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About Enlarged Prostate

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Prostate Specific Assessment

One of the approximately 6,000,000 men in your age group in the United States who suffers from an enlarged prostate. Or perhaps you know someone who has the symptoms of what is medically known as Benign Prostatic Hyperplasia (BPH). This non-cancerous but often difficult condition can now, in most instances, be treated without prescribed medications or surgery.

The American Urological Association (AUA) Symptom Index is recommended as the symptom scoring instrument to be used in the initial assessment of each patient presenting with symptoms of prostatism. When the AUA system is used, symptoms should be classified as mild (0 to 7), moderate (8 to 19), or severe (20 to 35). The symptom score should be the primary determinant of treatment response or disease progression in the followup period.

Most patients seeking treatment for BPH do so because of bothersome symptoms that affect the quality of their lives. Tools to quantify those symptoms are important to determine the severity of the disease and to document the response to therapy, to assess the patient's symptoms, and to follow them over time to determine the progression of the disease and points of necessary intervention. Such assessment tools also allow comparison of the effectiveness of various interventions. To the patient, of course, relief of symptoms is the single most important outcome, not flowrate, detrusor pressure, or urethral resistance factors.

At least two significant attempts to develop tools for assessing a patient's symptom status were made prior to the development of the AUA Symptom Index. In one system, by Madsen and Iversen (1983), patients are interviewed specifically about symptoms that include the quality of their urinary stream, straining to void, hesitancy, intermittency, bladder emptying, stress incontinence or postvoid dribbling, urgency, frequency, and nocturia. All symptoms are graded on a scale of 0 to 4, and the scores are added for a total score that can reach 27 points. Patients scoring less than 10 points are considered mildly symptomatic. Patients scoring from 10 to 20 points are considered moderately symptomatic. Patients scoring above 20 points are considered severely symptomatic. The symptom-score assessment is integrated in a comprehensive clinical evaluation sheet including residual urine, cystoscopic findings, presence or absence of urinary tract infections, urinary retention, and renal failure.

The Madsen-Iversen scoring system cannot be regarded as an ideal system to evaluate BPH patients. One especially important detraction is that differential weights for symptoms were assigned on the basis of expert opinion, not empirical data from patients.

Another tool to quantify patient symptoms is the Boyarsky system (Boyarsky, Jones, Paulson, et al., 1976). An ad hoc group convened by the Food and Drug Administration (FDA) in 1975 developed guidelines for the investigation of BPH. The main part of these guidelines includes the Boyarsky tool. This symptom-scoring system evaluates the severity of nocturia, frequency, hesitancy, intermittency, terminal dribbling, urgency, impairment of size and force of stream, dysuria, and sensation of incomplete voiding. The system allows 0 to 3 points for each of 9 questions, for a maximum of 27 points.

The Boyarsky scoring system, like the Madsen-Iversen system, is not ideal. Although the symptoms in the Boyarsky system are each scored similarly, from 0 to 3, symptoms such as terminal dribbling are weighted equally with symptoms that appear to be better predictors of the presence or absence of BPH. As in the Madsen-Iversen tool, the equal-weighting scheme is based on opinion rather than data. Moreover, the Boyarsky tool asks about several dimensions of some symptoms, such as frequency and severity, resulting in response frames that are not collectively exhaustive.

Recently, during the time the BPH Guideline Panel was meeting, the AUA formed a Measurement Committee to develop a symptom and quality-of-life questionnaire to provide outcome measures for a prospective study of BPH treatment. The committee initially drafted a composite questionnaire consisting of 73 questions, in part by reviewing prior instruments including the Madsen-Iversen and Boyarsky scoring systems. Although 18 questions dealt with the frequency and severity of urinary symptoms, another 17 dealt with the issue of how much the patient was bothered by these symptoms. Other items covered health-related quality of life, sexual function, and continence.

