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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty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 Awareness of clinical trial registration among healthcare professionals: An observational study.(Wiley-Blackwell, 2018) Ranawaka, U.K.; de Abrew, A.; Wimalachandra, M.; Wanigatunge, C.A.; Rajapakse, L.C.; Goonaratna, C.AIM: Prospective registration in a freely accessible public platform is a key step in the ethical conduct of clinical trials. Little is known of the awareness of clinical trial registration among the scientific community. This study aimed to assess awareness of clinical trial registration among participants attending a medical congress in Sri Lanka. METHODS: Knowledge of trial registration was assessed using a self-administered questionnaire, which spanned domains such as involvement in research, and knowledge and perceptions regarding trial registration. A knowledge score was calculated and correlated with demographic variables. RESULTS: Of 251 survey respondents, 53.4% were male, 74.9% were below the age of 40 years, and 56.6% were currently engaged in research. Registration was considered necessary for trial publication by 73.3%, and 70.5% agreed that trials should be registered prospectively. Most achieved a knowledge score of 'Acceptable' (41%) or 'Good' (19.9%). Mid- or advanced career stages, postgraduate training, current involvement in research, and recent research publications/presentations were correlated with higher knowledge scores (P < 0.05). Beneficial effects considered to be associated with trial registration were 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 conduct (52.2%), and the possibility of 'intellectual theft' (56.2%) were seen as potential negative effects. CONCLUSIONS: Most participants were aware of the need for prospective registration as a requirement for publication of clinical trials. Concerns were expressed regarding several perceived negative effects of trial registration.Item Ten years of clinical trial registration in a resource-limited setting: Experience of the Sri Lanka clinical trials registry(Wiley-Blackwell, 2018) Ranawaka, U.K.; de Abrew, A.; Wimalachandra, M.; Samaranayake, N.; Goonaratna, C.AIM: We describe our experience of the first 10 years at the Sri Lanka Clinical Trials Registry (SLCTR). METHODS: We analyzed all trial records of the SLCTR over the study period. We collected information regarding trial characteristics and completeness of data entry in the SLCTR data set. RESULTS: During the study period, 210 trials (63% of all applications) were registered with the SLCTR. The number of registered trials showed an increasing trend over the years. All trial registrations had complete entries for all the data fields studied. Only 17.6% of the trials were registered retrospectively. All the registered trials were interventional studies, and the majority (87.6%) were randomized controlled trials. A significant proportion of trials (28.6%) were on noncommunicable diseases, and 12.4% were on pregnancy and its outcomes. Several trials (9.5%) were international collaborative studies. A majority of the Principal Investigators (70.9%) were affiliated to a university. Most of the studies (41.9%) were self-funded by the investigators. Details of ethics review committee approval were available for 96.7% of registered trials. Over a third of the registered trials (37.1%) had completed recruitment at the time of analysis. A majority of the trials (72.8%) had updated trial data since registration. CONCLUSIONS: There is a steady increase in the number of trials registered at the SLCTR. Complete entries for all the data fields were seen in all trial registrations. The SLCTR has made a positive contribution to the emergence of a healthy clinical research environment in Sri Lanka.Item 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 - five years young, and growing.(Sri Lanka Medical Association, 2012) Ranawaka, U.K.; Wanigatunga, C.; de Abrew, A.; Wimalachandra, M.; Goonaratna, C.No Abstract AvailableItem 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 Available