now numbered and the syntax and order have been revised to improve the flow of information.

(4) "Title" and "Abstract" are now combined in the first item.

(5) While the content of the revised checklist is similar to the original, some items that previously were combined are now separate. For example, authors had been asked to describe "primary and secondary outcome(s) measure(s) and the minimum important difference(s), and indicate how the target sample size was projected." In the new version, issues pertaining to outcomes (item 6) and sample size (item 7) are separate, enabling authors to be more explicit about each. Moreover, some items request additional information. For example, for outcomes (item 6) authors are asked to report any methods used to enhance the quality of measurements, such as multiple observations.

(6) The item asking for the unit of randomization (eg, cluster) has been dropped because specific checklists have been developed for reporting cluster RCTs²⁰ and other design types¹³ since publication of the original checklist.

(7) Whenever possible, new evidence is incorporated into the revised checklist. For example, authors are asked to be explicit about whether the analysis reported is by intention-to-treat (item 16). This request is based in part on the observations²¹ that authors do not adequately describe and apply intention-to-treat analysis and reports that not providing this information are less likely to provide other relevant information, such as loss to follow-up.²²

(8) The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The revised diagram explicitly includes the number of participants, according to each intervention group, included in the primary data analysis. Inclusion of these numbers lets the reader know whether the authors have performed an intention-to-treat analysis,.^21-23 Because some of the information may not always be known and to accommodate other information, the structure of the flow diagram may need to be modified for a particular trial. Inclusion of the participant flow diagram in the report is strongly recommended but may be unnecessary for simple trials, such as those without any participant withdrawals or dropouts.

COMMENT

Jump to Section  • Top  • Introduction  • History of consort  • Revision of the consort...  • Changes to consort  • Comment  • Author information  • References

Specifically developed to guide authors about how to improve the quality of reporting of simple 2-group parallel RCTs, CONSORT encourages transparency in reporting the methods and results so that reports of RCTs can be interpreted both readily and accurately. However, CONSORT does not address other facets of reporting that also require attention, such as scientific content and readability of RCT reports. Some authors, in their enthusiasm to use CONSORT, have modified the checklist.²⁴ We recommend against such modifications because they may be based on a different process than the one used by the CONSORT group.

The use of CONSORT seems to reduce (if not eliminate) inadequate reporting of RCTs.^14-15 Potentially, the use of CONSORT should positively influence the manner in which RCTs are conducted. Granting agencies have noted this potential relationship and, in at least 1 case,²⁵ have encouraged grantees to consider in their application how they have dealt with the CONSORT items.

The evidence-based approach used to develop CONSORT also has been used to develop standards for reporting meta-analyses of randomized trials,²⁶ meta-analyses of observational studies,²⁷ and diagnostic studies (Jeroen Lijmer, MD, written communication, October 2000). Health economists also have started to develop reporting standards²⁸ to help improve the quality of their reports.²⁹ The intent of all these initiatives is to improve the quality of reporting of biomedical research³⁰ and by doing so to bring about more effective health care.

The revised CONSORT statement will replace the original one in the journals and groups that already support it. Journals that do not yet support CONSORT may do so by registering on the CONSORT Web site.¹³ To convey to authors the importance of improved quality in the reporting of RCTs, we encourage supporting journals to reference the revised CONSORT statement and the CONSORT Internet address¹³ in their "Instructions to Authors." Because the journals publishing the revised CONSORT statement have waived copyright protection, CONSORT is now widely accessible to the biomedical community. The CONSORT checklist and flow diagram can also be accessed at the CONSORT Web site.¹³

A lack of clarification of the meaning and rationale for each checklist item in the original CONSORT statement has been remedied with the development of the CONSORT explanation and elaboration document,¹⁹ which also can be found on the CONSORT Web site.¹³ This document reports the evidence on which the checklist items are based, including the references, which had annotated the checklist items in the previous version. We encourage journals to also include reference to this document in their Instructions to Authors.

Emphasizing the evolving nature of CONSORT, the CONSORT group invites readers to comment on the updated checklist and flow diagram through the CONSORT Web site.¹³ Comments and suggestions will be collated and considered at the next meeting of the group in 2001.

