Lead Investigator: Jeffrey Bower, Sana Health, Inc.
Title of Proposal Research: Anchor Based Minimal Clinical Important Difference Calculation for the Neuropathic Pain Inventory Scale
Vivli Data Request: 10290
Funding Source: This analysis will be funded by Sana Health Inc. Dr. Jeffrey Bower is an employee of Sana Health and receives a salary.
Potential Conflicts of Interest: Jeffrey is a paid Employee at Sana Health, inc. Sana Health is funding Jeffrey’s time to complete this project and his involvement is dependent on continued support for this project within the company. Given continued support, there are no other conflicts that will influence planning, conduct, interpretation, or outcomes of this research. Sana Health, if granted the opportunity to support Jeffrey in this project, has full interest in maintaining the accuracy and integrity of any shared data, to publishing the results under peer-review, and to disclose any future conflicts of interest.
Summary of the Proposed Research:
Neuropathic Pain (NP) is a type of pain caused by damage to the nerves. It affects about 10% of people, which means millions of Americans suffer from it. This pain can make everyday life difficult and lead to high medical costs, sometimes reaching up to $30,000 a year.
To understand the severity of this pain, health care professionals use special questionnaires and clinical examinations where patients describe their symptoms. One such tool is the Neuropathic Pain Symptom Inventory (NPSI), which helps measure different aspects of this pain. Although the NPSI is becoming more common in studies, there isn’t a clear guideline yet on how much improvement is considered significant.
Minimal Clinical Important Difference (MCID) is a way to measure how much change in a treatment’s outcome is meaningful to patients, beyond just the numbers. Right now, there is not a clear definition of the MCID for the Neuropathic Pain Symptom Inventory (NPSI). The Food and Drug Administration (FDA) suggests a method called the anchor method to figure this out. This method compares changes in NPSI scores with improvements measured by another tool, like the Patient Global Impression of Change (PGIC), to see what level of improvement really matters.
This research aims to find out the smallest meaningful improvement in NPSI scores that shows a treatment is working well for patients.
This is important for understanding and comparing the results of past and future studies. The proposed analysis will examine data from individual patients to determine the MCID for the NPSI, which will help improve how clinicians measure and treat neuropathic pain.
Requested Studies:
A TWO WEEK DOUBLE-BLIND PLACEBO-CONTROLLED CROSSOVER STUDY TO COMPARE THE EFFICACY AND SAFETY OF A PREGABALIN/PF-00489791 COMBINATION VERSUS PREGABALIN ALONE IN PATIENTS WITH POST-HERPETIC NEURALGIA
Data Contributor: Pfizer Inc.
Study ID: NCT00599638
Sponsor ID: B0261002