Advertisement

Reporting Guidelines: A Framework for Clarity and Transparency

  • Larissa Shamseer
  • David Moher
Chapter

Abstract

Complete and transparent reporting is imperative when assessing the validity of reported treatment effects and other findings of health research. A study’s methods should be described in enough detail so that they can be replicated, the analyses should follow the protocol, and the results should be provided in sufficient detail to be incorporated into future research, meta-analyses and practice guidelines. Complete and transparent reporting enables clinicians and others to make better, more informed healthcare decisions; it also reduces waste in healthcare research. Transparent reporting is an integral part of the research process and helps the reader judge whether good science has been used. For instance, without a description of the methods used to control internal validity (e.g. randomization, blinding) and external validity (e.g. definition of the population under study), the reader is left to ponder whether the reported effect of treatment is accurate and applicable to his/her own patients.

References

  1. 1.
    Macleod MR, Michie S, Roberts I, Dirnagl U, Chalmers I, Ioannidis JPA, et al. Biomedical research: increasing value, reducing waste. Lancet. 2014;383:101–4.CrossRefPubMedGoogle Scholar
  2. 2.
    Chalmers I, Bracken MBM, Djulbegovic B, Garattini S, Grant J, Gülmezoglu AM, et al. How to increase value and reduce waste when research priorities are set. Lancet. 2014;383:156–65.CrossRefPubMedGoogle Scholar
  3. 3.
    Ioannidis JPA, Greenland S, Hlatky MA, Khoury MJ, Macleod MR, Moher D, et al. Increasing value and reducing waste in research design, conduct, and analysis. Lancet. 2014;383:166–75.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Al-Shahi Salman R, Beller E, Kagan J, Hemminki E, Phillips RS, Savulescu J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014;383:176–85.CrossRefPubMedGoogle Scholar
  5. 5.
    Chan A-WA, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet. 2014;383:257–66.CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383:267–76.CrossRefPubMedGoogle Scholar
  7. 7.
    Tallon D, Chard J, Dieppe P. Relation between agendas of the research community and the research consumer. Lancet. 2000;355:2037–40.CrossRefPubMedGoogle Scholar
  8. 8.
    Pildal J, Hróbjartsson A, Jørgensen KJ, Hilden J, Altman DG, Gøtzsche PC. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol. 2007;36:847–57. Erratum in: Int J Epidemiol 2008;37:422.CrossRefPubMedGoogle Scholar
  9. 9.
    Odgaard-Jensen J, Vist GE, Timmer A, Kunz R, Akl EA, Schünemann H, et al. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev. 2011;(4):MR000012.  https://doi.org/10.1002/14651858.MR000012.pub3.
  10. 10.
    Hopewell S, Clarke M, Stewart L, Tierney J. Time to publication for results of clinical trials. Cochrane Database Syst Rev. 2007;(2):MR000011.Google Scholar
  11. 11.
    Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev. 2009;(1):MR000006.  https://doi.org/10.1002/14651858.MR000006.pub3.
  12. 12.
    A consensus statement on research misconduct in the UK. BMJ. 2012;344:e1111.  https://doi.org/10.1136/bmj.e1111.
  13. 13.
    Moher D. Reporting research results: a moral obligation for all researchers. Can J Anaesth. 2007;54:331–5.CrossRefPubMedGoogle Scholar
  14. 14.
    Groves T. Enhancing the quality and transparency of health research. BMJ. 2008;337:a718.  https://doi.org/10.1136/bmj.a718.CrossRefPubMedGoogle Scholar
  15. 15.
    Ioannidis JP. Contradicted and initially stronger effects in highly cited clinical research. JAMA. 2005;294:218–28.CrossRefPubMedGoogle Scholar
  16. 16.
    Tharyan P, George AT, Kirubakaran R, Barnabas JP. Reporting of methods was better in the Clinical Trials Registry–India than in Indian journal publications. J Clin Epidemiol. 2013;66:10–22.  https://doi.org/10.1016/j.jclinepi.2011.11.011.CrossRefPubMedGoogle Scholar
  17. 17.
    Mignini LE, Khan KS. Methodological quality of systematic reviews of animal studies: a survey of reviews of basic research. BMC Med Res Methodol. 2006;6:10.CrossRefPubMedPubMedCentralGoogle Scholar
  18. 18.
    Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? BMJ. 2008;336:1472–4.  https://doi.org/10.1136/bmj.39590.732037.47.CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ. 2010;340:c723.  https://doi.org/10.1136/bmj.c723.CrossRefPubMedPubMedCentralGoogle Scholar
  20. 20.
    Duff JM, Leather H, Walden EO, LaPlant KD, George TJ Jr. Adequacy of published oncology randomized controlled trials to provide therapeutic details needed for clinical application. J Natl Cancer Inst. 2010;102:702–5.  https://doi.org/10.1093/jnci/djq117.CrossRefPubMedGoogle Scholar
