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On 4 June 2020, after a week of increasing scientific concern and scrutiny, first The Lancet, then a little over an hour later the New England Journal of Medicine, retracted studies that were based on inaccessible data, provided by the Surgisphere corporation. The studies have been extremely damaging to chloroquine and hydroxychloroquine COVID-19 clinical trials around the globe. Here is MORU’s statement in response to these events.
Practice of ventilation in critically ill pediatric patients: protocol for an international, long-term, observational study, and results of the pilot feasibility study.
ObjectiveThis manuscript describes the protocol of an investigator-initiated, international, multicenter, long-term, prospective observational study named PRactice of VENTilation in PEDiatric Patients (PRoVENT-PED), designed to investigate the epidemiology, respiratory support practices and outcomes of critically ill pediatric patients.DesignData will be collected biannually over 10 years during predefined 4-week intervals, with an additional optional period to accommodate data collection during an epidemic or pandemic. The specific focus of PRoVENT-PED will evolve as the study progresses, initially emphasizing collecting detailed ventilator data from invasively ventilated patients. In later phases, the focus will shift to noninvasive respiratory support and typical aspects of respiratory support, like patient-ventilator asynchronies, weaning practices, and rescue therapies, as extracorporeal support. PRoVENT-PED includes patients under 18 years of age, admitted to a participating intensive care unit, and receiving respiratory support. The endpoints vary with the focus in each phase but will always include a set of key settings and ventilation parameters and related outcomes. If applicable, potentially modifiable factors and associations with outcomes will be studied. The pilot feasibility study demonstrated that the electronic capturing system effectively collects all necessary data within a reasonable time limit, with little missing data.ConclusionPRoVENT-PED is a 10-year, international, multicenter study focused on collecting data on respiratory support practices in critically ill pediatric patients. Its scope evolves from invasive to noninvasive ventilatory support, ultimately encompassing patient-ventilator asynchronies, weaning practices, and rescue therapies.
Enhanced data quality to improve malaria surveillance in Papua, Indonesia
Abstract Background Papua has a high burden of malaria, with an annual parasite incidence 300 times the national average. A key component of malaria elimination strategies is robust surveillance which is essential for monitoring trends in case numbers, guiding public health interventions, and prioritizing resource allocation. This study aimed to enhance malaria surveillance in Central Papua, Indonesia, by improving data collection, record-keeping, and treatment practices. Methods The study was conducted at five public clinics in Central Papua province, Indonesia, as part of a wider health systems strengthening programme to promote safer and more effective anti-malarial treatment (The SHEPPI Study). Clinical and laboratory details of patients with malaria and their treatment were documented in clinic registers which were digitalized into an electronic database. Automated reports were generated each month and used to provide regular feedback to clinic staff. Continuous Quality Improvement (CQI) workshops were conducted with clinic staff using the Plan-Do-Study-Act approach to address challenges and drive sustained improvements. Results Between January 2019 and December 2023, a total of 314,561 patients were tested for malaria, of whom 41.9% (131,948) had peripheral parasitaemia detected. The first round of Continuous Quality Improvement (CQI) workshops were held in May 2019 and improved data quality significantly, increasing data completeness from 46.3% (4540/9802) in the initial period (Jan–May 2019) to 71.5% (9053/12,665) after the first CQI (Jun–Oct 2019), p < 0.001. The second CQI round reduced DHP prescribing errors from 17.1% (1111/6489) in the initial period to 5.7% (607/10,669) after the second CQI (Sep 2019–Jan 2020) and PQ prescribing errors from 17.4% (552/3175) to 3.4% (160/4659) over the same time interval, p < 001. In total, 347 patients were prescribed fewer than the recommended number of PQ tablets during the initial period, 89 (25.6%) of whom were erroneously given only a single dose. Over the 4 year study period, a total of 11 workshops were conducted, driving continuous improvements in data quality and prescribing practices. Conclusion One or two rounds of CQI, supported by regular follow-up, can enhance the quality of malariometric surveillance, however interventions needed to be tailored to address specific needs of participating clinics. Improvements in data quality and prescribing practices have potential to contribute to better malaria management, improved clinical outcomes, and strengthened trust in healthcare providers.
FocaL mass drug Administration for Plasmodium vivax Malaria Elimination (FLAME): study protocol for an open-label cluster randomized controlled trial in Peru.
