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001science

  1. 1. Journal of Plastic, Reconstructive & Aesthetic Surgery (2011) 64, 703e709 REVIEW Evolution of reports of randomised clinical trials in plastic surgery D.F. Veiga a,b,e,*, J. Veiga-Filho a,b,e, R.F. Pellizzon c, Y. Juliano d, L.M. Ferreira a,e a ˜o ˜o Division of Plastic Surgery, Department of Surgery, Universidade Federal de Sa Paulo, Sa Paulo, Brazil ´ Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaı, Pouso Alegre, Brazil c ˜o ˜o Division of References, Central Library, Universidade Federal de Sa Paulo, Sa Paulo, Brazil d ´ Department of Bioestatistics, Universidade do Vale do Sapucaı, Pouso Alegre, Brazil e ˜o ˜o Plastic Surgery Postgraduate Program e Universidade Federal de Sa Paulo, Rua Napolea de Barros, ˜o 715 e 4 andar - CEP 04024-002, Sa Paulo e SP, Brazil b Received 26 May 2010; accepted 16 November 2010 KEYWORDS Randomised clinical trials; Plastic surgery; Review literature as topic; Quality; Evaluation Summary Well-designed, well-conducted and well-reported randomised clinical trials (RCTs) can significantly impact medical care, by contributing to a strong evidence base from which clinical guidelines can be derived. In a previous study, we assessed the quality of reports of RCTs in plastic surgery published from 1966 to 2003. The aim of the present study was to verify what have changed over the last years. RCTs in plastic surgery published from 2004 to 2008 were identified through electronic searches, and classified according to their allocation concealment. Trials with allocation concealment appropriately described were evaluated as to their quality. Two independent reviewers performed the evaluations, using two tools: the Delphi List and the Jadad’s quality scale. From 3840 identified studies, 96 were selected for classification according to allocation concealment; 28 (29%) of them appropriately described allocation concealment. From 1966 to 2003, 34 (17%) RCTs appropriately described allocation concealment (c2 Z 22.98, p 0.000). In the evaluation of the 28 RCTs by the Delphi List, the agreement coefficient between raters (kw) was 0.46 (z Z 7.24, p 0.000). Groups were similar at baseline in 96.4% of these trials, and this was the only item of the Delphi List, which significantly improved when compared with the period from 1966 to 2003 (c2 Z 18.53, p 0.000). When evaluated by Jadad’s criteria, 14% of the RCTs were scored two points or less and thus considered of low quality (kw Z 0.72, z Z 8.57, p 0.001). From 1966 to 2003, 59% of RCTs were scored two points or less (c2 Z 17.07, * Corresponding author. Rua Napoleao de Barros, 715 e 4 andar, CEP 04024-002, Sao Paulo e SP, Brazil. Tel.: þ55 35 34223298; fax: þ55 ˜ ˜ 35 34223299. E-mail address: danifveiga@uol.com.br (D.F. Veiga). 1748-6815/$ - see front matter ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2010.11.015
  2. 2. 704 D.F. Veiga et al. p 0.004). We concluded that the quality of reports of RCTs in plastic surgery (as measured by the Jadad’s criteria and only one component of the nine components of the Delphi List) significantly increased over the last years. ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. Research in plastic surgery will have a greater impact on clinicians’ practice if higher-impact-level studies are published.1 Considering the growing demands for state-of-theart treatment, and the limited health-care resources, increasing interest is being focussed on the practice of evidence-based medicine.2e4 The randomised controlled trial (RCT) is defined as a study design in which patients are allocated at random to an intervention group or to a control group.2,5,6 Well-designed RCTs provide the highest level of evidence in health-care interventions, and their outcomes can significantly impact medical care, by contributing to a strong evidence base from which clinical guidelines can be derived.7,8 The essence of evidence-based medicine is the integration of clinical expertise with the best available evidence from systematic research.2,9 By systematically identifying and assessing the reporting and methodologic quality of RCTs and their impact in our speciality, we can improve evidence-based practice in plastic surgery, thus directly benefiting our patients.2,8 However, the application of evidence-based medicine, and specifically the RCT, to surgical research has been slower than in medical specialities.3,4,10,11 