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Related Concept Videos

Assessment of the Mouth01:26

Assessment of the Mouth

1.2K
A thorough mouth assessment, including inspection and palpation of the lips, gums, tongue, tonsils, uvula, and pharynx, is crucial in detecting potential health issues. Diseases ranging from oral cancer to systemic conditions like diabetes could be identified early through careful oral examination. This article provides a detailed guide on conducting a comprehensive mouth assessment.
Mouth Inspection
The inspection begins with visually examining the mouth for symmetry, color, and size.
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Assessment of Respiration01:23

Assessment of Respiration

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The respiratory system's basic structures and primary functions lay the foundation for nurses' comprehensive respiratory assessments. This assessment includes subjective and objective data to gauge the patient's respiratory health.
Subjective Assessment: Nurses interview the patient to gather information directly during the subjective assessment. It includes questions about the individual's medical history, medications, and symptoms, focusing on past respiratory conditions like...
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Nursing Assessment01:29

Nursing Assessment

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The two sources for collecting information are primary and secondary. After gathering information, interpretation and validation help to complete the data. The purpose of assessment is to establish data with the initial information, to interpret data about the patient's perceived needs and health problems, and to respond to these problems identified.
The nurse collects all aspects of the patient's health in the initial assessment, establishing priorities for ongoing focused assessments...
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Assessment of the Rectum and Anus01:25

Assessment of the Rectum and Anus

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Evaluating the rectum and anus plays a crucial role in conducting a thorough physical examination of the gastrointestinal system. Although it may be uncomfortable and often embarrassing for the patient, it holds immense diagnostic value, particularly in detecting gastrointestinal diseases and abnormalities. This guide will explain how to perform this assessment using inspection and palpation methods.
Rectal Inspection
Begin by inspecting the perianal and anal areas for color, texture, rashes,...
1.3K
Pulse Assessment Sites01:11

Pulse Assessment Sites

2.7K
Pulse assessment sites are crucial in evaluating a patient's cardiovascular health. By assessing the pulsations of arteries at specific anatomical locations, healthcare professionals can gather valuable information about blood flow, heart rate, and peripheral circulation. Understanding these pulse assessment sites is essential for conducting comprehensive cardiovascular evaluations and monitoring patients' overall health. These sites are strategically chosen due to the accessibility and...
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Assessment of radial pulse01:11

Assessment of radial pulse

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Assessment of Radial Pulse
The radial pulse, located at the wrist, is often the preferred site for assessing peripheral pulse because of its accessibility and dependability. The process of determining the radial pulse involves several steps:
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Related Experiment Video

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Image Acquisition Method for the Sonographic Assessment of the Inferior Vena Cava
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Image Acquisition Method for the Sonographic Assessment of the Inferior Vena Cava

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Remaining Challenges in Assessing Non-Inferiority.

Steven Snapinn1, Qi Jiang1

  • 11 Global Biostatistical Science, Amgen, Thousand Oaks, CA, USA.

Therapeutic Innovation & Regulatory Science
|September 21, 2018
PubMed
Summary

Non-inferiority trials often use the wrong null hypothesis, potentially leading to flawed drug approval decisions. This review examines these issues and offers recommendations for better trial design.

Keywords:
indirect comparisonnon-inferiority marginnull hypothesispreservation of effecttype 1 error rate

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Area of Science:

  • Clinical Trials
  • Biostatistics
  • Pharmaceutical Research

Background:

  • Non-inferiority trials are widely used but remain controversial.
  • Fundamental disagreements exist regarding their design and interpretation.
  • Current practices may lead to inconsistencies in drug approval.

Purpose of the Study:

  • To critically evaluate the commonly used null hypothesis in non-inferiority trials.
  • To address the indirect comparison between experimental treatments and placebo.
  • To examine criteria for treatment effect preservation and preference.

Main Methods:

  • Review of existing methodologies and statistical frameworks for non-inferiority trials.
  • Analysis of the null hypothesis definition and its implications.
  • Evaluation of criteria for concluding treatment effect preservation.

Main Results:

  • The standard null hypothesis in non-inferiority trials may not align with the trial's objective of indirect comparison.
  • Current criteria for preserving a fraction of the control effect can conflict with preference criteria.
  • These issues can contribute to inconsistencies in regulatory decisions.

Conclusions:

  • Revisiting the null hypothesis in non-inferiority trials is crucial.
  • Aligning trial objectives with statistical criteria is necessary for robust drug approval.
  • Recommendations are provided to improve the design and interpretation of these trials.