Rina S. Fox

The Scleroderma Patient-centered Intervention Network (SPIN) Cohort: protocol for a cohort multiple randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitation interventions in a rare disease context

Introduction Psychosocial and rehabilitation interventions are increasingly used to attenuate disability and improve health-related quality of life (HRQL) in chronic diseases, but are typically not available for patients with rare diseases. Conducting rigorous, adequately powered trials of these interventions for patients with rare diseases is difficult. The Scleroderma Patient-centered Intervention Network (SPIN) is an international collaboration of patient organisations, clinicians and researchers. The aim of SPIN is to develop a research infrastructure to test accessible, low-cost self-guided online interventions to reduce disability and improve HRQL for people living with the rare disease systemic sclerosis (SSc or scleroderma). Once tested, effective interventions will be made accessible through patient organisations partnering with SPIN. Methods and analysis SPIN will employ the cohort multiple randomised controlled trial (cmRCT) design, in which patients consent to participate in a cohort for ongoing data collection. The aim is to recruit 1500–2000 patients from centres across the world within a period of 5 years (2013–2018). Eligible participants are persons ≥18 years of age with a diagnosis of SSc. In addition to baseline medical data, participants will complete patient-reported outcome measures every 3 months. Upon enrolment in the cohort, patients will consent to be contacted in the future to participate in intervention research and to allow their data to be used for comparison purposes for interventions tested with other cohort participants. Once interventions are developed, patients from the cohort will be randomly selected and offered interventions as part of pragmatic RCTs. Outcomes from patients offered interventions will be compared with outcomes from trial-eligible patients who are not offered the interventions. Ethics and dissemination The use of the cmRCT design, the development of self-guided online interventions and partnerships with patient organisations will allow SPIN to develop, rigourously test and effectively disseminate psychosocial and rehabilitation interventions for people with SSc.

Expressive writing interventions in cancer patients: a systematic review

Decades of research have suggested that expressive writing produces physical and psychological benefits in controlled laboratory experiments among healthy college students. This work has been extended to clinical and medical populations, including cancer patients. Although expressive writing could be a promising and inexpensive intervention for this population, the effects have not been systematically examined in oncology samples. A systematic review using PRISMA guidelines was conducted for experimental trials of cancer patients who participated in an expressive writing intervention. PsycINFO and PubMed/Medline were searched for peer-reviewed studies. Thirteen articles met the inclusion/exclusion criteria. Although the majority of the intervention effects were null, there were several main effects for expressive writing on sleep, pain, and general physical and psychological symptoms. Several moderators were identified, suggesting that expressive writing may be more or less beneficial based on individual characteristics such as social constraints. The reviewed studies were limited due to representativeness of the samples, performance, detection and patient-reported outcomes biases, and heterogeneity of the intervention protocol and writing prompts. Future studies with rigorous designs are needed to determine whether expressive writing is therapeutically effective in cancer patients.

Psychosocial Aspects of Scleroderma.

Patients with systemic sclerosis (SSc; also called scleroderma) have to cope with not only the physical impacts of the disease but also the emotional and social consequences of living with the condition. Because there is no cure for SSc, improving quality of life is a primary focus of treatment and an important clinical challenge. This article summarizes significant problems faced by patients with SSc, including depression, anxiety, fatigue, sleep disruption, pain, pruritus, body image dissatisfaction, and sexual dysfunction, and describes options to help patients cope with the consequences of the disease.

Psychosocial aspects of systemic sclerosis.

Purpose of reviewIn 2010, an international consortium of researchers published a consensus agenda for research on psychosocial aspects of systemic sclerosis (SSc; scleroderma). The present review summarizes recent research on SSc-related depression and anxiety, fatigue and sleep, pain, pruritus, body image distress, sexual function, work disability, healthcare needs, psychosocial interventions, and psychoneuroimmunology. Recent findingsResearchers have used structured interviews to establish prevalence rates for clinical mood disorders in SSc, although anxiety remains understudied and distress may be a useful outcome to consider. Longitudinal research has identified predictors of fatigue. Research on body image distress suggests the importance of changes in the facial skin and hands. Studies have identified sexual function problems in women and men with SSc. A prospective study found that breathing problems and fatigue predicted workplace disability. A randomized controlled trial evaluating multidisciplinary care showed benefits for health-related quality of life. SummaryThere has been a recent expansion in studies of psychosocial aspects of SSc, and in the validation of psychosocial measures that can be used in clinics to identify problems and track outcomes; however, prospective studies remain scarce. To better address the psychosocial needs of persons with SSc, interventions need to be developed and tested via randomized controlled trials with power to detect clinically meaningful changes.

Psychometric Evaluation of the Brief Acculturation Scale for Hispanics.

This study examined the psychometric properties of the Brief Acculturation Scale for Hispanics (BASH), a four-item, language-based measure of acculturation. Participants in the study were 435 Hispanic Americans from a large metropolitan area with English or Spanish language preference. Internal consistency reliability was strong in both language-preference groups. Multiple-group confirmatory factor analysis was used to evaluate the structural validity of the measure. A unidimensional factor structure was found for both English and Spanish language-preference groups and items loaded equivalently across groups, demonstrating measurement invariance. The BASH had good convergent validity and incremental validity. Overall, this study provides further evidence that the BASH offers a brief, reliable, and valid measure of acculturation to be used among Hispanic Americans.

The psychometric properties of the generalized anxiety disorder-7 scale in Hispanic Americans with English or Spanish language preference.

