Category: Statistics

Perfusion. 2024 Mar 19:2676591241239819. doi: 10.1177/02676591241239819. Online ahead of print.

ABSTRACT

INTRODUCTION: Over the past decade, there has been an increase in the use of recombinant Anti-Thrombin III (AT-III) administration during neonatal and pediatric short- and long-term mechanical support for the replacement of acquired deficiencies. Recombinant AT-III (Thrombate) administration is an FDA licensed drug indicated primarily for patients with hereditary deficiency to treat and prevent thromboembolism and secondarily to prevent peri-operative and peri-partum thromboembolism. Herein we propose further use of Thrombate for primary AT-III deficiency of the newborn as well as for acquired dilution and consumption secondary to cardiopulmonary bypass (CPB).

METHODOLOGY: All patients undergoing CPB obtain a preoperative AT-III level. Patients with identified deficiencies are normalized in the OR using recombinant AT-III as a patient load, in the CPB prime, or both. Patient baseline Heparin Dose Response (HDR) is assessed using the Heparin Management System (HMS) before being exposed to AT-III. If a patient load of AT-III is given, a second HDR is obtained and this AT-III Corrected HDR is used as the primary goal during CPB. Once CPB is initiated, an AT-III level is obtained with the first patient blood analysis. A subtherapeutic level results in an additional dose of AT-III. During the rewarm period, a final AT-III level is obtained and AT-III treated once again if subtherapeutic. A retrospective, matched analysis review of practice analyzing two groups, a Study Group (Repeat HDR, May 2022 onward) and Matched Group (Without Repeat HDR, July 2019 to April 2022), for age (D), weight (Kg) and operation was conducted. The focus of the study was to determine any change in heparin sensitivity identified post AT-III patient bolus load in the HDR (U/mL), Slope (U/mL/s), ACT (s), and total amount of heparin on CPB (U) and protamine (mg) used in each group.

RESULTS: No significance was seen in Baseline AT-III (%), post heparin load HDR (U/mL), first CPB ACT (s), first CPB HDR (U/mL), or total CPB heparin (u/Kg) between the two groups. Statistical significance was seen in Baseline ACT (s), Baseline HDR (U/mL), Baseline Slope (U/mL/s), Post Heparin Load ACT (s), first CPB AT-III (%), and Protamine (mg/Kg) (p < .05). No statistical significance was seen in the Study Intragroup between pre versus post AT-III patient load baseline sample in ACT (s), however significance was seen in HDR (U/mL) and Slope (U/mL/s) (p < .05).

CONCLUSION: Implementation of AT-III monitoring and therapy before and during CPB in conjunction with the HMS allows patients to maintain a steady state of anticoagulation with overall less need for excessive heparin replacement and potentially thrombin activation. The result is obtaining a steady state of anticoagulation, a reduced fluctuation in the heparin and ACT levels and a potential for lower co-morbidities associated with prolonged CPB times.

PMID:38503431 | DOI:10.1177/02676591241239819

BMJ Glob Health. 2024 Mar 18;9(3):e014739. doi: 10.1136/bmjgh-2023-014739.

ABSTRACT

INTRODUCTION: One of the ultimate goals of strengthening the health system is to achieve health equity. Vietnam is considered one of the ‘fast-track countries’ to achieve the health-related Millennium Development Goals, but research on its equity strategies remains inadequate.

METHODS: Using Vietnamese official health statistics, we investigated inequity in four dimensions including health resources, service delivery, service utilisation and residents’ health status from the perspectives of income levels, poverty rates and subnational regions. The Slope Index of Inequality, concentration curve/Concentration Index, absolute difference and Theil Index were used.

