A randomized controlled trial to assess operator radiation exposure from cardiac catheterization procedures using RAD BOARD® with standard pelvic shielding versus standard pelvic shielding alone

2019 ◽  
Vol 95 (1) ◽  
pp. 83-88 ◽  
Author(s):  
Ramya Suryadevara ◽  
Eddie D. Brown ◽  
Sandy M. Green ◽  
Thomas D. Scott ◽  
Cara M. Nordberg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Radiation Exposure ◽  
Cardiac Catheterization ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Feasibility and Efficacy of a Decision Aid for Emergency Department Patients with Suspected Ureterolithiasis: Protocol for an Adaptive Randomized Controlled Trial

2021 ◽  
Author(s):  
Elizabeth M Schoenfeld ◽  
Kye E Poronsky ◽  
Lauren M Westafer ◽  
Paul Visintainer ◽  
Brianna M DiFronzo ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Ct Scan ◽  
Radiation Exposure ◽  
Kidney Stone ◽  
Decision Aid ◽  
Controlled Trial ◽  
Signs And Symptoms ◽  
Patient Knowledge ◽  
Randomized Controlled

Abstract Background: Approximately 2 million patients present to Emergency Departments in the US annually with signs and symptoms of ureterolithiasis (or renal colic, the pain from an obstructing kidney stone). Both ultrasound and CT scan can be used for diagnosis, but the vast majority of patients receive a CT scan. Diagnostic pathways utilizing ultrasound have been shown to decrease radiation exposure to patients but are potentially less accurate. Because of these and other trade-offs, this decision has been proposed as appropriate for Shared Decision-Making (SDM), where clinicians and patients discuss clinical options and their consequences and arrive at a decision together. We developed a decision aid to facilitate SDM in this scenario. The objective of this study is to determine the effects of this decision aid, as compared to usual care, on patient knowledge, radiation exposure, engagement, safety, and healthcare utilization. Methods: This is the protocol for an adaptive randomized controlled trial to determine the effects of the intervention – a decision aid (“Kidney Stone Choice”) – on patient-centered outcomes, compared with usual care. Patients age 18-55 presenting to the Emergency Department with signs and symptoms consistent with acute uncomplicated ureterolithiasis will be consecutively enrolled and randomized. Participants will be blinded to group allocation. We will collect outcomes related to patient knowledge, radiation exposure, trust in physician, safety, and downstream healthcare utilization. Discussion: We hypothesize that this study will demonstrate that “Kidney Stone Choice,” the decision aid created for this scenario, improves patient knowledge and decreases exposure to ionizing radiation. The adaptive design of this study will allow us to identify issues with fidelity and feasibility and subsequently evaluate the intervention for efficacy. Trial registration: ClinicalTrials.gov - NCT04234035https://clinicaltrials.gov/ct2/show/NCT04234035Registered January 21, 2020 – Retrospectively Registered

scholarly journals Patient-specific template-guided versus standard freehand lumbar pedicle screw implantation: a randomized controlled trial

2021 ◽  
pp. 1-7
Author(s):  
José Miguel Spirig ◽  
Shayan Golshani ◽  
Nadja A. Farshad-Amacker ◽  
Mazda Farshad
Keyword(s):  
Randomized Controlled Trial ◽  
Radiation Exposure ◽  
Pedicle Screw ◽  
Controlled Trial ◽  
Patient Specific ◽  
Pedicle Screw Placement ◽  
Surgical Time ◽  
Screw Insertion ◽  
Pedicle Screw Insertion ◽  
Randomized Controlled

OBJECTIVE Patient-specific template-guided (TG) pedicle screw placement currently achieves the highest reported accuracy in cadaveric and early clinical studies, with reports of reduced use of radiation and less surgical time. However, a clinical randomized controlled trial (RCT) eliminating potential biases is lacking. This study compares TG and standard freehand (FH) pedicle screw insertion techniques in an RCT. METHODS Twenty-four patients (mean age 64 years, 9 men and 15 women) scheduled consecutively and independently from this study for 1-, 2-, or 3-level lumbar fusion were randomized to either the FH (n = 12) or TG (n = 12) group. Accuracy of pedicle screw placement, intraoperative parameters, and short-term complications were compared. RESULTS A total of 112 screws (58 FH and 54 TG screws) were implanted in the lumbar spine. Radiation exposure was significantly less in the TG group (78.0 ± 46.3 cGycm2) compared with the FH group (234.1 ± 138.1 cGycm2, p = 0.001). There were 4 pedicle screw perforations (6.9%) in the FH group and 2 (3.7%) in the TG group (p > 0.99), with no clinical consequences. Clinically relevant complications were 1 postoperative pedicle fracture in the FH group (p > 0.99), 1 infection in the FH group, and 2 infections in the TG group (p > 0.99). There were no significant differences in surgical exposure time, screw insertion time, overall surgical time, or blood loss between the FH and TG groups. CONCLUSIONS In this RCT, patient-specific TG pedicle screw insertion in the lumbar region achieved a high accuracy, but not better than a standardized FH technique. Even if intraoperative radiation exposure is less with the TG technique, the need for a preoperative CT scan counterbalances this advantage. However, more difficult trajectories might reveal potential benefits of the TG technique and need further research.

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