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[Estimation of disease-specific costs in a dataset of health insurance claims and its validation using simulation data].

PURPOSES: To estimate disease-specific costs in a dataset of health insurance claims with multiple diagnoses with known aggregate cost per claim and unknown disease-specific cost of each diagnosis using PDM (Proportional Disease Magnitude) method, validate its accuracy using simulation data with Monte Carlo method and improve its accuracy by developing an adjustment formula. METHODS: Developed simulation data with pre-assigned disease-specific costs, applied PDM method using arithmetic means of per-diem-per-disease cost as magnitude, validated its accuracy by observing the correlation between estimates by PDM method and known disease-specific costs and formulated an adjustment formula to improve accuracy. The reproducibility of the findings was assessed using Monte Carlo method by repeating the same procedures. RESULTS: The observed arithmetic means of per-diem-per-disease cost did not match well with actual values resulting in unsatisfactory accuracy. However, when the observed means were adjusted with a formula in which the observed mean is multiplied by (observed mean/overall mean) in the power of 2, PDM method yielded an accurate estimate of disease-specific cost. The accuracy was reproduced by Monte Carlo method with 0.9 or above R square value and slope of regression line in 76, 56 out of 100 iterations respectively. CONCLUSIONS: PDM method proved to be an objective, reproducible and accurate method for estimation of disease-specific costs of health insurance claims.

Insurance Claim Reporting↗

Vacuum-assisted breast biopsy: a critical review.

Vacuum-assisted biopsy is an image-guided technique introduced in 1995 that is thought to be superior to 14G automated-needle biopsy for the evaluation of non-palpable breast lesions. However, prospective randomised studies evaluating its accuracy are unavailable. We conducted a critical review of the currently available literature on the accuracy of vacuum-assisted biopsy and compared it with published data on the accuracy of 14G automated-needle biopsy. The diagnostic performance of vacuum-assisted biopsy was evaluated by reviewing all available English-language literature published in Medline between 1995 and November 2001. Four independent reviewers used standard forms to extract the data. Twenty-two published studies were included. High-risk and DCIS underestimate rates, as well as the miss-rate of cancer, were assessed. High-risk and DCIS underestimate rates for 11G vacuum biopsy were 16% (95% Confidence Interval (CI) 12-20%) and 11% (95% CI 9-12%), respectively, and both were lower than the rates reported for 14G automated-needle biopsy (40% (95% CI 26%;56%) and 15% (95% CI 8%;26%), respectively). Due to incomplete follow-up of the benign lesions, it was impossible to calculate the miss-rates and the sensitivity rate. The results of this review indicate that vacuum-assisted biopsy can decrease the high-risk and DCIS underestimate rates, but it is unclear whether it can also decrease the miss-rates of cancer.

Biopsy↗

Information quality in a remote rural maternity unit in Ghana.

The collection of accurate maternal outcome data enables causes of morbidity and mortality to be identified, which in turn permits interventions to be targeted appropriately. It also allows estimates to be made about the importance of various indicators in predicting birth outcome. These indicators can then be compared between health services, across time and against programme objectives, thus ensuring a management information system that informs policy and provides for real change. A review was done of data collection at the antenatal clinic and maternity ward in a remote rural hospital in northern Ghana. The data collected came from maternity ward records and participant observation, and they highlight deficiencies in the record management procedures. It is argued that exhorting staff to greater accuracy, although obvious, may not be the only solution, because of the structural impediments that often give an illusion of accuracy. The best data need to be collected within the constraints of the equipment and the people. Furthermore, to make the task more meaningful, regular feedback needs to be provided so that the process of record keeping is relevant to those who do it. Ministries of health need to conduct regular audits, like this microanalysis, so that policies are not based on data that are analyzed under a presumption of accuracy.

Data Collection↗

Inter observer variability of the transcranial Doppler ultrasound technique: impact of lack of practice on the accuracy of measurement.

OBJECTIVE: Published data on the observer variability with the transcranial doppler (TCD) ultrasound are limited by the use of the product moment correlation coefficient. This study was designed to quantify the intra and inter observer variability with the TCD in terms of the intra class correlation coefficient (ICC) and to assess the impact of lack of practice on the observer variability and the accuracy of data generated. METHODS: The study was performed in two phases. In phase I, three observers insonated the middle cerebral artery in 10 healthy volunteers and measured peak systolic and end diastolic cerebral blood flow velocities. In phase II, the same observers repeated the experiment on five healthy volunteers after an eight week break during which none of the observers were allowed to use the TCD system. The observers were blinded to the measurements obtained. RESULTS: The ICC for peak velocity measurement was 0.9 (0.81-0.99) in phase I and 0.85 (0.66-1.00) in phase II (p < 0.05). The ICCs for end diastolic velocity measurements for phase I and II were 0.8 (0.64-0.96) and 0.67 (0.33-1.00) respectively (p < 0.01). CONCLUSIONS: A high level of observer agreement is possible with the TCD for measurement of cerebral blood flow velocities. Lack of regular practice with the system reduces the accuracy of measurements and impacts on both measured and calculated indices.

