Detecting the extent of control over selection bias relating to oral health and otorhinolaryngology

cross-sectional study

Autores

Palavras-chave:

Bias, Randomized controlled trial [publication type], Random allocation, Oral health, Selection bias, Cross-sectional studies, Dentistry

Resumo

BACKGROUND: The authors of randomized controlled trials will usually claim that they have met the randomization process criterion. However, sequence generation schemes differ and some schemes that are claimed to be randomized are not genuinely randomized. Even less well understood, and often more difficult to ascertain, is whether the allocation was really concealed. OBJECTIVE: To detect the extent of control over selection bias, in a comparison between two Cochrane groups: oral health and otorhinolaryngology; and to describe the methods used to control for this bias. DESIGN AND SETTING: Cross-sectional study conducted in a public university in São Paulo, Brazil.METHODS: The risk of selection bias in 1,714 records indexed in Medline database up to 20 18 was assessed, independent of language and access. Two dimensions implicated in the allocation were onsidered: generation of the allocation sequence; and allocation concealment. RESULTS: We included 420 randomized controlled trials and all of them were evaluated to detect selection bias. In the sample studied, only 28 properly controlled the selection bias. Lack of control over selection bias was present in 80% of the studies evaluated in both groups. CONCLUSION: The two groups were similar regarding control over selection bias. They are also similar to the methods used. The dimension of allocation concealment appears to be a limiting factor with regard to production of randomized controlled trials with low risk of selection bias. The quality of reporting in studies on oral health and otorhinolaryngology is suboptimal and needs to be improved, in line with other fields of healthcare.

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Biografia do Autor

Christiane Alves Ferreira, Universidade Federal de São Paulo – Escola Paulista de Medicina

MSc. Doctoral Researcher within Health Sciences, Department of Internal Medicine and Therapeutics and Evidence-Based Healthcare, Universidade Federal de São Paulo – Escola Paulista de Medicina (UNIFESP-EPM), São Paulo (SP), Brazil.

Álvaro Nagib Atallah, Universidade Federal de São Paulo – Escola Paulista de Medicina

MD, PhD. Titular Professor, Department of Internal Medicine and Therapeutics and Evidence-Based Healthcare, and Director, Brazilian Cochrane Center, Universidade Federal de São Paulo – Escola Paulista de Medicina (UNIFESP-EPM), São Paulo (SP), Brazil.

Carlos Alfredo de Salles Loureiro, Universidade Federal de São Paulo – Escola Paulista de Medicina

MD. Doctoral Student, Department of Internal Medicine and Therapeutics and Evidence-Based Healthcare, Universidade Federal de São Paulo – Escola Paulista de Medicina (UNIFESP-EPM), São Paulo (SP), Brazil.

Referências

Kunz R, Vist G, Oxman AD. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev. 2007;(2):MR000012. PMID: 17443633; doi: 10.1002/14651858.MR000012.pub2.

Moher D, Jadad AR, Nichol G, et al. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials. 1995;16(1):62-73. PMID: 7743790; doi: 10.1016/0197-2456(94)00031-w.

Odgaard-Jensen J, Vist GE, Timmer A, et al. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev. 2011;(4):MR000012. PMID: 21491415; doi: 10.1002/14651858.MR000012.pub3.

Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. 2nd edition. New York: Churchill Livingstone; 2000. ISBN-10: 0443062404; ISBN-13: 978-0443062407.

Guyatt GH, Sackett DL, Cook DJ. Users’ guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA. 1993;270(21):2598-601. PMID: 8230645; doi: 10.1001/jama.270.21.2598.

Berger VW, Weinstein S. Ensuring the comparability of comparison groups: is randomization enough? Control Clin Trials. 2004;25(5):515-24. PMID: 15465620; doi: 10.1016/j.cct.2004.04.001.

Grant WC, Anstrom KJ. Minimizing selection bias in randomized trials: A Nash equilibrium approach to optimal randomization. Journal of Economic Behavior & Organization. 2008;66(3-4):606-24. doi: 10.1016/j.jebo.2006.07.001.

