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.

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.

Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka.

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.

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.

AIM: 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).

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.

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.

Measuring antenatal depressive symptoms across the world: A validation and cross-country invariance analysis of the Patient Health Questionnaire-9 (PHQ-9) in eight diverse low-resource settings.

Measures that produce valid and reliable antenatal depressive symptom scores in low-resource country contexts are important for efforts to illuminate risk factors, outcomes, and effective interventions in these contexts. Establishing the psychometric comparability of scores across countries also facilitates analyses of similarities and differences across contexts. To date, however, few studies have evaluated the psychometric properties and comparability of the most widely used antenatal depressive symptom measures across diverse cultural, political, and social contexts. To address this gap, we used data from the Evidence for Better Lives Study-Foundational Research (EBLS-FR) project to examine the internal consistency reliability, nomological network validity, and cross-country measurement invariance of the nine-item version of the Patient Health Questionnaire (PHQ-9) in antenatal samples across eight low-resource contexts. We found that the PHQ-9 scores had good internal consistency across all eight countries. Correlations between PHQ-9 scores and constructs conceptually associated with depression were generally consistent, with a few exceptions. In measurement invariance analyses, only partial metric invariance held and only across four of the countries. Our results suggest that the PHQ-9 yields internally consistent scores when administered in culturally diverse antenatal populations; however, the meaning of the scores may vary. Thus, interpretation of PHQ-9 scores should consider local meanings of symptoms of depression to ensure that context-specific conceptualizations and manifestations of antenatal depressive symptoms are adequately reflected. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial.

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. Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939.

Short-term pain trajectories in patients with knee osteoarthritis.

AIM: It is unknown if pain in knee osteoarthritis (KOA) follows distinct patterns over the short term. Therefore, the aim of this study was to identify whether persons with a previous history of KOA pain fluctuations have distinct trajectories of pain over 90 days and to examine associations between baseline characteristics and pain trajectories. METHOD: People with a previous history of KOA were selected from a web-based longitudinal study. Baseline variables were sex, age, being obese/overweight, years of KOA, knee injury, knee buckling, satisfactory Lubben Social Support Score, pain and stress scales, Intermittent Constant Osteoarthritis Pain Score (ICOAP), medication use, and physical activity. Participants completed a Knee Injury and Osteoarthritis Outcomes Score (KOOS) pain subscale (KOOS-p, rated 0 = extreme to 100 = no knee problems) at 10-day intervals for 90 days. Short-term KOOS-p trajectories were identified using latent growth mixture modeling and the baseline risk factors for these pain trajectories were examined. RESULTS: Participants (n = 313) had a mean age of 62.2 (SD ± 8.1) years and and a body mass index of 29.8 (SD ± 6.6) kg/m2 . The three-class latent growth mixture modeling quadratic model with best fit indices was chosen (based on lowest sample-size-adjusted Bayesian Information Criterion, high probability of belonging, interpretability). Three distinct pain trajectory clusters (over 90 days) were identified: low-moderate pain at baseline with large improvement (n = 11), minimal change in pain over 90 days (n = 248), and moderate-high pain with worsening (n = 46). Higher ICOAP (intermittent scale), perceived stress, negative affect score, and knee buckling at baseline were associated with a worse knee pain trajectory (P < 0.05). CONCLUSIONS: Persons with KOA showed unique short-term pain trajectories over 90 days, with distinct characteristics at baseline associated with each trajectory.

Incidence and prevalence of alcoholic fatty liver disease: a prospective, community-based study among adult Sri Lankans.

Background: Data on the alcoholic fatty liver (AFL) is limited. Therefore, we investigated alcohol use and AFL patterns among urban, adult Sri Lankans. 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>14units, females>7units 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]. Males [p<0.001], increased waist circumference (WC) [OR 4.9, p<0.01] and 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%), mean-age-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 males were 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 conclusion, in this community-based study among urban Sri Lankan adults, the annual incidence of AFL among unsafe alcohol users was 7.7%. Furthermore, new-onset AFL was associated with males.

Evaluating spatiotemporal dynamics of snakebite in Sri Lanka: Monthly incidence mapping from a national representative survey sample.

