BMJ  2004;328:22-24 (3 January), doi:10.1136/bmj.328.7430.22

Paper

Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group

¹ Department of Interdisciplinary Oncology, H Lee Moffitt Cancer Center and Research Institute, University of South Florida, 12902 Magnolia Drive, Tampa, FL 33612, USA, ² H Lee Moffitt Cancer Center and Research Institute, ³ UK Cochrane Centre, Oxford OX2 7LG, ⁴ Statistical Unit, Radiation Therapy Oncology Group, PA 19107, USA

Objective To determine whether poor reporting of methods in randomised controlled trials reflects on poor methods.

Design Observational study.

Setting Reports of randomised controlled trials conducted by the Radiation Therapy Oncology Group since its establishment in 1968.

Participants The Radiation Therapy Oncology Group.

Outcome measures Content of reports compared with the design features described in the protocols for all randomised controlled trials.

Results The methodological quality of 56 randomised controlled trials was better than reported. Adequate allocation concealment was achieved in all trials but reported in only 42% of papers. An intention to treat analysis was done in 83% of trials but reported in only 69% of papers. The sample size calculation was performed in 76% of the studies, but reported in only 16% of papers. End points were clearly defined and and errors were prespecified in 76% and 74% of the trials, respectively, but only reported in 10% of the papers. The one exception was the description of drop outs, where the frequency of reporting was similar to that contained in the original statistical files of the Radiation Therapy Oncology Group.

Conclusions The reporting of methodological aspects of randomised controlled trials does not necessarily reflect the conduct of the trial. Reviewing research protocols and contacting trialists for more information may improve quality assessment.

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

Relevant Articles

The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study

Eveline Nüesch, Sven Trelle, Stephan Reichenbach, Anne W S Rutjes, Elizabeth Bürgi, Martin Scherer, Douglas G Altman, and Peter Jüni
BMJ 2009 339: b3244. [Abstract] [Full Text] [PDF]

The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration

Alessandro Liberati, Douglas G Altman, Jennifer Tetzlaff, Cynthia Mulrow, Peter C Gøtzsche, John P A Ioannidis, Mike Clarke, P J Devereaux, Jos Kleijnen, and David Moher
BMJ 2009 339: b2700. [Abstract] [Full Text]

Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols

An-Wen Chan, Asbjørn Hróbjartsson, Karsten J Jørgensen, Peter C Gøtzsche, and Douglas G Altman
BMJ 2008 337: a2299. [Abstract] [Full Text] [PDF]

Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study

Lesley Wood, Matthias Egger, Lise Lotte Gluud, Kenneth F Schulz, Peter Jüni, Douglas G Altman, Christian Gluud, Richard M Martin, Anthony J G Wood, and Jonathan A C Sterne
BMJ 2008 336: 601-605. [Abstract] [Full Text] [PDF]

Are experimental treatments for cancer in children superior to established treatments? Observational study of randomised controlled trials by the Children's Oncology Group

Ambuj Kumar, Heloisa Soares, Robert Wells, Mike Clarke, Iztok Hozo, Archie Bleyer, Gregory Reaman, Iain Chalmers, and Benjamin Djulbegovic
BMJ 2005 331: 1295. [Abstract] [Full Text] [PDF]

Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study

Julie Pildal, An-Wen Chan, Asbjørn Hróbjartsson, Elisabeth Forfang, Douglas G Altman, and Peter C Gøtzsche
BMJ 2005 330: 1049. [Abstract] [Full Text] [PDF]

Quality of randomised controlled trials: Quality of trial methods is not good in all disciplines

Helen H G Handoll
BMJ 2004 328: 286. [Extract] [Full Text]

Poor reporting of trials does not mean poor quality trials
BMJ 2004 328: 0. [Full Text]

This article has been cited by other articles:

