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  • Investigating causal pathways in severe falciparum malaria: A pooled retrospective analysis of clinical studies

    Posted 2019-08-23 21:00:00 by: The HealthFolk Team

    by Stije J. Leopold, James A. Watson, Atthanee Jeeyapant, Julie A. Simpson, Nguyen H. Phu, Tran T. Hien, Nicholas P. J. Day, Arjen M. Dondorp, Nicholas J. White Background Severe falciparum malaria is a medical emergency characterised by potentially lethal vital organ dysfunction. Patient fatality rates even with parenteral artesunate treatment remain high. Despite considerable research into adjuvant therapies targeting organ and tissue dysfunction, none have shown efficacy apart from renal replacement therapy. Understanding the causal contributions of clinical and laboratory abnormalities to mortality is essential for the design and evaluation of novel therapeutic interventions. Methods and findings We used a structural model causal inference approach to investigate causal relationships between epidemiological, laboratory, and clinical variables in patients with severe falciparum malaria enrolled in clinical trials and their in-hospital mortality. Under this causal model, we analysed records from 9,040 hospitalised children (0–12 years, n = 5,635) and adults (n = 3,405, 12–87 years) with severe falciparum malaria from 15 countries in Africa and Asia who were studied prospectively over the past 35 years. On admission, patient covariates associated with increased in-hospital mortality were severity of acidosis (odds ratio [OR] 2.10 for a 7-mEq/L increase in base deficit [95% CI 1.93–2.28]), renal impairment (OR 1.71 for a 2-fold increase in blood urea nitrogen [95% CI 1.58, 1.86]), coma (OR 3.59 [95% CI 3.07–4.21]), seizures (OR 1.40 [95% CI 1.16–1.68]), shock (OR 1.51 [95% CI 1.14–1.99]), and presumed pulmonary oedema (OR 1.58 [95% CI 1.04–2.39]). Lower in-hospital mortality was associated with moderate anaemia (OR 0.87 for a decrease of 10 percentage points in haematocrit [95% CI 0.80–0.95]). Circulating parasite density was not associated with mortality (OR 1.02 for a 6-fold increase [95% CI 0.94–1.11]), so the pathological effects of ...

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  • Development and implementation of a quality improvement toolkit, iron deficiency in pregnancy with maternal iron optimization (IRON MOM): A before-and-after study

    Posted 2019-08-20 21:00:00 by: The HealthFolk Team

    by Jameel Abdulrehman, Andrea Lausman, Grace H. Tang, Rosane Nisenbaum, Jessica Petrucci, Katerina Pavenski, Lisa K. Hicks, Michelle Sholzberg Background Iron deficiency (ID) in pregnancy is a common problem that can compromise both maternal and fetal health. Although daily iron supplementation is a simple and effective means of treating ID in pregnancy, ID and ID anemia (IDA) often go unrecognized and untreated due to lack of knowledge of their implications and competing clinical priorities. Methods and findings In order to enhance screening and management of ID and IDA in pregnancy, we developed a novel quality-improvement toolkit: ID in pregnancy with maternal iron optimization (IRON MOM), implemented at St. Michael’s Hospital in Toronto, Canada. It included clinical pathways for diagnosis and management, educational resources for clinicians and patients, templated laboratory requisitions, and standardized oral iron prescriptions. To assess the impact of IRON MOM, we retrospectively extracted laboratory data of all women seen in both the obstetrics clinic and the inpatient delivery ward settings from the electronic patient record (EPR) to compare measures pre- and post-implementation of the toolkit: a process measure of the rates of ferritin testing, and outcome measures of the proportion of women with an antenatal (predelivery) hemoglobin value below 100 g/L (anemia), the proportion of women who received a red blood cell (RBC) transfusion during pregnancy, and the proportion of women who received an RBC transfusion immediately following delivery or in the 8-week postpartum period. The pre-intervention period was from January 2012 to December 2016, and the post-intervention period was from January 2017 to December 2017. From the EPR, 1,292 and 2,400 ferritin tests and 16,603 and 3,282 antenatal hemoglobin results were extracted pre- and post-intervention, respectively. One year after implementation of IRON MOM, we found a 10-fold increase in the rate of ...

