Medicine
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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
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Item Development and validation of a cardiovascular risk prediction model for Sri Lankans using machine learning.(Public Library of Science, 2024-10) Mettananda, C.; Sanjeewa, I.; Arachchi, T.B.; Wijesooriya, A.; Chandrasena, C.; Weerasinghe, T.; Solangaarachchige, M.; Ranasinghe, A.; Elpitiya, I.; Sammandapperuma, R.; Kurukulasooriya, S.; Ranawaka, U.; Pathmeswaran, A.; Kasturiratne, A.; Kato, N.; Wickramasinghe, R.; Haddela, P.; De Silva, J.INTRODUCTION AND OBJECTIVES Sri Lankans do not have a specific cardiovascular (CV) risk prediction model and therefore, World Health Organization(WHO) risk charts developed for the Southeast Asia Region are being used. We aimed to develop a CV risk prediction model specific for Sri Lankans using machine learning (ML) of data of a population-based, randomly selected cohort of Sri Lankans followed up for 10 years and to validate it in an external cohort.MATERIAL AND METHODS The cohort consisted of 2596 individuals between 40-65 years of age in 2007, who were followed up for 10 years. Of them, 179 developed hard CV diseases (CVD) by 2017. We developed three CV risk prediction models named model 1, 2 and 3 using ML. We compared predictive performances between models and the WHO risk charts using receiver operating characteristic curves (ROC). The most predictive and practical model for use in primary care, model 3 was named "SLCVD score" which used age, sex, smoking status, systolic blood pressure, history of diabetes, and total cholesterol level in the calculation. We developed an online platform to calculate the SLCVD score. Predictions of SLCVD score were validated in an external hospital-based cohort.RESULTS Model 1, 2, SLCVD score and the WHO risk charts predicted 173, 162, 169 and 10 of 179 observed events and the area under the ROC (AUC) were 0.98, 0.98, 0.98 and 0.52 respectively. During external validation, the SLCVD score and WHO risk charts predicted 56 and 18 respectively of 119 total events and AUCs were 0.64 and 0.54 respectively.CONCLUSIONS SLCVD score is the first and only CV risk prediction model specific for Sri Lankans. It predicts the 10-year risk of developing a hard CVD in Sri Lankans. SLCVD score was more effective in predicting Sri Lankans at high CV risk than WHO risk charts.Item Antenatal oral glucose tolerance test abnormalities in the prediction of future risk of postpartum diabetes in women with gestational diabetes: Results from the living study(Blackwell Publishing Asia, 2024) Gupta, Y.; Kapoor, D.; Lakshmi, J.K.; Praveen, D.; Santos, J.A.; Billot, L.; Naheed, A.; De Silva, H.A.; Gupta, I.; Farzana, N.; John, R.; Ajanthan, S.; Bhatla, N.; Desai, A.; Pathmeswaran, A.; Prabhakaran, D.; Teede, H.; Zoungas, S.; Patel, A.; Tandon, N.OBJECTIVES To explore associations between type and number of abnormal glucose values on antenatal oral glucose tolerance test (OGTT) with postpartum diabetes in South Asian women diagnosed with gestational diabetes (GDM) using International Association of the Diabetes and Pregnancy Study Groups criteria.METHODS This post-hoc evaluation of the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, a randomized controlled trial, was conducted among women with GDM in the index pregnancy, across 19 centers in Bangladesh, India, and Sri Lanka. Postpartum diabetes (outcome) was defined on OGTT, using American Diabetes Association (ADA) criteria.RESULTS We report data on 1468 women with GDM, aged 30.9 (5.0) years, and with median (interquartile range) follow-up period of 1.8 (1.4-2.4) years after childbirth following the index pregnancy. We found diabetes in 213 (14.5%) women with an incidence of 8.7 (7.6-10.0)/100 women-years. The lowest incidence rate was 3.8/100 women years, in those with an isolated fasting plasma glucose (FPG) abnormality, and highest was 19.0/100 women years in participants with three abnormal values. The adjusted hazard ratios for two and three abnormal values compared to one abnormal value were 1.73 (95% confidence interval [CI], 1.18-2.54; p = .005) and 3.56 (95% CI, 2.46-5.16; p < .001) respectively. The adjusted hazard ratio for the combined (combination of fasting and postglucose load) abnormalities was 2.61 (95% CI, 1.70-4.00; p < .001), compared to isolated abnormal FPG.CONCLUSIONS Risk of diabetes varied significantly depending upon the type and number of abnormal values on antenatal OGTT. These data may inform future precision medicine approaches such as risk prediction models in identifying women at higher risk and may guide future targeted interventions.Item Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka(BMJ Publishing Group Ltd, 2023) Mettananda, C.; Peiris, C.; Abeyrathna, D.; Gunasekara, A.; Egodage, T.; Dantanarayana, C.; Pathmeswaran, A.; Ranasinha, C.OBJECTIVES: To study if early initiation of inhaled beclomethasone 1200 mcg in patients with asymptomatic, mild or moderate COVID-19 reduces disease progression to severe COVID-19. DESIGN: Double-blinded, parallel-groups, randomised, placebo-controlled trial. SETTING: A hospital-based study in Sri Lanka. PARTICIPANTS: Adults with asymptomatic, mild or moderate COVID-19, presenting within the first 7 days of symptom onset or laboratory diagnosis of COVID-19, admitted to a COVID-19 intermediate treatment centre in Sri Lanka between July and November 2021. INTERVENTIONS: All participants received inhaled beclomethasone 600 mcg or placebo two times per day, for 10 days from onset of symptoms/COVID-19 test becoming positive if asymptomatic or until reaching primary endpoint, whichever is earlier. PRIMARY OUTCOME MEASURE: Progression of asymptomatic, mild or moderate COVID-19 to severe COVID-19. SECONDARY OUTCOME MEASURES: The number of days with a temperature of 38°C or more and the time to self-reported clinical recovery. RESULTS: A total of 385 participants were randomised to receive beclomethasone(n=193) or placebo(n=192) stratified by age (≤60 or >60 years) and sex. One participant from each arm withdrew from the study. All participants were included in final analysis. Primary outcome occurred in 24 participants in the beclomethasone group and 26 participants in the placebo group (RR 0.90 ; p=0.763). The median time for self-reported clinical recovery in all participants was 5 days (95% CI 3 to 7) in the beclomethasone group and 5 days (95% CI 3 to 8) in the placebo group (p=0.5). The median time for self-reported clinical recovery in patients with moderate COVID-19 was 5 days (95% CI 3 to 7) in the beclomethasone group and 6 days (95% CI 4 to 9) in the placebo group (p=0.05). There were no adverse events. CONCLUSIONS: Early initiation of inhaled beclomethasone in patients with asymptomatic, mild or moderate COVID-19 did not reduce disease progression to severe COVID-19. TRIAL REGISTRATION NUMBER: Sri Lanka Clinical Trials Registry; SLCTR/2021/017.Item The association between negative experiences during childhood and social anxiety disorder: A cross-sectional study among Sri Lankan university students(Sri Lanka Medical Association, 2023) de Silva, B.G.R.; De Zoysa, P.T.; Pathmeswaran, A.; Williams, S.S.INTRODUCTION: Social Anxiety Disorder (SAD) demonstrates early-onset, chronic course, and impairment in all social spheres. OBJECTIVES: The study objective was to explore the association between negative childhood experiences among a university student sample that indicated a high prevalence of SAD. METHODS: A cross-sectional study was conducted among 1137 students from five state universities. The Liebowitz Social Anxiety Scale – Sinhala version, and a correlates questionnaire including a culturally adapted Adverse Childhood Events Questionnaire and contextually appropriate parenting-related questions, were used as instruments. The analysis included chi-square tests for independence, spearman’s r correlations, and binary logistic regressions. RESULTS: Within the sample, 52.2% were female, and 66% were between 21-23 years. All faculties were represented with 27.5% from engineering. 