Journal of Ovarian Research | |
Harbin consensus conference and quality of infertility trials: reflections of a scientist on the Italian experience | |
Stefano Palomba1  | |
[1] Obstetrics and Gynecology Unit, Department of Obstetrics, Gynecology and Pediatrics, Azienda Ospedaliera “Santa Maria Nuova”, Istituto di Ricovero e Cura a Carattere Scientifico, University of Modena and Reggio Emilia, Via Risorgimento 80, Reggio Emilia 42123, Italy | |
关键词: Sterility; Reproductive medicine; RCT; Infertility; CONSORT; | |
Others : 804978 DOI : 10.1186/1757-2215-6-81 |
|
received in 2013-10-08, accepted in 2013-11-16, 发布年份 2013 | |
【 摘 要 】
During the days August 22–24, 2013 has been held in Harbin (China) an International Consensus Conference aimed to improve the quality and the reporting of the randomized controlled trials (RCTs) in infertility and subfertility field. I, as Italian scientist with experience in clinical infertility trials, was invited to have a speech on the Italian experience in RCTs, with particular regard for the surgical trials. Considerations on this subject were particularly interesting to highlight pitfalls and triumphs of research in Italy.
【 授权许可】
2013 Palomba; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20140708071500459.pdf | 575KB | download | |
Figure 3. | 48KB | Image | download |
Figure 2. | 29KB | Image | download |
Figure 1. | 39KB | Image | download |
【 图 表 】
Figure 1.
Figure 2.
Figure 3.
【 参考文献 】
- [1]Scuderi G, Guidoni L, Rosmini F, Petrini C: La normativa sulla protezione dei soggetti partecipanti a studi clinici in Italia: dagli anni Novanta al 2004. Ann Ist Super Sanita 2004, 40:495-507.
- [2]Matarese V: Relationship between quality and editorial leadership of biomedical research journals: a comparative study of Italian and UK journals. PLoS One 2008, 3:e2512.
- [3]Soteriades ES, Falagas ME: Comparison of the amount of biomedical research originating from the European Union and the United States. BMJ 2005, 331:192-195.
- [4]European Commission 2007. Available: http://cordis.europa.eu/indicators/publications.html webcite
- [5]Abbott A: Saving Italian science. Nature 2006, 440:264-265.
- [6]Becker SO, Ichino A, Peri G: How large is the “brain drain” from Italy?. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=%20378522 webcite
- [7]Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF: Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996, 276:637-639.
- [8]Schulz KF, Altman DG, Moher D: CONSORT Group: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c332.
- [9]Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001, 357:1191-1194.
- [10]Groves T: Enhancing the quality and transparency of health research. BMJ 2008, 337:a718.
- [11]Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF: CONSORT Group: CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 2008, 371:281-283.
- [12]Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: CONSORT Group: Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med 2008, 148:W60-W66.
- [13]Boers M: Updated Consolidated Standards of Reporting Trials (CONSORT): it just gets better. J Clin Epidemiol 2010, 63:813-814.
- [14]Schwartz D, Lellouch J: Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis 1967, 20:637-648.
- [15]Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D: CONSORT group: Pragmatic Trials in Healthcare (Practihc) group: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008, 337:a2390.
- [16]Schulz KF, Grimes DA: Sample size slippages in randomized trials. Exclusions and the lost and wayward. Lancet 2002, 359:781-785.
- [17]Schulz KF: Assessing allocation concealment and blinding in randomised controlled trials: why bother? Evid Based Nurs 2001, 4:4-6.
- [18]Schulz KF, Grimes DA: Blinding in randomised trials: hiding who got what. Lancet 2002, 359:696-700.
- [19]Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, Schulz KF, Plint AC, Moher D: Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev 2012., 11MR000030
- [20]Schulz KF, Grimes DA, Altman DG, Hayes RJ: Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology. BMJ 1996, 312:742-744.
- [21]Legro RS, Myers E: Surrogate end-points or primary outcomes in clinical trials in women with polycystic ovary syndrome? Hum Reprod 2004, 19:1697-1704.
- [22]Fergusson D, Aaron SD, Guyatt G, Hébert P: Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ 2002, 325:652-654.
- [23]Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F: Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod 2010, 25:2783-2791.
- [24]Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F: Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod 2008, 23:642-650.
- [25]Legro RS: Metformin as adjuvant therapy to IVF in women with PCOS: when is intention-to-treat unintentional? Hum Reprod 2011, 26:2043-2044.
- [26]Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, Bala MM, Bassler D, Mertz D, Diaz-Granados N, Vandvik PO, Malaga G, Srinathan SK, Dahm P, Johnston BC, Alonso-Coello P, Hassouneh B, Truong J, Dattani ND, Walter SD, Heels-Ansdell D, Bhatnagar N, Altman DG, Guyatt GH: The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review. BMJ 2011, 342:d1569.
- [27]Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D: CONSORT Group: Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004, 141:781-788.
- [28]Legro RS: Quo vadis randomized controlled trials in infertility? Fertil Steril 2012, 98:1350-1351.
- [29]Clarke M, Chalmers I: Discussion sections in reports of controlled trials published in general medical journals. JAMA 1998, 280:280-282.