Abstract
Despite availability of outcome measures and scales for assessing erectile dysfunction (ED) treatment efficacy, guidelines are not available for assessing broader therapeutic outcomes or defining treatment failure in ED. An International Consensus Advisory Panel was convened to develop guidelines, definitions and a new algorithm for evaluating treatment effectiveness in ED. These new guidelines are recommended for use in both research and clinical practice. A multidisciplinary, international panel, consisting of 11 senior researchers and clinicians, was convened to address pertinent issues concerning therapeutic outcome assessment for ED. The panel utilized a modified Delphi method of consensus development and proposed a new model for outcomes assessment. This model is inherently testable, using existing instruments and current methods of assessment. Following a comprehensive literature review and discussion, the Panel recommended adoption of a new treatment effectiveness conceptual framework or theoretical model for assessing therapeutic outcomes in ED. Treatment effectiveness is presumed to be a combined function of two other factors, treatment response and treatment satisfaction. Treatment response is based on the combined assessment of efficacy and tolerability, and treatment satisfaction on the combined assessment of patient and partner satisfaction. Taken together, these two domains define an overall domain of treatment effectiveness. This therapeutic index would be derived by independently assessing treatment efficacy and satisfaction by means of event logs, questionnaires or the more typical patient interview methods. In conclusion, the Ad Hoc Advisory Consensus Panel recommends adoption of a new framework or conceptual model for conducting ED outcome trials or clinical research. The concept of ‘treatment effectiveness’ is proposed as a new ‘umbrella concept’ or distal outcome to be evaluated.
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References
Jacobson NS, Christenson A . Studying the effectiveness of psychotherapy: how well can clinical trials do the job? Am Psychol 1996; 51: 1031–1039.
Shadish WR et al. Evidence that therapy works in clinically representative conditions. J Consul Clin Psychol 1997; 65: 355–365.
Klein DF, Smith LB . Organization requirements for effective clinical effectiveness studies. Prev Treatment 1999; 2: 126–132.
Mintz J, Drake RR, Crits-Christoph . Efficacy and effectiveness of psychotherapy: Two paradigms, one science. Am Psychol 1996; 51: 1084–1085.
Wells KB, Sturm R . Informing the policy process: from efficacy to effectiveness data on pharmacotherapy. J Consul Clin Psychol 1996; 64: 638–645.
Miklowitz DJ, Clarkin JF . Balancing internal and external validity. Prev Treatment 1999; 2: 133–138.
Jardin A et al (2000). First International Consultation on Erectile Dysfunction. Health Publications: Plymouth, UK.
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This work was supported by unrestricted educational grants from Glaxo-Smith-Kline and Bayer Corporation.
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Carson, C., Giuliano, F., Goldstein, I. et al. The ‘effectiveness’ scale—therapeutic outcome of pharmacologic therapies for ED: an international consensus panel report. Int J Impot Res 16, 207–213 (2004). https://doi.org/10.1038/sj.ijir.3901227
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DOI: https://doi.org/10.1038/sj.ijir.3901227
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