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Related Concept Videos

Ethical Dilemmas II01:30

Ethical Dilemmas II

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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:
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Methods of Documentation VI: Case Management Model01:15

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The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
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Types of Reports II: Incident or Occurrence Report01:21

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An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
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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.
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SBAR II: Application of SBAR01:14

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SBAR is an effective communication tool used by healthcare professionals to communicate patient information accurately. SBAR stands for Situation, Background, Assessment, and Recommendation. For a better understanding, an example is given below.
SBAR Report from a Nurse to a Health Care Provider
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Methods of Documentation III: PIE01:21

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Problem-intervention-evaluation (PIE) is a systematic approach to documentation used in healthcare settings for clinical decision-making and patient care planning. It is a structured approach to organizing patient data based on problems, interventions, and evaluations. Here's a breakdown of its key features and considerations:
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Related Experiment Video

Updated: Apr 11, 2026

Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
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Operationalizing a Decision-Making for Adverse Event Reporting Toolkit (DART) for Aging and Serious Illness Research.

Sara Lubetsky1, Christopher Woodrell1,2, Gabrielle Schiller1

  • 1Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Journal of the American Geriatrics Society
|April 10, 2026
PubMed
Summary

The new Decision-Making for Adverse Event Reporting Toolkit (DART) simplifies adverse event reporting for clinical trials not regulated by the FDA. This tool helps researchers focus on serious events possibly related to study procedures, reducing reporting burdens.

Keywords:
adverse event reportingbehavioral trialsresearch administrationresearch compliance

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Area of Science:

  • Clinical Trials
  • Patient Safety
  • Regulatory Science

Background:

  • Adverse events (AEs) monitoring is crucial for patient safety in clinical trials.
  • Studies in seriously ill and older adults often have high AE volumes due to underlying conditions.
  • Non-Food and Drug Administration (FDA)-regulated trials face reporting burdens beyond safety needs.

Purpose of the Study:

  • To operationalize a proposed alternative approach for AE evaluation in clinical research.
  • To develop a practical tool for researchers to streamline AE reporting.
  • To reduce unnecessary reporting burdens in non-FDA-regulated studies.

Main Methods:

  • A 31-member expert panel convened multiple times between 2024-2025.
  • The panel provided guidance on deliverables, concept acceptability, and tool review.
  • A multidisciplinary team developed content, incorporated feedback, and compliance experts validated the algorithm.

Main Results:

  • The Decision-Making for Adverse Event Reporting Toolkit Tailored to Social, Behavioral and Health Services Studies involving Seriously Ill and Older Adult Populations (DART) was developed.
  • DART features a decision algorithm assessing relatedness, goals of care alignment, seriousness, and harm risk.
  • The toolkit includes a case series, FAQs, and a reporting form; feedback indicated broad applicability beyond the target population.

Conclusions:

  • DART offers an innovative solution for AE reporting challenges in aging and serious illness research.
  • The toolkit is adaptable for research in any population and intervention type not regulated by the FDA.
  • Future pilot testing is planned to guide DART's implementation.