Theses - Faculty of Medicine
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Item Impact of medication counselling by pharmacists in patients with diabetes,attending rural and urban outpatient clinics in Sri Lanka.(University of Kelaniya, 2020) Mamunuwa, A.M.V.G.N.Introduction & Objective: The intervention of pharmacists in the management of diabetes is well studied throughout the world. Many countries include this practice to achieve target treatment outcomes of patients with diabetes. Our study assessed the effectiveness of pharmacist counselling on outpatient management of diabetes. Despite the high and rising prevalence of diabetes in Sri Lanka, this is the first study to evaluate a clinic-based pharmacy counseling service in the Sri Lankan diabetes population. Methods: 800 participants with diabetes attending outpatient clinics of two Sri Lankan hospitals were assigned to either intervention group (IG) or control group (CG). IG received pharmacist counseling for four consecutive monthly visits in addition to standard care. CG received standard care only. The effectiveness of the intervention was assessed in terms of glycaemic control, adherence to medicines, patients* knowledge regarding medicines and disease. Quality of life (QoL) and the detection and resolving of drug related problems. Data was analyzed using Statistical Package fbr the Social Science (SPSS) software. Nonparametric tests were used as the data did not follow normal distribution. Results: Age ranged from 23 to 87 years. 67. 25% were female. At the end of the study, 359 and 360 participants remained in the control and intervention groups respectively. The IG had a median HbAlc of 7.2% (IQR 1.5%) post-inte^ention compared with the CG median of 7.7% (IQR 1.95%) (p<0.05%). The IG had a median adherence score of 5 out of 8 (IQR 6-3.3) at baseline which increased to 7 (IQR 8-6) post-intervention (p<0.05). CG median score was 5.3 (IQR 7-4) and 5 (IQR 7-4.2) at baseline and post-intervention respectively. The IG had a median score of 53% (IQR 64% - 34%) for the medication related knowledge domain, which increased to 73.3% (IQR 81% - 65%) post-inte^ention (p<0.001) The CG score was 50% (IQR 63% - 34.25%) at baseline and 50% (IQR 63% ・ 33.47%) post¬intervention (P=0.84I). The IG had a median percentage score of 50.48% (IQR 59% -41%) for the QoL questionnaire, which increased to 51.13% (IQR 61% - 42.5%) post-inten^ention (P=0.001). The CG score was 49.19% (IQR 59% - 39%) at baseline and 49.06% (IQR 59% - 39%) post-intervention (P =0.659). A total of 252 DRPs were detected. Acceptance of pharmacy interventions was high with 75.64% of problems being totally or partially solved. Conclusion: Pharmacist counselling improved medication adherence, glycaemic control, patients' knowledge regarding medication management and quality of life of the patients. It is helpful in addressing and resolving the drug related problems. Thus, pharmacist counseling can effectively be used to improve the outpatient management of diabetes in Sri Lanka.Item Factors associated with symptom frequency and health seeking behaviour of the general population, Gampaha district -Sri Lanka(University of Kelaniya, 2022) Withana, S.S.Public outpatient department (OPD) visits are estimated to increase from 55 million in 2014 to 100 million in 2027. With the private sector handling a similar share, this will be an unsustainable burden to the healthcare system. High illness sensitivity of the population and increase in healthcare seeking associated with socio-demographic factors could be some of the reasons fbr increasing OPD visits. This study from the Gampaha district describes the symptom frequency, healthcare-seeking pattern, associated socio-demographic characteristics, factors associated with selection between public or private sectors and methods of sei-care practised by the study population. Using a community-based prospective study design, the data collection was done in Ragama(urban) and Mirigama(rural) areas fbr one month. Participant-held symptom diary combined with interviews were used to collect patient data. From Ragama and Mirigama, six midwife areas were randomly chosen. Clusters of 15-20 households were selected from 5-6 random locations in each area. The study population was 2046 individuals, majority females (n=l 127,55.1%) from 557 households. The majority were from Mirigama (rural) 1207(59%). Symptoms were reported by 1919(93.8%). Phlegm (7.0%), leg pain (6.6%) and cough (5.3%) were top symptoms. Adult males were less likely to have symptoms [p=0.016,OR=0.46,95%CI(0.244-0.865)]. Healthcare was sought by 924(45.1%) and the majority (n=763,37.3%) preferred the allopathic system. Urban children [p<0.001 ,OR=0.546,95%C1(0.389・0.767)], and adults [p=0.004,OR=0.663 95%CI(0.502-0.877)] were less Hkely to seek care than their rural counterparts. For OPD care, the majority preferred the private (n=515,25.2%) compared to the public sector (n=330,16.1%). Having a regular doctor increased health-seeking in the private sector in children [p<0.001,OR=5.86,95%CI(3.28-10.486)]. For adults, regular doctor [p<0.001 ,OR=4.105,95%CI(2.098-8.03 l)]and income [p=0.037,OR=5.177,95%CI (1.102-24.317)] increased private sector visits. Of the 47(2.3%) that needed in-ward care, 42 were admitted to public hospitals, of which 19 were to teaching hospitals. Only 4 were admitted to private institutions. Having a regular doctor reduced the admissions [p=0.08,OR=0.397 95%CI(0.201- 0.785)]. The majority practised Allopathic self-care methods. The study population had high symptom reporting and high healthcare-seeking behaviour which may explain the increasing trend of outpatient visits. The majority preferred private sector fbr outpatient care and having a regular doctor and income, increased private-sector visits. Public hospitals were the choice of the majority fbr admissions.Item Translation and validation of liebowitz social anxiety scale and a randomized controlled trial investigating the effectiveness of group cognitive behavior therapy versus a wait list control of university students with social phobia.(University of Kelaniya, 2020) Hapangama, A.Background: Despite being one of the most prevalent psychiatric disorders, social phobia remains to be under-diagnosed. To date no instrument to measure social phobia in available in Sinhalese. Cognitive Behavior Group Therapy (CBGT) has not only been proven effective but also cost-effective in other countries fbr adults with social phobia. Objective: to translate and validate the Liebowitz Social Anxiety Scale- self-rated (LSAS-SR) in to Sinhalese and to determine the effectiveness of CBGT as compared to a waitlist control of university students with social phobia. Method: Translation, adaptation and validation followed the standard procedure. DSM IV was used as the gold standard to diagnose social phobia. A single-blind randomized controlled trial consisting of an 8-week treatment phase with a modified form of CBGT versus a waitlist control was conducted among consenting university students with social phobia. Results: Cut- off of 39 had the best sensitivity and specificity. The Cronbach's alpha between the totals of avoidance and fear subscales was 0.919. The test-retest reliability fbr the fear subscale, avoidance subscale and the total score were 0.998, 0.999 and 0.994 respectively with a correlation significant at 0.01. Repeated measure analysis of the total scores of the Sinhala version of LSAS-SR in CBGT arm showed statistically significant (p<0.001) reduction in the total scores (13.6222) when compared to the scores in the waitlist arm. Conclusions: Cutoff value of 39 fbr the Sinhala translation of the LSAS-SR supports findings of other studies with regard to psychometric properties. CBGT is effective in treating university students with social phobia in Sri Lanka. Larger scale studies among other people with social phobia also looking at cost-effectiveness may provide more light on this.Item The association between asthma and functional abdominal pain disorders in paediatric population: common pathophysiological mechanisms causing this association(University of Kelaniya, 2019) Kumari, A.M.M.V.Asthma and functional abdominal pain disorders (FAPDs) are common paediatric disorders affecting quality of life. Though the association of asthma with irritable bowel syndrome has been reported, association with other FAPDs and possible underlying pathophysiological mechanisms have not been well described. This thesis describes the association between asthma and FAPDs (Phase I) and investigation of a possible pathophysiological mechanism using gastric motility and lung function tests (Phase II) in a cohort of children. In phase I, a cross-sectional survey was conducted among randomly selected adolescents. The validated Rome HI, and International Study on Asthma and Allergies in Childhood (ISAAC) questionnaires were utilized to identify adolescents