Adult↗

Digitizing graphic data.

Using a digitizing pad instead of a ruler and calipers accelerates and increases the accuracy of graphic data analysis. Factors important in choosing and using such a pad are discussed in this article. A program is presented which facilitates use of the Houston Instruments HiPad DT11, a digitizing pad which is particularly well suited to neurophysiological applications.

Computers↗

Ovarian reserve tests for predicting fertility outcomes for assisted reproductive technology: the International Systematic Collaboration of Ovarian Reserve Evaluation protocol for a systematic review of ovarian reserve test accuracy.

BACKGROUND: The presence of a wide range of tests of ovarian reserve suggests that no single test provides a sufficiently accurate result. Many tests are used without reference to an evidence base. So far, individual studies conducted on these tests are too small to give precise estimates of prognostic accuracy. OBJECTIVES: To systematically assess the accuracy of the available tests of ovarian reserve in terms of prediction of fertility outcomes. SEARCH STRATEGY: The search will be conducted using the name of the respective index test being studied (as listed on the MESH database), if more than 2000 citations are listed, 'ovary' and or 'ovarian', 'fertility' and or 'reserve' will be combined with the original search term as required. Studies of the accuracy of tests of ovarian reserve will be obtained without language restrictions from 1980 to 2005 using the following electronic databases and Ovid software: MEDLINE, EMBASE, PUBmed, Biological extracts, Pascal, Cochrane Library (CDSR, DARE, CCTR, HTA), Best Evidence databases, SCISEARCH, Conference Proceedings (ISI Proceedings, Healthstar, Current Contents, Science Citation Index, Cancerlit and Econlit and NHS Economic Evaluation database. The National Research Register, the Medical Research Council's Clinical Trials Register, MEDION, DARE, and the US Clinical Trials register. SELECTION CRITERIA: Studies will be selected if accuracy of tests are compared with a reference standard and include data that can be abstracted into a two-by-two table to calculate sensitivity and specificity. The studies to be included in this review will examine one of the following index 'tests' within a study population of women undergoing assisted reproductive technology: * Clinical variables--age, history of cancelled cycles. * Basal blood tests--follicle-stimulating hormone (FSH), lutenising hormone (LH), FSH:LH ratios, estradiol (E(2)), inhibin A and B, progesterone (P(4)), P(4):E(2) ratios, antimullerian hormone, testosterone, vascular endothelial growth factor, insulin-like growth factor-1:insulin-like growth factor binding protein-1 ratios. * Dynamic tests--clomiphene citrate challenge test, gonadotropin analogue stimulating test, exogenous FSH ovarian reserve test. * Ultrasound tests-antral follicle count, ovarian volume, ovarian stromal peak systolic velocity, including waveform and pulsatility index, ovarian follicular vascularity. * Histology--ovarian biopsy. Data collection and analysis Two independent reviewers will perform quality assessment and data extraction. Prognostic accuracy will be determined by calculating positive and negative likelihood ratios for the following outcomes or reference standards: live birth, ongoing pregnancy, clinical pregnancy, biochemical pregnancy, embryos available for transfer, eggs obtained at oocyte retrieval, cycles cancelled prior to oocyte retrieval. Main results and conclusions N/A.

Data Collection↗

Clinical methods for the objective estimation of loudness discomfort level (LDL) using auditory brainstem responses in patients.

Our previous work showed that the slope of the JV latency/intensity function can be used to estimate the loudness discomfort level (LDL). In this study, the previous work was repeated using normal subjects and patients whose LDL was unknown at the time of test. The results showed that the original model still applied. Further measures were taken to evaluate clinical methods of applying this technique. Four basic approaches were used, a 'correction factor' model and a 'curve-fitting' model and these were applied to data obtained from measurements taken in both 5 dB and 10 dB increments. The results showed that the 'correction factor' models were better than the 'curve-fit' approach. The prediction of LDL based upon the 5 dB increment data gave the greater accuracy but the 10 dB increment data gave predictions that were sufficiently accurate for clinical use (95% confidence limits of +/- 8 dB). Thus this ABR estimator has wide application and good accuracy in estimating subjective LDL. A clinical protocol for applying this technique is described.

