Related Experiment Videos
Differences between self-reported and verified adverse cardiovascular events in a randomised clinical trial
Mark J Bolland1, Alan Barber, Robert N Doughty
1Department of Medicine, University of Auckland, Auckland, New Zealand.
BMJ Open
|March 21, 2013
Summary
Many cardiovascular events in clinical trials go unreported or unverified. Researchers should improve adverse event detection by reviewing self-reports, hospital records, and discharge data for accurate trial outcomes.
Area of Science:
- Cardiology
- Clinical Trials Methodology
- Health Outcomes Research
Background:
- Adverse events in clinical trials are typically self-reported, with verification often limited to serious or high-interest events.
- Discrepancies between self-reported and verified cardiovascular events were noted in a calcium supplement trial.
- This study systematically analyzed these discrepancies to determine their significance.
Purpose of the Study:
- To assess the accuracy of self-reported adverse cardiovascular events in a clinical trial.
- To quantify the extent of underreporting and misclassification of myocardial infarctions and strokes.
- To evaluate the impact of event reporting and adjudication methods on trial outcomes.
Main Methods:
- Secondary analysis of cardiovascular events from a 5-year randomized, placebo-controlled calcium supplementation trial.
- Involved 1471 postmenopausal women (mean age 74 years).
- Adjudication of self-reported myocardial infarctions (MIs) and strokes; review of medical records, hospital discharge databases, and death certificates to identify unreported events.
Main Results:
- 52% of self-reported MIs and 58% of self-reported strokes were verified.
- An additional 25 MIs and 13 strokes were identified through record review and database searches, with 43% of verified MIs and 21% of verified strokes initially unreported.
- Neither the source of event data nor the adjudication level affected the relationship between calcium supplementation and cardiovascular events.
Conclusions:
- Self-reported adverse events in clinical trials may be inaccurate, with significant underreporting and misclassification.
- Researchers should consider adjudicating all self-reported events and systematically reviewing hospital discharge codes and databases.
- Implementing comprehensive methods to identify unreported events is crucial for critical adverse event accuracy in clinical research.
Related Concept Videos
01:19Pharmacovigilance
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:15Bioavailability 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,...
01:11Clinical 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...
01:16Clinical 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...
There are four phases in a clinical trial. A phase one...
01:23Assessment of the Cardiovascular System I: Subjective Data
A thorough health history and physical assessment are essential for identifying cardiovascular disease (CVD) symptoms and distinguishing them from other health issues.
Initial Enquiry
Ask the patient about their primary concern and thoroughly explore all reported symptoms.
Medical History
Investigate past illnesses affecting the cardiovascular system, such as angina, anemia, rheumatic fever, congenital heart disease, stroke, thrombophlebitis, dysrhythmias, varicosities
Inquire about symptoms...
Initial Enquiry
Ask the patient about their primary concern and thoroughly explore all reported symptoms.
Medical History
Investigate past illnesses affecting the cardiovascular system, such as angina, anemia, rheumatic fever, congenital heart disease, stroke, thrombophlebitis, dysrhythmias, varicosities
Inquire about symptoms...
01:23Types 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...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...