Dengue Infection in Children in Ratchaburi, Thailand: A Cohort Study. II. Clinical Manifestations

Dengue infection is one of the most important diseases transmitted to human by mosquito bite. The disease may be mild or severe. This study reveals the occurrence and clinical features of diseases caused by dengue infection in a 3-year follow-up in school-children aged 3–14 years in Ratchaburi Province, Thailand using an active surveillance for the episodes of fever. Children who had fever were laboratory tested for the evidence of dengue infection and recorded for clinical features. It was found that most of dengue infected patients had headache, anorexia, nausea/vomiting, and muscle ache. About half of the patients had clinical symptoms that closely mimic other diseases, especially respiratory tract infection, and were incorrectly diagnosed by pediatricians. Only 11% of the patients had more a severe disease called “dengue hemorrhagic fever.” This severe disease may be predicted by the presence of anorexia, nausea/vomiting, and abdominal pain after the second day of illness. This study provides better understanding in this disease

Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.

Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an "IRB Metrics" was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010-September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with positive outcomes for all parties involved in the conduct of human-subject research

Evaluation of Structure – IRB composition and qualifications.

<p>Evaluation of Structure – IRB composition and qualifications.</p

Evaluation of Structure – IRB workload & different types of new non-exempt protocol reviews, 2010–2013.

<p>Evaluation of Structure – IRB workload & different types of new non-exempt protocol reviews, 2010–2013.</p

Effects of issues reviewed and notified for revision on “above target duration” in total time from submission to final approval (>60 days).

<p>*PR = Prevalence Ratio.</p><p>Effects of issues reviewed and notified for revision on “above target duration” in total time from submission to final approval (>60 days).</p

Evaluation of Process – Timeliness of protocol review, 2010–2013.

<p>Note:</p>a<p>Excludes 14 studies in 2010–2012 (6 withdrawn by investigator due to internal study team matters; 8 terminated by the Ethics Committee due to very long delay/non-response after notification).</p>b<p>Excludes 41 studies that required no revision.</p>C<p>Includes all new non-exempt study submissions.</p>d<p>Some studies were amended more than once.</p><p>Evaluation of Process – Timeliness of protocol review, 2010–2013.</p

Evaluation of Outcome - Decision on new non-exempt and continuing/amended protocols reviewed by FTM-EC, 2010–2013.

<p><i>Note: Excludes 7 studies that are pending decision outcome at data cutoff, and 13 studies withdrawn by PI (for various reasons) or by EC (due to long non-response period).</i></p

Evaluation of Outcomes - Ethical issues notified to researcher.

<p>Evaluation of Outcomes - Ethical issues notified to researcher.</p

IRB Metrics structure-process-outcome model used at FTM-EC.

<p>IRB Metrics structure-process-outcome model used at FTM-EC.</p