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 of clinical research. The concept of 'treatment effectiveness' is proposed as a new 'umbrella concept' or distal outcome to be evaluated.
| Original language | English |
|---|---|
| Pages (from-to) | 207-213 |
| Number of pages | 7 |
| Journal | International Journal of Impotence Research |
| Volume | 16 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Jun 2004 |
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Keywords
- Drug efficacy
- Erectile dysfunction
- PDE-5 therapy
- Therapeutic effectiveness
- Tolerability
- Treatment satisfaction
ASJC Scopus subject areas
- Urology
Cite this
The 'effectiveness' scale - Therapeutic outcome of pharmacologic therapies for ED : An international consensus panel report. / Carson, C.; Giuliano, F.; Goldstein, I.; Hatzichristou, D.; Hellstrom, W.; Lue, T.; Montorsi, F.; Munarriz, R.; Nehra, A.; Porst, H.; Rosen, R.
In: International Journal of Impotence Research, Vol. 16, No. 3, 06.2004, p. 207-213.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The 'effectiveness' scale - Therapeutic outcome of pharmacologic therapies for ED
T2 - An international consensus panel report
AU - Carson, C.
AU - Giuliano, F.
AU - Goldstein, I.
AU - Hatzichristou, D.
AU - Hellstrom, W.
AU - Lue, T.
AU - Montorsi, F.
AU - Munarriz, R.
AU - Nehra, A.
AU - Porst, H.
AU - Rosen, R.
PY - 2004/6
Y1 - 2004/6
N2 - 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 of clinical research. The concept of 'treatment effectiveness' is proposed as a new 'umbrella concept' or distal outcome to be evaluated.
AB - 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 of clinical research. The concept of 'treatment effectiveness' is proposed as a new 'umbrella concept' or distal outcome to be evaluated.
KW - Drug efficacy
KW - Erectile dysfunction
KW - PDE-5 therapy
KW - Therapeutic effectiveness
KW - Tolerability
KW - Treatment satisfaction
UR - http://www.scopus.com/inward/record.url?scp=3042823702&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=3042823702&partnerID=8YFLogxK
U2 - 10.1038/sj.ijir.3901227
DO - 10.1038/sj.ijir.3901227
M3 - Article
C2 - 15164088
AN - SCOPUS:3042823702
VL - 16
SP - 207
EP - 213
JO - International Journal of Impotence Research
JF - International Journal of Impotence Research
SN - 0955-9930
IS - 3
ER -