with FAPDs and asthma respectively. Health-related quality of life (HRQoL) was evaluated using the Paediatric Quality of Life Inventory. Logistic regression showed independent association between asthma and functional abdominal pain [odds ratio (OR) 3.1, 95% confidence interval (CI) 1.6-6.0], functional dyspepsia (OR 3.9, 95% CI 1.1-13.5) and abdominal migraine (OR 10.2, 95% CI 2.6-39.5). HRQoL was significantly impaired among adolescents with both disorders. In phase II, an extensive review identified shared pathophysiological mechanisms; smooth muscle dysfunction, immune dysfunction, hypersensitivity, mucosal inflammation and barrier dysfunction, followed by a laboratory-based study involving 100 children (age 7-12 years), recruited into 4 groups of 25 each; asthma only, FAPDs only, asthma and FAPDs, and healthy controls. Asthma was diagnosed using clinical history and spirometry, and FAPDs by Rome III criteria. All subjects underwent real-time ultrasonography and spirometry. Gastric emptying rate, amplitude of antral contractions and antral motility index were significantly impaired in children with either disorder or both compared to controls (p<0.05). Antral motility index correlated with FEVi/FVC ratio (r=0.60, p=0.002) and FEF25%-75% (r=0.49,p=0.01) in children with both disorders. In conclusion, a strong independent association was noted between asthma and FAPDs. Gastric motility was significantly impaired in children with either disorder or both. Motility index measuring overall gastric motor function, shov/ed significant positive correlation with lung function parameters that measured airflow limitation. Primary disturbance of smooth muscle activity in airways and the gastrointestinal wall could be a possible pathophysiological mechanism for this association between asthma and FAPDs.Item The role of virgin coconut oil in the treatment of alzheimer's disease(University of Kelaniya, 2021) Fernando, M.G.Alzheimer disease (AD) is the most common cause of dementia and one of the leading causes of morbidity and mortality in aging population. Virgin coconut oil (VCO) is an emerging approach to improve cognition of AD patients. This double-blind placebo- controlled trial was designed to investigate the effect of VCO on memory and cognition of mild-to-moderate AD patients and to investigate the association of Apolipoprotein E (APOE) genotypes on the outcome. Subjects were 120 Sri Lankan mild-to-moderate AD patients aged >65 years and were randomly allocated to the treatment and control groups. Treatment group was fed 30 mL/ day of VCO and control group with a same amount of canola oil for 24 weeks. Memory and cognition were assessed by Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MOCA), and executive clock drawing task (CLOX) at the baseline and at the end of the intervention. Blood samples were collected and lipid profile and HbAlC at the baseline and at the post- intervention were analyzed. APOE genotype tests were performed. There was no significant difference in changes of memory scores, lipid profile and HbAlC between the treatment and control groups. However, MMSE scores were improved among A POE-4 carriers compared to the non-carriers (2.37, p=0.021) who had VCO, whereas APOE-4 status did not influence the memory scores of patients who had canola oil. In conclusion, oral supplementation with VCO for 24 weeks did not result an improvement in MMSE and MOCA scores in patients with mild-moderate AD compared to canola oil. However, intervention with VCO improved MMSE scores in patients who had APOE-4 allele compared to those did not have it. VCO supplementation did not compromise fasting lipid profile and HbAlC.Item Spatiotemporal methods and applications in neglected tropical diseases(University of Kelaniya, 2020) Ediriweera, E.P.D.S.In nature, diseases show spatial and temporal variations. The probability of acquiring diseases decline along with increasing distances and time lags. Spatial, temporal and spatiotemporal predictive models are useful to make recommendations in low-resource settings when disease registries are either non-existent or geographically incomplete. The National Snakebite Survey (NSS) was an island-wide, community based survey conducted over 11 months. The survey reported snakebites that occurred in the preceding 12 months, and the number of people surveyed in each month varied. Snakebite showed a spatial correlation between events. Spatial variation of snakebites at cluster