Evaluation of the methodological quality of 218 articles on autologous breast reconstruction

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1 Arbeitsgemeinschaft für ästhetische, Operationsverfahren plastische und in der Evaluation of the methodological quality of 218 articles on autologous breast reconstruction Katherine J Taylor, Ulrike Bussas, Volker Heyl, Hermann Zoche, Alberto Peek, Carolin Nestle-Krämling, Stefanie J Klug GMDS Mannheim, September 7th, 2010 Background AWOGyn intends to establish an S3 Guideline for breast reconstruction. Therefore they need a systematic review of the literature. 1. Step: Evaluation of the epidemiological and statistical quality of the available published articles. 2. Step: Evaluation of the medical data on the surgical methods used. 2 1

2 Background Our tasks: Conduct the literature search Design a method to evaluate the epidemiological soundness of each included article Create a database for extracting the surgical data. 3 Methods Surgical Techniques Investigated The seven surgical techniques of interest were: TRAM (transverse rectus abdominal myocutaneous flap) LADO (latissimus dorsi flap) DIEP (deep inferior epigastric perforator flap) SGAP (superior gluteal artery perforator flap) IGAP (inferior gluteal artery perforator flap) Gracilis perforator Four flap groups in total Rubens flap 4 2

3 Methods Literature Search Key words in the Pubmed search included various combinations of the surgical technique names and breast flap loss, hernia, abdominal wall, bulge, fat necrosis, patient satisfaction, cosmetic results, cost effects and length of stay, and donor site Search was completed in August, No publication date limits were included in the initial search. 5 Methods Inclusion and Exclusion Criteria Inclusion criteria: Study arms must have 20 or more patients each Only studies published in English or German Article must include one of the seven investigated surgical techniques Indication for reconstruction must be mastecomy due to breast cancer LADO technique published after 1970 TRAM technique published after 1982 DIEP and SGAP/IGAP techniques published after 1994 Exclusion criteria: Focus could not be nipple reconstruction, or pain management No animal or cadaver studies No reviews 6 3

4 Methods Preselection based on the abstract Included articles were obtained in full-text and reviewed using the Quality Criteria Check List Created a check list to evaluate included articles: Each article could receive up to 20 points. Quality points were awarded based on 18 quality criteria (two points were possible for two criteria) 7 Methods Quality Criteria Check List Content Points were awarded for information on: 1. study centre 2. timespan study subject recruitment 3. timespan and density of the operations. (2 points awarded if more than 25 patients/year) 4. characteristics of the included study population (eg. ethnicity) 5. statistical power 6. comparison study 7. primary outcomes outlined 8. use of blinding 9. methods to optimize judgement (multiple observations, training) 10.inclusion criteria/study population (2 points possible) 11.differences in baseline characteristics between study arms 12.number of planned examination points 13.statistical methods used explained 14.effect estimates plus confidence intervals or p-values 15. adjusting or stratification 16. selection problems or bias discussed 17.limitations discussed 18. generalizibility discussed 8 4

5 Results Pubmed search Pubmed search: 665 articles Read abstracts Excluded: 379 Included: Results Excluded Abstracts Overview articles: 45 Language: 38 Number of participants too small: 171 Excluded after reading abstracts: 379 Different surgical technique: 54 Different focus: 48 Animal or cadaver experiments: 16 Mixed results not reported separately, only a few patients had cancer, patients included only after complications occurred:

6 Results Abstracts Included Included after reading abstracts: 286 Evaluation of articles using the Check List Excluded: 68 Included: 218 TRAM: 156 * LADO: 55 * DIEP: 33* * SGAP/ IGAP: 4* * * The same article may be represented in more than one group 11 Results Quality Criteria Quality point distribution of the 218 included articles (20 points max.) Number of Articles Quality Score 12 6

7 Background Quality point distribution by surgical method 30 Number of Articles TRAM LADO DIEP SGAP/IGAP Quality Score 13 Results Problems with epidemiological/statistical quality Examples of quality criteria infrequently fulfilled: Statistical power reported: 2% Potential biases discussed: 4% Potential generalizability to other patients discussed: 4% Blinding used: 3% * * Not possible in every study 14 7

8 Conclusion Quality of studies reviewed was low to moderate. Researchers who conduct studies on breast reconstruction could benefit from reviewing basic epidemiological principles and obtaining statistical advice. Checklist provided a fairly objective tool for evaluating articles relative to each other. 15 Current and future plans Articles with 9 or more points will be used for surgical data extraction Number of Articles 67 articles Quality Score 16 8

9 Current and future plans Database was extended to accomodate surgical data from articles Surgical data evaluation and analysis is ongoing 17 Background Thank you for your attention Questions or comments? Katherine J. Taylor: Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre, University of Mainz Ulrike Bussas: Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre, University of Mainz Volker Heyl: Frauenklinik, Asklepios Paulinen Klinik, Wiesbaden Hermann Zoche: Frauenklinik Zentrum für Brusterkrankungen, Klinikum Coburg, Coburg Alberto Peek: Holle & Peek Gemeinschaftspraxis für Plastische Chirurgie, Frankfurt Carolin Nestle-Krämling: Frauenklinik Brustzentrum, Universitätsklinikum Düsseldorf Stefanie J. Klug: Tumour Epidemiology, University Cancer Centre, University Hospital,Technical University of Dresden 18 9