Category: Statistics

Malar J. 2024 Jun 22;23(1):195. doi: 10.1186/s12936-024-05014-w.

ABSTRACT

BACKGROUND: Imported malaria continues to be reported in Sri Lanka after it was eliminated in 2012, and a few progress to life-threatening severe malaria.

METHODS: Data on imported malaria cases reported in Sri Lanka from 2013 to 2023 were extracted from the national malaria database maintained by the Anti Malaria Campaign (AMC) of Sri Lanka. Case data of severe malaria as defined by the World Health Organization were analysed with regard to patients’ general characteristics and their health-seeking behaviour, and the latter compared with that of uncomplicated malaria patients. Details of the last three cases of severe malaria in 2023 are presented.

RESULTS: 532 imported malaria cases were diagnosed over 11 years (2013-2023); 46 (8.6%) were severe malaria, of which 45 were Plasmodium falciparum and one Plasmodium vivax. Most severe malaria infections were acquired in Africa. All but one were males, and a majority (87%) were 26-60 years of age. They were mainly Sri Lankan nationals (82.6%). Just over half (56.5%) were treated at government hospitals. The average time between arrival of the person in Sri Lanka and onset of illness was 4 days. 29 cases of severe malaria were compared with 165 uncomplicated malaria cases reported from 2015 to 2023. On average both severe and uncomplicated malaria patients consulted a physician equally early (mean = 1 day) with 93.3% of severe malaria doing so within 3 days. However, the time from the point of consulting a physician to diagnosis of malaria was significantly longer (median 4 days) in severe malaria patients compared to uncomplicated patients (median 1 day) (p = 0.012) as was the time from onset of illness to diagnosis (p = 0.042). All severe patients recovered without sequelae except for one who died.

CONCLUSIONS: The risk of severe malaria among imported cases increases significantly beyond 5 days from the onset of symptoms. Although patients consult a physician early, malaria diagnosis tends to be delayed by physicians because it is now a rare disease. Good access to expert clinical care has maintained case fatality rates of severe malaria at par with those reported elsewhere.

PMID:38909255 | DOI:10.1186/s12936-024-05014-w

Syst Rev. 2024 Jun 22;13(1):163. doi: 10.1186/s13643-024-02577-2.

ABSTRACT

BACKGROUND: This protocol outlines a scoping review with the objective of identifying and exploring planetary health considerations within existing health guidelines and health technology assessments (HTA). The insights gained from this review will serve as a basis for shaping future Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) guidance on planetary health.

METHODS: We will adhere to the JBI methodology for scoping reviews. We will conduct a comprehensive search and screening of results in all languages across various databases including MEDLINE, EMBASE, CINAHL, Global Health, Health Systems Evidence, Greenfile, and Environmental Issues. Additionally, we will supplement this search with resources such as the GIN library, BIGG database, Epistemonikos, GRADE guidelines repository, GRADEpro Guideline Development Tool Database, MAGICapp, NICE website, WHO websites, and a manual exploration of unpublished relevant documents using Google incognito mode. Two independent reviewers will screen and assess the full texts of identified documents according to the eligibility criteria. The following information from each full text will be extracted: document title; first author’s name; publication year; language; document type; document as a guideline or HTA; the topic/discipline; document purpose/study objective; developing/sponsoring organization; the country in which the study/guideline/HTA report was conducted; definition of planetary health or related concept provided; types of planetary health experts engaged; study methods; suggested methods to assess planetary health; use of secondary data on planetary health outcomes; description for use of life cycle assessment; description for assessing the quality of life cycle; population/intended audience; interventions; category; applicable planetary health boundaries; consideration of social justice/global equity; phase of intervention in life cycle related to planetary health addressed; the measure of planetary health impact; impact on biodiversity/land use; one health/animal welfare mention; funding; and conflict of interest. Data analysis will involve a combination of descriptive statistics and directed content analysis, with results presented in a narrative format and displayed in tables and graphs.