BACKGROUND: Outside of sub-Saharan Africa, Plasmodium vivax has become the dominant species of malaria. Focal mass drug administration (fMDA) is a potential strategy to support elimination efforts, but controlled studies are lacking. METHODS: The FocaL mass drug Administration for Plasmodium vivax Malaria Elimination (FLAME) study is a 3-year cluster randomized controlled trial to determine the impact and safety of fMDA to reduce P. vivax transmission. The study will be conducted in Loreto, Peru, where standard interventions have reduced P. vivax cases, but transmission persists due to a high proportion of subclinical infections. Thirty low transmission communities (API < 250 cases/1000 population) will be randomized 1:1 to fMDA versus control using a restricted randomization. All communities will receive Peruvian national standard malaria control measures. In the intervention arm, high-risk individuals (living within 200 meters of a P. vivax case reported in the prior two years) without contraindication to study medications, including G6PD deficiency, will receive three cycles of fMDA over a two-year period. Each cycle will include two rounds of directly observed therapy delivered 2 months apart. The fMDA regimen will include 25mg/kg chloroquine (CQ) plus a single 300mg dose of tafenoquine (TQ) for individuals age ≥16 years, and 25mg/kg of CQ plus 7 days of 0.5mg/kg/day of primaquine (PQ) if younger. The primary outcome is the cumulative incidence of symptomatic P. vivax malaria. The sample size provides 80% power to detect at least a 68% relative reduction in cumulative P. vivax incidence, based on alpha of 0.05 and a coefficient of variation (k) of 0.87. Secondary outcomes include safety, cost-effectiveness, and infection prevalence and seroprevalence which will be assessed in annual cross-sectional surveys. Safety will be assessed in passive and active pharmacovigilance, including post-treatment screening for G6PD-associated hemolysis by assessing for anemia and hematuria in a sample. DISCUSSION: The trial will generate evidence regarding fMDA for P. vivax and inform malaria elimination efforts in Peru and similarly endemic settings. Findings will be in peer-reviewed publications and through stakeholder meetings in Peruvian and international policy and research forums. TRIAL REGISTRATION: Clinicaltrials.gov NCT05690841. This trial was registered on 09 January 2023.
Using Abattoir-Based Surveillance to Establish Foot-and-Mouth Disease Non-Structural Protein Seropositivity in Cattle and Pigs in Cambodia
Foot-and-mouth disease (FMD) is a contagious transboundary animal disease that causes economic loss and obstacles to international trade. Frequent FMD outbreaks in Cambodia negatively impact farmers’ and smallholders’ incomes. This study aimed to estimate the seroprevalence of FMD Non-Structural Protein (NSP) antibodies, which are an indicator of FMD antibodies raised during a natural infection rather than those produced following vaccination, that were detected using a commercial enzyme-linked immunosorbent assay (ELISA). Sample collection from cattle and pigs (n = 2238) was performed at ten abattoirs in seven provinces between October 2019 and December 2020. Overall seroprevalence in cattle and pigs was 43.2% (363/839; 95% CI 39.8–46.7), and 0.6% (9/1399; 95% CI 0.2–1.2), respectively. Only the cattle dataset was included in the risk factor analysis, as the prevalence of sero-reactors was too low in the pig dataset to be analyzed. Significant risk factors identified by the logistic regression model included the province of origin (p = 0.02), body condition score (BCS) (p = 0.0002) and sex (p = 0.0007). Odds ratios of the significant risk factors were 7.05 (95% CI 1.43–34.67; p = 0.02) for cattle that originated from Kampong Thom, 1.41 (95% CI 1.05–1.89; p = 0.02) for female cattle, and 3.28 (95% CI 1.06–10.12; p = 0.04) for animals with BCS of 3/5. The study revealed that the seroprevalence of FMD NSP in cattle presented at the abattoirs was high, while the FMD NSP seroprevalence in abattoir pigs was very low. Further investigation is required to map the disease distribution in Cambodia, especially the serotypes and strains causing clinical disease. These findings call for the extension of work on effective disease prevention measures.
Paediatric anaemia in rural Kenya and the role of travel time to emergency care services.
BACKGROUND: Access to emergency care (EC) services is crucial for severe anaemia outcome. Limited information exists on the association between travel times to EC services and the presentation and severity of anaemia upon hospital admission. Here, we investigate the association between travel time and presentation of severe anaemia (compared to mild/moderate anaemia) at admission in western Kenya. METHODS: Data from January 2020 to July 2023 from Busia County Referral Hospital were assembled for paediatric admissions aged 1-59 months residing in Busia County. Travel time from a patient's village to the hospital was calculated using a least cost path algorithm. Anaemia severity was categorised as mild (Hb ≥ 7-<10 g dl-1), moderate (Hb ≥ 5-<7 g dl-1) and severe (Hb
Community perspectives of heat and weather warnings for pregnant and postpartum women in Kilifi, Kenya
Background Extreme weather is a recognised risk factor for stillbirth and preterm birth, disrupts women’s access to healthcare during pregnancy and childbirth, and negatively affects the care of newborns. Reliable and accessible heat and weather warning systems are key in alerting individuals to undertake protective measures. There is a notable gap in understanding how women and caregivers in rural East Africa perceive and utilize weather information. We investigated community members’ heat and weather warning information-seeking behaviour, identified available sources, assessed their reliability and utility, and examined their influence on behaviour. Settings Our research was conducted in rural Kilifi County in Kenya’s coastal region. The area experiences temperatures exceeding 23°C throughout the year, with extended periods of extreme temperatures [> 40°C] and long and severe droughts. Methods We conducted in-depth interviews [IDI] with pregnant and postpartum women [n = 21] and held six focus group discussions [FGDs] involving mothers-in-law and community health volunteers [CHVs]. The data were analysed in NVivo 12 using both inductive and deductive approaches. Results We found significant gaps concerning pregnant and post-partum women, and their caregivers, having timely access to weather forecasts and heat information from health or meteorological authorities. Information on heat and weather warnings is disseminated through various channels, including television, radio, mobile phones, and word of mouth, which are facilitated by community influencers such as CHVs and local chiefs. Indigenous methods of weather forecasting, such as cloud observation, consulting local “rainmakers”, and studying the behavioural patterns of amphibians, are employed in conjunction with warnings from the Kenyan Meteorological Department (KMD). Barriers to accessing weather information include the cost of television and smartphones and a lack of segmented information in local languages. Conclusions National and county meteorological services need to enhance public participation, communication, and the delivery of heat and weather information to guide community-level response measures and individual behaviour change. They should also collaborate with health professionals to address heat risks for vulnerable groups. Further research is needed to empower indigenous weather predictors with modern weather information and revise national policies to deliver tailored messages to vulnerable populations like pregnant and postpartum women.
