The Australian Health Care Homes trial: quality of care and patient outcomes. A propensity score-matched cohort study.

OBJECTIVE: To assess the impact of the Health Care Homes (HCH) primary health care initiative on quality of care and patient outcomes. DESIGN, SETTING: Quasi-experimental, matched cohort study; analysis of general practice data extracts and linked administrative data from ten Australian primary health networks, 1 October 2017 - 30 June 2021. PARTICIPANTS: People with chronic health conditions (practice data extracts: 9811; linked administrative data: 10 682) enrolled in the HCH 1 October 2017 - 30 June 2019; comparison groups of patients receiving usual care (1:1 propensity score-matched). INTERVENTION: Participants were involved in shared care planning, provided enhanced access to team care, and encouraged to seek chronic condition care at the HCH practice where they were enrolled. Participating practices received bundled payments based on clinical risk tier. MAIN OUTCOME MEASURES: Access to care, processes of care, diabetes-related outcomes, hospital service use, risk of death. RESULTS: During the first twelve months after enrolment, the mean numbers of general practitioner encounters (rate ratio, 1.14; 95% confidence interval [CI], 1.11-1.17) and Medicare Benefits Schedule claims for allied health services (rate ratio, 1.28; 95% CI, 1.24-1.33) were higher for the HCH than the usual care group. Annual influenza vaccinations (relative risk, 1.20; 95% CI, 1.17-1.22) and measurements of blood pressure (relative risk, 1.09; 95% CI, 1.08-1.11), blood lipids (relative risk, 1.19; 95% CI, 1.16-1.21), glycated haemoglobin (relative risk, 1.06; 95% CI, 1.03-1.08), and kidney function (relative risk, 1.13; 95% CI, 1.11-1.15) were more likely in the HCH than the usual care group during the twelve months after enrolment. Similar rate ratios and relative risks applied in the second year. The numbers of emergency department presentations (rate ratio, 1.09; 95% CI, 1.02-1.18) and emergency admissions (rate ratio, 1.13; 95% CI, 1.04-1.22) were higher for the HCH group during the first year; other differences in hospital use were not statistically significant. Differences in glycaemic and blood pressure control in people with diabetes in the second year were not statistically significant. By 30 June 2021, 689 people in the HCH group (6.5%) and 646 in the usual care group (6.1%) had died (hazard ratio, 1.07; 95% CI, 0.96-1.20). CONCLUSIONS: The HCH program was associated with greater access to care and improved processes of care for people with chronic diseases, but not changes in diabetes-related outcomes, most measures of hospital use, or risk of death.

Triple burden of malnutrition among Vietnamese 0·5-11-year-old children in 2020-2021: results of SEANUTS II Vietnam.

OBJECTIVE: SEANUTS II Vietnam aims to obtain an in-depth understanding of the nutritional status and nutrient intake of children between 0.5-11.9 years old. DESIGN: Cross-sectional survey. SETTING: A multistage cluster systematic random sampling method was implemented in different regions in Vietnam: North Mountainous, Central Highlands, Red River Delta, North Central and Coastal Area, Southeast and Mekong River Delta. PARTICIPANTS: 4001 children between 6 months and 11.9 years of age. RESULTS: Prevalence of stunting and underweight was higher in rural than in urban children, whereas overweight and obese rates were higher in urban areas. 12.0% of the children had anemia and especially children 0.5-1-year-old were affected (38.6%). Low serum retinol was found in 6.2% of children ≥ 4 years old. Prevalence of vitamin D insufficiency was 31.1% while 60.8% had low serum zinc. For nutrient intake, overall, 80.1% of the children did not meet the estimated energy requirements. For calcium intake, ∼60% of the younger children did not meet the RNI while it was 92.6% in children >7 years old. For vitamin D intake, 95.0% of the children did not meet RNI. CONCLUSIONS: SEANUTS II Vietnam indicated that overnutrition was more prevalent than undernutrition in urban areas, while undernutrition was found more in rural areas. The high prevalence of low serum zinc, vitamin D insufficiency and the inadequate intakes of calcium and vitamin D are of concern. Nutrition strategies for Vietnamese children should consider three sides of malnutrition and focus on approaches for the prevention malnutrition.

Elective spinal surgery in New South Wales adults, 2001-20, by procedure funding type: a cross-sectional study.