• Cherny, N. I., Abernethy, A. P., Strasser, F., Sapir, R., Currow, D., Zafar, S. Y. (2009). Improving the Methodologic and Ethical Validity of Best Supportive Care Studies in Oncology: Lessons From a Systematic Review. JCO 27: 5476-5486 [Abstract] [Full text]  
• Bausch, B., Spaar, A., Kleijnen, J., Puhan, M. A. (2009). Quality of randomised trials in COPD. Eur Respir J 34: 1060-1065 [Abstract] [Full text]  
• Nuesch, E., Trelle, S., Reichenbach, S., Rutjes, A. W S, Burgi, E., Scherer, M., Altman, D. G, Juni, P. (2009). The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study. BMJ 339: b3244-b3244 [Abstract] [Full text]  
• Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gotzsche, P. C., Ioannidis, J. P.A., Clarke, M., Devereaux, P. J., Kleijnen, J., Moher, D. (2009). The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration. ANN INTERN MED 151: W-65-W-94 [Abstract] [Full text]  
• Liberati, A., Altman, D. G, Tetzlaff, J., Mulrow, C., Gotzsche, P. C, Ioannidis, J. P A, Clarke, M., Devereaux, P J, Kleijnen, J., Moher, D. (2009). The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 339: b2700-b2700 [Abstract] [Full text]  
• Chan, A.-W., Hrobjartsson, A., Jorgensen, K. J, Gotzsche, P. C, Altman, D. G (2008). Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ 337: a2299-a2299 [Abstract] [Full text]  
• Booth, C. M., Cescon, D. W., Wang, L., Tannock, I. F., Krzyzanowska, M. K. (2008). Evolution of the Randomized Controlled Trial in Oncology Over Three Decades. JCO 26: 5458-5464 [Abstract] [Full text]  
• Abrahamyan, L., Johnson, S. R., Beyene, J., Shah, P. S., Feldman, B. M. (2008). Quality of randomized clinical trials in juvenile idiopathic arthritis. Rheumatology (Oxford) 47: 640-645 [Abstract] [Full text]  
• Djulbegovic, B., Kumar, A., Soares, H. P., Hozo, I., Bepler, G., Clarke, M., Bennett, C. L. (2008). Treatment Success in Cancer: New Cancer Treatment Successes Identified in Phase 3 Randomized Controlled Trials Conducted by the National Cancer Institute-Sponsored Cooperative Oncology Groups, 1955 to 2006. Arch Intern Med 168: 632-642 [Abstract] [Full text]  
• Wood, L., Egger, M., Gluud, L. L., Schulz, K. F, Juni, P., Altman, D. G, Gluud, C., Martin, R. M, Wood, A. J G, Sterne, J. A C (2008). Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 336: 601-605 [Abstract] [Full text]  
• Strevel, E. L., Chau, N. G., Pond, G. R., Murgo, A. J., Ivy, P. S., Siu, L. L. (2008). Improving the Quality of Abstract Reporting for Phase I Cancer Trials. Clin. Cancer Res. 14: 1782-1787 [Abstract] [Full text]  
• Mangoush, O., Purkayastha, S., Haj-Yahia, S., Kinross, J., Hayward, M., Bartolozzi, F., Darzi, A., Athanasiou, T. (2007). Heparin-bonded circuits versus nonheparin-bonded circuits: an evaluation of their effect on clinical outcomes. Eur. J. Cardiothorac. Surg. 31: 1058-1069 [Abstract] [Full text]  
• Baron, G., Boutron, I., Giraudeau, B., Ravaud, P. (2007). Reporting of radiographic methods in randomised controlled trials assessing structural outcomes in rheumatoid arthritis. Ann Rheum Dis 66: 651-657 [Abstract] [Full text]  
• Kumar, A., Soares, H. P., Balducci, L., Djulbegovic, B. (2007). Treatment Tolerance and Efficacy in Geriatric Oncology: A Systematic Review of Phase III Randomized Trials Conducted by Five National Cancer Institute-Sponsored Cooperative Groups. JCO 25: 1272-1276 [Abstract] [Full text]  
• Bainbridge, D., Cheng, D., Martin, J., Novick, R., The Evidence-based Peri-operative Clinical Outcome, (2007). Does off-pump or minimally invasive coronary artery bypass reduce mortality, morbidity, and resource utilization when compared with percutaneous coronary intervention? A meta-analysis of randomized trials. J. Thorac. Cardiovasc. Surg. 133: 623-631 [Abstract] [Full text]  
