This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Diaz-Insua, M. Search for Related Content Social Bookmarking                         What's this?

Review: Methodological quality in medical evidence, quo vadis?

Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA, MInsua1{at}hfhs.org

Efforts in research quality have led to a diffusion of publication guidelines for high-quality reporting of medical evidence with the aim to instill transparency to its evaluation. The maturity of this process has led to a second stage in which a surplus of scales measuring methodological quality is in place. However, there is no clear consensus as to which of these guidelines should be recommended for usage and how to integrate the methodological quality information into the evidence synthesis process. One major challenge that these scales poses is the fact that slight modifications performed to them in order to adapt to a specific research and/ or management question requires revalidation of the scale's properties, a clearly impractical endeavor. This article proposes a potential alternative to this challenge through the formulation of a framework in which quality elements are divided into tiers. This layering aims at separating quality constructs that should be uniformly present across all studies and thus could be validated from constructs that are question-specific and less likely to undergo a formal validation process. An example of this framework applied to the urological literature is presented.

Key Words: evidence-based medicine • research quality assessment • urinary continence • prostate cancer

References

• Abrams, P., Cardozo, L., Fall, M. Griffiths, D., Rosier, P., Ulmsten, U. et al. (2002) The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 21: 167-178.[CrossRef][Medline] [Order article via Infotrieve]
• Altman, D.G., Schulz, K.F., Moher, D., Egger, M., Davidoff, F., Elbourne, D. et al. (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134: 663-694.[Abstract/Free Full Text]
• Armijo, S., Gazzi, L., Gadotti, I.C., Fuentes, J., Stanton, T. and Magee, D.J. (2008) Scales to assess the quality of randomized controlled trials: a systematic review. Phys Ther 88: 156-175.[Abstract/Free Full Text]
• Balk, E.M., Bonis, P.A.L., Moskowitz, H., Schmid, C.H., Ioannidis, J.P.A., Wang, C. et al. (2002) Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials. J Am Med Assoc 287: 2973-2982.[Abstract/Free Full Text]
• Barry, M.J., Fowler, F.J., O'Leary, M.P., Bruskewitz, R.C., Holtgrewe, H.L., Mebust, W.K. and Cocket, A.T. (1992) The American Urological Association symptom index for benign prostatic hyperplasia. J Urol 148: 1549-1557.[Medline] [Order article via Infotrieve]
• Black, N. (1996) Why we need observational studies to evaluate the effectiveness of health care. Br Med J 312: 1215-1218.[Free Full Text]
• Boutron, I., Moher, D., Altman, D.G., Schulz, K.F. and Ravaud, P. (2008) Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 148: 295-309.[Abstract/Free Full Text]
• Campbell, M.K., Elbourne, D.R. and Altman, D.G. (2004) CONSORT statement: extension to cluster randomised trials. Br Med J 328: 702-708.[Free Full Text]
• Devereaux, P.J., Manns, B.J., Ghali, W.A., Quan, H. and Guyatt, G.H. (2002) The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Control Clin Trials 23: 380-388.[CrossRef][Medline] [Order article via Infotrieve]
• Devereaux, P.J., Bhandari, M., Clarke, M., Montori, V.M., Cook, D.J., Yusuf, S. et al. (2005) Need for expertise based randomized controlled trials. Br Med J 330: 88-92.[Free Full Text]
• Eldridge, S., Ashby, D., Bennett, C., Wakelin, M. and Feder, G. (2008) Internal and external validity of cluster randomised trials: systematic review of recent trials. Br Med J 336: 876-880.[Abstract/Free Full Text]