Adolescent↗

Frameless stereotactic localization in cranial base surgery.

Mastery of the three-dimensional anatomic relationships of the cranial base/paranasal sinuses is required to reduce the incidence of iatrogenic surgical complications, facilitate complete tumor extirpation, and enhance functional outcomes. Real-time intraoperative localization technology is one method available to assist the cranial base surgeon. We report our institutional experience with the StealthStationtrade mark treatment guidance platform. Eighty-eight consecutive patients with pathology of the cranial base/paranasal sinuses were operated on with the aid of real-time frameless stereotactic localization. Preoperative image data sets were acquired with either CT or MRI scans. Patient demographics, accuracy of the data sets, surgical approaches, pathology, complications, and further applications of this technology are presented. Procedures were performed on 47 women and 41 men ranging in age from 6 to 85 years. In these 88 procedures, 44 MRI and 44 CT scans with a mean accuracy of 1.57 and 1.23 mm, respectively, were used. Approaches to the cranial base included midface degloving (25), endoscopic (23), craniofacial (13), maxillectomy (12), rhinotomy without maxillectomy (5), transoral (5), pterional (2), transcondylar (1), and transcervical (2). Indications for surgery included severe inflammatory disease of the paranasal sinuses with epidural or subdoral abscess, or both (7), cerebrospinal fluid fistula or encephalocele, or both (11), and 40 benign and 30 malignant tumors. Complications occurred in 10 of 88 patients (11%). Real-time intraoperative localization can be applied to cranial base surgery in a variety of scenarios. The instantaneous transfer of imaging data to the surgical field is useful in localizing pathology, enhancing operative safety, and reducing morbidity, thereby improving outcomes. This technology will certainly play an integral role in minimizing complications and improving surgical outcomes as cranial base surgery moves into the next millennium.

Journal Article↗

Considerations on ultra-trace analysis of phthalates in drinking water.

Stir bar sorptive extraction with liquid desorption followed by large volume injection and capillary gas chromatography coupled to mass spectrometry (SBSE-LD/LVI-GC-MS), had been applied for the determination of ultra-traces of seven-phthalates (dimethyl phthalate, diethyl phthalate, di-n-butyl phthalate, butyl benzyl phthalate, bis(2-ethylhexyl) adipate, bis(2-ethylhexyl) phthalate and bis(1-octyl) phthalate) in drinking water samples, which are included in the priority lists set by several international regulatory organizations. Instrumental calibration under the selected-ion monitoring mode acquisition (LVI-GC-MS(SIM)), experimental parameters that could affect the SBSE-LD efficiency, as well as, the control of the contamination profile are fully discussed. Throughout systematic assays on 30 mL water samples spiked at the 0.40 microg/L level, it had been established that stir bars coated with 47 microL of polydimethylsiloxane, an equilibrium time of 60 min (1,000 rpm) and methanol as back extraction solvent, allowed the best analytical performance to monitor phthalates in water matrices. From the data obtained, good accuracy and a remarkable reproducibility (< 14.8%) were attained, providing experimental recovery data in agreement with the theoretical equilibrium described by the octanol-water partition coefficients (K(PDMS/W) approximately K(O/W)), with the exception of bis(2-ethylhexyl) adipate, bis(2-ethylhexyl) phthalate and bis(1-octyl) phthalate, for which lower yields were measured. Additionally, a remarkable linear dynamic range between 25 and 2,000 ng/L (r(2)>0.99) and low detection limits (3-40 ng/L) were also achieved for the seven-phthalates studied. The application of the present method to monitor phthalates in tap and bottled mineral water samples, allowed convenient selectivity and high sensitivity up to 1.0 microg/L level, using the standard addition methodology. The proposed method showed to be feasible and sensitive with a low sample volume requirement to monitor phthalates in drinking water matrices at the ultra-trace level, in compliance with international regulatory directives on water quality.

Adipates↗

Unit costs for house spraying and bednet impregnation with residual insecticides in Colombia: a management tool for the control of vector-borne disease.

