Cognitive Testing for the Pain Quality Assessment Scale (PQAS) (PQAS)

The purpose of the study is to improve a questionnaire (the Pain Quality Assessment Scale) used for measuring different types of pain people may experience. An improved version of this questionnaire will help researchers better understand the impact of pain treatments on different types of pain through the use of this questionnaire.

Study Overview

• Status: Completed
• Conditions: Pain; Multiple Sclerosis; Spinal Cord Injuries

Detailed Description

In recent years, a growing number of investigators have noticed a curious finding when summarizing the research literature on pain treatment: Most effective pain treatments show very similar effects on global pain intensity, despite vast differences in patient samples, and in presumed mechanisms of action (e.g., Collins et al., 2000; Gutierrez-Alvarez, 2007; Wiffen et al., 2005). As the list of available treatments for various pain conditions grows, and to the extent that only global measures of pain are used to assess outcomes, it is becoming increasingly difficult for any one treatment to stand out from the others; to understand when it might be chosen over other treatments for the management of any one patient's pain problem.

One way to better understand how treatments differ is to determine the effects of those treatments on pain quality. That is, to determine if treatment A is more effective for "aching" and "deep" pain than treatment B, which might be more effective for "electrical" and "surface" pain than treatment A. By systematically measuring the effects of pain treatments on different pain qualities, it becomes possible to begin to distinguish the effects of different treatments from one another.

To do so requires investigators to include measures of pain quality as secondary outcome measures in clinical trials. The NPS and PQAS (which includes the 10 NPS items) are increasingly used in clinical trials to detect the effects of pain treatments on pain qualities. Moreover, a growing body of research supports the validity of these measures for identifying the specific pain qualities impacted by different pain treatments. However, it is not entirely clear that either measure could be used for making labeling claims. The most recent draft of the FDA's guidance for industry for patient-reported outcomes specifies a number of criteria that measures must meet in order to be able to use them for making labeling claims. Although the NPS and PQAS meet many of those requirements, they do not meet three critical ones. First, the guidelines specify that a measures' items need to be generated with patient involvement. The NPS and PQAS items were generated from (1) the clinical experience of the measures' authors and (2) reviews of the literature concerning the pain qualities most often identified by patients with various chronic pain conditions. However, these items have not yet been directly checked using patients input (to clarify that the items reflect the most important and most common pain quality domains). Second, the guidelines specify that patients should be interviewed to help determine the readability and understanding of the items. These interviews then should be analyzed, and actions taken to delete or modify items in accordance with those interviews. Finally, the FDA recommends that the instrument development process include "… the generation of a user manual that specifies how to incorporate the measure into a clinical trial in a way that minimizes administrator burden, patient burden, missing data, and poor data quality." To date, no manual has been written for the NPS or PQAS.

To address these concerns, the current proposal seeks to address the limitations of the PQAS (and because the PQAS incorporates the NPS items, this would also address the limitation of the NPS) by performing cognitive testing of the PQAS instructions and items in two samples of patients with chronic pain, modify the PQAS/NPS as needed, and write a manual for the PQAS/NPS. The procedures would allow for critical testing and improvement of the PQAS and NPS, making these measures even more useful for understanding the impact of different pain treatments. In this way, these measures could be even more useful than they already are for identifying the unique advantages of new, and already developed, pain treatments.

• Study Type: Observational
• Enrollment (Actual): 213

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will consist of individuals from the general community who have participated in a survey study for SCI or multiple sclerosis(MS), experience chronic pain and indicated a willingness to be contacted for further studies. Subjects from the general population may learn about the study through UW-affiliated websites and newsletters.

Description

Inclusion Criteria:

• Phase 1: have a primary pain problem caused either by musculoskeletal or neuropathic pain for SCI subjects,and neuropathic pain for subjects with MS.
• have been diagnosed with an SCI or MS by a physician.
• read, speak and understand English.
• be at least 18 years of age.
• experienced pain in the last three months prior to recruitment.

Exclusion Criteria:

-Individuals will be enrolled in the study if they meet all the eligibility criteria listed above; there are no particular exclusion criteria for this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Neuropathic Pain; Subjects in this group experience chronic neuropathic pain.
Musculoskeletal Pain; Subjects in this group experience chronic musculoskeletal pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Quality Assessment Scale (PQAS)	All Phase 1 subjects will be administered the PQAS once. Subjects participating in Phase 2 will also be administered the PQAS and asked questions regarding the measure once during this phase.

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Mark P Jensen, Ph.D., University of Washington

Publications and helpful links

General Publications

• Lin CP, Kupper AE, Gammaitoni AR, Galer BS, Jensen MP. Frequency of chronic pain descriptors: implications for assessment of pain quality. Eur J Pain. 2011 Jul;15(6):628-33. doi: 10.1016/j.ejpain.2010.11.006. Epub 2011 Jan 8.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: July 11, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Estimate): May 9, 2012
• Last Update Submitted That Met QC Criteria: May 7, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Pain Assessment; Measurement
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Multiple Sclerosis; Spinal Cord Injuries
• Other Study ID Numbers: 33066-G