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Quality of Randomized Controlled Trials Published By Plastic Surgeons: Long-Term Follow-Up

  • Thiago Bezerra de Morais
  • Daniela Francescato VeigaEmail author
  • Joel Veiga-Filho
  • Andréia Cristina Feitosa do Carmo
  • Rosely de Fátima Pellizzon
  • Yara Juliano
  • Miguel Sabino-Neto
  • Lydia Masako Ferreira
Original Article Special Topics
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Abstract

Introduction

In two previous studies, the quality of randomized controlled trials (RCTs) with the participation of at least one plastic surgeon was evaluated in two periods: 1966–2003 and 2004–2008.

Objective

To evaluate the evolution of the quality of RCT publications by plastic surgeons in the subsequent 5-year period, from 2009 to 2013.

Methods

RCTs published from 2009 to 2013 in English with the participation of at least one plastic surgeon were identified by electronic search and classified for concealment of allocation by two independent evaluators. The studies with adequate allocation concealment had their quality evaluated by two evaluators using the Delphi List and the Jadad Quality Scale.

Results

Of the 6997 identified studies, 261 were classified as to concealment of allocation. Of these, 43 (16.47%) had adequate allocation concealment. According to the evaluation in the Delphi List, there was an improvement, in relation to 1966–2003, in the items “most important characteristics of the prognosis” (p < 0.001), “use of independent evaluator” (p = 0.0029), and “measures of variability and point estimate for the primary variable” (p = 0.0057); there was no difference in relation to 2004–2008. Regarding the Jadad Quality Scale, there was an increase in scores in relation to 1966–2003 (p < 0.0004) but not in relation to the 2004–2008 period.

Conclusion

There was no difference in the quality of publications of RCTs by plastic surgeons in the period 2009–2013 compared to the previous 5 years (2004–2008), but both periods presented higher quality than the period 1966–2003.

Level of Evidence III

This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Keywords

Randomized controlled trials Plastic surgery Quality Evaluation 

Notes

Compliance with Ethical Standards

Conflicts of interest

The authors declare that they have no conflict of interest to disclosure.

Ethical Approval

The institutional research ethics committee approved the study (Approval #842388).

Informed Consent

For this type of study informed consent is not required.