DISCUSSION: The final review results will be submitted to open-access peer-reviewed journals for publication when they become available. The research findings will also be disseminated at relevant planetary health conferences and workshops.

SYSTEMATIC REVIEW REGISTRATION: Open Science Framework ( https://osf.io/3jmsa ).

PMID:38909251 | DOI:10.1186/s13643-024-02577-2

Orphanet J Rare Dis. 2024 Jun 22;19(1):241. doi: 10.1186/s13023-024-03247-1.

ABSTRACT

BACKGROUND: Hereditary angioedema (HAE) is characterized by unpredictable and often severe cutaneous and mucosal swelling that affects the extremities, face, larynx, gastrointestinal tract, or genitourinary area. Introduction of novel long-term prophylactic treatment options (lanadelumab, berotralstat, and C1-esterase inhibitor SC [human]) into the treatment armamentarium has substantially reduced HAE attacks, allowing patients to be attack free for longer with improvements to their quality of life. Using data drawn from a wide-ranging survey of patients with HAE, we examined the relationship between duration of time attack free and health-related quality of life (HRQoL), exploring the possibility that there is an association between observed improvement in HRQoL and attack-free duration.

METHODS: A survey among patients with HAE on long-term prophylaxis (LTP) in six countries (the US, Australia, Canada, UK, Germany, and Japan) assessed the relationship between attack-free duration and mean Angioedema Quality of Life (AE-QoL) scores, quality of life benefits, and rescue medication used. Analysis of covariance (ANCOVA) was used to assess the roles of LTP and attack-free period (< 1 month, 1- < 6 months, ≥ 6 months) on total AE-QoL scores. Results include descriptive p-values for strength of association, without control for multiplicity. Descriptive statistics were used to show the relationship between time attack free and quality of life benefits.

RESULTS: Longer durations of time for which participants reported being attack free at the time of the survey correlated with better AE-QoL scores and less use of rescue medication. The mean total AE-QoL scores were 51.8, 33.2, and 19.9 for those who reported having been attack free for < 1 month, 1- < 6 months, and ≥ 6 months, respectively, with higher scores reflecting more impairment. The ANCOVA results showed a strong association between attack-free duration and AE-QoL total score.

CONCLUSION: This study shows that longer attack-free duration has an influential role for better HRQoL in patients receiving LTP. Prolonging the attack-free period is an important goal of therapy and recent advances in LTP have increased attack-free duration. However, opportunities exist for new treatments to further increase attack-free duration and improve HRQoL for all patients with HAE.

PMID:38909246 | DOI:10.1186/s13023-024-03247-1

J Cardiothorac Surg. 2024 Jun 22;19(1):356. doi: 10.1186/s13019-024-02846-0.

ABSTRACT

OBJECTIVE: Systematic evaluation of the safety of del Nido cardioplegia compared to cold blood cardioplegia in adult cardiac surgery.

METHODS: We systematically searched PubMed, EMbase, The Cochrane Library and ClinicalTrials.gov for randomized clinical trials (published by 14 January 2024) comparing del Nido cardioplegia to cold blood cardioplegia in adult. Our main endpoints were myocardial injury markers and clinical outcomes. We assessed pooled data by use of a random-effects model or a fixed-effects model.

RESULTS: A total of 10 studies were identified, incorporating 889 patients who received del Nido cardioplegia and 907 patients who received cold blood cardioplegia. The meta-analysis results showed that compared with the cold blood cardioplegia, the del Nido cardioplegia had less volume of cardioplegia, higher rate of spontaneous rhythm recovery after cross clamp release, lower levels of postoperative cardiac troponin T and creatinine kinase-myocardial band, all of which were statistically significant. However, there was no statistically significant difference in postoperative troponin I and postoperative left ventricular ejection fraction. The clinical outcomes including mechanical ventilation time, intensive care unit stay time, hospital stay time, postoperative stroke, postoperative new-onset atrial fibrillation, postoperative heart failure requiring intra-aortic balloon pump mechanical circulation support, and in-hospital mortality of both are comparable.

