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Nevin Manimala Statistics

Analysing Adverse Event Databases: Principles, Challenges, and Examples

J Eval Clin Pract. 2025 Aug;31(5):e70188. doi: 10.1111/jep.70188.

ABSTRACT

BACKGROUND: Databases of reported adverse events after vaccination are used to detect alarming signals by qualitative methods (case series) and quantitative methods (the proportional reporting ratio).

OBJECTIVE: This methodological-empirical paper explores several key questions: How useful are these databases for detecting alarming signals? To which study design do they correspond? Which measure of association should be computed? Which key biases might operate, and what can be done to avoid or reduce them?

METHODS: A contemporary methodological tool-causal diagrams-was used to answer these questions. The analytical approach was demonstrated for three possible outcomes of Covid vaccines: Thrombosis with Thrombocytopenia Syndrome, Guillain-Barré Syndrome, and reported death.

RESULTS: A database of reported adverse events corresponds to a case-control study and should be analysed accordingly. The preferred measure of association is the odds ratio, not the proportional reporting ratio. Reporting bias operates to overestimate the true odds ratio, whereas control selection bias operates in the opposite direction (underestimation). As illustrated by three examples of reported death, the magnitude of the biases depends on the choice of the reference vaccine. However, extended methodological and empirical work is needed.

CONCLUSIONS: Databases of reported adverse events after vaccination are a rich source for quantitative research, provided that several methodological guidelines are followed. These databases should be analysed according to the principles of a case-control study, and the inference should be drawn on a case-by-case basis. It is crucial to estimate the reporting accuracy of a particular event by the type of vaccine, and only a clinical evaluation of a sample of records can provide this information.

PMID:40618408 | DOI:10.1111/jep.70188

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Nevin Manimala Statistics

Service Improvement Needs an Understanding of Complex Environments: Causal Diagrams Help Elucidate Causes and Patient Safety Implications of Failure to Collect Vital Signs at Triage

J Eval Clin Pract. 2025 Aug;31(5):e70195. doi: 10.1111/jep.70195.

ABSTRACT

RATIONALE: Triage frequently fails to identify critically ill patients and needs improved methods. Limited understanding, or errors in multivariable models are likely to impede progress in service improvement.

AIMS: (1) to reveal a complex web of potential causal pathways stemming from nurses’ decisions at triage and patient flow. (2) to add to the understanding of, and research methodology for triage.

METHODS: Secondary data analysis of records from a 91 month convenience sample of all patients attending a general Emergency Department (ED) was used to pose new questions about the functioning of triage systems. A conceptual model of the impact of patient flow on triage decisions and subsequent events was developed. Directed Acyclic Graphs (DAGs) were constructed to assist in the understanding of results and future research.

RESULTS: Analysis showed a pivotal role for collection of vital signs data with far-reaching and surprisingly marked consequences. The response of triage nurses to time pressure revealed a complex ‘web’ of interactions and some unexpected findings. Safety and outcomes for patients were measurably affected and even the risky decisions some patients took to leave ED were influenced.

CONCLUSION: Triage is failing patients, ED staff and hospitals in complex ways and needs improvement. DAGs are useful for preventing mistakes in statistical analyses and improving research studies. By combining these with informal diagrams we hope to bridge communication barriers, since improving quality of care needs a multidisciplinary effort. Implications for the profession and patient care are outlined.

PMID:40618407 | DOI:10.1111/jep.70195

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Nevin Manimala Statistics

The Effects of Diagnosis-Related Group Payments on Hospitalisation Costs, Length of Stay, and In-Hospital Mortality: A Case Study in China

J Eval Clin Pract. 2025 Aug;31(5):e70153. doi: 10.1111/jep.70153.

ABSTRACT

OBJECTIVE: In this study, it was to evaluate the impact of diagnosis-related group (DRG) payments on hospitalisation costs, length of stay (LOS), and in-hospital mortality in Nanjing.

METHODS: A quasi-natural experiment was utilised. The intervention group consisted of patients enroled in the Urban Employee Basic Medical Insurance and Urban and Rural Resident Basic Medical Insurance programmes in Nanjing, while the other patients composed the comparison group. Interrupted time-series analysis and difference-in-differences combined with propensity score matching were employed in this study. The analysis was based on a case-level data set from a tertiary hospital between January 2021 and December 2022.