OBJECTIVE: To investigate elective rates of spinal fusion, decompression, and disc replacement procedures for people with degenerative conditions, by funding type (public, private, workers' compensation). DESIGN, SETTING: Cross-sectional study; analysis of hospitals admissions data extracted from the New South Wales Admitted Patient Data Collection. PARTICIPANTS: All adults who underwent elective spinal surgery (spinal fusion, decompression, disc replacement) in NSW, 1 July 2001 - 30 June 2020. MAIN OUTCOME MEASURES: Crude and age- and sex-adjusted procedure rates, by procedure, funding type, and year; annual change in rates, 2001-20, expressed as incidence rate ratios (IRRs). RESULTS: During 2001-20, 155 088 procedures in 129 525 adults were eligible for our analysis: 53 606 fusion, 100 225 decompression, and 1257 disc replacement procedures. The privately funded fusion procedure rate increased from 26.6 to 109.5 per 100 000 insured adults (per year: IRR, 1.06; 95% confidence interval [CI], 1.05-1.07); the workers' compensation procedure rate increased from 6.1 to 15.8 per 100 000 covered adults (IRR, 1.04; 95% CI, 1.01-1.06); the publicly funded procedure rate increased from 5.6 to 12.4 per 100 000 adults (IRR, 1.03; 95% CI, 1.01-1.06), and from 10.5 to 22.1 per 100 000 adults without hospital cover private health insurance (IRR, 1.03; 95% CI, 1.01-1.05). The privately funded decompression procedure rate increased from 93.4 to 153.6 per 100 000 people (IRR, 1.02; 95% CI, 1.01-1.03); the workers' compensation procedure rate declined from 19.7 to 16.7 per 100 000 people (IRR, 0.98; 95% CI, 0.96-0.99), and the publicly funded procedure rate did not change significantly. The privately funded disc replacement procedure rate increased from 6.2 per million in 2010-11 to 38.4 per million people in 2019-20, but did not significantly change for the other two funding groups. The age- and sex-adjusted rates for privately and publicly funded fusion and decompression procedures were similar to the crude rates. CONCLUSIONS: Privately funded spinal surgery rates continue to be larger than for publicly funded procedures, and they have also increased more rapidly. These differences may indicate that some privately funded procedures are unnecessary, or that the number of publicly funded procedures does not reflect clinical need.

Clinical efficacy of soft-tissue augmentation on tissue preservation at immediate implant sites: A randomized controlled trial.

AIM: This randomized controlled trial aimed to investigate the efficacy of soft-tissue augmentation (STA) with a subepithelial connective tissue graft (SCTG) or an acellular dermal matrix (ADM) on reducing tissue alterations at an immediate implant site. MATERIALS AND METHODS: This trial had three groups: (i) immediate implant with SCTG (ICT group); (ii) immediate implant with ADM (IAD group); (iii) immediate implant without STA (control group). Forty-six patients were randomly assigned to each group. Implants were placed at the maxillary anterior or premolar areas and restored after the 6-month visit. Clinical outcomes, including buccal soft-tissue contour, peri-implant mucosal level, soft-tissue thickness and keratinized tissue width, were measured at baseline and at 3-, 6- and 12-month follow-up visits. Radiographic bone levels were measured at baseline and at 6- and 12-month follow-up visits. Patient-reported outcomes were also collected. RESULTS: STA procedures increased peri-implant mucosal thickness and maintained buccal soft-tissue contours. Compared to the control group, STA groups did not prevent peri-implant mucosal recession or interproximal bone resorption. Generally, no significant differences in clinical outcomes were detected between the ICT and IAD groups. Most patients were highly satisfied with the immediate implant procedure and outcomes without significant differences between groups. CONCLUSIONS: STA at immediate implant sites enhanced soft-tissue thickness and maintained soft-tissue contours but did not prevent peri-implant mucosal recession or interproximal bone resorption. Long-term follow-up should be performed since these results were reported for only up to 1 year.

The effect of media literacy on effective learning outcomes in online learning.

Nowadays, online learning is already ubiquitous in the education of most countries and is one of the fastest-growing trends in the use of educational technology. However, despite literature on the effectiveness of online learning, little is known about the influence of student media literacy on effective learning outcomes in online learning. The present study tried to fill this research gap by exploring the effect of the four-factor construct of media literacy on effective learning outcomes that were measured by focusing on how students perceived their overall learning outcomes in online learning. Data were collected in a sample of 421 undergraduate students from 32 universities in Vietnam. The results of the structural equation modeling indicated that except for functional prosumption, the remaining three factors of media literacy (functional consumption, critical consumption, and critical prosumption) had significant positive effects on perceived learning outcomes. Critical prosumption was found to be the most powerful significant influence on student learning outcomes in the online learning environment. The findings provide some significant practical implications for stakeholders in setting up strategic plans for increasing the effectiveness of online classes.

Why using bed nets is a challenge among minority populations in Central Vietnam.