CONCLUSION: Existing evidence suggests that del Nido cardioplegia reduced volume of cardioplegia administration and attempts of defibrillation. The superior postoperative results in CTnT and CK-MB may provide a direction for further research on improvement of the composition of cardioplegia.

PMID:38909234 | DOI:10.1186/s13019-024-02846-0

Trials. 2024 Jun 22;25(1):409. doi: 10.1186/s13063-024-08228-0.

ABSTRACT

Adverse events suffer from poor reporting within randomised controlled trials, despite them being crucial to the evaluation of a treatment. A recent update to the CONSORT harms checklist aims to improve reporting by providing structure and consistency to the information presented. We propose an extension wherein harms would be reported in conjunction with effectiveness outcome(s) rather than in silo to provide a more complete picture of the evidence acquired within a trial. Benefit-risk methods are designed to simultaneously consider both benefits and risks, and therefore, we believe these methods could be implemented to improve the prominence of adverse events when reporting trials. The aim of this article is to use case studies to demonstrate the practical utility of benefit-risk methods to present adverse events results alongside effectiveness results. Two randomised controlled trials have been selected as case studies, the Option-DM trial and the SANAD II trial. Using a previous review, a shortlist of 17 benefit-risk methods which could potentially be used for reporting RCTs was created. From this shortlist, three benefit-risk methods are applied across the two case studies. We selected these methods for their usefulness to achieve the aim of this paper and which are commonly used in the literature. The methods selected were the Benefit-Risk Action Team (BRAT) Framework, net clinical benefit (NCB), and the Outcome Measures in Rheumatology (OMERACT) 3 × 3 table. Results using the benefit-risk method added further context and detail to the clinical summaries made from the trials. In the case of the SANAD II trial, the clinicians concluded that despite the primary outcome being improved by the treatment, the increase in adverse events negated the improvement and the treatment was therefore not recommended. The benefit-risk methods applied to this case study outlined the data that this decision was based on in a clear and transparent way. Using benefit-risk methods to report the results of trials can increase the prominence of adverse event results by presenting them alongside the primary efficacy/effectiveness outcomes. This ensures that all the factors which would be used to determine whether a treatment would be recommended are transparent to the reader.

PMID:38909232 | DOI:10.1186/s13063-024-08228-0

BMC Oral Health. 2024 Jun 22;24(1):717. doi: 10.1186/s12903-024-04430-3.

ABSTRACT

BACKGROUND: One of the main goals for pediatric dentists is to offer a painless anesthesia experience. Laser photobiomodulation is among the suggested strategies to decrease injection pain. So, this study aimed to assess the impact of laser photobiomodulation on local anesthesia (LA) injection pain in children and its effect on the efficacy of LA during pulpotomy and SSC procedures.

METHODS: The research was carried out as a randomized controlled clinical trial with two parallel group design. It involved 64 cooperative healthy children, age range from 5 to 7 years, each having at least one maxillary molar indicated for pulpotomy. Children were randomly allocated to one of the two groups based on the pre-anesthetic tissue management technique used: test group received laser photobiomodulation, while control group received topical anesthetic gel. Pain during injection, pulpotomy, and SSC procedures was assessed using physiological measures (Heart Rate (HR)), subjective evaluation (modified Face-Pain-Scale (FPS), and objective analysis (Sound-Eye-Motor scale (SEM)).

RESULTS: A total of 64 children with mean age 6.23 ± 0.78 participated in this research. The mean HR scores were significantly lower in the laser PBM group during buccal and palatal infiltration injections. The SEM mean scores were significantly lower in the laser PBM group during both injections. For the FPS scale, the number of children who recorded satisfaction during injection was significantly higher in laser PBM group. There was no statistically significant difference in mean HR as well as in SEM and FPS scores between the two groups during pulpotomy and SSC procedures. Comparisons between the two study groups were performed using independent samples t- and Mann-Whitney U tests. Significance was set at p value < 0.05.