• Bauwens, K., Matthes, G., Wich, M., Gebhard, F., Hanson, B., Ekkernkamp, A., Stengel, D. (2007). Navigated Total Knee Replacement. A Meta-Analysis. JBJS 89: 261-269 [Abstract] [Full text]  
• Bower, P., Gilbody, S., Richards, D., Fletcher, J., Sutton, A. (2006). Collaborative care for depression in primary care: Making sense of a complex intervention: systematic review and meta-regression. Br. J. Psychiatry 189: 484-493 [Abstract] [Full text]  
• Tiruvoipati, R., Balasubramanian, S. P., Atturu, G., Peek, G. J., Elbourne, D. (2006). Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: The way forward.. J. Thorac. Cardiovasc. Surg. 132: 233-240 [Abstract] [Full text]  
• Newton-Howes, G., Tyrer, P., Johnson, T. (2006). Authors' reply. Br. J. Psychiatry 189: 187-187 [Full text]  
• Kober, T., Trelle, S., Engert, A. (2006). Reporting of randomized controlled trials in Hodgkin lymphoma in biomedical journals.. JNCI J Natl Cancer Inst 98: 620-625 [Abstract] [Full text]  
• Gluud, L. L. (2006). Bias in Clinical Intervention Research. Am J Epidemiol 163: 493-501 [Abstract] [Full text]  
• Lai, R., Chu, R., Fraumeni, M., Thabane, L. (2006). Quality of Randomized Controlled Trials Reporting in the Primary Treatment of Brain Tumors. JCO 24: 1136-1144 [Abstract] [Full text]  
• Kumar, A., Soares, H., Wells, R., Clarke, M., Hozo, I., Bleyer, A., Reaman, G., Chalmers, I., Djulbegovic, B. (2005). Are experimental treatments for cancer in children superior to established treatments? Observational study of randomised controlled trials by the Children's Oncology Group. BMJ 331: 1295- [Abstract] [Full text]  
• Stengel, D., Bauwens, K., Rademacher, G., Mutze, S., Ekkernkamp, A. (2005). Association between Compliance with Methodological Standards of Diagnostic Research and Reported Test Accuracy: Meta-Analysis of Focused Assessment of US for Trauma. Radiology 236: 102-111 [Abstract] [Full text]  
• Pildal, J., Chan, A.-W., Hrobjartsson, A., Forfang, E., Altman, D. G, Gotzsche, P. C (2005). Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ 330: 1049- [Abstract] [Full text]  
• Fervers, B., Burgers, J. S., Haugh, M. C., Brouwers, M., Browman, G., Cluzeau, F., Philip, T. (2005). Predictors of high quality clinical practice guidelines: examples in oncology. Int J Qual Health Care 17: 123-132 [Abstract] [Full text]  
• Soares, H. P., Kumar, A., Daniels, S., Swann, S., Cantor, A., Hozo, I., Clark, M., Serdarevic, F., Gwede, C., Trotti, A., Djulbegovic, B. (2005). Evaluation of New Treatments in Radiation Oncology: Are They Better Than Standard Treatments?. JAMA 293: 970-978 [Abstract] [Full text]  
• Grann, A., Grann, V. R. (2005). The Case for Randomized Trials in Cancer Treatment: New Is Not Always Better. JAMA 293: 1001-1003 [Full text]  
• SAUERLAND, S., DAVIS, T. R. C. (2004). The Consolidated Standards of Reporting Trials (CONSORT): Better Presentation of Surgical Trials in the Journal of Hand Surgery. J Hand Surg Eur Vol 29: 621-624 [Abstract] [Full text]  
• Griffin, S. J., Kinmonth, A.-L., Veltman, M. W. M., Gillard, S., Grant, J., Stewart, M. (2004). Effect on Health-Related Outcomes of Interventions to Alter the Interaction Between Patients and Practitioners: A Systematic Review of Trials. Ann Fam Med 2: 595-608 [Abstract] [Full text]  
• Chan, A.-W., Hrobjartsson, A., Haahr, M. T., Gotzsche, P. C., Altman, D. G. (2004). Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles. JAMA 291: 2457-2465 [Abstract] [Full text]  
• Handoll, H. H G (2004). Quality of randomised controlled trials: Quality of trial methods is not good in all disciplines. BMJ 328: 286-286 [Full text]  

Rapid Responses:

Read all Rapid Responses

"Intention to read"

Patricio Herrera
bmj.com, 6 Jan 2004 [Full text]

Other areas give less encouraging results

Helen HG Handoll
bmj.com, 9 Jan 2004 [Full text]

Online poll

Find out more on doc2doc >>