A mixed methods evaluation of Advanced Life Support in Obstetrics (ALSO) and Basic Life Support in Obstetrics (BLSO) in a resource-limited setting on the Thailand-Myanmar border.

Background: Short emergency obstetric care (EmOC) courses have demonstrated improved provider confidence, knowledge and skills but impact on indicators such as maternal mortality and stillbirth is less substantial. This manuscript evaluates Advanced Life Support in Obstetrics (ALSO) and Basic Life Support (BLSO) as an adult education tool, in a protracted, post-conflict and resource-limited setting. Methods: A mixed methods evaluation was used. Basic characteristics of ALSO and BLSO participants and their course results were summarized. Kirkpatrick's framework for assessment of education effectiveness included: qualitative data on participants' reactions to training (level 1); and quantitative health indicator data on change in the availability and quality of EmOC and in maternal and/or neonatal health outcomes (level 4), by evaluation of the post-partum haemorrhage (PPH) related maternal mortality ratio (MMR) and stillbirth rate in the eight years prior and following implementation of ALSO and BLSO. Results: 561 Thailand-Myanmar border health workers participated in ALSO (n=355) and BLSO (n=206) courses 2008-2020. Pass rates on skills exceeded 90% for both courses while 50% passed the written ALSO test. Perceived confidence significantly improved for all items assessed. In the eight-year block preceding the implementation of ALSO and BLSO (2000-07) the PPH related MMR per 100,000 live births was 57.0 (95%CI 30.06-108.3)(9/15797) compared to 25.4 (95%CI 11.6-55.4)(6/23620) eight years following (2009-16), p=0.109. After adjustment, PPH related maternal mortality was associated with birth before ALSO/BLSO implementation aOR 3.825 (95%CI 1.1233-11.870), migrant (not refugee) status aOR 3.814 (95%CI 1.241-11.718) and attending ≤four antenatal consultations aOR 3.648 (95%CI 1.189-11.191). Stillbirth rate per 1,000 total births was 18.2 (95%CI 16.2-20.4)(291/16016) before the courses, and 11.1 (95%CI 9.8-12.5)(264/23884) after, p=0.038. Birth before ALSO/ BLSO implementation was associated with stillbirth aoR 1.235 (95%CI 1.018-1.500). Conclusions: This evaluation suggests ALSO and BLSO are sustainable, beneficial, EmOC trainings for adult education in protracted, post-conflict, resource-limited settings.

Video-based feedback as a method for training rural healthcare workers to manage medical emergencies: a pilot study.

BACKGROUND: Video-based feedback has been shown to aid knowledge retention, skills learning and improve team functionality. We explored the use of video-based feedback and low fidelity simulation for training rural healthcare workers along the Thailand-Myanmar border and Papua New Guinea (PNG) to manage medical emergencies effectively. METHODS: Twenty-four study participants were recruited from three Shoklo Malaria Research Unit clinics along the Thailand-Myanmar border and eight participants from Kudjip Nazarene Hospital, PNG. The teams were recorded on video managing a simulated medical emergency scenario and the video was used to aid feedback and assess performance using Observed Structured Clinical Examination (OSCE) scoring and Team Emergency Assessment Measure (TEAM) questionnaire. The process was repeated post-feedback at both sites and at 6 weeks at the Thailand-Myanmar border site. Thailand-Myanmar border participants' individual confidence levels and baseline knowledge (using OSCE scoring) were assessed before team assessment and feedback at week 1 and repeated post-feedback and at 6 weeks. Focus group discussions (FGD) were held at each Thailand-Myanmar border clinic at week 1 (8 participants at each clinic). RESULTS: Individual paired tests of OSCE scores showed significant improvement post-feedback at week 1 (p < 0.001) and week 6 (p < 0.001) compared to baseline OSCE scores. There was a trend for increased team OSCE scores compared to baseline at week 1 (p = 0.068) and week 6 (p = 0.109) although not significant. Thailand-Myanmar border TEAM scores demonstrated improvement post-feedback mainly in leadership, teamwork and task management which was sustained up to week 6. PNG showed an improvement mainly in teamwork and task management. The global rating of the teams' non-technical performance at both sites improved post feedback and at week 6 on the Thailand-Myanmar border site. Self-rated confidence scores by Thailand-Myanmar border participants increased significantly from baseline following training at week 1 (p = 0.020), and while higher at 6 weeks follow up than at baseline, this was not significant (p = 0.471). The FGD revealed majority of participants felt that watching the video recording of their performance and the video-based feedback contributed most to their learning. CONCLUSION: Video-assisted feedback resulted in an improvement in clinical knowledge, confidence and quality of teamwork for managing medical emergencies in two low resource medical facilities in South East Asia and the South Pacific.

