Cultural adaptation and validation of the Sinhala version of the Frail Non-disabled tool (FiND).

BACKGROUND: Frailty, a common geriatric syndrome of vulnerability, is associated with a decline in health and function. The most problematic expression of population ageing is associated with weakness, slowing, decreased energy, lower activity and when severe, unintended weight loss. Frailty is not consciously identified in clinical practice and is not widely studied in Sri Lanka. A validated tool for screening frailty in a busy clinical setting is therefore much needed. This study was done as a part of validating the Sinhala version of the Frail Non-Disabled (S-FiND) tool. METHODS: The FiND tool was translated from English to Sinhala by two translators, blinded to each other. They were combined and translated back to the original language by two separate translators. After verifying the content validity, unambiguity and clarity of items in a focused group discussion, the pre-final version was piloted among 30 volunteers. After assessing the psychometric properties of the pre-final version, the final version was tested among 100 adults older than 65 years from the Colombo South Teaching Hospital. The tool was compared with Fried's frailty phenotype taken as the gold standard. RESULTS: Data were analysed for the agreement with the reference standard, the Fried Phenotype. The mean (SD) age of subjects was 73.9 (7.8) years. The overall time taken to fill out the questionnaire was 2 min. The agreement (Kappa) between the S-FiND questionnaire and the Fried phenotype was 0.7 (P < 001). The sensitivity and specificity of FiND in detecting frailty were 92% and 74%, respectively. The agreements (Kappa) between the individual items of S-Find: involuntary loss of weight/ more than 4.5 kg over one year, the feeling of effort/ not getting going and level of physical activity, with the Fried phenotype, were 0.28 (p = 0.001), 0.06 (p = 0.045) and 0.339 (p < 0.001). respectively. When subjects were categorized frail and robust based on FiND, frail subjects reported a higher incidence of falls (50%) during the previous 12 months, compared to those robust (13%) (p < 0.001 for Chi stat). CONCLUSION: The S-FiND is a reliable, valid and well-received tool that can be used in detecting the frailty of non-disabled Sinhala-speaking older adults.

Age Related Trends in Structural Indices of Proximal Femur in Women Aged 20-70 in Southern Sri Lanka.

Age related trends of the indices of hip structure help understanding how bone strength changes with age and the increased bone fragility in old age. Community-dwelling women aged 20-70years (n = 419) were selected by stratified random method and divided into age categories; 20-29years (n-69), 30-39years (n = 60), 40-49years (n = 69), 50-59years (n = 107) and 60-70years (n = 114). All subjects underwent dual energy x-ray absorptiometry (DXA) and hip structure analysis using Hologic Discovery scanner (Hologic Inc, Bedford, USA). Measured indices included hip axis length (HAL) and neck shaft angle (NSA) of the proximal femur. Cross sectional area (CSA), cross sectional moment of inertia (CSMI), section modulus (SM), cortical thickness (CT), buckling ration (BR) of three regions of interest; narrow neck, intertrochanteric region and femoral shaft, were also measured. Age related trends of all indices were studied with Locally Weighted Scatterplot Smoothing lines (LOESS) and ANOVA. Mean HAL and NSA values were not different between age categories. CSA, CSMI, SM and CT in three different regions showed curvilinear relationships with age. These indices gradually increased with age between 20-50 years and the maximum values were seen in the 40-49years age category and they declined afterwards. The decline of these indices was more rapid in the narrow neck and intertrochanter regions when compared with femoral shaft and the lowest mean CSA, CSMI, SM and CT in these two regions were seen in the 60-70 age category. BR showed a gradual decrease with age between 20-50 years and the lowest mean value was seen in the 40-49 age category. BR increased afterwards and the maximum mean value was seen in the 60-70 age category. This study demonstrates the dynamics of structural properties of proximal femur in the three selected cross sections of community-dwelling women aged 20-70 years and the increased bone fragility in old age.

Trimester-specific thyroid hormone reference data in Sri Lankan women.