BACKGROUND: Snakebite incidence shows both spatial and temporal variation. However, no study has evaluated spatiotemporal patterns of snakebites across a country or region in detail. We used a nationally representative population sample to evaluate spatiotemporal patterns of snakebite in Sri Lanka. METHODOLOGY: We conducted a community-based cross-sectional survey representing all nine provinces of Sri Lanka. We interviewed 165 665 people (0.8% of the national population), and snakebite events reported by the respondents were recorded. Sri Lanka is an agricultural country; its central, southern and western parts receive rain mainly from Southwest monsoon (May to September) and northern and eastern parts receive rain mainly from Northeast monsoon (November to February). We developed spatiotemporal models using multivariate Poisson process modelling to explain monthly snakebite and envenoming incidences in the country. These models were developed at the provincial level to explain local spatiotemporal patterns. PRINCIPAL FINDINGS: Snakebites and envenomings showed clear spatiotemporal patterns. Snakebite hotspots were found in North-Central, North-West, South-West and Eastern Sri Lanka. They exhibited biannual seasonal patterns except in South-Western inlands, which showed triannual seasonality. Envenoming hotspots were confined to North-Central, East and South-West parts of the country. Hotspots in North-Central regions showed triannual seasonal patterns and South-West regions had annual patterns. Hotspots remained persistent throughout the year in Eastern regions. The overall monthly snakebite and envenoming incidences in Sri Lanka were 39 (95%CI: 38-40) and 19 (95%CI: 13-30) per 100 000, respectively, translating into 110 000 (95%CI: 107 500-112 500) snakebites and 45 000 (95%CI: 32 000-73 000) envenomings in a calendar year. CONCLUSIONS/SIGNIFICANCE: This study provides information on community-based monthly incidence of snakebites and envenomings over the whole country. Thus, it provides useful insights into healthcare decision-making, such as, prioritizing locations to establish specialized centres for snakebite management and allocating resources based on risk assessments which take into account both location and season.

Place of cardiovascular risk prediction models in South Asians; agreement between Framingham risk score and WHO/ISH risk charts.

INTRODUCTION AND OBJECTIVES: There are no cardiovascular risk prediction models developed in South Asian cohorts. Therefore, different risk models not validated in South Asians are being used. We aimed to compare cardiovascular risk predictions of Framingham risk score (FRS) and World Health Organization/International Society of Hypertension (WHO/ISH) charts for agreement in a sample of South Asians. METHODS: Ten-year cardiovascular risk predictions of patients without previous cardiovascular diseases attending a non-communicable disease clinic were calculated using FRS (with BMI and with cholesterol) and WHO/ISH charts (with and without cholesterol). Patients were categorised into low (<20%) and high (≥20%) cardiovascular risk groups on risk predictions. Agreement in risk categorisation with different prediction models was compared using Cohen's kappa coefficient (κ). RESULTS: One hundred sixty-nine patients (females 130 (81.1%)) mean age 65 ± 6.9 years were studied. Of the participants, 80 (47.3%), 62 (36.7%), 18 (10.7%), 16 (9.5%), were predicted high risk by FRS BMI-based, FRS cholesterol-based, WHO/ISH without-cholesterol and WHO/ISH with-cholesterol models, respectively. Agreement between the two FRS models (κ = 0.736, P < .0001) and the two WHO/ISH models (κ = 0.804, P < .0001) in stratifying patients into high and low-risk groups, was "good." However, the agreements between FRS BMI-based and WHO/ISH without-cholesterol models (κ = 0.234, P < .0001) and FRS cholesterol-based and WHO/ISH with-cholesterol models (κ = 0.306, P < .0001) were only "fair." CONCLUSION: Cardiovascular risk predictions of FRS were higher than WHO/ISH charts and the agreement in risk stratification was not satisfactory in Sri Lankans. Therefore, different cardiovascular risk prediction models should not be used interchangeably in the follow-up of South Asians.

Outcomes of NAFLD and MAFLD: Results from a community-based, prospective cohort study.