BACKGROUND: Despite freely distributed insecticide-treated nets (ITNs) and health information campaigns to increase their use among populations at risk, malaria transmission persists in forested areas in Vietnam, especially among ethnic minority communities. A mixed-methods study was conducted in four villages of Ca Dong and M'nong ethnicity in Central Vietnam between 2009 and 2011 to assess factors limiting the uptake of ITNs. METHODS: The mixed-methods research design consisted of a qualitative study to explore the context and barriers to ITN use, and a cross-sectional household survey (n = 141) to quantify factors for limited and appropriate net use. RESULTS: The Ca Dong and M'nong's livelihood was dependent on swidden farming in the forest. Poverty-related factors, including the lack of beds, blankets, the practice of sleeping around the kitchen fire and deteriorated ITNs due to open housing structures, were reasons for alternative and non-use of ITNs. When household members stayed overnight in plot huts at fields, ITNs were even more unavailable and easily deteriorated. 72.5% of households reported having received one net for every two persons, and 82.2% of participants reported to have used ITNs the night before the survey. However, only 18.4% of participants were estimated to be effectively protected by ITNs after accounting for the availability of torn ITNs and the way ITNs were used, for example as blankets, at both village and fields. Multi-variable logistic regression showed the effect of four significant factors for appropriate ITN use: i) being female (AOR = 8.08; p = 0.009); ii) aware of mosquito bites as the sole cause of malaria (AOR = 7.43; p = 0.008); iii) not sleeping around the kitchen fire (AOR = 24.57; p = 0.001); and iv) having sufficient number of ITNs in the household (AOR = 21.69; p = 0.001). CONCLUSION: This study showed how social factors rooted in poverty and swidden agriculture limited the effective use of ITNs, despite high coverage, among ethnic minority populations in Central Vietnam. An in-depth understanding of the local context is essential to develop specific indicators for measuring ITN use.

Understanding the epidemiology, clinical characteristics, knowledge and barriers to treatment and prevention of malaria among returning international laborers in northern Vietnam: a mixed-methods study.

BACKGROUND: With the decline in local malaria transmission in Vietnam as a result of the National Malaria Control Program (NMCP) elimination activities, a greater focus on the importation and potential reintroduction of transmission are essential to support malaria elimination objectives. METHODS: We conducted a multi-method assessment of the demographics, epidemiology, and clinical characteristics of imported malaria among international laborers returning from African or Southeast Asian countries to Vietnam. Firstly, we conducted a retrospective review of hospital records of patients from January 2014 to December 2016. Secondly, we conducted a mixed-methods prospective study for malaria patients admitted to the study sites from January 2017 to May 2018 using a structured survey with blood sample collection for PCR analysis and in-depth interviews. Data triangulation of the qualitative and quantitative data was used during analysis. RESULTS: International laborers were young (median age 33.0 years IQR 28.0-39.5 years), predominantly male (92%) adults returning mostly from the African continent (84%) who stayed abroad for prolonged periods (median time 13.5 months; IQR 6.0-331.5 months) and were involved in occupations that exposed them to a higher risk of malaria infection. Epidemiological trends were also similar amongst study strands and included the importation of Plasmodium falciparum primarily from African countries and P. vivax from Southeast Asian countries. Of 11 P. malariae and P. ovale infections across two study strands, 10 were imported from the African continent. Participants in the qualitative arm demonstrated limited knowledge about malaria prior to travelling abroad, but reported knowledge transformation through personal or co-worker's experience while abroad. Interestingly, those who had a greater understanding of the severity of malaria presented to the hospital for treatment sooner than those who did not; median of 3 days (IQR 2.0-7.0 days) versus 5 days (IQR 4.0-9.5 days) respectively. CONCLUSION: To address the challenges to malaria elimination raised by a growing Vietnamese international labor force, consideration should be given to appropriately targeted interventions and malaria prevention strategies that cover key stages of migration including pre-departure education and awareness, in-country prevention and prophylaxis, and malaria screening upon return.

Vast assembly of vocal marine mammals from diverse species on fish spawning ground.

Observing marine mammal (MM) populations continuously in time and space over the immense ocean areas they inhabit is challenging but essential for gathering an unambiguous record of their distribution, as well as understanding their behaviour and interaction with prey species. Here we use passive ocean acoustic waveguide remote sensing (POAWRS) in an important North Atlantic feeding ground to instantaneously detect, localize and classify MM vocalizations from diverse species over an approximately 100,000 km(2) region. More than eight species of vocal MMs are found to spatially converge on fish spawning areas containing massive densely populated herring shoals at night-time and diffuse herring distributions during daytime. We find the vocal MMs divide the enormous fish prey field into species-specific foraging areas with varying degrees of spatial overlap, maintained for at least two weeks of the herring spawning period. The recorded vocalization rates are diel (24 h)-dependent for all MM species, with some significantly more vocal at night and others more vocal during the day. The four key baleen whale species of the region: fin, humpback, blue and minke have vocalization rate trends that are highly correlated to trends in fish shoaling density and to each other over the diel cycle. These results reveal the temporospatial dynamics of combined multi-species MM foraging activities in the vicinity of an extensive fish prey field that forms a massive ecological hotspot, and would be unattainable with conventional methodologies. Understanding MM behaviour and distributions is essential for management of marine ecosystems and for accessing anthropogenic impacts on these protected marine species.