A study of unit costs and cost components of two malaria-control strategies (house spraying and bednet impregnation with residual insecticides) was undertaken in 11 malaria-endemic states (departamentos) of Colombia, using data provided by control staff on self-administered questionnaires. The accuracy of the data was verified by personal visits, telephone conversations and complementary information from 10 other states. Allthe financial-cost components of the malaria-control operations carried out in the previous 6 months and the results of the control operations themselves (including the numbers of houses sprayed and numbers of bednets impregnated/day) were recorded. The information was stratified according to whether the target communities were 'near' or 'far away' from an operational base, the far-away communities being those that needed overnight stays by the control staff. The main variables analysed were unit costs/house treated, and annual cost/person protected. The results show that house spraying was generally more expensive for the health services than bednet impregnation. This is particularly the case in 'nearby' communities, where most of those at-risk live. In such communities, spraying one house was 7.2 times more expensive than impregnating one bednet. Even if only those sleeping under an impregnated net were assumed to be protected, the unit costs/person protected in a 'nearby' community were twice as high for house spraying than for bednet impregnation. In 'nearby' communities, where technicians could return to the operational base each evening, insecticides made up 80% of the total spraying costs and 42% of the costs of bednet impregnation. In 'far-away' communities, however, salaries and 'per diems' were the most important cost components, representing, respectively, 23% and 22% of the costs of spraying, and 34% plus 27% of the costs of impregnation. Insecticide wastage and non-use of discounts on insecticide prices (available through the national Ministry of Health) increased the overall costs considerably. The multiple uses of these cost calculations for district health managers are presented.

Animals↗

Data integrity-conduct of clinical investigations: university investigator perspective.

Clinical investigations are studies designed to evaluate the effectiveness of a new animal drug. Expectations for documentation of events occurring during clinical investigations have been greatly increased. The Food and Drug Administration (FDA) through its Center for Veterinary Medicine (CVM) division recently issued a guideline to address the responsibilities (under 21 CFR 511.1 and 512[j] of the Federal, Food, Drug and Cosmetic Act) of investigators who conduct clinical investigations of new animal drugs and of monitors of these investigations. The guideline is part of a continuing effort by FDA/CVM to propose data integrity initiatives that will continue to assure the reliability and accuracy of the data upon which decisions to approve new animal drugs are based. In addition to the increased documentation, FDA/CVM intends to make real-time inspection of clinical investigations a routine practice. In response to these changes; those involved with clinical investigations will need to make appropriate adjustments. The purpose of this review is to provide additional notification to clinical investigators of the changes in their responsibilities under the new guideline and to provide an investigator perspective of how these changes might impact research efforts.

Animals↗

A user-oriented validation method for clinical data.

The patient data in hospitals is prone to many errors during computerization because of the large human element involved during the processes concerned. A user-oriented validation method, which has been found to be practical and acceptable, is suggested. A non-statistical approach is adopted in this regard. The qualitative requirements of all users for validation have been taken as the guidelines to achieve maximum user acceptability. A user-oriented data code sheet, whose format changes for different disease groups, has been devised to prevent most of the typographical errors. These code sheets have also been found to be of considerable help to doctors in keeping a check on any missed or incomplete investigations, examinations and history recording. The validation program detects all errors of a typographical nature and all commonly possible logical errors. In addition, the program outputs data values, whose accuracy is doubtful, in the form of warning messages like WARNED DATA and ERRONEOUS DATA. The data fields which do not contain any data are also output to help the clinicians to take note of investigations and clinical tests not done or whose results are awaited. The logical errors, if any, also help them in detecting and identifying atypical cases in any given disease group at the earliest possible stage of a patient's hospitalization. In this paper, the need for a user-oriented and non-statistical approach to the validation of clinical data has been discussed in detail and its advantages enumerated.

Electronic Data Processing↗

Accuracy of the ambulatory ECG monitoring system Cardio-Data Mk4 in detecting exercise-induced myocardial ischaemia.

The accuracy of ST-segment analysis in a direct-recording ambulatory ECG monitoring (AEGG) system (CardioData Mk 4 with recorder CardioData PR3) was compared with that obtained in a standard ECG recorder. Twenty two patients with coronary heart disease and a positive exercise test were submitted to a second bicycle exercise test with concomitant AECG monitoring. Application of a junction box made it possible to record the two bipolar AECG leads simultaneously on both standard ECG (leads ECG 1 and 2) and AECG (leads 1 and 2). We determined the time of the beginning, end and maximum and the magnitude of the ST-segment depression in bipolar leads AECG 1 and 2, and ECG 1 and 2. AECG monitoring was just as accurate as standard ECG: time intervals between the different leads showed good alignment. The degree of maximum ST-segment depression in ECG 1 (mean +/- SD: 0.22 +/- 0.11 mV) was identical to that in AECG 1 (0.22 +/- 0.13 mV). Maximum extent of ST-segment depression was lower in ECG 2 and AECG 2 but also comparable (ECG 2: 0.13 +/- 0.14 mV, AECG 2: 0.15 +/- 0.17 mV). Thus, ST-segment depressions found with a standard ECG recorder can also be reliably detected with a direct recording AECG monitoring system.