Introduction: Regional differences in thyroid hormones are noted, especially during pregnancy. Objectives: Establish reference values for thyroid function tests for Sri Lankan pregnant women and to determine their comparability with regional data; and determine the prevalence of 2. Thyroid Peroxidase (TPO) antibody positivity and 3. Iodine deficiency among pregnant women with uncomplicated clinical history. Methods: A cross-sectional study conducted in antenatal clinics of a tertiary care maternity center recruited a minimum of 56 women in each trimester in a multistep approach to derive an "ideal-reference population"; Participants with clinically manifested thyroid disease, followed by subjects with sonographically abnormal thyroids and finally those at high risk for thyroid disease as shown by positive TPO levels and urine iodine deficiency were excluded in sequence. Thyroid hormones were measured by chemiluminescence in the ideal reference population. Reference ranges were derived using median and 5th and 95th centiles. Results: Final sample included 369 women. TSH reference ranges of the first (n=64), second (n=188) and third (n=117) trimesters were 0.014-2.77mIU/L, 0.31-3.2 mIU/L and 0.34-3.4 mIU/L, respectively. TPO antibody level showed a weak but significant correlation with TSH (r=0.10,p 0.021) in the final sample. No significant association was found between urine iodine and thyroid function tests. Conclusions: TSH reference ranges observed in this study are concordant with the Caucasian reference values more than the regional values. Discrepancies in study methodology, defining and selection of reference population and methods employed in measuring thyroid hormones in different studies may have accounted for these differences.

Factors associated with measures of sarcopenia in pre and postmenopausal women.

BACKGROUND: Menopause associated low serum estradiol marks varieties of derangements in muscle mass and functions leading to sarcopenia. This cross-sectional study was carried out to examine the factors associated with measures of sarcopenia; skeletal muscle mass (SMM), muscle strength and physical performance (PP) in a group of premenopausal (PrMW) and postmenopausal women (PMW) selected from Sri Lanka. METHODS: Randomly selected 184 PrMW and 166 PMW from Galle district, Sri Lanka were studied. SMM was measured with duel energy X ray absorptiometry and relative appendicular SMM index (RSMI; kg/m2) was calculated. Other measurements made include handgrip strength (HGS; kg) and gait speed (GS; m/s), anthropometric indices, consumption of macro and micronutrients, and pattern of physical activities (PA). A serum sample was analyzed for fasting insulin, serum estradiol and vitamin D. Variables which significantly correlated with RSMI, HGS and GS of PrMW and PMW were separately entered into multiple linear regression models to extract the associated factors. RESULTS: Mean (SD) age of PrMW and PMW were 42.4 (6.0) and 55.8 (3.8) years respectively. In the regression analysis, RSMI in PrMW showed significant associations with body mass index (BMI), HGS, total-body-fat-mass (TBFM) and weight (adjusted R2 = 0.85) and in PMW with BMI, weight, TBFM, hip-circumference and fasting insulin (adjusted R2 = 0.80). BMI showed the strongest association with RSMI in both PrMW (r = 0.87, R2 = 0.76) and in PMW (r = 0.87, R2 = 0.76). HGS in PrMW showed significant associations with appendicular SMM (ASMM), total-body-bone-mineral-content, vigorous PA score, age and weight (adjusted R2 = 0.33) and in PMW with ASMM and height (adjusted R2 = 0.23). ASMM showed the strongest association with HGS in both PrMW (r = 0.44, R2 = 0.20) and PMW (r = 0.44, R2 = 0.20). GS in PrMW showed significant associations with height, BMI and energy consumption (adjusted R2 = 0.13) while in PMW, with carbohydrate consumption and total-body-bone-mineral-density (adjusted R2 = 0.09). While in PrMW, height showed the strongest association with GS (r = 0.28, R2 = 0.08) in PMW, it was carbohydrate consumption (r = 0.24, R2 = 0.06). CONCLUSIONS: Factors that are associated with different measures of sarcopenia are not uniform and vary widely from anthropometry to nutrient intake indicating that these measures are somewhat independent and are governed by different factors.

Applicability of health promoting lifestyle profile-II for postmenopausal women in Sri Lanka; a validation study.