Berger VW. Selection bias and covariate imbalances in randomized clinical trials. Chichester, UK: John Wiley and Sons Ltd.; 2005. ISBN: 978-0-470-86362-6.

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. [updated March 2011]. The Cochrane Collaboration; 2011. Available from: Available from: http://www.handbook.cochrane.org Accessed in 2019 (Oct 23).

Veith FJ. How can good randomized controlled trials in leading journals be so misinterpreted? J Vasc Surg. 2013;57(2 Suppl):3S-7S. PMID: 23336854; doi: 10.1016/j.jvs.2012.04.076.

Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005;365(9465):1159-62. PMID: 15794971; doi: 10.1016/S0140-6736(05)71879-1.

Dettori J. The random allocation process: two things you need to know. Evid Based Spine Care J. 2010;1(3):7-9. PMID: 22956922; doi: 10.1055/s-0030-1267062.

Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet. 2002;359(9305):515-9. PMID: 11853818; doi: 10.1016/S0140-6736(02)07683-3.

Altman DG, Schulz KF. Statistics notes: Concealing treatment allocation in randomised trials. BMJ. 2001;323(7310):446-7. PMID: 11520850; doi: 10.1136/bmj.323.7310.446.

Schulz KF. Subverting randomization in controlled trials. JAMA. 1995;274(18):1456-8. PMID: 7474192.

Dumbrigue HB, Jones JS, Esquivel JF. Control of bias in randomized controlled trials published in prosthodontic journals. J Prosthet Dent. 2001;86(6):592-6. PMID: 11753309; doi: 10.1067/mpr.2001.119980.

Sjögren P, Halling A. Quality of reporting randomised clinical trials in dental and medical research. Br Dent J. 2002;192(2):100-3. PMID: 11838001; doi: 10.1038/sj.bdj.4801304.

Bhandari M, Richards RR, Sprague S, Schemitsch EH. The quality of reporting of randomized trials in the Journal of Bone and Joint Surgery from 1988 through 2000. J Bone Joint Surg Am. 2002;84(3):388-96. PMID: 11886908; doi: 10.2106/00004623-200203000-00009.

Montenegro R, Needleman I, Moles D, Tonetti M. Quality of RCTs in periodontology--a systematic review. J Dent Res. 2002;81(12):866-70. PMID: 12454104; doi: 10.1177/154405910208101214.

Gummesson C, Atroshi I, Ekdahl C. The quality of reporting and outcome measures in randomized clinical trials related to upper-extremity disorders. J Hand Surg Am. 2004;29(4):727-34. PMID: 15249101; doi: 10.1016/j.jhsa.2004.04.003.

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(4):480-7. PMID: 16054580; doi: 10.1016/j.cct.2005.02.008.

Hewitt C, Hahn S, Torgerson DJ, Watson J, Bland JM. Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. BMJ. 2005;330(7499):1057-8. PMID: 15760970; doi: 10.1136/bmj.38413.576713.AE.

Dumbrigue HB, Al-Bayat MI, Ng CC, Wakefield CW. Assessment of bias in methodology for randomized controlled trials published on implant dentistry. J Prosthodont. 2006;15(4):257-63. PMID: 16827739; doi: 10.1111/j.1532-849X.2006.00115.x.

Dulai SK, Slobogean BL, Beauchamp RD, Mulpuri K. A quality assessment of randomized clinical trials in pediatric orthopaedics. J Pediatr Orthop. 2007;27(5):573-81. PMID: 17585270; doi: 10.1097/bpo.0b013e3180621f3e.

Scales CD Jr, Norris RD, Keitz SA, et al. A critical assessment of the quality of reporting of randomized, controlled trials in the urology literature. J Urol. 2007;177(3):1090-4; discussion 1094-5. PMID: 17296417; doi: 10.1016/j.juro.2006.10.027.

Randelli P, Arrigoni P, Lubowitz JH, Cabitza P, Denti M. Randomization procedures in orthopaedic trials. Arthroscopy. 2008;24(7):834-8. PMID: 18589273; doi: 10.1016/j.arthro.2008.01.011.