BACKGROUND: The term "metabolic (dysfunction)-associated fatty liver disease" (MAFLD) is suggested alternative for "non-alcoholic fatty liver disease" (NAFLD), as it better reflects metabolic dysfunction. No study has compared outcomes of the two diagnostic criteria. METHODS: In an ongoing, community-based, cohort-study in suburban Sri Lanka, participants were randomly selected in 2007. They were reassessed in 2014 to evaluate new-onset metabolic traits (MTs) and cardiovascular-events (CVEs). Baseline characteristics, MTs and CVEs after 7-years were compared in NAFLD and MAFLD and vs. controls. Similarly, we compared these parameters in those excluded by the NAFLD definition but captured by the MAFLD definition and vice versa, and vs. controls. FINDINGS: Of 2985 recruited in 2007, 940 (31.5%) had NAFLD, 990 (33.1%) had MAFLD and 362 (12.1%) were controls. When compared to NAFLD, MAFLD captured an additional 2.9% and lost 1.3% individuals. At baseline, anthropometric and metabolic traits were similar in NAFLD and MAFLD. At follow-up in 7-years, the risk of having new-onset MTs and fatal/non-fatal CVEs were similar in the groups, but were significantly higher compared to controls. Those excluded by the NAFLD definition but captured by the MAFLD definition showed higher baseline MTs compared to those excluded by the MAFLD definition but captured by the NAFLD definition, and had substantially higher risk for having new-onset MTs and CVEs compared to controls. INTERPRETATION: Although NAFLD and MAFLD had similar MTs at baseline, and similar outcomes after 7-years, those who were excluded by the NAFLD definition but captured by the MAFLD definition seem at higher risk of adverse outcomes than those excluded by the MAFLD definition but captured by the NAFLD definition. Although the increase in the index population was small, redefining NAFLD as MAFLD seemed to improve clinical utility.

Physical Activity Tracking Among Sri Lankan Adults: Findings From a 7-Year Follow-up of the Ragama Health Study.

Limited data are available on physical activity tracking among adults in low- and middle-income countries. Using a longitudinal design, we assessed trends and correlates of physical activity among Sri Lankan adults. Individuals selected through age-stratified random sampling, were screened initially in 2007 (n = 2986) and reevaluated in 2014 (n = 2148). On both occasions, structured interviews and clinical measurements were completed. Approximately 40% of the participants engaged in recommended levels of physical activity both at baseline and follow-up. One-fifth reported increased physical activity at follow-up, a similar proportion reported being persistently inactive or a reduction in physical activity. In the adjusted analysis, being persistently active was associated with male sex, a lower educational level and income, being free of any chronic disease conditions, better self-rated health, and sitting time <8 hours. Our findings support public health interventions to help maintain recommended physical activity levels over time, particularly for subgroups at high-risk of physical inactivity.

The clinical utility of accurate NAFLD ultrasound grading: Results from a community-based, prospective cohort study.

OBJECTIVES: Despite its widespread use there is no consensus on ultrasound criteria to diagnose fatty liver. METHOD: In an ongoing, cohort-study, participants were initially screened in 2007 and reassessed in 2014 by interview, anthropometric measurements, liver ultrasonography, and blood tests. We evaluated utility of increased hepatic echogenicity alone (intermediate) compared to using additional criteria which included signal attenuation and/or vascular blunting along with increase of hepatic echogenicity (moderate-severe), to diagnose fatty liver in NAFLD. We made a comparison of the two radiologically defined groups, in order to choose a classification method for NAFLD, which may better predict baseline adverse metabolic traits (MT), and adverse metabolic and cardiovascular events (CVE) after 7-year of follow-up. RESULTS: Of 2985 recruited in 2007, 940 (31.5 %) had moderate-severe NAFLD, 595 (19.9 %) intermediate NAFLD, and 957 (32.1 %) were controls (no fatty liver). 2148 (71.9 %) attended follow-up in 2014; they included 708 who had moderate-severe NAFLD, 446 intermediate NAFLD and 674 controls, at baseline (in 2007). At baseline, adverse anthropometric indices and MTs were significantly higher in both moderate-severe NAFLD and intermediate NAFLD compared to controls, except for low HDL. They were commoner in moderate-severe NAFLD than in intermediate NAFLD. After seven years, the odds of developing new-onset metabolic traits and CVEs were significantly higher compared to controls only in moderate-severe NAFLD. CONCLUSIONS: Only moderate-severe NAFLD predicted risk of incident adverse MTs and CVEs. However, both moderate-severe and intermediate NAFLD were associated with higher prevalence of adverse anthropometric and metabolic traits, thereby identifying individuals who need medical intervention even among those with milder degrees of fatty liver. We therefore recommend using increased hepatic echogenicity, and not only the more stringent criteria (which include signal attenuation and/or vascular blunting), for the diagnosis of fatty liver in individuals with NAFLD.

Is being barefoot, wearing shoes and physical activity associated with knee osteoarthritis pain flares? Data from a usually barefoot Sri Lankan cohort.