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  • An association between maternal weight change in the year before pregnancy and infant birth weight: ELFE, a French national birth cohort study

    Posted 2019-08-20 21:00:00 by: The HealthFolk Team

    by Marion Lecorguillé, Madalina Jacota, Blandine de Lauzon-Guillain, Anne Forhan, Marie Cheminat, Marie-Aline Charles, Barbara Heude Background Weight-control interventions in pregnant women with overweight or obesity have limited effectiveness for fetal growth and birth outcomes. Interventions or prevention programs aiming at the pre-pregnancy period should be considered. However, how the woman’s weight change before pregnancy affects fetal growth is not known. We investigated the association between weight change over the year before pregnancy and birth weight. Methods and findings We used the inclusion data of 16,395 women from the ELFE French national birth cohort, a nationally representative cohort in which infants were enrolled at birth with their families in 2011. Maternal weight change was self-reported and classified into 3 groups: moderate weight variation or stable weight, weight loss > 5 kg, and weight gain > 5 kg or both weight loss and gain > 5 kg. Multiple linear regression models were used to investigate the association between pre-pregnancy weight change and a birth weight z-score calculated according to the French Audipog reference, adjusted for a large set of maternal characteristics. The analyses were stratified by maternal body mass index (BMI) at conception ...

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  • Associations of fat mass and fat-free mass accretion in infancy with body composition and cardiometabolic risk markers at 5 years: The Ethiopian iABC birth cohort study

    Posted 2019-08-20 21:00:00 by: The HealthFolk Team

    by Rasmus Wibaek, Dorte Vistisen, Tsinuel Girma, Bitiya Admassu, Mubarek Abera, Alemseged Abdissa, Marit E. Jørgensen, Pernille Kæstel, Kim F. Michaelsen, Henrik Friis, Jonathan C. K. Wells, Gregers S. Andersen Background Accelerated growth in early childhood is an established risk factor for later obesity and cardiometabolic disease, but the relative importance of fat mass (FM) and fat-free mass (FFM) accretion is not well understood. We aimed to study how FM and FFM at birth and their accretion during infancy were associated with body composition and cardiometabolic risk markers at 5 years. Methods and findings Healthy children born at term were enrolled in the Infant Anthropometry and Body Composition (iABC) birth cohort between December 2008 and October 2012 at Jimma University Specialized Hospital in the city of Jimma, Ethiopia. FM and FFM were assessed using air displacement plethysmography a median of 6 times between birth and 6 months of age. In 507 children, we estimated individual FM and FFM at birth and their accretion over 0–3 and 3–6 months of age using linear-spline mixed-effects modelling. We analysed associations of FM and FFM at birth and their accretion in infancy with height, waist circumference, FM, FFM, and cardiometabolic risk markers at 5 years using multiple linear regression analysis. A total of 340 children were studied at the 5-year follow-up (mean age: 60.0 months; girls: 50.3%; mean wealth index: 45.5 out of 100; breastfeeding status at 4.5 to 6 months post-partum: 12.5% exclusive, 21.4% almost exclusive, 60.6% predominant, 5.5% partial/none). Higher FM accretion in infancy was associated with higher FM and waist circumference at 5 years. For instance, 100-g/month higher FM accretion in the periods 0–3 and 3–6 months was associated with 339 g (95% CI: 243–435 g, ...

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  • Assessing trends in the content of maternal and child care following a health system strengthening initiative in rural Madagascar: A longitudinal cohort study

    Posted 2019-08-20 21:00:00 by: The HealthFolk Team

    by Camille Ezran, Matthew H. Bonds, Ann C. Miller, Laura F. Cordier, Justin Haruna, David Mwanawabenea, Marius Randriamanambintsoa, Hery-Tiana R. Razanadrakato, Mohammed Ali Ouenzar, Bénédicte R. Razafinjato, Megan Murray, Andres Garchitorena Background In order to reach the health-related Sustainable Development Goals (SDGs) by 2030, gains attained in access to primary healthcare must be matched by gains in the quality of services delivered. Despite the broad consensus around the need to address quality, studies on the impact of health system strengthening (HSS) have focused predominantly on measures of healthcare access. Here, we examine changes in the content of maternal and child care as a proxy for healthcare quality, to better evaluate the effectiveness of an HSS intervention in a rural district of Madagascar. The intervention aimed at improving system readiness at all levels of care (community health, primary health centers, district hospital) through facility renovations, staffing, equipment, and training, while removing logistical and financial barriers to medical care (e.g., ambulance network and user-fee exemptions). Methods and findings We carried out a district-representative open longitudinal cohort study, with surveys administered to 1,522 households in the Ifanadiana district of Madagascar at the start of the HSS intervention in 2014, and again to 1,514 households in 2016. We examined changes in healthcare seeking behavior and outputs for sick-child care among ...

