Dataset Information

The impact of antenatal syphilis point of care testing on pregnancy outcomes: A systematic review.

ABSTRACT:

Background

Mother-to-child transmission of syphilis remains a leading cause of neonatal death and stillbirth, disproportionally affecting women in low-resource settings where syphilis prevalence rates are high and testing rates low. Recently developed syphilis point-of-care tests (POCTs) are promising alternatives to conventional laboratory screening in low-resource settings as they do not require a laboratory setting, intensive technical training and yield results in 10-15 minutes thereby enabling both diagnosis and treatment in a single visit. Aim of this review was to provide clarity on the benefits of different POCTs and assess whether the implementation of syphilis POCTs is associated with decreased numbers of syphilis-related adverse pregnancy outcomes.

Methods

Following the PRISMA guidelines, three electronic databases (PubMed, Medline (Ovid), Cochrane) were systematically searched for intervention studies and cost-effectiveness analyses investigating the association between antenatal syphilis POCT and pregnancy outcomes such as congenital syphilis, low birth weight, prematurity, miscarriage, stillbirth as well as perinatal, fetal or infant death.

Results

Nine out of 278 initially identified articles were included, consisting of two clinical studies and seven modelling studies. Studies compared the effect on pregnancy outcomes of treponemal POCT, non-treponemal POCT and dual POCT to laboratory screening and no screening program. Based on the clinical studies, significantly higher testing and treatment rates, as well as a significant reduction (93%) in adverse pregnancy outcomes was reported for treponemal POCT compared to laboratory screening. Compared to no screening and laboratory screening, modelling studies assumed higher treatment rates for POCT and predicted the most prevented adverse pregnancy outcomes for treponemal POCT, followed by a dual treponemal and non-treponemal POCT strategy.

Conclusion

Implementation of treponemal POCT in low-resource settings increases syphilis testing and treatment rates and prevents the most syphilis-related adverse pregnancy outcomes compared to no screening, laboratory screening, non-treponemal POCT and dual POCT. Regarding the benefits of dual POCT, more research is needed. Overall, this review provides evidence on the contribution of treponemal POCT to healthier pregnancies and contributes greater clarity on the impact of diverse diagnostic methods available for the detection of syphilis.

SUBMITTER: Brandenburger D

PROVIDER: S-EPMC7993761 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveDespite an increase in the proportion of women who access antenatal care, mother-to-child transmission of syphilis continues to be a consequence of undiagnosed, untreated, or inadequately treated maternal syphilis. We reviewed evidence on the optimal timing of antenatal interventions to prevent mother-to-child transmission of syphilis and its associated adverse outcomes.DesignSystematic review and meta-analysis of published literature. English-language articles were included if they (1) reported the gestational age at which the mother was screened or tested for syphilis; (2) reported on pregnancy outcome. No publication date limits were set.ResultsWe identified a total of 1,199 publications, of which 84 were selected for further review and five were included. All showed a lower prevalence of any adverse outcome among women who received an intervention (to include screening and treatment) in the first and second trimesters of pregnancy compared to the third trimester. The overall odds ratio for any adverse outcome was 2.24 (95% CI 1.28, 3.93). All sub-analyses by type of outcome presented important heterogeneity between studies, except for those studies reporting an infected infant (odds ratio 2.92, 95% CI 0.66, 12.87; I(2)?=?48.2%, p?=?0.165).ConclusionsOur review has shown that the timing of antenatal care interventions makes a significant difference in the risk of having an adverse outcome due to syphilis. Women who sought care in the first two trimesters of their pregnancy, and received the appropriate intervention, were more likely to have a healthy infant, compared to women screened and treated in the third trimester. Encouraging ALL pregnant women to seek care in the first two trimesters of their pregnancy should be a priority for health programmes. For interventions to be effective within these health programmes, health systems and community engagement programmes need to be strengthened to enable pregnant women to seek antenatal care early.

