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Reporting and Interpreting of Results

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Fundamentals of Clinical Trials

Abstract

The final phase in any experiment is to interpret and report the results. Finding the answer to a challenging question is the goal of any research endeavor. Proper communication of the results to clinicians also provides the basis for advances in medicine [1]. To communicate appropriately, the investigators have to review their results critically and avoid the temptation of overinterpretation. They are in the privileged position of knowing the quality and limitations of the data better than anyone else. Therefore, they have the responsibility for presenting the results clearly and concisely, together with any issues that might bear on their interpretation. Investigators should devote adequate care, time, and attention to this critical part of the conduct of clinical trials. We believe that a policy of “conservative” interpretation and reporting best serves the interests of readers.

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References

  1. Comroe JH Jr. The road from research to new diagnosis and therapy. Science 1978;200:931–937.

    Article  Google Scholar 

  2. Glantz SA. Biostatistics: how to detect, correct and prevent errors in the medical literature. Circulation 1980;61:1–7.

    Article  Google Scholar 

  3. Relman AS. What a good medical journal does. New York Times, March 19, 1978; Section IV; p. 22.

    Google Scholar 

  4. Ellenberg SS, Epstein JS, Fratantoni JC, et al. A trial of RSV immune globulin in infants and young children: the FDA view. N Engl J Med 1994;331:203–204.

    Article  Google Scholar 

  5. Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001;357:1191–1194.

    Google Scholar 

  6. 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.

    Google Scholar 

  7. Ioannidis JPA, Evans SJW, Gøtzsche PC, et al, for the CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781–788.

    Google Scholar 

  8. Piaggio G, Elbourne DR, Altman DG, et al, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006;295:1152–1160.

    Google Scholar 

  9. Moher D, Liberati A, Tetziaff J, Altman DG, The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009;6:e1000097.

    Article  Google Scholar 

  10. Mills EJ, Wu P, Gagnier J, Devereaux PJ. The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemp Clin Trials 2005;26:480–487.

    Article  Google Scholar 

  11. Van Spall HGC, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA 2007;297:1233–1240.

    Article  Google Scholar 

  12. Wang R, Lagakos SW, Ware JH, et al. Special Report: Statistics in medicine – reporting of subgroup analyses in clinical trials. N Engl J Med 2007;357:2189–2194.

    Article  Google Scholar 

  13. National Institutes of Health Public Access. http://publicaccess.nih.gov/

  14. Zarin DA, Tse T. Moving toward transparency of clinical trials. Science 2008;319:1340–1342.

    Article  Google Scholar 

  15. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication (updated October 2008). http://www.icmje.org/.

  16. International Committee of Medical Journal Editors. Is this clinical trial fully registered?: a statement from the International Committee of Medical Journal Editors. http://www.icmje.org/clin_trialup.htm

  17. Haynes RB, McKibbon KA, Walker CJ, et al. Online access to MEDLINE in clinical settings: a study on the use and usefulness. Ann Intern Med 1990;112:78–84.

    Article  Google Scholar 

  18. Ad hoc Working Group for Critical Appraisal of the Medical Literature. A proposal for more informative abstracts of clinical articles. Ann Intern Med 1987;106:598–604.

    Article  Google Scholar 

  19. Haynes RB, Mulrow CD, Huth EJ, et al. More informative abstracts revisited. Ann Intern Med 1990;113:69–76.

    Article  Google Scholar 

  20. Huth EJ. Preparing to write. In: How to write and publish papers in medical sciences. Philadelphia: ISI Press, 1982, pp. 37–40.

    Google Scholar 

  21. Huth EJ. Guidelines on authorship of medical papers. Ann Intern Med 1986;104:269–274.

    Article  Google Scholar 

  22. Kassirer JP, Angell M. On authorship and acknowledgments. N Engl J Med 1991;325:1510–1512.

    Article  Google Scholar 

  23. Meinert CL. In defense of the corporate author for multicenter trials. Control Clin Trials 1993;14:255–260.

    Article  Google Scholar 

  24. Gøtzsche PC, Hróbjartsson A, Johansen HK, et al. Ghost authorship in industry-initiated randomised trials. PLoS Med 2007; 4:e19.

    Article  Google Scholar 

  25. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008;299:1800–1812.

