Julie Gutman - Academia.edu (original) (raw)

Papers by Julie Gutman

Journal of Travel Medicine, Dec 13, 2018

Background: Malaria during pregnancy increases the risk of maternal and foetal complications. The... more Background: Malaria during pregnancy increases the risk of maternal and foetal complications. There are very limited options for prophylaxis in pregnant travellers. Atovaquone-Proguanil (AP or Malarone ®) is an effective and well-tolerated antimalarial medication, but is not recommended for use in pregnancy due to limited data on safety. Passively reported adverse event data may provide additional information on the safety of AP during pregnancy. Methods: We analysed adverse event data on pregnancy and birth outcomes following accidental exposures to AP during pregnancy, which were passively reported to GlaxoSmithKline LLC (GSK) between 13 May 1997 and 15 August 2017. Birth outcomes of interest included live birth, miscarriage, and stillbirth. Adverse outcomes of interest were defined as any of the following: small for gestational age (SGA), low birth weight (LBW, <2500 gm), congenital anomalies, and a composite 'poor live birth outcome,' including preterm birth (PTB), LBW or SGA. Results: Among 198 women who received AP during pregnancy or breastfeeding, 96.5% occurred in women taking malaria prophylaxis, and 79.8% of exposures occurred in the first trimester. Among 195 with available birth outcome data, 18.5% resulted in miscarriage and 11.8% were elective terminations. Available adverse outcomes included SGA in 3.5% (3/85), LBW in 7.0% of infants (6/86), and the composite 'poor live birth outcome' in 13.7% (14/102). Congenital anomalies were reported in 30/124 (24.2%), with no specific pattern to suggest an effect related to AP. Conclusions: These data provide a description of outcomes in the pregnancies reported to this dataset, and it should be noted that there is likely a bias towards reporting cases resulting in poor outcomes. While there was no specific signal to suggest a teratogenic effect of AP, AP data during pregnancy were too limited to determine AP's safety with confidence. As inadvertent exposures are not infrequent, better data are needed.

Zenodo (CERN European Organization for Nuclear Research), May 10, 2022

Zenodo (CERN European Organization for Nuclear Research), May 18, 2022

Systematic reviews, background papers and other unpublished evidence considered in the developmen... more Systematic reviews, background papers and other unpublished evidence considered in the development of recommendations Prevention/Preventive chemotherapies Section 4.2. 1 Intermittent preventive treatment of malaria in pregnancy (IPTp). In WHO Guidelines for malaria, 3 June 2022.

Zenodo (CERN European Organization for Nuclear Research), May 18, 2022

Systematic reviews, background papers and other unpublished evidence considered in the developmen... more Systematic reviews, background papers and other unpublished evidence considered in the development of recommendations Prevention/Preventive chemotherapies Section 4.2.4 Intermittent preventive treatment of malaria in school-aged children (IPTsc). In WHO Guidelines for malaria, 3 June 2022.

Research Square (Research Square), Aug 5, 2020

Background Malaria in pregnancy is responsible for 8-14% of low birth weight and 20% of stillbirt... more Background Malaria in pregnancy is responsible for 8-14% of low birth weight and 20% of stillbirths in sub-Saharan Africa. To prevent these adverse consequences, the World Health Organization recommends intermittent preventive treatment of pregnant women (IPTp) with sulfadoxine-pyrimethamine be administered at each ANC visit starting as early as possible in the second trimester. Global IPTp coverage in targeted countries remains unacceptably low. Community delivery of IPTp was explored as a means to improve coverage. Methods A cluster randomized, controlled trial was conducted in 12 health facilities in a 1:1 ratio to either an intervention group (IPTp delivered by CHWs) or a control group (standard practice, with IPTp delivered at HFs) in three districts of Burkina Faso to assess the effect of IPTp administration by community health workers (CHWs) on the coverage of IPTp and antenatal care (ANC). The districts and facilities were purposively selected taking into account malaria epidemiology, IPTp coverage, and the presence of active CHWs. Pre-and post-intervention surveys were carried out in March 2017 and July-August 2018, respectively. A difference in differences (DiD) analysis was conducted to assess the change in coverage of IPTp and ANC over time, accounting for clustering at the health facility level. Results Altogether 374 and 360 women were included in the baseline and endline surveys, respectively. At baseline, women received a median of 2.1 doses; by endline, women received a median of 1.8 doses in the