AIM: To identify the association between hours of being barefoot/wearing footwear, physical activity (PA) and knee osteoarthritis pain flares (KOAF). METHODS: Persons with a diagnosis of knee osteoarthritis, who reported previous KOAF, were followed up in a 3 months long telephone-based case-crossover study. Exposures to risk factors were assessed every 10 days and whenever the participants experienced a KOAF. Conditional logistic regression examined associations of KOAF with following: hours of being barefoot/using footwear and PA performed (P < .05). RESULTS: There were 260 persons recruited, of whom 183 continued longitudinal follow up. Of them, 120 persons had at least one valid KOAF and control period. Participants were female (90%) with mean (SD) age and body mass index of 59.9 (7.0) years, 28.0 (5.0) kg/m2 respectively. Participants were barefoot for a mean duration of 12.7 hours (SD 4.6) and used footwear for 5.1 (SD 4.7) hours daily; 99% wore heel heights <2.5 cm. Duration of being barefoot, 1 and 2 days before, demonstrated reduced multivariate odds of KOAF (odds ratio [OR] = 0.85; 95% CI 0.80-0.90). Moderate PA performed 1, 2 days prior was associated with a significantly increased risk of KOAF (multivariate OR 4.29; 2.52-7.30 and OR 3.36; 2.01-5.61). Similarly, hours of using footwear 1 and 2 days before flare demonstrated increased odds of KOAF (OR 1.15; 1.07-1.23 and 1.10; 1.03-1.18). CONCLUSIONS: Increased duration of being barefoot 1 to 2 days before is associated with reduced risk of KOAF. Performing moderate PA 1 to 2 days before was associated with an increased risk of KOAF.

Patterns and predictors of mortality in a semi-urban population-based cohort in Sri Lanka: findings from the Ragama Health Study.

OBJECTIVE: To describe patterns and predictors of mortality in a semi-urban population in Sri Lanka. DESIGN: A prospective population-based cohort study. SETTING: Ragama Medical Officer of Health area in the Gampaha district, Sri Lanka. PARTICIPANTS: Adults between 35 and 64 years of age were recruited using an age stratified random sampling technique in 2007. MEASURES: At baseline, we recorded socio-demographic, lifestyle, anthropometric, biochemical and clinical data of the participants. Over 10 years, we obtained the cause and date of death from the death registration documents of deceased participants. We determined the survival probability of the cohort over 10 years and estimated Hazard ratios (HRs) for all-cause mortality (ACM), cardiovascular mortality (CVM) and cancer-related mortality (CRM) using Cox's proportional hazards model. We also estimated the survival probabilities for men and women in each 10-year age group and standardised mortality ratio relative to the source population. RESULTS: There were 169 deaths over 10 years with standardised mortality rates of 5.3 and 2.4 per 1000 years of follow-up for men and women, respectively. Independent predictors of: ACM were older age, lower income, smoking and diabetes mellitus while gender, education, occupation, harmful alcohol use, waist circumference and hypertension were not; CVM were older age, lower income, smoking, diabetes and hypertension while gender and harmful alcohol use were not; CRM was older age while gender, smoking and diabetes were not. Those engaged in clerical and technical occupations or unemployed had a lower risk of CRM as compared with those engaged in elementary occupations. CONCLUSIONS: Older age, lower income, smoking, diabetes and hypertension strongly predict mortality in this cohort. Addressing the identified modifiable predictors through behavioural modification will improve longevity in similar populations.

Vaginal, sexual and urinary symptoms following hysterectomy: a multi-centre randomized controlled trial.

