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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Clinical Trials01:16

Clinical Trials

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...
Patient-centered Care01:13

Patient-centered Care

Patient-centered care involves delivering care beyond inpatient hospitalization. Reflective practice can enhance a patient-centered approach. Reflective practice is a process of reasoning that considers all aspects of the present situation, including practicalities, learning from personal practice, and consideration of patient needs. Patients appreciate care decisions made while considering their input. Involving the patient in their care provides the patient with a sense of contribution rather...
Guidelines for Writing Outcome01:11

Guidelines for Writing Outcome

When developing expected outcomes for a patient care plan, the nurse should adhere to the following recommendations:
Patient outcomes reflect the patient's response to the goal rather than what the nurse aims to achieve. Terminology should be observable and measurable to avoid the reader's interpretation. The desired outcome should be realistic and achievable in the designated care timeframe. Expected outcomes should align with adjunctive therapies. The outcome should enhance care evaluation by...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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,...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...

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Updated: Jun 14, 2026

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
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Operationalizing patient and stakeholder engagement in high-acuity trials: Lessons from IMPROVE-AD.

Motutama Sipelii1, Jake Howitt2, Keeley McConnell1

  • 1Division of Vascular and Endovascular Surgery, Department of Surgery, Oregon Health & Science University, Portland, OR.

Seminars in Vascular Surgery
|June 12, 2026
PubMed
Summary

Structured patient and stakeholder engagement strategies can be integrated into complex surgical trials. Early input refined trial design, recruitment, and communication, enhancing transparency and addressing potential barriers.

Keywords:
HypertensionStent-graft placementThoracic endovascular aortic repairUncomplicated type B aortic dissectionUnresolved pain

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Last Updated: Jun 14, 2026

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Area of Science:

  • Clinical Trials
  • Patient Engagement
  • Surgical Research

Background:

  • Patient and stakeholder engagement is crucial in clinical research.
  • Practical guidance for high-acuity, multicenter surgical trials is limited.

Purpose of the Study:

  • To describe the design and early implementation of a structured engagement strategy in the IMPROVE-AD trial.
  • To integrate patient perspectives into trial design and conduct.

Main Methods:

  • Established a patient engagement committee and stakeholder engagement core.
  • Gathered input on trial design, recruitment, participant materials, and communication.
  • Utilized aggregated screening and enrollment data.

Main Results:

  • Engagement informed refinement of trial design, prioritizing clinical endpoints.
  • Patient input revised informed consent, public materials, and recruitment messaging for clarity and transparency.
  • Data analysis identified recruitment barriers and underrepresentation.

Conclusions:

  • Structured engagement can be incorporated into high-acuity, multicenter randomized trials.
  • Engagement strategies may inform communication, recruitment, and implementation.
  • Selected elements may be adaptable, but further evaluation of impact and scalability is needed.