Journal of Clinical Microbiology, Aug 1, 2018

In the United States, the gold standard for malaria diagnosis is microscopic blood smear examinat... more In the United States, the gold standard for malaria diagnosis is microscopic blood smear examination. Because malaria is not endemic in the United States, diagnostic capabilities may be limited, causing delays in diagnosis and increased morbidity and mortality. A survey of the malaria diagnostic practices of U.S. laboratories was conducted from June to July 2017; members of the American Society for Microbiology's listserv received a questionnaire inquiring about malaria diagnostic test availability, techniques, and reporting. Results were assessed using the Clinical and Laboratory Standards Institute (CLSI) guidelines for malaria diagnostics. After excluding incomplete and duplicate responses, responses representing 175 laboratories were included. Most labs (99%) received at least one specimen annually for malaria diagnosis, and 31% reported receiving only 1 to 10 specimens. The majority (74%) diagnosed five or fewer cases of malaria per year. Most (90%) performed blood smears on-site. Two-thirds (70%) provided initial blood smear results within 4 h. Although diagnostic testing for malaria was available 24/7 at 74% (141) of responding laboratories, only 12% (17) met criteria for analysis and reporting of malaria testing, significantly more than reported in a similar survey in 2010 (3%; P Ͻ 0.05). The majority of laboratories surveyed had the capability for timely diagnosis of malaria; few comply with CLSI guidelines. Inexperience may factor into this noncompliance; many laboratories see few to no cases of malaria per year. Although reported adherence to CLSI guidelines was higher than in 2010, there is a need to further improve laboratory compliance with recommendations. KEYWORDS malaria, diagnostic testing, United States, CLSI guidelines I n 2016, there were an estimated 216 million cases of malaria, with 445,000 deaths globally (1). Malaria is endemic in 91 countries, and it continues to be a leading cause of morbidity and mortality worldwide (1). An estimated 74 million U.S. travelers departed for international destinations in 2015 (2), and up to four million will develop illnesses that are severe enough to prompt care seeking during or after their trip (3). Nearly one-quarter of travelers develop a febrile illness and of those, nearly one-third were diagnosed with malaria (4). In the United States, 1,500 to 1,900 imported cases of malaria are reported to the Centers for Disease Control and Prevention (CDC) annually, with 1,517 cases reported in 2015 (5-11). Between 2010 and 2015, a total of 46 fatalities due to malaria occurred in the United States (5-11). Diagnostic delays potentially contributed to 18 of these deaths, highlighting the need for prompt and accurate diagnosis and timely treatment (6-12). Up to 92% of patients presenting to physicians without expertise in tropical medicine

Research Square (Research Square), Jun 16, 2023

Background Concerns about emerging resistance to artemether-lumefantrine (AL) in Africa prompted ... more Background Concerns about emerging resistance to artemether-lumefantrine (AL) in Africa prompted the pilot introduction of multiple rst-line therapies (MFT) in Western Kenya, potentially exposing women-ofchildbearing-age (WOCBA) to antimalarials with unknown safety pro les in the rst trimester. We assessed healthcare provider knowledge and adherence to national guidelines for managing malaria in pregnancy in the context of the MFT pilot. Methods From March to April 2022, we conducted a cross-sectional study in 50 health facilities (HF) and 40 drug outlets (DO) using structured questionnaires to assess pregnancy detection, malaria diagnosis, and treatment choices by trimester. Differences between HF and DO providers and between MFT and non-MFT HFs were assessed using Chi-square tests. Results Of 174 providers (77% HF, 23% DO), 56% were from MFT pilot facilities. Most providers had tertiary education; 5% HF and 20% DO had only primary or secondary education. More HF than DO providers had knowledge of malaria treatment guidelines (62% vs 40%, p=0.023), received training in malaria in pregnancy (49% vs 20%, p=0.002), and reported assessing for pregnancy in WOCBA (98% vs 78%, p<0.001). Most providers insisted on parasitological diagnosis, with 59% HF using microscopy and 85% DO using rapid diagnostic tests. More HF than DO providers could correctly name the drugs for treating uncomplicated malaria in the rst trimester (oral quinine, or AL if quinine is unavailable) (90% vs 58%, p<0.001), second and third trimesters (artemisinin-based combination therapies) (84% vs 70%, p=0.07), and for severe malaria (parenteral artesunate/artemether) (94% vs 60%, p<0.001). Among HF providers, those in the MFT pilot had more knowledge of malaria treatment guidelines (67% vs 49%, p=0.08) and had received training on treatment of malaria in pregnancy (56% vs 32%, p=0.03). Few providers (10% HF and 12% DO) had adequate knowledge of malaria treatment in pregnancy, de ned as the correct drug and dose for uncomplicated and severe malaria in all trimesters. Conclusions Knowledge of national malaria in pregnancy treatment guidelines among providers in western Kenya is suboptimal. Robust training on appropriate antimalarial and dosage is needed. Supervision of DO and HF practices is essential for correct treatment of malaria in pregnancy in the context of MFT programmes. Background Malaria remains a signi cant public health challenge and a major cause of morbidity and mortality. In 2021, 247 million cases were reported, with 89% of all pregnancies in the World Health Organization

