Doerte U. Junghaenel

Written emotional expression produces health benefits in fibromyalgia patients.

Objective: Written expression of traumatic experiences, an intervention found to have health benefits in rheumatoid arthritis, asthma, and breast cancer, was tested in a randomized, controlled trial with female fibromyalgia patients. It was hypothesized that relative to controls, patients engaging in the writing intervention would experience improved status on psychological well-being and physical health variables. Methods: Patients (N = 92) were randomized into a trauma writing group, a control writing group, or usual care control group. The two writing groups wrote in the laboratory for 20 minutes on 3 days at 1-week intervals. Psychological well-being, pain, and fatigue were the primary outcome variables. Assessments were made at pretreatment, posttreatment, 4-month follow-up, and 10-month follow-up. Results: The trauma writing group experienced significant reductions in pain (effect size [ES] = 0.49) and fatigue (ES = 0.62) and better psychological well-being (ES = 0.47) at the 4-month follow-up relative to the control groups. Benefits were not maintained at the 10-month follow-up. Conclusion: Fibromyalgia patients experienced short-term benefits in psychological and health variables through emotional expression of personal traumatic experiences. ED = written emotional disclosure; RA = rheumatoid arthritis; QOL = Quality of Life Scale; STAI-S = state version, State-Trait Anxiety Inventory; BDI = Beck Depression Inventory; MOS = Medical Outcome Study; CLINHAQ = Clinical Health Assessment Questionnaire; FIQ = Fibromyalgia Impact Questionnaire; VAS = visual analogue scale; NW = neutral writing group; UC = usual-care control group; ANOVA = analysis of variance; ES = effect size.

How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example.

OBJECTIVE To illustrate how measurement practices can be advanced by using as an example the fatigue item bank (FIB) and its applications (short forms and computerized adaptive testing [CAT]) that were developed through the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) Cooperative Group. DESIGN Psychometric analysis of data collected by an Internet survey company using item response theory-related techniques. SETTING A U.S. general population representative sample collected through the Internet. PARTICIPANTS Respondents used for dimensionality evaluation of the PROMIS FIB (N=603) and item calibrations (N=14,931). INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Fatigue items (112) developed by the PROMIS fatigue domain working group, 13-item Functional Assessment of Chronic Illness Therapy-Fatigue, and 4-item Medical Outcomes Study 36-Item Short Form Health Survey Vitality scale. RESULTS The PROMIS FIB version 1, which consists of 95 items, showed acceptable psychometric properties. CAT showed consistently better precision than short forms. However, all 3 short forms showed good precision for most participants in that more than 95% of the sample could be measured precisely with reliability greater than 0.9. CONCLUSIONS Measurement practice can be advanced by using a psychometrically sound measurement tool and its applications. This example shows that CAT and short forms derived from the PROMIS FIB can reliably estimate fatigue reported by the U.S. general population. Evaluation in clinical populations is warranted before the item bank can be used for clinical trials.

Cognitive interviewing in the evaluation of fatigue items: Results from the patient-reported outcomes measurement information system (PROMIS)

ObjectivesCognitive Interviewing (CI) is a technique increasingly used to obtain respondent feedback on potential items during questionnaire development. No standard guidelines exist by which to incorporate CI feedback in deciding to retain, revise, or eliminate potential items. We used CI in developing fatigue items for the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative. Our aims were to describe the CI process, formally evaluate the utility of decisions made on the basis of CI, and offer suggestions for future research.MethodsParticipants were 22 patients with a diverse range of chronic health conditions. During CI, each participant provided feedback on a series of items. We then reviewed the CI data and decided whether to retain, revise, or eliminate each potential item. Following this, we developed or adopted three quantitative methods to compare retained versus eliminated items.ResultsRetained items raised fewer serious concerns, were less likely to be viewed as non-applicable, and were less likely to display problems with clarity or to make incorrect assumptions about respondents.ConclusionsCI was useful in developing the PROMIS fatigue items and the methods used to judge CI for the present item set may be useful for future investigations.

Method of administration of PROMIS scales did not significantly impact score level, reliability, or validity

OBJECTIVES To test the impact of the method of administration (MOA) on score level, reliability, and validity of scales developed in the Patient Reported Outcomes Measurement Information System (PROMIS). STUDY DESIGN AND SETTING Two nonoverlapping parallel forms each containing eight items from each of three PROMIS item banks (Physical Function, Fatigue, and Depression) were completed by 923 adults with chronic obstructive pulmonary disease, depression, or rheumatoid arthritis. In a randomized crossover design, subjects answered one form by interactive voice response (IVR) technology, paper questionnaire (PQ), personal digital assistant (PDA), or personal computer (PC) and a second form by PC, in the same administration. Method equivalence was evaluated through analyses of difference scores, intraclass correlations (ICCs), and convergent/discriminant validity. RESULTS In difference score analyses, no significant mode differences were found and all confidence intervals were within the prespecified minimal important difference of 0.2 standard deviation. Parallel-forms reliabilities were very high (ICC = 0.85-0.93). Only one across-mode ICC was significantly lower than the same-mode ICC. Tests of validity showed no differential effect by MOA. Participants preferred screen interface over PQ and IVR. CONCLUSION We found no statistically or clinically significant differences in score levels or psychometric properties of IVR, PQ, or PDA administration compared with PC.

Validity and reliability of patient-reported outcomes measurement information system instruments in osteoarthritis.

Evaluation of known‐group validity, ecological validity, and test–retest reliability of 4 domain instruments from the Patient‐Reported Outcomes Measurement Information System (PROMIS) in osteoarthritis (OA) patients.

