scholarly journals Preparing for a randomized controlled trial: Strategies to optimize the design of a cardiovascular surgical patient education intervention.

2021 ◽  
Author(s):  
Suzanne Fredericks ◽  
Terrence M. Yau
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Education ◽  
Complex Intervention ◽  
Randomized Control Trial ◽  
Controlled Trial ◽  
Surgical Patient ◽  
Education Programs ◽  
Randomized Controlled ◽  
Clinical Methods ◽  
Randomized Control

Randomized controlled trial (RCT) designs are standardized to control for bias and allow for replication. Conducting RCTs is generally straightforward when dealing with interventions that contain a single component, such as a drug. However, interventions that do not contain single components, such as a patient education programs, are more difficult to standardize, as they contain multiple elements, which may act independently or interdependently of each other. The purpose of this discursive clinical methods paper is to describe and explain a methodology that can be used to optimize the design of a complex intervention prior to its evaluation in a randomized control trial.

scholarly journals Preparing for a randomized controlled trial: Strategies to optimize the design of a cardiovascular surgical patient education intervention.

2021 ◽  
Author(s):  
Suzanne Fredericks ◽  
Terrence M. Yau
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Education ◽  
Complex Intervention ◽  
Randomized Control Trial ◽  
Controlled Trial ◽  
Surgical Patient ◽  
Education Programs ◽  
Randomized Controlled ◽  
Clinical Methods ◽  
Randomized Control

Randomized controlled trial (RCT) designs are standardized to control for bias and allow for replication. Conducting RCTs is generally straightforward when dealing with interventions that contain a single component, such as a drug. However, interventions that do not contain single components, such as a patient education programs, are more difficult to standardize, as they contain multiple elements, which may act independently or interdependently of each other. The purpose of this discursive clinical methods paper is to describe and explain a methodology that can be used to optimize the design of a complex intervention prior to its evaluation in a randomized control trial.

scholarly journals Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial

2020 ◽  
Vol 18 (3) ◽  
pp. 2025
Author(s):  
Mariam A. Alameri ◽  
Syed A. Syed Sulaiman ◽  
Abdullah M. Ashour ◽  
Ma’ad F. Al-Saati
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Education ◽  
Risk Stratification ◽  
Controlled Trial ◽  
Education Programs ◽  
Randomized Controlled ◽  
Group A ◽  
Total Knee ◽  
The Mean ◽  
Group B

Background: Total knee replacement (TKR) is a major orthopedic surgery that is considered high risk for the development of venous thromboembolism (VTE). Objective: The aim of this study is to evaluate the clinical outcomes that resulted from the use of a new proposed VTE risk stratification protocol for selecting a suitable extended VTE prophylaxis for post TKR surgery patients administered in conjunction with patient education programs. Method: A randomized controlled trial was conducted in two medical centers in Saudi Arabia. A total of 242 patients were enrolled in the study, 121 patients in each group. The experimental group (A) was assessed by using the proposed VTE risk stratification protocol and also took part in patient education programs about TKR and its complications. The control group (B) was assessed by using the 2005 Caprini risk assessment tool and no education programs were given to this group. Both groups were followed for 35 days post operation. Results: The mean age of the participants was 65.86 (SD 8.67) and the majority of them were female 137 (56.6%). The mean body mass index of the study sample was 32.46 (SD 5.51). There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p˂0.05). There were no confirmed pulmonary embolism cases in the study sample and diagnosis of deep-vein thrombosis was confirmed in 12/242 (5.0%) of patients: 1/121 (0.8%) in group A and 11/121 (9.1%) in group B (p˂0.05). The readmission rate for all patients was 2.5% (6/242), all of whom were in group B (p˂0.05). Conclusion: The proposed VTE risk stratification protocol that was applied in conjunction with patient education programs reduced VTE complications and readmission events, post TKR surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04031859.

Defatted flaxseed flour improves weight loss and lipid profile in overweight and obese adults: a randomized controlled trial

2020 ◽  
Vol 11 (9) ◽  
pp. 8237-8247
Author(s):  
Xiaotong Kuang ◽  
Yan Kong ◽  
Xiaojie Hu ◽  
Kelei Li ◽  
Xiaofei Guo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Randomized Control Trial ◽  
Blood Lipids ◽  
Controlled Trial ◽  
Obese Adults ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
Flaxseed Meal ◽  
Flaxseed Flour ◽  
Randomized Control

A randomized control trial to investigate the effect of flaxseed meal (FM) supplemented biscuits in overweight and obese participants found that it has beneficial effects on body weight, body composition, and blood lipids.

scholarly journals Feasibility of conducting a randomized control trial for liver cancer screening: Is a randomized controlled trial for liver cancer screening feasible or still needed?

Hepatology ◽  
2011 ◽  
Vol 54 (6) ◽  
pp. 1998-2004 ◽  
Author(s):  
Hossein Poustchi ◽  
Geoffrey C. Farrell ◽  
Simone I. Strasser ◽  
Alice U. Lee ◽  
Geoffrey W. McCaughan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Screening ◽  
Liver Cancer ◽  
Randomized Control Trial ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Randomized Control

scholarly journals The use of virtual reality in reducing anxiety during cast removal: a randomized controlled trial

2020 ◽  
Vol 14 (6) ◽  
pp. 574-580
Author(s):  
Bejaan A. Jivraj ◽  
Emily Schaeffer ◽  
Jeffrey N. Bone ◽  
Chelsea Stunden ◽  
Eva Habib ◽  
...  
Keyword(s):  
Virtual Reality ◽  
State Anxiety ◽  
Randomized Control Trial ◽  
Additional Data ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Randomized Control ◽  
Anxiety Levels ◽  
Paediatric Orthopaedics ◽  
Facial Component

Purpose While virtual reality (VR) has been shown to be an effective distractor in children across a range of procedures, no studies have looked at its use within paediatric orthopaedics. The purpose of this study was to look at the use of VR in reducing anxiety levels in children during cast removal. In addition, the study aimed to find ways to enhance the efficiency of future VR trials in paediatrics. Methods A non-blinded randomized control trial took place in children aged four to 18 years. Intraprocedural anxiety was measured using the Children’s Emotional Manifestation Scale (CEMS), while pre- and post-procedural anxiety was measured using the Short State Anxiety Inventory Scale. Additional data was collected on trait anxiety, nausea levels, desire for future VR use and areas of improvement for future VR studies. Results A total of 90 subjects were included in the study (control n = 45, intervention n = 45) with a mean age of 10.25 years (sd 3.35). Post-procedural anxiety and intraprocedural anxiety were 18% (p = 0.03) and 24% (p = 0.01) lower in the VR group, respectively, with the CEMS facial component showing a 31% (p < 0.001) reduction in the VR group. In all, 99% (n = 89) of subjects experienced no nausea, with one patient experiencing mild nausea that may have been present prior to VR use. Finally, 90% (n = 81) of subjects said they would like to use VR again, 1% (n = 1) said ‘no’ and 9% (n = 8) said ‘maybe’. Conclusion VR appears to be an effective distraction technique in reducing anxiety levels in children during cast removal.

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