Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PURPOSE: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. RESULTS: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). CONCLUSIONS: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Colorectal Cancer in the Central Region of Thailand.

BACKGROUND: Colorectal cancer is one of the major health problems worldwide. However, limited studies have been reported from ASEAN countries. This study was conducted to evaluate clinical characteristics and survival of colorectal cancer cases aged <65 years and ≥65 years in the central region of Thailand. MATERIALS AND METHODS: Clinical information, histological features, endoscopic findings and treatment outcome were collected and reviewed from Thammasat University Hospital, Pathumthani, Thailand between November 2011 and October 2015. RESULTS: A total of 121 colorectal cancer patients, comprising 69 men and 52 women with a mean age of 65.8 years, were included. There were 57 aged <65 years and 64 aged ≥65 years. Common presenting symptoms were abdominal pain (37%), weight loss (34%) and anemia (32%). Mean duration of symptoms prior to diagnosis was 173 days. However, longer diagnosis time was demonstrated in patients aged <65 years than age more than ≥65 years (119.4 vs 58.4 days, Pvalue=0.30). Colonic fungating mass was the most common endoscopic finding (64.4%) and the location was significantly more commonly left than right side of the colon, both in younger and elderly groups (87.7% vs 12.3%, P=0.02 and 70.3% vs 29.7%, P=0.02, respectively). Adenocarcinoma with moderated differentiated was the most common histology (67.3%). More than half of the patients presented with advanced stage (28.9% with TNM stage 3 and 38.8% TNM stage 4, respectively). Overall 1year and 5year survival rates were 76.9% and 5%. CONCLUSIONS: Most colorectal cancer patients in Thailand have adenocarcinomas and present at advanced stage with poor prognosis. Screening of high risk patients and early detection might be essential factors to improve the treatment outcome and overall survival rate of colon cancer patients in Thailand and other ASEAN countries.

Effect of IL-1 Polymorphisms, CYP2C19 Genotype and Antibiotic Resistance on Helicobacter pylori Eradication Comparing Between 10-day Sequential Therapy and 14-day Standard Triple Therapy with Four-Times-Daily-Dosing of Amoxicillin in Thailand: a Prospective Randomized Study.

BACKGROUND: Studies of effects of IL-1 polymorphisms, CYP2C19 genotype together with antibiotic resistance for H. pylori eradication are rare worldwide. The present study was designed to evaluate efficacy of 10-day sequential therapy (SQT) and 14-day standard triple therapy (STT) with four- times-daily dosing of amoxicillin for H. pylori eradication related to these important host and bacterial factors in Thailand. MATERIALS AND METHODS: This prospective randomized study was performed during March 2015 to January 2016. H. pylori infected gastritis patients were randomized to receive 10-day sequential therapy and 14-day standard triple therapy. CYP2C19 genotyping, IL1 polymorphism (IL-1B and IL-1RN genotypes) and antibiotic susceptibility tests were performed in all patients. 13C-UBT was conducted to confirm H. pylori eradication at least 4 weeks after treatment. RESULTS: A total of 100 patients (33 males and 67 females, mean age=51.1 years) were enrolled. Eradication rate by PP analysis was 97.9% (47/48) with the 10-day SQT regimen and 87.8% (43/49) with 14-day STT regimen (97.9% vs 87.8%; p-value=0.053). Antibiotic susceptibility testing demonstrated 45% resistance to metronidazole, 14.8% to clarithromycin, and 24.1% to levofloxacin. CYP2C19 genotyping revealed 44.9% RM, 49% IM and 6.1% PM. IL-1B and IL-1RN genotypes were demonstrated as 21.4% for CC, 48.1% for TC, 36.8% for TT, 72.7% for 1/1, and 21.2% for 1/2 genotypes, respectively. The 10-day SQT regimen provided 100% eradication in patients with clarithromycin or dual clarithromycin and levofloxacin H. pylori resistant strains. Moreover, the 10-day SQT regimen resulted in a 100% eradication rate in all patients with CYP2C19 genotype RM and almost type of IL-1B (TC and TT) and IL1-RN genotypes ( 1/2 and other). CONCLUSIONS: Treatment with 10-day sequential therapy is highly effective for H. pylori eradication regardless of the effects of clarithromycin resistance, dual clarithromycin and levofloxacin resistance, CYP2C19 genotype, IL-1B and IL1-RN genetic polymorphisms and can be used as effective first line therapy in Thailand.