Zenodo (CERN European Organization for Nuclear Research), May 18, 2022

Systematic reviews, background papers and other unpublished evidence considered in the developmen... more Systematic reviews, background papers and other unpublished evidence considered in the development of recommendations Prevention/Preventive chemotherapies Section 4.2.5 Post-discharge malaria chemoprevention (PDMC). In WHO Guidelines for malaria, 3 June 2022. Title AMSTAR2 review of post-discharge malaria chemoprevention in children admitted with severe anaemia in malaria-endemic settings in Africa: a systematic review and meta-analysis

Zenodo (CERN European Organization for Nuclear Research), May 18, 2022

Systematic reviews, background papers and other unpublished evidence considered in the developmen... more Systematic reviews, background papers and other unpublished evidence considered in the development of recommendations Prevention/Preventive chemotherapies Section 4.2.1 Intermittent preventive treatment of malaria in pregnancy (IPTp). In WHO Guidelines for malaria, 3 June 2022.

Zenodo (CERN European Organization for Nuclear Research), May 18, 2022

Systematic reviews, background papers and other unpublished evidence considered in the developmen... more Systematic reviews, background papers and other unpublished evidence considered in the development of recommendations Prevention/Preventive chemotherapies Section 4.2.4 Intermittent preventive treatment of malaria in school-aged children (IPTsc). In WHO Guidelines for malaria, 3 June 2022.

Zenodo (CERN European Organization for Nuclear Research), May 10, 2022

Journal of Travel Medicine, May 18, 2020

Pregnant travelers face numerous risks, notably increased susceptibility to or severity of multip... more Pregnant travelers face numerous risks, notably increased susceptibility to or severity of multiple infections, including malaria. Because pregnant women residing in areas non-endemic for malaria are unlikely to have protective immunity, travel to endemic areas poses risk of severe illness and pregnancy complications, such as low birthweight and fetal loss. If travel to malaria endemic areas cannot be avoided, preventive measures are critical. However, malaria chemoprophylaxis in pregnancy can be challenging, since commonly used regimens have varying levels of safety data, and national guidelines differ. Furthermore, although chloroquine

Scientific Reports, Jun 26, 2023

In areas of moderate to intense Plasmodium falciparum transmission, malaria in pregnancy remains ... more In areas of moderate to intense Plasmodium falciparum transmission, malaria in pregnancy remains a significant cause of low birth weight, stillbirth, and severe anaemia. Previously, fetal sex has been identified to modify the risks of maternal asthma, pre-eclampsia, and gestational diabetes. One study demonstrated increased risk of placental malaria in women carrying a female fetus. We investigated the association between fetal sex and malaria in pregnancy in 11 pregnancy studies conducted in sub-Saharan African countries and Papua New Guinea through meta-analysis using log binomial regression fitted to a random-effects model. Malaria infection during pregnancy and delivery was assessed using light microscopy, polymerase chain reaction, and histology. Five studies were observational studies and six were randomised controlled trials. Studies varied in terms of gravidity, gestational age at antenatal enrolment and bed net use. Presence of a female fetus was associated with malaria infection at enrolment by light microscopy (risk ratio 1.14 [95% confidence interval 1.04, 1.24]; P = 0.003; n = 11,729). Fetal sex did not associate with malaria infection when other time points or diagnostic

