#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration


Background:
Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract.

Methods and Findings:
We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item.

Conclusions:
CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.


Vyšlo v časopise: CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration. PLoS Med 5(1): e20. doi:10.1371/journal.pmed.0050020
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.0050020

Souhrn

Background:
Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract.

Methods and Findings:
We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item.

Conclusions:
CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.


Zdroje

1. SchererRWLangenbergPvon ElmE

2007

Full publication of results initially presented in abstracts.

Cochrane Database of Systematic Reviews

Issue 4

Art. No.: MR000005. doi:10.1002/14651858.MR000005.pub3. Available: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/MR000005/frame.html. Accessed 1 May 2007.

2. HarbourtAMKnechtLSHumphreysBL

1995

Structured abstracts in MEDLINE, 1989–1991.

Bull Med Libr Assoc

83

190

195

3. HopewellSMcDonaldSClarkeMEggerM

2007

Grey literature in meta-analyses of randomized trials of health care interventions.

Cochrane Database of Systematic Reviews

Issue 4

Art. No.: MR000010. doi:10.1002/14651858.MR000010.pub3. Available: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/MR000010/frame.html. Accessed 1 May 2007.

4. HopewellSEisingaAClarkeM

2007

Better reporting of randomized trials in biomedical journal and conference abstracts.

J Info Sci

doi:10.1177/0165551507080415.

5. ChalmersIAdamsMDickersinKHetheringtonJTarnow-MordiW

1990

A cohort study of summary reports of controlled trials.

JAMA

263

1401

1405

6. HerbisonP

2005

The reporting quality of abstracts of randomised controlled trials submitted to the ICS meeting in Heidelberg.

Neurourol Urodyn

24

21

24

7. HopewellSClarkeM

2005

Abstracts presented at the American Society of Clinical Oncology conference: how completely are trials reported?

Clin Trials

2

265

268

8. KrzyzanowskaMKPintilieMTannockIF

2003

Factors associated with failure to publish large randomized trials presented at an oncology meeting.

JAMA

290

495

501

9. SchererR

2006

Are harms reported in abstracts of trial results from conference proceedings?

XIV Cochrane Colloquium

23–26 October,

Dublin, Ireland:

63

10. HopewellSClarkeMAskieL

2006

Reporting of trials presented in conference abstracts needs to be improved.

J Clin Epidemiol

59

681

684

11. TomaMMcAlisterFABialyLAdamsDVandermeerB

2006

Transition from meeting abstract to full-length journal article for randomized controlled trials.

JAMA

295

1281

1287

12. DundarYDoddSDicksonRWalleyTHaycoxA

2006

Comparison of conference abstracts and presentations with full-text articles in the health technology assessments of rapidly evolving technologies.

Health Technol Assess

10

1

145

13. ChokkalingamASchererRDickersinK

1998

Agreement of data abstracts compared to full publications.

Control Clin Trials

19

61S

62S

14. EstradaCABlochRMAntonacciDBasnightLLPatelSR

2000

Reporting and concordance of methodologic criteria between abstracts and articles in diagnostic test studies.

J Gen Intern Med

15

183

187

15. FroomPFroomJ

1993

Deficiencies in structured medical abstracts.

J Clin Epidemiol

46

591

594

16. HarrisAHStandardSBrunningJLCaseySLGoldergJH

2002

The accuracy of abstracts in psychology journals.

J Psychol

136

141

148

17. PitkinRMBranaganMABurmeisterLF

1999

Accuracy of data in abstracts of published research articles.

JAMA

281

1110

1111

18. WardLGKendrachMGPriceSO

2004

Accuracy of abstracts for original research articles in pharmacy journals.

Ann Pharmacother

38

1173

1177

19. IoannidisJPLauJ

2001

Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.

JAMA

285

437

443

20. IoannidisJPEvansSJGøtzschePCO'NeillRTAltmanDG

2004

Better reporting of harms in randomized trials: an extension of the CONSORT statement.

Ann Intern Med

141

781

788

21. BeggCChoMEastwoodSHortonRMoherD

1996

Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

JAMA

276

637

639

22. MoherDSchulzKFAltmanDGLepageL

2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.

Lancet

357

1191

1194

23. International Committee of Medical Journal Editors

2006

Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication

[Updated February 2006.] Available: http://www.icmje.org. Accessed 1 December 2006.

24. SchrigerDLAroraSAltmanDG

2006

The content of medical journal Instructions for authors.

Ann Emerg Med

48

743

749

25. Ad Hoc Working Group for Critical Appraisal of the Medical Literature

1987

A proposal for more informative abstracts of clinical articles.

Ann Intern Med

106

598

604

26. HaynesRBMulrowCDHuthEJAltmanDGGardnerMJ

1990

More informative abstracts revisited.

Ann Intern Med

113

69

76

27. HaynesRBMulrowCDHuthEJAltmanDGGardnerMJ

1996

More informative abstracts revisited.