RESULTS: Four indicators showed ‘pro-poor’ inequality in health resources, including the per capita health budget, per capita health personnel, per capita health personnel at the community level and per capita hospital beds at the community level, while provincial hospital beds showed ‘pro-rich’ inequality. Two health service delivery indicators (delivery of antenatal care ≥3 times and proportion of community health service centres with medical doctors) show ‘pro-rich’ inequality, although two health status indicators, mortality and malnutrition rates for children under five, showed ‘pro-poor’ inequality. The Northern Midlands and Mountain Areas, and the Central Highlands were disadvantaged regarding service delivery and health status. Intraregional differences were the main factors contributing to the inequalities in delivery of antenatal care ≥3 times, provincial hospital beds and percentage of community health centres with medical doctors, with the Red River Delta and the South East region experiencing the greatest inequalities.

CONCLUSION: The overall level of health equity in Vietnam has increased over the past decade, although inequality in health service delivery has hindered progress towards health equity based on income, poverty and subnational regions. Targeted policies need to be introduced to reduce inequities relating to the health workforce and service delivery capacity.

PMID:38503427 | DOI:10.1136/bmjgh-2023-014739

BMJ Open. 2024 Mar 18;14(3):e082761. doi: 10.1136/bmjopen-2023-082761.

ABSTRACT

INTRODUCTION: Children with cerebral palsy (CP) are prescribed home exercise programmes (HEPs) to increase the frequency of movement practice, yet adherence to HEPs can be low. This paper outlines the protocol for a single-case experimental design (SCED) with alternating treatments, using a new home therapy exercise application, Bootle Boot Camp (BBCamp), offered with and without movement tracking feedback. This study will explore the impact of feedback on engagement, movement quality, lower limb function and family experiences to help understand how technology-supported HEPs should be translated and the added value, if any, of movement tracking technology.

METHODS AND ANALYSIS: In this explanatory sequential mixed-methods study using a SCED, 16 children with CP (aged 6-12 years, Gross Motor Function Classification System levels I-II) will set lower limb goals and be prescribed an individualised HEP by their physiotherapist to complete using BBCamp on their home television equipped with a three-dimensional camera-computer system. Children will complete four weekly exercise sessions over 6 weeks. Children will be randomised to 1 of 16 alternating treatment schedules where BBCamp will provide or withhold feedback during the first 4 weeks. The version of BBCamp that results in the most therapeutic benefit will be continued for 2 final weeks. Goals will be re-evaluated and families interviewed. The primary outcome is adherence (proportion of prescribed exercise repetitions attempted) as a measure of behavioural engagement. Secondary outcomes are affective and cognitive engagement (smiley face ratings), exercise fidelity, lower limb function, goal achievement and participant experiences. SCED data will be analysed using visual and statistical methods. Quantitative and qualitative data will be integrated using joint displays.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the Research Ethics Boards at Bloorview Research Institute and the University of Toronto. Results will be distributed through peer-reviewed journals and scientific conferences.

TRIAL REGISTRATION NUMBER: NCT05998239; pre-results.

PMID:38503423 | DOI:10.1136/bmjopen-2023-082761

BMJ Open. 2024 Mar 18;14(3):e078878. doi: 10.1136/bmjopen-2023-078878.

ABSTRACT

INTRODUCTION: Ulcerative colitis (UC) is a global chronic inflammatory bowel disease, and the poor efficacy of currently available pharmacological regimens makes the management of UC a great challenge. Moxibustion has shown great potential in the management of UC. However, its effectiveness and safety are still controversial. The purpose of this study is to synthesise the latest evidence regarding the clinical efficacy and safety of moxibustion for UC.

METHODS AND ANALYSIS: The Cochrane Library, PubMed, EMBASE, CNKI, Wanfang, VIP and SinoMed databases will be searched from inception to July 2023, to identify all randomised controlled trials with moxibustion for UC. The primary outcome will be clinical efficacy, as measured by validated scales. The serum inflammatory factor, colonoscopy results, quality of life, recurrence rate and adverse events will be the secondary outcomes. The Cochrane Risk of Bias 2.0 tool will be used to assess the methodological quality of each included trial. All data extraction will be carried out independently by two investigators. RevMan V.5.4 software will be used for data analysis and Cochran’s Q statistic and I² test will be used to assess heterogeneity between studies. In addition, we will perform subgroup analyses, sensitivity analyses and publication bias if the available data are sufficient. The strength of evidence will be graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.