BACKGROUND AND OBJECTIVE: Health Promoting Lifestyle Profile-II (HPLP-II), developed in the West, evaluates 52 health promoting behaviors (HPB) under six subscales. In this study we evaluated the applicability of HPLP-II to assess the HPB of postmenopausal women (PMW) conversant in the Sinhala language in Sri Lanka. METHODS: The Sinhala version of HPLP-II was adapted following standard methodology of cross cultural adaptation. It included forward and backward translations, review by an expert group, focus group discussion and pre-testing. It was self-administered among randomly selected healthy, Sinhalese, community-dwelling PMW (n = 245, aged 55.9 ± 3.4 years), along with the Short Form 36 (SF-36) survey. The Sinhala version of HPLP-II was re-administered among a subsample (n = 105) after two weeks of first administration. Psychometric properties - reliability and validity, were evaluated. RESULTS: In the Sinhala version of HPLP-II, both internal consistency (Cronbach's alpha = 0.98) and test-retest reliability (intra class correlation / ICC = 0.98, 95%CI = 0.97-0.99) were high. Structural validity assessment with Factor analysis using Principal Component Analysis extracted seven factors explaining 80.65% cumulative variance with few exceptions from the original version. Health responsibility (HR) and spiritual growth (SG) subscales of HPLP-II and physical and psychological health dimensions scores of SF-36 scores correlated significantly (r > 0.63, p < 0.001) ensuring strong concurrent validity. CONCLUSIONS: The Sinhala version of HPLP-II adapted by us is a tool with high reliability and validity.

Features of Covid-19 patients detected during community screening: A study from a rural hospital in Sri Lanka.

ABSTRACT: We studied the clinical course and virus shedding of all patients referred to Welikanda Hospital, in one month. There were 53 positives for Covid-19 by PCR. 24 (45%) were male, with an age range of 11-94 years. Of these, 41 (77%) were asymptomatic, 9 had cough, 4 had sore throat and six had fever. Pulse, blood pressure, respiratory rate and capillary oxygen were normal in all. A proportion of them had poor prognostic factors: asthma (n=4), hypertension (n=11), age above 60 years (n=9), and diabetes (n=11). Lymphopenia was seen in 20 and elevated CRP in 14. Viral shedding continued beyond 14 days in several persons and continued in symptomatic patients for a significantly longer time than asymptomatic patients. Covid-19 was an asymptomatic or mild illness in this group of people. Several of them continued to be RT-PCR positive even after 14 days. Such cases are an important source of community spread.

Sequel and therapeutic modalities of leptospirosis associated severe pulmonary haemorrhagic syndrome (SPHS); a Sri Lankan experience.

BACKGROUND: The emergence of leptospirosis-associated severe pulmonary hemorrhagic syndrome (SPHS) with high case fatality has been reported from many countries. Understanding of clinical disease and sequel of SPHS needs larger studies with adequate numbers. The purpose of this study was to describe the characteristics and sequel by different therapeutic approaches for SPHS in Leptospirosis in Sri Lanka. METHODS: This study was conducted at Teaching Hospital-Karapitiya (THK), Galle, Sri Lanka from June 2015 to December 2017. THK is the main tertiary care center for the Southern Province. All confirmed-cases of leptospirosis who presented during this period and were admitted to five medical units of THK were included in this study. SPHS was defined as a patient presenting; haemoptysis, arterial hypoxemia (Acute Lung Injury Score < 2.5), haemoglobin drop (10% from the previous value), or diffused alveolar shadows in the chest radiograph, without alternative explanation other than leptospirosis. RESULTS: Of the 128 MAT confirmed cases of leptospirosis, 111 (86.7%) had acute kidney injury (AKI) whilst SPHS was seen in 80 (62.5%). Patients typically developed SPHS within the first week of illness, mostly on days 4 and 5. The case fatality rate of this study sample was 28.1% (n = 36), while for patients with SPHS, it was 41.5%. Most of the deaths (n = 19) were within the first 3 days of admission (on the same day 8, and within next 48 h 11). Among SPHS patients, 59 received therapeutic plasma exchange (TPE). The survival rate was higher (n = 35, 74.5%) when the TPE was performed within the first 48 h of detecting SPHS compared to patients in whom the procedure was done after 48 h (n = 5, 54.5%). Of the 19 leptosprosis patients with SPHS who did not receive TPE, 17 died (89.5%). However, the group of patients who received TPE was primarily the patients survived beyond day 3. CONCLUSIONS: We observed that during the study period, SPHS was common and the mortality rate was higher in the study area. The treatment modalities tested need further evaluation and confirmation.

