Psychometric Evaluation of the Patient-Reported Outcomes Measurement Information System Fatigue-Short Form Across Diverse Populations.

BACKGROUND: The need for reliable, valid tools to measure patient-reported outcomes (PROs) is critical both for research and for evaluating treatment effects in practice. The Patient-Reported Outcomes Measurement Information System Fatigue-Short Form v1.0-Fatigue 7a (PROMIS F-SF) has had limited psychometric evaluation in various populations. OBJECTIVES: The aim of the study is to examine psychometric properties of PROMIS F-SF item responses across various populations. METHODS: Data from five studies with common data elements were used in this secondary analysis. Samples from patients with fibromyalgia, sickle cell disease, cardiometabolic risk, pregnancy, and healthy controls were used. Reliability was estimated using Cronbach's alpha. Dimensionality was evaluated with confirmatory factor analysis. Concurrent validity was evaluated by examining Pearson's correlations between scores from the PROMIS F-SF, the Multidimensional Fatigue Symptom Inventory-Short Form, and the Brief Fatigue Inventory. Discriminant validity was evaluated by examining Pearson's correlations between scores on the PROMIS F-SF and measures of stress and depressive symptoms. Known groups validity was assessed by comparing PROMIS F-SF scores in the clinical samples to healthy controls. RESULTS: Reliability of PROMIS F-SF scores was adequate across samples, ranging from .72 in the pregnancy sample to .88 in healthy controls. Unidimensionality was supported in each sample. Concurrent validity was strong; across the groups, correlations with scores on the Multidimensional Fatigue Symptom Inventory-Short Form and Brief Fatigue Inventory ranged from .60 to .85. Correlations of the PROMIS F-SF with measures of stress and depressive mood were moderate to strong, ranging from .37 to .64. PROMIS F-SF scores were significantly higher in clinical samples compared to healthy controls. DISCUSSION: Reliability and validity of the PROMIS F-SF were acceptable. The PROMIS F-SF is a suitable measure of fatigue across the four diverse clinical populations included in the analysis.

Biobehavioral examination of fatigue across populations: report from a P30 Center of Excellence.

OBJECTIVES: This article reports the cross-studies analysis of projects from the P30 Center of Excellence for Biobehavioral Approaches to Symptom Management. Although the projects investigated diverse populations, a consistent theoretical and empirical approach guided each project. METHODS: Common data elements included the following measures of psychobehavioral variables: the PROMIS Short-Form Fatigue Scale, the Center of Epidemiologic Studies Depression Scale, and the Perceived Stress Scale. Plasma cytokines were measured as the shared biological data element. RESULTS: Data were analyzed from 295 participants with fibromyalgia (n = 72), second trimester pregnancy (n = 73), sickle cell anemia (n = 60), and cardiometabolic risk (n = 91). The mean age of participants was 35.4 years, and the most participants were female. Levels of symptoms were generally elevated across samples; the level of fatigue ranged from 18.9 to 24.7, depressive symptoms from 12.5 to 23.4, and perceived stress from 16.5 to 21.8. Intercorrelations among symptom measures and perceived stress were strong across the samples. However, correlations among psychobehavioral variables and cytokines were variable, indicating a separate relationship for the measures with cytokines. CONCLUSIONS: Future work in symptom science could benefit from common data elements, including biomarkers, across populations to better develop the taxonomy of symptom profiles across conditions.

X-Ray Imaging in the Simulated Microgravity Environment of Parabolic Flight.

INTRODUCTION: The advancement of human spaceflight has made urgent the need to develop medical imaging technology to ensure a high level of in-flight care. To date, only ultrasound has been used in spaceflight. Radiography has multiple advantages over ultrasound, including lower operator dependence, more rapid acquisition, typically higher spatial resolution, and characterization of tissue with acoustic impedance precluding ultrasound. This proof-of-concept work demonstrates for the first time the feasibility of performing human radiographs in microgravity.METHODS: Radiographs of a phantom and human subject's hand, knee, chest, cervical spine, and pelvis were obtained aboard a parabolic flight in microgravity and simulated lunar gravity with various subject and operator positions. Control radiographs were acquired with the same system on the ground. These radiographs were performed with a Food and Drug Administration-approved ultra-portable, wireless, battery-powered, digital x-ray system.RESULTS: The radiographs of the phantom acquired in reduced gravity were qualitatively and quantitatively compared to the ground controls and found to exhibit similar diagnostic adequacy. There was no statistically significant difference in contrast resolution or spatial resolution with a spatial resolution across all imaging environments up to the Nyquist frequency of 3.6 line-pairs/mm and an average contrast-to-noise ratio of 2.44.DISCUSSION: As mass, power, and volume limitations lessen over the coming decades and the miniaturization of imaging equipment continues, in-flight implementation of nonsonographic modalities will become practical. Given the demonstrated ease of use and satisfactory image quality, portable radiography is ready to be the new frontier of space medical imaging.Lerner D, Pohlen M, Wang A, Walter J, Cairnie M, Gifford S. X-ray imaging in the simulated microgravity environment of parabolic flight. Aerosp Med Hum Perform. 2023; 94(10):786-791.