AUTHOR INFORMATION

Jump to Section  • Top  • Introduction  • History of consort  • Revision of the consort...  • Changes to consort  • Comment  • Author information  • References

Simultaneous Publication: The revised CONSORT statement also appears in Annals of Internal Medicine (2001;134:657-662) and The Lancet (2001;357:1191-1194).

Author Contributions: Mr Moher and Drs Schulz and Altman participated in regular conference calls, identified participants, contributed to the CONSORT meetings, and drafted the manuscript. Mr Moher planned the CONSORT meetings, secured funding, invited the participants, and planned the meeting agenda. Members of the CONSORT group attended the meetings and provided input for the revised checklist, flow diagram, and/or text of this article. Mr Moher is the guarantor of this article.

Contributors to this version of the CONSORT statement: Frank Davidoff, MD, Annals of Internal Medicine (Philadelphia, Pa); Susan Eastwood, ELS(D), University of California at San Francisco; Matthias Egger, MD, Department of Social Medicine, University of Bristol (Bristol, England); Diana Elbourne, PhD, London School of Hygiene and Tropical Medicine (London, England); Peter Gøtzsche, MD, Nordic Cochrane Centre (Copenhagen, Denmark); Sylvan B. Green, PhD, MD, School of Medicine, Case Western Reserve University (Cleveland, Ohio); Leni Grossman, BA, Merck & Co Inc (Whitehouse Station, NJ); Barbara S. Hawkins, PhD, Wilmer Ophthalmological Institute, Johns Hopkins University (Baltimore, Md); Richard Horton, MB, The Lancet (London, England); Wayne B. Jonas, MD, Uniformed Services University of the Health Sciences (Bethesda, Md); Terry Klassen, MD, Department of Pediatrics, University of Alberta (Edmonton); Leah Lepage, PhD, Thomas C. Chalmers Centre for Systematic Reviews (Ottawa, Ontario); Thomas Lang, MA, Tom Lang Communications (Lakewood, Ohio); Jeroen Lijmer, MD, Department of Clinical Epidemiology, University of Amsterdam (Amsterdam, the Netherlands); Rick Malone, BS, TAP Pharmaceuticals (Lake Forest, Ill); Curtis L. Meinert, PhD, Johns Hopkins University (Baltimore, Md); Mary Mosley, BS, Life Science Publishing (Tokyo, Japan); Stuart Pocock, PhD, London School of Hygiene and Tropical Medicine (London, England); Drummond Rennie, MD, JAMA (Chicago, Ill); David S. Riley, MD, University of New Mexico Medical School (Santa Fe); Roberta W. Scherer, PhD, Epidemiology and Preventive Medicine, University of Maryland School of Medicine (Baltimore); Ida Sim, MD, PhD, University of California at San Francisco; and Donna Stroup, PhD, MSc, Epidemiology Program Office, Centers for Disease Control and Prevention (Atlanta, Ga).

Funding/Support: Financial support to convene meetings of the CONSORT group was provided in part by Abbott Laboratories, American College of Physicians, GlaxoWellcome, The Lancet, Merck, Canadian Institutes for Health Research, National Library of Medicine, and TAP Pharmaceuticals.

Acknowledgment: The effort to improve the reporting of randomized trials, from its beginnings with the Standards of Reporting Trials (SORT) group to the current activities of the CONSORT group, have involved a large number of people around the globe. We wish to thank Leah Lepage, PhD, for keeping everybody all lined up and moving in the same direction.

Correspondence and Reprints: Leah Lepage, PhD, Thomas C. Chalmers Centre for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, Room R235, 401 Smyth Rd, Ottawa, Ontario, Canada K1H 8L1 (e-mail: llepage{at}uottawa.ca).

Author Affiliations: University of Ottawa, Thomas C. Chalmers Centre for Systematic Reviews, Ottawa, Ontario (Mr Moher); Family Health International and Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill (Dr Schulz); and ICRF Medical Statistics Group and Centre for Statistics in Medicine, Institute of Health Sciences, Oxford, England (Dr Altman).