In a pilot study, the full questionnaire was administered to patients with a clinical diagnosis of BPH who were drawn from urologic practices and to younger control subjects without urinary complaints who were drawn from a general medical practice (Barry, Fowler, O'Leary, et al., 1992a). Based on how well the individual symptom questions correlated to two ratings of the overall "bother" of each subject's urinary difficulties, a question set was selected for further testing. It covered the symptoms of incomplete emptying, frequency, intermittency, urgency, a weak stream, hesitancy, and nocturia.

This seven-question set was internally consistent (Cronbach's alpha = 0.85). Moreover, the reliability of the index was high, with a test-retest correlation of 0.93.

The index correlated strongly with patients' global ratings of their urinary difficulties (r = 0.78), providing evidence of the construct validity of the instruments. The tentative AUA index was also correlated with the Madsen-Iversen and Boyarsky scores obtained on the same subjects. The correlations, 0.85 and 0.93, respectively, were high. This provided additional evidence of construct validity (Barry, Fowler, O'Leary, et al., 1992b).

Finally, as a test of criterion validity, the ability of the index to separate the BPH patients from the control subjects in the validation study was examined. The area under the Receiver Operating Characteristic (ROC) curve for these indices, a measure of discrimination that uses each patient's score as a diagnostic test for BPH, was 0.87. This measure suggests that a randomly selected BPH patient and a randomly selected control subject from the study population would be correctly classified 87 percent of the time.

Based on the results of this initial validation study, several questions were modified (in response to subject feedback), and the 7-item index was revalidated using the same design (this time with 107 BPH patients and 49 control subjects). The AUA Symptom Index as administered in the second validation study is shown in Figure 1.

Each question on the AUA Symptom Index can yield 0 to 5 points, producing a total symptom score that can range from 0 to 35. On revalidation, the scores again demonstrated high internal consistency (Cronbach's alpha = 0.86) and high test-retest reliability (r =0.92). Scores were again correlated with subjects' two global ratings of their urinary problem (r = 0.65 and 0.72) and again discriminated BPH patients from control subjects (ROC area = 0.85).

As a final validation step, the sensitivity of the AUA Symptom Index, its ability to capture clinically important changes in patients' conditions, was assessed. Twenty-seven men with symptomatic BPH answered the questionnaire before and 1 month after having a prostatectomy. Their scores dropped from a mean of 17.6 to 7.1 over this period (95-percent CI 8.1-12.9 percent). This is statistically a highly significant result.

Data from the two validation studies were pooled to correlate subjects' symptom scores with the subjects' global ratings of how bothered they were by their condition (Table 4). These data can be used to divide the range of the AUA score into "mild," "moderate," and "severe" symptom categories. As can be seen from Table 4, only 1 of 120 men with scores from 0 to 7 was bothered more than a little by his symptoms; these men can be considered the mild symptom group. The majority of the 108 men with symptom scores from 8 to 19 were still bothered "not at all" or "a little." Only 4 of the 108 men were bothered "a lot." These men can be labeled as having moderate symptoms. Most men with scores from 20 to 35 were bothered by their condition "some" or "a lot" and can be considered to have severe symptoms.

Clearly, symptom scores alone do not capture the morbidity of a prostate problem as perceived by the individual patient. Symptom impact on a patient's lifestyle must be considered as well. An intervention may make more sense for a moderately symptomatic patient who finds his symptoms very bothersome than for a severely symptomatic patient who finds his symptoms quite tolerable.

The division of the AUA symptom scores into mild, moderate, and severe ranges is somewhat arbitrary. Depending on how the scores are to be used, different cutoff points may be more suitable for different purposes. Using the cutoff points chosen, Table 5 shows the distribution of scores for BPH patients and control subjects in the validation studies previously discussed.

In conclusion, the panel considers the objective documentation of a patient's symptom level the most essential part of its recommendation for the diagnosis, evaluation, treatment planning, and followup of patients with prostatism. The AUA Symptom Index, currently the best available instrument, is recommended by the panel. However, the panel emphasizes that optimal treatment decisions for individual patients will also need to take into account how a given level of symptoms affects each patient's quality of life (bothersomeness)

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