Objectives : To systematically review the literature regarding the reliability and validity of assessment methods available in primary care for bladder outlet obstruction or benign prostatic obstruction in men with lower urinary tract symptoms (LUTS). Design : Systematic review with best evidence synthesis. Setting : Primary care. Participants : Men with LUTS due to bladder outlet obstruction or benign prostatic obstruction. Review methods: PubMed, Ebsco/CINAHL and Embase databases were searched for studies on the validity and reliability of assessment methods for bladder outlet obstruction and benign prostatic obstruction in primary care. Methodological quality was assessed with the COSMIN checklist. Studies with poor methodology were excluded from the best evidence synthesis. Results : Of the 5644 studies identified, 61 were scored with the COSMIN checklist, 37 studies were included in the best evidence synthesis, 18 evaluated bladder outlet obstruction and 17 benign prostatic obstruction, 2 evaluated both. Overall, reliability was poorly evaluated. Transrectal and transabdominal ultrasound showed moderate to good validity to evaluate bladder outlet obstruction. Measured prostate volume with these ultrasound methods, to identify benign prostatic obstruction, showed moderate to good accuracy, supported by a moderate to high level of evidence. Uroflowmetry for bladder outlet obstruction showed poor to moderate diagnostic accuracy, depending on used cut-off values. Questionnaires were supported by high-quality evidence, although correlations and diagnostic accuracy were poor to moderate compared with criterion tests. Other methods were supported by low level evidence. Conclusion :Clinicians in primary care can incorporate transabdominal and transrectal ultrasound or uroflowmetry in the evaluation of men with LUTS but should not solely rely on these methods as the diagnostic accuracy is insufficient and reliability remains insufficiently researched. Low-to-moderate levels of evidence for most assessment methods were due to methodological shortcomings and inconsistency in the studies. This highlights the need for better study designs in this domain.
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From the article: Abstract Sub-chronic toxicity studies of 163 non-genotoxic chemicals were evaluated in order to predict the tumour outcome of 24-month rat carcinogenicity studies obtained from the EFSA and ToxRef databases. Hundred eleven of the 148 chemicals that did not induce putative preneoplastic lesions in the sub-chronic study also did not induce tumours in the carcinogenicity study (True Negatives). Cellular hypertrophy appeared to be an unreliable predictor of carcinogenicity. The negative predictivity, the measure of the compounds evaluated that did not show any putative preneoplastic lesion in de sub-chronic studies and were negative in the carcinogenicity studies, was 75%, whereas the sensitivity, a measure of the sub-chronic study to predict a positive carcinogenicity outcome was only 5%. The specificity, the accuracy of the sub-chronic study to correctly identify non-carcinogens was 90%. When the chemicals which induced tumours generally considered not relevant for humans (33 out of 37 False Negatives) are classified as True Negatives, the negative predictivity amounts to 97%. Overall, the results of this retrospective study support the concept that chemicals showing no histopathological risk factors for neoplasia in a sub-chronic study in rats may be considered non-carcinogenic and do not require further testing in a carcinogenicity study.
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