REFERENCES

Jump to Section  • Top  • Introduction  • History of consort  • Revision of the consort...  • Changes to consort  • Comment  • Author information  • References

1. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408-412. FREE FULL TEXT 2. Moher D, Pham B, Jones A, et al. Does the quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet. 1998;352:609-613. FULL TEXT | ISI | PUBMED 3. Jadad AR, Boyle M, Cunningham C, Kim M, Schachar R. Treatment of Attention-Deficit/Hyperactivity Disorder. Hamilton, Ontario: McMaster University; 2000. Evidence Report/Technology Assessment No. 11. 4. Thornley B, Adams CE. Content and quality of 2000 controlled trials in schizophrenia over 50 years. BMJ. 1998;317:1181-1184. FREE FULL TEXT 5. Hotopf M, Lewis G, Normand C. Putting trials on trial: the costs and consequences of small trials in depression: a systematic review of methodology. J Epidemiol Community Health. 1997;51:354-358. FREE FULL TEXT 6. Dickinson K, Bunn F, Wentz R, Edwards P, Roberts I. Size and quality of randomised controlled trials in head injury: review of published studies. BMJ. 2000;320:1308-1311. FREE FULL TEXT 7. Begg CB, Cho MK, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA. 1996;276:637-639. FREE FULL TEXT 8. Freemantle N, Mason JM, Haines A, Eccles MP. CONSORT: an important step toward evidence-based health care. Ann Intern Med. 1997;126:81-83. FREE FULL TEXT 9. Altman DG. Better reporting of randomized controlled trials: the CONSORT statement. BMJ. 1996;313:570-571. FREE FULL TEXT 10. Schulz KF. The quest for unbiased research: randomized clinical trials and the CONSORT reporting guidelines. Ann Neurol. 1997;41:569-573. FULL TEXT | ISI | PUBMED 11. Huston P, Hoey J. CMAJ endorses the CONSORT statement. CMAJ. 1996;155:1277-1279. PUBMED 12. Davidoff F. News from the International Committee of Medical Journal Editors. Ann Intern Med. 2000;133:229-231. FREE FULL TEXT 13. CONSORT Web site. Available at: http://www.consort-statement.org. Accessibility verified March 14, 2001. 14. Moher D, Jones A, Lepage L for the CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001;285:1992-1995. FREE FULL TEXT 15. Egger M, Jüni P, Bartlett C for the CONSORT Group. Value of flow diagrams in reports of randomized controlled trials. JAMA. 2001;285:1996-1999. FREE FULL TEXT 16. Meinert CL. Beyond CONSORT: need for improved reporting standards for clinical trials. JAMA. 1998;279:1487-1489. FREE FULL TEXT 17. Chalmers I. Current controlled trials: an opportunity to help improve the quality of clinical research. Curr Control Trials Cardiovasc Med. 2000;1:3-8. 18. Bailer III JC, Mosteller F. Guidelines for statistical reporting in articles for medical journals: amplifications and explanations. Ann Intern Med. 1988;108:266-273. FREE FULL TEXT 19. Altman DG, Schulz KF, Moher D, et al for the CONSORT group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134:663-694. FREE FULL TEXT 20. Elbourne DR, Campbell MK. Extending the CONSORT statement to cluster randomised trials: for discussion. Stat Med. 2001;20:489-496. FULL TEXT | ISI | PUBMED 21. Hollis S, Campbell F. What is meant by intention-to-treat analysis? survey of published randomized controlled trials. BMJ. 1999;319:670-674. FREE FULL TEXT 22. Ruiz-Canela M, Martinez-Gonzalez MA, de Irala-Estevez J. Intention-to-treat analysis is related to methodological quality. BMJ. 2000;320:1007-1008. FREE FULL TEXT 23. Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB. Analysis of clinical trials by treatment actually received: is it really an option? Stat Med. 1991;10:1595-1605. ISI | PUBMED 24. Bentzen SM. Towards evidence based radiation oncology: improving the design, analysis, and reporting of clinical outcome studies in radiotherapy. Radiother Oncol. 1998;46:5-18. FULL TEXT | ISI | PUBMED 25. O'Toole LB. MRC uses checklist similar to CONSORT's. BMJ. 1997;314:1127. FREE FULL TEXT 26. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF for the QUOROM group. Improving the quality of reports of meta-analyses of randomized controlled trials: the QUOROM statement. Lancet. 1999;354:1896-1900. FULL TEXT | ISI | PUBMED 27. Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. JAMA. 2000;283:2008-2012. FREE FULL TEXT 28. Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analysis. JAMA. 1996;276:1339-1341. FREE FULL TEXT 29. Neumann PJ, Stone PW, Chapman RH, Sandberg EA, Bell CM. The Quality of Reporting in Published Cost-Utility Analyses, 1976-1997. Ann Intern Med. 2000;132:964-972. FREE FULL TEXT 30. Altman DG. The scandal of poor medical research. BMJ. 1994;308:283-284. FREE FULL TEXT