Development & cross-validation of anthropometric predictive models to estimate the appendicular skeletal muscle mass in middle-aged women in Sri Lanka.

Background & objectives: Attempts have been made to estimate appendicular skeletal muscle mass (ASMM) using anthropometric indices and most of these are country specific. This study was designed to develop and cross-validate simple predictive models to estimate the ASMM based on anthropometry in a group of healthy middle-aged women in Sri Lanka. Methods: The study was conducted on a randomly selected group of community-dwelling women aged 30-60 years. ASMM (kg) quantified with dual-energy X-ray absorptiometry (DXA) (ASMMDXA) was used as the reference standard. Anthropometric measurements such as body weight (kg), height (m), limb circumferences (cm) and skinfold thickness (mm) which showed significant correlations with ASMMDXA, were used to develop the models. The models were developed using a group of 165 women (aged 30-60 yr) and were cross-validated using a separate sample of women (n=167) (mean age: 48.9±8.56 yr), selected randomly. Results: Nine anthropometry-based models were developed using weight, height, skinfold thicknesses, circumferences, body mass index, menopausal status (MS) and age as independent variables. Four models which were based on height, weight, triceps skinfold thickness (TSFT), age and MS met all the validation criteria with high correlations (ranged 0.89-0.92) and high predictive values explaining high variance (80-84%) with low standard error of estimate (1.10-1.24 kg). Interpretation & conclusions: The four models (ASMM 1-ASMM 4) developed based on height, weight, TSFT, age and MS showed a high accuracy in estimating the ASMM in middle-aged women.

Vitamin D deficiency among children aged 10-18 years in Sri Lanka

Background: Vitamin D deficiency (VDD) and insufficiency (VDI) are public health problems in many countries, and limited data is available on the prevalence of VDD/VDI in Sri Lanka. Objectives: To determine the prevalence and associated factors of VDD in children aged 10- 18 years. Methods: This was a cross-sectional study among school children aged 10-18 years at national level. A representative sample of 2525 children were recruited from July to November 2017. Serum 25(OH)D concentration and the patterns of vitamin D rich foods consumption were assessed. VDD and VDI cut offs were set at serum 25(OH)D concentrations of <12 ng/mL and 12-20 ng/mL, respectively as defined by global consensus in 2016. Results: The mean serum 25(OH)D level was 19.3±7.4 ng/mL. The prevalence of VDD and VDI were 13.2% (95%CI: 11.9%-14.5%) and 45.6% (95%CI: 43.7%-47.5%), respectively. The prevalence of VDD was highest in the central province (32.2%) and highest prevalence of VDI was in the Inabaragamuwa province (58.9%). VDD and VDI were lowest in North Central province (0.7% and 34.7%, respectively). Significantly higher serum 25(OH)D levels were observed with male gender (p=0.000), BMI for age <-2SD (p=0.000), daily milk consumption (p=0.000) and residing in dry zone (p=0.0 Conclusions: Though Sri Lanka is a tropical country, VDD is prevalent among school children aged 10-18 years. It is important to develop a VDD preventive strategy, especially for high risk groups.

Cross cultural adaptation and analysis of psychometric properties of Sinhala version of Menopause Rating Scale.