Cleft Palate-Craniofac J

33

1

9

28. DeeksJJAltmanDG

1998

Inadequate reporting of controlled trials as short reports.

Lancet

318

193

194

29. HopewellS

2004

Impact of grey literature on systematic reviews of randomized trials

[PhD dissertation].

Oxford (UK)

Wolfson College, University of Oxford

30. HassonFKeeneySMcKennaH

2000

Research guidelines for the Delphi survey method.

J Adv Nurs

32

1008

1015

31. AltmanDGSchulzKFMoherDEggerMDavidoffF

2001

The revised CONSORT statement for reporting randomized trials: explanation and elaboration.

Ann Intern Med

134

663

694

32. BossuytPMReitsmaJBBrunsDEGatsonisCAGlasziouPP

2003

The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration.

Ann Intern Med

138

W1

12

33. ThiamSLeFevreAMHaneFNdiayeABaF

2007

Effectiveness of a strategy to improve adherence to tuberculosis treatment in a resource-poor setting: a cluster randomized controlled trial.

JAMA

297

380

386

34. DickersinKManheimerEWielandSRobinsonKALefebvreC

2002

Development of the Cochrane Collaboration's CENTRAL register of controlled clinical trials.

Eval Health Prof

25

38

64

35. CampbellMKElbourneDRAltmanDGCONSORT group

2004

CONSORT statement: extension to cluster randomised trials.

BMJ

328

702

708

36. HalonenJHalonenPJarvinenOTaskinenPAuvinenT

2007

Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial.

JAMA

297

1562

1567

37. OosterheertJJBontenMJSchneiderMMBuskensELammersJW

2006

Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia: multicentre randomised trial.

BMJ

33

1193

38. MebazaaANieminenMSPackerMCohen-SolalAKleberFX

2007

Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE randomized trial.

JAMA

297

1883

1891

39. ChanAWHrobjartssonAHaahrMTGøtzschePCAltmanDG

2004A

Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.

JAMA

291

2457

2465

40. ChanAWAltmanDG

2004B

Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors.

BMJ

330

753

41. WilliamsonPRGambleC

2005

Identification and impact of outcome selection bias in meta-analysis.

Stat Med

24

1547

1561

42. JohnsonNPFarquharCMHaddenWESucklingJYuY

2004

The FLUSH trial: flushing with lipiodol for unexplained (and endometriosis-related) subfertility by hysterosalpingography: a randomized trial.

Hum Reprod

19

2043

2051

43. GluudLL

2006

Bias in clinical intervention research.

Am J Epidemiol

163

493

501

44. PildalJHrobjartssonAJorgensenKHildenJAltmanD

2007

Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials.

Int J Epidemiol

36

847

857

45. JuniPAltmanDGEggerM

2001

Systematic reviews in health care: assessing the quality of controlled clinical trials.

BMJ

323

42

46

46. SchulzKFGrimesDA

2002

Allocation concealment in randomised trials: defending against deciphering.

Lancet

359

614

618

47. SchererRWCrawleyB

1998

Reporting of randomized clinical trial descriptors and use of structured abstracts.

JAMA

280

269

272

48. BurnsKEAAdhikariNKJKhoMMeadeMOPatelRV

2005

Abstract reporting in randomized clinical trials of acute lung injury: an audit and assessment of a quality of reporting score.

Crit Care Med

33

1937

1945

49. TaddioAPainTFassosFFBoonHIlersichAL

1994

Quality of nonstructured and structured abstracts of original research articles in the British Medical Journal, the Canadian Medical Association Journal and the Journal of the American Medical Association.

CMAJ

150

1611

1618

50. ClarkEPlintACCorrellRGabouryIPassiB

2007

A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma.

Pediatrics

119

460

467

51. SchulzKFGrimesDA

2006

The Lancet handbook of essential concepts in clinical research

London

Elsevier

52. SchulzKFAltmanDGMoherD

2007

Blinding is better than masking.

BMJ

334

918

53. DevereauxPJMannsBJGhaliWAQuanHLacchettiC

2001

Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials.

JAMA

285

2000

2003

54. PoolmanRWStruijsPAKripsRSiereveltINMartiRK

2007

Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter?

J Bone Joint Surg

89-A

550

558

55. SazawalSDhingraUDhingraPHiremathGKumarJ

2007

Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial.

BMJ

334

140

56. KimKBLeghaSSGonzalezRAndersonCPapadopoulosNE

2006

A phase III randomized trial of adjuvant biochemotherapy (BC) versus interferon-α-2b (IFN) in patients (pts) with high risk for melanoma recurrence.

J Clin Oncol

ASCO Annual Meeting Proceedings Part I. Vol

24

8003

57. PocockSJHughesMDLeeRJ

1987

Statistical problems in the reporting of clinical trials.

N Engl J Med

317

426

432

58. MontoriVMDevereauxPJAdhikariNKBurnsKEEggertCH

2005

Randomized trials stopped early for benefit: a systematic review.