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Methods for therapeutic trials in COPD: lessons from the TORCH trial
Keene et al.
Eur Respir J 2009;34:1018-1023.
ABSTRACT | FULL TEXT  

Research design issues for the use of magnetic resonance imaging machines in brain studies of psychological/psychiatric variables
Czarnolewski
Behav Res Methods 2009;41:1061-1072.
ABSTRACT  

Quality of randomised trials in COPD
Bausch et al.
Eur Respir J 2009;34:1060-1065.
ABSTRACT | FULL TEXT  

Caveats for Scientific Publication in the Modern Marketplace
Will
CJASN 2009;4:1693-1695.
FULL TEXT  

Risk of bias versus quality assessment of randomised controlled trials: cross sectional study
Hartling et al.
BMJ 2009;339:b4012-b4012.
ABSTRACT | FULL TEXT  

Prophylactic Intravenous Magnesium Sulphate in Addition to Oral {beta}-Blockade Does Not Prevent Atrial Arrhythmias After Coronary Artery or Valvular Heart Surgery: A Randomized, Controlled Trial
Cook et al.
Circulation 2009;120:S163-S169.
ABSTRACT | FULL TEXT  

Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials
Mathieu et al.
JAMA 2009;302:977-984.
ABSTRACT | FULL TEXT  

Mobile and Fixed-Bearing (All-Polyethylene Tibial Component) Total Knee Arthroplasty Designs. A Prospective Randomized Trial
Gioe et al.
JBJS 2009;91:2104-2112.
ABSTRACT | FULL TEXT  

The Efficacy of Adherence Interventions for Chronically Ill Children: A Meta-Analytic Review
Graves et al.
J Pediatr Psychol 2009;0:jsp072v1-jsp072.
ABSTRACT | FULL TEXT  

Strength training combined with plyometric jumps in adults: sex differences in fat-bone axis adaptations
Martyn-St. James and Carroll
J. Appl. Physiol. 2009;107:636-636.
FULL TEXT  

Reporting of adverse events in randomized controlled trials of highly active antiretroviral therapy: systematic review
Chowers et al.
J Antimicrob Chemother 2009;64:239-250.
ABSTRACT | FULL TEXT  

AJPH Endorsement of Transparency, Clarity, and Rigor
Vaughan
AJPH 2009;99:1356-1359.
FULL TEXT  

Effect Size Estimation: A Necessary Component of Statistical Analysis
Livingston et al.
Arch Surg 2009;144:706-712.
FULL TEXT  

A Randomized Controlled Trial of Standard vs Endobronchial Ultrasonography-Guided Transbronchial Needle Aspiration in Patients With Suspected Sarcoidosis
Tremblay et al.
Chest 2009;136:340-346.
ABSTRACT | FULL TEXT  

Review Paper: Gene Expression Profiling in Veterinary and Human Medicine: Overview of Applications and Proposed Quality Control Practices
Kort et al.
Vet Pathol 2009;46:598-603.
ABSTRACT | FULL TEXT  

Lower protein in infant formula is associated with lower weight up to age 2 y: a randomized clinical trial
Koletzko et al.
Am. J. Clin. Nutr. 2009;89:1836-1845.
ABSTRACT | FULL TEXT  

Clinical Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients, 2009
American Society for Parenteral and Enteral Nutrit
JPEN J Parenter Enteral Nutr 2009;33:255-259.
FULL TEXT  

Interpreting Trial Results in Light of Conflicting Evidence: A Bayesian Analysis of Adjuvant Chemotherapy for Non-Small-Cell Lung Cancer
Miksad et al.
JCO 2009;27:2245-2252.
ABSTRACT | FULL TEXT  

