Category: Statistics

Natl Med J India. 2023 Nov-Dec;36(6):370-373. doi: 10.25259/NMJI_944_2021.

ABSTRACT

Numerous studies have investigated the causes of falls in the elderly. However, there is little information about metabolic syndrome (MS) as a risk factor for falls in older adults. No evaluations have given a qualitative overview of studies examining the relationship between MS and falls in the elderly. We did a literature search in electronic databases to look for studies that assessed a link between MS and falls among people over the age of 55 years. We found three studies of high quality. These included 2774 people with an average age of 72 years. Even after controlling for other risk factors, two studies found that MS was significantly associated with an older adult’s 1.3-2.5-fold increased risk of falling. We found that MS and its independent components were strongly linked with falls among the elderly, even after correcting for numerous variables.

PMID:38909297 | DOI:10.25259/NMJI_944_2021

Med Sci Monit. 2024 Jun 23;30:e944628. doi: 10.12659/MSM.944628.

ABSTRACT

BACKGROUND Cephalometric radiography evaluates facial skeleton development and aids in diagnosis and treatment phases (pre and post) in orthodontics. This study aimed to compare digital cephalometric tracing using a smartphone application (App), a tablet-based platform, and manual tracing in 30 orthodontic patients. MATERIAL AND METHODS Thirty orthodontic pretreatment, criteria based, lateral cephalometric radiographs were analyzed/grouped for Steiner analysis parameters (5 skeletal, 3 dentals, 1 soft tissue) by 3 tracing methods [manual – group (Gp M), smartphone (Android – OS9) – Gp S, tablet (Apple – IOS13) – Gp T) after mandatory standardization/calibration. Measurements include 5 angular (SNA, SNB, ANB, SNMPA, SNOP), 3 linear U1NA, L1NB, U1L1, and 1 soft tissue (S line) (millimeters and degrees). Inter-examiner rating was determined using Dahlberg’s test. After normality distribution testing (Shapiro-Wilk), data were analyzed using one-way analysis of variance (ANOVA) for group differences. Homogeneity of variance was verified using the Levene test. Differences were determined on probability value of (p≤0.05). RESULTS The results showed that Steiner’s analysis parameters were similar in all groups with homogenous variances. Highest differences in mean values were found for L1NB, U1L1, and S line measurement, with higher values being observed in Gp S tracings. However, these differences were not statistically significant (p≤0.05). All parameters, irrespective of being measured in either degrees or millimeters, had means comparable to each other. CONCLUSIONS Smartphone and tablet-based applications produced tracings that were comparable and reliable when compared to conventional manual tracings. Standardization of images, processing, printing, and calibration of devices is important to achieve good results.

PMID:38909276 | DOI:10.12659/MSM.944628

Cardiooncology. 2024 Jun 22;10(1):39. doi: 10.1186/s40959-024-00242-0.

ABSTRACT

BACKGROUND: Doxorubicin (DXR) is an effective chemotherapeutic agent. DOX-induced cardiomyopathy (DICM), a major limitation of DXR, is a complication with limited treatment options. We previously reported that Red Ginseng (steamed and dried the root of Panax Ginseng cultivated for over six years; RGin) is beneficial for the treatment of DICM. However, the mechanism underlying the action of RGin remains unclear. In this study, we investigated the mechanism of action underlying the efficacy of RGin in the treatment of DICM.

METHODS: Four-week-old DBA/2 mice were divided into: vehicle, DXR, RGin, and DXR + RGin (n = 10/group). Mice were treated with DXR (4 mg/kg, once a week, accumulated 20 mg/kg, i.p.) or RGin (0.5 g/kg, three times a week, i.p.). To evaluate efficacy, the survival rate and left ventricular ejection fraction (LVEF) were measured as a measure of cardiac function, and cardiomyocytes were subjected to Masson trichrome staining. To investigate the mechanism of action, western blotting was performed to evaluate the expression of nuclear factor erythroid 2-related factor 2 (Nrf2), heme oxygenase 1, transferrin receptor (TfR), and other related proteins. Data were analyzed using the Easy R software. Between-group comparisons were performed using one-way analysis of variance and analyzed using a post-hoc Tukey test. Survival rates were estimated using the Kaplan-Meier method and compared using the log-rank test. P < 0.05 was considered statistically significant in all analyses.