Study protocol: understanding pain after dental procedures, an observational study within the National Dental PBRN.

BACKGROUND: Patient-reported outcome measures provide an essential perspective on the quality of health care provided. However, how data are collected, how providers value and make sense of the data, and, ultimately, use the data to create meaningful impact all influence the success of using patient-reported outcomes. OBJECTIVES: The primary objective is to assess post-operative pain experiences by dental procedure type through 21 days post-procedure as reported by patients following dental procedures and assess patients' satisfaction with pain management following dental surgical procedures. Secondary objectives are to: 1) assess post-operative pain management strategies 1 week following dental surgical procedures, as recommended by practitioners and reported by patients, and 2) evaluate practitioner and patient acceptance of the FollowApp.Care post visit patient monitoring technology (FollowApp.Care). We will evaluate FollowApp.Care usage, perceived usefulness, ease of use, and impact on clinical workload. DESIGN AND METHODS: We describe the protocol for an observational study involving the use of the FollowApp.Care platform, an innovative mobile application that collects dental patients' assessments of their post-operative symptoms (e.g., pain). The study will be conducted in collaboration with the National Dental Practice-based Research Network, a collective Network of dental practices that include private and group practices, public health clinics, community health centers and Federal Qualified Health Centers, academic institutional settings, and special patient populations. We will recruit a minimum of 150 and up to 215 dental providers and up to 3147 patients who will receive push notifications through text messages FollowApp.Care on their mobile phones at designated time intervals following dental procedures. This innovative approach of implementing an existing and tested mobile health system technology into the real-world dental office setting will actively track pain and other complications following dental procedures. Through patients' use of their mobile phones, we expect to promptly and precisely identify specific pain levels and other issues after surgical dental procedures. The study's primary outcome will be the patients' reported pain experiences. Secondary outcomes include pain management strategies and medications implemented by the patient and provider and perceptions of usefulness and ease of use by patients and providers.

Risk factors for malaria in high incidence areas of Viet Nam: a case-control study.

BACKGROUND: A key step to advancing the goal of malaria elimination in Viet Nam by 2030 is focusing limited resources for treatment and prevention to groups most at risk for malaria transmission. METHODS: To better understand risk factors for malaria transmission in central Viet Nam, a survey of 1000 malaria positive cases and 1000 malaria negative controls was conducted. Cases and controls were matched for age and gender and self-presented at commune health stations (CHS) in Binh Phuoc, Dak Nong and Dak Lak Provinces. Diagnoses were confirmed with microscopy, rapid diagnostic test and PCR. Participants were interviewed about 50 potential risk factors for malaria, which included information about occupation, forest visitation, travel, healthcare-seeking behaviour and prior use of anti-malaria interventions. Participants were enrolled by trained government health workers and the samples were analysed in Vietnamese government laboratories. Data were analysed by univariable, block-wise and multivariable logistic regression. RESULTS: Among cases, 61.8% had Plasmodium falciparum, 35.2% Plasmodium vivax and 3% mixed species infections. Median (IQR) age was 27 (21-36) years and 91.2% were male. Twenty-five risk factors were associated with being a case and eleven with being a control. Multivariable analysis found that malaria cases correlated with forest workers, recent forest visitation, longer duration of illness, having a recorded fever, number of malaria infections in the past year, having had prior malaria treatment and having previously visited a clinic. CONCLUSIONS: This study demonstrates the benefits of increased statistical power from matched controls in malaria surveillance studies, which allows identification of additional independent risk factors. It also illustrates an example of research partnership between academia and government to collect high quality data relevant to planning malaria elimination activities. Modifiable risk factors and implications of the findings for malaria elimination strategy are presented.

Timeliness of contact tracing among flight passengers during the COVID-19 epidemic in Vietnam.