The execution of a plastic surgery RCT is challenging. Challenges include surgical equipoise, surgical learning curve, differential care, randomisation, concealment, blinding and loss to follow-up, among others.3,4 Despite of the difficulties in conducting RCTs in plastic surgery, if the field of plastic surgery is to advance, it must adopt well-established methodologic principles.4 A previous study identified RCTs in plastic surgery published from 1966 to 2003, and assessed the quality of reports of the RCTs, which have appropriately described allocation concealment.12 The aim of the present study was to evaluate the quality of reports of RCTs in plastic surgery published from January 2004 to December 2008, using the same tools, to verify what have changed over the last years. Methods An electronic search was conducted to identify the maximum number of studies published as RCTs in plastic surgery, in the English language, from January 2004 to December 2008. Strategies of electronic search were elaborated for each database consulted: Cochrane Controlled Trials Register (CCTR), Excerpta Medica Database (EMBASE), Latin-American and Caribbean Literature in Sciences of Health (LILACS) and MEDLARS e Medical Literature Retrieval System e online (MEDLINE). These strategies are presented in Table 1. Possible RCTs in plastic surgery were identified and selected. Trials that have not been carried out by plastic surgeons or with the participation of at least one plastic surgeon were excluded. One author conducted the searches and another author performed the selection of trials, by reading all the abstracts. After selection, the full texts of the trials were assessed. Two reviewers independently classified the trials according to allocation concealment;13 disagreements were resolved at a consensus meeting. RCTs in plastic surgery with allocation concealment appropriately described were then selected, and they constituted the sample of this study. For each of these RCTs, basic data were gathered, such as journal and year of publication and country of association. The selected RCTs were then evaluated as to their quality. The assessment was independently made by two raters and cross-checked. Two validated tools were used to assess the quality of RCTs: the Delphi List14 and the Jadad’s quality scale15 (Table 2). The Delphi List is a generic criteria list for quality assessment in RCTs, which should be used alongside other instruments.14 The Jadad’s quality scale is scored thus: a score of one point is given for each “yes” and zero points for each “no”. Point awards for the first two items (randomisation and double blinding) depend not only on whether the trial is described as randomised or double blind, but also on the appropriateness of the methods used to randomise and blind the trial: if these methods are described and are appropriate, one additional point is given for each item. Conversely, if the methods used to generate a randomisation sequence or create blinded conditions are described, but are inappropriate, the relevant item is given zero points. Thus, the scale produces scores from 0 to 5. A trial could be judged as having poor quality, if it is awarded two points or less.15 The results were compared with data from the previous study, which has assessed quality of reports of RCTs in plastic surgery from 1966 to December 2003.12 Statistical method The chi-square test for two independent variables was applied to compare the time periods 1966e2003 and 2004e2008 with regard to percentile distribution of trials among the four searched databases. The same test was used to compare time periods (1966e2003 and 2004e2008) with regard to distribution of the RCTs with allocation concealment appropriately described, according to journal where they were published, continent (country) of origin and items of Delphi List. The chi-square test for one variable was used to compare 5-year periods, from 1984 to 2008, with regard to distribution of RCTs with allocation concealment appropriately described. Kappa statistic was used to study agreement between the two reviewers in the assessment of trials’ allocation concealment, in data collection for the Delphi List and in data collection for Jadad’s quality scale. The agreement coefficients (kw) were calculated, and significance was
