Related Experiment Video
Updated: Jan 18, 2026
06:28
E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
8.8K
Improving Patient Engagement in Phase 2 Clinical Trials With a Trial-Specific Patient Decision Aid: Development and
Iva Halilaj1, Relinde Lieverse1,2, Cary Oberije3
1Department of Precision Medicine, Faculty of Health, Medicine and Life Sciences, Maastricht University, Universiteitssingel 40, Maastricht, 6229 ER, The Netherlands, 31 433883549.
Journal of Medical Internet Research
|September 11, 2025
Summary
Trial-specific patient decision aids (tPDAs) improve patient understanding of complex clinical trial information. This study shows tPDAs enhance informed decision-making and patient engagement in clinical trials.
Area of Science:
- Clinical trial methodology
- Patient decision support
- Health informatics
Background:
- Clinical trial participation involves complex information, posing challenges for informed decision-making.
- Patient decision aids (PDAs) can simplify treatment options, but trial-specific PDAs (tPDAs) are underutilized.
Purpose of the Study:
- To develop and evaluate a user-friendly, accessible tPDA for the ImmunoSABR phase 2 trial.
- To enhance patient comprehension and shared decision-making in clinical trial participation.
Main Methods:
- Developed a tPDA following International Patient Decision Aid Standards.
- Validated through iterative evaluations with computer scientists, clinicians, medical students, and patients.
- Assessed usability via System Usability Scale (SUS), time spent, satisfaction, and self-reported understanding.
Main Results:
- The tPDA achieved a good usability score (mean SUS 79.4).
- Patients completed the tPDA efficiently, mostly within 30-60 minutes.
- Qualitative feedback indicated improved patient understanding of trial details.
Conclusions:
- Trial-specific patient decision aids (tPDAs) are feasible and effective in improving patient comprehension.
- tPDAs enhance patient engagement and informed decision-making in clinical trials.
- Integrating tPDAs complements traditional communication methods, supporting patient-centered care.
Related Concept Videos
01:16Clinical Trials
10.2K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
10.2K
01:11Clinical Trials: Overview
4.6K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.6K
01:24Nursing Process for Patient and Caregiver Teaching I: Assessment and Diagnosis
2.3K
The nursing process provides a clinical decision-making framework for patients and families to establish and implement a personalized care plan. Since part of the nurse's duties is to teach patients, the steps of the nursing process are the most effective way to approach instruction. The nursing process and the teaching-learning process are inextricably linked.
It is critical to determine the patient's learning needs during the assessment. Determination of learning needs compounds data...
It is critical to determine the patient's learning needs during the assessment. Determination of learning needs compounds data...
2.3K
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
144
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
144
01:26Drug Administration and Therapy Phases: Overview
1.3K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
1.3K
01:28Preclinical Development: Overview
5.9K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.9K