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Information about ongoing health services research and public health projects
|Extending PROMIS pain item banks: pain self-efficacy and pain catastrophizing|
|Investigator (PI):||Amtmann, Dagmar|
|Performing Organization (PO):||
(Current): University of Washington, School of Medicine, Department of Rehabilitation Medicine / (206) 744-3167
|Supporting Agency (SA):||Patient-Centered Outcomes Research Institute (PCORI)|
|Record Source/Award ID:||PCORI/ME-1403-12550|
|Funding:||Total Award Amount: $742,242|
|Award Information:||PCORI: More information and project results (when completed)|
|Abstract:||Background: Estimates suggest that over 100 million American adults suffer from chronic pain, which exacts a tremendous toll in health care costs, rehabilitation resources, and lost worker productivity (estimated to exceed $550 million annually), as well as the emotional and financial burden imposed on patients and their families. Unrelieved pain can result in excessive diagnostic tests, increased outpatient services, and decreased ability to function, resulting in lost income and disability. While acute pain is normal, indicating possible injury, chronic pain associated with a wide array of conditions (e.g., cancer, arthritis) and specific disorders (e.g., low back pain, painful diabetic neuropathy) is different and persists. Pain is typically assessed by a self-report of severity, but severity is too narrow to capture its complexity and impact. Patient Reported Outcomes Measurement Information System (PROMIS) is a system of reliable, precise, and flexible measures of patient-reported health status. PROMIS has developed several specific pain item banks and measures including pain intensity, quality, interference, and behaviors. However, two important pain-related domains are missing from PROMIS: Pain Catastrophizing (PC) and Pain-Related Self-efficacy (PRSE). In the cognitive model of depression, catastrophizing is a form of cognitive distortion that can lead to negative affect, which is highly prevalent in people with chronic pain and can amplify their symptoms and distress. Understanding and measuring the belief that people with chronic pain can successfully self-manage and live effectively with pain (i.e., PRSE) is important for designing treatments that can lead to an improved quality of life. In the study of pain, self-efficacy (SE) beliefs have been used to explain a range of behaviors and aspects of pain experience and response to treatment. SE beliefs for people experiencing chronic pain incorporate not just the expectation that a person can perform a particular activity, but also their confidence in their ability to do it despite pain. Adding measures of these domains would greatly enhance the utility of PROMIS pain instruments for conducting comparative effectiveness research in chronic pain. We propose to develop item response theory (IRT)-calibrated item banks for measuring PC and PRSE, because an IRT approach allows the greatest flexibility in administration (e.g., CAT, short forms) and greater scientific rigor in the process of development and evaluation of the instruments. To achieve this goal we propose the following specific aims: (aim 1) to develop an item pool for assessing PC and PRSE: a) obtain expert consensus on the definition and subdomains of PC and PRSE, b) develop an item pool for PC and PRSE that covers all subdomains, and c) evaluate the items from the patients' perspective using qualitative methods such as cognitive interviewing; (aim 2) to conduct IRT analyses to calibrate the item banks: a) assess IRT assumptions, b) calibrate items to the IRT graded response model and evaluate model fit, and c) evaluate differential item function (DIF); and (aim 3) to examine psychometric properties of the new PC and PRSE scores: a) examine the relationships among scores on new measures and (1) scores obtained from legacy PC and PRSE measures, and (2) scores from measures of other domains that assess constructs similar and dissimilar to PC and PRSE (construct validity), b) examine known group validity, and c) assess stability (test-retest reliability). Methods: We plan to follow the PROMIS methodology (Reeve, 2007). First, we will conduct expert panels to refine the definitions of the constructs and the relevant sub-domains. We will review literature and assemble a comprehensive list of items. Based on these efforts, we will identify gaps and write items to fill the gaps. Once we have the candidate item banks we will conduct cognitive interviews with individuals with various chronic pain disorders to ensure that the items are meaningful, understandable, and represent all aspects important to people living with chronic pain. Next, the items that function well in cognitive interviews will be administered to a calibration sample of approximately 500 individuals with chronic pain for each domain (a total of at least 1000 people with CP). Numerous chronic pain conditions will be represented (e.g., osteoarthritis, back pain, painful diabetic neuropathy, headache, multiple sclerosis, spinal cord injury). We will recruit people from specific diagnostic groups as well as patients receiving treatment in chronic pain facilities. We will use the data collected to develop the final item banks and score the items using IRT. Finally, we will develop short forms that can be administered and scored without computerized administration. We will co-administer legacy measures to evaluate the validity of new scores. A subset of 100 individuals will be asked to respond to the items twice within 48 to 72 hours to assess test-retest reliability. Patient and stakeholder engagement PC and PRSE are important constructs for individuals with pain and are being used by researchers to understand chronic pain better and to develop more effective interventions. Preliminary intervention studies targeting these constructs have been found effective in treating chronic pain patients and improving their quality of life. The main stakeholders for these measures are researchers and clinicians who treat and study individuals with chronic pain and people with chronic pain. Thus, chronic pain experts will participate in expert panels and at every step of the development. They will guide all decision making aided by the results of statistical analyses. Following the rigorous PROMIS methodology, individuals with chronic pain will be extensively involved in the development of the instruments to ensure that the items are meaningful and represent all important facets of living with chronic pain. Anticipated impact: Elimination of or substantial relief from persistent pain is rarely achieved by current treatments. In the absence of effective treatments, research has focused on identifying constructs associated with chronic pain, such as pain catastrophizing and pain-related self-efficacy as potential treatment targets to facilitate better outcomes. Conducting comparative effectiveness research requires availability of clinically meaningful, brief, but valid and precise instruments that can be used to evaluate patients and treatment outcomes. PCORI seeks projects that focus on PROMIS-related research and item bank expansion is specifically identified as an important emphasis. The proposed expansion of the PROMIS pain item banks will provide pain researchers and clinicians with important tools for studying and treating chronic pain patients. Importantly, rigorously developed and patient-centered item banks will facilitate the development of effective treatments and better outcomes for millions of people with chronic pain.|
|Record History:||('2017: Project extended to 2018',)|