Potentially coercive self-citation by peer reviewers: a cross-sectional study.

OBJECTIVE: Peer reviewers sometimes request that authors cite their work, either appropriately or via coercive self-citation to highlight the reviewers' work. The objective of this study was to determine in peer reviews submitted to one biomedical journal (1) the extent of peer reviewer self-citation; (2) the proportion of reviews recommending revision or acceptance versus rejection that included reviewer self-citations; and (3) the proportion of reviewer self-citations versus citations to others that included a rationale. METHODS: Peer reviews for manuscripts submitted in 2012 to the Journal of Psychosomatic Research were evaluated. Data extraction was performed independently by two investigators. RESULTS: There were 616 peer reviews (526 reviewers; 276 manuscripts), of which 444 recommended revision or acceptance and 172 rejection. Of 428 total citations, there were 122 peer reviewer self-citations (29%) and 306 citations to others' work (71%). Self-citations were more common in reviews recommending revision or acceptance (105 of 316 citations; 33%) versus rejection (17/112; 15%; p<0.001). The percentage of self-citations with no rationale (26 of 122; 21%) was higher than for citations to others' work (15 of 306; 5%; p<0.001). CONCLUSIONS: Self-citation in peer reviews is common and may reflect a combination of appropriate citation to research that should be cited in published articles and inappropriate citation intended to highlight the work of the peer reviewer. Providing instructions to peer reviewers about self-citation and asking them to indicate when and why they have self-cited may help to limit self-citation to appropriate, constructive recommendations.

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.

Prevalence and clinical correlates of pruritus in patients with systemic sclerosis: an updated analysis of 959 patients.

OBJECTIVES: One previous study has estimated the prevalence of pruritus in SSc, but that study had important limitations due to a relatively small sample size. The present study updates the analyses of the previous study using a substantially larger patient sample. The objectives were to (i) document the proportion of patients who experience pruritus on most days overall and by disease duration and (ii) identify clinical correlates of pruritus. METHODS: Patients from the Canadian Scleroderma Research Group Registry ≥1 year after registry enrolment were asked on two consecutive annual visits whether they had experienced pruritus in the past month on most days and underwent clinical history and medical examination. Multiple logistic regression was used to assess the association between sociodemographic and clinical variables and pruritus. RESULTS: Among 959 patients, 42.6% reported pruritus. Of 693 patients with data for both visits, 333 (48%) did not report pruritus at either visit, 209 (30%) reported pruritus at both visits and 151 (22%) reported pruritus at one, but not the other, visit. The presence of pruritus was independently associated with greater skin involvement [odds ratio (OR) = 1.02, 95% CI 1.00, 1.04, P = 0.017] and greater gastrointestinal involvement (OR = 1.24, 95% CI 1.04, 1.48, P = 0.018). CONCLUSION: Pruritus is common in SSc across the course of the disease and has small but statistically significant associations with the degree of skin involvement and gastrointestinal system involvement.

Utility of the Patient Health Questionnaire-9 to assess suicide risk in patients with systemic sclerosis.

OBJECTIVE: Item 9 of the Patient Health Questionnaire-9 (PHQ-9), which inquires about both passive thoughts of death and active ideas of self-harm, has been used to assess suicide risk in arthritis. The objectives of this study were 1) to determine the proportion of systemic sclerosis (SSc; scleroderma) patients who responded "yes" to item 9 who endorsed active suicidal ideation in response to more direct questions during a structured clinical interview, and 2) to report whether the PHQ-8, which does not include item 9 from the PHQ-9, performs similarly to the PHQ-9. METHODS: Patients were recruited from the Canadian Scleroderma Research Group Registry. The PHQ-9 and Composite International Diagnostic Interview (CIDI) depression module were administered during a phone interview. Scores on the PHQ-8 were calculated by removing item 9 from the PHQ-9. Item 9 responses were compared to suicidal ideation and intent in the last year based on the CIDI. Scores on the PHQ-8 and PHQ-9 were compared using Pearson's correlations. RESULTS: There were 345 patients interviewed, of whom 31 (9.0%) endorsed item 9 of the PHQ-9. Of those, based on the CIDI, 14 (45.2%) had passive thoughts of suicide or death. Only 1 patient (3.2%) had thoughts about suicide in some detail at any point in the last 12 months. The correlation between PHQ-9 and PHQ-8 scores was 0.998. CONCLUSION: Item 9 appears to identify many patients who do not report active suicidal ideation. The PHQ-8 may be a better option for assessment of depressive symptoms than the PHQ-9 in patients with SSc.

Prevalence of current, 12-month and lifetime major depressive disorder among patients with systemic sclerosis.