• Glickman, L., Godoy, G. and Lepor, H. (2009) Changes in continence and erectile function between 2 and 4 years after radical prostatectomy. J Urol 181: 731-735.
• Horn, S.D. (2006) Performance measures and clinical outcomes. J Am Med Assoc 296: 2731-2732.[Free Full Text]
• Jüni, P., Witschi, A., Block, R. and Egger, M. (1999) The hazards of scoring the quality of clinical trials for meta-analysis. J Am Med Assoc 282: 1054-1060.[Abstract/Free Full Text]
• Kane, R.L., Wang, J. and Garrard, J. (2007) Reporting in randomized clinical trials improved after adoption of the CONSORT statement. J Clin Epidemiology 60: 241-249.[CrossRef][Medline] [Order article via Infotrieve]
• Lawrence, W. (1991) Some problems with clinical trials. James Ewing lecture. Arch Surg 126: 370-378.[Abstract/Free Full Text]
• Lohr, K.N. and Carey, T.S. (1999) Assessing `best evidence': issues in grading the quality of studies for systematic reviews. J Qual Improv 25: 470-479.
• McCulloch, P., Taylor, I., Sasako, M., Lovett, B. and Griffin, D. (2002) Randomised trials in surgery: problems and possible solutions. Br Med J 324: 1448-1451.[Free Full Text]
• Mills, E., Wu, P., Gagnier, J., Heels-Ansdell, D. and Montori, V.M. (2005) An analysis of general medical and specialist journals that endorse CONSORT found that reporting was not enforced consistently. J Clin Epidem 58: 662-667.[CrossRef][Medline] [Order article via Infotrieve]
• Moher, D., Schulz, K.F. and Altman, D. (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. J Am Med Assoc 285: 1987-1991.[Abstract/Free Full Text]
• Moher, A.J. and Lepage, L. (2001) Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. J Am Med Assoc 285: 1992-1995.[Abstract/Free Full Text]
• Moja, L.P., Telaro, E., D'Amico, R., Moschetti, I., Coe, L. and Liberati, A. (2005) Assessment of methodological quality of primary studies by systematic reviews: results of the metaquality cross sectional study. Br Med J 330: 1053-1057.[Abstract/Free Full Text]
• Puffer, S., Torgerson, D.J. and Watson, J. (2003) Evidence for risk of bias in cluster randomized trials: review of recent trials published in three general medical journals. Br Med J 327: 785-789.[Abstract/Free Full Text]
• Scales, C.D., Norris, R.D., Keitz, S.A., Peterson, B.L., Preminger, G.M., Vieweg, J. et al. (2008a) A critical assessment of the quality of reporting of randomized, controlled trials in the Urology literature. J Urol 177: 1090-1095.[CrossRef]
• Scales, C.D., Norris, R.D., Preminger, G.M., Vieweg, J., Peterson, B.L. and Dahm, P. (2008b) Evaluating the evidence: statistical methods in randomized controlled trials in the urological literature. J Urol 180: 1463-1467.[CrossRef][Medline] [Order article via Infotrieve]
• Schulz, K.F., Chalmers, I., Hayes, R.J. and Altman, D.G. (1995) Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. J Am Med Assoc 273: 408-412.[Abstract/Free Full Text]
• Walach, H., Falkenberg, T., Fonnebo, V., Lewith, G. and Jonas, W.B. (2006) Circular instead of hierarchical: methodological principles for the evaluation of complex interventions. BMC Medical Res Meth 6: 29-37.[CrossRef]
• West, S., King, V., Carey, T.S., Lohr, K.N., McKoy, N., Sutton, S.F. and Lux, L. (2002) Systems to rate the strength of scientific evidence. Evidence Report/Technical Assessment No. 47. Rockville, MD. Agency for Health Research and Quality, Publication NO. 02-E016.
• Wood, L., Egger, M., Gluud, L.L., Schulz, K.F., Juni, P., Altman, D.G. et al. (2008) Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. Br Med J 336: 601-605.[Abstract/Free Full Text]

Therapeutic Advances in Urology, Vol. 1, No. 1, 51-59 (2009)
DOI: 10.1177/1756287209104311


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Diaz-Insua, M. Search for Related Content Social Bookmarking                         What's this?