Accelerated Training of Skilled Birth Attendants in a Marginalized Population on the Thai-Myanmar Border: A Multiple Methods Program Evaluation.

BACKGROUND: To evaluate a skilled birth attendant (SBA) training program in a neglected population on the Thai-Myanmar border, we used multiple methods to show that refugee and migrant health workers can be given effective training in their own environment to become SBAs and teachers of SBAs. The loss of SBAs through resettlement to third countries necessitated urgent training of available workers to meet local needs. METHODS AND FINDINGS: All results were obtained from student records of theory grades and clinical log books. Qualitative evaluation of both the SBA and teacher programs was obtained using semi-structured interviews with supervisors and teachers. We also reviewed perinatal indicators over an eight-year period, starting prior to the first training program until after the graduation of the fourth cohort of SBAs. RESULTS: Four SBA training programs scheduled between 2009 and 2015 resulted in 79/88 (90%) of students successfully completing a training program of 250 theory hours and 625 supervised clinical hours. All 79 students were able to: achieve pass grades on theory examination (median 80%, range [70-89]); obtain the required clinical experience within twelve months; achieve clinical competence to provide safe care during childbirth. In 2010-2011, five experienced SBAs completed a train-the-trainer (TOT) program and went on to facilitate further training programs. Perinatal indicators within Shoklo Malaria Research Unit (SMRU), such as place of birth, maternal and newborn outcomes, showed no significant differences before and after introduction of training or following graduate deployment in the local maternity units. Confidence, competence and teamwork emerged from qualitative evaluation by senior SBAs working with and supervising students in the clinics. CONCLUSIONS: We demonstrate that in resource-limited settings or in marginalized populations, it is possible to accelerate training of skilled birth attendants to provide safe maternity care. Education needs to be tailored to local needs to ensure evidence-based care of women and their families.

Opposite malaria and pregnancy effect on oral bioavailability of artesunate - a population pharmacokinetic evaluation.

AIM: The aim was to compare the pharmacokinetic properties of artesunate and dihydroartemisinin in the same women: i) pregnant with acute uncomplicated malaria on day 1 and 2, ii) pregnant with convalescent malaria on day 7 and iii) in a healthy state 3 months post-partum on day 1, 2 and 7. METHODS: Non-linear mixed-effects modelling was used to compare plasma concentration-time profiles of artesunate and dihydroartemisinin over 7 days of treatment following oral and intravenous artesunate administration to pregnant women with uncomplicated Plasmodium falciparum malaria during their second or third trimesters of pregnancy. The same women were restudied 3 months after delivery when fully recovered. Non-compartmental results of the same study have been published previously. RESULTS: Twenty pregnant patients on the Thailand-Myanmar border were studied and 15 volunteered to be restudied 3 months post-partum. Malaria and pregnancy had no effect on the pharmacokinetic properties of artesunate or dihydroartemisinin after intravenous artesunate administration. However, malaria and pregnancy had opposite effects on the absorption of orally administered artesunate. Malaria increased the absolute oral bioavailability of artesunate by 87%, presumably by inhibiting first pass effect, whereas pregnancy decreased oral bioavailability by 23%. CONCLUSIONS: The population pharmacokinetic analysis demonstrated opposite effects of malaria and pregnancy on the bioavailability of orally administered artesunate. Lower drug exposures during the second and third trimesters of pregnancy may contribute to lower cure rates and thus the development of drug resistance. Dose optimization studies are required for artesunate containing artemisinin-based combination therapies (ACTs) in later pregnancy.

A tool to improve competence in the management of emergency patients by rural clinic health workers: a pilot assessment on the Thai-Myanmar border.

BACKGROUND: Shoklo Malaria Research Unit has been providing health care in remote clinics on the Thai-Myanmar border to refugee and migrant populations since 1986 and 1995, respectively. Clinics are staffed by local health workers with a variety of training and experience. The need for a tool to improve the competence of local health workers in basic emergency assessment and management was recognised by medical faculty after observing the case mix seen at the clinic and reviewing the teaching programme that had been delivered in the past year (Jan-13 to March-14). AIMS: To pilot the development and evaluation of a simple teaching tool to improve competence in the assessment and management of acutely unwell patients by local health workers that can be delivered onsite with minimal resources. METHODS: A structured approach to common emergencies presenting to rural clinics and utilizing equipment available in the clinics was developed. A prospective repeated-measures observed structured clinical examination (OSCE) assessment design was used to score participants in their competence to assess and manage a scenario based 'emergency patient' at baseline, immediately post-course, and 8 weeks after the delivery of the teaching course. The assessment was conducted at 3 clinic sites and staff participation was voluntary. Participants filled out questionnaires on their confidence with different scenario based emergency patients. RESULTS: All staff who underwent the baseline assessment failed to carry out the essential steps in initial emergency assessment and management of an unconscious patient scenario. Following delivery of the teaching session, all groups showed improved competence in both objective assessment and subjective confidence levels. CONCLUSIONS: Structured and practical teaching and learning with minimal theory in this resource limited setting had a positive short-term effect on the competence of individual staff to carry out an initial assessment and manage an acutely unwell patient. Health-worker confidence likewise improved. Workplace assessments are needed to determine if this type of skills training impacts upon mortality or near miss mortality patients at the clinic.