CONCLUSION: Laser photobiomodulation is a promising non-pharmacological pre-anesthetic tissue management technique in children that offered less painful injection compared to topical anesthetic gel without compromising the effectiveness of LA.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05861154. Registered on 16/5/2023.

PMID:38909229 | DOI:10.1186/s12903-024-04430-3

BioData Min. 2024 Jun 22;17(1):18. doi: 10.1186/s13040-024-00370-4.

ABSTRACT

Deep learning shows great promise for medical image analysis but often lacks explainability, hindering its adoption in healthcare. Attribution techniques that explain model reasoning can potentially increase trust in deep learning among clinical stakeholders. In the literature, much of the research on attribution in medical imaging focuses on visual inspection rather than statistical quantitative analysis.In this paper, we proposed an image-based saliency framework to enhance the explainability of deep learning models in medical image analysis. We use adaptive path-based gradient integration, gradient-free techniques, and class activation mapping along with its derivatives to attribute predictions from brain tumor MRI and COVID-19 chest X-ray datasets made by recent deep convolutional neural network models.The proposed framework integrates qualitative and statistical quantitative assessments, employing Accuracy Information Curves (AICs) and Softmax Information Curves (SICs) to measure the effectiveness of saliency methods in retaining critical image information and their correlation with model predictions. Visual inspections indicate that methods such as ScoreCAM, XRAI, GradCAM, and GradCAM++ consistently produce focused and clinically interpretable attribution maps. These methods highlighted possible biomarkers, exposed model biases, and offered insights into the links between input features and predictions, demonstrating their ability to elucidate model reasoning on these datasets. Empirical evaluations reveal that ScoreCAM and XRAI are particularly effective in retaining relevant image regions, as reflected in their higher AUC values. However, SICs highlight variability, with instances of random saliency masks outperforming established methods, emphasizing the need for combining visual and empirical metrics for a comprehensive evaluation.The results underscore the importance of selecting appropriate saliency methods for specific medical imaging tasks and suggest that combining qualitative and quantitative approaches can enhance the transparency, trustworthiness, and clinical adoption of deep learning models in healthcare. This study advances model explainability to increase trust in deep learning among healthcare stakeholders by revealing the rationale behind predictions. Future research should refine empirical metrics for stability and reliability, include more diverse imaging modalities, and focus on improving model explainability to support clinical decision-making.

PMID:38909228 | DOI:10.1186/s13040-024-00370-4

BMC Pediatr. 2024 Jun 22;24(1):403. doi: 10.1186/s12887-024-04879-9.

ABSTRACT

BACKGROUND: Diarrhea is considered to be one of the major public health concerns in developing countries. It has a detrimental impact, reflecting one of the highest child mortality rates globally, especially in Sub-Saharan Africa, where 2 out of every 10 children in Uganda under the age of five die. The objective of this study was to investigate the factors associated with time to treatment seeking by caretakers of children under-five with Diarrhea in Uganda.

METHOD: DOVE dataset of 745 caretakers in a prospective and retrospective incidence-based study using multi-stage sampling design was used in the assessment. The analysis was done using a time-to-event approach using life tables, Kaplan Meier survival analysis and multilevel proportional hazards model.

RESULTS: Kaplan-Meier survival analysis indicated the median time to seeking treatment among 745 caretakers of children under-Five after onset of diarrhea was 2 days. The multi-level proportional hazards model of a Weibull distribution showed that the estimated frailty variance was 0.13, indicating heterogeneity of treatment seeking time by caretakers of under-five children with diarrhea across regions in Uganda. Significant factors found to influence time to treatment-seeking by caretakers of children under-five with diarrhea were, male children (HR = 0.82; 95% CI = 0.71-0.95, p = 0.010), belonging to richest wealth quintile (HR = 1.37; 95% CI = 1.05-1.78, p = 0.022), and residing more than 5 km away from a health facility (HR = 0.68; 95% CI = 0.56-0.84, p = 0.000).

