A novel method for expediting the development of patient-reported outcome measures and an evaluation across several

Lili Garrard1, Larry R Price2, Marjorie J Bott3

  • 1Division of Biometrics III, OB/OTS/CDER, U.S. Food and Drug Administration, Silver Spring, MD 20993.

Related Concept Videos

Analysis of Population Pharmacokinetic Data01:12

Analysis of Population Pharmacokinetic Data

Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
894
Measurement of Bioavailability: Pharmacodynamic Methods01:20

Measurement of Bioavailability: Pharmacodynamic Methods

Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
937
Nursing Evaluation01:15

Nursing Evaluation

The evaluation stage signals the end of the nursing process. The nurse gathers evaluative data to assess whether or not the patient has attained the expected results. Whereas the nurse collects data in the nursing assessment to identify the patient's health concerns, the evaluation stage data determines if the indicated health issues are resolved. Evaluative data collection includes two sections: the data acquired to evaluate patient outcomes and the time criteria for data collection.
4.6K
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,...
199
Methods of Documentation II: POMR01:26

Methods of Documentation II: POMR

The Problem-Oriented Medical Record (POMR) revolutionized medical record-keeping by introducing a systematic approach focusing on the patient's problems rather than merely listing symptoms. Dr. Lawrence Weed's introduction of this method in the 1960s marked a significant advancement in medical documentation. The POMR framework consists of four key components: the database, problem list, plan of care, and progress notes.
1.6K
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...
4.2K