RESULTS: The introduction of the DRG payment caused a 13.5% decrease in hospitalisation costs per admission for the intervention group compared with the comparison group. Furthermore, the intervention group exhibited a slight reduction in the LOS of 0.75 days in comparison to the comparison group. No significant changes were observed in care quality, as measured by in-hospital mortality.

CONCLUSION: The DRG payment was effective in decreasing hospitalisation costs and length of stay. No compelling evidence was identified in terms of the changes in in-hospital mortality. The evidence from China may also be valuable to other developing countries considering the adoption of DRG payments.

PMID:40618405 | DOI:10.1111/jep.70153

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Nevin Manimala Statistics

Introduction of a Third Trimester Pregnancy Patient Education Guide and Effects on Patient Satisfaction With Counseling: A Prospective Cohort Study

J Eval Clin Pract. 2025 Aug;31(5):e70202. doi: 10.1111/jep.70202.

ABSTRACT

AIMS AND OBJECTIVES: To assess whether a workflow change introducing a third trimester pregnancy education guide would be associated with increased patient satisfaction regarding prenatal counseling.

METHODS: We surveyed pregnant patients between 34w0d-41w6d during a single prenatal appointment at one of two hospital-associated offices. We enrolled 49 ‘pre-guide’ patients March-May 2023 and 50 ‘post-guide’ patients October-December 2023, after a 4-month washout period. We performed t-tests and chi-squared analyses to compare the groups.

RESULTS: The cohorts had similar sociodemographic characteristics aside from lower education level in the post-guide cohort (p = 0.01). There was no significant difference between the groups and their reported satisfaction with third trimester and delivery counseling (p = 0.92). Those who received the guide were more likely to feel they were more adequately counseled regarding ‘pain management in childbirth’ (p = 0.01), but there were no other statistically significant differences between the groups. Of those who received the guide, 75% felt that it reduced their anxiety and stress about the unknown and 100% would recommend it to others.

CONCLUSIONS: We did not find that introduction of an informational guide about the third trimester of pregnancy significantly affected their satisfaction with their third trimester and delivery counseling or patient perception of the adequacy of counseling on specific pregnancy topics. All patients who received the guide noted they would recommend it to others.

PMID:40618398 | DOI:10.1111/jep.70202

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Nevin Manimala Statistics

Oral Health Status of the Elderly Population in Iran

Clin Exp Dent Res. 2025 Aug;11(4):e70170. doi: 10.1002/cre2.70170.

ABSTRACT

OBJECTIVES: To evaluate the oral, periodontal, and dental health of the elderly population of Iran.

MATERIAL AND METHODS: This was a cross-sectional study as a part of the second wave of Birjand Longitudinal Aging Study (BLAS), which is a community-based prospective cohort study. The comprehensive geriatric oral health assessment tool was used for data collection. Data was collected through clinical examinations.

RESULTS: Among the 1017 participants, the mean DMFT was 27.04. 67% (n = 681) were periodontally healthy, while mild to moderate periodontitis was diagnosed in 33% (n = 336) and severe periodontitis in 2.4% (n = 24). Xerostomia was diagnosed in 30% (305 individuals). 56.10% (n = 570) had removable dentures, among which 30.21% (n = 172) had poor retention, and 36.26% (n = 207) had poor stability. Red/white and exophytic lesions were diagnosed in 18.36% (n = 187) and 11.35% (n = 115), respectively. Tooth loss was prevalent, with 12.19% (n = 124) having mild tooth loss, 20.35% (n = 207) mild to moderate tooth loss, and 67.45% (n = 686) experiencing severe tooth loss.

CONCLUSIONS: Our study revealed significant oral health challenges among the elderly population. High DMFT and the prevalence of xerostomia, periodontitis, tooth loss and poorly fitted dentures underscore the need for targeted dental care interventions. Comprehensive strategies, including raising awareness and improving access to oral healthcare, are essential to enhance the quality of life and overall health of the elderly population.

PMID:40618396 | DOI:10.1002/cre2.70170

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Nevin Manimala Statistics

Prevalence and Determinants of Malocclusion among Preschool Children in Maiduguri

West Afr J Med. 2025 Feb 28;42(2):121-126.

ABSTRACT

BACKGROUND: Malocclusion is an abnormality of teeth alignment from interactions of hereditary and environmental factors, associated with stimuli present at the period of formation and development of the face and oral tissues.

OBJECTIVES: To determine the prevalence and determinants of malocclusion among preschool children in Maiduguri, Borno State.