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  • Early occupational intervention for people with low back pain in physically demanding jobs: A randomized clinical trial

    Posted 2019-08-16 21:00:00 by: The HealthFolk Team

    by Bjarke Brandt Hansen, Lilli Kirkeskov, Luise Moelenberg Begtrup, Mikael Boesen, Henning Bliddal, Robin Christensen, Ditte Lundsgaard Andreasen, Lars Erik Kristensen, Esben Meulengracht Flachs, Ann Isabel Kryger Background Occupational medicine seeks to reduce sick leave; however, evidence for an add-on effect to usual care is sparse. The objective of the GOBACK trial was to test whether people with low back pain (LBP) in physically demanding jobs and at risk of sick leave gain additional benefit from a 3-month complex intervention that involves occupational medicine consultations, a work-related evaluation and workplace intervention plan, an optional workplace visit, and a physical activity program, over a single hospital consultation and an MRI. Methods and findings We enrolled people from the capital region of Denmark to an open-label, parallel-group randomized controlled trial with a superiority design from March 2014 through December 2015. In a hospital setting 305 participants (99 women) with LBP and in physically demanding jobs were randomized to occupational intervention (n = 153) or no additional intervention (control group; n = 152) added to a single hospital consultation giving a thorough explanation of the pain (i.e., clinical examination and MRI) and instructions to stay active and continue working. Primary outcome was accumulated sick leave days due to LBP during 6 months. Secondary outcomes were changes in neuropathic pain (painDETECT questionnaire [PDQ]), pain 0–10 numerical rating scale (NRS), Fear-Avoidance Beliefs Questionnaire (FABQ), Roland–Morris Disability Questionnaire (RMDQ), Short Form Health Survey (SF-36) for physical and mental health-related quality of life (HRQoL), and self-assessed ability to continue working (range 0–10). An intention-to-treat analysis of sick leave at 6 months showed no significant difference between groups (mean difference in days suggestively in favor of no additional intervention: 3.50 [95% CI –5.08 ...

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  • Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons

    Posted 2019-08-15 21:00:00 by: The HealthFolk Team

    by Amita Gupta, Michael D. Hughes, Anthony J. Garcia-Prats, Katherine McIntire, Anneke C. Hesseling Amita Gupta and colleagues discuss priorities in clinical research aimed at improving tuberculosis prevention and treatment in pregnant women, children, and people with ...

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  • A novel nutritional supplement to reduce plasma homocysteine in nonpregnant women: A randomised controlled trial in The Gambia

    Posted 2019-08-13 21:00:00 by: The HealthFolk Team

    by Philip T. James, Ousubie Jawla, Nuredin I. Mohammed, Kabiru Ceesay, Fatai M. Akemokwe, Bakary Sonko, Ebrima A. Sise, Andrew M. Prentice, Matt J. Silver Background Infant DNA methylation profiles are associated with their mother’s periconceptional nutritional status. DNA methylation relies on nutritional inputs for one-carbon metabolic pathways, including the efficient recycling of homocysteine. This randomised controlled trial in nonpregnant women in rural Gambia tests the efficacy of a novel nutritional supplement designed to improve one-carbon-related nutrient status by reducing plasma homocysteine, and assesses its potential future use in preconception trials. Methods and findings We designed a novel drink powder based on determinants of plasma homocysteine in the target population and tested it in a three-arm, randomised, controlled trial. Nonpregnant women aged between 18 and 45 from the West Kiang region of The Gambia were randomised in a 1:1:1 allocation to 12 weeks daily supplementation of either (a) a novel drink powder (4 g betaine, 800 μg folic acid, 5.2 μg vitamin B12, and 2.8 mg vitamin B2), (b) a widely used multiple micronutrient tablet (United Nations Multiple Micronutrient Preparation [UNIMMAP]) containing 15 micronutrients, or (c) no intervention. The trial was conducted between March and July 2018. Supplementation was observed daily. Fasted venepuncture samples were collected at baseline, midline (week 5), and endline (week 12) to measure plasma homocysteine. We used linear regression models to determine the difference in homocysteine between pairs of trial arms at midline and endline, adjusted for baseline homocysteine, age, and body mass index (BMI). Blood pressure and pulse were measured as secondary outcomes. Two hundred and ninety-eight eligible women were enrolled and randomised. Compliance was >97.8% for both interventions. At endline (our primary endpoint), the drink powder and UNIMMAP reduced mean plasma homocysteine by 23.6% ...