  21. 21.
    de Vries TW, van Roon EN. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials. Arch Dis Child. 2010;95:1023–6.  https://doi.org/10.1136/adc.2009.175562.CrossRefPubMedGoogle Scholar
  22. 22.
    Nolte S, Wong D, Lachford G. Amphetamines for schizophrenia. Cochrane Database Syst Rev. 2004;(4):CD004964.Google Scholar
  23. 23.
    Birnie AJ, Bath-Hextall FJ, Ravenscroft JC, Williams HC. Interventions to reduce Staphylococcus aureus in the management of atopic eczema. Cochrane Database Syst Rev. 2008;(3):CD003871.  https://doi.org/10.1002/14651858.CD003871.pub2.
  24. 24.
    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;273:408–12.CrossRefPubMedGoogle Scholar
  25. 25.
    Moher D, Weeks L, Ocampo M, Seely D, Sampson M, Altman DG, et al. Describing reporting guidelines for health research: a systematic review. J Clin Epidemiol. 2011;64:718–42.  https://doi.org/10.1016/j.jclinepi.2010.09.013.CrossRefPubMedGoogle Scholar
  26. 26.
    Winters BD, Gurses AP, Lehmann H, Sexton JB, Rampersad CJ, Pronovost PJ. Clinical review: checklists—translating evidence into practice. Crit Care. 2009;13:210.  https://doi.org/10.1186/cc7792.CrossRefPubMedPubMedCentralGoogle Scholar
  27. 27.
    Gawande A. The checklist manifesto: how to get things right. New York: Metropolitan Books; 2010.Google Scholar
  28. 28.
    Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491–9.  https://doi.org/10.1056/NEJMsa0810119.CrossRefPubMedGoogle Scholar
  29. 29.
    Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006;355:2725–32. Erratum in: N Engl J Med 2007;356:2660.CrossRefPubMedGoogle Scholar
  30. 30.
    Shamseer L, Stevens A, Skidmore B, Turner L, Altman DG, Hirst A, et al. Does journal endorsement of reporting guidelines influence the completeness of reporting of health research? A systematic review protocol. Syst Rev. 2012;1:24.  https://doi.org/10.1186/2046-4053-1-24.CrossRefPubMedPubMedCentralGoogle Scholar
  31. 31.
    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.  https://doi.org/10.1136/bmj.c869.CrossRefPubMedPubMedCentralGoogle Scholar
  32. 32.
    Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009;6:e1000100.  https://doi.org/10.1371/journal.pmed.1000100.CrossRefPubMedPubMedCentralGoogle Scholar
  33. 33.
    Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. PLoS Med. 2007;4:e297.CrossRefPubMedPubMedCentralGoogle Scholar
  34. 34.
    Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann Intern Med. 1994;121:894–5.Google Scholar
  35. 35.
    A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. JAMA. 1994;272:1926–31. Erratum in: JAMA 1995;273:776.Google Scholar
  36. 36.
    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 statement. JAMA. 1996;276:637–9.CrossRefPubMedGoogle Scholar
  37. 37.
    Moher D, Schulz KF, Altman DG, CONSORT. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol. 2001;1:2.CrossRefPubMedPubMedCentralGoogle Scholar
  38. 38.
    Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726–32.  https://doi.org/10.7326/0003-4819-152-11-201006010-00232.CrossRefPubMedGoogle Scholar
  39. 39.
    Gabriel SE, Normand SL. Getting the methods right—the foundation of patient-centered outcomes research. N Engl J Med. 2012;367:787–90.  https://doi.org/10.1056/NEJMp1207437.CrossRefPubMedGoogle Scholar
  40. 40.
    Williams HC. Cars, CONSORT 2010, and clinical practice. Trials. 2010;11:33.  https://doi.org/10.1186/1745-6215-11-33.CrossRefPubMedPubMedCentralGoogle Scholar
  41. 41.
    Simera I, Moher D, Hirst A, Hoey J, Schulz KF, Altman DG. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network. BMC Med. 2010;8:24.  https://doi.org/10.1186/1741-7015-8-24.CrossRefPubMedPubMedCentralGoogle Scholar
  42. 42.
    Simera I, Altman DG. Writing a research article that is ‘fit for purpose’: EQUATOR Network and reporting guidelines. Evid Based Med. 2009;14:132–4.  https://doi.org/10.1136/ebm.14.5.132.CrossRefPubMedGoogle Scholar
  43. 43.
    Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med. 2010;7(2):e1000217.  https://doi.org/10.1371/journal.pmed.1000217.CrossRefPubMedPubMedCentralGoogle Scholar
  44. 44.
    International Steering Committee of Medical Editors. Uniform requirements for manuscripts submitted to biomedical journals. Br Med J. 1979;1:532–5.CrossRefGoogle Scholar
  45. 45.
    Jefferson T, Rudin M, Brodney Folse S, Davidoff F. Editorial peer review for improving the quality of reports of biomedical studies. Cochrane Database Syst Rev. 2007;(2):MR000016.Google Scholar
  46. 46.
