INTRODUCTION: No clinical study data in which the AMS scale was applied as outcome measure has been reported until today. METHOD: An open post-marketing study was performed by office-based urologists in Germany in 2000/01. We analysed data of 1174 androgen-deficient males who were treated with testosterone enanthate. The AMS scale was applied prior to and after 12 weeks treatment. RESULTS: The improvement of complaints during treatment relative to the baseline score was 32% on average. Patients with little or no symptoms before therapy improved by 11%, those with mild complaints at entry by 24%, with moderate by 31%, and with severe symptoms by 39% compared with the baseline score. We showed that the distribution of complaints of testosterone-deficient men before therapy almost returned to norm values after 12 weeks of testosterone treatment. We also demonstrated that the AMS results can predict the independent (physician's) opinion about the individual treatment effect. The positive predictive value was 89%, the negative predictive value 59%, sensitivity (correct prediction of a positive assessment by the urologist) 96%, however, the specificity (correct prediction of a negative assessment by the physician) was only 30%. CONCLUSION: The AMS scale showed a convincing ability to measure treatment effects on quality of life across the full range of severity of complaints. In addition, results of the scale can predict the subjective clinical expert opinion on the treatment efficiency. Copyright 2004 Elsevier B.V.
INTRODUCTION: No clinical study data in which the AMS scale was applied as outcome measure has been reported until today. METHOD: An open post-marketing study was performed by office-based urologists in Germany in 2000/01. We analysed data of 1174 androgen-deficient males who were treated with testosterone enanthate. The AMS scale was applied prior to and after 12 weeks treatment. RESULTS: The improvement of complaints during treatment relative to the baseline score was 32% on average. Patients with little or no symptoms before therapy improved by 11%, those with mild complaints at entry by 24%, with moderate by 31%, and with severe symptoms by 39% compared with the baseline score. We showed that the distribution of complaints of testosterone-deficient men before therapy almost returned to norm values after 12 weeks of testosterone treatment. We also demonstrated that the AMS results can predict the independent (physician's) opinion about the individual treatment effect. The positive predictive value was 89%, the negative predictive value 59%, sensitivity (correct prediction of a positive assessment by the urologist) 96%, however, the specificity (correct prediction of a negative assessment by the physician) was only 30%. CONCLUSION: The AMS scale showed a convincing ability to measure treatment effects on quality of life across the full range of severity of complaints. In addition, results of the scale can predict the subjective clinical expert opinion on the treatment efficiency. Copyright 2004 Elsevier B.V.
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