JAMA

294

2203

2209

59. BhandariMDevereauxPJGuyattGHCookDJSwiontkowskiMF

2002

An observational study of orthopaedic abstracts and subsequent full-text publications.

J Bone Joint Surg

84-A

615

621

60. DryverEHuxJE

2002

Reporting of numerical and statistical differences in abstracts: improving but not optimal.

J Gen Intern Med

17

203

206

61. GøtzschePC

2006

Believability of relative risks and odds ratios in abstracts: cross sectional study.

BMJ

333

231

234

62. SchwartzLMWoloshinSDvorinELWelchHG

2006

Ratio measures in leading medical journals: structured review of accessibility of underlying absolute risks.

BMJ

333

1248

1250

63. JohnsonBARosenthalNCapeceJAWiegandFMaoL

2007

Topiramate for treating alcohol dependence: a randomized controlled trial.

JAMA

298

1641

1651

64. DerrySKong LokeYAronsonJK

2001

Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials.

BMC Med Res Methodol

1

7

65. FawziWWMsamangaGIUrassaWHertzmarkEPetraroP

2007

Vitamins and perinatal outcomes among HIV-negative women in Tanzania.

N Engl J Med

356

1423

1431

66. DickersinK

1997

How important is publication bias? A synthesis of available data.

AIDS Educ Prev

9

Supplement A

15

21

67. TramerMRReynoldsDJMooreRAMcQuayHJ

1997

Impact of covert duplicate publication on meta-analysis: a case study.

BMJ

315

635

640

68. SimesRJ

1986

Publication bias: the case for an international registry of clinical trials.

J Clin Oncol

4

1529

1541

69. WhittingtonCJKendallTFonagyPCottrellDCotgroveA

2004

Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data.

Lancet

363

1341

1345

70. De AngelisCDDrazenJMFrizelleFAHaugCHoeyJ

2005

Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors.

Lancet

365

1827

1829

71. ZarinDAIdeNCTseTHarlanWRWestJC

2007

Issues in the registration of clinical trials.

JAMA

297

2112

2120

72. ZellarsRCFrassicaDStearnsVFettingJHArmstrongDK

2006

Partial breast irradiation (PBI) concurrent with adjuvant dose-dense doxorubicin and dyclophosphamide (ddAC) chemotherapy in early-stage breast cancer: Preliminary safety results from a feasibility trial.

J Clin Oncol

ASCO Annual Meeting Proceedings Part I.

Vol 24

No. 18S (June 20 Supplement), 2006

10675

73. LexchinJBeroLADjulbegovicBClarkO

2003

Pharmaceutical industry sponsorship and research outcome and quality: systematic review.

BMJ

326

1167

1170

74. BeroLOostvogelFBacchettiPLeeK

2007

Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others.

PLoS Med

4

e184

doi: 10.1371/journal.pmed.0040184

75. HartleyJ

2004

Current findings from research on structured abstracts.

J Med Libr Assoc

92

368

371

76. GuimaraesCA

2006

Structured abstracts: narrative review.

Acta Cir Bras

21

263

268

77. SollaciLBPereiraMG

2004

The introduction, methods, results, and discussion (IMRAD) structure: a fifty-year survey.

J Med Libr Assoc

92

364

367

78. GulmezogluAMPangTHortonRDickersinK

2005

WHO facilitates international collaboration in setting standards for clinical trial registration.

Lancet

365

1829

1831

79. World Health Organisation

2007

International Clinical Trials Registry Platform

http://www.who.int/ictrp/en/. Accessed 12 June 2007.

80. LaineCHortonRDeangelisCDDrazenJMFrizelleFA

2007

Clinical trial registration: looking back and moving ahead.

BMJ

334

1177

1178

81. PiaggioGElbourneDRAltmanDGPocockSJEvansSJW

2006

Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement.

JAMA

295

1152

1160

82. National Library of Medicine

2007

MEDLINE / PubMed data element (field) descriptions

Available: http://www.nlm.nih.gov/bsd/mms/medlineelements.html. Accessed 16 April 2007.

83. HillCLBuchbinderROsborneR

2007

Quality of reporting of randomized clinical trials in abstracts of the 2005 Annual Meeting of the American College of Rheumatology.

J Rheumatol

34

2476

2480

Štítky
Interné lekárstvo

Článok vyšiel v časopise

PLOS Medicine


2008 Číslo 1
Najčítanejšie tento týždeň
Najčítanejšie v tomto čísle
Kurzy

Zvýšte si kvalifikáciu online z pohodlia domova

Získaná hemofilie - Povědomí o nemoci a její diagnostika
nový kurz

Eozinofilní granulomatóza s polyangiitidou
Autori: doc. MUDr. Martina Doubková, Ph.D.

Všetky kurzy
Prihlásenie
Zabudnuté heslo

Zadajte e-mailovú adresu, s ktorou ste vytvárali účet. Budú Vám na ňu zasielané informácie k nastaveniu nového hesla.

Prihlásenie

Nemáte účet?  Registrujte sa

#ADS_BOTTOM_SCRIPTS#