32.2% of participants were first years. Bivariate analyses identified that being an eyewitness towards violence towards mother, feeling unsafe, feeling mistreated by family, experiencing physical abuse, experiencing sexual abuse, experiencing emotional abuse, experiencing parental dissatisfaction, and parental overcontrol to be significantly (p<0.05) associated with SAD. Continuous variables of Parent dissatisfaction (AOR=1.07, 95% CI 1.01-1.13, p<0.05), parent overcontrol (AOR=1.08, 95% CI 1.02-1.15, p<0.01) and experiences of emotional abuse (AOR=1.31, 95%CI 1.11-1.54, p=0.001) remained independently associated with SAD on regression analysis. CONCLUSIONS: Findings from this study corroborate the literature on the association between childhood experiences and parenting-related factors and SAD. The findings also highlight for the first time that Sri Lankan university students are no exception. An urgent need for awareness and prevention of adverse experiences within the family context, and early intervention to prevent the development of SAD are crucial.Item Identification of type 2 diabetes patients with non-alcoholic fatty liver disease who are at increased risk of significant hepatic fibrosis: a cross-sectional study(Sri Lanka Medical Association, 2023) Mettananda, K.C.D.; Egodage, T.; Dantanarayana, C.; Solangarachchi, M.B.; Fernando, R.; Ranaweera, L.; Siriwardhena, S.; Ranawaka, C.K.; Kottahachchi, D.; Pathmeswaran, A.; Dassanayake, A.S.; de Silva, H.J.INTRODUCTION: Annual screening of patients with diabetes for fatty liver, and identifying those with significant hepatic fibrosis using the FIB-4 score and vibration-controlled transient elastography (VCTE) has been recommended to detect patients who may progress to advanced hepatic fibrosis/cirrhosis. However, VCTE is not freely available in resource-limited settings. OBJECTIVES: To identify clinical and biochemical predictors of significant liver fibrosis in diabetics with fatty liver. METHODS: We conducted a cross-sectional study among all consenting adults with T2DM and non-alcoholic fatty liver disease (NAFLD) attending the Colombo North Teaching Hospital, Ragama, Sri Lanka from November 2021 to November 2022. FIB-4 scores were calculated and patients with a score ≥1.3 underwent VCTE. Risk associations for liver fibrosis were identified by comparing patients with significant fibrosis (LSM ≥8 kPa) with those without significant fibrosis (FIB-4<1.3). RESULTS: A total of 363 persons were investigated. Of these, 243 had a score of FIB-4 <1.3. Of the 120 with a FIB-4 ≥1.3, 76 had LSM ≥8 kPa. Significant fibrosis was individually associated with age (OR 1.01, p<0.0001), duration of diabetes (OR 1.02, p=0.006), family history of liver disease (OR 1.42, p=0.035), waist (OR 1.04, p=0.035), and FIB-4 (OR 2.08, p<0.0001). However, on adjusted analysis, significant fibrosis was only associated with a family history of liver disease (OR 2.69, p=0.044) and FIB-4 (OR 1.43, p<0.001). CONCLUSION: In patients with T2DM and fatty liver, advancing age, increased duration of diabetes, a family history of liver disease, waist circumference and a high FIB-4 score increase the risk of significant hepatic fibrosis. Targeted interventions in this group may help prevent progression to advanced hepatic fibrosis/cirrhosis.Item The incidence and risk factors of postpartum diabetes in women from Bangladesh, India and Sri Lanka (South Asia) with prior gestational diabetes mellitus: Results from the LIVING study(Elsevier, 2023) Gupta, Y.; Kapoor, D.; Lakshmi, J.K.; Praveen, D.; Santos, J.A.; Billot, L.; Naheed, A.; de Silva, H.A.; Gupta, I.; Farzana, N.; John, R.; Ajanthan, S.; Bhatla, N.; Desai, A.; Pathmeswaran, A.; Prabhakaran, D.; Teede, H.; Zoungas, S.; Patel, A.; Tandon, N.; LIVING Collaborative GroupAIM: To study, the incidence and risk factors for postpartum diabetes (DM), in women with gestational diabetes mellitus (GDM) from South Asia (Bangladesh, India and Sri Lanka), followed for nearly two years after delivery. METHODS: Women with prior GDM diagnosed using IADPSG criteria were invited at 19 centres across Bangladesh, India and Sri Lanka for an oral glucose tolerance test (OGTT) following childbirth, and were enrolled in a randomized controlled trial. The glycaemic category (outcome) was defined from an OGTT based on