ETHICS AND DISSEMINATION: Ethics approval is not required for this review. Our findings will be published in a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER: CRD42023425481.

PMID:38503422 | DOI:10.1136/bmjopen-2023-078878

BMJ Open. 2024 Mar 18;14(3):e079570. doi: 10.1136/bmjopen-2023-079570.

ABSTRACT

INTRODUCTION: Despite Ethiopia’s policy intention to provide recommended vaccination services to underprivileged populations, inequity in polio immunisation persists.

OBJECTIVE: This study examined inequity and trends in polio immunisation and determinant factors among children aged 12-23 months in Ethiopia between 2000 and 2019.

METHODS: Cross-sectional data from 2000, 2005, 2011, 2016 and 2019 Ethiopian demographic and health surveys were analysed with the updated version of the WHO’s Health Equity Assessment Toolkit software. Six standard equity measures: equity gaps, equity ratios, population attributable risk, population attributable fraction, slope index of inequality and relative index of inequality were used. Datasets were analysed and disaggregated by the five equality stratifiers: economic status, education, place of residence, sex of the child and regions. Multilevel logistic regression analysis was used to identify determinant factors.

RESULTS: Polio immunisation coverage was increased from 34.5% (2000) to 60.0% (2019). The wealth index-related inequity, in coverage of polio immunisation between quintiles 5 and 1, was 20 percentage points for most surveys. The population attributable risk and population attributable fraction measure in 2011 indicate that the national polio immunisation coverage in that year could have been improved by nearly 36 and 81 percentage points, respectively, if absolute and relative wealth-driven inequity, respectively, had been avoided. The absolute difference between Addis Ababa and Afar Region was 74 percentage points in 2000 and 60 percentage points in 2019. In multilevel analysis result, individual-level factors like wealth index, maternal education antenatal care and place of delivery showed statistical significance.

CONCLUSION: Although polio immunisation coverage gradually increased over time, in the 20-year survey periods, still 40% of children remained unvaccinated. Inequities in coverage by wealth, educational status, urban-rural residence and administrative regions persisted. Increasing service coverage and improving equitable access to immunisations services may narrow the existing inequity gaps.

PMID:38503420 | DOI:10.1136/bmjopen-2023-079570

BMJ Open. 2024 Mar 18;14(3):e077613. doi: 10.1136/bmjopen-2023-077613.

ABSTRACT

INTRODUCTION: Diffuse intrinsic pontine glioma (DIPG) and paediatric high-grade glioma (pHGG) are aggressive glial tumours, for which conventional treatment modalities fall short. Dendritic cell (DC)-based immunotherapy is being investigated as a promising and safe adjuvant therapy. The Wilms’ tumour protein (WT1) is a potent target for this type of antigen-specific immunotherapy and is overexpressed in DIPG and pHGG. Based on this, we designed a non-randomised phase I/II trial, assessing the feasibility and safety of WT1 mRNA-loaded DC (WT1/DC) immunotherapy in combination with conventional treatment in pHGG and DIPG.

METHODS AND ANALYSIS: 10 paediatric patients with newly diagnosed or pretreated HGG or DIPG were treated according to the trial protocol. The trial protocol consists of leukapheresis of mononuclear cells, the manufacturing of autologous WT1/DC vaccines and the combination of WT1/DC-vaccine immunotherapy with conventional antiglioma treatment. In newly diagnosed patients, this comprises chemoradiation (oral temozolomide 90 mg/m² daily+radiotherapy 54 Gy in 1.8 Gy fractions) followed by three induction WT1/DC vaccines (8-10×10⁶ cells/vaccine) given on a weekly basis and a chemoimmunotherapy booster phase consisting of six 28-day cycles of oral temozolomide (150-200 mg/m² on days 1-5) and a WT1/DC vaccine on day 21. In pretreated patients, the induction and booster phase are combined with best possible antiglioma treatment at hand. Primary objectives are to assess the feasibility of the production of mRNA-electroporated WT1/DC vaccines in this patient population and to assess the safety and feasibility of combining conventional antiglioma treatment with the proposed immunotherapy. Secondary objectives are to investigate in vivo immunogenicity of WT1/DC vaccination and to assess disease-specific and general quality of life.