References

  1. 1.
    Swanson JA, Schmitz D, Chung KC (2010) How to practice evidence based medicine. Plast Reconstr Surg 126:286–294CrossRefGoogle Scholar
  2. 2.
    Rohrich RJ, Eaves FF 3rd (2011) So you want to be an evidence-based plastic surgeon? A lifelong journey. Plast Reconstr Surg 127:467–472CrossRefGoogle Scholar
  3. 3.
    Kowalski E, Chung KC (2013) The outcomes movement and evidence-based medicine in plastic surgery. Clin Plast Surg 40:241–247CrossRefGoogle Scholar
  4. 4.
    Sears ED, Burns PB, Chung KC (2007) The outcomes of outcome studies in plastic surgery: a systematic review of 17 years of plastic surgery research. Plast Reconstr Surg 120:2059–2065CrossRefGoogle Scholar
  5. 5.
    Rohrich RJ, Cho MJ (2017) Evidence based medicine in aesthetic surgery: the significance of level to aesthetic surgery. Plast Reconstr Surg 139:1195eCrossRefGoogle Scholar
  6. 6.
    Leal DG, Rodrigues MA, Tedesco ACB, Nahas FX, Ferreira LM, Roxo ACW, de Castro CC, Aboudib JH (2018) Evidence-based medicine in plastic surgery: are we there yet? Ann Plast Surg 80:71–75Google Scholar
  7. 7.
    Boden C, Bidonde J, Busch A (2017) Gaps exist in the current guidance on the use of randomized controlled trial study protocols in systematic reviews. J Clin Epidemiol 85:59–69CrossRefGoogle Scholar
  8. 8.
    Veiga DF, Veiga-Filho J, Pellizzon RF, Juliano Y, Ferreira LM (2011) Evolution of reports of randomised clinical trials in plastic surgery. J Plast Reconstr Aesthet Surg 64:703–709CrossRefGoogle Scholar
  9. 9.
    Waljee JF, Larson BP, Chung KC (2012) Measuring treatment effectiveness: a guide to incorporating the principles of evidence-based medicine. Plast Reconstr Surg 130:1382–1394CrossRefGoogle Scholar
  10. 10.
    Taghinia AH, Liao EC, May JW Jr (2008) Randomized controlled trials in plastic surgery: a 20-year review of reporting standards, methodologic quality, and impact. Plast Reconstr Surg 122:1253–1263CrossRefGoogle Scholar
  11. 11.
    Momeni A, Becker A, Antes G, Diener MK, Blümle A, Stark BG (2009) Evidence-based plastic surgery: controlled trials in three plastic surgical journals (1990–2005). Ann Plast Surg 62:293–296CrossRefGoogle Scholar
  12. 12.
    Karri V (2006) Randomised clinical trials in plastic surgery: survey of output and quality of reporting. J Plast Reconstr Aesthet Surg 59:787–796CrossRefGoogle Scholar
  13. 13.
    Loonen MPJ, Hage JJ, Kon M (2007) Publications of plastic surgery research 1972 trough 2004: a longitudinal trend analysis of three international journals. J Plast Reconstr Aesthet Surg 60:934–945CrossRefGoogle Scholar
  14. 14.
    Becker A, Blümle A, Antes G, Bannasch H, Torio-Padron N, Stark GB, Momeni A (2008) Controlled trials in aesthetic plastic surgery: a 16-year analysis. Aesthetic Plast Surg 32:359–362CrossRefGoogle Scholar
  15. 15.
    Rohrich RJ (2010) So you want to be better: the role of evidence-based medicine in plastic surgery. Plast Reconstr Surg 126:1395–1398CrossRefGoogle Scholar
  16. 16.
    Agha RA, Camm CF, Edison E, Orgill DP (2013) The methodological quality of randomized controlled trials in plastic surgery needs improvement: a systematic review. J Plast Reconstr Aesthet Surg 66:447–452CrossRefGoogle Scholar
  17. 17.
    Veiga Filho J, Castro AA, Veiga DF, Juliano Y, Castilho HT, Rocha JL, Ferreira LM (2005) Quality of reports of randomized clinical trials in plastic surgery. Plast Reconstr Surg 115:320–323Google Scholar
  18. 18.
    Guidugli F, Castro AA, Atallah AN (2000) Systematic reviews on leptospirosis. Rev Inst Med Trop 42:47–49CrossRefGoogle Scholar
  19. 19.
    Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Bouter LM, Knipschild PG (1998) The Delphi List: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. J Clin Epidemiol 51:1235–1241CrossRefGoogle Scholar
  20. 20.
    Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 17:1–12CrossRefGoogle Scholar
  21. 21.
    Siegel S, Castellan NJ Jr (2006) Non-parametric statistics for the behavioral sciences. Portuguese language edition, 2nd edn. Artmed/Bookman, Porto AlegreGoogle Scholar
  22. 22.
    McCarthy CM, Collins ED, Pusic AL (2008) Where do we find the best evidence? Plast Reconstr Surg 122:1942–1947CrossRefGoogle Scholar
  23. 23.
    Thoma A, Sprague S, Temple C, Archibald S (2008) The role of the randomized controlled trial in plastic surgery. Clin Plast Surg 35:275–284CrossRefGoogle Scholar
  24. 24.
    McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D (2002) Randomised trials in surgery: problems and possible solutions. BMJ 324:1448–1451CrossRefGoogle Scholar
  25. 25.
