Selective outcome reporting in root coverage randomized clinical trials.
gingival recession
publication bias
randomized controlled trials as topic
surgery
Journal
Journal of clinical periodontology
ISSN: 1600-051X
Titre abrégé: J Clin Periodontol
Pays: United States
ID NLM: 0425123
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
revised:
31
12
2020
received:
16
08
2020
accepted:
16
02
2021
pubmed:
22
3
2021
medline:
21
5
2021
entrez:
21
3
2021
Statut:
ppublish
Résumé
Outcome discrepancies between protocols and respective publications represent a concerning bias. The purpose of this study was to assess the prevalence of selective outcome reporting (SOR) in root coverage randomized clinical trials (RCTs). Published root coverage RCTs (July 2005 to March 2020) were included if a corresponding protocol could be identified in a public registry. Discrepancies between protocol and its correspondent publication(s) were compared regarding primary and secondary outcomes and other study characteristics. Associations between trial characteristics and SOR were evaluated. Forty four studies (54 publications) were included. The majority of studies (77.3%) were retrospectively registered. SOR was frequent (40.9% of trials) and consisted of primary outcome downgrade (22.7%); secondary outcome upgrade (11.4%); new primary outcome introduced in publication (25%); protocol primary outcome omitted from publication (13.6%) and discrepancy in primary outcome timing (18.2%). SOR was unclear in 20.5% of studies and favoured statistical significance in 12 studies (27.3%). SOR was significantly associated with study significance (p < 0.001) and unclear outcome definition in the publication (p < 0.001). Only a third (32.8%) of primary outcomes were completely defined. The present study identified high prevalence of SOR in root coverage RCTs.
Sections du résumé
BACKGROUND
Outcome discrepancies between protocols and respective publications represent a concerning bias. The purpose of this study was to assess the prevalence of selective outcome reporting (SOR) in root coverage randomized clinical trials (RCTs).
METHODS
Published root coverage RCTs (July 2005 to March 2020) were included if a corresponding protocol could be identified in a public registry. Discrepancies between protocol and its correspondent publication(s) were compared regarding primary and secondary outcomes and other study characteristics. Associations between trial characteristics and SOR were evaluated.
RESULTS
Forty four studies (54 publications) were included. The majority of studies (77.3%) were retrospectively registered. SOR was frequent (40.9% of trials) and consisted of primary outcome downgrade (22.7%); secondary outcome upgrade (11.4%); new primary outcome introduced in publication (25%); protocol primary outcome omitted from publication (13.6%) and discrepancy in primary outcome timing (18.2%). SOR was unclear in 20.5% of studies and favoured statistical significance in 12 studies (27.3%). SOR was significantly associated with study significance (p < 0.001) and unclear outcome definition in the publication (p < 0.001). Only a third (32.8%) of primary outcomes were completely defined.