Research Square (Research Square), Apr 28, 2023

Background Emergence of Plasmodium falciparum resistance to artemether-lumefantrine in Africa pro... more Background Emergence of Plasmodium falciparum resistance to artemether-lumefantrine in Africa prompted the pilot introduction of multiple rst-line therapies (MFT) against malaria in Kenya, potentially exposing women-of-childbearing-age (WOCBAs) to antimalarials with unknown safety pro les in the rst trimester. We undertook a qualitative study to explore knowledge and perceptions among healthcare providers providing malaria treatment to WOCBAs and pregnant women. Methods In-depth interviews were conducted with purposively selected public and private health facility (HF) and drug outlet (DO) providers within and outside the pilot-MFT area. County health managers were interviewed about their knowledge of the national treatment guidelines. Transcripts were coded by content analysis using the WHO health system building blocks (leadership/governance, nancing, health workforce, health information systems, access to medicines, and service delivery). Results Thirty providers (HF:21, DO:9) and three health managers were interviewed. Eighteen providers were from HFs in the pilot-MFT area; the remaining three and all nine DOs were outside the pilot-MFT area. The analysis revealed that providers had not been trained in malaria case management in the previous twelve months. DO providers were unfamiliar with national treatment guidelines in pregnancy and reported having no pregnancy tests. Health managers were unable to supervise DOs due to resource limitations. Providers from HFs and DOs noted poor sensitivity of malaria rapid diagnostic tests (RDTs) and hesitancy among patients who associated malaria-RDTs with HIV testing. Almost all providers reported antimalarial stock-outs, with quinine most affected. Patient preference was a major factor in prescribing antimalarials. Providers in HFs and DOs reported preferentially using artemether-lumefantrine in the rst trimester due to the side effects and unavailability of quinine. Conclusion Knowledge of malaria case management in drug outlets and health facilities remains poor. Improved regulation of DO providers is warranted. Optimising treatment of malaria in pregnancy requires training, availability of malaria commodities, and pregnancy tests. women in early pregnancy to the newer generation of ACTs not yet recommended for use in the rst trimester because WOCBA are not routinely screened for pregnancy and don't know or don't report they are pregnant, and are therefore treated with the same drugs used in non-pregnant adults. In addition, in 2021, a prospective, observational study (MiMBa pregnancy registry) was launched in Homa Bay to generate more evidence on the safety of the other ACTs used in the MFT pilot, including pyronaridine-artesunate, dihydroartemisinin-piperaquine, amodiaquineartesunate (Clinical trials registration NCT04825782). We undertook a qualitative study to explore knowledge and perceptions among healthcare providers providing malaria treatment to WOCBA and pregnant women to determine awareness of malaria diagnosis and treatment regimens in different trimesters in the context of the Kenyan Ministry of Health MFT pilot in western Kenya. Methods Study sites The study was conducted from March to April 2022 in Homa Bay County in western Kenya, located along the shores of Lake Victoria. Malaria transmission is perennial and holo-endemic, with peaks following the two rainy seasons, March through May and October through December. In collaboration with private partners, the government piloted a rotational MFT project in all government and not-for-pro t health facilities in the