Community perspectives of heat and weather warnings for pregnant and postpartum women in Kilifi, Kenya
Extreme weather is a recognised risk factor for stillbirth and preterm birth, disrupts women’s access to healthcare during pregnancy and childbirth, and negatively affects the care of newborns. Reliable and accessible heat and weather warning systems are key in alerting individuals to undertake protective measures. There is a notable gap in understanding how women and caregivers in rural East Africa perceive and utilize weather information. We investigated community members’ heat and weather warning information-seeking behaviour, identified available sources, assessed their reliability and utility, and examined their influence on behaviour. Our research was conducted in rural Kilifi County in Kenya’s coastal region. The area experiences temperatures exceeding 23°C throughout the year, with extended periods of extreme temperatures [> 40°C] and long and severe droughts. We conducted in-depth interviews [IDI] with pregnant and postpartum women [n = 21] and held six focus group discussions [FGDs] involving mothers-in-law and community health volunteers [CHVs]. The data were analysed in NVivo 12 using both inductive and deductive approaches. We found significant gaps concerning pregnant and post-partum women, and their caregivers, having timely access to weather forecasts and heat information from health or meteorological authorities. Information on heat and weather warnings is disseminated through various channels, including television, radio, mobile phones, and word of mouth, which are facilitated by community influencers such as CHVs and local chiefs. Indigenous methods of weather forecasting, such as cloud observation, consulting local “rainmakers”, and studying the behavioural patterns of amphibians, are employed in conjunction with warnings from the Kenyan Meteorological Department (KMD). Barriers to accessing weather information include the cost of television and smartphones and a lack of segmented information in local languages. National and county meteorological services need to enhance public participation, communication, and the delivery of heat and weather information to guide community-level response measures and individual behaviour change. They should also collaborate with health professionals to address heat risks for vulnerable groups. Further research is needed to empower indigenous weather predictors with modern weather information and revise national policies to deliver tailored messages to vulnerable populations like pregnant and postpartum women.
Long-term retention and positive deviant practices in Uganda’s community client-led antiretroviral distribution groups (CCLADs): a mixed-methods study
BackgroundHIV testing and starting antiretroviral therapy (ART) are pivotal in treating people living with HIV (PLHIV) but sustaining PLHIV on treatment remains challenging. We assessed retention and attrition in community client-led antiretroviral distribution groups (CCLADs) in Uganda and identified positive deviant practices that foster long-term retention.MethodsUsing explanatory mixed methods, we collected longitudinal medical data from 65 health facilities across 12 districts in East Central Uganda. Quantitative phase, from 18 April 2021 to 30 May 2021, employed survival analysis and Cox regression to assess retention and identify attrition risk factors. Qualitative inquiry focused on four districts with high attrition from 11 August 2021 to 20 September 2021, where we identified nine health facilities exhibiting high retention in CCLADs. We purposively selected 50 clients for in-depth interviews (n=22) or focus group discussions (n=28). Using thematic analysis, we identified positive deviant practices. We integrated quantitative and qualitative findings into joint displays.ResultsInvolving 3055 PLHIV, the study showed retention rates of 97.5% at 6 months, declining to 89.7% at 96 months. Attrition risk factors were lower levels of care (health centre three (adjusted HR (aHR) 2.80, 95% CI 2.00 to 3.65) and health centre four (aHR 3.61, 95% CI 2.35 to 5.54)); being unemployed (aHR 2.21, 95% CI 1.00 to 4.84); enrolment year into CCLAD (aHR 23.93, 95% CI 4.66 to 123.05) and virological failure (aHR 3.41, 95% CI 2.51 to 4.63). Of 22 clients interviewed, 8 were positive deviants. Positive deviants were characterised by prolonged retention in CCLADs, improved clinical outcomes and practised uncommon behaviours that enabled them to find better solutions than their peers. Positive deviant practices included fostering family-like settings, offering financial or self-development advice, and promoting healthy lifestyles.ConclusionsFindings underscore the importance of addressing factors contributing to attrition and leveraging positive deviant practices to optimise retention and long-term engagement in HIV care.