- Email: [email protected]
Clinical practice guidelines for men with luts. To what extent can they be trusted?
06
BPH:EVALUATION Sunday;February24, 15.30=17:00 hrs, RoomC
CLINICAL PRACTICE GUIDELINES FOR W H A T E X T E N T C A N T H E Y BE T R U S T E D ?
189
MEN WITH
LUTS. TO
Irani Jacques ~, Brown Christian 2, van der Meulen Jan z, Emberton Mark 2 ~Urology, CHU La Miletrie, Poitiers, France, 2Clinical Effectiveness Unit, Royal College of Surgeons of England, London, United Kingdom I N T R O D U C T I O N & O B J E C T I V E S : There is theoretical evidence that guidelines can improve patient care. However, there is increasing concern that many of the guidelines produced may be of insufficient quality. We have evaluated national and supra national guidelines for the diagnosis and management of benign prostatic hyperplasia (BPH) using a validated generic critical appraisal instrument, that assesses whether developers have minimised the biases inherent in creating guidelines. M A T E R I A L & M E T H O D S : A computer-assisted literature search completed by hand-search identified Web-published BPH guidelines produced by national and supra national organisations. Guidelines were appraised by 2 independent examiners using a validated instrument (Cluzeau F et al, J Clin Effectiveness 1997" 2(4): 120-3) including 37 items describing suggested predictors of guideline quality grouped into 3 dimensions covering the rigour of development, clarity of presentation and implementation issues. RESULTS: Eight (6 nationals and 2 supranationals) BPH guidelines were identified. There was variation in the performance of guidelines with most not achieving half of the criteria in each dimension.
Criteria (n) G u i d e l i n e s (n a m o n g 8 a n a l y s e d guidelines) a c h i e v i n g at least h a l f o f the criteria
Dimension 1 Rigour of development
Dimension 2 Clarity o f presentation
Dimension 3 Implementation issues
20
12
5
2
4
1
190 LONGITUDINAL CHANGES IN MEASURES EFFICIENCY: THE OLMSTED COUNTY STUDY
CONCLUSIONS: Use of a formal appraisal of BPH guidelines should encourage developers to create guidelines that reflect relevant research evidence more accurately. Groups adapting guidelines for local use could apply the instrument to help decide which one to follow. Local clinicians should concentrate on effective dissemination and implementation strategies, rather than creating new guidelines.
~Health Sciences Research, Mayo Clinic, Rochester, United States of America 2Urology, Mayo Clinic, Rochester, United States of America, 3Epidemiology, Merck Research Laboratories, Blue Bell, United States of America INTRODUCTION & OBJECTIVES: Post-void residual urine volume and related measures have been used to characterise bladder outlet obstruction but few populationbased longitudinal data are available to provide normative comparisons. To this end, we used data from the continued follow-up of the Olmsted County Study of Urinary Symptoms and Health Status among Men. MATERIAL & METHODS: A cohort of 2115 Caucasian men ages 40 to 79 years was randomly selected from an enumeration of the Olmsted County, Minnesota population (55% participation rate) in 1990. Of these, a 25 percent random subsample (n=475) had a detailed clinical examination that included sonographic imaging of the bladder to estimate its volume following micturition. These examinations were repeated biennially through 2000. Two-stage regression models were used to estimate the average annual longitudinal changes in post-void residual urine volume, voiding efficiency (voided volume/voided+residual urine volume) and voiding index (residual urine volume/voided+residual volume). For analysis, men who were treated for prostate disease were censored prior to treatment. RESULTS: During the 3442 person-years of follow-up, there were strong age-related differences in measures of voiding efficiency (Table).
i0-49 i0-59 i0-69 70-79
KeSltlual Volume Voiding Enleieney Baseline Ann % Chg Baseline Ann % Chg Median Median 75th % Median Median 25th % tile file 6.0 1.2 14.2 98.5 -0.09 -0.53 6.5 1.3 20A ~98.3 -0.10 -1.3 ]4.4 1.2 23.9 96.2 -0.38 -28 36.6 -4.8 19.5 84.5 -0.47 -5.0
Voiding Index Baselim Ann % Chg Median Median 75th % tile 1.5 2.0 12.3 1.7 3.4 16.2 3.8 5.7 22.3 151 3.3 18.1
CONCLUSIONS: These data demonstrate a measurable deterioration in all measures of voiding function despite the considerable variability between individuals. The pattern of change differs by measure, however, and voiding efficiency appears to be less variable across time. As treatment decisions are often made on the basis of measurements of residual urine volume, these data suggest that it may be more appropriate to consider using one of the less variable alternative measures.