    Article  Google Scholar 

  26. Drazen JM, Van Der Weyden MB, Sahni P, et al. Editorial: Uniform format for disclosure of competing interests in ICMJE journals. N Engl J Med 2009;361:1896–1897 http://content.nejm.org/cgi/reprint/NEJMe0909052.pdf?resourcetype=HWCIT

    Google Scholar 

  27. DeAngelis CD, Fontanarosa PB. Editorial: Resolving unreported conflicts of interest. JAMA 2009;302:198–199.

    Article  Google Scholar 

  28. Weinfurt KP, Seils DM, Tzeng JP, et al. Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents. PLoS One 2008; 3:e2128.

    Article  Google Scholar 

  29. Berry G. Statistical significance and confidence intervals. Med J Aust 1986;144:618–619.

    Google Scholar 

  30. Gardner MJ, Altman DG. Confidence intervals rather than p-values: estimation rather than hypothesis testing. Br Med J 1986;292:746–750.

    Article  Google Scholar 

  31. Simon R. Confidence intervals for reporting results of clinical trials. Ann Intern Med 1986;105:429–435.

    Article  Google Scholar 

  32. Bulpitt CJ. Confidence intervals. Lancet 1987;i:494–497.

    Article  Google Scholar 

  33. Braitman LE. Confidence intervals extract clinically useful information from data. Ann Intern Med 1988;108:296–298.

    Article  Google Scholar 

  34. Freeman PR. The role of p-values in analysing trial results. Stat Med 1993;12:1443–1452.

    Article  Google Scholar 

  35. Braitman LE. Statistical estimates and clinical trials. J Biopharm Stat 1993;3:249–256.

    Article  Google Scholar 

  36. Goodman SN, Berlin JA. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med 1994;121:200–206.

    Article  Google Scholar 

  37. Pocock SJ, Ware JH. Translating statistical findings into plain English. Lancet 2009;373:1926–1928.

    Article  Google Scholar 

  38. Wulff HR, Andersen B, Brandenhoff P, Guttler F. What do doctors know about statistics? Stat Med 1987;6:3–10.

    Article  Google Scholar 

  39. Haynes RB, McKibbon KA, Fitzgerald D, et al. How to keep up with the medical literature. Ann Intern Med 1986;105:149–153, 309–312, 474–478, 636–640, 810–816, 978–984.

    Article  Google Scholar 

  40. Moon TE. Interpretation of cancer prevention trials. Prev Med 1989;18:721–731.

    Article  Google Scholar 

  41. Fowkes FGR, Fulton PM. Critical appraisal of published research: introductory guidelines. Br Med J 1991;302:1136–1140.

    Article  Google Scholar 

  42. Cuddy PG, Elenbaas RM, Elenbaas JK. Evaluating the medical literature. Ann Emerg Med 1998;12:549–555, 610–620, 679–686.

    Article  Google Scholar 

  43. Oxman AD, Sackett DL, Guyatt GH, for the Evidence-Based Medicine Working Group. Users’ guides to the medical literature: I. How to get started. JAMA 1993;270:2093–2095.

    Google Scholar 

  44. Guyatt GH, Sackett DL, Cook DJ, for the Evidence-Based Medicine Working Group. Users’ guides to the medical literature: II. How to use an article about therapy or prevention: A. Are the results of the study valid? JAMA 1993;270:2598–2601.

    Google Scholar 

  45. Pocock SJ. Clinical trials. A practical approach. Chichester: John Wiley & Sons, 1983.

    Google Scholar 

  46. Evans M, Pollock AV. Trials on trial. A review of trials of antibiotic prophylaxis. Arch Surg 1984;119:109–113.

    Article  Google Scholar 

  47. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med 1987;317:426–432.

    Article  Google Scholar 

  48. Altman DG. Statistics in medical journals. Stat Med 1982;1:59–71.

    Article  Google Scholar 

  49. Gøtzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal anti-inflammatory drugs in rheumatoid arthritis. Control Clin Trials 1989;10:31–56.

    Article  Google Scholar 

  50. Altman DG, Doré CJ. Randomization and baseline comparisons in clinical trials. Lancet 1990;335:149–153.

    Article  Google Scholar 

  51. Tonkin K, Tritchler D, Tannock I. Criteria of tumor response used in clinical trials of chemotherapy. J Clin Oncol 1985;3:870–875.

    Google Scholar 

  52. Baar J, Tannock I. Analyzing the same data in two ways: a demonstration model to illustrate the reporting and misreporting of clinical trials. J Clin Oncol 1989;7:969–978.

    Google Scholar 

  53. Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988;318:1728–1733.

    Article  Google Scholar 

  54. Forrow L, Taylor WC, Arnold RM. Absolutely relative: how research results are summarized can affect treatment decisions. Am J Med 1992;92:121–124.