The Generalized Anxiety Disorder-7 scale (GAD-7) is a self-report questionnaire that is widely used to screen for anxiety. The GAD-7 has been translated into numerous languages, including Spanish. Previous studies evaluating the structural validity of the English and Spanish versions indicate a unidimensional factor structure in both languages. However, the psychometric properties of the Spanish language version have yet to be evaluated in samples outside of Spain, and the measure has not been tested for use among Hispanic Americans. This study evaluated the reliability, structural validity, and convergent validity of the English and Spanish language versions of the GAD-7 for Hispanic Americans in the United States. A community sample of 436 Hispanic Americans with an English (n = 210) or Spanish (n = 226) language preference completed the GAD-7. Multiple-group confirmatory factor analysis (CFA) was used to examine the goodness-of-fit of the unidimensional factor structure of the GAD-7 across language-preference groups. Results from the multiple-group CFA indicated a similar unidimensional factor structure with equivalent response patterns and item intercepts, but different variances, across language-preference groups. Internal consistency was good for both English and Spanish language-preference groups. The GAD-7 also evidenced good convergent validity as demonstrated by significant correlations in expected directions with the Perceived Stress Scale, the Patient Health Questionnaire-9, and the Physical Health domain of the World Health Organization Quality of Life-BREF assessment. The unidimensional GAD-7 is suitable for use among Hispanic Americans with an English or Spanish language preference.

Evaluation of the Satisfaction with Appearance Scale and Its Short Form in Systemic Sclerosis: Analysis from the UCLA Scleroderma Quality of Life Study

Objective. Changes in appearance are common in patients with systemic sclerosis (SSc) and can significantly affect well-being. The Satisfaction with Appearance Scale (SWAP) measures body image dissatisfaction in persons with visible disfigurement; the Brief-Satisfaction with Appearance Scale (Brief-SWAP) is its short form. The present study evaluated the reliability and validity of SWAP and Brief-SWAP scores in SSc. Methods. A sample of 207 patients with SSc participating in the University of California, Los Angeles Scleroderma Quality of Life Study completed the SWAP. Brief-SWAP scores were derived from the SWAP. The structural validity of both measures was investigated using confirmatory factor analysis. Internal consistency reliability of total and subscale scores was assessed with Cronbach’s alpha coefficients. Convergent and divergent validity was evaluated using the Center for Epidemiological Studies Depression Scale, the Health Assessment Questionnaire-Disability Index, and the Medical Outcomes Study Short Form-36 questionnaire. Results. SWAP and Brief-SWAP total scores were highly correlated (r = 0.97). The 4-factor structure of the SWAP fit well descriptively; the 2-factor structure of the Brief-SWAP fit well descriptively and statistically. Internal consistencies for total and subscale scores were good, and results supported convergent and divergent validity. Conclusion. Both versions are suitable for use in patients with SSc. The Brief-SWAP is most efficient; the full SWAP yields additional subscales that may be informative in understanding body image issues in patients with SSc.

Further Examining Berry’s Model: The Applicability of Latent Profile Analysis to Acculturation

This study used latent profile analysis (LPA) to identify acculturation profiles. A three-profile solution fit the data best, and comparisons on demographic and psychosocial outcomes as a function of profile yielded expected results. The findings support using LPA as a parsimonious way to model acculturation without anticipating profiles in advance.

Multidimensional profiles of health locus of control in Hispanic Americans.

Latent profile analysis identified health locus of control profiles among 436 Hispanic Americans who completed the Multidimensional Health Locus of Control scales. Results revealed four profiles: Internally Oriented-Weak, -Moderate, -Strong, and Externally Oriented. The profile groups were compared on sociocultural and demographic characteristics, health beliefs and behaviors, and physical and mental health outcomes. The Internally Oriented-Strong group had less cancer fatalism, religiosity, and equity health attributions, and more alcohol consumption than the other three groups; the Externally Oriented group had stronger equity health attributions and less alcohol consumption. Deriving multidimensional health locus of control profiles through latent profile analysis allows examination of the relationships of health locus of control subtypes to health variables.

Multiple Group Confirmatory Factor Analysis of the DASS-21 Depression and Anxiety Scales: How Do They Perform in a Cancer Sample?:

The DASS-21 is a public domain instrument that is commonly used to evaluate depression and anxiety in psychiatric and community populations; however, the factor structure of the measure has not previously been examined in oncologic settings. Given that the psychometric properties of measures of distress may be compromised in the context of symptoms related to cancer and its treatment, the present study evaluated the psychometric properties of the DASS-21 Depression and Anxiety scales in cancer patients (n = 376) as compared to noncancer control participants (n = 207). Cancer patients ranged in age from 21 to 84 years (mean = 58.3, standard deviation = 10.4) and noncancer control participants ranged in age from 18 to 81 years (mean = 45.0, standard deviation = 11.7). Multiple group confirmatory factor analysis supported the structural invariance of the DASS-21 Depression and Anxiety scales across groups; the factor variance/covariance invariance model was the best fit to the data. Cronbach’s coefficient alpha values demonstrated acceptable internal consistency reliability across the total sample as well as within subgroups of cancer patients and noncancer control participants. Expected relationships of DASS-21 Depression and Anxiety scale scores to measures of suicidal ideation, quality of life, self-rated health, and depressed mood supported construct validity. These results support the psychometric properties of the DASS-21 Depression and Anxiety scales when measuring psychological distress in cancer patients.