CONCLUSIONS
The present study identified high prevalence of SOR in root coverage RCTs.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
867-877Informations de copyright
© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Références
Aggarwal, R., & Oremus, M. (2019). Selective outcome reporting is present in randomized controlled trials in lung cancer immunotherapies. Journal of Clinical Epidemiology, 106, 145-146. https://doi.org/10.1016/j.jclinepi.2018.10.010
Agudio, G., Chambrone, L., & Pini Prato, G. (2017). Biologic remodeling of periodontal dimensions of areas treated with gingival augmentation procedure: A 25-year follow-up observation. Journal of Periodontology, 88(7), 634-642. https://doi.org/10.1902/jop.2017.170010
Albandar, J. M., & Kingman, A. (1999). Gingival recession, gingival bleeding, and dental calculus in adults 30 years of age and older in the United States, 1988-1994. Journal of Periodontology, 70(1), 30-43. https://doi.org/10.1902/jop.1999.70.1.30
Cairo, F., Barootchi, S., Tavelli, L., Barbato, L., Wang, H. L., Rasperini, G., Graziani, F., & Tonetti, M. (2020). Aesthetic- and patient-related outcomes following root coverage procedures: A systematic review and network meta-analysis. Journal of Clinical Periodontology, 47(11), 1403-1415. https://doi.org/10.1111/jcpe.13346
Calméjane, L., Dechartres, A., Tran, V. T., & Ravaud, P. (2018). Making protocols available with the article improved evaluation of selective outcome reporting. Journal of Clinical Epidemiology, 104, 95-102. https://doi.org/10.1016/j.jclinepi.2018.08.020
Chambrone, L., Faggion, C. M. Jr, Pannuti, C. M., & Chambrone, L. A. (2010). Evidence-based periodontal plastic surgery: An assessment of quality of systematic reviews in the treatment of recession-type defects. Journal of Clinical Periodontology, 37(12), 1110-1118. https://doi.org/10.1111/j.1600-051X.2010.01634.x
Chambrone, L., Ortega, M. A. S., Sukekava, F., Rotundo, R., Kalemaj, Z., Buti, J., & Prato, G. P. P. (2019). Root coverage procedures for treating single and multiple recession-type defects: An updated Cochrane systematic review. Journal of Periodontology, 90(12), 1399-1422. https://doi.org/10.1002/jper.19-0079
Chambrone, L., Pannuti, C. M., Tu, Y. K., & Chambrone, L. A. (2012). Evidence-based periodontal plastic surgery. II. An individual data meta-analysis for evaluating factors in achieving complete root coverage. Journal of Periodontology, 83(4), 477-490. https://doi.org/10.1902/jop.2011.110382.
Chambrone, L., & Tatakis, D. N. (2015). Periodontal soft tissue root coverage procedures: A systematic review from the AAP Regeneration Workshop. Journal of Periodontology, 86(2 Suppl), S8-S51. https://doi.org/10.1902/jop.2015.130674
Chambrone, L., & Tatakis, D. N. (2016). Long-term outcomes of untreated buccal gingival recessions: A systematic review and meta-analysis. Journal of Periodontology, 87(7), 796-808. https://doi.org/10.1902/jop.2016.150625
Chan, A. W., Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., & Altman, D. G. (2004). Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published articles. JAMA, 291(20), 2457-2465. https://doi.org/10.1001/jama.291.20.2457
De Angelis, C., Drazen, J. M., Frizelle, F. A., Haug, C., Hoey, J., Horton, R., Kotzin, S., Laine, C., Marusic, A., Overbeke, A. J. P. M., Schroeder, T. V., Sox, H. C., & Van Der Weyden, M. B. (2004). Clinical trial registration: A statement from the International Committee of Medical Journal Editors. Annals of Internal Medicine, 141(6), 477-478. https://doi.org/10.7326/0003-4819-141-6-200409210-00109
Dickersin, K., & Min, Y. I. (1993). NIH clinical trials and publication bias. The Online Journal of Current Clinical Trials, Doc no 50, [4967. words; 4953 paragraphs].