Editorial: How to Write an Effective Results and Discussion for the Journal of Pediatric Psychology
Drotar
J Pediatr Psychol 2009;34:339-343.
FULL TEXT  

Conflict of Interest, Disclosure, and Trial Reports
Psaty
JAMA 2009;301:1477-1479.
FULL TEXT  

Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions--A Systematic Review
Li et al.
Evid Based Complement Alternat Med 2009;0:nep022v1-nep022.
ABSTRACT | FULL TEXT  

Review: Methodological quality in medical evidence, quo vadis?
Diaz-Insua
Therapeutic Advances in Urology 2009;1:51-59.
ABSTRACT  

Editorial: How to Report Methods in the Journal of Pediatric Psychology
Drotar
J Pediatr Psychol 2009;34:227-230.
FULL TEXT  

Carbon Monoxide Poisoning
Weaver
NEJM 2009;360:1217-1225.
FULL TEXT  

Mistletoe Preparation Iscador: Are there Methodological Concerns with Respect to Controlled Clinical Trials?
Ziegler
Evid Based Complement Alternat Med 2009;6:19-30.
ABSTRACT | FULL TEXT  

STrengthening the REporting of Genetic Association Studies (STREGA): An Extension of the STROBE Statement
Little et al.
ANN INTERN MED 2009;150:206-215.
ABSTRACT | FULL TEXT  

Patient reported outcome measures in trials
Garratt
BMJ 2009;338:a2597-a2597.
FULL TEXT  

Application of Systematic Review Methodology to the Field of Nutrition
Lichtenstein et al.
J. Nutr. 2008;138:2297-2306.
ABSTRACT | FULL TEXT  

Methodologic Shortcomings of the INSPIRE Randomized Trial
Wedzicha et al.
Am. J. Respir. Crit. Care Med. 2008;178:1091-1092.
FULL TEXT  

Statistical analysis of COPD exacerbations
Keene et al.
Eur Respir J 2008;32:1421-1422.
FULL TEXT  

Acronyms and Anachronisms
Reider
Am J Sports Med 2008;36:2081-2082.
FULL TEXT  

Cardiovascular Outcomes in Trials of Oral Diabetes Medications: A Systematic Review
Selvin et al.
Arch Intern Med 2008;168:2070-2080.
ABSTRACT | FULL TEXT  

Isolated Disease of the Proximal Left Anterior Descending Artery: Comparing the Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Surgery
Kapoor et al.
J Am Coll Cardiol Intv 2008;1:483-491.
ABSTRACT | FULL TEXT  

The "number needed to treat" turns 20 -- and continues to be used and misused
McAlister
CMAJ 2008;179:549-553.
FULL TEXT  

Adalimumab with or without Methotrexate in Juvenile Rheumatoid Arthritis
Lovell et al.
NEJM 2008;359:810-820.
ABSTRACT | FULL TEXT  

Alternatives to the Randomized Controlled Trial
West et al.
AJPH 2008;98:1359-1366.
ABSTRACT | FULL TEXT  

Evidence-based Effectiveness of Topical Fluorides
Marinho
ADR 2008;20:3-7.
FULL TEXT  

Practitioner Expertise in Evidence-Based Practice Decision Making
McCracken and Marsh
Research on Social Work Practice 2008;18:301-310.
ABSTRACT  

Meta-Analysis of Psychological Interventions to Promote Adherence to Treatment in Pediatric Chronic Health Conditions
Kahana et al.
J Pediatr Psychol 2008;33:590-611.
ABSTRACT | FULL TEXT  

Is Office-Based Counseling About Media Use, Timeouts, and Firearm Storage Effective? Results From a Cluster-Randomized, Controlled Trial
Barkin et al.
Pediatrics 2008;122:e15-e25.
ABSTRACT | FULL TEXT  

Quality of Efficacy Research in Complementary and Alternative Medicine
Chan
JAMA 2008;299:2685-2686.
FULL TEXT  

Cognitive Behavior Therapy for Schizophrenia: Effect Sizes, Clinical Models, and Methodological Rigor
Wykes et al.
Schizophr Bull 2008;34:523-537.
ABSTRACT | FULL TEXT  

Effectiveness of Specialized Palliative Care: A Systematic Review
Zimmermann et al.
JAMA 2008;299:1698-1709.
ABSTRACT | FULL TEXT  

