VALIDATION OF DIAGNOSTIC PROCEDURES IN SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA. CONCORDANCE BETWEEN INITIAL AND FINAL DIAGNOSIS IN DAILY CLINICAL PRACTICE
Author(s)
Carballido J1, Badia X2, Gimeno A3, Regadera L4, Dal-Re R5, Guilera M61Hospital Puerta de Hierro, Madrid, Spain; 2 Health Outcomes Research Europe Group, Barcelona, Cataluña, Spain; 3 Hospital General La Mancha, Ciudad Real, Spain; 4 Glaxo Smith Kline, Madrid, Spain; 5 GlaxoSmithKline, Madrid, Spain; 6 Health Outcomes Research Europe, Barcelona, Spain
OBJECTIVES: To assess the usefulness of daily practice diagnostic methods (medical history, I-PSS questionnaire, digital rectal examination (DRE) and prostate-specific antigen (PSA)) for the diagnosis of Benign Prostatic Hyperplasia (BPH). METHODS: A total of 363 consecutive patients with suspected BPH seen at urological outpatient clinics, between April and November 2003, participated in the study. The following steps were sequentially followed to define the Initial Diagnosis: 1) medical history; 2) I-PSS questionnaire; 3) DRE; and 4) PSA. It was then compared to the Final Diagnosis (gold-standard) after step 5) urinary sediment, residual volume and prostate size by ultrasonography, and urinary flow rate. Physician's diagnosis according to their experience, was recorded after each step A descriptive analysis was conducted and validity and concordance were measured between strategies. RESULTS: A total of 356 patients, mean age (SD) of 65.2 (8.4) years, with suspected BPH participated in the study. Sensitivity, specificity, positive predictive value and negative predictive value were 91%, 65%, 95% and 50%, respectively. Percentage of agreement and kappa index between initial and final diagnosis were 87.9% and 0.5, respectively. CONCLUSION: Concordance between initial diagnosis based on medical history, I-PSS questionnaire, DRE and PSA with final diagnosis of BPH was high. This group of diagnostic procedures may be recommended for BPH initial diagnosis in daily practice.
Conference/Value in Health Info
2005-11, ISPOR Europe 2005, Florence, Italy
Value in Health, Vol. 8, No.6 (November/December 2005)
Code
CO1
Topic
Medical Technologies
Topic Subcategory
Diagnostics & Imaging
Disease
Gastrointestinal Disorders, Urinary/Kidney Disorders