  3. 3. Evolution of reports of randomised clinical trials Table 1 Database 705 Strategies of electronic search elaborated for databases consulted. Strategy of electronic search LILACS, MEDLINE, (Pt randomized controlled trial or Pt controlled clinical trial or Mh Randomized Controlled EMBASE Trials as Topic or Clinical Trials, Randomized or Controlled Clinical Trials, Randomized or Mh Random allocation or Randomisation or Mh Double-Blind Method or Double-Masked Study or Mh Single-Blind Method or Single-Masked Study) and Ct humans and not (Ct animals or (Ct animals and Ct humans)) and (Ex E04.680$ or Mh Surgery, Plastic orTw cirurg$ OR Tw cirug$ OR Tw surg$ OR Tw procedure$ OR Tw procedim$ OR Tw metodo$ OR Tw method$ OR Tw tecnic$ OR Tw technique$) and (Tw reconstru$ OR Tw cosmetic$ OR Tw plastic$ OR Tw esthetic$ OR Tw estetic$ OR Tw aesthetic$) and (pd 2004 or pd 2005 or pd 2006 or pd 2007 or pd 2008) [Words] CCTR 1. ((Surgery Plastic or Plastic Surgery or (cirurg$ or cirug$ or surg$ or procedure$ or procedim$ or metodo$ or method$ or tecnic$ or technique$)) and (reconstru$ or cosmetic$ or plastic$ or esthetic$ or estetic$ or aesthetic$)).mp. [mp Z title, original title, abstract, mesh headings, heading words, keyword] (3778) 2. limit 1 to yr Z 2008 (145) 3. limit 2 to last 5 years (145) 4. ((Surgery Plastic or Plastic Surgery or (cirurg$ or cirug$ or surg$ or procedure$ or procedim$ or metodo$ or method$ or tecnic$ or technique$)) and (reconstru$ or cosmetic$ or plastic$ or esthetic$ or estetic$ or aesthetic$)).mp. [mp Z title, original title, abstract, mesh headings, heading words, keyword] (3778) 5. limit 4 to yr Z 2004e2008 (1480) 6. limit 4 to (yr Z 2004e2008 and last 5 years) (1480) 7. ((Surgery Plastic or Plastic Surgery or (cirurg$ or cirug$ or surg$ or procedure$ or procedim$ or metodo$ or method$ or tecnic$ or technique$)) and (reconstru$ or cosmetic$ or plastic$ or esthetic$ or estetic$ or aesthetic$)).mp. [mp Z title, original title, abstract, mesh headings, heading words, keyword] (3778) 8. limit 7 to yr Z 2004 - 2008 (1480) 9. from 8 keep 1-200 (200) 10. from 8 keep 1-100 (100) 11. from 8 keep 201-400 (200) assessed by the calculated z-values. Values of the kappa statistic are generally interpreted as kw values below 0.40, poor agreement; from 0.40 to 0.75, fair-to-good agreement; above 0.75, excellent agreement.16 The KolmogoroveSmirnov test was used to compare the periods 1966e2003 and 2004e2008 with regard to percentile distribution of Jadad’s quality scale scores. Statistical analysis was performed using Statistical Package for Social Sciences (SPSS) version 18 (SPSS, Inc., Chicago, IL, USA). A p value 0.05 was considered statistically significant. Results The electronic search identified 3840 reports in the four consulted databases. Table 3 presents the distribution Table 2 Table 3 surgery. Items of the Jadad’s quality scale.15 Yes Was the study described as randomized (this includes the use of words such as randomly, random and randomisation)? Was the method appropriate? Was the study described as double blind? Was the method appropriate? Was there a description of withdrawals and dropouts? among the databases, as well as data from 1966 to 2003,12 and their statistical comparison. One reviewer selected 223 reports, excluding the 3617 studies that clearly were not RCTs, or that have not been carried out by plastic surgeons or with the participation of at least one plastic surgeon. Of the 223 studies, 91 were common to two or more databases or they repeated inside of the same database. After examining the full text of the 132 remaining reports, the reviewer excluded 36, for the following reasons: seven studies were not RCTs and 29 studies have not been carried out by at least one plastic surgeon. Thus, the final selection had 96 studies. Two reviewers independently classified the 96 selected studies according to allocation concealment.13 The description of allocation concealment was considered adequate when the manoeuvre employed by the authors to No Database Results of electronic search of RCTs in plastic Trials 1966e2003 n CCTR EMBASE LILACS MEDLINE 635 2354 127 1811 Total 4927 c Z 1536.2, p 0.000. 2 2004e2008 % 12.9 47.8 2.6 36.7 100 n 1480 500 8 1852 3840 % 38.5 13.0 0.2 48.2 100