Using radon risk to motivate smoking reduction II: randomized evaluation of brief telephone counseling and a targeted video
Lichtenstein et al.
Health Educ Res 2008;23:191-201.
ABSTRACT | FULL TEXT  

Improving the Quality of Abstract Reporting for Phase I Cancer Trials
Strevel et al.
Clin. Cancer Res. 2008;14:1782-1787.
ABSTRACT | FULL TEXT  

Anesthesia Awareness and the Bispectral Index
Avidan et al.
NEJM 2008;358:1097-1108.
ABSTRACT | FULL TEXT  

Promoting Regular Mammography Screening I. A Systematic Assessment of Validity in a Randomized Trial
del Junco et al.
JNCI J Natl Cancer Inst 2008;100:333-346.
ABSTRACT | FULL TEXT  

A critical evaluation of a percutaneous diagnostic and treatment strategy for chylothorax after thoracic surgery
Boffa et al.
Eur. J. Cardiothorac. Surg. 2008;33:435-439.
ABSTRACT | FULL TEXT  

Improving the reporting of public health intervention research: advancing TREND and CONSORT
Armstrong et al.
J Public Health (Oxf) 2008;30:103-109.
ABSTRACT | FULL TEXT  

In women with suspected TB, brief sputum-submission instruction improved sampling quality and TB detection
Gonzalez and Menzies
Evid. Based Med. 2008;13:14-14.
FULL TEXT  

Negative Pressure Wound Therapy: A Vacuum of Evidence?
Gregor et al.
Arch Surg 2008;143:189-196.
ABSTRACT | FULL TEXT  

Generalizability of the Results of Randomized Trials
Weiss et al.
Arch Intern Med 2008;168:133-135.
FULL TEXT  

Amiodarone Cost Effectiveness in Preventing Atrial Fibrillation After Coronary Artery Bypass Graft Surgery
Zebis et al.
Ann. Thorac. Surg. 2008;85:28-32.
ABSTRACT | FULL TEXT  

Cognitive-Behavioral Interventions to Reduce Suicide Behavior: A Systematic Review and Meta-Analysis
Tarrier et al.
Behav Modif 2008;32:77-108.
ABSTRACT  

Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups
Tong et al.
Int J Qual Health Care 2007;19:349-357.
ABSTRACT | FULL TEXT  

Weight Loss in Overweight Mexican American Children: A Randomized, Controlled Trial
Johnston et al.
Pediatrics 2007;120:e1450-e1457.
ABSTRACT | FULL TEXT  

Hip Protectors and Hip Fracture
Cummings
JAMA 2007;298:2139-2139.
FULL TEXT  

Propensity-score matching in the cardiovascular surgery literature from 2004 to 2006: a systematic review and suggestions for improvement.
Austin
J. Thorac. Cardiovasc. Surg. 2007;134:1128-1135.
ABSTRACT | FULL TEXT  

Does Adjuvant Vaccine Therapy Really Have Activity in Malignant Melanoma?
Wheatley et al.
JCO 2007;25:4693-4693.
FULL TEXT  

The Long-term Consequence of Anterior Cruciate Ligament and Meniscus Injuries: Osteoarthritis
Lohmander et al.
Am J Sports Med 2007;35:1756-1769.
ABSTRACT | FULL TEXT  

Association Between Funding and Quality of Published Medical Education Research
Reed et al.
JAMA 2007;298:1002-1009.
ABSTRACT | FULL TEXT  

The Quality of Reporting of Orthopaedic Randomized Trials with Use of a Checklist for Nonpharmacological Therapies
Chan and Bhandari
JBJS 2007;89:1970-1978.
ABSTRACT | FULL TEXT  

The intention-to-treat approach in randomized controlled trials: Are authors saying what they do and doing what they say?
Gravel et al.
Clin Trials 2007;4:350-356.
ABSTRACT  

Evidence-based Radiology: Review and Dissemination
Medina and Blackmore
Radiology 2007;244:331-336.
ABSTRACT | FULL TEXT  

Meta-analysis: The Effect of Dietary Counseling for Weight Loss
Dansinger et al.
ANN INTERN MED 2007;147:41-50.
ABSTRACT | FULL TEXT  