RESULTS: RGin treatment prolongs survival and protects against reduced LVEF. In the DXR group, Nrf2 was not activated and cell death was accelerated. Furthermore, there was an increase in the TfR levels, suggesting abnormal iron metabolism. However, the DXR + RGin group showed activation of the Nrf2 pathway and suppression of myocardial cell death. Furthermore, there was no increase in TfR expression, suggesting that there were no abnormalities in iron metabolism. Therefore, the mechanism of action of RGin in DICM involves an increase in antioxidant activity and inhibition of cell death through activation of the Nrf2 pathway.

CONCLUSION: RGin is a useful therapeutic candidate for DICM. Its efficacy is supported by the activation of the Nrf2 pathway, which enhances antioxidant activity and inhibits cell death.

PMID:38909271 | DOI:10.1186/s40959-024-00242-0

Perioper Med (Lond). 2024 Jun 22;13(1):61. doi: 10.1186/s13741-024-00423-6.

ABSTRACT

BACKGROUND: Previous Ethiopian literature on surgical capacity and challenges has focused on quantitative investigations, lacking contextual understanding. This explanatory sequential mixed-methods research (MMR) aimed to assess perioperative capacity and contextual challenges at three teaching hospitals in southern Ethiopia.

METHODS: A quantitative survey assessed workforce, infrastructure, service delivery, financing, and information systems. The survey findings were explained by qualitative semi-structured interviews of twenty perioperative providers. Descriptive statistics were integrated with qualitative thematic analysis findings using the narrative waving approach. Key findings from both datasets were linked using a joint display table.

RESULTS: The survey revealed shortages in the specialist workforce (with a ratio of 0.58 per 100,000 population), surgical volume (at 115 surgeries per 100,000 population), equipment, supplies, financing, and perioperative data tracking. Hospitals’ radiology services and blood products were only available 25-50% of the time, while anesthetic agents and essential laboratory services were often available 51-75% of the time. Perioperative management protocols were used rarely (1-25% of the time). Over 90% of patients lack health insurance coverage. Qualitative data also revealed scarcity of perioperative resources and equipment; unaffordable perioperative costs, lack of health insurance coverage, and unforeseen expenses; poor patient safety culture and communication barriers across the perioperative continuum of care; workforce shortages, job dissatisfaction, and concerns of competence; and weak national governance, and sociopolitical turmoil, and global market volatility exacerbating local challenges. These challenges are linked to risks in quality of care and patient safety, according to clinicians.

CONCLUSION: The study identifies deficiencies in the health system and sociopolitical landscape affecting safe surgery conduct. It highlights the need for comprehensive health system strengthening to expand workforce, upgrade facilities, improve safety culture, resilience, and leadership to ensure timely access to essential surgery. Exploring external factors, such as the impact of national governance and sociopolitical stability on reform efforts is also essential.

PMID:38909267 | DOI:10.1186/s13741-024-00423-6

Alzheimers Res Ther. 2024 Jun 22;16(1):133. doi: 10.1186/s13195-024-01499-4.

ABSTRACT

BACKGROUND: Aim of this study was to detect predictors of better adherence to the AgeWell.de-intervention, a two-year randomized multi-domain lifestyle intervention against cognitive decline.

METHODS: Data of 317 intervention group-participants comprising a risk group for dementia (Cardiovascular Risk Factors, Ageing and Dementia (CAIDE) score of ≥ 9; mean age 68.9 years, 49.5% women) from the AgeWell.de intervention study were analysed. Regression models with four blocks of predictors (sociodemographic, cognitive and psychosocial, lifestyle factors and chronic conditions) were run on adherence to the components of nutrition, enhancement of social and physical activity and cognitive training. Adherence to each component was operationalised by assessing the degree of goal achievement per component at up to seven time points during the intervention period, measured using a 5-point Likert scale (mean score of goal achievement).

RESULTS: Increasing age was negatively associated with adherence, while higher education positively predicted adherence. Participants with better mental state (Montreal Cognitive Assessment (MoCA)-score > 25) at baseline and higher self-efficacy adhered better. Diabetes and cardiovascular conditions were not associated with adherence, whereas smoking negatively affected adherence. Highest education and quitting smoking in the past were the only predictors associated with all four intervention components.

CONCLUSION: Results identified predictors for better and worse adherence. Particularly self-efficacy seems to be of considerable influence on adherence. This should be considered when designing future intervention trials.

TRIAL REGISTRATION: German Clinical Trials Register (ref. number: DRKS00013555).

PMID:38909256 | DOI:10.1186/s13195-024-01499-4

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