  4. 4. 706 D.F. Veiga et al. assure that group allocation cannot be influenced by the investigators or the study participants was explicit in the report. The agreement coefficient (kw) between the two reviewers was 0.70 (z Z 9.82, p 0.000). After a consensus meeting, they had 28 studies that were RCTs in plastic surgery, with allocation concealment properly described. Table 4 presents the distribution of these RCTs published over time periods of 5 years, comparing the results of the present study with data from 1966 to 2003.12 The first time period presented was 1984e1988 because the first RCT in plastic surgery with allocation concealment appropriately described that was found was published in 1984.17 There was a significant increase in the number of trials with allocation concealment properly described along the time (c2 Z 22.98; p 0.000). The distribution of these RCTs publications in three major plastic surgery journals (Plastic and Reconstructive Surgery; Journal of Plastic, Reconstructive Aesthetic Surgery; and Annals of Plastic Surgery) is pointed out in Table 5. Europe and North America published over 80% of the RCTs with allocation concealment properly described, and there was no statistical difference as compared with the time period 1966e2003 (Table 6).12 The agreement coefficient between the two independent raters in the assessment of the 28 RCTs by the Delphi List14 was 0.46 (z Z 7.24, p 0.000). The assessment by the Delphi List,14 after the consensus meeting, is shown in Table 7, which also presents data from 1966 to 2003.12 A significant improvement, compared with 1966e2003, was noted only for the item ‘similarity of the groups at baseline regarding the most important prognostic factors’ (c2 Z 18.53, p 0.000). The agreement coefficient between the raters in the assessment of the 28 RCTs by Jadad’s quality scale was 0.72 (z Z 8.57, p 0.000). After the consensus meeting, the median Jadad score was 3 (mean 3.7). Table 8 shows the distribution of RCTs, according to Jadad score,15 published from 1966 to 2003 and 2004 to 2008.12 There was a significant improvement in Jadad scores during 2004e2008 (c2 Z 12.18, p Z 0.002). Discussion Decisions makers in health care are increasingly seeking high-quality scientific evidence to support clinical and Table 4 Distribution of the RCTs with allocation concealment appropriately described according to the year of publication. Year Trials n 1984e1988 1989e1993 1994e1998 1999e2003 2004e2008 6 8 8 12 28 Total 62 c Z 22.98, p 0.000. 2 % 9.7 12.9 12.9 19.3 45.2 100 Table 5 Distribution of the RCTs with allocation concealment appropriately described according to the journal where they were published. Journal Trials 1966e2003 2004e2008 n n Plast Reconstr Surg J Plast Reconstr Aesth Surg Ann Plast Surg Other 13 10 2 9 Total 34 % 38.2 29.4 5.9 26.5 100 13 2 1 12 28 % 46.4 7.1 3.6 42.9 100 c Z 5.6, p Z 0.14. 2 health policy choices.16,18 RCTs provide the highest level of evidence in health-care interventions.14,15,19 However, the nature of surgical practice is such that evidence-based medicine is less popular in surgery than in the medical specialities.3,4,8 Furthermore, when RCTs have been conducted in the field of plastic surgery, their validity is many times in question because of poor methodology.4 Limitations of RCT research in plastic surgery, including technical, practical and ethical issues are intrinsic to our speciality and cannot readily be changed.3 Despite the difficulty in performing RCTs in plastic surgery, trials that are performed need higher methodologic and reporting standards. Instituting higher standards may improve the impact of trials and make them more influential in plastic surgery practice.2,8,20 Our study has limitations that deserve mention. They include performing just electronic searches, not associated with hand searches, and only evaluating quality of RCTs with allocation concealment appropriately described, thus, eventually excluding RCTs well designed and well conducted but which failed in describing allocation concealment. Another limitation is that strategies of search included neither hand surgery nor any other specific surgical field, such as cleft or maxillofacial surgery. The inclusion of terms such these in the strategies of electronic search could have greatly increased the number of RCTs reported. However, the main point is that we were limited to the methodology applied to the previous study;12 otherwise, we could not compare the results. Compared with 1966e2003, we observed a statistically significant difference in the distribution of trials among databases. Particularly, there was an important increase in the output of CCTR. We speculate that this statistically significant increase could be attributed to the recent inclusion of Cochrane Library in the databases of the Institute for Scientific Information (ISI). We noted also a statistically significant decrease in the number of RCTs recovered from EMBASE. Our analysis of continent (country) of origin revealed that Europe has published the majority of RCTs (50%), followed by North America (32%). The fact that the majority of RCTs are published by researchers from Europe and North America has already been demonstrated.2,7,21,22 Despite the fact that the majority of RCTs with allocation concealment appropriately described was conducted by