level was assessed using purely spatial models after collapsing the time dimension and accounting for spatial correlation between events. Temporal variation of snakebites at each month was assessed using purely temporal models after collapsing the spatial dimension and accounting for recall bias and survey effort. Subsequently, the spatial and temporal models were combined to explain spatiotemporal variation incoiporating individual-level data. Overall, snakebites and envenoming bites showed clear spatial and temporal variations in Sri Lanka. Snakebites were higher in intermediate and wet zones. However, envenomings were higher in the dry zone. At the national level, the highest snakebite incidence was observed from November to December, whilst the highest envenoming incidence occurred from March to April. Snakebite and envenoming hotspots showed dynamic changes throughout the year. The average monthly snakebite and envenoming incidence in Sri Lanka were 39 and 19 per 100,000 respectively. This translates into 110,000 snakebites and 45,000 envenomings each year. The models that were developed were then used to demonstrate the residual confbunding effect and explain the health-seeking behaviour of snakebite victims. Health seeking behaviour of snakebite victims depended on probable envenoming caused by bites. Victims in high endemic areas fbr envenoming sought allopathic treatment over traditional treatment and vice versa. The thesis also presents a case study to illustrate spatial modelling in the absence of spatial correlation between events. The thesis presents some solutions to problems encountered in spatial, temporal and spatiotemporal epidemiology. These results would facilitate informed healthcare decision making in Sri Lanka, and the methods described are replicable for studies of a similar nature.Item Development of a quantum dot-based rapid diagnostic assay for the detection of dengue NS1 antigen.(University of Kelaniya, 2022) Munasinghe, M.M.E.Dengue is a mosquito bom viral disease which is considered as one of the most important and most prevalent infectious diseases in tropical and sub-tropical world. This is caused by a virus from the genus Flavivirus that has four closely related serotypes. The differentiation of the clinical symptoms of dengue fever (DF) is challenging fbr the clinicians due to its similarity with other febrile illnesses. Diagnosis of the disease as early as possible would improve the patient management, vector controlling and lower the fatality rate. The main objective in this study was to develop a cost effective rapid Lateral Flow Immunoassay (LF1A) using nanotechnology for detection of dengue infection. The specific objectives were to develop monoclonal antibodies against dengue NS1 protein as the capturing agent and to synthesize L-Cysteine capped CdTe quantum dots as the detecting agent. In this study, four serotype specific synthetic peptides (Pl, P2, P3 and P4) were designed from the NS 1 region of the serotype 1, 2, 3 and 4 respectively, considering various factors. These peptides were used to immunize four, female Balb/c mice and fusions were carried out to produce hybridoma clones. Enzyme Linked Immunosorbent Assays (ELISA) were developed to screen the antibodies reacting with peptides as well as the native protein present in clinical samples. The selected antibody was used to anchor on L-Cysteine capped CdTe quantum dots. The quantum dot conjugated antibody was used in the development of LFIA. A total number of 28 IgG secreting hybridoma clones out of 1830 growing clones produced dengue specific monoclonal antibodies. A monoclonal antibody (Pl.18) resulted from the fusion of Pl immunized mice, showed significantly high antibody response fbr all four dengue serotypes. This antibody was used as the detector antibody in LFIA. During the LFIA, a fluorescent band was visible under ultra violet light (UV) fbr the detection of dengue NS1 protein in infected urine samples implying the successful development of a cost effective LFIA fbr detection dengue. Detection of infected blood was not feasible due to fluorescent quenching resulted by high lysozyme concentration present in blood and has to be further optimized. These findings can be further used to develop a user friendly low cost diagnostic test kit fbr detection of dengue infection from urine.Item The genetic origin(s) and the distribution of the sickle cell gene and the clinical description of sickle cell disease