191 P R E D I C T O R S OF P R O G R E S S I O N IN M E N W I T H M I L D S Y P M T O M S OF BLADDER OUTLET OBSTRUCTION Djavan Bob, Wammak Robert, Bagheri Fariborz, Zlotta Alexandre, Harik Mike, Kramer Gero, Chaudry Aziz, Hruby Stephan, Waldert Matthias, M~irk Isabel, Marberger Michael Urology, University of Vienna, Vienna, Austria INTRODUCTION & OBJECTIVES: Early identification of patients with bladder outlet obstruction (BOO) at risk for progression of clinical and symptomatic parameters will allow an early onset of treatment and will represent an ideal target group for preventive action. The objective of this study was to identify progression parameters for patients presenting with mild symptoms of BOO (International Prostate Symptom score (IPSS)<8). Correlations between clinical, biochemical and urodynamical parameters as well as total and TZ prostate volume were analysed. MATERIAL & METHODS: A total of 915 patients who presented to our clinics for LUTS due to BOO were included in the analysis. Patients with an IPSS<8 were identified and watchful waiting initiated. All were followed for up to 24 mo at 3 mo intervals. Data parameters included age, PSA, IPSS, the total obstructive symptom score (OSS), the irritative symptom score (IRR), the quality of life score (QOL) and the maximal and mean flow rate. In addition, the total prostate volume and the transition zone volume were recorded by TRUS for each patient. The artificial neural network (ANN) used in the analysis was an advanced multiplayer perceptron selected for accuracy by a genetic algorithm. A tenth-order cross validation methodology was used to insure proper generalisation (nonoverfitting). Progression as was included in the analysis was defined as a change form the mild-lPSS group into the moderate-(IPSS 8-18) or severe IPSS group (IPSS >18). The occurrence of urinary retention or the need for surgery (TURP) was also qualified as disease progression. Quality of life scores were also recorded separately and cross-analysed.
VOIDING
Jacobsen Steven ~, Jacobson Debra ~, Girman Cynthia 3, Roberts Rosebud t, Rhodes Thomas3, Lieber Michael 2
t,ge Years
All of the guidelines overlooked the implementation issues. Most of the guidelines did not explicitly state the search strategy used to identify the relevant evidence for the recommendations and the methods used for assessing the evidence.
OF
192 DEVELOPMENT OF A NEW QUESTIONNAIRE (QUIS-1I) FOR THE EVALUATION OF LUTS AND THE RELEVANT BOTHER FROM THE DATA OF T H E QUIBUS STUDY Prezioso D. ~, Scarpa R.M. 4, Zattoni F ) , Rizzi C . A ? for the QUIBUS Study Group ~Urology, University of Naples, Naples, Italy, 2Urology, Boehringer Ingelheim Italy, Milan, Italy, 3Urology, University of Udine, Udine, Italy, 4Urology, University of Turin, Turin, Italy I N T R O D U C T I O N & O B J E C T I V E S : The aim of the present work is to develop a new questionnaire on LUTS and QoL. on the basis of the data of the observational study QUIBUS (1998-2000), by reducing the 60 items of the ICS-BPH questionnaire. M A T E R I A L & METHODS: The new questionnaire has been worked out taking into account the three following principles: a) reduction of the large number of items of the ICS-BPH questionnaire b) integration of symptom severity and relevant bother c) inclusion, besides urinary symptoms, of incontinence and sexual function which are not considered in the IPSS. The following integrated score has been applied to each item of the ICS-BPH questionnaires collected from 798 patients, at baseline and after a l-year follow up of the QUIBUS study: It is not a p r o b l e m Never
0
Sometimes
l 2
Often/Always
It is a p r o b l e m 3 4
RESULTS: Of 915 men evaluated, 296 had mild symptoms of BOO (IPSS<8). Cumulative progression rate was 6%, 13%, 15% and 24% at 6 too, 12 too, 18 mo and 24 mo respectively. The overall accuracy of the ANN in predicting disease progression was 82% and 84% for predicting the need for surgery, respectively. The variables of importance for disease progression in the ANN analysis were in order of significance: PSA, OSS and age. The combination of age correlated PSA and OSS offered an 88% accuracy. The variables IPSS, ISS, QoL, Qmax and mean flow rate, as well PVR were not found to add significant predictive value. Overall accuracy was best in patients with PSA greater than 1.8 ng/ml.
