Rapid testing for group B streptococcus during labour: a test accuracy study with evaluation of acceptability and cost-effectiveness

被引:43
作者
Daniels, J. [1 ,2 ]
Gray, J. [3 ,4 ]
Pattison, H. [5 ]
Roberts, T. [6 ]
Edwards, E. [4 ]
Milner, P. [4 ]
Spicer, L.
King, E. [2 ]
Hills, R. K. [2 ]
Gray, R. [2 ]
Buckley, L. [2 ]
Magill, L. [2 ]
Elliman, N. [5 ]
Kaambwa, B. [6 ]
Bryan, S. [6 ]
Howard, R.
Thompson, P. [3 ]
Khan, K. S. [1 ,4 ]
机构
[1] Univ Birmingham, Birmingham Womens Hosp, Acad Dept Obstet & Gynaecol, Birmingham B15 2TT, W Midlands, England
[2] Univ Birmingham, Clin Trials Unit, Birmingham B15 2TT, W Midlands, England
[3] Birmingham Childrens Hosp NHS Fdn Trust, Birmingham, W Midlands, England
[4] Birmingham Womens Healthcare NHS Fdn Trust, Birmingham, W Midlands, England
[5] Aston Univ, Sch Life & Hlth Sci, Birmingham B4 7ET, W Midlands, England
[6] Univ Birmingham, Dept Hlth Econ, Birmingham B15 2TT, W Midlands, England
关键词
DIAGNOSTIC-ACCURACY; INTRAPARTUM CHEMOPROPHYLAXIS; VERTICAL TRANSMISSION; REGRESSION-MODELS; MATERNAL ANXIETY; PREGNANT-WOMEN; DISEASE; COLONIZATION; PREVENTION; PENICILLIN;
D O I
10.3310/hta13420
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Objective: To determine the accuracy, acceptability and cost-effectiveness of polymerase chain reaction (PCR) and optical immunoassay (OIA) rapid tests for maternal group B streptococcal (GBS) colonisation at labour. Design: A test accuracy study was used to determine the accuracy of rapid tests for GBS colonisation of women in labour. Acceptability of testing to participants was evaluated through a questionnaire administered after delivery, and acceptability to staff through focus groups. A decision-analytic model was constructed to assess the cost-effectiveness of various screening strategies. Setting: Two large obstetric units in the UK. Participants: Women booked for delivery at the participating units other than those electing for a Caesarean delivery. Interventions: Vaginal and rectal swabs were obtained at the onset of labour and the results of vaginal and rectal PCR and OIA (index) tests were compared with the reference standard of enriched culture of combined vaginal and rectal swabs. Main outcome measures: The accuracy of the index tests, the relative accuracies of tests on vaginal and rectal swabs and whether test accuracy varied according to the presence or absence of maternal risk factors. Results: PCR was significantly more accurate than OIA for the detection of maternal GBS colonisation. Combined vaginal or rectal swab index tests were more sensitive than either test considered individually [combined swab sensitivity for PCR 84% (95% CI 79-88%); vaginal swab 58% (52-64%); rectal swab 71% (66-76%)]. The highest sensitivity for PCR came at the cost of lower specificity [combined specificity 87% (95% CI 85-89%); vaginal swab 92% (90-94%); rectal swab 92% (90-93%)]. The sensitivity and specificity of rapid tests varied according to the presence or absence of maternal risk factors, but not consistently. PCR results were determinants of neonatal GBS colonisation, but maternal risk factors were not. Overall levels of acceptability for rapid testing amongst participants were high. Vaginal swabs were more acceptable than rectal swabs. South Asian women were least likely to have participated in the study and were less happy with the sampling procedure and with the prospect of rapid testing as part of routine care. Midwives were generally positive towards rapid testing but had concerns that it might lead to overtreatment and unnecessary interference in births. Modelling analysis revealed that the most cost-effective strategy was to provide routine intravenous antibiotic prophylaxis (IAP) to all women without screening. Removing this strategy, which is unlikely to be acceptable to most women and midwives, resulted in screening, based on a culture test at 35-37 weeks' gestation, with the provision of antibiotics to all women who screened positive being most cost-effective, assuming that all women in premature labour would receive IAR The results were sensitive to very small increases in costs and changes in other assumptions. Screening using a rapid test was not cost-effective based on its current sensitivity, specificity and cost. Conclusions: Neither rapid test was sufficiently accurate to recommend it for routine use in clinical practice. IAP directed by screening with enriched culture at 35-37 weeks' gestation is likely to be the most acceptable cost-effective strategy, although it is premature to suggest the implementation of this strategy at present.
引用
收藏
页码:1 / +
页数:151
相关论文
共 174 条
[1]   RANDOMIZED STUDY OF VAGINAL CHLORHEXIDINE DISINFECTION DURING LABOR TO PREVENT VERTICAL TRANSMISSION OF GROUP-B STREPTOCOCCI [J].
ADRIAANSE, AH ;
KOLLEE, LAA ;
MUYTJENS, HL ;
NIJHUIS, JG ;
DEHAAN, AFJ ;
ESKES, TKAB .
EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY, 1995, 61 (02) :135-141
[2]   Neonatal early onset group B streptococcal infection. A nine-year retrospective study in a tertiary care hospital [J].
Adriaanse, AH ;
Lagendijk, I ;
Muytjens, HL ;
Nijhuis, JG ;
Kollee, LAA .
JOURNAL OF PERINATAL MEDICINE, 1996, 24 (05) :531-538
[3]   Serotype distribution and mother-to-baby transmission rate of Streptococcus agalactiae among expectant mothers in Kuwait [J].
Al-Sweih N. ;
Hammoud M. ;
Al-Shimmiri M. ;
Jamal M. ;
Neil L. ;
Rotimi V. .
Archives of Gynecology and Obstetrics, 2005, 272 (2) :131-135
[4]   Sample size calculations for comparative studies of medical tests for detecting presence of disease [J].
Alonzo, TA ;
Pepe, MS ;
Moskowitz, CS .
STATISTICS IN MEDICINE, 2002, 21 (06) :835-852
[5]  
*AM COLL OBST GYN, 1996, 173 ACOG COMM
[6]  
[Anonymous], HLTH TECHNOL ASSESS
[7]  
[Anonymous], SCREENING HEALTHCARE
[8]  
[Anonymous], HLTH TECHNOL ASSESS
[9]  
[Anonymous], 1998, MRC GUID GOOD CLIN P
[10]  
[Anonymous], 2004, GUID METH TECHN APPR