BACKGROUND: Menopause Rating Scale (MRS) evaluates eleven menopausal symptoms and health related quality of life (HRQOL) of postmenopausal women under three subscales. In this study we attempted cross cultural adaptation and evaluation of psychometric properties of a Sinhala translation of MRS. METHODS: Sinhala version of MRS was adapted following standard methodology; forward and backward translations, review by an expert group, focus group discussion (FGD) and pre-testing. It was self-administered among randomly selected healthy, Sinhalese, community-dwelling 166 postmenopausal women (aged; median = 56.5, IQR, 53.0-59.0 years) along with the Short Form 36 (SF-36) survey questionnaire. MRS was re-administered among a subsample (n = 80) after two weeks of first administration. Psychometric properties; reliability and validity were evaluated. RESULTS: In Sinhala version of MRS, both internal consistency (Cronbach's alpha coefficient = 0.79) and test retest reliability (intra class correlation / ICC = 0.86, 95%CI = 0.82-0.91, p < 0.001 and Pearson correlation / r = 0.93) were high. Factor analysis (FA) with Principal Component Analysis (PCA) extracted three factors explaining 59.82% cumulative variance with few exceptions from the original version. In the item-subscale correlation analysis items showed stronger correlations within their own subscale score (r range between 0.56-0.84) than with other subscales scores and subscales' scores showed strong correlations with the overall MRS score (r range between 0.70-0.86) indicating strong convergent validity. Mean (SD) symptom severities of each item were significantly different between symptomatic and asymptomatic women (p < 0.05) emphasizing good discriminant validity. The overall MRS and SF-36 scores correlated significantly (Pearson correlation: - 0.52, p < 0.01 and Kendall's tau-b: - 0.39, p < 0.01) ensuring strong criterion validity. CONCLUSIONS: The Sinhala version of MRS we adapted is an informative tool with high reliability and validity and this tool can be used to evaluate the menopausal symptoms and HRQOL in postmenopausal women conversant in Sinhala.

Prevalence of normoalbuminuric renal insufficiency and associated clinical factors in adult onset diabetes.

BACKGROUND: Microalbuminuria signifies the onset of diabetic nephropathy, but normoalbuminuric patients with diabetes who have a low Glomerular Filtration Rate (GFR) are not uncommon. The purpose of the study was to estimate the prevalence of such patients and to assess the clinical correlates. METHODS: Cross-sectional study included patients with diabetes attending medical clinics at Teaching Hospital Galle. Diagnosis of albuminuria was made if urinary albumin excretion was > 30 mg/g of creatinine in two out of three samples. Patients were stratified into chronic kidney disease stages according to the estimated GFR (eGFR) calculated by Modification of Diet in Renal Disease (MDRD). RESULTS: Mean (SD) age and duration of the disease of 456 (348 females) patients with diabetes were 60 (12) years and 10 (4) years. Sixty (13.2%) patients had low eGFR and 26.7% of them had normoalbuminuria. In the total sample, the proportion of patients with low eGFR and normoalbuminuria was 16 (3.5%). Among the patients with normoalbuminuria and low eGFR, 12.5% had retinopathy and none had any form neuropathy. When age, duration of disease, systolic and diastolic blood pressures, smoking, glycaemic control, presence of hypertension and ischaemic heart disease were included in binary logistic regression model, only age was found to be significant different (OR = 1.1, P = 0.03). CONCLUSION: A considerable proportion of adult diabetics are normoalbuminuric despite low eGFR. This limits the role of microalbuminuria as a screening tool to detect the onset of diabetic nephropathy. These patients do not exhibit distinct clinical features that facilitate identification of them using clinical information.

Age-dependent FRAX-based assessment and intervention thresholds for therapeutic decision making in osteoporosis in the Malaysian population.