    Demicheli V, Di Pietrantonj C. Peer review for improving the quality of grant applications. Cochrane Database Syst Rev. 2007;(2):MR000003.Google Scholar
  47. 47.
    Cobo E, Cortés J, Ribera JM, Cardellach F, Selva-O’Callaghan A, Kostov B, et al. Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical journal: masked randomised trial. BMJ. 2011;343:d6783.  https://doi.org/10.1136/bmj.d6783.CrossRefPubMedPubMedCentralGoogle Scholar
  48. 48.
    Cobo E, Selva-O’Callagham A, Ribera JM, Cardellach F, Dominguez R, Vilardell M. Statistical reviewers improve reporting in biomedical articles: a randomized trial. PLoS One. 2007;2:e332.CrossRefPubMedPubMedCentralGoogle Scholar
  49. 49.
    Hirst A, Altman DG. Are peer reviewers encouraged to use reporting guidelines? A survey of 116 health research journals. PLoS One. 2012;7:e35621.  https://doi.org/10.1371/journal.pone.0035621.CrossRefPubMedPubMedCentralGoogle Scholar
  50. 50.
    Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012;(11):MR000030.  https://doi.org/10.1002/14651858.MR000030.pub2.
  51. 51.
    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 controlled trials? A systematic review. Med J Aust. 2006;185:263–7.PubMedGoogle Scholar
  52. 52.
    Funai EF, Rosenbush EJ, Lee MJ, Del Priore G. Distribution of study designs in four major US journals of obstetrics and gynecology. Gynecol Obstet Invest. 2001;51:8–11.CrossRefPubMedGoogle Scholar
  53. 53.
    Scales CD Jr, Norris RD, Peterson BL, Preminger GM, Dahm P. Clinical research and statistical methods in the urology literature. J Urol. 2005;174(4 Pt 1):1374–9.CrossRefPubMedGoogle Scholar
  54. 54.
    Stevens A, Shamseer L, Weinstein E, Yazdi F, Turner L, Thielman J, et al. Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines: systematic review. BMJ. 2014;348:g3804.CrossRefPubMedPubMedCentralGoogle Scholar
  55. 55.
    Altman DG. Endorsement of the CONSORT statement by high impact medical journals: survey of instructions for authors. BMJ. 2005;330:1056–7.CrossRefPubMedPubMedCentralGoogle Scholar
  56. 56.
    Hopewell S, Altman DG, Moher D, Schulz KF. Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal ‘Instructions to Authors’. Trials. 2008;9:20.  https://doi.org/10.1186/1745-6215-9-20.CrossRefPubMedPubMedCentralGoogle Scholar
  57. 57.
    von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007;335:806–8.CrossRefGoogle Scholar
  58. 58.
    Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.  https://doi.org/10.1136/bmj.b2535.CrossRefPubMedPubMedCentralGoogle Scholar
  59. 59.
    Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. Clin Chem. 2003;49:1–6.CrossRefPubMedGoogle Scholar
  60. 60.
    Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin Chem. 2003;49:7–18.CrossRefPubMedGoogle Scholar
  61. 61.
    Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomized controlled trials. Cochrane Database Syst Rev. 2011;(1):MR000031.  https://doi.org/10.1002/14651858.MR000031.pub2.
  62. 62.
    Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340:c365.  https://doi.org/10.1136/bmj.c365.CrossRefPubMedGoogle Scholar
  63. 63.
    Kirkham JJ, Altman DG, Williamson PR. Bias due to changes in specified outcomes during the systematic review process. PLoS One. 2010;5:e9810.  https://doi.org/10.1371/journal.pone.0009810.CrossRefPubMedPubMedCentralGoogle Scholar
  64. 64.
    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 outcome reporting bias. PLoS One. 2008;3:e3081.  https://doi.org/10.1371/journal.pone.0003081.CrossRefPubMedPubMedCentralGoogle Scholar
  65. 65.
    Chan AW, Krleza-Jerić K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ. 2004;171:735–40.CrossRefPubMedPubMedCentralGoogle Scholar
  66. 66.
    Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.  https://doi.org/10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMedPubMedCentralGoogle Scholar
  67. 67.
    Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentralGoogle Scholar
  68. 68.
    Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1.  https://doi.org/10.1186/2046-4053-4-1.CrossRefPubMedPubMedCentralGoogle Scholar
  69. 69.
    Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;349:g7647.CrossRefGoogle Scholar
  70. 70.
    Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swann S, Djulbegovic B, Radiation Therapy Oncology Group. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ. 2004;328:22–4.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© The National Medical Journal of India 2018

Authors and Affiliations

  1. 1.Clinical Epidemiology Program, Ottawa Hospital Research InstituteOttawaCanada
  2. 2.School of Epidemiology, Public Health and Preventative MedicineUniversity of OttawaOttawaCanada

Personalised recommendations