Artesunate/dihydroartemisinin pharmacokinetics in acute falciparum malaria in pregnancy: absorption, bioavailability, disposition and disease effects.

AIM: To determine if reported lower plasma concentrations of artemisinin derivatives for malaria in pregnancy result from reduced oral bioavailability, expanded volume of distribution or increased clearance. METHODS: In a sequentially assigned crossover treatment study, pregnant women with uncomplicated falciparum malaria received i.v. artesunate (i.v. ARS) (4mgkg(-1) ) on the first day and oral ARS (4mgkg(-1) ) on the second, or, oral on the first and i.v. on the second, in both groups followed by oral ARS (4mgkg(-1) day(-1) ) for 5 days. Plasma concentrations of ARS and dihyroartemisinin (DHA) were measured by liquid chromatography-mass-spectrometry on days 0, 1, 2 and 6. Controls were the same women restudied when healthy (3 months post partum). RESULTS: I.v. ARS administration resulted in similar ARS and DHA pharmacokinetics in pregnant women with malaria (n= 20) and in controls (n= 14). Oral administration resulted in higher total drug exposure in pregnancy [AUC (95% CI) in (ngml(-1) h)/(mgkg(-1) )] of 55.1 (30.1, 100.0) vs. 26.5 (12.2, 54.3) for ARS, P= 0.002 and 673 (386, 1130) vs. 523 (351, 724) for DHA, P= 0.007. The corresponding median absolute oral bioavailability (F%) was 21.7 (12.6, 75.1) vs. 9.9 (6.0, 36.81) for ARS (P= 0.046) and 77.0 (42.2, 129) vs. 72.7 (42.0, 87.7) for DHA, P= 0.033. Total DHA exposure was lower at day 6 in pregnant women with malaria (P < 0.001) compared with day 0 or 1, but not in the controls (P= 0.084). CONCLUSIONS: This study demonstrates the effects of malaria on oral ARS drug disposition are greater than those of pregnancy. This probably results from a disease related reduction in first pass metabolism. The data are reassuring regarding current dosing recommendations.

Pharmacokinetics of dihydroartemisinin and piperaquine in pregnant and nonpregnant women with uncomplicated falciparum malaria.

Dihydroartemisinin-piperaquine is a fixed-dose artemisinin-based combination treatment. Some antimalarials have altered pharmacokinetics in pregnancy. Pregnant women in the 2nd or 3rd trimester and matched nonpregnant women with uncomplicated falciparum malaria were treated with a total of 6.4 mg/kg of body weight dihydroartemisinin and 51.2 mg/kg piperaquine once daily for 3 days. Venous blood samples were drawn at prespecified time points over 9 weeks. Plasma dihydroartemisinin and piperaquine concentrations were analyzed by liquid chromatography-mass spectrometry. Piperaquine and dihydroartemisinin pharmacokinetics were well described. There were no significant differences in total piperaquine exposure (P = 0.80) or drug exposure during the terminal elimination phase (72 h to infinity) (P = 0.64) between the two groups. The apparent volume of distribution of piperaquine was significantly smaller (602 liters/kg versus 877 liters/kg) in pregnant women than in nonpregnant women (P = 0.0057), and the terminal elimination half-life was significantly shorter (17.8 days versus 25.6 days; P = 0.0023). Dihydroartemisinin exposure after the first dose was significantly lower (844 h × ng/ml versus 1,220 h × ng/ml, P = 0.0021) in pregnant women, but there were no significant differences in total dihydroartemisinin exposure or maximum concentrations between the two groups. There were no significant differences in any pharmacokinetic parameters between the second and third trimester. These results obtained through noncompartmental analysis suggest that in the treatment of falciparum malaria, there are no clinically important differences in the pharmacokinetics of dihydroartemisinin or piperaquine between pregnant and nonpregnant women. However, a more detailed analysis using population pharmacokinetic modeling is needed to fully investigate the differences found for some of the pharmacokinetic parameters, such as the terminal half-life.