A randomized clinical trial of alternative stress management interventions in persons with HIV infection.

Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of three 10-week stress management approaches--cognitive-behavioral relaxation training (RLXN), focused tai chi training (TCHI), and spiritual growth groups (SPRT)--in comparison to a wait-listed control group (CTRL) among 252 individuals with HIV infection. Using repeated measures mixed modeling, the authors found that in comparison to the CTRL group, (a) both the RLXN and TCHI groups used less emotion-focused coping, and (b) all treatment groups had augmented lymphocyte proliferative function. Despite modest effects of the interventions on psychosocial functioning, robust findings of improved immune function have important clinical implications, particularly for persons with immune-mediated illnesses.

Cytokine comparisons between women with breast cancer and women with a negative breast biopsy.

BACKGROUND: Understanding the biological milieu associated with disease states has important implications for biobehavioral research. Cytokines, signaling molecules that mediate and regulate immunity, inflammation, and hematopoiesis, are an important component of the biological milieu associated with breast cancer. Cytokines have been used as biomarkers in research for prognosis and have been associated with symptoms and adverse outcomes in multiple conditions, including breast cancer. To date, however, the examination of cytokine patterns has been limited by traditional laboratory methods. Advances in proteomic technology now permit the characterization of a broader array of cytokines in a single specimen. Because cytokines operate in integrated networks, a more complete understanding will be gained as multiple cytokines can be examined for patterns of response that may be associated with symptoms and prognosis. OBJECTIVES: To use proteomic technology (a) to examine whether there was a difference in cytokine levels and patterns in women with breast cancer compared with controls, (b) to define and compare the receiver operator characteristic curves for standard cytokine classifications, and (c) to identify the best-fitting empirical model of cytokines to distinguish groups of women found to have breast cancer from those with negative biopsies. METHODS: The cytokine levels of 35 women who had been diagnosed recently with breast cancer were compared with 24 women with a suspicious breast mass who were found subsequently to have a negative breast biopsy. Multiplex bead array assays permitted the simultaneous measure of multiple markers in a small volume of serum. Nonparametric procedures were used to determine differences in the median values and the distributions for each cytokine. The receiver operator characteristic curves were defined to identify patterns of cytokines. RESULTS: There were significantly higher systemic cytokine values in women with cancer in comparison with those in women without cancer for all cytokines measured, with the exception of granulocyte colony-stimulating factor and interferon-gamma. The only significant associations found between cytokines and age or race were increased levels of interleukin-8 (r = .53) and macrophage inflammatory protein-1 beta (r = .45) with increased age in women with a negative biopsy. Three cytokines (granulocyte colony-stimulating factor, interleukin-6, and interleukin-17) distinguished between the breast cancer and no-cancer groups with an exceptionally high areas under the curve (0.981; SE = 0.017). DISCUSSION: Levels of cytokines and their patterns were markedly different in women with breast cancer as compared with those in women who did not have breast cancer. Results from this study highlight the need for further research to examine the levels and patterns of cytokines that may serve as biomarkers in clinical research. Innovations in proteomic technology have implications for expanding biobehavioral research.

Implementing a comprehensive approach to the study of health dynamics using the psychoneuroimmunology paradigm.

This article addresses psychoneuroimmunology (PNI) as an integrative paradigm for advancing both theoretical and empirical knowledge of physiological patterns that contribute to the dynamics of health. We depict relationships among relevant psychobehavioral and physiological components in a PNI-based framework. We then provide examples of how this framework guided 2 clinical trials designed to assess the effectiveness of selected nursing interventions to reduce stress and enhance coping, one in persons with human immunodeficiency viral disease and the other in persons with cancer. The examples address disease-specific measures for assessing the components of the PNI-based framework.

Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer.

PURPOSE: Women with breast cancer may experience symptoms of depression, anxiety, pain, fatigue and sleep disturbances during chemotherapy. However, there are few modalities that address multiple, commonly occurring symptoms that may occur in individuals receiving cancer treatment. Cranial electrical stimulation (CES) is a treatment that is FDA cleared for depression, anxiety and insomnia. CES is applied via electrodes placed on the ear that deliver pulsed, low amplitude electrical current to the head. METHODS: This phase III randomized, sham-controlled study aimed to examine the effects of cranial microcurrent stimulation on symptoms of depression, anxiety, pain, fatigue, and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Patients were randomly assigned to either an actual or sham device and used the device daily for 1 h. The study was registered at clinicaltrials.gov, NCT00902330. RESULTS: The sample included N = 167 women with early-stage breast cancer. Symptom severity of depression, anxiety, and fatigue and sleep disturbances were generally mild to moderate. Levels of pain were low. Anxiety was highest prior to the initial chemotherapy and decreased over time. The primary outcome assessment (symptoms of depression, anxiety, fatigue, pain, sleep disturbances) revealed no statistically significant differences between the two groups, actual CES vs. sham. CONCLUSION: In this study, women receiving chemotherapy for breast cancer experienced multiple symptoms in the mild to moderate range. Although there is no evidence for the routine use of CES during the chemotherapy period for symptom management in women with breast cancer, further symptom management modalities should be evaluated to mitigate symptoms of depression, anxiety, fatigue, pain and sleep disturbances over the course of chemotherapy.