Individual differences in the day-to-day variability of pain, fatigue, and well-being in patients with rheumatic disease: Associations with psychological variables

Summary Daily variability in pain is a challenge for patients’ ability to cope with persistent pain; evidence suggests variability as focus of clinical assessment and treatment outcome. Abstract This report examines day‐to‐day variability in rheumatology patients’ ratings of pain and related quality‐of‐life variables as well as predictors of that variability. Data from 2 studies were used. The hypothesis was that greater psychological distress (i.e., depression and anxiety) and poorer coping appraisals (i.e., higher pain catastrophizing and lower self‐efficacy) are associated with more variability. Electronic daily diary ratings were collected from 106 patients from a community rheumatology practice across 28 days (study 1) and from 194 osteoarthritis patients across 7 days (study 2). In multilevel modeling analyses, substantial day‐to‐day variability was evident for all variables in both studies, and individual patients differed considerably and somewhat reliably in the magnitude of their variability. Higher levels of depression significantly predicted greater variability in pain, as well as in happiness and frustration (study 1). Lower self‐efficacy was associated with more variability in patients’ daily satisfaction with accomplishments and in the quality of their day (study 2). Greater pain catastrophizing and higher depression predicted more variability in interference with social relationships (study 2). Anxiety was not significantly associated with day‐to‐day variability. The results of these studies suggest that individual differences in the magnitude of symptom fluctuation may play a vital role in understanding patients’ adjustment to pain. Future research will be needed to examine the clinical utility of measuring variability in patients’ pain and well‐being, and to understand whether reducing variability may be an important treatment target.

Difference in method of administration did not significantly impact item response: an IRT-based analysis from the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative

PurposeTo test the impact of method of administration (MOA) on the measurement characteristics of items developed in the Patient-Reported Outcomes Measurement Information System (PROMIS).MethodsTwo non-overlapping parallel 8-item forms from each of three PROMIS domains (physical function, fatigue, and depression) were completed by 923 adults (age 18–89) with chronic obstructive pulmonary disease, depression, or rheumatoid arthritis. In a randomized cross-over design, subjects answered one form by interactive voice response (IVR) technology, paper questionnaire (PQ), personal digital assistant (PDA), or personal computer (PC) on the Internet, and a second form by PC, in the same administration. Structural invariance, equivalence of item responses, and measurement precision were evaluated using confirmatory factor analysis and item response theory methods.ResultsMultigroup confirmatory factor analysis supported equivalence of factor structure across MOA. Analyses by item response theory found no differences in item location parameters and strongly supported the equivalence of scores across MOA.ConclusionsWe found no statistically or clinically significant differences in score levels in IVR, PQ, or PDA administration as compared to PC. Availability of large item response theory-calibrated PROMIS item banks allowed for innovations in study design and analysis.

Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial

Summary A multisite, randomized, controlled trial showed that nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain. ABSTRACT A multisite, randomized, controlled clinical effectiveness trial was conducted for osteoarthritis patients with chronic pain of the knee or hip. Adult health nurse practitioners provided a 10‐session intervention, pain coping skills training (PCST), in patients’ doctors’ offices (N = 129 patients); the control group received usual care (N = 127 patients). Primary outcomes assessed at baseline, posttreatment, 6‐month follow‐up, and 12‐month follow‐up were: pain intensity, physical functioning, psychological distress, self‐efficacy, catastrophizing, use of coping strategies, and quality of life. Secondary measures included fatigue, social functioning, health satisfaction, and use of pain medication. Methods favoring external validity, consistent with pragmatic, effectiveness research, were utilized. Primary ITT and secondary per‐protocol analyses were conducted. Attrition was within the expected range: 11% at posttreatment and 29% at 12‐month follow‐up; rates did not differ between groups. Omnibus ITT analyses across all assessment points indicated significant improvement for the PCST group compared with the control group for pain intensity, physical functioning, psychological distress, use of pain coping strategies, and self‐efficacy, as well as fatigue, satisfaction with health, and reduced use of pain medication. Treatment effects were robust to covariates (demographics and clinical sites). Trends in the outcomes across the assessments were examined. All outcomes, except for self‐efficacy, were maintained through the 12‐month follow‐up; effects for self‐efficacy degraded over time. Per‐protocol analyses did not yield greater effect sizes. Comparisons of PCST patients who were more vs less treatment adherent suggested greater effectiveness for patients with high adherence. Results support the effectiveness of nurse practitioner delivery of PCST for chronic osteoarthritis pain.

Stability of patient adaptation classifications on the multidimensional pain inventory

&NA; This study examined the adaptational classification stability of the multidimensional pain inventory (MPI) in two samples of female fibromyalgia syndrome patients. Retest resulted in one‐third of patients being assigned to a different classification. Twenty patients had four repeated MPI assessments over a 10‐month period; 85% of them changed classification at least once. Prediction of classification stability using demographic variables and measures of pain, depression, anxiety, impression management, and self‐deception was unsuccessful. Examination of the MPI Variable Response Scale and an index of the goodness of fit of the cluster for each patient did not yield sufficient predictive power. The implication of this study is that for a sizable number of chronic pain patients, MPI classifications may not be stable, trait‐like characterizations. As such, caution must be applied when treatment is tailored to MPI clusters and when classification change is used as an outcome measure.

Differential efficacy of written emotional disclosure for subgroups of fibromyalgia patients

OBJECTIVES To identify differential health benefits of written emotional disclosure (ED). METHODS Pain-coping style and demographic characteristics were examined as potential moderators of ED treatment efficacy in a randomized controlled trial with female fibromyalgia patients. RESULTS Of three pain-coping styles, only patients classified as interpersonally distressed (ID) experienced significant treatment effects on psychological well-being, pain, and fatigue. Treatment effects on psychological well-being were also significantly greater for patients with a high level of education. CONCLUSIONS Patients with an ID-coping style and/or high education appear to benefit most from ED.