Fracture risk stratification is crucial in countries with limited access to bone density measurement. 24.8% women were in the high-risk category while 30.4% were in the low-risk category. In the intermediate risk group, after recalculation of fracture risk with bone density, 38.3% required treatment. In more than half, treatment decisions can be made without bone density. PURPOSE: We aimed to examine the role of age-dependent intervention thresholds (ITs) applied to the Fracture Risk Assessment (FRAX) tool in therapeutic decision making for osteoporosis in the Malaysian population. METHODS: Data were collated from 1380 treatment-naïve postmenopausal women aged 40-85 years who underwent bone mineral density (BMD) measurements for clinical reasons. Age-dependent ITs, for both major osteoporotic fracture (MOF) and hip fracture (HF), were calculated considering a woman with a BMI of 25 kg/m2, aged between 40 and 85years, with a prior fragility fracture, sans other clinical risk factors. Those with fracture probabilities equal to or above upper assessment thresholds (UATs) were considered to have high fracture risk. Those below the lower assessment thresholds (LATs) were considered to have low fracture risk. RESULTS: The ITs of MOF and HF ranged from 0.7 to 18% and 0.2 to 8%, between 40 and 85years. The LATs of MOF ranged from 0.3 to 11%, while those of HF ranged from 0.1 to 5.2%. The UATs of MOF and HF were 0.8 to 21.6% and 0.2 to 9.6%, respectively. In this study, 24.8% women were in the high-risk category while 30.4% were in the low-risk category. Of the 44.8% (n=618) in the intermediate risk group, after recalculation of fracture risk with BMD input, 38.3% (237/618) were above the ITs while the rest (n=381, 61.7%) were below the ITs. Judged by the Youden Index, 11.5% MOF probability which was associated with a sensitivity of 0.62 and specificity of 0.83 and 4.0% HF probability associated with a sensitivity of 0.63 and a specificity 0.82 were found to be the most appropriate fixed ITs in this analysis. CONCLUSION: Less than half of the study population (44.8%) required BMD for osteoporosis management when age-specific assessment thresholds were applied. Therefore, in more than half, therapeutic decisions can be made without BMD based on these assessment thresholds.

Asia-Pacific consensus on long-term and sequential therapy for osteoporosis.

Objectives: This study aimed to present the Asia-Pacific consensus on long-term and sequential therapy for osteoporosis, offering evidence-based recommendations for the effective management of this chronic condition. The primary focus is on achieving optimal fracture prevention through a comprehensive, individualized approach. Methods: A panel of experts convened to develop consensus statements by synthesizing the current literature and leveraging clinical expertise. The review encompassed long-term anti-osteoporosis medication goals, first-line treatments for individuals at very high fracture risk, and the strategic integration of anabolic and antiresorptive agents in sequential therapy approaches. Results: The panelists reached a consensus on 12 statements. Key recommendations included advocating for anabolic agents as the first-line treatment for individuals at very high fracture risk and transitioning to antiresorptive agents following the completion of anabolic therapy. Anabolic therapy remains an option for individuals experiencing new fractures or persistent high fracture risk despite antiresorptive treatment. In cases of inadequate response, the consensus recommended considering a switch to more potent medications. The consensus also addressed the management of medication-related complications, proposing alternatives instead of discontinuation of treatment. Conclusions: This consensus provides a comprehensive, cost-effective strategy for fracture prevention with an emphasis on shared decision-making and the incorporation of country-specific case management systems, such as fracture liaison services. It serves as a valuable guide for healthcare professionals in the Asia-Pacific region, contributing to the ongoing evolution of osteoporosis management.

Associations between body composition and cardiovascular disease risk in pre- and postmenopausal women.

BACKGROUND: Menopause transition is a critical phase of women's life since body composition and cardiovascular risk factors begin to change during this period. This study investigated the associations between body composition and cardiovascular disease risk (CVDR) in pre (PrMW) and postmenopausal women (PMW). METHODS: A community-based cross-sectional study involving 184 PrMW and 166 PMW, selected randomly from Bope-Poddala area in Galle, Sri Lanka was carried out. Total-body fat mass (TBFM, kg), total body skeletal muscle mass (TBSMM, kg), total body bone mineral density (TBBMD, g/cm2) and total body bone mineral content (TBBMC, g) were measured with total body DXA scanner and they were taken as indices of body composition. CVDR was evaluated using Framingham risk score (FRS%) and individual CVDR factors, such as systolic blood pressure (SBP, mmHg), diastolic blood pressure (DBP, mmHg), fasting blood sugar (FBS, mg/dl), total cholesterol, (TC, mg/dl), tryglycerides (TG, mg/dl), high-density lipoprotein (HDL, mg/dl) and low-density lipoprotein (LDL, mg/dl). Correlations between indices of body composition and CVDR factors were assessed with adjusted partial correlation (adjusted for socio-demographic and gynecologic status, age, daily calorie consumption and physical activity level). RESULTS: Mean(SD) age of PrMW and PMW were 42.4(6.0) and 55.8(3.8) years respectively. TBFM correlated with SBP and DBP (r range; 0.15 to 0.21) and TBSMM correlated with SBP, DBP and HDL (r range; - 0.24 to 0.17) only in PrMW (p < 0.05). TBBMD correlated only with FBS in PMW (r; - 0.21, p = 0.01). TBBMC did not show correlations with CVDR factors (p > 0.05). Body composition indices did not show correlations with total CVDR estimated by FRS and in both groups of women (p > 0.05). CONCLUSIONS: Both SBP and DBP are associated with FM and SMM in different ways among PrMW. This association, however, was not seen among PMW. FBS is associated with BMD only in PMW.

