This two-phase study was conducted to identify relevant domains of patient-reported outcomes from the perspective of people who experience chronic pain. In Phase 1, focus groups were conducted to generate a pool of patient outcome-related domains and their components. The results of the focus groups identified 19 aspects of their lives that were significantly impacted by the presence of their symptoms and for which improvements were important criteria they would use in evaluating the effectiveness of any treatment. Phase 2 was conducted to examine the importance and relevance of domains identified from a much larger and diverse sample of people with chronic pain. A survey was developed and posted on the American Chronic Pain Association website. Participants were asked to rate the importance of each item or domain identified by the focus groups on a scale of 0 to10 (i.e., 0="not at all important" and 10="extremely important"). The survey was completed by 959 individuals. The results indicate that all 19 aspects of daily life derived from the focus groups were considered important with a majority of respondents indicating a score of 8 or greater. In addition to pain reduction, the most important aspects were enjoyment of life, emotional well-being, fatigue, weakness, and sleep-related problems. Chronic pain clearly impacts health-related quality of life. The results of the two phases of the study indicate that people with chronic pain consider functioning and well-being as important areas affected by the presence of symptoms and as appropriate targets of treatment. These multiple outcomes should be considered when evaluating the efficacy and effectiveness of chronic pain treatments.
AimThe purpose of the present study was to identify the domains of functioning that people with chronic pain consider important and that they can use as a basis for determining the value of and satisfaction with a treatment.
ContributorsTurk, Dennis C. Dworkin, Robert H. Revicki, Dennis Harding, Gale Burke, Laurie B. Cella, David Cleeland, Charles S. Cowan, Penney Farrar, John T. Hertz, Sharon Max, Mitchell B. Rappaport, Bob A.
Disease Category: Anaesthesia & pain control
Disease Name: Pain (chronic)
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Not specified
- Consumers (patients)
- Prioritising
- COS for clinical trials or clinical research
- Focus group(s)
- Survey
Phase 1 used focus groups to identify important domains of PROs from the perspective of individuals seeking treatment for a range of chronic pain conditions. Findings from these focus groups were used to generate a pool of specific outcomes that were used in Phase 2. To examine the importance and relevance
of these domains from a much larger and diverse sample of individuals with chronic pain, a web-based survey was developed and posted on a public website for people with chronic pain.
Potential participants were recruited from 4 clinics (2 tertiary-care pain clinics, 1 oncology clinic, and 1 research clinic) in Round Rock TX, Jacksonville FL, Trenton NJ,
and Annapolis MD during June and July 2003 to participate in focus group sessions regarding their experience of chronic pain. A site investigator from within each clinical site served as the primary contact person for the study. The site investigator identified potential participants using a screening form to ensure that participants met all pre-specified criteria. To be eligible, participants had to be at least 21 years of age; have a history of chronic pain for the past 6 months;
and be able to speak and understand English. Those who met eligibility criteria were provided an explanation of the purpose of the study and, if they agreed to participate, completed an informed consent form. A total of 31 individuals participated in one of four focus groups.
Focus group meetings were held at times and locations convenient to participants. To facilitate in-depth discussion, four separate 90 minute sessions were led by a moderator trained in qualitative research methods. All sessions were audiotaped with permission from the participants. Specific questions were designed to maintain the focus of the discussion on pain and maximize consistency across the focus groups. A discussion outline served as a question and prompt guide. The discussions
addressed symptoms of pain, impact of pain on daily life, and experiences with treatments. Participants were given an honorarium of $50 to compensate them for their time and travel expenses. A content analysis approach was used to analyze the data from the focus group sessions. Findings from the initial focus groups were
used to generate an item pool of outcomes relevant to individuals who have chronic pain using the question structure detailed below.
A web-based survey was conducted using the items generated from the focus groups to examine the importance of the outcomes and their components from a much larger and diverse sample of persons with chronic pain. The survey included items identified by the initial chronic pain focus groups as well as ancillary measures of HRQoL for purposes of exploratory analyses. For the items generated by the focus groups, participants were asked to rate the importance of each in terms of how their life was impacted by pain on a scale of 0 to 10, where 0 represents ‘‘not at all important’’ and 10 represents ‘‘extremely important.’’ In addition, participants were asked to list other aspects of their daily life affected by pain that were not included in the questionnaire.
.The American Chronic Pain Association (ACPA) is a nonprofit organization dedicated to providing education and support to people with chronic pain to help them better manage their pain and their lives. An invitation to complete the survey was posted on the ACPA website. Those experiencing chronic pain were invited to complete a screening form to ensure that they met all pre-specified criteria. To be eligible for the study, participants had to be 21 years of age or older and have at least one chronic pain condition for at least 3 months prior to participating in the survey. Those who met eligibility criteria were provided further explanation of the study and asked to complete an informed consent form. After obtaining informed consent, participants immediately began the survey. The survey was posted on the website of the ACPA from November 2004 to January 2005. A total of 1407 individuals met study eligibility criteria and were invited to participate in the survey. Of these, 1148 agreed to participate and started to complete the survey. Among these 1148 respondents, 189 were excluded from the analysis because of incomplete data (i.e., less than 50% of items were completed) or inconsistent responses between the screening questions and the survey related to select demographic and clinical characteristics; this resulted in a final sample size of 959 participants.