RESULTS: By means of a multiple groups factor analysis, l l items have been selected from the ICS-BPH as the most representatives on a clinical and statistical basis. Of them, 3 are related to irritative and 3 to obstructive urinary symptoms, 2 to incontinence symptoms, 2 to sexual function and one single question to QoL. Cronbach's alpha for the total score of the selected items was 0.71 at baseline and 0.75 in the follow-up questionnaires, this indicating a good internal consistency.
CONCLUSIONS: Progression rates in men with mild symptoms of BOO (IPSS<8) increase form 13% to 24% at 12 and 24 mo respectively. Serum PSA, OSS and age were strongly correlated with disease progression overall, symptomatic progression, rate of urinary retention and need for surgery. Using the ANN as presented herein, disease progression can be predicted based on clinical and biochemical parameters. This will allow a more accurate identification of patients at risk for progression and will allow the selection of an ideal target group for preventive modalities.
CONCLUSIONS: These results indicate that the first objective of the new questionnaire validation (the content validity) has been reached. The new questionnaire (QUIBUS Score, Q U I S - I I ) represents a significant reduction of the number of questions of the ICS-BPH questionnaire, without theoretical loss of information. In addition, a limited number of questions, comparable to the ones of the IPSS (7+1) overcome the lack of information on incontinence and sexual activity. A test-retest prospective study is now under way for a full validation of the new tool.
European Urology Supplements 1 (2002) No. 1, pp. 50
BPH:EVALUATION Sunday;February24, 15.30=17:00 hrs, RoomC
CLINICAL PRACTICE GUIDELINES FOR W H A T E X T E N T C A N T H E Y BE T R U S T E D ?
189
MEN WITH
LUTS. TO
Irani Jacques ~, Brown Christian 2, van der Meulen Jan z, Emberton Mark 2 ~Urology, CHU La Miletrie, Poitiers, France, 2Clinical Effectiveness Unit, Royal College of Surgeons of England, London, United Kingdom I N T R O D U C T I O N & O B J E C T I V E S : There is theoretical evidence that guidelines can improve patient care. However, there is increasing concern that many of the guidelines produced may be of insufficient quality. We have evaluated national and supra national guidelines for the diagnosis and management of benign prostatic hyperplasia (BPH) using a validated generic critical appraisal instrument, that assesses whether developers have minimised the biases inherent in creating guidelines. M A T E R I A L & M E T H O D S : A computer-assisted literature search completed by hand-search identified Web-published BPH guidelines produced by national and supra national organisations. Guidelines were appraised by 2 independent examiners using a validated instrument (Cluzeau F et al, J Clin Effectiveness 1997" 2(4): 120-3) including 37 items describing suggested predictors of guideline quality grouped into 3 dimensions covering the rigour of development, clarity of presentation and implementation issues. RESULTS: Eight (6 nationals and 2 supranationals) BPH guidelines were identified. There was variation in the performance of guidelines with most not achieving half of the criteria in each dimension.
Criteria (n) G u i d e l i n e s (n a m o n g 8 a n a l y s e d guidelines) a c h i e v i n g at least h a l f o f the criteria
Dimension 1 Rigour of development
Dimension 2 Clarity o f presentation
Dimension 3 Implementation issues
20
12
5
2
4
1
190 LONGITUDINAL CHANGES IN MEASURES EFFICIENCY: THE OLMSTED COUNTY STUDY
CONCLUSIONS: Use of a formal appraisal of BPH guidelines should encourage developers to create guidelines that reflect relevant research evidence more accurately. Groups adapting guidelines for local use could apply the instrument to help decide which one to follow. Local clinicians should concentrate on effective dissemination and implementation strategies, rather than creating new guidelines.