BACKGROUND: Hysterectomy is the most common major gynaecological procedure. The aim of this study was to study vaginal, sexual and urinary symptoms following total abdominal hysterectomy (TAH), non-descent vaginal hysterectomy (NDVH) and total laparoscopic hysterectomy (TLH) in a low resource setting. METHODS: A multi-centre randomized controlled trial (RCT) was conducted in two public sector hospitals in Sri Lanka. Participants were patients requiring hysterectomy for non-malignant uterine causes. Exclusion criteria were uterus> 14 weeks, previous pelvic surgery, medical illnesses which contraindicated laparoscopic surgery, and those requiring incontinence surgery or pelvic floor surgery.Vaginal, sexual function and urinary symptoms were assessed by the validated translations of ICIQ-VS and ICIQ-FLUTS questionnaires. Post-operative improvement (pre-operative - post-operative) was assessed. RESULTS: There was an improvement (median (IQ1-IQ3) in vaginal symptoms [TAH 6(2-8) vs 4(0-8), p < 0.001; NDVH 6(4-8.5) vs 5(0-8), p < 0.001; TLH 4(2-10.5) vs 4(0-10), p < 0.001], urinary flow symptoms [TAH 2(1-4) vs 1 (0-3), p < 0.001; NDVH 3 (2-5) vs 2 (0.5-4), p < 0.001; TLH 1(1-4) vs 1(0-3), p < 0.05], urinary voiding symptoms [TAH 0(0-0) vs 0(0-0), p = 0.20; NDVH 0(0-1) vs 0(0-0.8), p < 0.05; TLH 0(0-0) vs 0(0-0), p < 0.05] and urinary incontinence symptoms [TAH 0(0-2) vs 0(0-2), p = 0.06; NDVH 0(0-3) vs 0(0-3), p < 0.001; TLH 0(0-3) vs 0(0-2), p < 0.05] at 1-year (TAH n = 47, NDVH n = 45, TLH n = 47). There was an improvement in sexual symptoms only in the TLH group [TAH 0(0-11.5) vs 0(0-14), p = 0.08); NDVH 0(0-0) vs 0(0-0), p = 0.46; TLH 0(0-0) vs 0(0-4), p < 0.05].There was no significant difference among the three different routes in terms of vaginal symptoms score [TAH 2 (0-2), NDVH 0 (0-2), TLH 0 (0-2), p = 0.33], sexual symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), p = 0.52], urinary flow symptoms [TAH 0 (0-1), NDVH 0 (0-1), TLH 0 (0-2), p = 0.56], urinary voiding symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), p = 0.64] and urinary incontinence symptoms [TAH 0 (0-0), NDVH 0 (0-1), TLH 0 (0-1), p = 0.35] at 1-year. CONCLUSIONS: There was a post-operative improvement in vaginal symptoms and urinary symptoms in all three groups. There was no significant difference in pelvic organ symptoms between the three routes; TAH, NDVH and TLH. TRIAL REGISTRATION: Sri Lanka clinical trials registry, SLCTR/2016/020 and the International Clinical Trials Registry Platform, U1111-1194-8422, on 26 July 2016. Available from: http://slctr.lk/trials/515.

Clinicopathological characteristics and oncological outcomes of patients with renal cell carcinoma.

ABSTRACT: Although certain characteristics of renal cell carcinoma (RCC) seen in Sri lanka are different to the developed world and incidence is rising, no data on oncological outcome and patient survival are avaialble. A hospital-based cohort study was done in a tertiary referral centre over a period of eight years (2012-2019). A total of 285 newly diagnosed RCC had a mean follow-up period of 28.3 months. Radical nephrectomy was performed in 189 patients while 91 patients had partial nephrectomy. Clear cell RCC which was seen in 231 (81.1%) patients while papillary RCC was seen in 43 (15.1%). There were 54 deaths during the follow-up. The 30-day postoperative mortality was 2.1%. Thirty (10.5%) patients developed metastases while three patients developed local recurrences. The overall five -year survival rate was 72.8% (95%CI=65.9-80.5). Five-year survival of papillary RCC (60.5%) was lower than clear cell RCC (74.1%). Tumour stage, presence of metastases and histological grade of the tumour influenced the survival. Gender (p= 0.3), histological type (p= 0.5) or type of surgery (p=0.2) had no statistically significant effect on survival.

Feasibility of a Lifestyle Intervention Program for Prevention of Diabetes Among Women With Prior Gestational Diabetes Mellitus (LIVING Study) in South Asia: A Formative Research Study.

Aim: To refine and contextually adapt a postpartum lifestyle intervention for prevention of type 2 diabetes mellitus (T2DM) in women with prior gestational diabetes mellitus (GDM) in Bangladesh, India, and Sri Lanka. Materials and Methods: In-depth interviews (IDIs) and focus group discussions (FGDs) were conducted with women with current diagnosis of GDM, and health care professionals involved in their management, to understand relevant local contextual factors for intervention optimization and implementation. This paper describes facilitators and barriers as well as feedback from participants on how to improve the proposed intervention. These factors were grouped and interpreted along the axes of the three main determinants of behavior-capability, opportunity, and motivation. IDIs and FGDs were digitally recorded, transcribed, and translated. Data-driven inductive thematic analysis was undertaken to identify and analyze patterns and themes. Results: Two interrelated themes emerged from the IDIs and FGDs: (i) The lifestyle intervention was acceptable and considered to have the potential to improve the existing model of care for women with GDM; and (ii) Certain barriers such as reduced priority of self-care, and adverse societal influences postpartum need to be addressed for the improvement of GDM care. Based on the feedback, the intervention was optimized by including messages for family members in the content of the intervention, providing options for both text and voice messages as reminders, and finalizing the format of the intervention session delivery. Conclusion: This study highlights the importance of contextual factors in influencing postpartum care and support for women diagnosed with GDM in three South Asian countries. It indicates that although provision of postpartum care is complex, a group lifestyle intervention program is highly acceptable to women with GDM, as well as to health care professionals, at urban hospitals.

