Related Experiment Video

Updated: Jul 6, 2025

Working with Human Tissues for Translational Cancer Research
07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

9.9K

Stakeholders' perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a

Elizabeth Deja1, Chloe Donohue2, Malcolm G Semple3,4

  • 1Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UK e.deja@liverpool.ac.uk.

BMJ Open
|January 3, 2024
PubMed

Insights

Parents and staff found the Bronchiolitis Endotracheal Surfactant Study (BESS) acceptable. Streamlining the informed consent process and addressing staffing are key to improving future pediatric trials for critically ill infants.

Area of Science:

  • Pediatric critical care medicine
  • Respiratory medicine
  • Clinical trial methodology

Background:

  • Bronchiolitis is a common respiratory infection in infants, often requiring intensive care.
  • Endotracheal surfactant therapy is being investigated as a treatment for severe bronchiolitis.
  • The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomized controlled trial evaluating this therapy.

Purpose of the Study:

  • To assess the acceptability of the BESS trial among parents and healthcare staff.
  • To explore experiences with the informed consent process in a time-sensitive pediatric trial.
  • To identify areas for protocol refinement to improve trial conduct.

Main Methods:

  • A mixed-methods embedded study was conducted alongside the BESS trial.
  • Data were collected through staff surveys and questionnaires and interviews with parents.
  • Participants included parents of infants with bronchiolitis and healthcare staff from UK pediatric intensive care units.

Main Results:

  • Both parents and staff found the BESS trial acceptable, meeting all constructs of the Adapted Theoretical Framework of Acceptability.
  • Parents perceived surfactant therapy as low-risk and supported future research.
  • Parents recommended continuing prospective informed consent but suggested streamlining the process; staff noted missed patients due to resource limitations.

Conclusions:

  • The BESS trial is acceptable to participants, but protocol refinements are needed, particularly for the informed consent process.
  • Streamlining consent procedures and addressing staffing issues are crucial for efficient trial conduct.
  • Findings will inform consent strategies for future pediatric trials with time-critical interventions.
Abstract

Keywords:
ETHICS (see Medical Ethics)Feasibility StudiesPaediatric intensive & critical careQUALITATIVE RESEARCHRandomized Controlled TrialRespiratory infections

More Related Videos

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting14:43

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Published on: January 12, 2018

11.8K
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition00:04

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

10.7K

Related Concept Videos

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...
6.7K
Ethics in Research01:56

Ethics in Research

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
23.0K
Ethical Dilemmas II01:30

Ethical Dilemmas II

Resolving an ethical dilemma in healthcare involves a systematic approach that considers every aspect of the issue, respecting both the patient's needs and values and the healthcare professional's ethical obligations. Here are potential steps to resolve an ethical dilemma:
1.1K
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,...
129
Persuasion Strategies01:52

Persuasion Strategies

Researchers have tested many persuasion strategies, including the foot-in-the door and the door-in-the-face techniques, in a variety of contexts. Ultimately, the principles are effective in selling products and changing people’s attitude, ideas, and behaviors (Cialdini & Goldstein, 2004).
38.6K
Ethical Issues01:27

Ethical Issues

Nurses are essential in patient care, upholding the ethical principles of their profession and effectively navigating ethical dilemmas. Neglecting ethical issues can lead to inadequate patient care, compromised therapeutic relationships, and moral distress among healthcare workers.
Ethical Concerns in Healthcare:
969