A collaborative effort to apply the evidence-based review process to the field of nutrition: challenges, benefits, and lessons learned
Balk et al.
Am. J. Clin. Nutr. 2007;85:1448-1456.
ABSTRACT | FULL TEXT  

Inadequate statistical power in Barrett's oesophagus ablation study * Authors' response
Lim et al.
Gut 2007;56:884-885.
FULL TEXT  

Studies Should Report Estimates of Treatment Effects With Confidence Intervals
Cummings
Arch Pediatr Adolesc Med 2007;161:518-519.
FULL TEXT  

Chinese herbal medicine for schizophrenia: Cochrane systematic review of randomised trials
Rathbone et al.
Br. J. Psychiatry 2007;190:379-384.
ABSTRACT | FULL TEXT  

A meta-analysis of randomized control trials comparing minimally invasive direct coronary bypass grafting versus percutaneous coronary intervention for stenosis of the proximal left anterior descending artery
Jaffery et al.
Eur. J. Cardiothorac. Surg. 2007;31:691-697.
ABSTRACT | FULL TEXT  

Vision for a Global Registry of Anticipated Public Health Studies
Choi et al.
AJPH 2007;97:S82-S87.
ABSTRACT | FULL TEXT  

Eligibility Criteria of Randomized Controlled Trials Published in High-Impact General Medical Journals: A Systematic Sampling Review
Van Spall et al.
JAMA 2007;297:1233-1240.
ABSTRACT | FULL TEXT  

Identifying Key Processes of Exercise Behaviour Change Associated with Movement through the Stages of Exercise Behaviour Change
Lowther et al.
J Health Psychol 2007;12:261-272.
ABSTRACT  

Best-Evidence Interventions: Findings From a Systematic Review of HIV Behavioral Interventions for US Populations at High Risk, 2000-2004
Lyles et al.
AJPH 2007;97:133-143.
ABSTRACT | FULL TEXT  

Effect of a Mailed Brochure on Appointment-Keeping for Screening Colonoscopy: A Randomized Trial
Denberg et al.
ANN INTERN MED 2006;145:895-900.
ABSTRACT | FULL TEXT  

Effect of a Pharmacy Care Program on Medication Adherence and Persistence, Blood Pressure, and Low-Density Lipoprotein Cholesterol: A Randomized Controlled Trial
Lee et al.
JAMA 2006;296:2563-2571.
ABSTRACT | FULL TEXT  

Effects of n-3 long-chain polyunsaturated fatty acids on depressed mood: systematic review of published trials
Appleton et al.
Am. J. Clin. Nutr. 2006;84:1308-1316.
ABSTRACT | FULL TEXT  

Enhancing the Quality of Life of Dementia Caregivers from Different Ethnic or Racial Groups: A Randomized, Controlled Trial.
Belle et al.
ANN INTERN MED 2006;145:727-738.
ABSTRACT | FULL TEXT  

Fondaparinux in patients with ST-segment elevation myocardial infarction.
Hartig et al.
JAMA 2006;296:2087-2087.
FULL TEXT  

Meta-analysis in Surgery--Invited Critique
Chang
Arch Surg 2006;141:1131-1131.
FULL TEXT  

A Primer on the Design, Conduct, and Interpretation of Clinical Trials
Appel
CJASN 2006;1:1360-1367.
ABSTRACT | FULL TEXT  

Evidence-Based Practice in Communication Disorders: Progress not Perfection
Kent
LSHSS 2006;37:268-270.
ABSTRACT | FULL TEXT  

Commentary on "Making Evidence-Based Decisions About Child Language Intervention in Schools" by Gillam and Gillam
Fey
LSHSS 2006;37:316-319.
ABSTRACT | FULL TEXT  

EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee For International Clinical Studies Including Therapeutics (ESCISIT)
Zhang et al.
Ann Rheum Dis 2006;65:1312-1324.
ABSTRACT | FULL TEXT  

Evidence of publication bias in reporting acute stroke clinical trials.
Liebeskind et al.
Neurology 2006;67:973-979.
ABSTRACT | FULL TEXT  

Underrepresentation of renal disease in randomized controlled trials of cardiovascular disease.
Coca et al.
JAMA 2006;296:1377-1384.
ABSTRACT | FULL TEXT