Froud R, Eldridge S, Diaz Ordaz K, Marinho VC, Donner A. Quality of cluster randomized controlled trials in oral health: a systematic review of reports published between 2005 and 2009. Community Dent Oral Epidemiol. 2012;40(Suppl. 1):3-14. PMID: 22369703; doi: 10.1111/j.1600-0528.2011.00660.x.

Falagas ME, Grigori T, Ioannidou E. A systematic review of trends in the methodological quality of randomized controlled trials in various research fields. J Clin Epidemiol. 2009;62(3):227-31, 231.e1-9. PMID: 19013764; doi: 10.1016/j.jclinepi.2008.07.012.

Greenfield ML, Mhyre JM, Mashour GA, et al. Improvement in the quality of randomized controlled trials among general anesthesiology journals 2000 to 2006: a 6-year follow-up. Anesth Analg. 2009;108(6):1916-21. PMID: 19448222; doi: 10.1213/ane.0b013e31819fe6d7.

Cioffi I, Farella M. Quality of randomized controlled trials in dentistry. Int Dent J. 2011;61(1):37-42. PMID: 21382032; doi: 10.1111/j.1875-595X.2011.00007.x.

Ferreira CA, Loureiro CA, Saconato H, Atallah AN. Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. Sao Paulo Med J. 2011;129(2):85-93. PMID: 21603785; doi: 10.1590/s1516-31802011000200006.

Koletsi D, Pandis N, Polychronopoulou A, Eliades T. What’s in a title? An assessment of whether randomized controlled trial in a title means that it is one. Am J Orthod Dentofacial Orthop. 2012;141(6):679-85. PMID: 22640669; doi: 10.1016/j.ajodo.2011.12.020.

Hopewell S, Boutron I, Altman DG, Ravaud P. Incorporation of assessments of risk of bias of primary studies in systematic reviews of randomised trials: a cross-sectional study. BMJ Open. 2013;3(8):e003342. PMID: 23975265; doi: 10.1136/bmjopen-2013-003342.

Habib Agahi R, Navabi N, Shahravan A, Ghassemi A. Critical appraisal of reporting randomized clinical trials published in Iranian dental journals during 2003-2010. J Dent (Tehran). 2014;11(3):310-8. PMID: 25628666.

Peters JP, Hooft L, Grolman W, Stegeman I. Assessment of the quality of reporting of randomised controlled trials in otorhinolaryngologic literature - adherence to the CONSORT statement. PLoS One. 2015;10(3):e0122328. PMID: 25793517; doi: 10.1371/journal.pone.0122328.

Watson HJ, Goodman EL, McLagan NB, et al. Quality of randomized controlled trials in eating disorder prevention. Int J Eat Disord. 2017 May;50(5):459-70. doi: 10.1002/eat.22712.

Feng X, Fang SN, Gao YX, Liu JP, Chen W. Evaluation of reporting quality of RCT on nephrotoxicity of Tripterygium wilfordii preparations according to CONSORT HARMs statement. Zhongguo Zhong Yao Za Zhi. 2018 Feb;43(3):440-5. doi: 10.19540/j.cnki.cjcmm.2018.0011.

Tabatabaei-Malazy O, Shadman Z, Ejtahed HS, et al. Quality of reporting of randomized controlled trials of herbal medicines conducted in metabolic disorders in Middle East countries: A systematic review. Complement Ther Med. 2018;38:61-6. PMID: 29857881; doi: 10.1016/j.ctim.2018.04.004.

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Publicado

2020-06-04

Como Citar

1.
Ferreira CA, Atallah Álvaro N, Loureiro CA de S. Detecting the extent of control over selection bias relating to oral health and otorhinolaryngology: cross-sectional study. Sao Paulo Med J [Internet]. 4º de junho de 2020 [citado 14º de março de 2025];138(3):184-9. Disponível em: https://periodicosapm.emnuvens.com.br/spmj/article/view/634

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