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  • Variation of all-cause and cause-specific mortality with body mass index in one million Swedish parent-son pairs: An instrumental variable analysis

    Posted 2019-08-09 21:00:00 by: The HealthFolk Team

    by Kaitlin H. Wade, David Carslake, Per Tynelius, George Davey Smith, Richard M. Martin Background High body mass index (BMI) is associated with mortality, but the pervasive problem of confounding and reverse causality in observational studies limits inference about the direction and magnitude of causal effects. We aimed to obtain estimates of the causal association of BMI with all-cause and cause-specific mortality. Methods and findings In a record-linked, intergenerational prospective study from the general population of Sweden, we used two-sample instrumental variable (IV) analysis with data from 996,898 fathers (282,407 deaths) and 1,013,083 mothers (153,043 deaths) and their sons followed up from January 1, 1961, until December 31, 2004. Sons’ BMI was used as the instrument for parents’ BMI to compute hazard ratios (HRs) for risk of mortality per standard deviation (SD) higher parents’ BMI. Using offspring exposure as an instrument for parents’ exposure is unlikely to be affected by reverse causality (an important source of bias in this context) and reduces confounding. IV analyses supported causal associations between higher BMI and greater risk of all-cause mortality (HR [95% confidence interval (CI)] per SD higher fathers’ BMI: 1.29 [1.26–1.31] and mothers’ BMI: 1.39 [1.35–1.42]) and overall cancer mortality (HR per SD higher fathers’ BMI: 1.20 [1.16–1.24] and mothers’ BMI: 1.29 [1.24–1.34]), including 9 site-specific cancers in men (bladder, colorectum, gallbladder, kidney, liver, lung, lymphatic system, pancreas, and stomach) and 11 site-specific cancers in women (gallbladder, kidney, liver, lung, lymphatic system, ovaries, pancreas, stomach, uterus, cervix, and endometrium). There was evidence supporting causal associations between higher BMI in mothers and greater risk of mortality from kidney disease (HR: 2.17 [1.68–2.81]) and lower risk of mortality from suicide (HR: 0.77 [0.65–0.90]). In both sexes, there was evidence ...

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  • Expectations of healthcare quality: A cross-sectional study of internet users in 12 low- and middle-income countries

    Posted 2019-08-07 21:00:00 by: The HealthFolk Team

    by Sanam Roder-DeWan, Anna D. Gage, Lisa R. Hirschhorn, Nana A. Y. Twum-Danso, Jerker Liljestrand, Kwanele Asante-Shongwe, Viviana Rodríguez, Talhiya Yahya, Margaret E. Kruk Background High satisfaction with healthcare is common in low- and middle-income countries (LMICs), despite widespread quality deficits. This may be due to low expectations because people lack knowledge about what constitutes good quality or are resigned about the quality of available services. Methods and findings We fielded an internet survey in Argentina, China, Ghana, India, Indonesia, Kenya, Lebanon, Mexico, Morocco, Nigeria, Senegal, and South Africa in 2017 (N = 17,996). It included vignettes describing poor-quality services—inadequate technical or interpersonal care—for 2 conditions. After applying population weights, most of our respondents lived in urban areas (59%), had finished primary school (55%), and were under the age of 50 (75%). Just over half were men (51%), and the vast majority reported that they were in good health (73%). Over half (53%) of our study population rated the quality of vignettes describing poor-quality services as good or better. We used multilevel logistic regression and found that good ratings were associated with less education (no formal schooling versus university education; adjusted odds ratio [AOR] 2.22, 95% CI 1.90–2.59, P < 0.001), better self-reported health (excellent versus poor health; AOR 5.19, 95% CI 4.33–6.21, P < 0.001), history of discrimination in healthcare (AOR 1.47, 95% CI 1.36–1.57, P < 0.001), and male gender (AOR 1.32, 95% CI 1.23–1.41, P < 0.001). The survey did not reach nonusers of the internet thus only representing the internet-using population. Conclusions Majorities of the internet-using public in 12 LMICs have low expectations of healthcare quality as evidenced by high ratings given to poor-quality care. Low expectations of health services likely dampen demand for quality, reduce pressure on systems to deliver ...

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