Randomised controlled trial of whether erotic material is required for semen collection: impact of informed consent on outcome

Andrology ◽  
2013 ◽  
Vol 1 (6) ◽  
pp. 943-947 ◽  
Author(s):  
D. J. Handelsman ◽  
T. Sivananathan ◽  
L. Andres ◽  
F. Bathur ◽  
V. Jayadev ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Semen Collection ◽  
Randomised Controlled

scholarly journals Multimedia in improving informed consent for caesarean section: A randomised controlled trial

2020 ◽  
Vol 60 (5) ◽  
pp. 683-689
Author(s):  
Alice Truong ◽  
Lenore Ellett ◽  
Lauren Hicks ◽  
Gabrielle Pell ◽  
Susan P. Walker
Keyword(s):  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Performance of biological mesh materials in abdominal wall reconstruction: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024091 ◽  
Author(s):  
David A Carver ◽  
Andrew W Kirkpatrick ◽  
Tammy L Eberle ◽  
Chad G Ball
Keyword(s):  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Abdominal Wall ◽  
Controlled Trial ◽  
Abdominal Wall Reconstruction ◽  
Hernia Recurrence ◽  
Biological Mesh ◽  
Common Source ◽  
Porcine Dermis ◽  
Randomised Controlled

IntroductionAbdominal wall hernias are a common source of morbidity and mortality. The use of biological mesh has become an important adjunct in successful abdominal wall reconstruction. There are a variety of biological mesh products available; however, there is limited evidence supporting the use of one type over another. This study aims to compare the performance (eg, the rate of hernia recurrence) of either a crosslinked biological mesh product or a non-crosslinked product in patients undergoing abdominal wall reconstruction.Methods and analysisThis is a single-centre, dual arm randomised controlled trial. Patients requiring abdominal wall reconstruction will be assessed for eligibility. Eligible patients will then undergo an informed consent process following by randomisation to either (1) crosslinked porcine dermis mesh (Permacol); or (2) non-crosslinked porcine dermis mesh (Strattice). These groups will be compared for the rate of hernia recurrence at 1 and 2 years as well as the rate of postoperative complications (eg, surgical site infections).Ethics and disseminationThis study has been approved by the institution’s research ethics board and registered with clinicaltrials.gov. All eligible participants will provide informed consent prior to randomization. The results of this study may help guide the choice of biologic mesh for this population. The results of this study will be published in peer-reviewed journals as well as national and international conferences.Trial registration numberNCT02703662.

scholarly journals Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT)

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049217
Author(s):  
Abhijit Pal ◽  
Sarah Stapleton ◽  
Christina Yap ◽  
Julia Lai-Kwon ◽  
Robert Daly ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Early Phase ◽  
Controlled Trial ◽  
Full Length ◽  
Patient Understanding ◽  
Validated Questionnaire ◽  
Randomised Controlled ◽  
Improve Patient

IntroductionEarly phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures—this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.Methods and analysisThis is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).Ethics and disseminationEthics approval was granted by the National Health Service Health Research Authority on 15 June 2020—IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.Trial registration numberNCT04407676; Pre-results.

scholarly journals Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045770
Author(s):  
Chuqing He ◽  
Xiaoqing He ◽  
Yan Liang ◽  
Taotao Sun ◽  
Li Yan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Hysteroscopic Surgery ◽  
Institutional Review ◽  
System Versus ◽  
Urological Symptoms ◽  
Registration Number ◽  
Uterine Scar ◽  
Randomised Controlled

IntroductionRecently, the rate of caesarean sections (CS) worldwide has risen and CS-associated complications such as niche have increased substantially. Until now, evidence-based clinical guidelines for the treatment of niche-related symptoms remain absent. In patients with postmenstrual spotting, it has not been studied if the effect of levonorgestrel 52 mg intrauterine system (LNG-IUS 52 mg) is superior to that of hysteroscopy. This study will answer the question of whether LNG-IUS 52 mg is more effective in improving postmenstrual spotting than hysteroscopic niche resection in women with niche-related spotting at 6 months after randomisation.Methods and analysisThis is a randomised controlled trial. A total of 208 women with postmenstrual spotting related to niche in the caesarean uterine scar of at least 2 mm and residual myometrium of at least 2.2 mm evaluated by MRI will be included. Women desiring to conceive within 1 year, with contraindications for LNG-IUS 52 mg or hysteroscopic surgery will be excluded. After informed consent is obtained, eligible women will be randomly allocated to LNG-IUS 52 mg or hysteroscopic niche resection at 1:1. The primary outcome is the efficacy in reducing postmenstrual spotting at 6 months after randomisation. The secondary outcomes include menstrual pattern, total days of blood loss per month, rate of amenorrhoea, side effects and complications.We will use a Visual Analogue Scale for chronic pelvic pain, urological symptoms and women’s satisfaction (five-point Likert scale).Ethics and disseminationThe study was approved by the local medical ethics committee and by the Institutional Review Board of the International Peace Maternity and Child Health Hospital, Shanghai, China (No. GKLW 2019-08). Participants will sign a written informed consent before participation. The results of this study will be submitted to a peer-reviewed journal for publication.Trial registration numberChiCTR1900025677.

scholarly journals Differences in demographics and outcomes based on method of consent for a randomised controlled trial on heat loss prevention in the delivery room

2020 ◽  
pp. fetalneonatal-2020-319045
Author(s):  
Sunita Vohra ◽  
Maureen Reilly ◽  
Valeria E Rac ◽  
Zafira Bhaloo ◽  
Denise Zayak ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomised Controlled Trial ◽  
Heat Loss ◽  
Controlled Trial ◽  
Neonatal Resuscitation ◽  
Loss Prevention ◽  
Apgar Scores ◽  
Antenatal Steroids ◽  
Prior Consent ◽  
Randomised Controlled

ObjectiveInformed consent is standard in research. International guidelines allow for research without prior consent in emergent situations, such as neonatal resuscitation. Research without prior consent was incorporated in the Vermont Oxford Network Heat Loss Prevention Trial. We evaluated whether significant differences in outcomes exist based on the consent method.DesignSubgroup analysis of infants enrolled in a randomised controlled trial conducted from 2004 to 2010.SettingA multicentre trial with 38 participating centres.ParticipantsInfants born 24–27 weeks of gestation. 3048 infants assessed, 2231 excluded due to fetal congenital anomalies, failure to obtain consent or gestation less than 24 weeks. 817 randomised, 4 withdrew consent, total of 813 analysed.Main outcome measureThe difference in mortality between consent groups.ResultsNo significant differences were found in mortality at 36 weeks (80.2%, 77.4%, p=0.492) or 6 months corrected gestational age (80.7%, 79.7%, p=0.765). Infants enrolled after informed consent were more likely to have mothers who had received antenatal steroids (95.2%, 84.0%, p<0.0001). They also had significantly higher Apgar scores at 1 (5.0, 4.4, p=0.019), 5 (7.3, 6.7, p=0.025) and 10 min (7.5, 6.3, p=0.0003).Conclusions and relevanceResearch without prior consent resulted in the inclusion of infants with different baseline characteristics than those enrolled after informed consent. There were no significant differences in mortality. Significantly higher Apgar scores in the informed consent group suggest that some of the sicker infants would have been excluded from enrolment under informed consent. Research without prior consent should be considered in neonatal resuscitation research.

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