Awareness of clinical trial registration among healthcare professionals: An observational study.

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.

Ten years of clinical trial registration in a resource-limited setting: Experience of the Sri Lanka clinical trials registry.

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.

Nursing intensive care skills training: a nurse led, short, structured, and practical training program, developed and tested in a resource-limited setting.

PURPOSE: To assess the impact of a nurse-led, short, structured training program for intensive care unit (ICU) nurses in a resource-limited setting. METHODS: A training program using a structured approach to patient assessment and management for ICU nurses was designed and delivered by local nurse tutors in partnership with overseas nurse trainers. The impact of the course was assessed using the following: pre-course and post-course self-assessment, a pre-course and post-course Multiple Choice Questionnaire (MCQ), a post-course Objective Structured Clinical Assessment station, 2 post-course Short Oral Exam (SOE) stations, and post-course feedback questionnaires. RESULTS: In total, 117 ICU nurses were trained. Post-MCQ scores were significantly higher when compared with pre-MCQ (P < .0001). More than 95% passed the post-course Objective Structured Clinical Assessment (patient assessment) and SOE 1 (arterial blood gas analysis), whereas 76.9% passed SOE 2 (3-lead electrocardiogram analysis). The course was highly rated by participants, with 98% believing that this was a useful experience. CONCLUSIONS: Nursing Intensive Care Skills Training was highly rated by participants and was effective in improving the knowledge of the participants. This sustainable short course model may be adaptable to other resource-limited settings.