Psychoneuroimmunology-Based Stress Management during Adjuvant Chemotherapy for Early Breast Cancer.

Objective. In a randomized trial of women with early stage breast cancer undergoing adjuvant chemotherapy, two stress management interventions, tai chi training and spiritual growth groups, were compared to a usual care control group, to evaluate psychosocial functioning, quality of life (QOL), and biological markers thought to reflect cancer- and treatment-specific mechanisms. Method. The sample consisted of 145 women aged 27-75 years; 75% were Caucasian and 25% African American. A total of 109 participants completed the study, yielding a 75% retention rate. Grounded in a psychoneuroimmunology framework, the overarching hypothesis was that both interventions would reduce perceived stress, enhance QOL and psychosocial functioning, normalize levels of stress-related neuroendocrine mediators, and attenuate immunosuppression. Results. While interesting patterns were seen across the sample and over time, the interventions had no appreciable effects when delivered during the period of chemotherapy. Conclusions. Findings highlight the complex nature of biobehavioral interventions in relation to treatment trajectories and potential outcomes. Psychosocial interventions like these may lack sufficient power to overcome the psychosocial or physiological stress experienced during the chemotherapy treatment period. It may be that interventions requiring less activity and/or group attendance would have enhanced therapeutic effects, and more active interventions need to be tested prior to and following recovery from chemotherapy.

Challenges in interpreting cytokine biomarkers in biobehavioral research: a breast cancer exemplar.

PURPOSE: This report extends the findings of a prior study comparing the level of plasma cytokines in women with breast cancer to those of women with a benign breast biopsy with the addition of a normal comparison group. The results of this three-group comparison are presented as background for discussing several methodologic challenges for biobehavioral research in inflammatory-based conditions. METHOD: This study used a descriptive, cross-sectional design to compare the levels of plasma cytokines in women with breast cancer, women with a benign breast biopsy, and a normal comparison group. The levels of 17 cytokines were measured using multiplex bead array assays (Bio-Plex®). Data analysis included a variety of descriptive and graphical techniques to illustrate between-group differences in cytokine profiles. RESULTS: The levels of plasma cytokines in the sample of 35 women who had recently been diagnosed with breast cancer, 24 women with a suspicious breast mass, who subsequently were found to have a benign breast biopsy, and 33 women in a normal comparison group present a background for discussing the implications of extreme between-group differences for biobehavioral nursing research. Both the levels of individual cytokines and their patterns were distinctly different in the three groups. CONCLUSION: The exemplar presented from the three-group comparison has implications for planning biobehavioral nursing research in patients with conditions characterized by inflammation.

Tryptophan degradation in women with breast cancer: a pilot study.

BACKGROUND: Altered tryptophan metabolism and indoleamine 2,3-dioxygenase activity are linked to cancer development and progression. In addition, these biological factors have been associated with the development and severity of neuropsychiatric syndromes, including major depressive disorder. However, this biological mechanism associated with both poor disease outcomes and adverse neuropsychiatric symptoms has received little attention in women with breast cancer. Therefore, a pilot study was undertaken to compare levels of tryptophan and other proteins involved in tryptophan degradation in women with breast cancer to women without cancer, and secondarily, to examine levels in women with breast caner over the course of chemotherapy. FINDINGS: Blood samples were collected from women with a recent diagnosis of breast cancer (n = 33) before their first cycle of chemotherapy and after their last cycle of chemotherapy. The comparison group (n = 24) provided a blood sample prior to breast biopsy. Plasma concentrations of tryptophan, kynurenine, and tyrosine were determined. The kynurenine to tryptophan ratio (KYN/TRP) was used to estimate indoleamine 2,3-dioxygenase activity. On average, the women with breast cancer had lower levels of tryptophan, elevated levels of kynurenine and tyrosine and an increased KYN/TRP ratio compared to women without breast cancer. There was a statistically significant difference between the two groups in the KYN/TRP ratio (p = 0.036), which remained elevated in women with breast cancer throughout the treatment trajectory. CONCLUSIONS: The findings of this pilot study suggest that increased tryptophan degradation may occur in women with early-stage breast cancer. Given the multifactorial consequences of increased tryptophan degradation in cancer outcomes and neuropsychiatric symptom manifestation, this biological mechanism deserves broader attention in women with breast cancer.

Research on psychoneuroimmunology: tai chi as a stress management approach for individuals with HIV disease.

Psychoneuroimmunology is a framework for mind-body practice and research that combines cutting-edge scientific exploration with holistic philosophy to appreciate and understand stress responses. The rapidly growing research literature provides a foundation for building an integrative stress management model with the potential to positively influence the stress-disease relationship and, ultimately, health outcomes. This article introduces a novel tai chi intervention and provides quantitative and qualitative data from a randomized clinical trial indicating its effects on psychosocial variables in individuals living with various stages of HIV disease.