in Sri Lanka(University of Kelaniya, 2020) Darshana, L.G.T.Case reports and limited case series of Sickle cell disease (SCD) in Sri Lanka have been reported since 1962. Yet, no attempt has been made up till now to undertake a comprehensive genotypic-phenotypic analysis of this "rare" group of patients in Sri Lanka. The national thalassaemia prevention programme in Sri Lanka is currently using Full Blood Count with (FBC) red cell indices as the technique for haemoglobionopathy screening. This approach is likely to miss sickle haemoglobin (Hb S) carriers. Present study intends to describe the clinical picture of SCD in Sri Lanka, analyze its molecular basis, including the effects of genetic modifiers on the phenotype and describe the screening utility of sickling test in identifying sickle carriers among a relatively high-risk population in Hambantota district of Sri Lanka. All accessible sickle patients, totaling 60, including, 51 Sickle p-thalassaemia (SBT) and 9 homozygous sickle patients (Hb SS) were enrolled from seven thalassaemia treatment centres. All the patients were clinically evaluated and details were recorded. P-globin haplotypes, p - thalassaemia mutations, common a+ thalassaemia gene deletions and 5 known Fetal haemoglobin (Hb F) modifiers (rs6545816, rs 1427407, rs66650371, rs9402686, rs7482144) were assessed. Geographically, two prominent patient clusters were identified and the distribution of Hb S in the island contrasted with that of the other haemoglobinopathies. 3/ 9 Hb SS and 3/ 51 SBT patients were receiving regular transfusion. Joint pain was the commonest clinical presentation among all SCD patients (n=39, 65.0%). Dactylitis was significantly more common in Hb SS patients compared with the SBT group (p 0.034). Two genetic backgrounds Hb S mutation were identified and confirmed namely, Arab Indian and Benin. Among the Hb F regulators rs 1427407 G>T seemed to be the most prominent modifier, with a significant association with Hb F levels (p 0.04). Sickling test demonstrated 100 % sensitivity and 100 % specificity. FBC by itself was unreliable to detect Hb S but if combined with sickling test was able to pick up Hb S in addition to most other haemoglobinopathies.Item Assessment of background radiation and frequency of micronuclei formation in two selected populations in Sri Lanka.(University of Kelaniya, 2019) Weerakkody, W.A.T.L.This study assessed background radiation and frequency of micronuclei formation in persons living in Norochcholai and Ragama. Ninety-six healthy individuals (20-59 years of age) from both sexes were selected for the study, comprising 50 from Norochcholai (area closest to the power plant) and 46 from Ragama (control). Ten milliliters of venous blood was drawn and the cytokinesis—block micronuclei assay was performed. Thousand binucleate cells were assessed; the median spontaneous micronuclei formation was estimated. Background radiation was measured using an Automess dose rate meter 6150AD. There was no significant difference in the median micronuclei (MN) frequency between the two sexes (p= 0.538) and the two study areas (p=0.539). There was no correlation between background radiation and MN frequency. Fifty-four water samples (26 from Norochcholai and 28 from Ragama) were analyzed by gamma spectrometry and radioactivity was not detected in any of the water samples. Fifty-one soil samples (25 from Norochcholai and 26 from Ragama) were analyzed by gamma spectrometry. The median radioactivity concentration (IQ range) of 232 Th, 40 K, 226Ra and 210Pb in Norochcholai were 50.0Bqkg-l (31.3-91.2), 99Bqkg-1 (84.0-111.3), 22Bqkg-l (14.3-40.3Bqkg-l) and 27Bqkg-l (23-44Bqkg-l) respectively; in Ragama, the median radioactivity concentrations (IQ range) of were significantly higher in Norochcholai than that of Ragama area exceþt for 40K.The gamma ray absorbed dose rates in soil samples of Norochcholai varied between 32.1 nGyh-l and 81.1 nGyh-l with an average of 51.2nGy h-l which is lower than the global average of 57 nGyh-l; in Ragama, this varied between 27.8-40. lnGyh-1. The mean Raeq of Norochcholai was 149.7 Bqkg-l. A radium equivalent activity above 370, the limit set by the Nuclear Energy Agency group of experts as safe to be used in building materials, was observed in 2 soil samples from Norochcholai. All the soil samples from Ragama had a Raeq below 370Bq/kg. The median Raeq was 73.7 Bq/kg. The median annual effective dose in Norochcholai was 0.062 mSv.y-l and in Ragama it was 0.040mSvy-l. They were within the safe limit of ImSv/y. Hex of all the samples were below I. Thus the soil from both the study areas are safe for human health. Pb were 38.4Bq/kg (26.4-52.1), 100.7Bq/kg (93.1-163.9), 11.7Bq/kg (10.1-16.3) and 25.9 Bq/kg (19.8-47.5) respectively. 