ETHICS AND DISSEMINATION: The ethics committee of the Antwerp University Hospital and the University of Antwerp granted ethics approval. Results of the clinical trial will be shared through publication in a peer-reviewed journal and presentations at conferences.

TRIAL REGISTRATION NUMBER: NCT04911621.

PMID:38503417 | DOI:10.1136/bmjopen-2023-077613

BMJ Open. 2024 Mar 18;14(3):e080374. doi: 10.1136/bmjopen-2023-080374.

ABSTRACT

OBJECTIVE: Health system leadership plays a critical role in sustaining healthcare delivery during emergencies. Thus, we aimed to assess the contribution of health system leadership in sustaining healthcare delivery under emergency conditions based on adaptive leadership theoretical framework.

DESIGN: We employed a concurrent mixed-methods study approach to assess health system leadership roles during emergency. This involved a quantitative survey administered to 150 health facilities managers/service focal persons selected via multistage sampling method from 15 districts, and qualitative interviews with 48 key informants who purposively selected.

PARTICIPANTS: We interviewed health facility managers, services focal persons, district health officers and residential district commissioners. We also reviewed weekly emergency situation reports and other relevant documents related to the emergency response. We used structured questionnaire, observation checklist and semistructured questionnaire to collect data. We employed descriptive statistics to analyse quantitative data and thematic analysis for qualitative data.

MAIN OUTCOME: Health system leadership contributions in sustaining healthcare delivery during emergencies.

RESULTS: Health system leadership was effective in leading emergency response and ensuring the continuity of health service during emergencies. Community engagement, partners coordination and intersectoral collaboration were effectively used in the emergency response and ensuring continuity of healthcare delivery. Deployment of experienced personnel and essential medical and non-medical supplies played a critical role in the continuity of health service. Availability of incidence management teams across health system significantly contributed to health system leadership. Participation of village health teams in community engagement and information communication helped in the success of health system leadership under emergency.

CONCLUSION: Adaptive health system leadership played a crucial role in managing health services delivery under emergency conditions. Effective partnership coordination and collaboration across sectors, frequent information communication, building local actor capacity and implementing scheduled supportive supervisions emerged as key strategies for sustaining health services during emergencies.

PMID:38503408 | DOI:10.1136/bmjopen-2023-080374

J Gynecol Obstet Hum Reprod. 2024 Mar 17:102770. doi: 10.1016/j.jogoh.2024.102770. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare Foley catheter insertion by digital blind method to its placement with a sterile speculum in women with unripe cervix for induction of labor.

METHODS: A systematic search was conducted in Cochrane Library, PubMed, Web of Science, and Scopus databases for randomized clinical trials (RCTs) from inception to July 2023. Included studies compared digital to speculum placement of the Foley catheter for labor induction. Data from the included studies were extracted and pooled using RevMan software for meta-analysis. The primary outcome was pain score during the procedure measured by the Visual Analog Scale (VAS). Secondary outcomes included Foley catheter insertion duration, cesarean delivery rate, induction to delivery interval, Bishop score, need for other cervical ripening methods, maternal satisfaction, and maternal fever.

