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.

Clinical features and sociodemographic factors affecting Trichomonas vaginalis infection in women attending a central sexually transmitted diseases clinic in Sri Lanka.

INTRODUCTION: Trichomoniasis is a relatively neglected area of research in Sri Lanka. Given the number of infections observed, an analysis of sociodemographic characteristics of patients would be valuable in prevention. MATERIALS AND METHODS: Data were collected from 359 newly registered women at a tertiary level sexually transmitted diseases clinic over a period of 18 months. Trichomoniasis was diagnosed by culture of vaginal swabs collected from the posterior fornix. RESULTS: The prevalence of trichomoniasis in the sample was 7.2%. Of those who tested positive for trichomoniasis, 76% were in the age group of 21-45 years, 68% were married and living with a spouse and 60% were unemployed. A diagnosis of Trichomoniasis was associated with being married (OR, 1.6; CI, 0.56-4.41), age over 33 years (OR=1.3, CI, 0.55-2.9), being employed (OR, 1.3; CI, 0.56 - 2.94), having an education of less than ten years at school (OR, 3.0; CI 1.28-7.26) and not using condoms during the last sexual act (OR 2.0, CI 0.84-4.86). The risk was less among commercial sex workers (OR, 0.3, CI: 0.14-0.85), those with multiple sexual partners (OR, 0.2; CI; 0.073-0.408) and women reporting extramarital sexual relationships (OR, 0.3; CI, 0.128-0.733). CONCLUSIONS: Education on safe sex and recognition of symptoms is currently targeted at high risk groups such as commercial sex workers. Extending these programmes to the rest of the community will further reduce the risk of transmission of trichomonas.

Incidence of childhood Haemophilus influenzae type b meningitis in Sri Lanka.

OBJECTIVE: To demonstrate the burden of Haemophilus influenzae type b (Hib) disease in Sri Lanka and provide information for decision-making in public health planning and vaccine introduction. METHODS: This was a prospective, population-based study carried out in 2004, to describe the epidemiology and calculate the incidence of meningitis caused by Hib in children <5 years of age in the district of Colombo, Sri Lanka. Hib was identified in cerebrospinal fluid (CSF) specimens by culture and antigen detection (latex agglutination test; LAT). RESULTS: The lumbar puncture rate in children <5 years of age was 1.9%. A causative bacterial organism was identified in 108 meningitis cases, and in 54 (50%) this was Hib. The LAT increased the Hib detection rate in CSF four-fold. In 2004, the annual incidence of Hib meningitis in Colombo was 20.1 cases per 100000 children aged <5 years. CONCLUSIONS: This study is the first from Sri Lanka reporting the Hib meningitis incidence rate pre-vaccine introduction. The reported incidence rate is one of the highest from the Asian region, but is likely an underestimation considering the difficulties in the laboratory identification of Hib.