The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008

Valid and reliable assessment of pain is essential for both clinical trials and effective pain management. The nature of pain makes objective measurement impossible. Acute pain can be reliably assessed, both at rest (important for comfort) and during movement (important for function and risk of postoperative complications), with one-dimensional tools such as numeric rating scales or visual analogue scales. Both these are more powerful in detecting changes in pain intensity than a verbal categorical rating scale. In acute pain trials, assessment of baseline pain must ensure sufficient pain intensity for the trial to detect meaningful treatment effects. Chronic pain assessment and its impact on physical, emotional, and social functions require multidimensional qualitative tools and health-related quality of life instruments. Several disease- and patient-specific functional scales are useful, such as the Western Ontario and MacMaster Universities for osteoarthritis, and several neuropathic pain screening tools. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations for outcome measurements of chronic pain trials are also useful for routine assessment. Cancer pain assessment is complicated by a number of other bodily and mental symptoms such as fatigue and depression, all affecting quality of life. It is noteworthy that quality of life reported by chronic pain patients can be as much affected as that of terminal cancer patients. Any assessment of pain must take into account other factors, such as cognitive impairment or dementia, and assessment tools validated in the specific patient groups being studied.

Assessment of pain

Background
Psychological treatments are designed to treat pain, distress and disability, and are in common practice. This review updates and extends the 2009 version of this systematic review.

Objectives
To evaluate the effectiveness of psychological therapies for chronic pain (excluding headache) in adults, compared with treatment as usual, waiting list control, or placebo control, for pain, disability, mood and catastrophic thinking.

Search methods
We identified randomised controlled trials (RCTs) of psychological therapy by searching CENTRAL, MEDLINE, EMBASE and Psychlit from the beginning of each abstracting service until September 2011. We identified additional studies from the reference lists of retrieved papers and from discussion with investigators.

Selection criteria
Full publications of RCTs of psychological treatments compared with an active treatment, waiting list or treatment as usual. We excluded studies if the pain was primarily headache, or was associated with a malignant disease. We also excluded studies if the number of patients in any treatment arm was less than 20.

Data collection and analysis
Forty-two studies met our criteria and 35 (4788 participants) provided data. Two authors rated all studies. We coded risk of bias as well as both the quality of the treatments and the methods using a scale designed for the purpose. We compared two main classes of treatment (cognitive behavioural therapy(CBT) and behaviour therapy) with two control conditions (treatment as usual; active control) at two assessment points (immediately following treatment and six months or more following treatment), giving eight comparisons. For each comparison, we assessed treatment effectiveness on four outcomes: pain, disability, mood and catastrophic thinking, giving a total of 32 possible analyses, of which there were data for 25.

Main results
Overall there is an absence of evidence for behaviour therapy, except a small improvement in mood immediately following treatment when compared with an active control. CBT has small positive effects on disability and catastrophising, but not on pain or mood, when compared with active controls. CBT has small to moderate effects on pain, disability, mood and catastrophising immediately post-treatment when compared with treatment as usual/waiting list, but all except a small effect on mood had disappeared at follow-up. At present there are insufficient data on the quality or content of treatment to investigate their influence on outcome. The quality of the trial design has improved over time but the quality of treatments has not.

Authors' conclusions
Benefits of CBT emerged almost entirely from comparisons with treatment as usual/waiting list, not with active controls. CBT but not behaviour therapy has weak effects in improving pain, but only immediately post-treatment and when compared with treatment as usual/waiting list. CBT but not behaviour therapy has small effects on disability associated with chronic pain, with some maintenance at six months. CBT is effective in altering mood and catastrophising outcomes, when compared with treatment as usual/waiting list, with some evidence that this is maintained at six months. Behaviour therapy has no effects on mood, but showed an effect on catastrophising immediately post-treatment. CBT is a useful approach to the management of chronic pain. There is no need for more general RCTs reporting group means: rather, different types of studies and analyses are needed to identify which components of CBT work for which type of patient on which outcome/s, and to try to understand why.

Psychological therapies for the management of chronic pain (excluding headache) in adults

The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS®). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and cognitive interviewing), 168 items (56 for each construct) were written in a first person, past tense format with a 7-day time frame and five response options reflecting frequency. The calibration sample included nearly 15,000 respondents. Final banks of 28, 29, and 29 items were calibrated for depression, anxiety, and anger, respectively, using item response theory. Test information curves showed that the PROMIS item banks provided more information than conventional measures in a range of severity from approximately -1 to +3 standard deviations (with higher scores indicating greater distress). Short forms consisting of seven to eight items provided information comparable to legacy measures containing more items.