CONCLUSIONS: There are delays in seeking diarrhea treatment in Uganda because two days are enough to claim a life after dehydration.The policymakers should pay attention to formulate effective intervention to sensitize caregivers on the importance of early treatment-seeking behavior to avoid severe malnutrition caused by diarrhea. Community awareness program should also be encouraged particularly in areas of more than 5 km from the health facility to make people aware of the necessity to take prompt action to seek care in the early stage.

PMID:38909217 | DOI:10.1186/s12887-024-04879-9

BMC Med Res Methodol. 2024 Jun 22;24(1):136. doi: 10.1186/s12874-024-02257-8.

ABSTRACT

BACKGROUND: Generating synthetic patient data is crucial for medical research, but common approaches build up on black-box models which do not allow for expert verification or intervention. We propose a highly available method which enables synthetic data generation from real patient records in a privacy preserving and compliant fashion, is interpretable and allows for expert intervention.

METHODS: Our approach ties together two established tools in medical informatics, namely OMOP as a data standard for electronic health records and Synthea as a data synthetization method. For this study, data pipelines were built which extract data from OMOP, convert them into time series format, learn temporal rules by 2 statistical algorithms (Markov chain, TARM) and 3 algorithms of causal discovery (DYNOTEARS, J-PCMCI+, LiNGAM) and map the outputs into Synthea graphs. The graphs are evaluated quantitatively by their individual and relative complexity and qualitatively by medical experts.

RESULTS: The algorithms were found to learn qualitatively and quantitatively different graph representations. Whereas the Markov chain results in extremely large graphs, TARM, DYNOTEARS, and J-PCMCI+ were found to reduce the data dimension during learning. The MultiGroupDirect LiNGAM algorithm was found to not be applicable to the problem statement at hand.

CONCLUSION: Only TARM and DYNOTEARS are practical algorithms for real-world data in this use case. As causal discovery is a method to debias purely statistical relationships, the gradient-based causal discovery algorithm DYNOTEARS was found to be most suitable.

PMID:38909216 | DOI:10.1186/s12874-024-02257-8

BMC Womens Health. 2024 Jun 22;24(1):366. doi: 10.1186/s12905-024-03218-5.

ABSTRACT

BACKGROUND: Insulin resistance (IR) induces hyperinsulinemia, which activates downstream signaling pathways such as the phosphatidylinositol-3-kinase/protein kinase B (PI3K/AKT) pathway, ultimately leading to abnormal proliferation and apoptosis of endometrial cells. This is thought to be a key pathogenic mechanism underlying the development of endometrial polyps (EP). This study aims to investigate the relationship between IR and the development of EP, the expression levels of downstream signaling molecules, including PI3K and AKT, and related laboratory parameters were examined.

METHODS: A total of 100 patients who visited the gynecology outpatient clinic of Zhongda Hospital affiliated with Southeast University from May 2021 to March 2023 and were diagnosed with abnormal endometrial echoes by vaginal ultrasound and underwent hysteroscopic diagnostic curettage were enrolled in this study. General data and relevant hematological indicators were compared, and intraoperative specimens were obtained for pathological examination. Possible factors influencing the development of endometrial polyps were analyzed using Pearson correlation analysis and logistic regression analysis.

RESULTS: In terms of body mass index, waist circumference, fasting insulin, insulin resistance index, serum total testosterone, and free testosterone index, women of childbearing age in the endometrial polyp group had higher values than those in the non-polyp group, while sex hormone-binding globulin in the endometrial polyp group was lower than that in the non-polyp group, and the differences were statistically significant (P < 0.05). The expression scores and mRNA expression levels of PI3K and AKT proteins were higher in the EP group than in the non-EP group (p < 0.05). Pearson correlation analysis showed a positive correlation between HOMA-IR and the expression scores of PI3K and AKT proteins (p < 0.01).

CONCLUSIONS: Insulin resistance and abnormal activation of the phosphatidylinositol 3-kinase/protein kinase B signaling pathway may be potential pathogenic mechanisms for the development of endometrial polyps.

PMID:38909214 | DOI:10.1186/s12905-024-03218-5