BACKGROUND: International air travel plays an important role in the global spread of SARS-CoV-2, and tracing of close contacts is an integral part of the public health response to COVID-19. We aimed to assess the timeliness of contact tracing among airline passengers arriving in Vietnam on flights containing COVID-19 cases and investigated factors associated with timeliness of contact tracing. METHODS: We included data from 2228 passengers on 22 incoming flights between 2 and 19 March 2020. Contact tracing duration was assessed separately for the time between the date of index case confirmation and date of contact tracing initiation (interval I), and the date of contact tracing initiation and completion (interval II). We used log-rank tests and multivariable Poisson regression models to identify factors associated with timeliness. RESULTS: The median duration of interval I and interval II was one (IQR: 1-2) and 3 days (IQR: 2-5), respectively. The contact tracing duration was shorter for passengers from flights where the index case was identified through mandatory testing directly upon arrival (median = 4; IQR: 3-5) compared to flights with index case detection through self-presentation at health facilities after arrival (median = 7; IQR: 5-8) (p-value = 0.018). Cumulative hazards for successful tracing were higher for Vietnamese nationals compared to non-Vietnamese nationals (p < 0.001). CONCLUSIONS: Contact tracing among flight passengers in the early stage of the COVID-19 epidemic in Vietnam was timely though delays occurred on high workload days. Mandatory SARS-CoV-2 testing at arrival may reduce contact tracing duration and should be considered as an integrated screening tool for flight passengers from high-risk areas when entering low-transmission settings with limited contact tracing capacity. We recommend a standardized risk-based contact tracing approach for flight passengers during the ongoing COVID-19 epidemic.

The Comparative Effectiveness of Varenicline and Nicotine Patches for Smoking Abstinence During Pregnancy: Evidence From a Population-based Cohort Study.

INTRODUCTION: In the general population, varenicline is consistently shown to be more efficacious for smoking cessation than nicotine replacement therapy (NRT). Current clinical guidelines for the management of smoking during pregnancy recommend against the use of varenicline, whilst supporting the use of NRT. However, little is known about the comparative effectiveness of these smoking cessation therapies among pregnant women. AIMS AND METHODS: Routinely-collected records of all births in two Australian States during 2011 and 2012 were used to create a population-based cohort of women who smoked during the first half of pregnancy. Pharmaceutical dispensing data were used to identify varenicline and nicotine patch dispensings in the first half of pregnancy. Propensity score matching was used to account for the potentially different distribution of confounding factors between the treatment groups. The outcome was defined as smoking abstinence during the second half of pregnancy. RESULTS: After propensity score-matching, our cohort comprised 60 women who used varenicline and 60 who used nicotine patches during the first half of pregnancy. More varenicline users (33.3%, 95% CI: 21.7%-46.7%) quit smoking than nicotine patch users (13.3%, 95% CI: 5.9%-24.6%). The adjusted rate difference was 24.2% (95% CI: 10.2%-38.2%) and the adjusted relative risk was 2.8 (95% CI: 1.4-5.7). CONCLUSIONS: Varenicline was almost three times more effective than nicotine patches in assisting pregnant women to quit smoking. Further studies are needed to corroborate our results. Together with data on the safety of varenicline during pregnancy, evidence regarding the relative benefit of varenicline and NRT during pregnancy important for informing clinical decisions for pregnant smokers. IMPLICATIONS: This study is the first to measure the comparative effectiveness of varenicline and nicotine patches during pregnancy - women using varenicline were almost three times as likely to quit smoking than those using nicotine patches. This study addressed a clinically important question using an observational study, noting that there is an absence of evidence from randomized controlled trials because of the ethical issues associated with including pregnant women in clinical trials of medicines of unknown safety.

Medications used disproportionately during pregnancy: Priorities for research on the risks and benefits of medications when used during pregnancy.

PURPOSE: To identify medications used disproportionately more or less among pregnant women relative to women of childbearing age. METHODS: Medication use among pregnant women in New South Wales, Australia was identified using linked perinatal and pharmaceutical dispensing data from 2006 to 2012. Medication use in women of childbearing age (including pregnant women) was identified using pharmaceutical dispensing data for a 10% random sample of the Australian population. Pregnant social security beneficiaries (n = 111 612) were age-matched (1:3) to female social security beneficiaries in the 10% sample. For each medication, the risk it was dispensed during pregnancy relative to being dispensed during an equivalent time period among matched controls was computed. Medications were mapped to Australian pregnancy risk categories. RESULTS: Of the 181 included medications, 35 were statistically significantly more commonly dispensed to pregnant women than control women. Of these, 23 are categorised as posing no increased risk to the foetus. Among medications suspected of causing harm or having insufficient safety data, the strongest associations were observed for hydralazine, ondansetron, dalteparin sodium and ranitidine. Use was less likely during pregnancy than control periods for 127 medications, with the strongest associations observed for hormonal contraceptives and progestogens. CONCLUSIONS: Most medications found to be used disproportionately more by pregnant women are indicated for pregnancy-related problems. A large number of medications were used disproportionately less among pregnant women, where avoidance of some of these medications may pose a greater risk of harm. For many other medications avoided during pregnancy, current data are insufficient to inform this risk-benefit assessment.

