scholarly journals Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial

Stroke ◽  
2021 ◽  
Author(s):  
Zhe Kang Law ◽  
Jason P. Appleton ◽  
Polly Scutt ◽  
Ian Roberts ◽  
Rustam Al-Shahi Salman ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Randomized Controlled Trial ◽  
Acute Stroke ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Controlled Trial ◽  
Two Stage ◽  
Unique Identifier ◽  
Randomized Controlled ◽  
Patient Consent

Background and Purpose: Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) randomized controlled trial. Methods: Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours. Results: Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%]) or a doctor (all 2-stage, 188 [12%]). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38–93) minutes for doctor consent, 55 (37–95) minutes for 2-stage patient, 69 (43–110) minutes for 2-stage relative, 75 (48–124) minutes for 1-stage patient, and 90 (56–155) minutes for 1-stage relative consents ( P <0.001). Two-stage consent was associated with onset-to-randomization time of ≤3 hours compared with 1-stage consent (adjusted odds ratio, 1.9 [95% CI, 1.5–2.4]). Doctor consent increased the odds (adjusted odds ratio, 2.3 [1.5–3.5]) while relative consent reduced the odds of randomization ≤3 hours (adjusted odds ratio, 0.10 [0.03–0.34]) compared with patient consent. Only 2 of 771 patients (0.3%) in the 2-stage pathways withdrew consent when full consent was sought later. Two-stage consent process did not result in higher withdrawal rates or loss to follow-up. Conclusions: The use of initial brief consent was associated with shorter times to enrollment, while maintaining good participant retention. Seeking written consent from relatives was associated with significant delays. Registration: URL: https://www.isrctn.com ; Unique identifier: ISRCTN93732214.

scholarly journals Cone beam computed tomography for detecting residual stones in percutaneous nephrolithotomy, a randomized controlled trial (CAPTURE) protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
R. A. Kingma ◽  
I. J. de Jong ◽  
M. J. W. Greuter ◽  
S. Roemeling
Keyword(s):  
Computed Tomography ◽  
Randomized Controlled Trial ◽  
Percutaneous Nephrolithotomy ◽  
Cone Beam Computed Tomography ◽  
Controlled Trial ◽  
Cone Beam ◽  
Total Study Population ◽  
Randomized Controlled ◽  
Free Status

Abstract Introduction Percutaneous nephrolithotomy (PCNL) is the standard surgical treatment method for large kidney stones. Its aim is to achieve a stone-free status, since any residual fragments (RFs) after PCNL are likely to cause additional morbidity or stone growth. Enhancing intraoperative detectability of RFs could lead to increased stone-free rates and decreased re-intervention rates. Cone beam computed tomography (CBCT) has recently been introduced in urology as a feasible method for intraoperatively imaging RFs. The aim of this trial is to determine the added value of CBCT in percutaneous nephrolithotomy, by measuring differences in stone-related morbidity for patients with procedures in which a CBCT is used versus patients with procedures without the use of CBCT. Methods The CAPTURE trial is an investigator-initiated single-center, randomized controlled trial (RCT) in adult patients who have an indication for percutaneous nephrolithotomy. A contemporary percutaneous nephrolithotomy is performed. Once the surgeon is convinced of a stone-free status by means of fluoroscopy and nephroscopy, randomization allocates patients to either the study group in whom an intraoperative CBCT scan is performed or to the control group in whom no intraoperative CBCT scan is performed. The main endpoint is the stone-free status as assessed four weeks postoperatively by low-dose non-contrast abdominal CT, as a standard follow-up procedure. Secondary endpoints include the number of PCNL procedures required and the number of stone-related events (SREs) registered. The total study population will consist of 320 patients that undergo PCNL and are eligible for randomization for an intraoperative CBCT scan. Discussion We deem a randomized controlled trial to be the most effective and reliable method to assess the efficacy of CBCT in PCNL. Though some bias may occur due to the impossibility of blinding the urologist at randomization, we estimate that the pragmatic nature of the study, standardized circumstances, and follow-up methods with pre-defined outcome measures will result in a high level of evidence. Trial registration Netherlands Trial Register (NTR) NL8168, ABR NL70728.042.19. Registered on 15 October 2019. Prospectively registered.

scholarly journals ONE-STAGE VERSUS TWO-STAGE PROTOCOL IN MANAGEMENT OF INFECTED NONUNITED FRACTURE FEMUR; RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Vol 72 (3) ◽  
pp. 505-515
Author(s):  
Khaled Emara ◽  
Ramy Diab ◽  
Mohamed El-Kersh ◽  
Ayman Mounir ◽  
Ahmed Badreldin
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Stage Versus ◽  
Two Stage ◽  
Fracture Femur ◽  
Randomized Controlled ◽  
One Stage

scholarly journals Increasing response rates to follow-up questionnaires in health intervention research: Randomized controlled trial of a gift card prize incentive