Malaria Journal, Jun 21, 2022

Background: Malaria in pregnancy doubles the risk of low birthweight; up to 11% of all neonatal d... more Background: Malaria in pregnancy doubles the risk of low birthweight; up to 11% of all neonatal deaths in sub-Saharan Africa are associated with malaria in pregnancy. To prevent these and other adverse health consequences, the World Health Organization recommends administering intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine for all pregnant women at each antenatal care (ANC) visit, starting as early as possible in the second trimester. The target is for countries to administer a minimum of three doses (IPTp3+) to at least 85% of pregnant women. Methods: A cluster randomized, controlled trial was conducted to assess the effect of delivery of IPTp by community health workers on the coverage of IPTp3 + and ANC visits in Malawi. Community delivery of IPTp was implemented within two districts in Malawi over a 21-month period, from November 2018 to July 2020. In control sites, IPTp was delivered at health facilities. Representative samples of women who delivered in the prior 12 months were surveyed at baseline (n = 370, December 2017) and endline (n = 687, August 2020). A difference in differences analysis was conducted to assess the change in coverage of IPTp and ANC over time, accounting for clustering at the health facility level. Results: Overall IPTp coverage increased over the study period. At baseline, women received a mean of 2.3 IPTp doses (range 0-5 doses) across both arms, and at endline, women received a mean of 2.8 doses (range 0-9 doses). Despite overall increases, the change in IPTp3 + coverage was not significantly different between intervention and control groups (6.9%, 95% CI:-5.9%, 19.6%). ANC4 + coverage increased significantly in the intervention group compared with the control group, with a difference-indifferences of 25.3% points (95% CI: 1.3%, 49.3%). Conclusions: In order to reduce the burden of malaria in pregnancy, new strategies are needed to improve uptake of effective interventions such as IPTp. While community health workers' delivery of IPTp did not increase uptake in this study, they may be effective in other settings or circumstances. Further research can help identify the health systems

Malaria Journal, May 15, 2018

Background: Malaria chemoprophylaxis options in pregnancy are limited, and atovaquone-proguanil (... more Background: Malaria chemoprophylaxis options in pregnancy are limited, and atovaquone-proguanil (AP) is not recommended because of insufficient safety evidence. An anonymous, internet-based survey was disseminated to describe outcomes of pregnancies accidentally exposed to AP. Outcomes of interest included miscarriage (defined as pregnancy loss before 20 weeks), stillbirth (defined as pregnancy loss at or after 20 weeks), preterm birth or live birth prior to 37 weeks, and the presence of congenital anomalies. Results: A total of 487 women responded and reported on 822 pregnancies. Of the 807 pregnancies with information available on exposure and outcomes, 10 (1.2%) had atovaquone-proguanil exposure, all in the first trimester, and all resulted in term births with no birth defects. Conclusions: Use of an anti-malarial not recommended in pregnancy is likely to occur before the woman knows of her pregnancy. This study adds to the limited evidence of the safety of AP in pregnancy. Further study on use of AP in pregnancy should be a high priority, as an alternative option for the prevention of malaria in pregnancy in nonimmune travellers is urgently needed.

Travel Medicine and Infectious Disease, 2019

Background:Malaria infection poses a significant risk in pregnancy, yet chemoprophylaxis for preg... more Background:Malaria infection poses a significant risk in pregnancy, yet chemoprophylaxis for pregnant women is limited. A systematic review was conducted to evaluate the incidence of adverse outcomes after atovaquone-proguanil (AP) exposure during pregnancy.Methods:Following PRISMA guidelines, the authors searched PubMed, MEDLINE, and the Malaria in Pregnancy Consortium Library to identify relevant literature including infant outcomes after exposure to atovaquone, proguanil, or AP in pregnancy. Two authors independently screened the titles, abstracts, and full texts, and extracted data into an EpiInfo database. Overall proportions and 95% confidence intervals of adverse outcomes were determined by pooling data across studies.Results:Of 455 records identified, 16 studies were included: ten AP studies and six proguanil studies. The overall proportions and 95% confidence intervals (CI) of adverse outcomes reported for the 446 women exposed to AP include miscarriage (8.08% CI: 5.07, 12.08%), stillbirth (1.05% CI: 0.03, 5.73%), early neonatal death (0% CI: 0, 7.4%), and congenital anomalies (2.56% CI: 1.28, 4.53%).Conclusions:The limited available data suggest that outcomes following AP exposure during pregnancy are similar to expected rates in similar populations. AP may be a promising option for pregnant women, but further data are needed on its safety in pregnancy.