Katz index of activities of daily living in assessing functional status of older people: Reliability and validity of Sinhala version.

Purpose: This study evaluated the reliability and validity of the Sinhala version of Katz index of activities of daily living (ADL) in assessing the functional status of older people aged >65 years. Materials and methods: The Katz index was translated to Sinhala, cross-culturally adapted and administered in two stages. In stage 01, 200 patients aged ≥65 years, selected randomly from out-patient medical clinics, were asked to fill the Sinhala version of Katz index along with the Sinhala version of the 10-item Barthel index (BI). The Katz index was re-administered after two weeks among a subgroup of 45 patients selected randomly. In stage 02, Katz index was administered among randomly selected 200 community dwelling older people, aged ≥65 years. In addition, performance-based physical functions [gait speed (GS) and short physical performance battery (SPPB)] were also measured. Results: The analysis of stage 01 data showed internal consistency measured with Cronbach's alpha of 0.82 and test-retest reliability evaluated with intra-class correlation (ICC) (95% CI) of 0.94 (0.89-0.96) (p < 0.001). Exploratory Factor Analysis with the Principal Component Analysis revealed the presence of two factors with Eigen value exceeding 01, explaining 75.9% of cumulative variance. Further, the Sinhala version of Katz index total score showed a strong correlation with the BI total score (r = 0.91, p < 0.001) indicating strong concurrent validity. The stage 02 data revealed that older people with poor perception of general health status had lower mean (SD) Katz index score (3.58 ± 1.82) compared to those with good perception of health (5.56 ± 0.79) (p < 0.001). Similarly older people with prevalent diseases had comparatively lower scores of Katz index, compared to those without, indicating the known group validity (p < 0.05). Further, moderate correlations between the Katz index and performance based physical functions were observed showing the agreement (with GS - r; -0.26, p < 0.001, with SPPB - r; 0.31, p < 0.001). Conclusions: We conclude that the Sinhala version of Katz index has satisfactory psychometric properties and it is a reliable and valid tool to assess the functional status of Sinhala conversant older people in Sri Lanka.

Service availability and readiness for hip fracture care in low- and middle-income countries in South and Southeast Asia.

Aims: The aim of this study was to describe the current pathways of care for patients with a fracture of the hip in five low- and middle-income countries (LMIC) in South Asia (Nepal and Sri Lanka) and Southeast Asia (Malaysia, Thailand, and the Philippines). Methods: The World Health Organization Service Availability and Readiness Assessment tool was used to collect data on the care of hip fractures in Malaysia, Thailand, the Philippines, Sri Lanka, and Nepal. Respondents were asked to provide details about the current pathway of care for patients with hip fracture, including pre-hospital transport, time to admission, time to surgery, and time to weightbearing, along with healthcare professionals involved at different stages of care, information on discharge, and patient follow-up. Results: Responses were received from 98 representative hospitals across the five countries. Most hospitals were publicly funded. There was consistency in clinical pathways of care within country, but considerable variation between countries. Patients mostly travel to hospital via ambulance (both publicly- and privately-funded) or private transport, with only half arriving at hospital within 12 hours of their injury. Access to surgery was variable and time to surgery ranged between one day and more than five days. The majority of hospitals mobilized patients on the first or second day after surgery, but there was notable variation in postoperative weightbearing protocols. Senior medical input was variable and specialist orthogeriatric expertise was unavailable in most hospitals. Conclusion: This study provides the first step in mapping care pathways for patients with hip fracture in LMIC in South Asia. The previous lack of data in these countries hampers efforts to identify quality standards (key performance indicators) that are relevant to each different healthcare system.