METHODS: This study involved 239 pre-school children selected by systematic random sampling. The independent variables were ‘presence / absence of sucking habits’, ‘type of sucking habit’, ‘molar relationship’ and ‘nutritional status. The dependent variable was presence of malocclusion and ‘type of malocclusion. Frequency distribution of independent and dependent variables were presented. Association between the independent and dependent variables were obtained using Chi-Square test. Statistical significance was placed at 95% confidence intervals, p value ≤ 0.05. Data was analysed using SPSS for Windows (version 23).

RESULTS: Majority of participants were in the higher social class, (P=0.07), never had a dental visit (78.2%), P=0.08 and did not have any sucking habit (82.4%), P= 0.03. Most had mesial step (42.7%) or flush terminal molar relationship (37.7%), P=0.05. Prevalence of malocclusion was 4.5%, majority were cross bite (64.4%) SE=0.04. Distal step and flush terminal molar relationship were associated with prevalence of malocclusion (12.5% and 4.4% respectively), P=0.08.Fifty percent of those with digit sucking habit had cross bite, P=0.01.

CONCLUSIONS: Prevalence of malocclusion among preschool children in this study was low and majority had cross-bite. Digit sucking was significantly associated with cross bite. Children with distal step occlusion exhibited higher proportion of malocclusion. There is need for dental awareness on malocclusion among the population.

PMID:40618390

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Nevin Manimala Statistics

Paracetamol-Diclofenac Versus Pentazocine-Diclofenac for Post-Caesarean Section Pain Relief: A Double Blind Randomized Controlled Trial

West Afr J Med. 2025 Feb 28;42(2):114-120.

ABSTRACT

BACKGROUND: Effective pain relief after caesarean section (CS) is desirable but pentazocine which has been a common component of multimodal analgesia may delay early mobilization and mother-child interaction due to its side effects.

OBJECTIVE: This study compared the efficacy of paracetamol-diclofenac with pentazocine-diclofenac for post- CS analgesia.

METHODS: A double-blind randomized controlled trial of three hundred and eighteen consenting parturients who had elective or emergency caesarean section were randomly assigned to two groups. A total of 159 participants were assigned to each group: one group received 750 mg of intravenous paracetamol, while the other received 30 mg of intravenous pentazocine. Both also had 100 mg of rectal suppository diclofenac as multimodal post-caesarean section analgesia in the first 24 hours after surgery. Post-operative pain was assessed by a visual analogue scale six hourly post-operatively. Data obtained was analysed using SPSS 26 and statistical significance was at p < 0.05. The study is registered with the Pan African Clinical Trials Registry with trial number PACTR202501703002153.

RESULTS: The median pain scores in both groups ranged from 2.5 to 4 across all periods of assessment. However, at the first assessment conducted at six hours post-operatively, the scores were higher-4.5 in the pentazocine-diclofenac arm and 5 in the paracetamol-diclofenac arm. Pain relief was slightly better in the pentazocine-diclofenac group, but this was not statistically significant. The pentazocine-diclofenac group experienced significantly more side effects, specifically nausea and drowsiness, compared to the paracetamol-diclofenac group (P < 0.001). Patient satisfaction with pain relief was not significantly different between both groups (p=0.101).

CONCLUSION: Pentazocine-Diclofenac provided better analgesia than Paracetamol-Diclofenac in the first 24 hours after caesarean section but was associated with more side effects.

PMID:40618387

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Nevin Manimala Statistics

Work-Related Stress among Academic Staff of a Higher Institution in South-west, Nigeria: A Cross-sectional Study

West Afr J Med. 2025 Feb 28;42(2):90-96.

ABSTRACT

BACKGROUND AND OBJECTIVES: Work-related stress has been described as a global epidemic of the 21st century. University lecturers are observed to be exposed to various degrees of occupational stress which influence their multiple roles to impart knowledge and skills to students. This study assessed the prevalence of work-related stress and the factors influencing it among university lecturers in Lagos.

METHODS: A cross-sectional study design among 424 respondents using a multi-stage sampling technique was conducted. Work Stress Questionnaire (WSQ) tool, covering 4 main domains, (Influence at work, Indistinct organization and conflict, Individual demand and commitment, & Leisure time interference) was used to assess work-related stress among university lecturers in LASU, Ojo, Nigeria. Data was collected with KoboCollect app using an interviewer-administered questionnaire, and analyzed using SPSS software version 25 software. Data was presented using descriptive (percentages, summary measures) and inferential statistics (Chi-square test). Level of statistical significance set at p-value<0.05.