Project description:BACKGROUND:Syphilis infection has been associated with an increased risk of HIV infection during pregnancy which poses greater risk for maternal mortality, and antenatal syphilis point-of-care (POC) testing has been introduced to improve maternal and child health outcomes. There is limited evidence on the impact of syphilis POC testing on maternal outcomes in high HIV prevalent settings. We used syphilis POC testing as a model to evaluate the impact of POC diagnostics on the improvement of maternal mortality in KwaZulu-Natal, South Africa. METHODS:We extracted 132 monthly data points on the number of maternal deaths in facilities and number of live births in facilities for 12 tertiary healthcare facilities in KwaZulu-Natal (KZN), South Africa from 2004 to 2014 from District Health Information System (DHIS) health facility archived. We employed segmented Poisson regression analysis of interrupted time series to assess the impact of the exposure on maternal mortality ratio (MMR) before and after the implementation of antenatal syphilis POC testing. We processed and analyzed data using Stata Statistical Software: Release 13. (Stata, Corp LP, College Station, TX, USA). RESULTS:The provincial average annual maternal mortality ratio (MMR) was estimated at 176.09 ± 43.92 ranging from a minimum of 68.48 to maximum of 225.49 per 100,000 live births. The data comprised 36 temporal points before the introduction of syphilis POC test exposure and 84 after the introduction in primary health care clinics in KZN. The average annual MMR for KZN from 2004 to 2014 was estimated at 176.09 ± 43.92. A decrease in MMR level was observed during 2008 after syphilis POC test implementation, followed by a rise during 2009. Analysis of the MMR trend estimates a significant 1.5% increase in MMR trends during the period before implementation and 1.3% increase after implementation of syphilis POC testing (p < 0.001). CONCLUSION:Although our finding suggests a brief reduction in the MMR trend after the implementation of antenatal syphilis POC testing, a continued increase in syphilis rates is seen in KwaZulu-Natal, South Africa. The study used one of the most powerful quasi-experimental research methods, segmented Poisson regression analysis of interrupted time series to model the impact of syphilis POC on maternal outcome. The study finding requires confirmation by use of more rigorous primary study design.

Project description:BackgroundUntreated syphilis in pregnancy is associated with adverse clinical outcomes for the infant. Most syphilis infections occur in sub-Saharan Africa (SSA), where coverage of antenatal screening for syphilis is inadequate. Recently introduced point-of-care syphilis tests have high accuracy and demonstrate potential to increase coverage of antenatal screening. However, country-specific cost-effectiveness data for these tests are limited. The objective of this analysis was to evaluate the cost-effectiveness and budget impact of antenatal syphilis screening for 43 countries in SSA and estimate the impact of universal screening on stillbirths, neonatal deaths, congenital syphilis, and disability-adjusted life years (DALYs) averted.Methods and findingsThe decision analytic model reflected the perspective of the national health care system and was based on the sensitivity (86%) and specificity (99%) reported for the immunochromatographic strip (ICS) test. Clinical outcomes of infants born to syphilis-infected mothers on the end points of stillbirth, neonatal death, and congenital syphilis were obtained from published sources. Treatment was assumed to consist of three injections of benzathine penicillin. Country-specific inputs included the antenatal prevalence of syphilis, annual number of live births, proportion of women with at least one antenatal care visit, per capita gross national income, and estimated hourly nurse wages. In all 43 sub-Saharan African countries analyzed, syphilis screening is highly cost-effective, with an average cost/DALY averted of US$11 (range: US$2-US$48). Screening remains highly cost-effective even if the average prevalence falls from the current rate of 3.1% (range: 0.6%-14.0%) to 0.038% (range: 0.002%-0.113%). Universal antenatal screening of pregnant women in clinics may reduce the annual number of stillbirths by up to 64,000, neonatal deaths by up to 25,000, and annual incidence of congenital syphilis by up to 32,000, and avert up to 2.6 million DALYs at an estimated annual direct medical cost of US$20.8 million.ConclusionsUse of ICS tests for antenatal syphilis screening is highly cost-effective in SSA. Substantial reduction in DALYs can be achieved at a relatively modest budget impact. In SSA, antenatal programs should expand access to syphilis screening using the ICS test. Please see later in the article for the Editors' Summary.

