DIAGNOSTIC ACCURACY STUDY OF THE SPOT URINARY PROTEIN
Publication Date
03.08.2010
Nature of Contract
Service contract
Deadline
30.09.2010
Date of Document
Place of Delivery
,
Region
UK: SOUTH EAST (ENGLAND)
I.D.:
6108826
Type of Document
Tender (all procedures)
Description
A diagnostic accuracy study of the spot urinary protein: creatinine ratio with a modelled evaluation of its diagnostic utility in the assessment of pre-eclampsia Introduction The aim of the HTA programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technologies is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis. Question What is the diagnostic accuracy of the spot urinary protein: creatinine ratio (SPCr) (and/or the spot urinary albumin: creatinine (SACr)) and how does it compare to the use of 24 hour urine collection in patients with suspected pre-eclampsia Can it safely avoid the need for admission 1 Technology: SPCr and/or SACr (applicants to justify choice). 2 Patient group: Hypertensive pregnant women with possible proteinuria on dipstick test. 3 Setting: Secondary care/primary care interface. 4 Comparator: 24 hour urine collection. 5 Design: A diagnostic accuracy study to compare the diagnostic accuracy of SPCr/SACr at different thresholds with 24 hour urine collection. Applicants will then develop a model of the diagnostic utility of SPCr/SACr as a potential replacement for 24 hour urine collection in UK primary care and obstetric practice and, if appropriate, advise on the most cost-effective threshold. The model should be stratified according to patient and clinical characteristics and ensure adverse events are fully captured. 6 Important outcomes: Measures of diagnostic accuracy of SPCr/SACr at different thresholds compared to 24 hour urine collection. Other outcomes: A model of cost-effectiveness, impact on resource use including cost savings and avoidance of admissions to hospital, adverse events for mother and baby. 7 Follow up: To discharge of mother (and baby) post delivery. Background to commissioning brief: About 1 in 4 women develop high blood pressure in their first pregnancy. Of these hypertensive pregnant women, 1 in 5 go on to develop pre-eclampsia, defined as hypertension and proteinuria detected for the first time in the second half of pregnancy (after 20 weeks gestation). Pre-eclampsia not only causes high blood pressure, but also affects the kidneys, liver, and blood vessels in the mother. It causes protein to leak from the kidneys into the urine which is why urine is tested regularly for protein during pregnancy. There are a number of ways to determine if a woman has significant proteinuria. In many places women with positive proteinuria on a dipstick test are admitted to hospital for observation for 36-48 hours and until a 24 hour urine collection result is available, which is inconvenient and has significant resource and economic implications. The SPCr/SACr test performed on a urine sample for protein quantification has the advantage that only a single specimen is required, which removes the risk of incomplete sample collection or errors and the result may be available within several hours.
CPV
71241000, 73110000
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