Medicine
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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
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Item Gastroenterology Update(Gastroenterological and Digestive Endoscopy Society Sri Lanka Colombo, Sri Lanka, 1993) Goonaratna, C.; de Silva, H.J.No abstract availableItem Quality of clinical trial registration at the Sri Lanka clinical trials registry: a 5-year analysis(Sri Lanka Medical Association, 2017) Ranawaka, U.K.; de Abrew, A.; Ranasinghe, R.M.A.G.; Kulathunga, K.A.C.J.; Wimalachandra, M.; Samaranayake, N.; Goonaratna, C.INTRODUCTION & OBJECTIVES: Previous studies have highlighted the poor quality of clinical trial registration in international registries. We sought to evaluate the quality of trial registration in the Sri Lanka Clinical Trials Registry (SLCTR). METHODS: We studied all trial records at SLCTR over a 5-year period (2012-2016). Records were evaluated for data quality, using pre-defined criteria, regarding the following: WHO minimum trial registration data set (WHO-TRDS), ethics review approval, and detailed analysis of contact information, interventions and outcomes. RESULTS: A total of 144 trial records were studied. All records had meaningful entries for 12 out of the 20 items in WHO-TRDS, and over 95% of records had meaningful entries for 16 items, while the mean TRDS score was 17.76 ±1.03. Details of ethics approval were provided in all records. Intervention specifics were recorded for 174 experimental or active comparator arms. Meaningful information was provided regarding intervention name, dose, duration, frequency and route in 173 (99.4%). 156 (89.7%), 123 (70.7%), 132 (75.9%) and 109 (62.6%) arms respectively. A total of 388 primary outcome measures were recorded. Of them, 79.1% (n=307) were considered to be of good quality (specific – 76%; safety monitoring – 3.1%). Recording of time frame was considered to be of good quality for 94.4% (n=366) of outcomes (meaningful – 83.8%; irrelevant – 10.6%). All records provided either email address or telephone number of contact person; 98% (n= 141) had both. CONCLUSION: Quality of clinical trial registration at the SLCTR is better compared to other international registries in almost all the domains studied. Trial registration of good quality is feasible and sustainable in a resource-limited setting.Item Awareness of clinical trial registration(Sri Lanka Medical Association, 2012) Wimalachandra, B.C.M.; Ranawaka, U.K.; de Abrew, K.A.G.; Wanigatunga, C.A.; Rajapaksa, L.C.; Goonaratna, C.INTRODUCTION: Prospective registration in a freely accessible public domain is mandatory for clinical trials. Little is known regarding awareness of clinical trial registration among the scientific community. AIMS: To assess awareness of clinical trial registration among participants attending a scientific meeting in Sri Lanka. METHODS: Knowledge of trial registration was assessed using a self-administered questionnaire. Results: Only 251 out of 714 participants (35.6%) returned completed valid questionnaires. Of them, 53.4% were males, 74.9% were below the age of 40 years, and 49% had less than 5 years of professional experience. Majority (56.6%) were currently involved in research. Registration was considered necessary for trial publication by 73.3%, for presentation of findings by 56.2%, and for ethics approval by 54.6%. Over 70% agreed that trials should be registered prospectively. Majority felt it was beneficial to have research findings freely accessible to other researchers (81.3%), clinicians (84.5%) and research participants (76.7%). Many agreed on the positive effects of trial registration - access to findings of all trials (61.4%), access to negative results (47.8%), preventing trial duplication (69.3%) and preventing multiple publications (70.1%). Increasing research workload (49.8%), additional restrictions on research (52.2%) and possibility of'intellectual theft' (56.2%) were seen as potential negative effects. Awareness of access to registration mechanisms for trials conducted in Sri Lanka (49%), and a Sri Lankan trial registry (31.5%) was poor. CONCLUSIONS: Awareness of clinical trial registration was satisfactory in some aspects, but several areas need improvement.Item The Sri Lanka Clinical Trials Registry - a 5 year audit(Sri Lanka Medical Association, 2012) de Abrew, K.A.G.; Ranawaka, U.K.; Wanigatunge, C.A.; Wimalachandra, M.; Goonaratna, C.INTRODUCTION: Prospective registration is mandatory for the conduct and publication of clinical trials. The Sri Lanka Clinical Trials Registry (SLCTRJ was established in November 2006. It is a Primary Registry of the International Clinical Trials Registry Network of the WHO. AIMS: To audit the process of trial registration at the SLCTR during the 5 year period from the first trial registration (February 2007-January 2012). Methods: An internal audit of the online registry and the functioning of the SLCTR was carried out. We evaluated- (1J all trial applications, including those rejected, for accuracy and completeness of the Trial Registration Data Set (TRDS), (2) all registered trials for maintenance of records and (3) in-house procedures related to trial registration. RESULTS: Seventy trials were registered; 14 were rejected. Over half (n=37) were prospective registrations. All registrations since July 2010 (n=21) were prospective. Four were international multi-centre trials; 13 were industry sponsored. Median time from submission of all relevant documentation to registration was 7 days. All applications from 2010 were registered within 7 working days. Majority (n=41J were drug trials, including herbal preparations (n=7), while 19 were for procedures. 