Project description:IntroductionThere is limited access to life-saving antenatal ultrasound in rural and low-resource settings largely due to shortages in skilled staff. Studies have shown healthcare practitioners can be upskilled in PoCUS through focused training, offering a viable solution to this deficit. However, standards for training and competency assessment are unclear and regulation surrounding practice is lacking. We aimed to review published literature examining antenatal PoCUS training programs, comparing teaching approaches and study methodologies.MethodsA search of electronic databases EMBASE, MEDLINE and Google Scholar was conducted. Original research articles evaluating antenatal PoCUS training of healthcare professionals worldwide were identified for analysis. Articles with limited detail on the PoCUS training intervention and those describing comprehensive diagnostic training programs were excluded. Evaluations were compared against the Kirkpatrick Evaluation Framework (KEF).ResultsTwenty-seven studies were included from an initial search result of 484 articles. There was considerable heterogeneity between the PoCUS training programs described. Course duration ranged from 3 hours to 2 years, with 11 of the 27 studies delivering obstetric-exclusive content. 44% trained multidisciplinary groups of health professionals. Long-term follow-up training and skills assessments were lacking in over half of the reviewed studies. Study quality and reporting detail varied, but overall beneficial outcomes were reported with 3/4s of the studies reaching upper KEF levels 3 and 4.ConclusionPoCUS performed by upskilled healthcare professionals offers an attractive solution to the problem of inequitable access to antenatal ultrasound. A review of available literature highlighted a paucity of comparable high-quality studies needed to establish a stronger evidence base for antenatal PoCUS, and a need to standardise training and competency assessment. This review may inform educators, researchers and policy-makers on existing training formats and methodologies to assist in establishing best practice antenatal PoCUS training methods for safe service delivery by remote healthcare professionals.

Project description:BackgroundIn sub-Saharan Africa, HIV, syphilis, malaria and anaemia are leading preventable causes of adverse pregnancy outcomes. In Kenya, policy states women should be tested for all four conditions (malaria only if febrile) at first antenatal care (ANC) visit. In practice, while HIV screening is conducted, coverage of screening for the others is suboptimal and early pregnancy management of illnesses is compromised. This is particularly evident at rural dispensaries that lack laboratories and have parallel programmes for HIV, reproductive health and malaria, resulting in fractured and inadequate care for women.MethodsA longitudinal eight-month implementation study integrating point-of-care diagnostic tests for the four conditions into routine ANC was conducted in seven purposively selected dispensaries in western Kenya. Testing proficiency of healthcare workers was observed at initial training and at three monthly intervals thereafter. Adoption of testing was compared using ANC register data 8.5 months before and eight months during the intervention. Fidelity to clinical management guidelines was determined by client exit interviews with success defined as ≥90% adherence.FindingsFor first ANC visits at baseline (n = 529), testing rates were unavailable for malaria, low for syphilis (4.3%) and anaemia (27.8%), and near universal for HIV (99%). During intervention, over 95% of first attendees (n = 586) completed four tests and of those tested positive, 70.6% received penicillin or erythromycin for syphilis, 65.5% and 48.3% received cotrimoxazole and antiretrovirals respectively for HIV, and 76.4% received artemether/lumefantrine, quinine or dihydroartemisinin-piperaquine correctly for malaria. Iron and folic supplements were given to nearly 90% of women but often at incorrect doses.ConclusionsIntegrating point-of-care testing into ANC at dispensaries with established HIV testing programmes resulted in a significant increase in testing rates, without disturbing HIV testing rates. While more cases were detected and treated, treatment fidelity still requires strengthening and an integrated monitoring and evaluation system needs to be established.

Project description:Untreated syphilis in pregnancy is associated with adverse clinical outcomes to the infant. In low- and middle-income countries in Asia and Latin America, 20%-30% of women are not tested for syphilis during pregnancy. We evaluated the cost-effectiveness of increasing the coverage for antenatal syphilis screening in 11 Asian and 20 Latin American countries, using a point-of-care immunochromatographic strip (ICS) test.The decision analytical cost-effectiveness models reported incremental costs per disability-adjusted life years (DALYs) averted from the perspectives of the national health care payer. Clinical outcomes were stillbirths, neonatal deaths, and congenital syphilis. DALYs were computed using WHO disability weights. Costs included the ICS test, three injections of benzathine penicillin, and nurse wages. Country-specific inputs included the antenatal prevalence of syphilis and the proportion of women in the antenatal care setting that are screened for syphilis infection as reported in the 2014 WHO baseline report on global sexually transmitted infection surveillance. Country-specific data on the annual number of live births, proportion of women with at least one antenatal care visit, and per capita gross national income were also included in the model.The incremental cost/DALY averted of syphilis screening is US$53 (range: US$10-US$332; Prob<1*per capita GDP=99.71%) in Asia and US$60 (range: US$5-US$225; Prob<1*per capita GDP=99.77%) in Latin America. Universal screening may reduce the annual number of stillbirths by 20,344 and 4,270, neonatal deaths by 8,201 and 1,721, cases of congenital syphilis by 10,952 and 2,298, and avert 925,039 and 197,454 DALYs in the aggregate Asian and Latin American panel, respectively.Antenatal syphilis screening is highly cost-effective in all the 11 Asian and 20 Latin American countries assessed. Our findings support the decision to expand syphilis screening in countries with currently low screening rates or continue national syphilis screening programs in countries with high rates.

