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.

scholarly journals Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029530
Author(s):  
Nut Koonrungsesomboon ◽  
Chanchai Traivaree ◽  
Charnunnut Tiyapsane ◽  
Juntra Karbwang
Keyword(s):  
Informed Consent ◽  
Primary Endpoint ◽  
Drug Trial ◽  
Consent Form ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Ethical Review ◽  
Paediatric Drug ◽  
Randomized Controlled ◽  
Informed Consent Form

ObjectiveThis study was designed to evaluate 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 paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF.DesignA prospective, randomized, controlled design.SettingPaediatric Outpatients Department, Phramongkutklao Hospital, Thailand.Participants210 parents of children with thalassemia (age=35.6 ± 13.1 years).InterventionsThe parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial.Primary and secondary outcome measuresParental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score.ResultsForty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).ConclusionsThe SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information.

scholarly journals Mat Pilates and aquatic aerobic exercises for women with fibromyalgia: a protocol for a randomised controlled blind study

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e022306 ◽  
Author(s):  
Hugo Jario de Almeida Silva ◽  
Caio Alano de Almeida Lins ◽  
Thaiza Teixeira Xavier Nobre ◽  
Vanessa Patrícia Soares de Sousa ◽  
Renata Trajano Jorge Caldas ◽  
...  
Keyword(s):  
Informed Consent ◽  
Visual Analogue Scale ◽  
Analogue Scale ◽  
Ethics Committee ◽  
Consent Form ◽  
Controlled Study ◽  
Human Beings ◽  
Informed Consent Form ◽  
Health Council ◽  
Randomised Controlled

IntroductionPhysical exercises have been recommended to improve the overall well-being of patients with fibromyalgia, with the main objective of repairing the effects of lack of physical conditioning and of improving the symptoms, especially pain and fatigue. Although widely recommended and widely known, few studies support the use of Pilates as an effective method in improving the symptoms of the disease, comparing it with other well-founded exercise modalities. This protocol was developed to describe the design of a randomised controlled study with a blind evaluator that evaluates the effectiveness of mat Pilates, comparing it with aquatic aerobic exercises, in improving pain in women with fibromyalgia.MethodsSixty women aged 18–60 years with a diagnosis of fibromyalgia, with a score of between 3 and 8 points on the Visual Analogue Scale for pain, and who sign the clear and informed consent form will be recruited according to the inclusion criteria. They will be randomised into one of the two intervention groups: (1) Pilates, to perform an exercise programme based on mat Pilates; and (2) aquatic exercise, to participate in a programme of aerobic exercises in the swimming pool. The protocol will correspond to 12 weeks of treatment, with both groups performing the exercises with supervision twice a week. The primary outcome will be pain (Visual Analogue Scale for pain). The secondary outcomes are to include impact related to the disease, functional capacity, sleep quality and overall quality of life. The evaluations will be performed at three points: at baseline and after 6 weeks and 12 weeks of treatment.Ethics and disseminationThis protocol has been approved by the Ethics Committee of FACISA/UFRN (number: 2.116.314). Data collection will begin after approval by the ethics committee. There will be prior contact with the women, at which time all the information about the study and the objectives will be presented, as well as resolution no 466/2012 of the National Health Council of Brazil for the year 2012, which provides guidelines and regulatory standards for research involving human beings. Participants must sign the informed consent form before the study begins.Trial registration numberNCT03149198.

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

scholarly journals Improved participants’ understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study

2015 ◽  
Vol 72 (4) ◽  
pp. 413-421 ◽  
Author(s):  
Nut Koonrungsesomboon ◽  
Supanimit Teekachunhatean ◽  
Nutthiya Hanprasertpong ◽  
Junjira Laothavorn ◽  
Kesara Na-Bangchang ◽  
...  
Keyword(s):  
Informed Consent ◽  
Healthy Volunteer ◽  
Consent Form ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Informed Consent Form ◽  
Volunteer Study ◽  
Healthy Volunteer Study

Acupuncture for Insomnia in Pregnancy – a Prospective, Quasi-Randomised, Controlled Study

2005 ◽  
Vol 23 (2) ◽  
pp. 47-51 ◽  
Author(s):  
João Bosco Guerreiro da Silva ◽  
Mary Uchiyama Nakamura ◽  
José Antonio Cordeiro ◽  
Luiz Kulay
Keyword(s):  
Pregnant Women ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Randomised Controlled Study ◽  
Numerical Rating ◽  
Randomised Controlled

Objective This study was undertaken to test the effects of acupuncture on insomnia in a group of pregnant women under real life conditions, and to compare the results with a group of patients undergoing conventional treatment alone (sleep hygiene). Methods A total of 30 conventionally treated pregnant women were allocated at random into groups with or without acupuncture. Seventeen patients formed the study group and 13 the control group. The pregnant women scored the severity of insomnia using a Numerical Rating Scale from 0 to 10. Women were followed up for eight weeks and interviewed five times, at two-week intervals. Results Eight women dropped out, five in the study group and three in the control group. The study group reported a larger reduction on insomnia rating (5.1) than the control group (0.0), a difference which was statistically significant (P=0.0028). Average insomnia scores decreased by at least 50% over time in nine (75%) patients in the study group and in three (30%) of the control group. Conclusion The results of this study suggest that acupuncture alleviates insomnia during pregnancy and further research is justified.

Sign in / Sign up

Export Citation Format

Share Document