Recruitment challenges of a multicenter randomized controlled varicocelectomy trial

Fertility and Sterility

Volumn 96, Issue 6, 2011, Pages 1299-1305

  Trussell, J C ^a   Christman, Gregory M ^b   Ohl, Dana A ^b   Legro, Richard S ^c   Krawetz, Stephen A ^d   Snyder, Peter J ^e   Patrizio, Pasquale ^f   Polotsky, Alex J ^g   Diamond, Michael P ^d,h   Casson, Peter R ⁱ   Coutifaris, Christos ^e   Barnhart, Kurt ^e   Brzyski, Robert G ^j   Schlaff, William D ^g   Meacham, Randall ^g   Shin, David ^k   Thomas, Tracey ^l   Zhang, Meizhuo ^l   Santoro, Nanette ^g   Eisenberg, Esther ^m,n   Zhang, Heping ^l   more..

^a University Hospital   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c PENN STATE COLLEGE OF MEDICINE   (United States)

^d WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^h WAYNE STATE UNIVERSITY   (United States)

ⁱ UNIVERSITY OF VERMONT   (United States)

^j Mays Cancer Center at UT Health San Antonio   (United States)

^k HACKENSACK UNIVERSITY MEDICAL CENTER   (United States)

^l YALE UNIVERSITY   (United States)

^m VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

ⁿ EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

more..

Author keywords

Accrual; consent; enrollment; prospective; randomization; recruitment; varicocele; varicocelectomy

Indexed keywords

ARTICLE; HUMAN; INTERMETHOD COMPARISON; INTRAUTERINE INSEMINATION; MALE INFERTILITY; MULTICENTER STUDY (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH SUBJECT; VARICOCELECTOMY;

EID: 82455217339     PISSN: 00150282     EISSN: 15565653     Source Type: Journal    
DOI: 10.1016/j.fertnstert.2011.10.025     Document Type: Review

References (31)