Project description:ObjectivePoint-of-care testing (POCT) has become an essential diagnostic technology for optimal patient care. Its implementation, however, still falls behind. This paper reviews the available evidence on the health economic impact of introducing POCT to assess if poor POCT uptake may be related to lacking evidence.Study designThe Scopus and PubMed databases were searched to identify publications describing a health economic evaluation of a point-of-care (POC) test. Data were extracted from the included publications, including general and methodological characteristics as well as the study results summarized in either cost, effects or an incremental cost-effectiveness ratio. Results were sorted into six groups according to the POC test's purpose (diagnosis, screening or monitoring) and care setting (primary care or secondary care). The reporting quality of the publications was determined using the CHEERS checklist.ResultsThe initial search resulted in 396 publications, of which 44 met the inclusion criteria. Most of the evaluations were performed in a primary care setting (n = 31; 70.5%) compared with a secondary care setting (n = 13; 29.5%). About two thirds of the evaluations were on POC tests implemented with a diagnostic purpose (n = 28; 63.6%). More than 75% of evaluations concluded that POCT is recommended for implementation, although in some cases only under specific circumstances and conditions. Compliance with the CHEERS checklist items ranged from 20.8% to 100%, with an average reporting quality of 72.0%.ConclusionThere were very few evaluations in this review that advised against the implementation of POCT. However, the uptake of POCT in many countries remains low. Even though the evaluations included in this review did not always include the full long-term benefits of POCT, it is clear that health economic evidence across a few dimensions of value already indicate the benefits of POCT. This suggests that the lack of evidence on POCT is not the primary barrier to its implementation and that the low uptake of these tests in clinical practice is due to (a combination of) other barriers. In this context, aspects around organization of care, support of clinicians and quality management may be crucial in the widespread implementation of POCT.

Project description:Maternal syphilis results in an estimated 500,000 stillbirths and neonatal deaths annually in Sub-Saharan Africa. Despite the existence of national guidelines for antenatal syphilis screening, syphilis testing is often limited by inadequate laboratory and staff services. Recent availability of inexpensive rapid point-of-care syphilis tests (RST) can improve access to antenatal syphilis screening. A 2010 pilot in Zambia explored the feasibility of integrating RST within prevention of mother-to-child-transmission of HIV services. Following successful demonstration, the Zambian Ministry of Health adopted RSTs into national policy in 2011. Cost data from the pilot and 2012 preliminary national rollout were extracted from project records, antenatal registers, clinic staff interviews, and facility observations, with the aim of assessing the cost and quality implications of scaling up a successful pilot into a national rollout. Start-up, capital, and recurrent cost inputs were collected, including costs of extensive supervision and quality monitoring during the pilot. Costs were analysed from a provider's perspective, incremental to existing antenatal services. Total and unit costs were calculated and a multivariate sensitivity analysis was performed. Our accompanying qualitative study by Ansbro et al. (2015) elucidated quality assurance and supervisory system challenges experienced during rollout, which helped explain key cost drivers. The average unit cost per woman screened during rollout ($11.16) was more than triple the pilot unit cost ($3.19). While quality assurance costs were much lower during rollout, the increased unit costs can be attributed to several factors, including higher RST prices and lower RST coverage during rollout, which reduced economies of scale. Pilot and rollout cost drivers differed due to implementation decisions related to training, supervision, and quality assurance. This study explored the cost of integrating RST into antenatal care in pilot and national rollout settings, and highlighted important differences in costs that may be observed when moving from pilot to scale-up.