Pyronaridine-artesunate Efficacy and Safety in Uncomplicated Plasmodium falciparum Malaria in Areas of Artemisinin-resistant Falciparum in Viet Nam (2017-2018).

BACKGROUND: Multidrug-resistant Plasmodium falciparum undermines the efficacy of currently deployed antimalarial therapies in southern Viet Nam. METHODS: Between May 2017 and December 2018, this prospective, open-label, single-arm, observational clinical trial, conducted in Binh Phuoc, Dak Nong, Gia Lai, Khanh Hoa, and Ninh Thuan provinces, evaluated the safety and efficacy of oral pyronaridine-artesunate once daily for 3 consecutive days in adults and children with microscopically confirmed P. falciparum malaria. Patients were treated as inpatients for Days 0-3, with follow-up visits on Days 7, 14, 21, 28, 35, and 42. The primary outcome was the proportion of polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 42. RESULTS: The cumulative incidence of PCR-adjusted ACPR at Day 42 was 96.1% (95% confidence interval [CI] 91.4-98.2; Kaplan-Meier). In the per-protocol analysis, the proportion of patients with Day 42 PCR-adjusted ACPR was 96.1% (147/153; 95% CI 91.7-98.5). The proportion of patients with parasitemia at Day 3 was 24.0% (40/167; 95% CI 17.7-31.2). The prevalences of the Kelch13 (C580Y) mutation were: in Binh Phuoc, 97.7% (43/44); in Dak Nong, 96.2% (25/26); in Gia Lai, 57.8% (37/64); in Khanh Hoa, 66.6% (6/9); and in Ninh Thuan, 3.6% (1/28). The majority of artemisinin-resistant isolates also had increased plasmepsin2 copy number (75.9%; 85/112). There was 1 isolate (Binh Phuoc) that had Kelch13 (C580Y) plus increased plasmepsin2 and Pfmdr1 copy numbers. Asymptomatic transient increases in alanine transaminase and aspartate transaminase were observed at Day 7, resolving by Day 28. CONCLUSIONS: Pyronaridine-artesunate can be used to diversify antimalarial therapy in areas of artemisinin-resistant P. falciparum in Viet Nam. CLINICAL TRIALS REGISTRATION: ACTRN12618001274268.

Use of smoking cessation pharmacotherapies during pregnancy is not associated with increased risk of adverse pregnancy outcomes: a population-based cohort study.

BACKGROUND: Varenicline, bupropion and nicotine replacement therapy (NRT) are three effective pharmacotherapies for smoking cessation, but data about their safety in pregnancy are limited. We assessed the risk of adverse perinatal outcomes and major congenital anomalies associated with the use of these therapies in pregnancy in Australia. METHODS: Perinatal data for 1,017,731 deliveries (2004 to 2012) in New South Wales and Western Australia were linked to pharmaceutical dispensing, hospital admission and death records. We identified 97,875 women who smoked during pregnancy; of those, 233, 330 and 1057 were exposed to bupropion, NRT and varenicline in pregnancy, respectively. Propensity scores were used to match exposed women to those who were unexposed to any smoking therapy (1:10 ratio). Propensity scores and gestational age at exposure were used to match varenicline-exposed to NRT-exposed women (1:1 ratio). Time-dependent Cox proportional hazards models estimated hazard ratios (HR) with 95% confidence intervals (95% CI) for any adverse perinatal event (a composite of 10 unfavourable maternal and neonatal outcomes) and any major congenital anomaly. RESULTS: The risk of any adverse perinatal event was not significantly different between bupropion-exposed and unexposed women (39.2% versus 39.3%, HR 0.93, 95% CI 0.73-1.19) and between NRT-exposed and unexposed women (44.8% vs 46.3%, HR 1.02, 95% CI 0.84-1.23), but it was significantly lower in women exposed to varenicline (36.9% vs 40.1%, HR 0.86, 95% CI 0.77-0.97). Varenicline-exposed infants were less likely than unexposed infants to be born premature (6.5% vs 8.9%, HR 0.72, 95% CI 0.56-0.92), be small for gestational age (11.4% vs 15.4%, HR 0.68, 95% CI 0.56-0.83) and have severe neonatal complications (6.6% vs 8.2%, HR 0.74, 95% CI 0.57-0.96). Among infants exposed to varenicline in the first trimester, 2.9% had a major congenital anomaly (3.5% in unexposed infants, HR 0.91, 95% CI 0.72-1.15). Varenicline-exposed women were less likely than NRT-exposed women to have an adverse perinatal event (38.7% vs 51.4%, HR 0.58, 95% CI 0.33-1.05). CONCLUSIONS: Pregnancy exposure to smoking cessation pharmacotherapies does not appear to be associated with an increased risk of adverse birth outcomes. Lower risk of adverse birth outcomes in varenicline-exposed pregnancies is inconsistent with recommendations that NRT be used in preference to varenicline.