2017 ◽  
Vol 14 (4) ◽  
pp. 381-386 ◽  
Author(s):  
Amy J Morgan ◽  
Ronald M Rapee ◽  
Jordana K Bayer
Keyword(s):  
Randomized Controlled Trial ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Response Rate ◽  
Controlled Trial ◽  
Response Rates ◽  
Health Intervention ◽  
Randomized Controlled ◽  
Gift Card

Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety. A total of 433 participants were randomly allocated to one of two groups: (1) being informed that they would enter a gift card prize-draw if they completed the final study questionnaire (24-week follow-up) and (2) not informed about the prize-draw. All participants had a 1 in 20 chance of winning an AUD50 gift card after they completed the online questionnaire. Results The odds of the informed group completing the follow-up questionnaire were significantly higher than the uninformed group, (79.6% vs 68.5%, odds ratio = 1.79, 95% confidence interval = 1.15–2.79). This response rate increase of 11.1% (95% confidence interval = 2.8–19.1) occurred in both intervention and control groups in the host randomized controlled trial. The incentive was also effective in increasing questionnaire commencement (84.6% vs 75.9%, odds ratio = 1.74, 95% confidence interval = 1.07–2.84) and reducing the delay in completing the questionnaire (19.9 vs 22.6 days, hazard ratio = 1.34, 95% confidence interval = 1.07–1.67). Conclusion This study adds to evidence for the effectiveness of incentives to increase response rates to follow-up questionnaires in health intervention trials.

scholarly journals Predictors and Outcomes of Neurological Deterioration in Intracerebral Hemorrhage: Results from the TICH-2 Randomized Controlled Trial

2020 ◽  
Author(s):  
Zhe Kang Law ◽  
◽  
Rob Dineen ◽  
Timothy J England ◽  
Lesley Cala ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intracerebral Hemorrhage ◽  
Tranexamic Acid ◽  
Controlled Trial ◽  
Neurological Deterioration ◽  
Unique Identifier ◽  
Risk Of Death ◽  
Randomized Controlled ◽  
Early Neurological Deterioration ◽  
The Uk

Abstract Neurological deterioration is common after intracerebral hemorrhage (ICH). We aimed to identify the predictors and effects of neurological deterioration and whether tranexamic acid reduced the risk of neurological deterioration. Data from the Tranexamic acid in IntraCerebral Hemorrhage-2 (TICH-2) randomized controlled trial were analyzed. Neurological deterioration was defined as an increase in National Institutes of Health Stroke Scale (NIHSS) of ≥ 4 or a decline in Glasgow Coma Scale of ≥ 2. Neurological deterioration was considered to be early if it started ≤ 48 h and late if commenced between 48 h and 7 days after onset. Logistic regression was used to identify predictors and effects of neurological deterioration and the effect of tranexamic acid on neurological deterioration. Of 2325 patients, 735 (31.7%) had neurological deterioration: 590 (80.3%) occurred early and 145 (19.7%) late. Predictors of early neurological deterioration included recruitment from the UK, previous ICH, higher admission systolic blood pressure, higher NIHSS, shorter onset-to-CT time, larger baseline hematoma, intraventricular hemorrhage, subarachnoid extension and antiplatelet therapy. Older age, male sex, higher NIHSS, previous ICH and larger baseline hematoma predicted late neurological deterioration. Neurological deterioration was independently associated with a modified Rankin Scale of > 3 (aOR 4.98, 3.70–6.70; p < 0.001). Tranexamic acid reduced the risk of early (aOR 0.79, 0.63–0.99; p = 0.041) but not late neurological deterioration (aOR 0.76, 0.52–1.11; p = 0.15). Larger hematoma size, intraventricular and subarachnoid extension increased the risk of neurological deterioration. Neurological deterioration increased the risk of death and dependency at day 90. Tranexamic acid reduced the risk of early neurological deterioration and warrants further investigation in ICH. URL:https://www.isrctn.com Unique identifier: ISRCTN93732214

One‐ versus two‐stage crown lengthening surgical procedure for aesthetic restorative purposes: A randomized controlled trial

2020 ◽  
Vol 47 (12) ◽  
pp. 1511-1521
Author(s):  
Oscar González‐Martín ◽  
Georgina Carbajo ◽  
Marta Rodrigo ◽  
Eduardo Montero ◽  
Mariano Sanz
Keyword(s):  
Randomized Controlled Trial ◽  
Surgical Procedure ◽  
Controlled Trial ◽  
Two Stage ◽  
Randomized Controlled ◽  
Crown Lengthening
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