1. I.D. Sharlip, J. Jarow, A.M. Belker, M. Damewood, S.S. Howards, and L.I. Lipshultz Report on varicocele and infertility 2001 American Urological Association Linthicum, MD 1-9
2. V. Ficarra, M.A. Cerruto, G. Ligouri, G. Mazzoni, S. Minnuci, and A. Tracia Treatment of varicocele in subfertile men: the Cochrane review - a contrary opinion Eur Urol 49 2006 258 263 (Pubitemid 43197861)
3. T.A. Abdel-Meguid, A. Al-Sayyad, A. Tayib, and H.M. Farsi Does varicocele repair improve male infertility? An evidence-based perspective from a randomized, controlled trial Eur Urol 59 2011 455 461
4. J.A. Daitch, M.A. Bedaiwy, E.B. Pasqualotto, B.N. Hendin, J. Hallak, and T. Falcone Varicocelectomy improves intrauterine insemination success rates in men with varicocele J Urol 165 2001 1510 1513 (Pubitemid 32410226)
5. Male Infertility Best Practice Policy Committee of the American Urological Association; Practice Committee of the American Society for Reproductive Medicine Report on varicocele and infertility Fertil Steril 82 Suppl 1 2004 S142 S145
6. R. Kunz, G. Vist, and A.D. Oxman Randomisation to protect against selection bias in healthcare trials Cochrane Database Syst Rev 2 2007 MR000012
7. S. Barton Which clinical studies provide the best evidence? The best RCT still trumps the best observational study BMJ 321 2000 255 256
8. D.L. Sackett, W.M. Rosenberg, J.A. Gray, R.B. Haynes, and W.S. Richardson Evidence based medicine: what it is and what it isn't BMJ 312 1996 71 72
9. S. Treweek, M. Pitkethly, J. Cook, M. Kjeldstrom, T. Taskila, and M. Johansen Strategies to improve recruitment to randomised controlled trials Cochrane Database Syst Rev 4 2010 1 10
10. P.D. Walson Patient recruitment: US perspective Pediatrics 104 1999 619 622 (Pubitemid 29426633)
11. P.J. Easterbrook, and D.R. Matthews Fate of research studies J R Soc Med 85 1992 71 76
12. D.G. Altman, and J.M. Bland Absence of evidence is not evidence of absence BMJ 311 1995 485
13. P.H.Y. Caldwell, S. Hamilton, A. Tan, and J.C. Craig Strategies for increasing recruitment to randomised controlled trails: Systematic review PLoS Med 7 2010 1 16
14. S.M. Zifferblatt Recruitment in large-scale clinical trials S.M. Weiss, Proceedings of the National Heart and Lung Institute Working Conference on health behavior 1975 National Institutes of Health Bethesda, MD 187 195
15. M.E. Charlson, and R.I. Horwitz Applying results of randomised trials to clinical practice: impact of losses before randomisation BMJ 289 1984 1281 1284 (Pubitemid 15217616)
16. A.B. Haidich, and J.P.A. Ioannidis Patterns of patient enrollment in randomized controlled trials J Clin Epidemiol 54 2001 877 883 (Pubitemid 32755779)
17. R. Foy, J. Parry, A. Duggan, B. Delaney, S. Wilson, and N.T. Lewin-van den Broek How evidence-based are recruitment strategies for randomized controlled trials in primary care? Experience from seven studies Fam Pract 20 2003 83 92 (Pubitemid 36163791)
18. A.M. McDonald, R.C. Knight, M.K. Campbell, V.A. Entwistle, A.M. Grant, and J.A. Cook What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies Trials 7 2006 9
19. A. Agarwal, F. Deepinder, M. Cocuzza, A. Agarwal, F. Deepinder, and M. Cocuzza Efficacy of varicocelectomy in improving semen parameters: new meta-analytical approach Urology 70 2007 532 538 (Pubitemid 47464479)
20. J.L. Marmar, A. Agarwal, S. Prabakaran, R. Agarwal, R.A. Short, and S. Benoff Reassessing the value of varicocelectomy as a treatment for male subfertility with a new meta-analysis Fertil Steril 88 2007 639 646
21. J.L. Evers, and J.A. Collins Surgery or embolization for varicocele in subfertile men Cochrane Database Syst Rev 3 2004 CD000479
22. J.L. Evers, and J.A. Collins Assessment of efficacy of varicocele repair for male subfertility: a systematic review Lancet 361 2003 1849 1852 (Pubitemid 36645179)
23. J.M. Watson, and D.J. Torgerson Increasing recruitment to randomised trails: a review of randomised controlled trails BMC Med Res Methodol 6 2006 34
24. J.L.H. Evers, J. Collins, and J. Clarke Surgery or embolization for varicoceles in subfertile men Cochrane Database Syst Rev 11 2010 1 20
25. M.A. Will, J. Swain, M. Fode, J. Sonksen, G.M. Christman, and D. Ohl The great debate: varicocele treatment and impact on fertility Fertil Steril 95 2011 841 852
26. W. Krause, H.H. Muller, H. Schafer, and W. Weidner Does treatment of varicocele improve male fertility? Results of the "Deutsche Varikozelenstudie," a multicentre study of 14 collaborating centres Andrologia 34 2002 164 171 (Pubitemid 34639199)
27. S. Nilson, A. Edvinsson, and B. Nilson Improvement of semen and pregnancy rate after ligation and division of the internal spermatic vein: fact or fiction? Br J Urol 51 1979 591 596 (Pubitemid 10180231)
28. R. Breznik, V. Vlausavlievic, and E. Borko Treatment of varicocele and male fertility Arch Androl 30 1993 157 160 (Pubitemid 23167205)
29. I. Madgar, R. Weissenberg, B. Lunenfeld, A. Karasik, and B. Goldwasser Controlled trail of high spermatic vein ligation for varicocele in infertile men Fertil Steril 63 1995 120 124
30. E. Nieschlag, L. Hertle, A. Fischedick, K. Abshagen, and H.M. Behre Update on treatment of varicocele: counseling as effective as occlusion of the vena spermatica Hum Reprod 113 1998 2147 2150 (Pubitemid 28425104)
31. M. Yamamoto, H. Hibi, Y. Hirata, K. Miyake, and T. Ishigaki Effect of varicocelectomy on sperm parameters and pregnancy rate in patients with subclinical varicocele: a randomized prospective controlled study J Urol 155 1996 1636 1638 (Pubitemid 26126966)