Metabolic syndrome, but not non-alcoholic fatty liver disease, increases 10-year mortality: A prospective, community-cohort study.

BACKGROUND: Data on outcomes of non-alcoholic fatty liver disease (NAFLD) from South Asia are lacking. We compared mortality, among those with- and without-NAFLD, after 10-years follow-up among urban, adult Sri Lankans. METHOD: Participants (aged 35-64 years), selected by age-stratified random sampling, were screened by structured-interview in 2007. Anthropometric measurements, liver ultrasonography and biochemical/serological tests were done. NAFLD was diagnosed on ultrasound criteria, safe-alcohol consumption (Asian-standards) and absence of hepatitis B/C. Subjects without NAFLD were those without any ultrasound criteria of fatty liver, safe-alcohol consumption and absence of hepatitis B/C. The cohort was re-evaluated to assess mortality in 2017. Participants or their households were contacted by telephone/post, and deaths confirmed by home-visits and death certificate review. Cox-regression was used to determine predictors of all-cause mortality (ACM) and cardiovascular mortality (CVM) in those with- and without-NAFLD. RESULTS: 2724 (91.2%) of 2985 original participants were contacted (851-with NAFLD and 1072-without NAFLD). Overall there were 169 (6.2%) deaths [41-deaths among NAFLD (17-cardiovascular; 9-cancer-related; 4-liver-specific; 11-other) and 79-deaths among no-NAFLD (28-cardiovascular; 17-cancer-related; 1-liver-specific; 33-other)]. Metabolic syndrome (MetS), low-education level, higher age and male-gender independently predicted ACM. MetS, increasing age and male-gender independently predicted CVM. NAFLD did not predict either ACM or CVM. In those with NAFLD, MetS and age >55-years were independently associated with ACM, while MetS and male-gender were associated with CVM. CONCLUSION: In this community-based study, increasing age, male-gender and MetS, but not NAFLD, predicted 10-year ACM and CVM. Among those with NAFLD, only those metabolically abnormal were at a higher risk for mortality.

Adjusting for spatial variation when assessing individual-level risk: A case-study in the epidemiology of snake-bite in Sri Lanka.

BACKGROUND: Health outcomes and causality are usually assessed with individual level sociodemographic variables. Studies that consider only individual-level variables can suffer from residual confounding. This can result in individual variables that are unrelated to risk behaving as proxies for uncaptured information. There is a scarcity of literature on risk factors for snakebite. In this study, we evaluate the individual-level risk factors of snakebite in Sri Lanka and highlight the impact of spatial confounding on determining the individual-level risk effects. METHODS: Data was obtained from the National Snakebite Survey of Sri Lanka. This was an Island-wide community-based survey. The survey sampled 165,665 individuals from all 25 districts of the country. We used generalized linear models to identify individual-level factors that contribute to an individual's risk of experiencing a snakebite event. We fitted separate models to assess risk factors with and without considering spatial variation in snakebite incidence in the country. RESULTS: Both spatially adjusted and non-adjusted models revealed that middle-aged people, males, field workers and individuals with low level of education have high risk of snakebites. The model without spatial adjustment showed an interaction between ethnicity and income levels. When the model included a spatial adjustment for the overall snakebite incidence, this interaction disappeared and income level appeared as an independent risk factor. Both models showed similar effect sizes for gender and age. HEmployment and education showed lower effect sizes in the spatially adjusted model. CONCLUSIONS: Both individual-level characteristics and local snakebite incidence are important to determine snakebite risk at a given location. Individual level variables could act as proxies for underling residual spatial variation when environmental information is not considered. This can lead to misinterpretation of risk factors and biased estimates of effect sizes. Both individual-level and environmental variables are important in assessing causality in epidemiological studies.