Research Square (Research Square), Apr 13, 2020

Background The World Health Organization recommends three or more doses of intermittent preventiv... more Background The World Health Organization recommends three or more doses of intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP) to mitigate the negative effects of malaria in pregnancy (MIP). Many pregnant women in Malawi are not receiving the recommended number of doses. Community delivery of IPTp (cIPTp) is being piloted as a new approach to increase coverage. This survey assessed recently pregnant women's knowledge of MIP and their experiences with community health workers (CHWs) prior to implementing cIPTp. Methods Data were collected via a household survey in Ntcheu and Nkhata Bay Districts, Malawi, from women aged 16-49 years who had a pregnancy resulting in a live birth in the previous 12 months. Survey questions were primarily open response and utilized review of the woman's health passport whenever possible. Analyses accounted for selection weighting and clustering at the health facility level and explored heterogeneity between districts. Results A total of 370 women were interviewed. Women in both districts found their CHWs to be helpful (77.9%), but only 35.7% spoke with a CHW about antenatal care and 25.8% received assistance for malaria during their most recent pregnancy. A greater proportion of women in Nkhata Bay than Ntcheu reported receiving assistance with malaria from a CHW (42.7% vs 21.9%, p=0.01); women in Nkhata Bay were more likely to cite IPTp-SP as a way to prevent MIP (41.0% vs 24.8%, p=0.02) and were more likely to cite mosquito bites as the only way to spread malaria (70.6% vs 62.0% p=.03). Women in Nkhata Bay were more likely to receive 3+ doses of IPTp-SP (IPTp3) (59.2% vs 41.8%, p=0.0002). Adequate knowledge was associated with increased odds of receiving IPTp3, although not statistically significantly so (adjusted odds ratio = 1.50, 95% confidence interval 0.97-2.32, p-value 0.066). Conclusions Women reported positive experiences with CHWs, but there was not a focus on MIP. Women in Nkhata Bay were more likely to be assisted by a CHW, had better knowledge, and were more likely to receive IPTp3+. Increasing CHW focus on the dangers of MIP and implementing cIPTp has the potential to increase IPTp coverage.

Journal of Travel Medicine, Dec 13, 2018

Zenodo (CERN European Organization for Nuclear Research), May 10, 2022

Zenodo (CERN European Organization for Nuclear Research), May 18, 2022

Systematic reviews, background papers and other unpublished evidence considered in the developmen... more Systematic reviews, background papers and other unpublished evidence considered in the development of recommendations Prevention/Preventive chemotherapies Section 4.2.4 Intermittent preventive treatment of malaria in school-aged children (IPTsc). In WHO Guidelines for malaria, 3 June 2022.

Research Square (Research Square), Aug 5, 2020

Journal of Clinical Microbiology, Aug 1, 2018

Research Square (Research Square), Jun 16, 2023

Zenodo (CERN European Organization for Nuclear Research), May 18, 2022

Systematic reviews, background papers and other unpublished evidence considered in the developmen... more Systematic reviews, background papers and other unpublished evidence considered in the development of recommendations Prevention/Preventive chemotherapies Section 4.2.5 Post-discharge malaria chemoprevention (PDMC). In WHO Guidelines for malaria, 3 June 2022. Title AMSTAR2 review of post-discharge malaria chemoprevention in children admitted with severe anaemia in malaria-endemic settings in Africa: a systematic review and meta-analysis

Zenodo (CERN European Organization for Nuclear Research), May 18, 2022

Systematic reviews, background papers and other unpublished evidence considered in the developmen... more Systematic reviews, background papers and other unpublished evidence considered in the development of recommendations Prevention/Preventive chemotherapies Section 4.2.1 Intermittent preventive treatment of malaria in pregnancy (IPTp). In WHO Guidelines for malaria, 3 June 2022.

Zenodo (CERN European Organization for Nuclear Research), May 18, 2022

Systematic reviews, background papers and other unpublished evidence considered in the developmen... more Systematic reviews, background papers and other unpublished evidence considered in the development of recommendations Prevention/Preventive chemotherapies Section 4.2.4 Intermittent preventive treatment of malaria in school-aged children (IPTsc). In WHO Guidelines for malaria, 3 June 2022.

Zenodo (CERN European Organization for Nuclear Research), May 10, 2022

Journal of Travel Medicine, May 18, 2020

Scientific Reports, Jun 26, 2023

Research Square (Research Square), Apr 28, 2023

Malaria Journal, Jun 21, 2022

Malaria Journal, May 15, 2018

Travel Medicine and Infectious Disease, 2019

Research Square (Research Square), Apr 13, 2020