232Th activity concentration in both were higher than the world average. Activity concentrations of all the radionuclides. The results of this study can be used as baseline data to monitor exposure to radiation in the selected population in the future. This is important for monitoring radiation hazards and will be useful in case of a nuclear accident. KEYWORDS: Background radiation, micronuclei, Nuclear accident, baseline data, gamma spectrometryItem Establishment of a geographic information system (GIS) based mathematical model for prediction of dengue epidemics within Colombo and Kandy districts of Sri Lanka.(University of Kelaniya, 2019) Udayanga, N.W.B.A.L.Dengue fever, which is primarily transmitted by Aedes aegypti and Aedes albopictus, is responsible for approximately 390 million infections globally per annum. The current study was conducted to characterize the dengue risk within the districts of Colombo and Kandy. Information on socio-economic and demographic status, and knowledge, attitudes and practices (KAP) were gathered from 1000 randomly selected patients and 1000 non-dengue reported households within each district using an interviewer administered questionnaire. Routine entomological surveillance was conducted from February 2016 to July 2018 at monthly intervals within 10 high risk Medical Officer of Health (MOH) areas in both districts. Monthly vector indices, [Premise Index (PI), Container Index (CI) and Breteau Index (BI)], meteorological parameters (monthly total rainfall, minimum and maximum temperature and relative humidity), landuse practices and socio-demographic data from all the 39 MOH areas relevant to the period of January, 2012 to December, 2018 were collected as secondary data. The socio-economic attribute. were statistically analysed by using the Chi-square test of independence and cluster analysis. Receiver Operating Characteristic (ROC) curves analysis was used to develop thresholds for dengue epidemic management. Principal Component based Linear Regression (PCLR) and Principal Component based Poisson Regression (PCPR) approaches were used to develop a spatial risk characterization model for dengue, while Seasonal Autoregressive Integrated Moving Average (SARIMA) approach was used to develop a temporal dengue prediction model. The climate change vulnerability of the local communities to dengue was evaluated by using the composite index method. Significant differences were identified among the test and control groups for basic demographic factors, living standards, knowledge, attitude and practices. The test group indicated similar risk factors, while the control group also shared more or less similar characteristics as depicted by the findings of cluster analysis. Further, improvement in key infrastructural facilities such as urbanization and waste collection, community education, public motivation, coordination and integration of control programmes, were recognized to be vital. Only PI and BI for Ae. aeopti (Blagp) were significantly associated with dengue epidemics at lag periods of one and two months. Based on Ae. aegypti, average threshold values were defined for Colombo as Low Risk (Blagp ≤2.4), Moderate Risk (3.8 ≤ Blagp ≥5), High Risk (Blagp ≥ 5), along with Blagp ≤ 3.0 (Low Risk), 4.2 ≤ Blagp < 5.3 (Moderate Risk) and Blagp ≥ 5.3 (High Risk) for Kandy. Further, PI ≤ 5.5, 8.9 ≤ PI ≥ 11.9 and PI ≥11.9 were defined as Low Risk, Moderate Risk and High Risk average thresholds for PI in Colombo, while PI ≤ 6.9 (Low Risk), 9.1≤ PI ≥ 11.8 (Moderate Risk) and PI ≥ 11.8 (High Risk) were defined for Kandy. The best fitting model converged by PCPR was the best risk characterization model, with higher levels of goodness of fit indicators such as R2 and Adjusted R2 values of 90.08% and 89.88%, with an AIC value of 205.86. The best fitting forecasting models fitted for Colombo and Kandy are SARIMA (0,1,0) (3,0,0) and SARIMA (2,1,2) (1,0,0)12 respectively. Colombo Municipal Council MOH area had the highest vulnerability (0.49: moderate vulnerability) to dengue, while the Galaha MOH showed the lowest (0.15; very low vulnerability). KEYWORDS: Dengue, Risk prediction, GIS, Spatial model, threshold.