Dmitrienko, A., & D'Agostino, R. B. Sr (2018). Multiplicity considerations in clinical trials. New England Journal of Medicine, 378(22), 2115-2122. https://doi.org/10.1056/NEJMra1709701
Farquhar, C. M., Showell, M. G., Showell, E. A. E., Beetham, P., Baak, N., Mourad, S., & Jordan, V. M. B. (2017). Clinical trial registration was not an indicator for low risk of bias. Journal of Clinical Epidemiology, 84, 47-53. https://doi.org/10.1016/j.jclinepi.2016.11.011
Fleming, P. S., Koletsi, D., Dwan, K., & Pandis, N. (2015). Outcome discrepancies and selective reporting: impacting the leading journals? PLoS One, 10(5), e0127495. https://doi.org/10.1371/journal.pone.0127495
Goodman, S. N., Fanelli, D., & Ioannidis, J. P. (2016). What does research reproducibility mean? Science Translational Medicine, 8(341), 341ps312. https://doi.org/10.1126/scitranslmed.aaf5027
Hannink, G., Gooszen, H. G., & Rovers, M. M. (2013). Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions. Annals of Surgery, 257(5), 818-823. https://doi.org/10.1097/SLA.0b013e3182864fa3
Higgins, J. P., & Green, S. (2008) Cochrane handbook for systematic reviews of interventions version 5.0.1. The Cochrane Collaboration. www.cochrane-handbook.org
Jones, C. W., & Platts-Mills, T. F. (2012). Quality of registration for clinical trials published in emergency medicine journals. Annals of Emergency Medicine, 60(4), 458-464.e1. https://doi.org/10.1016/j.annemergmed.2012.02.005
Kaplan, R. M., & Irvin, V. L. (2015). Likelihood of null effects of large NHLBI clinical trials has increased over time. PLoS One, 10(8), e0132382. https://doi.org/10.1371/journal.pone.0132382
Koufatzidou, M., Koletsi, D., Fleming, P. S., Polychronopoulou, A., & Pandis, N. (2019). Outcome reporting discrepancies between trial entries and published final reports of orthodontic randomized controlled trials. European Journal of Orthodontics, 41(3), 225-230. https://doi.org/10.1093/ejo/cjy046
Li, G., Abbade, L. P. F., Nwosu, I., Jin, Y., Leenus, A., Maaz, M., Wang, M., Bhatt, M., Zielinski, L., Sanger, N., Bantoto, B., Luo, C., Shams, I., Shahid, H., Chang, Y., Sun, G., Mbuagbaw, L., Samaan, Z., Levine, M. A. H., … Thabane, L. (2018). A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research. BMC Medical Research Methodology, 18(1), 9. https://doi.org/10.1186/s12874-017-0465-7
Li, T., Mayo-Wilson, E., Fusco, N., Hong, H., & Dickersin, K. (2018). Caveat emptor: The combined effects of multiplicity and selective reporting. Trials, 19(1), 497. https://doi.org/10.1186/s13063-018-2888-9
Mathieu, S., Boutron, I., Moher, D., Altman, D. G., & Ravaud, P. (2009). Comparison of registered and published primary outcomes in randomized controlled trials. JAMA, 302(9), 977-984. https://doi.org/10.1001/jama.2009.1242
Mayo-Wilson, E., Fusco, N., Li, T., Hong, H., Canner, J. K., & Dickersin, K. (2017). Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis. Journal of Clinical Epidemiology, 86, 39-50. https://doi.org/10.1016/j.jclinepi.2017.05.007
Mounssif, I., Stefanini, M., Mazzotti, C., Marzadori, M., Sangiorgi, M., & Zucchelli, G. (2018). Esthetic evaluation and patient-centered outcomes in root-coverage procedures. Periodontology 2000, 77(1), 19-53. https://doi.org/10.1111/prd.12216
Nankervis, H., Baibergenova, A., Williams, H. C., & Thomas, K. S. (2012). Prospective registration and outcome-reporting bias in randomized controlled trials of eczema treatments: A systematic review. The Journal of Investigative Dermatology, 132(12), 2727-2734. https://doi.org/10.1038/jid.2012.231
Pandis, N., Fleming, P. S., Worthington, H., Dwan, K., & Salanti, G. (2015). Discrepancies in outcome reporting exist between protocols and published oral health cochrane systematic reviews. PLoS One, 10(9), e0137667. https://doi.org/10.1371/journal.pone.0137667
