Perception of medical personnel on informed consent for research participation in Phramongkutklao Hospital and Phramongkutklao College of Medicine.

OBJECTIVE: To evaluate the perception of medical personnel and medical cadets toward informed consent obtained from potential research participants. MATERIAL AND METHOD: The authors conducted a study using self-administered questionnaires which included questions about perception on informed consent regarding its objectives, investigator's role, vulnerable subjects, family involvement and children's assent. The answer for each question was graded into 5 scales. RESULTS: A selection of 380, 30.5%, 37.6% and 31.8% of 669 were attending staff residents, and medical cadets, respectively. A total of 85.5% agreed that informed consent in therapeutic trials should be obtained by their own doctors. A total of 75.3% agreed that the primary objective of informed consent was to protect investigators from lawsuits. A total of 60.8% agreed that participant spouses had to be involved in the informed consent process. A total of 79.5% agreed that permission from children was necessary in research conducted in children. CONCLUSION: The role of investigators in therapeutic clinical trial, primary objectives of informed consent, and role of spouse were misunderstood among medical personnel and medical cadets. Education on research ethics should concentrate on these issues.

Sensitivity of clinical assessment in term neonates by general pediatric residents.

OBJECTIVES: To determine the accuracy of physical examination in detecting congenital heart diseases by pediatric residents and identify risk factors of congenital heart diseases. MATERIAL AND METHOD: Five hundred term infants (GA > or = 37wks) who were born at Phramongkutklao Hospital from July 1st, 1999 to June 3th, 2000 were examined by pediatric residents and pediatric cardiologists within the first week of life. The echocardiography was performed in all 500 infants for definite diagnosis. The accuracy of physical examination was determined by comparing with echocardiographic finding and presented as sensitivity and specificity. RESULTS: Congenital heart diseases were found in 18 of 500 term infants (3.6%). The physical examination by pediatric residents and pediatric cardiologists showeds a sensitivity of 39% and 94% and the specificity of 98% and 97%, respectively. After excluding spontaneously closed PDA within 2 weeks, the first and second most common congenital heart diseases in infants were Ventricular septum defect (VSD) (44%) and Patent ductus arteriosus (PDA) (33%). The positive other cardiovascular signs, such as cyanosis or abnormal pulses with heart murmur were significantly associated to diagnosis of congenital heart diseases. CONCLUSION: Although echocardiography is the major tool to determine the definite diagnosis, most congenital heart diseases can be well detected during physical examination by skilled physicians. As a result, the value of physical examination of the cardiovascular system should be emphasized in training general pediatricians concerning lower costs and early detection of congenital heart diseases.

Incidence of neonatal infection in newborn infants with a maternal history of premature rupture of membranes (PROM) for 18 hours or longer by using Phramongkutklao Hospital Clinical Practice Guideline (CPG).

BACKGROUND: Phramongkutklao CPG was developed for detecting infants with maternal PROM > or = 18 hours who had a high risk of infection. OBJECTIVE: To determine efficacy of the CPG, and risk factors of infection. STUDY DESIGN: Prospective cohort study. MATERIAL AND METHOD: Eligible infants were categorized into group I (symptomatic), group II (chorioamnionitis) or group III (asymptomatic). Infants in group I, II and those in group III who had scores > or = 3 were treated with antibiotics. Infants were followed-up until 28 days of age. RESULTS: 104 infants were recruited into the present study. 29 of 104 (27.88%) infants had infection. Risk factors were Apgar scores < or = 5, PROM > 72 hours, gestational age < 34 weeks, and low birth weight. The success rate of using CPG was 98.08% and antibiotic use was reduced by 53.08%. CONCLUSION: Phramongkutklao CPG on PROM is safe and cost saving. All risk factors should be included in the guideline.

A randomized study of 3 umbilical cord care regimens at home in thai neonates: comparison of time to umbilical cord separation, parental satisfaction and bacterial colonization.

OBJECTIVE: To compare time to cord separation, parental satisfaction and bacterial colonization, among 3 regimens of cord care at home. STUDY DESIGN: Randomized controlled trial. MATERIAL AND METHOD: Term infants were randomly assigned based on cord care regimens at home: 1) triple dye, 2) alcohol, and 3) no antiseptic agent. Timing of cord separation, and parental satisfaction were evaluated during the first month of age. RESULTS: 185 infants were recruited. Time to cord separation in infants of group I was significantly longer than in group 2 (p = 0.036) and group 3 (p = 0.003). The satisfaction scores of group I were significantly lower than those of group 2 and group 3. 180 culture specimens were performed and positive in all but none had omphalitis. CONCLUSION: Triple dye delayed time to cord separation and was less satisfactory. The authors conclude that using alcohol or dry clean could be alternative ways of umbilical cord care at home.

Health economic evaluation of CDC s recommendation (1996 and 2002) for prevention of early onset group B streptococcal disease in Thailand

Background: Group B streptococcus (GBS) infection is one of the leading causes of morbidity and mortality in the neonatal period in the USA. The Centers for Disease Control and Prevention (CDC) issued a recommendation to prevent early-onset GBS infection in 1996 and a revised recommendation in 2002. Objectives: To perform a health economic analysis of the CDC recommendation using clinical data currently available in Thailand. Study design: Health economic analysis. Materials and Methods: After reviewing the literature regarding clinical data I Thailand, a decision analysis was performed to evaluate the outcomes of 3 strategies: universal culture screening, intrapartum risk factors assessment, and no prevention. Outcomes: The medical care cost for each strategy and incremental medical care cost for the prevention of one GBS case were analyzed. Results: Under the present conditions in Thailand and using the cost estimated from Siriraj Hospital’s charge in the year 2005, the no prevention practice was the most cost-effective strategy. The incremental medical care cost to prevent one GBS case for the universal culture screening and the intrapartum risk assessment were 594,754.17 Baht and 83,677.78 Baht, respectively. Conclusion: Although neither of the preventive strategies recommended by the CDC was cost-effective in general clinical practice in the present situation in Thailand, the intrapartum risk assessment strategy may be reasonable because the incremental cost to prevent one GBS case was less than 100,000 Baht.

Megacystis microcolon intestinal hypoperistalsis syndrome (MMIHS): a case report in Thailand.

Megacystis microcolon intestinal hypoperistalsis syndrome (MMIHS) is a rare congenital disease with high mortality rate. The authors report a case of a female term infant with massive abdominal distension at birth. Abdominal ultrasonography revealed a huge cystic mass resolved after urinary catheterization. Exploratory laparotomy was performed and intraoperative findings were an enlarged urinary bladder, microcolon, short bowel and malrotation of the small intestine. Ladd's procedure, ileostomy and vesicostomy were performed. Pathological findings of rectal biopsy revealed normal ganglion cells. Although prokinetic drugs were given for promoting bowel motility, enteral feedings were not tolerated. She died from septicemia at the age of 50 days.