The application of quantitative methods for identifying and exploring the presence of bias in systematic reviews: PDE-5 inhibitors for erectile dysfunction

International Journal of Impotence Research

Volumn 20, Issue 3, 2008, Pages 264-277

  Bekkering, G E ^a,b   Abou Setta, A M ^c   Kleijnen, J ^b  

^a BeSyRe Bekkering Systematic Reviews   (Belgium)

^b UNIVERSITY OF LEUVEN   (Belgium)

^c Kleijnen Systematic Reviews Ltd ^*

Author keywords

Erectile dysfunction; Meta analysis; Methodology; PDE 5 inhibitors; Publication bias

Indexed keywords

PHOSPHODIESTERASE V INHIBITOR; SILDENAFIL; TADALAFIL; VARDENAFIL;

ANALYTIC METHOD; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; DATA EXTRACTION; ERECTILE DYSFUNCTION; HUMAN; PRIORITY JOURNAL; PUBLISHING; QUALITY CONTROL; QUANTITATIVE ANALYSIS; RISK; STATISTICAL ANALYSIS; SYSTEMATIC REVIEW;

BIAS (EPIDEMIOLOGY); CARBOLINES; CONTROLLED CLINICAL TRIALS AS TOPIC; ERECTILE DYSFUNCTION; HUMANS; IMIDAZOLES; MALE; META-ANALYSIS AS TOPIC; PHOSPHODIESTERASE INHIBITORS; PIPERAZINES; PURINES; REVIEW LITERATURE AS TOPIC; SULFONES; TREATMENT OUTCOME; TRIAZINES;

EID: 43649108404     PISSN: 09559930     EISSN: 14765489     Source Type: Journal    
DOI: 10.1038/sj.ijir.3901626     Document Type: Article

References (35)

1. Fink HA, Mac DR, Rutks IR, Nelson DB, Wilt TJ. Sildenafil for male erectile dysfunction: a systematic review and metaanalysis [see comment]. [Review] [37 refs]. Arch Intern Med 2002; 162: 1349-1360.
2. Markou S, Perimenis P, Gyftopoulos K, Athanasopoulos A, Barbalias G. Vardenafil (Levitra) for erectile dysfunction: a systematic review and meta-analysis of clinical trial reports. [Review] [34 refs]. Int J Impot Res 2004; 16: 470-478.
3. Carson CC, Rajfer J, Eardley I, Carrier S, Denne JS, Walker DJ et al. The efficacy and safety of tadalafil: an update. BJU Int 2004; 93: 1276-1281.
4. Berner MM, Kriston L, Harms A. Efficacy of PDE-5-inhibitors for erectile dysfunction. A comparative meta-analysis of fixed-dose regimen randomized controlled trials administering the International Index of Erectile Function in broad-spectrum populations. Int J Impot Res 2006; 18: 229-235.
5. Moore RA, Derry S, McQuay HJ. Indirect comparison of interventions using published randomised trials: systematic review of PDE-5 inhibitors for erectile dysfunction. BMC Urol 2005; 5: 18.
6. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273: 408-412.
7. Moher D, Pham B, Jones A, Cook DJ, Jadad AR. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 1998; 352: 609-613.
8. Dickersin K, Min YI, Meinert CL. Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA 1992; 267: 374-378.
9. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet 1991; 337: 867-872.
10. Broderick GA, Donatucci CF, Hatzichristou D, Torres LO, Valiquette L, Zhao YL et al. Efficacy of tadalafil in men with erectile dysfunction naive to phosphodiesterase 5 inhibitor therapy compared with prior responders to sildenafil citrate. J Sex Med 2006; 3: 668-675.
11. Gehr BT, Weiss C, Porzsolt F. The fading of reported effectiveness. A meta-analysis of randomised controlled trials. BMC Med Res Methodol 2006; 6: 25.
12. US Food and Drug Administration, http://www.fda.gov/cder/. Accessed: September 4, 2007.
13. Robinson KA, Dickersin K. Development of a highly sensitive search strategy for the retrieval of reports of controlled trials using PubMed. Int J Epidemiol 2002; 31: 150-153.
14. Altman DG. Practical Statistics for Medical Research, 2nd edn. Chapman & Hall: London, 1997.
15. Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 1997; 50: 683-691.
16. Song F, Altman DG, Glenny AM, Deeks JJ. Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ 2003; 326: 472.
17. Deeks JJ, Altman DG, Bradburn J. Statistical methods for examining heterogeneity and combining results from several studies in meta-analysis. In: Egger M, Davey SG, Altman DG (eds). Systematic Reviews in Health Care. Meta-Analysis in Context, 3rd edn. BMJ: London, 2003, pp 285-312.
18. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002; 21: 1539-1558.
19. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003; 327: 557-560.
20. Sterne JA, Gavaghan D, Egger M. Publication and related bias in meta-analysis: power of statistical tests and prevalence in the literature. J Clin Epidemiol 2000; 53: 1119-1129.
21. Sterne JA, Egger M. Funnel plots for detecting bias in meta-analysis: guidelines on choice of axis. J Clin Epidemiol 2001; 54: 1046-1055.
22. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994; 50: 1088-1101.
23. Egger M, Davey SG, Schneider M, Minder C. Bias in metaanalysis detected by a simple, graphical test. BMJ 1997; 315: 629-634.
24. Duval S, Tweedie R. Trim and fill: a simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis. Biometrics 2000; 56: 455-463.
25. Duval SJ, Tweedie RL. A non-parametric 'trim and fill' method of assessing publication bias in meta-analysis. J Am Stat Assoc 2000; 95: 89-98.
26. Begg CB, Cho MK, Eastwood S, Horton R, Moher D, Olkin I et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276: 637-639.
27. Lau J, Ionnidis JPA, Terrin N, Schmidt CH, Olkin I. The case of the misleading funnel plot. BMJ 2006; 333: 597-600.
28. Sterne JA, Egger M. Re: High false positive rate for trim and fill method. Website only: http://www.bmj.com/cgi/eletters/320/7249/1574 2000.
29. Sutton AJ, Duval SJ, Tweedie RL. Re: Re: High false positive rate for trim and fill method. Website only: http://www.bmj.com/cgi/eletters/320/7249/ 1574 2000.
30. Lewis R, Bennett CJ, Borkon WD, Boykin WH, Althof SE, Stecher VJ et al. Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. Urology 2001; 57: 960-965.
31. Brock G, Nehra A, Lipshultz LI, Karlin GS, Gleave M, Seger M et al. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol 2003; 170(4 Part 1): 1278-1283.
32. Carson C, Shabsigh R, Segal S, Murphy A, Fredlund P, Kuepfer C et al. Efficacy, safety, and treatment satisfaction of tadalafil versus placebo in patients with erectile dysfunction evaluated at tertiary-care academic centers. Urology 2005; 65: 353-359.
33. Gravel J, Opatmy L, Shapiro S. The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say? Clin Trials 2007; 4: 350-356.
34. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomized controlled trials. BMJ 1999; 319: 670-674.
35. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine - selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003; 326: 1171-1173.