Popelut, A., Valet, F., Fromentin, O., Thomas, A., & Bouchard, P. (2010). Relationship between sponsorship and failure rate of dental implants: A systematic approach. PLoS One, 5(4), e10274. https://doi.org/10.1371/journal.pone.0010274
Rios, F. S., Costa, R. S., Moura, M. S., Jardim, J. J., Maltz, M., & Haas, A. N. (2014). Estimates and multivariable risk assessment of gingival recession in the population of adults from Porto Alegre, Brazil. Journal of Clinical Periodontology, 41(11), 1098-1107. https://doi.org/10.1111/jcpe.12303
Santamaria, M. P., Silveira, C. A., Mathias, I. F., Neves, F. L. D. S., Santos, L. M., Jardini, M. A. N., Tatakis, D. N., Sallum, E. A., & Bresciani, E. (2018). Treatment of single maxillary gingival recession associated with non-carious cervical lesion: Randomized clinical trial comparing connective tissue graft alone to graft plus partial restoration. Journal of Clinical Periodontology, 45(8), 968-976. https://doi.org/10.1111/jcpe.12907
Sarfati, A., Bourgeois, D., Katsahian, S., Mora, F., & Bouchard, P. (2010). Risk assessment for buccal gingival recession defects in an adult population. Journal of Periodontology, 81(10), 1419-1425. https://doi.org/10.1902/jop.2010.100102
Schulz, K. F., Altman, D. G., & Moher, D. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. Trials, 11(1), 32. https://doi.org/10.1186/1745-6215-11-32
Sendyk, D. I., Rovai, E. S., Souza, N. V., Deboni, M. C. Z., & Pannuti, C. M. (2019). Selective outcome reporting in randomized clinical trials of dental implants. Journal of Clinical Periodontology, 46(7), 758-765. https://doi.org/10.1111/jcpe.13128
Seong, J., Bartlett, D., Newcombe, R. G., Claydon, N. C. A., Hellin, N., & West, N. X. (2018). Prevalence of gingival recession and study of associated related factors in young UK adults. Journal of Dentistry, 76, 58-67. https://doi.org/10.1016/j.jdent.2018.06.005
Smaïl-Faugeron, V., Fron-Chabouis, H., & Durieux, P. (2015). Clinical trial registration in oral health journals. Journal of Dental Research, 94(3 Suppl), 8S-13S. https://doi.org/10.1177/0022034514552492
Thaler, K., Kien, C., Nussbaumer, B., Van Noord, M. G., Griebler, U., Klerings, I., & Gartlehner, G. (2015). Inadequate use and regulation of interventions against publication bias decreases their effectiveness: A systematic review. Journal of Clinical Epidemiology, 68(7), 792-802. https://doi.org/10.1016/j.jclinepi.2015.01.008
U.S. National Library of Medicine. ClinicalTrials.gov [Internet]. (2020) [cited 2020 Mar 15]. (pp. 1) https://clinicaltrials.gov/
van den Bogert, C. A., Souverein, P. C., Brekelmans, C. T. M., Janssen, S. W. J., Koëter, G. H., Leufkens, H. G. M., & Bouter, L. M. (2017). Primary endpoint discrepancies were found in one in ten clinical drug trials. Results of an inception cohort study. Journal of Clinical Epidemiology, 89, 199-208. https://doi.org/10.1016/j.jclinepi.2017.05.012
Wagner, T. P., Costa, R. S., Rios, F. S., Moura, M. S., Maltz, M., Jardim, J. J., & Haas, A. N. (2016). Gingival recession and oral health-related quality of life: A population-based cross-sectional study in Brazil. Community Dentistry and Oral Epidemiology, 44(4), 390-399. https://doi.org/10.1111/cdoe.12226
Wayant, C., Scheckel, C., Hicks, C., Nissen, T., Leduc, L., Som, M., & Vassar, M. (2017). Evidence of selective reporting bias in hematology journals: A systematic review. PLoS One, 12(6), e0178379. https://doi.org/10.1371/journal.pone.0178379
World Health Organization - WHO [Internet]. 2020; https://www.who.int/ictrp/en
Zarin, D. A., Tse, T., Williams, R. J., Califf, R. M., & Ide, N. C. (2011). The ClinicalTrials.gov results database-update and key issues. New England Journal of Medicine, 364(9), 852-860. https://doi.org/10.1056/NEJMsa1012065
Zhang, S., Liang, F., & Li, W. (2017). Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting. Journal of Clinical Epidemiology, 91, 87-94. https://doi.org/10.1016/j.jclinepi.2017.07.010