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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...
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...
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...
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.
Health Information Technology and Healthcare Information System01:30

Health Information Technology and Healthcare Information System

Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Strategies for Assessing and Addressing Confounding01:25

Strategies for Assessing and Addressing Confounding

Confounding is a critical issue in epidemiological studies, often leading to misleading conclusions about associations between exposures and outcomes. It occurs when the relationship between the exposure and the outcome is mixed with the effects of other factors that influence the outcome. Given that, addressing confounding is of high importance for drawing accurate inferences in research.
Confounding can be addressed at both the design phase of a study and through analytical methods after data...

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Related Experiment Video

Updated: Jul 4, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

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

Published on: September 20, 2019

Methodologic issues in health informatics trials: the complexities of complex interventions.

Ivan Shcherbatykh1, Anne Holbrook, Lehana Thabane

  • 1Centre for Evaluation of Medicines, St Joseph's Healthcare Hamilton, Hamilton, Ontario L8N1G6, Canada. shcheriy@mcmaster.ca

Journal of the American Medical Informatics Association : JAMIA
|June 27, 2008
PubMed
Summary

This study reviews challenges in health informatics trials for electronic health (e-health) interventions. It offers practical recommendations for designing and reporting robust randomized controlled trials in health information technology research.

Related Experiment Videos

Last Updated: Jul 4, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

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

Published on: September 20, 2019

Area of Science:

  • Health Informatics
  • Clinical Trial Design
  • Health Information Technology

Background:

  • Electronic health (e-health) interventions require rigorous validation.
  • Health informatics trials face design, methodology, and analysis challenges.
  • Complex interventions necessitate careful planning and execution.

Purpose of the Study:

  • To review key methodologic issues in conducting and reporting randomized controlled trials (RCTs) for e-health interventions.
  • To provide practical recommendations for health informatics trialists.
  • To illustrate these issues using the COMPETE III study.

Main Methods:

  • Review of selected methodologic issues in health informatics trials.
  • Case illustration using the COMPETE III randomized controlled clinical trial.
  • Development of practical recommendations for trialists.

Main Results:

  • Identified methodologic, logistic, and statistical issues in planning and implementing complex e-health intervention trials.
  • Provided practical recommendations for conducting and reporting these trials.
  • Demonstrated issues and recommendations using a vascular disease management study.

Conclusions:

  • Recommendations focus on validity and pragmatic considerations for e-health RCTs.
  • Findings are valuable for health informaticians evaluating e-health studies.
  • Emphasizes the need for robust trial design in health information technology validation.