  5. 5. Evolution of reports of randomised clinical trials Table 6 707 Distribution of the RCTs with allocation concealment properly described according to continent of origin. Continent (country) Trials 1966e2003 n 2004e2008 % n % Europe (Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Sweden, United Kingdon) North America (Canada, Puerto Rico, United States) South America (Brazil, Chile) Asia (India, Japan) Oceania (Australia) 24 70.6 14 50.0 8 e 1 1 23.5 e 2.9 2.9 9 3 2 e 32.1 10.7 7.1 e Total 34 100 28 100 c Z 6.5, p Z 0.17. 2 European researchers, most of them were published in Plastic and Reconstructive Surgery, followed by Journal of Plastic, Reconstructive Aesthetic Surgery. This fact has also been demonstrated previously.2,12,18 Despite the visible difference for the period from 2004 to 2008, there was no statistical difference in the number of publications of RCTs with allocation concealment appropriately described among the plastic surgery journals. Unless more RCTs will be published in plastic surgery journals, we will never be able to determine statistical significance for these data. Table 7 On assessing the quality of reports of RCTs in plastic surgery published from 1966 to 2003, we concluded that their quality was low (mean Jadad score 2.4).12 Taghinia et al. critically assessed the quality of RCTs published from 1986 to 2006 in three major plastic surgery journals. They used the Jadad criteria, besides other parameters such as allocation concealment, appropriate blinding and intention-to-treat analysis. The mean Jadad score in their study was similar: 2.3.8 In the present study, the mean Jadad score was 3.7, clearly demonstrating the increase in quality of reports of RCTs with adequate allocation concealment. When the Quality assessment by Delphi List14 after co nsensus meeting. 1966-2003 2004-2008 Chi-square Yes NS Z non significant. Yes No n (%) Treatment allocation: Was a method of randomisation performed? Was the treatment allocation concealed? Were the groups similar at baseline regarding the most important prognostic indicators? Were the eligibility criteria specified? Was the outcome assessor blinded? Was the care provider blinded? Was the patient blinded? Were point estimates and measures of variability presented for the primary outcome measures? Did the analysis include an intention-to-treat analysis? No n (%) n (%) n (%) 34(100.0) e 28(100.0) e e 34(100.0) e 28(100.0) e e 14(41.2) 20(58.8) 27(96.4) 1(3.6) c2 Z 18.53***p Z 0.000 17(50.0) 17(50.0) 19(67.9) 9(32.1) NS 17(50.0) 17(50.0) 18(64.3) 10(35.7) NS 11(32.4) 23(67.6) 9(32.1) 19(67.9) NS 20(58.8) 15(44.1) 14(41.2) 19(55.9) 14(50.0) 19(67.9) 14(50.0) 9(32.1) NS NS 13(38.2) 21(61.8) 9(32.1) 19(67.9) NS
  6. 6. 708 D.F. Veiga et al. Table 8 Scores of the Jadad’s quality scale15 after consensus meeting. progressively introducing our speciality to a higher evidencelevel research. Scores Conflict of interest statement Trials 1966-2003 n 0 1 2 3 4 5 4 1 15 7 4 3 Total 34 2004-2008 % 11.8 2.9 44.1 20.6 11.8 8.8 100 n % e e 4 11 2 11 e e 14.2 39.3 7.1 39.3 28 100 c Z 12.18, p Z 0.002. 2 Delphi List was applied, however, we had a statistically significant improvement only in the item ‘similarity of groups at baseline regarding prognostic indicators’. Of the multiple published scales used to evaluate methodologic quality, the Jadad score is the most commonly used.8 It has been validated for this purpose using well-established procedures.8,15 The scale was originally developed using studies from the pain literature, and it has some limitations when applied to surgical trials. A major one is that 40% of the total score is based on the definition of double blinding, which is difficult to achieve in surgical trials.7 Thus, Jadad recommends that the quality scale should be used alongside other