American Diabetes Association criteria. RESULTS: Participants (n = 1808) recruited had a mean ± SD age of 31.0 ± 5.0 years. Incident DM was identified, between childbirth and the last follow-up, in 310 (17.1 %) women [incidence 10.75/100 person years], with a median follow-up duration of 1.82 years after childbirth. Higher age, lower education status, higher prior pregnancy count, prior history of GDM, family history of DM, and postpartum overweight/obese status were significantly associated with incident DM. Women in Bangladesh had a higher cumulative incidence of DM [16.49/100 person years] than in Sri Lanka [12.74/100 person years] and India [7.21/100 person years]. CONCLUSIONS: A high incidence of DM was found in women with prior GDM in South Asia, with significant variation between countries. Women from Bangladesh had a significantly higher pregnancy count, family history of DM and overweight/obese status, despite having significantly lower age, which could be responsible for their higher rates of DM. Registration of this study: The study was registered with the Clinical Trials Registry of India (CTRI/2017/06/008744), Sri Lanka Clinical Trials Registry (SLCTR/2017/001), and ClinicalTrials.gov (NCT03305939).Item Identification of patients with type 2 diabetes with non-alcoholic fatty liver disease who are at increased risk of progressing to advanced fibrosis: a cross-sectional study(BMJ Publishing Group Ltd, 2023) Mettananda, C.; Egodage, T.; Dantanarayana, C.; Fernando, R.; Ranaweera, L.; Luke, N.; Ranawaka, C.; Kottahachchi, D.; Pathmeswaran, A.; de Silva, H.J.; Dassanayake, A.S.INTRODUCTION: Identification of advanced hepatic fibrosis in non-alcoholic fatty liver disease (NAFLD) is important as this may progress to cirrhosis and hepatocellular carcinoma. The risk of hepatic fibrosis is especially high among patients with diabetes with NAFLD. Annual screening of patients with diabetes for fatty liver and calculation of Fibrosis-4 (FIB-4) score and exclusion of significant fibrosis with vibration-controlled transient elastography (VCTE) have been recommended. However, VCTE is expensive and may not be freely available in resource-limited settings. We aim to identify predictors of significant liver fibrosis who are at increased risk of progression to advanced liver fibrosis and to develop a prediction model to prioritise referral of patients with diabetes and NAFLD for VCTE. METHODS AND ANALYSIS: This cross-sectional study is conducted among all consenting adults with type 2 diabetes mellitus with NAFLD at the Colombo North Teaching Hospital, Ragama, Sri Lanka. All patients get the FIB-4 score calculated. Those with FIB-4 ≥1.3 undergo VCTE (with FibroScan by Echosens). Risk associations for progression to advanced liver fibrosis/cirrhosis will be identified by comparing patients with significant fibrosis (liver stiffness measure (LSM) ≥8 kPa) and without significant fibrosis (LSM <8 kPa). A model to predict significant liver fibrosis will be developed using logistic regression. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Committee of the Faculty of Medicine, University of Kelaniya (P/66/07/2021). Results of the study will be disseminated as scientific publications in reputable journals.Item Alcohol use and alcoholic fatty liver disease: a prospective, communitybased study among adults in an urban community in Sri Lanka(The Sri Lanka Medical Association, 2022) Niriella, M.A.; Kasturiratne, A.; Beddage, T.; de Silva, S.T.; Dassanayake, A.S.; Pathmeswaran, A.; Wickremasinghe, A.R.; Kato, N.; de Silva, H.J.Background: Data on alcoholic fatty liver (AFL) is limited. Therefore, we investigated alcohol use and AFL in a cohort of adults in an urban community in Sri Lanka. Methods: The study population (selected by age-stratified random sampling) was screened in 2007 (35-64 years) and re-evaluated in 2014. They were assessed by structured interviews, anthropometric measurements, liver-ultrasound, and biochemical and serological tests. AFL was diagnosed on ultrasound criteria, ‘unsafe’ alcohol consumption (Asian standards: males>14 units, females >7 units per week) and absence of hepatitis B/C markers. Controls were unsafe alcohol consumers who had no fatty liver on ultrasound. Results: 2985/3012 (99%) had complete data for analysis. 