RESULTS: Four RCTs involving a total of 600 patients met the inclusion criteria. Pain during the procedure and Foley catheter insertion duration were significantly reduced in the digital insertion group compared to the speculum-guided group (p > 0.05). The Bishop score showed a significant improvement in the digital Foley catheter placement group. However, there were no statistically significant differences in the cesarean delivery rate or the requirement for additional cervical ripening methods between the two groups. Maternal satisfaction with the delivery process was significantly improved in the digital insertion group (p > 0.001). Induction to delivery interval and maternal fever were comparable between both groups.

CONCLUSIONS: Digital placement of Foley catheter can be considered as an alternative to the sterile speculum method for pre-induction cervical ripening. More trials are required to confirm our findings.

PMID:38503382 | DOI:10.1016/j.jogoh.2024.102770

Acta Trop. 2024 Mar 17:107181. doi: 10.1016/j.actatropica.2024.107181. Online ahead of print.

ABSTRACT

The POC-CCA test is subject to variations in reading interpretations depending on the intensity of its results, and trace test reading have implications for determining prevalence. The aim of this study was to assess whether the readings obtained from the POC-CCA tests, conducted using a semi-quantitative scale (the G-score classification for test determination), exhibited concurrence with the direct visual interpretation (positive, negative, or trace) performed by two distinct analysts, using photographs from previously performed POC-CCA test carried out in the municipality of Maruim, in the state of Sergipe-Brazil, a region of high endemicity. The devices used to read the photographs were smartphones, so as to simulate field usage, and a desktop, a tool with higher image quality that would help the researchers in the evaluation and establishment of the final result at a later. In direct visual interpretation of the POC-CCA photographs, the most discordant results occurred in the identification of the trace response (T). The Kappa index established for the direct visual interpretation between the two analysts, in which T is considered as positive, in the desktop was κ=0.826 and in the smartphone, κ=0.950. When we use the G-score as a reading standardization technique and classify the results according to the manufacturer, with trace being evaluated as positive, the highest level of agreement was obtained. Some disagreement remains between the direct visual interpretation and the G-score when performed on the desktop, with more individuals being classified as negative in the direct visual interpretation, by both analysts. However, this result was not statistically significant. The use of the G-score scale proved to be an excellent tool for standardizing the readings and classifying the results according to the semi-quantitative scale showed greater concordance of results both among analysts and among the different devices used to view the photographs.

PMID:38503365 | DOI:10.1016/j.actatropica.2024.107181

Curr Probl Cardiol. 2024 Mar 17:102532. doi: 10.1016/j.cpcardiol.2024.102532. Online ahead of print.

ABSTRACT

BACKGROUND: Cardiac procedures often induce pain and anxiety in patients, adversely impacting recovery. Pharmachological approaches have limitations, prompting exploration of innovative digital solutions like virtual reality (VR). Although early evidence suggests a potential favourable benefit with VR, it remains unclear whether the implementation of this technology can improve pain and anxiety. We aimed to assess by a systematic review and meta-analysis the effectiveness of VR in alleviating anxiety and pain on patients undergoing cardiac procedures.

METHODS: Our study adhered to the PRISMA method and was registered in PROSPERO under the code CRD42024504563. The search was carried out in the PubMed, Web of Science, Scopus, and the Cochrane Library databases in January 2024. Four randomized controlled trials were included (a total of 382 patients). Risk of bias was employed to assess the quality of individual studies, and a random-effects model was utilized to examine the overall effect.

RESULTS: The results showed that VR, when compared to the standard of care, had a statistically significant impact on anxiety (SMD= -0.51, 95% CI: -0.86 to -0.16, p=0.004), with a heterogeneity I2 = 57%. VR did not show a significant difference in terms of pain when compared to standard care (SMD= -0.34, 95% CI: -0.75 to -0.07, p=0.10). The included trials exhibited small sample sizes, substantial heterogeneity, and variations in VR technology types, lengths, and frequencies.

CONCLUSIONS: VR effectively lowers anxiety levels in patients undergoing cardiac procedures, however, did not show a statistically significant difference on pain.

PMID:38503359 | DOI:10.1016/j.cpcardiol.2024.102532