instruments.5 Clark et al., assessing the reliability of the Jadad scale, saw a low interobserver agreement.23 However, in the present study, the inter-rater agreement coefficient was good (0.72). Recent studies demonstrated that the plastic surgical community has recognised the necessity of improving the evidence level of plastic surgery research, reflected by the continuous increase in publications of RCTs.2,7,18,21 In the present study, besides the statistically significant increase in the number of RCTs in plastic surgery published over the last years, we observed a statistically significant increase in the quality scores of these RCTs, particularly with regard to randomisation methods and blinding. Plastic surgeons were also successful in appropriately describing withdrawals and dropouts and similarity of groups at baseline. The quality of reports of RCTs in plastic surgery, however, still needs improvement.8 There are many other issues, such as including an intention-to-treat analysis, which must be improved. It was encouraging to verify that 86% of the RCTs with allocation concealment appropriately described were considered of high quality (Jadad’s score up to 3). Further, 46% of these high-quality RCTs reached the highest Jadad score of 5.24e34 However, as compared with other specialities, RCTs in plastic surgery still are fewer and of lower impact.1,8,35,36 We agree with McCarthy et al. when they affirm that “as plastic surgeons, we can assume an increased leadership role in producing impartial evidence on the efficacy of our surgical interventions.”17 We believe that our results highlight the recognition, by plastic surgeons, of the importance of The authors have no conflicts of interest, no financial or personal relationships with other people or organisations that could inappropriately influence this work. References 1. Sears ED, Burns PB, Chung KC. The outcomes of outcome studies in plastic surgery: a systematic review of 17 years of plastic surgery research. Plast Reconstr Surg 2007;120:2059e65. 2. Momeni A, Becker A, Antes G, Diener M, Bluemle A, Stark BG. Evidence-based plastic surgery: controlled trials in three plastic surgery journals (1990 to 2005). Ann Plast Surg 2009;62:293e6. 3. Loiselle F, Mahabir RC, Harrop AR. Levels of evidence in plastic surgery research over 20 years. Plast Reconstr Surg 2008;121: 207ee11e. 4. Thoma A, Sprague S, Temple C, Archibald S. The role of the randomized controlled trial in plastic surgery. Clin Plast Surg 2008;35:274e84. 5. Jadad AR. Randomized controlled trials. London: BMJ Books; 1998. 6. Van der Widjen CL, Overbeke JA. Audit of reports of randomized randomised clinical trials published in one journal over 45 years. BMJ 1995;311:918. 7. Karri V. Randomised clinical trials in plastic surgery: survey of output and quality of reporting. J Plast Reconstr Aesthet Surg 2006;59:787e96. 8. Taghinia AH, Liao EC, May Jr JW. Randomised controlled trials in plastic surgery: a 20-year review of reporting standards, methodologic quality, and impact. Plast Reconstr Surg 2008;122: 1253e63. 9. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312:71e2. 10. Solomon MJ, McLeod RS. Should we be performing more randomized controlled trials evaluating surgical operations? Surgery 1995;118:459e67. 11. Gattellari M, Ward JE, Solomon MJ. Randomized controlled trials in surgery. Dis Colon Rectum 2001;4:1413e20. 12. Veiga-Filho J, Castro AA, Veiga DF, et al. Quality of reports of randomized clinical trials in plastic surgery. Plast Reconstr Surg 2005;115:320e3. 13. Guidugli F, Castro AA, Atallah AN. Systematic reviews on leptospirosis. Rev Inst Med Trop 2000;42:47e9. 14. Verhagen AP, De Vet HCW, De Bie RA, et al. The Delphi List: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. J Clin Epidemiol 1998;51:1235e41. 15. Jadad AR, Moore RA, Carrol D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1e12. 16. McCarthy CM, Collins ED, Pusic AL. Where do we find the best evidence? Plast Reconstr Surg 2008;122:1942e9. 17. Asplund O. Capsular contracture in silicone gel and saline-filled breast implants after reconstruction. Plast Reconstr Surg 1984; 73:270e5. 18. Loonen MPJ, Hage JJ, Kon M. Publications of plastic surgery research 1972 trough 2004: a longitudinal trend analysis of three international journals. J Plast Reconstr Aesthet Surg 2007;60: 934e45. 19. Schultz KF, Grimes DA. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet 2002;359: 781e5.