272/2985 (9.1%) were unsafe-drinkers in 2007 [males-270; mean-age-51.9, SD-8.0 years]. 86/272 (31.6%) had AFL [males-85; mean-age-50.2, SD-8.6 years]. Male gender [p<0.001], increased waist circumference (WC) [OR 4.9, p<0.01], BMI>23kg/m2 [OR 3.5, p<0.01] and raised alanine aminotransferase (ALT) [OR 2.8, p<0.01] were independently associated with AFL. 173/272 (63.6%) unsafe alcohol consumers from 2007 were re-evaluated in 2014. 134/173 had either had AFL or had changed to ‘safe’ or no alcohol consumption. 21/39 (53.8%) [males-21 (100%), meanage- 57.9, SD-7.9 years] who remained ‘unsafe’ alcohol users who had no fatty liver in 2007 developed AFL after 7-years (annual incidence 7.7%). On bivariate analysis, only male gender was associated with new-onset AFL. Of the 42 who had AFL at baseline but changed their drinking status from unsafe to safe or no alcohol, 6 had resolution of fatty liver in 2014. Conclusion: In this community-based study among adults from an urban community, unsafe alcohol use was found in 9.1%. Among unsafe alcohol users, the prevalence of AFL was 31.6% and the annual incidence of AFL was 7.7%. New-onset AFL was independently associated with male gender.Item Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial(American Medical Association, 2022) Tandon, N.; Gupta, Y.; Kapoor, D.; Lakshmi, J.K.; Praveen, D.; Bhattacharya, A.; Billot, L.; Naheed, A.; de Silva, A.; Gupta, I.; Farzana, N.; John, R.; Ajanthan, S.; Divakar, H.; Bhatla, N.; Desai, A.; Pathmeswaran, A.; Prabhakaran, D.; Joshi, R.; Jan, S.; Teede, H.; Zoungas, S.; Patel, A.; LIVING Collaborative Group.Importance: Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. Objective: To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. Design, setting, and participants: This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021. Interventions: A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care. Main outcomes and measures: The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight. Results: A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome. Conclusions and relevance: This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals.Item Impact of COVID-19 on stroke admissions in a Sri Lankan tertiary care hospital:Data from the Ragama stroke registry(Ceylon College of Physicians, 2021) Deelaka, A.G.S.; Dep WDC, W.D.C.; Nanayakkara, Y.P.; Chandrasiri, H.M.J.; Mettananda, K.C.D.; Pathmeswaran, A.; Ranawaka, U.K.Introduction and Objectives The coronavirus disease 2019 (COVID-19) pandemic has had a tremendous impact on stroke care globally. We investigated the impact of the pandemic on stroke admissions in a Sri Lankan tertiary care hospital. Methods We studied the number of admissions to the Stroke Unit and the University Medical Unit, Colombo North Teaching Hospital (CNTH) over four years, and delays in seeking medical care of patients admitted to the Stroke Unit. We compared data during a calendar year of COVID pandemic (01.04.2020 - 31.03.2021) with the preceding 3 pre-COVID years (01.04.2017 一 31.03.2020). Data regarding COVID year was compared with pre-COVID years using independent-samples t-test and nonparametric test. Results Mean number of stroke admissions per month during the pandemic was significantly lower compared to that of pre-COVID years: Stroke Unit (monthly mean admissions, COVID year vs pre-COVID years; 11 ± 3.5 vs 20 ± 3.1; pv0.01); University Medical Unit (12 ± .2 vs 18 ± 3.4; p<0.01). The lowest number of admissions was reported during the period with the highest COVID caseload in Sri Lanka. However, there was no significant difference in the median delays to seeking medical care between the COVID pandemic and pre-COVID years: delay to first medical contact: 2.0 h vs 2.4 h, p=0.208; first hospital admission: 3.0 h vs 3.0 h; p=0.993, admission to CNTH: 3.4 h vs 5.0 h; p=0.174. Conclusions Stroke admissions were significantly lower during the COVID pandemic, but there was no difference in the delays in seeking medical care during the same period.