Approach to Study the Efficacy and Safety of New Complementary and Alternative Medicine Formulations: Lesson during COVID-19 from Sri Lanka.

COVID-19 affected Sri Lanka from early 2020, a time of considerable ignorance accompanied by wide media coverage of a devastating epidemic in Italy and Europe. Many were attracted to complementary and alternative medicine (CAM) or traditional medicine (TM) in this desperate situation. Several preparations were claimed to be effective against COVID-19 globally. Dammika Bandara Syrup© was one such preparation promoted for preventing and treating SARS-CoV-2 infection. It was based on bees' honey, pericarp and mace of Myristica fragrans (nutmeg), the seed of Foeniculum vulgare and fresh rhizome of Zingiber officinale, all believed to have anti-viral properties. Following an unpublished clinical study claiming efficacy, Dammika Bandara Syrup© gained wide media publicity and political patronage. The producer claimed of Goddess Kali revealing the formula added an anthropological, cultural, and religious complexity to the issue. The demand for the product increased rapidly as a debate raged both in public and in the parliament on utilizing such products in combating COVID-19. The Department of Ayurveda, which is statutorily responsible for regulating CAM/TM had to respond to the situation. The legislation to regulate such indigenous medicinal products was weak, and the crisis deepened as thousands converged to the production facility, defying mobility restrictions introduced to control COVID-19. This led to the Ministry of Health requesting academics to form a team and conduct a clinical trial to prove its efficacy. This paper outlines the process and issues faced during the regulatory approval for the trial in a polarized political environment. Some health professionals accused the researchers of bowing to political pressure and questioned the scientific justification for the trial. However, the team considered this as an opportunity to streamline a path for research into CAM/TM therapies in situations such as COVID-19. Several processes were identified and addressed, such as the provisional registration of CAM preparations, assessing the potential efficacy of a CAM product, confirmation of authenticity and safety, standardization and supervision of production respecting cultural identities, obtaining approval for human use, choice of comparators, and ethical issues. We believe the study has helped set standards and a benchmark for CAM and TM research in Sri Lanka.

Age-Related Trends in Body Composition among Women Aged 20-80 Years: A Cross-Sectional Study.

The determinants of body composition are likely to vary geographically due to the diversity of genetic and environmental factors between populations. Age-related trends in body composition in a population help understanding the health issues that are linked with different body compartments. In general, such studies are scarce in the South Asian region and this cross-sectional study examined the age-related trends in body composition in a selected group of healthy women aged 20-80 years in Sri Lanka. The study included randomly selected 784 healthy women aged 20-80 years from the Southern province, Sri Lanka. Women were divided into five age groups: 20-29 years (n = 79), 30-39 years (n = 144), 40-49 years (n = 185), 50-59 years (n = 281), and ≥60 years (n = 85). Total body bone mineral density (TBBMD, g/cm2), total body bone mineral content (TBBMC, g), total body fat mass (TBFM, kg), and total body lean mass (TBLM, kg) were measured with central-type dual-energy X-ray absorptiometry (DXA). Multivariate analysis of variance with Bonferroni post hoc test was performed. The age-related trends of TBBMD and TBBMC were similar with a peak in 40-49-year age group. Between 50 and 59 and ≥60 age categories, TBBMD and TBBMC showed a rapid decline: 16% and 23%, respectively. The rate of TBBMD decline was 0.008 g/cm2 per year after 50 years. TBFM increased by 14% between age categories 20-29 and 40-49 years and remained unchanged after 49 years. TBLM increased by 15% between age groups 20-29 and 40-49 years and then decreased by 13% between age categories 50-59 and ≥60 years. Of the 13% decrease in TBLM after 50 years, 9% loss occurred after 59 years. The trends observed help to understand the occurrence of diseases linked with body composition.