39 trials have been completed, 8 have published their findings and 7 reported protocol changes. Eight trials (11.4%) do not have current progress reports. CONCLUSIONS: The SLCTR has provided a platform for registration of clinical trials in Sri Lanka. In-house registration processes have improved with time. There is a need to improve awareness among trial registrants regarding maintenance of trial records.Item The Sri Lanka clinical trials registry-Moving forward(Wiley-Blackwell, 2011) Ranawaka, U.K.; Goonaratna, C.The Sri Lanka Clinical Trials Registry (SLCTR) is a Primary Registry in the Registry Network of the World Health Organization's International Clinical Trials Registry Platform (WHO-ICTRP), and regularly feeds data to its Clinical Trials Search Portal. Over the last few years, the SLCTR has been able to achieve its original objective of providing a national trial register for Sri Lankan researchers, but it has always been more than that of a mere storehouse of trial data. The research landscape is rapidly changing in Sri Lanka, and the SLCTR has been a key stimulus to a resurgent interest in clinical research among the Sri Lankan research community. The SLCTR is working together with its partner stakeholders to facilitate research in the country, and to ensure that clinical trials conducted in Sri Lanka meet the highest ethical and scientific standards.Item Establishing the sri lanka clinical trials registry(Wiley-Blackwell, 2009) Ranawaka, U.K.; Goonaratna, C.Recognizing the need for a national body for trial registration, the Sri Lanka Medical Association took up the challenge of setting up the Sri Lanka Clinical Trials Registry. The registry was established in November 2006, the first functioning trial registry in South Asia. The Sri Lanka Clinical Trials Registry is now a primary registry affiliated to the Registry Network of the International Clinical Trials Registry Platform of the World Health Organization. The Sri Lanka Clinical Trials Registry has not been a mere repository for trial data but has also had a positive influence on the research community in Sri LankaItem Sri Lanka clinical trials registry(Sri Lanka Medical Association, 2007) Ranawaka, U.K.; Goonaratna, C.No Abstract AvailableItem Iron absorption from a traditio nal Sri Lankan weaning food and the enhancing effect of ascorbic acid in adult male volunteers(Sri Lanka Medical Association, 1996) Liyanage, C.; Goonaratna, C.; Thabrew, I.OBJECTIVE:To study absorption of iron from Centella gruel and the enhancing effect of ascorbic acid in young adult males.DESIGN: An in vivo absorption study. SETTING: Faculty of Medicine, Galle. METHODS: The percentage of iron absorbed from the Centella gruel was measured using a double isotope technique with 55Fe and 59Fe on 10 healthy male volunteers. OUTCOME MEASURE: Percentage of iron absorption from the gruel with and without ascorbic acid. RESULTS: The mean iron absorption from each meal of Centella gruel was 2.2% (SEM 0.8). This increased to 5% (SEM 1.6) by addition of 50 mg ascorbic acid. When ingested with ascorbic acid, the bioavailable nutrient density (BND) of the weaning food was increased from 0.23 to 0.53 mg iron/1,000 kcal. To satisfy the daily physiological requirements of iron in infants and toddlers, it was calculated that apart from ascorbic acid supplementation, the total iron content also needs to be increased from 2.05 mg to 4.0 mg/meal. CONCLUSION: Centella gruel cannot provide the amount of iron to meet the BND for iron required by infants and toddlers, unless supplemented with an enhancer of iron absorption such as ascorbic acid and its total iron content is increased.Item Iron deficiency anaemia in children aged 9-24 months a rural area in South of Sri Lanka(1995) Liyanage, C.E.; Thabrew, M.I.; Goonaratna, C.The prevalence of iron deficiency anaemia was examined in a group of 200 rural children, aged 9 to 24 months in the Galle district. Anaemia, defined as a haemoglobin concentration (Ob) less than 110 g/L, was present in 55 percent. Majority of the subjects (70 percent) had serum ferritin (SF) below normal. There was a correlation between the severity of anaemia and a stepwise decrease in serum iron, transferrin saturation and SF. The total iron intake of subjects was marginal; however, this did not show any association with the iron status in them. It is therefore, concluded that iron deficiency anaemia is a potentially serious consequence in children of weaning age and quality of weaning foods that are in practice have to be improved to maintain the iron balance.Item Neonatal and post-neonatal mortality in the Galle district(Sri Lanka Medical Association, 1994) Fonseka, P.; Wijewardene, K.; de Silva, D.G.H.; Goonaratna, C.; Wijeyasiri, W.A.DESIGN: Descriptive study. SETTING: Galle district in Sri Lanka. SUBJECTS: 350 infant deaths of singleton births. MEASUREMENTS: Association between variables. RESULTS: Neonatal: post-neonatal death ratio was 3.2:1, and 62.3% (218) were early neonatal deaths. First day deaths comprised 28.6% (100); 67.8% (237) died at the Teaching Hospital. A high incidence (65.7%) of low birthweight (LBW) was noted. Mean birthweights of neonates and post-neonates were 1925 +/- 729 and 2520 +/- 620 gram respectively, and the difference between means was statistically significant (p < 0.001). LBW and related disorders were the major cause of death in 44% (154) of the total sample, and in 55.8% (149) of neonates. Infections were the commonest cause (55.8%) of death in post-neonates. Pediatric clinical assessment to differentiate small-for-dates (SFD) was not recorded in 90.3%. Statistically significant associations were found between the period of death (neonatal and post-neonatal) and the following variables: period of gestation (p < 0.001); birthweight (p < 0.001) and cause of death (p < 0.001). CONCLUSIONS: There was a high incidence of neonatal deaths and a high proportion of early neonatal deaths. About one-third of deaths occurred on the first day of life. Incidence of LBW was high. The major cause of death was LBW and related disorders in the total sample and in neonates. Assessment of SFD was not carried out in the vast majority of infants.