Targeting high risk forest goers for malaria elimination: a novel approach for investigating forest malaria to inform program intervention in Vietnam.

BACKGROUND: Individuals that work and sleep in remote forest and farm locations in the Greater Mekong Subregion continue to remain at high risk of both acquiring and transmitting malaria. These difficult-to-access population groups largely fall outside the reach of traditional village-centered interventions, presenting operational challenges for malaria programs. In Vietnam, over 60% of malaria cases are thought to be individuals who sleep in forests or on farms. New malaria elimination strategies are needed in countries where mobile and migrant workers frequently sleep outside of their homes. The aim of this study was to apply targeted surveillance-response based investigative approaches to gather location-specific data on confirmed malaria cases, with an objective to identify associated malaria prevention, treatment and risk behaviors of individuals sleeping in remote forest and farms sites in Vietnam. METHODS: A cross-sectional study using novel targeted reactive investigative approaches at remote area sleeping sites was conducted in three mountainous communes in Phu Yen province in 2016. Index cases were defined as individuals routinely sleeping in forests or farms who had tested positive for malaria. Index cases and non-infected neighbors from forest and farm huts within 500 m of the established sleeping locations of index cases were interviewed at their remote-area sleeping sites. RESULTS: A total of 307 participants, 110 index cases and 197 neighbors, were enrolled. Among 93 participants who slept in the forest, index cases were more likely to make > 5 trips to the forest per year (prevalence odds ratio (POR) 7.41, 95% confidence interval (CI) 2.66-20.63), sleep in huts without walls (POR 44.00, 95% CI 13.05-148.33), sleep without mosquito nets (POR 2.95, 95% CI 1.26-6.92), and work after dark (POR 5.48, 95% CI 1.84-16.35). Of the 204 farm-based respondents, a significantly higher proportion of index cases were involved in non-farming activities (logging) (POR 2.74, 95% CI 1.27-5.91). CONCLUSION: Investigative approaches employed in this study allowed for the effective recruitment and characterization of high-priority individuals frequently sleeping in remote forest and farm locations, providing relevant population and site-specific data that decision makers can use to design and implement targeted interventions to support malaria elimination.

Plasmodium vivax morbidity after radical cure: A cohort study in Central Vietnam.

BACKGROUND: In Vietnam, the importance of vivax malaria relative to falciparum during the past decade has steadily increased to 50%. This, together with the spread of multidrug-resistant Plasmodium falciparum, is a major challenge for malaria elimination. A 2-year prospective cohort study to assess P. vivax morbidity after radical cure treatment and related risk factors was conducted in Central Vietnam. METHODS AND FINDINGS: The study was implemented between April 2009 and December 2011 in four neighboring villages in a remote forested area of Quang Nam province. P. vivax-infected patients were treated radically with chloroquine (CQ; 25 mg/kg over 3 days) and primaquine (PQ; 0.5 mg/kg/day for 10 days) and visited monthly (malaria symptoms and blood sampling) for up to 2 years. Time to first vivax recurrence was estimated by Kaplan-Meier survival analysis, and risk factors for first and recurrent infections were identified by Cox regression models. Among the 260 P. vivax patients (61% males [159/260]; age range 3-60) recruited, 240 completed the 10-day treatment, 223 entered the second month of follow-up, and 219 were followed for at least 12 months. Most individuals (76.78%, 171/223) had recurrent vivax infections identified by molecular methods (polymerase chain reaction [PCR]); in about half of them (55.61%, 124/223), infection was detected by microscopy, and 84 individuals (37.67%) had symptomatic recurrences. Median time to first recurrence by PCR was 118 days (IQR 59-208). The estimated probability of remaining free of recurrence by month 24 was 20.40% (95% CI [14.42; 27.13]) by PCR, 42.52% (95% CI [35.41; 49.44]) by microscopy, and 60.69% (95% CI [53.51; 67.11]) for symptomatic recurrences. The main risk factor for recurrence (first or recurrent) was prior P. falciparum infection. The main limitations of this study are the age of the results and the absence of a comparator arm, which does not allow estimating the proportion of vivax relapses among recurrent infections. CONCLUSION: A substantial number of P. vivax recurrences, mainly submicroscopic (SM) and asymptomatic, were observed after high-dose PQ treatment (5.0 mg/kg). Prior P. falciparum infection was an important risk factor for all types of vivax recurrences. Malaria elimination efforts need to address this largely undetected P. vivax transmission by simultaneously tackling the reservoir of P. falciparum and P. vivax infections.

Risk factor assessment for clinical malaria among forest-goers in a pre-elimination setting in Phu Yen Province, Vietnam.