Aged↗

Ability of laboratories to detect emerging antimicrobial resistance: proficiency testing and quality control results from the World Health Organization's external quality assurance system for antimicrobial susceptibility testing.

The accuracy of antimicrobial susceptibility data submitted by microbiology laboratories to national and international surveillance systems has been debated for a number of years. To assess the accuracy of data submitted to the World Health Organization by users of the WHONET software, the Centers for Disease Control and Prevention distributed six bacterial isolates representing key antimicrobial-resistance phenotypes to approximately 130 laboratories, all but one of which were outside of the United States, for antimicrobial susceptibility testing as part of the World Health Organization's External Quality Assurance System for Antimicrobial Susceptibility Testing. Each laboratory also was asked to submit 10 consecutive quality control values for several key organism-drug combinations. Most laboratories were able to detect methicillin (oxacillin) resistance in Staphylococcus aureus, high-level vancomycin resistance in Enterococcus faecium, and resistance to extended-spectrum cephalosporins in Klebsiella pneumoniae. Many laboratories, particularly those using disk diffusion tests, had difficulty in recognizing reduced susceptibility to penicillin in an isolate of Streptococcus pneumoniae. The most difficult phenotype for laboratories to detect was reduced susceptibility to vancomycin in an isolate of Staphylococcus epidermidis. The proficiency testing challenge also included a request for biochemical identification of a gram-negative bacillus, which most laboratories recognized as Enterobacter cloacae. Although only a small subset of laboratories have submitted their quality control data, it is clear that many of these laboratories generate disk diffusion results for oxacillin when testing S. aureus ATCC 25923 and S. pneumoniae ATCC 49619 that are outside of the acceptable quality control range. The narrow quality control range for vancomycin also proved to be a challenge for many of the laboratories submitting data; approximately 27% of results were out of range. Thus, it is important to establish the proficiency of laboratories submitting data to surveillance systems in which the organisms are tested locally, particularly for penicillin resistance in pneumococci and glycopeptide resistance in staphylococci.

Anti-Bacterial Agents↗

Conventional energy and macronutrient variables distort the accuracy of children's dietary reports: illustrative data from a validation study of effect of order prompts.

OBJECTIVE: Validation-study data are used to illustrate that conventional energy and macronutrient (protein, carbohydrate, fat) variables, which disregard accuracy of reported items and amounts, misrepresent reporting accuracy. Reporting-error-sensitive variables are proposed which classify reported items as matches or intrusions, and reported amounts as corresponding or overreported. METHODS: 58 girls and 63 boys were each observed eating school meals on 2 days separated by > or =4 weeks, and interviewed the morning after each observation day. One interview per child had forward-order (morning-to-evening) prompts; one had reverse-order prompts. Original food-item-level analyses found a sex-x-order prompt interaction for omission rates. Current analyses compared reference (observed) and reported information transformed to energy and macronutrients. RESULTS: Using conventional variables, reported amounts were less than reference amounts (ps<0.001; paired t-tests); report rates were higher for the first than second interview for energy, protein, and carbohydrate (ps< or =0.049; mixed models). Using reporting-error-sensitive variables, correspondence rates were higher for girls with forward- but boys with reverse-order prompts (ps< or =0.041; mixed models); inflation ratios were lower with reverse- than forward-order prompts for energy, carbohydrate, and fat (ps< or =0.045; mixed models). CONCLUSIONS: Conventional variables overestimated reporting accuracy and masked order prompt and sex effects. Reporting-error-sensitive variables are recommended when assessing accuracy for energy and macronutrients in validation studies.

Bias↗

Prediction of genetic structure in eukaryotic DNA using reference point logistic regression and sequence alignment.

