Table 2UROLOGICAL CANCER: investigations

AuthorSettingDescriptionNo.InclusionExclusionResultsGold StdQuality
Garnick, 1996This review was one of a series concerned with aspects of prostate cancer. Articles published 1992–1996 were sought in a search of Medline. A largely qualitative analysis of the identified articles was undertakenMost of the initial screening studies that had assessed an abnormal PSA had used 4.0ng/ml as the upper limit of normal. Several studies have considered methods of refining interpretation of the PSA test. The PSA density refers to a numerical ratio determined by dividing the PSA serum value by the volume of the prostate gland as determined by transrectal ultrasonography. This gives the PSA value per gram of prostate, and densities of 0.15 or more may strongly indicate the presence of cancer. However, estimation of the volume of the prostate gland is subject to error. Prostate-specific antigen velocity refers to the rate of change in the PSA value over time. A value that continues to increase over time may signal cancer. Two studies of the value of PSA velocity were included in the review, and they indicated that a change of more than 0.75ng/ml per year should be regarded with a high degree of suspicion. Recent studies have also suggested that the upper-limit of normal PSA value varies by age, being lower in younger than older men. Some preliminary studies have been undertaken of the potential role of the relative percentage of free PSA and PSA bound to serum proteins.
Glas et al, 2003Systematic review of articles that evaluated tumour markers in the diagnosis of primary bladder cancer. The markers included cytology, bladder tumour antigen, BTA stat, BTA TRAK, NMP22, telomerase and fibrin degradation product. Relevant studies that evaluated at least one of these markers were sought in a search of Medline and Embase for articles published 1990 to 2001.42 studies.
Selley et al, 1997This was a systematic review of the diagnosis, management and screening of early localised prostate cancerPSA is a protease produced almost exclusively by prostatic epithelium. The normal range is between 0–4ng/ml, although some men with cancer have values in the normal range, and high values can be caused by conditions other than cancer. Reports of PSA sensitivity range from 57–99%, and specificity from 59–97%. The gold standard test used in studies of PSA testing is prostate biopsy, but in the primary studies not all men with elevated results would have undergone biopsy. Therefore, the true number of cancers cannot be accurately determined. The review found that evidence to support use of PSA density was equivocal, and that further research was needed into the role of PSA velocity, free and bound PSA and age-specific reference ranges for PSA normal values.
Thomas et al, 2003General practices were randomized to receive the intervention for either lower urinary tract symptoms or microscopic haematuria, serving as controls for the other condition. The intervention consisted of referral guidelines plus access to the investigation service.66 general practicesGeneral practitioner compliance with the guidelines increased (pre-intervention scores 2.6 and 2.8 in the intervention and control practices respectively, and 3.2 and 2.8 post intervention), and the intervention reduced waiting time from referral to initial out-patient appointment (106 and 130 pre-intervention to 36 and 75 days post intervention in the intervention and control groups respectively) and increased the proportion of patients who had a management decision reached at the initial appointment (0.18 and 0.24 pre – and 0.50 and 0.19 post-intervention in the intervention and control groups respectively).
Vinata et al, 2001A systematic review. Pubmed was used to identify relevant articles. The tests included were urine cytology, haematuria detected by dipstick, and tests currently undergoing evaluation, including human complement tests, nuclear mitotic apparatus protein testing, cytology plus immunofluorescence, telomerase testing and the hyaluronic acid and hyaluronidase test.Urine cytology was reported to have a sensitivity of 35–40% (range between studies 16–60%) for detecting bladder cancer. Haematuria can be caused by many conditions other than cancer, and therefore the specificity for cancer is low, but the sensitivity was reported to be 67–90%. There is insufficient evidence available to determine which of the other tests, or which combination of tests, can be recommended as non-invasive methods of detecting bladder cancers.
Weller et al, 2003AustraliaGenerl practioners were randomised to receive either an outreach visit or mailed education. There was also a control group.
The written materials consisted of printed summaries of evidence on PSA testing, patient education materials and epidemiological information on prostate cancer in Australia.
145 general practioners.In the 12 months after the interventions, the educational outreach group undertook significantly fewer PSA tests. This group also had the greatest improvement in knowledge of treatment effectiveness and appreciation of guidance on screening asymptomatic men.

From: Appendix B, Evidence Tables

Cover of Referral Guidelines for Suspected Cancer in Adults and Children
Referral Guidelines for Suspected Cancer in Adults and Children [Internet].
NICE Clinical Guidelines, No. 27.
Clinical Governance Research and Development Unit (CGRDU), Department of Health Sciences, University of Leicester.
Copyright © 2005, National Collaborating Centre for Primary Care.

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