/pdf/item-banks-for-measuring-emotional-distress-from-the-patient-21olowl3pz.pdf

Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS®): depression, anxiety, and anger.

America's health care system has become too complex and costly to continue business as usual. Best Care at Lower Cost explains that inefficiencies, an overwhelming amount of data, and other economic and quality barriers hinder progress in improving health and threaten the nation's economic stability and global competitiveness. According to this report, the knowledge and tools exist to put the health system on the right course to achieve continuous improvement and better quality care at a lower cost.The costs of the system's current inefficiency underscore the urgent need for a systemwide transformation. About 30 percent of health spending in 2009--roughly $750 billion--was wasted on unnecessary services, excessive administrative costs, fraud, and other problems. Moreover, inefficiencies cause needless suffering. By one estimate, roughly 75,000 deaths might have been averted in 2005 if every state had delivered care at the quality level of the best performing state. This report states that the way health care providers currently train, practice, and learn new information cannot keep pace with the flood of research discoveries and technological advances.About 75 million Americans have more than one chronic condition, requiring coordination among multiple specialists and therapies, which can increase the potential for miscommunication, misdiagnosis, potentially conflicting interventions, and dangerous drug interactions. Best Care at Lower Cost emphasizes that a better use of data is a critical element of a continuously improving health system, such as mobile technologies and electronic health records that offer significant potential to capture and share health data better. In order for this to occur, the National Coordinator for Health Information Technology, IT developers, and standard-setting organizations should ensure that these systems are robust and interoperable. Clinicians and care organizations should fully adopt these technologies, and patients should be encouraged to use tools, such as personal health information portals, to actively engage in their care.This book is a call to action that will guide health care providers; administrators; caregivers; policy makers; health professionals; federal, state, and local government agencies; private and public health organizations; and educational institutions.

Best Care at Lower Cost: The Path to Continuously Learning Health Care in America

Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations

Background:The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes

The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years.

In a process involving hundreds of scientists in 2002, the National Institutes of Health (NIH) identified high-priority scientific opportunities and needs the agency should pursue. Criteria used to identify the most important initiatives included: goals that could not be accomplished by a single institute, but were the responsibility of the NIH as a whole; initiatives that the NIH could not afford not to do; initiatives that no other entity could or would do; and initiatives that would transform biomedical research. This “Roadmap for Medical Research” included, as 1 of 3 major theme areas, the goal of “re-engineering the clinical research enterprise.” Initiatives developed under this roadmap theme are intended to facilitate and enhance clinical research in numerous ways, including promoting integration of clinical research networks, harmonizing regulatory processes, revolutionizing clinical research training, and developing technologies to improve clinical outcomes assessment. This supplemental issue of Medical Care describes the last of these initiatives, the Patient-Reported Outcomes Measurement Information System (PROMIS)—its rationale, the funded network, and the network’s conceptual, analytic, empirical work, and goals. One clinical research issue highlighted by the roadmap process was the need for more valid, reliable, and generalizable measures of clinical outcomes that are important to patients. Conventional measures of disease status do not fully capture the ways that chronic diseases and their treatment affect individuals. Many aspects of patients’ subjective experience, such as symptom severity and frequency, emotional and social wellbeing, and perceived level of health and functional ability, are important targets for disease intervention. Measurement of patient-reported outcomes (PROs) is particularly important in clinical trials, where laboratory or imaging results may not translate into important benefit to patients, or in trials where 2 treatments may be comparably effective, but have different adverse-effect profiles that differentially affect symptoms, functioning, or other aspects of patients’ quality of life. The identified need for improved PRO measurement engendered an NIH request for applications to develop a validated, dynamic system to measure PROs efficiently in study participants with a wide range of chronic diseases and demographic characteristics. The intent was to create a collaborative group of funded investigators that would take advantage of computer technologies and advances in modern measurement theory to develop an improved tool for measuring PROs. The broad objectives outlined in the request for applications were to: (1) develop and test a large bank of items measuring PROs; (2) create a computerized adaptive testing system that will allow for efficient, psychometrically robust assessment of PROs in clinical research on a wide range of chronic diseases; and (3) create a publicly-available system that can be added to and modified periodically, and that will allow researchers to access a common item repository and a computerized adaptive test (CAT).

Deborah N. Ader

Papers

Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations

The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years.

Developing the Patient-reported Outcomes Measurement Information System (promis)