  7. 7. Evolution of reports of randomised clinical trials 20. Moher D, Schulz KF, Altman DCONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987e91. 21. Becker A, Blumle A, Antes G, et al. Controlled trials in ¨ aesthetic plastic surgery: a 16-year analysis. Aesth Plast Surg 2008;32:359e62. 22. Huemer GM, Bauer T, Gurunluoglu R, Sakho C, Oehlbauer M, Dunst KM. Analysis of publications in three plastic surgery journals for the year 2002. Plast Reconstr Surg 2004;114: 1147e54. 23. Clark HD, Wells GA, Huet C, et al. Assessing the quality if randomized trials: reliability of the Jadad scale. Control Clin Trials 1999;20:448e52. 24. Anzarut A, Guenther CR, Edwards DC, Tsuyuki RT. Completely autologous platelet gel in breast reduction surgery: a blinded, randomized, controlled trial. Plast Reconstr Surg 2007;119: 1159e66. 25. Araco A, Gravante G, Araco F, Delogu D, Cervelli V. Comparison of power watereassisted and traditional liposuction: a prospective randomized trial of postoperative pain. Aesthetic Plast Surg 2007;31:259e65. 26. Danielsen P, Jorgensen B, Karlsmark T, Jorgensen LN, Agren MS. Effect of topical autologous platelet-rich fibrin versus no intervention on epithelialization of donor sites and meshed split-thickness skin autografts: a randomized clinical trial. Plast Reconstr Surg 2008;122:431e40. 27. Hari IK, Kawashima M. A double-blind, randomized, placebocontrolled, two-dose comparative study of botulinum toxin type A for treating glabellar lines in japanese subjects. Aesthetic Plast Surg 2008;32:724e30. 28. Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for 709 29. 30. 31. 32. 33. 34. 35. 36. pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg 2008;122:1010e8. Kazmier FR, Henry SL, Christiansen D, Puckett CL. A prospective, randomized, double-blind, controlled trial of continuous local anesthetic infusion in cosmetic breast augmentation. Plast Reconstr Surg 2008;121:711e5. Kono T, Kinney BM, Groff WF, Chan HH, Ercocen AR, Nozaki M. Randomized, evaluator-blind, split-face comparison study of single cross-linked versus double cross-linked hyaluronic acid in the treatment of glabellar lines. Dermatol Surg 2008;34 (Suppl. 1):S25e30. Rawlani V, Kryger ZB, Lu L, Fine NA. A local anesthetic pump reduces postoperative pain and narcotic and antiemetic use in breast reconstruction surgery: a randomized controlled trial. Plast Reconstr Surg 2008;122:39e52. Romundstad L, Breivik H, Roald H, et al. Methylprednisolone reduces pain, emesis, and fatigue after breast augmentation surgery: a single-dose, randomized, parallel-group study with methylprednisolone 125 mg, parecoxib 40 mg, and placebo. Anesth Analg 2006;102:418e25. Sun T, Sacan O, White PF, Coleman J, Rorich RJ, Kenkel JM. Perioperative versus postoperative celecoxib on patient outcomes after major plastic surgery procedures. Anesth Analg 2008;106:950e8. Taghizadeh R, Shoaib T, Hart AM, Weiler-Mithoff EM. Triamcinolone reduces seroma re-accumulation in the extended latissimus dorsi donor site. J Plast Reconstr Aesthet Surg 2008; 61:636e42. Margaliot Z, Chung KC. Systematic reviews: a primer for plastic surgery research. Plast Reconstr Surg 2007;120:1834e41. Labanaris AP, Vassiliadu AP, Polykandriotis E, Tjiawi J, Arkudas A, Horch RE. Impact factors and publication times for plastic surgery journals. Plast Reconstr Surg 2007;120: 2076e81.

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