~Health Sciences Research, Mayo Clinic, Rochester, United States of America 2Urology, Mayo Clinic, Rochester, United States of America, 3Epidemiology, Merck Research Laboratories, Blue Bell, United States of America INTRODUCTION & OBJECTIVES: Post-void residual urine volume and related measures have been used to characterise bladder outlet obstruction but few populationbased longitudinal data are available to provide normative comparisons. To this end, we used data from the continued follow-up of the Olmsted County Study of Urinary Symptoms and Health Status among Men. MATERIAL & METHODS: A cohort of 2115 Caucasian men ages 40 to 79 years was randomly selected from an enumeration of the Olmsted County, Minnesota population (55% participation rate) in 1990. Of these, a 25 percent random subsample (n=475) had a detailed clinical examination that included sonographic imaging of the bladder to estimate its volume following micturition. These examinations were repeated biennially through 2000. Two-stage regression models were used to estimate the average annual longitudinal changes in post-void residual urine volume, voiding efficiency (voided volume/voided+residual urine volume) and voiding index (residual urine volume/voided+residual volume). For analysis, men who were treated for prostate disease were censored prior to treatment. RESULTS: During the 3442 person-years of follow-up, there were strong age-related differences in measures of voiding efficiency (Table).
i0-49 i0-59 i0-69 70-79
KeSltlual Volume Voiding Enleieney Baseline Ann % Chg Baseline Ann % Chg Median Median 75th % Median Median 25th % tile file 6.0 1.2 14.2 98.5 -0.09 -0.53 6.5 1.3 20A ~98.3 -0.10 -1.3 ]4.4 1.2 23.9 96.2 -0.38 -28 36.6 -4.8 19.5 84.5 -0.47 -5.0
Voiding Index Baselim Ann % Chg Median Median 75th % tile 1.5 2.0 12.3 1.7 3.4 16.2 3.8 5.7 22.3 151 3.3 18.1
CONCLUSIONS: These data demonstrate a measurable deterioration in all measures of voiding function despite the considerable variability between individuals. The pattern of change differs by measure, however, and voiding efficiency appears to be less variable across time. As treatment decisions are often made on the basis of measurements of residual urine volume, these data suggest that it may be more appropriate to consider using one of the less variable alternative measures.
191 P R E D I C T O R S OF P R O G R E S S I O N IN M E N W I T H M I L D S Y P M T O M S OF BLADDER OUTLET OBSTRUCTION Djavan Bob, Wammak Robert, Bagheri Fariborz, Zlotta Alexandre, Harik Mike, Kramer Gero, Chaudry Aziz, Hruby Stephan, Waldert Matthias, M~irk Isabel, Marberger Michael Urology, University of Vienna, Vienna, Austria INTRODUCTION & OBJECTIVES: Early identification of patients with bladder outlet obstruction (BOO) at risk for progression of clinical and symptomatic parameters will allow an early onset of treatment and will represent an ideal target group for preventive action. The objective of this study was to identify progression parameters for patients presenting with mild symptoms of BOO (International Prostate Symptom score (IPSS)<8). Correlations between clinical, biochemical and urodynamical parameters as well as total and TZ prostate volume were analysed. MATERIAL & METHODS: A total of 915 patients who presented to our clinics for LUTS due to BOO were included in the analysis. Patients with an IPSS<8 were identified and watchful waiting initiated. All were followed for up to 24 mo at 3 mo intervals. Data parameters included age, PSA, IPSS, the total obstructive symptom score (OSS), the irritative symptom score (IRR), the quality of life score (QOL) and the maximal and mean flow rate. In addition, the total prostate volume and the transition zone volume were recorded by TRUS for each patient. The artificial neural network (ANN) used in the analysis was an advanced multiplayer perceptron selected for accuracy by a genetic algorithm. A tenth-order cross validation methodology was used to insure proper generalisation (nonoverfitting). Progression as was included in the analysis was defined as a change form the mild-lPSS group into the moderate-(IPSS 8-18) or severe IPSS group (IPSS >18). The occurrence of urinary retention or the need for surgery (TURP) was also qualified as disease progression. Quality of life scores were also recorded separately and cross-analysed.