    Article  Google Scholar 

  55. Naylor CD, Chen E, Strauss B. Measured enthusiasm: does the method of reporting trial results alter perceptions of therapeutic effectiveness? Ann Intern Med 1992;117:916–921.

    Article  Google Scholar 

  56. Sterling TD. Publication decisions and their possible effects on inferences drawn from test of significance – or vice versa. J Am Stat Assoc 1959;54:30–34.

    Google Scholar 

  57. Dickersin K, Min YI. Publication bias: the problem that won’t go away. Ann NY Acad Sci 1993;703:135–146.

    Article  Google Scholar 

  58. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol 1987;4:1529–1541.

    Google Scholar 

  59. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine – selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. Br Med J 2003;326:1171–1173.

    Article  Google Scholar 

  60. Chan A-W, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. Br Med J 2005;330:753. Epub 2005 Jan 28.

    Article  Google Scholar 

  61. Chan A-W, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457–2465.

    Article  Google Scholar 

  62. Turer AT, Mahaffey KW, Compton KL, et al. Publication or presentation of results from multicenter clinical trials: evidence from an academic medical center. Am Heart J 2007;153:674–680.

    Article  Google Scholar 

  63. Turner EH, Matthews AM, Linardatos E, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008;358:252–260.

    Article  Google Scholar 

  64. Perlis RH, Perlis CS, Wu Y, et al. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am J Psychiatry 2005;162:1957–1960.

    Article  Google Scholar 

  65. Goldman L, Loscalzo A. Fate of cardiology research originally published in abstract form. N Engl J Med 1980;303:255–259.

    Article  Google Scholar 

  66. Dickerson K, Chan S, Chalmers TC, et al. Publication bias and clinical trials. Control Clin Trials 1987;8:343–353.

    Article  Google Scholar 

  67. Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA 1990;263:1385–1389.

    Article  Google Scholar 

  68. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet 1991;337:867–872.

    Article  Google Scholar 

  69. Gøtzsche PC. Reference bias in reports of drug trials. Br Med J 1987;295:654–656.

    Article  Google Scholar 

  70. Al-Marzouki S, Roberts I, Marshall T, Evans S. The effect of scientific misconduct on the results of clinical trials: a Delphi survey. Contemp Clin Trials 2005;26:331–337.

    Article  Google Scholar 

  71. Karlowski TR, Chalmers TC, Frenkel LD, et al. Ascorbic acid for the common cold: a prophylactic and therapeutic trial. JAMA 1975;231:1038–1042.

    Article  Google Scholar 

  72. Report from the Committee of Principal Investigators. Cooperative trial in the primary prevention of ischaemic heart disease using clofibrate. Br Heart J 1978;40:1069–1118.

    Google Scholar 

  73. Marantz PR, Alderman MH, Tobin JN. Diagnostic heterogeneity in clinical trials for congestive heart failure. Ann Intern Med 1988;109:55–61.

    Article  Google Scholar 

  74. Packer M. Clinical trials in congestive heart failure: why do studies report conflicting results. Ann Intern Med 1988;109:3–5.

    Article  Google Scholar 

  75. Bero LA, Galbraith A, Rennie D. The publication of sponsored symposiums in medical journals. N Engl J Med 1992;327:1135–1140.

    Article  Google Scholar 

  76. Psaty BM, Furberg CD, Ray WA, Weiss NS. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA 2004;292:2622–2631.

    Article  Google Scholar 

  77. Fineberg HV. Clinical evaluation: how does it influence medical practice? Bull Cancer 1987;74:333–346.

    Google Scholar 

  78. Collins R, Julian D. British Heart Foundation surveys (1987 and 1989) of United Kingdom treatment policies for acute myocardial infarction. Br Heart J 1991;66:250–255.

    Article  Google Scholar 

  79. Lamas GA, Pfeffer MA, Hamm P, et al., The SAVE Investigators. Do the results of randomized clinical trials of cardiovascular drugs influence medical practice? N Engl J Med 1992;327:241–247.

    Google Scholar 

  80. Manolio TA, Cutler JA, Furberg CD, et al. Trends in pharmacologic management of hypertension in the United States. Arch Intern Med 1995;155:829–837.

    Article  Google Scholar 

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Correspondence to Lawrence M. Friedman .

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Friedman, L.M., Furberg, C.D., DeMets, D.L. (2010). Reporting and Interpreting of Results. In: Fundamentals of Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-1586-3_19

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