BACKGROUND: The transition from malaria control to elimination requires understanding and targeting interventions among high-risk populations. In Vietnam, forest-goers are often difficult to test, treat and follow-up for malaria because they are highly mobile. If undiagnosed, forest-goers can maintain parasite reservoirs and contribute to ongoing malaria transmission. METHODS: A case-control study was conducted to identify malaria risk factors associated with forest-goers in three communes in Phu Yen Province, Vietnam. Cases (n = 81) were residents from the study area diagnosed with malaria and known to frequent forest areas. Controls (n = 94) were randomly selected forest-going residents from within the study area with no identified malaria infection. Participants were interviewed face-to-face using a standard questionnaire to identify malaria risk factors. Logistic regression was used to calculate odds ratios (ORs) and 95% CI for risk factors after adjusting for socio-demographic characteristics. RESULTS: Among the cases, malaria infection varied by species: 66.7% were positive for Plasmodium falciparum, 29.6% for Plasmodium vivax, and 3.7% were diagnosed as mixed infection. Cases were less likely than controls to use treated nets (aOR = 0.31; 95% CI 0.12-0.80), work after dark (aOR = 2.93; 95% CI 1.35, 6.34), bath in a stream after dark (aOR = 2.44; 95% CI 1.02-5.88), and collect water after dark (aOR = 1.99; 95% CI 1.02-3.90). CONCLUSIONS: As Vietnam moves toward malaria elimination, these findings can inform behaviour change communication and malaria prevention strategies, incorporating the risk of after-dark and water-related activities, in this priority and difficult-to-access population group.

Identifying patients using antidepressants for the treatment of depression: A predictive algorithm for use in pharmaceutical and medical claims data.

PURPOSE: Records of antidepressant dispensings are often used as a surrogate measure of depression. However, as antidepressants are frequently prescribed for indications other than depression, this is likely to result in misclassification. This study aimed to develop a predictive algorithm that identifies patients using antidepressants for the treatment of depression. METHODS: Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) claims data were linked to follow-up questionnaires (completed in 2012-2013) for participants of the 45 and Up Study-a cohort study of residents of New South Wales, Australia, aged 45 years and older. The sample composed participants who were dispensed an antidepressant in the 30 days prior to questionnaire completion (n = 3162). An algorithm based on patient characteristics, pharmaceutical dispensings, and claims for mental health services was built using group-lasso interaction network (glinternet), with self-reported receipt of treatment for depression as the outcome. The predictive performance of the algorithm was assessed via bootstrap resampling. RESULTS: The algorithm composes 15 main effects and 11 interactions, with type of antidepressant dispensed and claims for mental health services the strongest predictors. The ability of the algorithm to discriminate between antidepressant users with and without depression was 0.73. At a predicted probability cut-off of 0.6, specificity was 93.8% and sensitivity was 23.6%. CONCLUSIONS: Using this algorithm with a high probability cut-off yields high specificity and facilitates the exclusion of individuals using antidepressants for indications other than depression, thereby mitigating the risk of confounding by indication when evaluating the outcomes of antidepressant use.

Trajectories of antipsychotic use before and during pregnancy and associated maternal and birth characteristics.

OBJECTIVE: To identify distinct trajectories of antipsychotic use prior to and during pregnancy and describe the associated maternal and birth characteristics. METHODS: We conducted a population-based cohort study of births (2005-2012) using linked administrative data in New South Wales, Australia. We used group-based trajectory modelling to classify trajectories of antipsychotic use in the 450 days prior to pregnancy and during pregnancy. We characterised women with different trajectories according to maternal sociodemographic characteristics, mental health diagnoses and hospitalisations, use of psychotropic medicines and birth outcomes. RESULTS: Of 137,993 women who gave birth, 2741 (2.0%) were exposed to antipsychotics prior to or during pregnancy. We identified six trajectories of antipsychotic use: two involved short-term use of low daily doses prior to pregnancy (51.1%), while three involved long-term use of low (20.9%), moderate (11.0%) and high (2.0%) daily doses throughout pregnancy. One trajectory (15.0%) involved increasing use during pregnancy. Women with long-term use were more likely to have a schizophrenia or bipolar disorder diagnosis, to have used multiple psychotropics and to have a mental health hospitalisation during pregnancy. Overall, women using antipsychotics had elevated rates of adverse birth outcomes compared to unexposed women. Women with the greatest antipsychotic exposure had the highest rates of gestational diabetes and gestational hypertension. CONCLUSION: Women using antipsychotics around pregnancy are heterogeneous, with varying patterns of use and associated birth outcomes, reflecting underlying differences in the indications for treatment and/or severity of illness. This diversity should be considered when developing clinical guidelines and designing safety studies.