RESULTS: Mean age of respondents was 49.9+8.2SD years. Male respondents were twice as more than female respondents. Majority (93.4%) of respondents were married and average work experience was 16.7+8.6SD years. Overall prevalence of work-related stress was (80.5%). However, stress due to leisure time interference was (36.1%). There was a statistically significant association between work-related stress and family size(p<0.05), gender(p<0.05), marital status(p<0.05) and work experience(p<0.05).

CONCLUSION: The prevalence of work-related stress was high. High family size, male gender, being single and shorter work experience, were statistically significantly associated with work-related stress. Adequate awareness of work-life balance measures should be entrenched with enabling environment.

PMID:40618379

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Nevin Manimala Statistics

Predictors of Erectile Dysfunction among Nigerian Men with Type 2 Diabetes Mellitus

West Afr J Med. 2025 Feb 28;42(2):83-89.

ABSTRACT

INTRODUCTION AND OBJECTIVES: Erectile dysfunction (ED) is common among men over 40years and prevalence increases with age. ED occurs at an earlier age in the diabetic population and strongly associated with serum testosterone, age, hypertension and obesity. The aim of this study was to determine the predictors of ED among type 2 diabetic Nigerian men.

MATERIALS AND METHODS: A cross-sectional hospital-based study done among patients with ED and diabetes. ED was assessed using International Index of Erectile Function (IIEF) 5 questionnaire. Age, BMI serum testosterone, glycosylated haemoglobin and fasting lipid profile were measured in each group.

RESULTS: A total of 102 participants were recruited; 51 participants in each study group. Majority, were >55 years in the diabetic and non-diabetic groups respectively (p = 0.456). The BMI and the waist circumference of the two groups showed statistically significant difference (0.006 and 0.007 respectively). The weight, hip circumference and waist/hip ratio of the two groups showed no statistical significance. The median value of serum testosterone for the non-diabetic group (622.2ng/ml) was significantly higher than the diabetic group (288ng/ml) (p=0.001). Multivariate logistic regression analysis showed increased risk of ED in diabetic patients aged > 60years ( OR 4.9), serum testosterone <270ng/ml (OR 3.8), hypertension (OR 2.93), fasting blood glucose (FBS) >125mg/dl (OR 2.6), low density lipoprotein (LDL) > 160mg/dl (OR 6.3) and triglyceride >150mg/dl (OR 2.9).

CONCLUSION: The study showed that age, serum testosterone, hypertension, elevated FBS and dyslipidaemia are independent predictors of ED among type 2 diabetic men.

PMID:40618378

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Nevin Manimala Statistics

Identifying risk factors for soil-transmitted helminths among indigenous communities in Simalungun, North Sumatra

Trop Biomed. 2025 Jun 1;42(2):85-89. doi: 10.47665/tb.42.2.001.

ABSTRACT

Soil-transmitted helminths (STH) are among the most common parasitic infections associated with neglected tropical diseases (NTDs), particularly in regions with poor sanitation and hygiene. The prevalence of STH is disproportionately high in middle- to low-income countries due to inadequate infrastructure and hygiene practices. This study aimed to identify risk factors associated with STH infections among native communities in the rural Simalungun District, North Sumatra, Indonesia. A cross-sectional study was conducted among 592 native Simalungun Bataknese individuals living and working in 14 villages across the district. Participants were interviewed regarding sanitation, hygiene practices, and demographic factors, while fecal samples were collected for parasitological examination using the direct smear and Kato-Katz methods. All laboratory analyses were conducted at the Parasitology Laboratory, Faculty of Medicine, Universitas Sumatera Utara, and interpreted by a parasitologist. Statistical analysis was performed using chi-square tests and multivariate logistic regression to identify significant risk factors for STH infection. The overall STH prevalence was 14.5% (86/592 participants), with identified species including Trichuris trichiura (33.7%), hookworm (31.4%), Ascaris lumbricoides (11.6%), and mixed infections (23.3%). Multivariate analysis revealed two significant risk factors for STH infection: consumption of uncooked drinking water (AOR 2.05, 95% CI 1.10-3.81, p=0.000) and not using a toilet with a septic tank (AOR 2.38, 95% CI 1.46-3.87). These findings highlight the critical role of sanitation and water safety in reducing STH transmission. Improving access to safe drinking water and proper sanitation facilities is essential for controlling STH infections in rural communities.

PMID:40618354 | DOI:10.47665/tb.42.2.001