scholarly journals Informed consent, parental awareness, and reasons for participating in a randomised controlled study

1998 ◽  
Vol 79 (2) ◽  
pp. 120-125 ◽  
Author(s):  
M. van Stuijvenberg ◽  
M. H Suur ◽  
S. de Vos ◽  
G. C H Tjiang ◽  
E. W Steyerberg ◽  
...  
Keyword(s):  
Informed Consent ◽  
Controlled Study ◽  
Parental Awareness ◽  
Randomised Controlled Study ◽  
Randomised Controlled

Improved pregnant women’s understanding of research information by an enhanced informed consent form: a randomised controlled study nested in neonatal research

2017 ◽  
Vol 103 (5) ◽  
pp. F403-F407 ◽  
Author(s):  
Nut Koonrungsesomboon ◽  
Chanchai Traivaree ◽  
Sangkae Chamnanvanakij ◽  
Pimchitr Rungtragoolchai ◽  
Yawana Thanapat ◽  
...  
Keyword(s):  
Informed Consent ◽  
Pregnant Women ◽  
Primary Endpoint ◽  
Consent Form ◽  
School Level ◽  
Controlled Study ◽  
Ethical Review ◽  
Informed Consent Form ◽  
Randomised Controlled Study ◽  
Randomised Controlled

ObjectiveThis study aimed to test the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in neonatal research requiring maternal consent.DesignA single-centre open-label randomised controlled study.SettingAntenatal care clinics at Phramongkutklao Hospital, Thailand.Patients234 pregnant women who were at risk of preterm labour were enrolled; 232 individuals completed the study.InterventionsThe participants were randomly assigned to read either the SIDCER ICF or the conventional ICF.Main outcome measuresThe participants’ understanding of essential trial-related information was assessed using 25 closed-ended questions. The primary endpoint was the proportion of the participants who obtained the satisfactory level of understanding at 80% (score of ≥20/25).Results72.5% (87/120) of the participants in the SIDCER ICF group and 59.8% (67/112) of the conventional ICF group achieved the primary endpoint (relative risk (RR)=1.212, 95% CI 1.005 to 1.462, p=0.041). The superiority of the SIDCER ICF over the conventional ICF was significant, particularly among the participants whose education was at the high school level or below (63.5% vs 44.1%, RR=1.441, 95% CI 1.022 to 2.030, p=0.031).ConclusionsThe SIDCER ICF methodology is applicable to neonatal research requiring maternal consent. The SIDCER ICF significantly improved the understanding of pregnant women, particularly among those with lower levels of education. The present study confirms the value of the SIDCER ICF methodology in research involving individuals with a limited academic background.

EFFECTS OF “HOE HOA TAN II” REMEDY IN THE TREATMENT OF INTERNAL HAEMORROHIDS GRADE I, II AND III

2015 ◽  
pp. 80-85
Author(s):  
Van Anh Nguyen ◽  
Van Nhan Le ◽  
Nguyen Nhu Phuong Phan
Keyword(s):  
Side Effects ◽  
Key Words ◽  
Patient Group ◽  
Controlled Study ◽  
Therapeutic Effects ◽  
Radix Angelicae Sinensis ◽  
Randomised Controlled Study ◽  
Citrus Deliciosa ◽  
Randomised Controlled ◽  
Angelicae Sinensis

Objectives: To investigate and evaluate the therapeutic effects of Hoe hoa tan II in the treatment of internal haemorroids grade I, II and III. Ingredients of the remedy include: Hoe Hoa (Styphonolonium japonicum), Chi xac (Fructus citri Aurantii), Hau phac (Magnolia offinalis), Tran bi (Citrus deliciosa Tenore), Thuong thuat (Atractylodes lancea), O mai (Armeniaca vulgaris Lamk), Cam thao (Clycyrrhiza uralensis), Duong quy (Radix Angelicae Sinensis). Subjects and methods: Randomised controlled study (RCT) has been conducted on 60 patients which were divided into two groups, i.e. the first 30 patient group were treated with Hoe hoa tan II remedy 20 g, and the second 30 patient group were treated with Daflon 500 mg in the course of 14 days. Results: Study showed that Hoe hoa tan II has helped improve symptoms of internal haemorroids grade I, II and III such as bleeding, anal exudation, pain, reducing the size of the haemorroid tissues. The remedy has been shown to have the most significant effect on relieving constipation which is typical in haemorroids. The study also revealed no unwanted effects caused by this formula. Conclusion: Hoe hoa tan II can be therapeutically used to treat internal haemorroids grade I, II and III without causing any serious side effects. Key words: Hoe hoa tan II, internal haemorroids grade I, II, III.

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