MOTIVATION: Current software tools are moderately effective in predicting genetic structure (exons, introns, intergenic regions, and complete genes) from raw DNA sequence data. Improvements in accuracy and speed are needed to deal with the increasing volume of data from large scale sequencing projects. RESULTS: We present a two-stage computer program to predict genetic structure in eukaryotic DNA. The first stage makes use of a novel statistical technique, called reference point logistic (RPL) regression, to calculate scores for potential functional sites. These site scores are combined with interval content, length, and state scores, via a Generalized Hidden Markov Model, to determine a combined score for each possible parse of a given DNA sequence into exons, introns, and intergenic regions. An optimal parse is found using a dynamic programming algorithm. In the second stage, protein sequence alignment methods are applied to improve the accuracy of the initial parse. Computation in the first stage of the program is very fast (1 s on a 360 MHz CPU for a 16 kb sequence) and its predictive accuracy typically matches or exceeds the best results reported for other methods (Sensitivity = 0.93 and Specificity = 0.93 for the Burset/Guigótest set). Computation in the second stage is slower, but the final predictions are more accurate (Sn = 0.97, Sp = 0.97). The program (called GRPL) can handle partial, single, and multi-gene sequences. The program is also capable of predicting the genetic structure of vertebrate, invertebrate, and plant DNA with nearly equal accuracy. Statistical techniques have also been introduced to model the effects of varying C+G content in a continuous manner and to control overfitting of parameters for smaller training sets. AVAILABILITY: An academic implementation of GRPL, compiled for SUN workstations, is available by anonymous ftp from snipe.pharmacy. ualberta.ca/pub. The training and test sets used in this work, together with supplementary material, can be found at the same location. A commercial implementation is available as a component of GeneTool (BioTools Inc., http://biotools.com).

Algorithms↗

GASP: Gapped Ancestral Sequence Prediction for proteins.

BACKGROUND: The prediction of ancestral protein sequences from multiple sequence alignments is useful for many bioinformatics analyses. Predicting ancestral sequences is not a simple procedure and relies on accurate alignments and phylogenies. Several algorithms exist based on Maximum Parsimony or Maximum Likelihood methods but many current implementations are unable to process residues with gaps, which may represent insertion/deletion (indel) events or sequence fragments. RESULTS: Here we present a new algorithm, GASP (Gapped Ancestral Sequence Prediction), for predicting ancestral sequences from phylogenetic trees and the corresponding multiple sequence alignments. Alignments may be of any size and contain gaps. GASP first assigns the positions of gaps in the phylogeny before using a likelihood-based approach centred on amino acid substitution matrices to assign ancestral amino acids. Important outgroup information is used by first working down from the tips of the tree to the root, using descendant data only to assign probabilities, and then working back up from the root to the tips using descendant and outgroup data to make predictions. GASP was tested on a number of simulated datasets based on real phylogenies. Prediction accuracy for ungapped data was similar to three alternative algorithms tested, with GASP performing better in some cases and worse in others. Adding simple insertions and deletions to the simulated data did not have a detrimental effect on GASP accuracy. CONCLUSIONS: GASP (Gapped Ancestral Sequence Prediction) will predict ancestral sequences from multiple protein alignments of any size. Although not as accurate in all cases as some of the more sophisticated maximum likelihood approaches, it can process a wide range of input phylogenies and will predict ancestral sequences for gapped and ungapped residues alike.

Amino Acid Sequence↗

Rapid tests for group B Streptococcus colonization in laboring women: a systematic review.

OBJECTIVES: We set out to determine the accuracy and rapidity of various intrapartum group B Streptococcus (GBS) colonization tests. STUDY DESIGN: We performed a systematic review of test-accuracy studies, which were identified without language restriction from Medline and Cochrane databases; bibliographies of known primary and review articles; and contact with authors, experts, and manufacturers. Studies were selected if they tested pregnant women intrapartum for GBS colonization and confirmed by "gold-standard" laboratory cultures. Two reviewers independently selected studies and extracted data on their characteristics, quality, and results. Accuracy data were used to form 2 x 2 contingency tables. Heterogeneity was assessed, and LRs for positive and negative test results were pooled in subgroups of studies of various tests. RESULTS: There were 29 test-accuracy studies in 15,691 women, evaluating 6 different tests: polymerase chain reaction (PCR), optical immunoassay (OIA), DNA hybridization, enzyme immunoassay, latex agglutination, and Islam starch medium tests. The methodologic quality of the studies was generally poor. The most accurate was the real-time PCR test, but it was less rapid than OIA test. Real-time PCR took 40 minutes to complete, whereas the OIA took 30 minutes. CONCLUSIONS: Real-time PCR and OIA are candidates for rapid near patient intrapartum GBS testing to determine the need for antibiotic prophylaxis to prevent neonatal GBS disease. Before implementation in practice, a robust technology assessment of their accuracy, acceptability, and cost-effectiveness is required.

Adult↗