    Farrokhyar F, Karanicolas PJ, Thoma A, Simunovic M, Bhandari M, Devereaux PJ, Anvari M, Adili A, Guyatt G (2010) Randomized controlled trials of surgical interventions. Ann Surg 251:409–416CrossRefGoogle Scholar
  26. 26.
    Solomon MJ, McLeod RS (1995) Should we be performing more randomized controlled trials evaluating surgical operations? Surgery 118:459–467CrossRefGoogle Scholar
  27. 27.
    Gattellari M, Ward JE, Solomon MJ (2001) Randomized controlled trials in surgery. Dis Colon Rectum 44(10):1413–1420CrossRefGoogle Scholar
  28. 28.
    Huemer GM, Bauer T, Gurunluoglu R, Sakho C, Oehlbauer M, Dunst KM (2004) Analysis of publications in three plastic surgery journals for the year 2002. Plast Reconstr Surg 114:1147–1154CrossRefGoogle Scholar
  29. 29.
    Loiselle F, Mahabir RC, Harrop AR (2008) Levels of evidence in plastic surgery research over 20 years. Plast Reconstr Surg 121:207e–211eCrossRefGoogle Scholar
  30. 30.
    Goulden O, Waters R (2017) Evidence-based plastic surgery in 2017. JPRAS Open 12:31–38CrossRefGoogle Scholar
  31. 31.
    Agha RA, Orgill DP (2016) Evidence-based plastic surgery: its rise, importance, and a practical guide. Aesthet Surg J 36:366–371CrossRefGoogle Scholar
  32. 32.
    Asplund O (1984) Capsular contracture in silicone gel and saline-filled breast implants after reconstruction. Plast Reconstr Surg 73:270–275CrossRefGoogle Scholar
  33. 33.
    Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF (1996) Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 276:637–639CrossRefGoogle Scholar
  34. 34.
    Moher D, Jones A, Lepage L (2001) Use of the CONSORT Statement and quality of reports of randomized trials. A comparative before-and-after evaluation. JAMA 285:1992–1995CrossRefGoogle Scholar
  35. 35.
    Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 340:c869.  https://doi.org/10.1136/bmj.c869 CrossRefGoogle Scholar
  36. 36.
    Agha RA, Barai I, Rajmohan S, Lee S, Anwar MO, Fowler AJ, Orgill DP, Altman DG (2017) Support for reporting guidelines in surgical journals needs improvement: a systematic review. Int J Surg 45:14–17CrossRefGoogle Scholar
  37. 37.
    Agha RA, Altman DG, Rosin D (2015) The SPIRIT 2013 statement—defining standard protocol items for trials. Int J Surg 13:288–291CrossRefGoogle Scholar
  38. 38.
    von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP (2007) The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 147:573–577CrossRefGoogle Scholar
  39. 39.
    Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA, PRISMA-P Group (2015) Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ 350:g7647CrossRefGoogle Scholar
  40. 40.
    Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 6:e1000097CrossRefGoogle Scholar
  41. 41.
    Agha RA, Borrelli MR, Farwana R, Koshy K, Fowler AJ, Orgill DP, SCARE Group (2018) The SCARE 2018 statement: updating consensus Surgical Case Report (SCARE) guidelines. Int J Surg 60:132–136CrossRefGoogle Scholar
  42. 42.
    Agha RA, Borrelli MR, Farwana R, Koshy K, Fowler AJ, Orgill DP, PROCESS Group (2018) The PROCESS 2018 statement: updating consensus preferred reporting of case series in surgery (PROCESS) guidelines. Int J Surg 60:279–282CrossRefGoogle Scholar
  43. 43.
    Olivo SA, Macedo LG, Gadotti IC, Fuentes J, Stanton T, Magee DJ (2008) Scales to assess the quality of randomized controlled trials: a systematic review. Phys Ther 88:156–175CrossRefGoogle Scholar
  44. 44.
    Yu J, Li X, Li Y, Sun X (2017) Quality of reporting in surgical randomized clinical trials. Br J Surg 104:296–303CrossRefGoogle Scholar
  45. 45.
    Agha RA, Camm CF, Doganay E, Edison E, Siddiqui MR, Orgill DP (2014) Randomised controlled trials in plastic surgery: a systematic review of reporting quality. Eur J Plast Surg 37:55–62CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery 2019

Authors and Affiliations

  • Thiago Bezerra de Morais
    • 1
  • Daniela Francescato Veiga
    • 1
    • 2
    Email author
  • Joel Veiga-Filho
    • 2
  • Andréia Cristina Feitosa do Carmo
    • 3
  • Rosely de Fátima Pellizzon
    • 3
  • Yara Juliano
    • 4
    • 5
  • Miguel Sabino-Neto
    • 1
    • 6
  • Lydia Masako Ferreira
    • 1
    • 6
  1. 1.Graduate Program in Translational SurgeryUniversidade Federal de São Paulo (UNIFESP)São PauloBrazil
  2. 2.Division of Plastic SurgeryUniversidade do Vale do Sapucaí (UNIVAS)Pouso AlegreBrazil
  3. 3.Division of References, Central LibraryUNIFESPSão PauloBrazil
  4. 4.Department of BiostatisticsUNIVASPouso AlegreBrazil
  5. 5.Universidade de Santo Amaro (UNISA)Santo AmaroBrazil
  6. 6.Division of Plastic SurgeryUNIFESPSão PauloBrazil

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