VOIDING
Jacobsen Steven ~, Jacobson Debra ~, Girman Cynthia 3, Roberts Rosebud t, Rhodes Thomas3, Lieber Michael 2
t,ge Years
All of the guidelines overlooked the implementation issues. Most of the guidelines did not explicitly state the search strategy used to identify the relevant evidence for the recommendations and the methods used for assessing the evidence.
OF
192 DEVELOPMENT OF A NEW QUESTIONNAIRE (QUIS-1I) FOR THE EVALUATION OF LUTS AND THE RELEVANT BOTHER FROM THE DATA OF T H E QUIBUS STUDY Prezioso D. ~, Scarpa R.M. 4, Zattoni F ) , Rizzi C . A ? for the QUIBUS Study Group ~Urology, University of Naples, Naples, Italy, 2Urology, Boehringer Ingelheim Italy, Milan, Italy, 3Urology, University of Udine, Udine, Italy, 4Urology, University of Turin, Turin, Italy I N T R O D U C T I O N & O B J E C T I V E S : The aim of the present work is to develop a new questionnaire on LUTS and QoL. on the basis of the data of the observational study QUIBUS (1998-2000), by reducing the 60 items of the ICS-BPH questionnaire. M A T E R I A L & METHODS: The new questionnaire has been worked out taking into account the three following principles: a) reduction of the large number of items of the ICS-BPH questionnaire b) integration of symptom severity and relevant bother c) inclusion, besides urinary symptoms, of incontinence and sexual function which are not considered in the IPSS. The following integrated score has been applied to each item of the ICS-BPH questionnaires collected from 798 patients, at baseline and after a l-year follow up of the QUIBUS study: It is not a p r o b l e m Never
0
Sometimes
l 2
Often/Always
It is a p r o b l e m 3 4
RESULTS: Of 915 men evaluated, 296 had mild symptoms of BOO (IPSS<8). Cumulative progression rate was 6%, 13%, 15% and 24% at 6 too, 12 too, 18 mo and 24 mo respectively. The overall accuracy of the ANN in predicting disease progression was 82% and 84% for predicting the need for surgery, respectively. The variables of importance for disease progression in the ANN analysis were in order of significance: PSA, OSS and age. The combination of age correlated PSA and OSS offered an 88% accuracy. The variables IPSS, ISS, QoL, Qmax and mean flow rate, as well PVR were not found to add significant predictive value. Overall accuracy was best in patients with PSA greater than 1.8 ng/ml.
RESULTS: By means of a multiple groups factor analysis, l l items have been selected from the ICS-BPH as the most representatives on a clinical and statistical basis. Of them, 3 are related to irritative and 3 to obstructive urinary symptoms, 2 to incontinence symptoms, 2 to sexual function and one single question to QoL. Cronbach's alpha for the total score of the selected items was 0.71 at baseline and 0.75 in the follow-up questionnaires, this indicating a good internal consistency.
CONCLUSIONS: Progression rates in men with mild symptoms of BOO (IPSS<8) increase form 13% to 24% at 12 and 24 mo respectively. Serum PSA, OSS and age were strongly correlated with disease progression overall, symptomatic progression, rate of urinary retention and need for surgery. Using the ANN as presented herein, disease progression can be predicted based on clinical and biochemical parameters. This will allow a more accurate identification of patients at risk for progression and will allow the selection of an ideal target group for preventive modalities.
CONCLUSIONS: These results indicate that the first objective of the new questionnaire validation (the content validity) has been reached. The new questionnaire (QUIBUS Score, Q U I S - I I ) represents a significant reduction of the number of questions of the ICS-BPH questionnaire, without theoretical loss of information. In addition, a limited number of questions, comparable to the ones of the IPSS (7+1) overcome the lack of information on incontinence and sexual activity. A test-retest prospective study is now under way for a full validation of the new tool.
European Urology Supplements 1 (2002) No. 1, pp. 50