OBJECTIVES: Patients with SSc experience a range of problems affecting their quality of life, but only one small study has assessed the prevalence of major depressive disorder (MDD) in SSc. The objectives of this study were: (i) to assess the prevalence of current (30-day), 12-month and lifetime MDD in a large sample of Canadian SSc patients; and (ii) to investigate socio-demographic and disease factors associated with 12-month MDD. METHODS: SSc patients were recruited from seven Canadian Scleroderma Research Group Registry sites (April 2009 to May 2012). MDD and history of a prior depression episode (major or minor) were assessed with the Composite International Diagnostic Interview. RESULTS: Among 345 patients, prevalence of 30-day, 12-month and lifetime MDD was 3.8% (95% CI 2.2%, 6.3%; n = 13), 10.7% (95% CI 7.9%, 14.4%; n = 37) and 22.9% (95% CI 18.8%, 27.6%; n = 79), respectively. Patients with 12-month MDD had more severe gastrointestinal track involvement than patients without 12-month MDD, but there were no other significant differences on socio-demographic or disease variables. Among patients with 12-month MDD, 81.1% (95% CI 65.8%, 90.3%) reported a prior depression episode compared with 3.9% (95% CI 2.2%, 6.7%) among patients without 12-month MDD (P < 0.01). CONCLUSION: The prevalence of 30-day, 12-month and lifetime MDD among Canadian SSc patients is approximately twice that of the Canadian general population and somewhat higher than in arthritis. SSc patients face a range of psychosocial problems and may benefit from a broad supportive care approach.

The PHQ-9 versus the PHQ-8--is item 9 useful for assessing suicide risk in coronary artery disease patients? Data from the Heart and Soul Study.

OBJECTIVE: Item 9 of the Patient Health Questionnaire-9 (PHQ-9), which inquires about both passive thoughts of death and active ideas of self-harm, has been used to assess suicide risk. The objectives of this study were (1) to determine the proportion of patients who responded "yes" to Item 9 who endorsed active suicidal ideation in response to more direct questions from a structured clinical interview and (2) to compare the sensitivity and specificity for detecting cases of depression of the PHQ-9 and the PHQ-8, which does not include Item 9, as well as the correlation between the PHQ-8 and PHQ-9. METHODS: Coronary artery disease (CAD) outpatients were administered the PHQ-9 and the Computerized Diagnostic Interview Schedule (C-DIS). Item 9 responses were compared to suicidal ideation and intent in the last year based on the C-DIS. Scores on the PHQ-8 were obtained by eliminating Item 9 from the PHQ-9. Test characteristics of the PHQ-9 and PHQ-8 were compared. RESULTS: Of 1022 patients, 110 (10.8%) endorsed Item 9. Of those, only 22 (19.8%) reported thoughts about committing suicide, and only 9 of those (8.1%) reported a suicide plan any time in the last year based on the C-DIS. Correlation between PHQ-9 and PHQ-8 scores was r=0.997. Sensitivity and specificity for the PHQ-9 (54%, 90%) and PHQ-8 (50%, 91%) to detect major depression were similar. CONCLUSION: Item 9 does not appear to be an accurate suicide screen. The PHQ-8 may be a better option than the PHQ-9 in CAD patients.

New directions for patient-centred care in scleroderma: the Scleroderma Patient-centred Intervention Network (SPIN).

Systemic sclerosis (SSc), or scleroderma, is a chronic multisystem autoimmune disorder characterised by thickening and fibrosis of the skin and by the involvement of internal organs such as the lungs, kidneys, gastrointestinal tract, and heart. Because there is no cure, feasibly-implemented and easily accessible evidence-based interventions to improve health-related quality of life (HRQoL) are needed. Due to a lack of evidence, however, specific recommendations have not been made regarding non-pharmacological interventions (e.g. behavioural/psychological, educational, physical/occupational therapy) to improve HRQoL in SSc. The Scleroderma Patient-centred Intervention Network (SPIN) was recently organised to address this gap. SPIN is comprised of patient representatives, clinicians, and researchers from Canada, the USA, and Europe. The goal of SPIN, as described in this article, is to develop, test, and disseminate a set of accessible interventions designed to complement standard care in order to improve HRQoL outcomes in SSc.

Clinical correlates of sleep problems in systemic sclerosis: the prominent role of pain.

OBJECTIVE: Problems with sleep are common in patients with SSc and impact daily function. Little research, however, has examined factors associated with sleep disruption in SSc. Therefore, the objective of this study was to investigate socio-demographic and medical factors associated with sleep disruption in SSc. METHODS: Cross-sectional study of 70 patients from one Canadian Scleroderma Research Group site who were assessed with a 100-mm sleep disruption visual analogue scale (VAS). Patients also completed measures of pain and depressive symptoms and underwent clinical histories and medical examinations. Pearson's correlations were used to assess bivariate association of socio-demographic and medical variables with sleep VAS scores. Multivariable associations of socio-demographic (Step 1) and medical (Step 2) variables with sleep VAS scores were assessed using hierarchical multiple linear regression. RESULTS: The mean (s.d.) sleep disruption VAS score was 38.5 (29.9). In bivariate analyses, sleep disruption was associated with marital status (r = -0.24, P = 0.042), smoking (r = 0.27, P = 0.025), gastrointestinal symptoms (r = 0.27, P = 0.023), breathing problems (r = 0.31, P = 0.009), pain (r = 0.53, P < 0.001) and symptoms of depression (r = 0.34, P = 0.004). In multivariate analysis, only marital status (standardized ß = -0.24, P = 0.049) and pain (standardized ß = 0.50, P < 0.001) were significantly associated with sleep disruption. CONCLUSION: Sleep disruption scores were as high in SSc as in RA and higher than in the general population. Pain was robustly associated with sleep disruption. Additional research is needed on sleep in SSc so that well-informed sleep interventions can be developed and tested.

Association of pruritus with quality of life and disability in systemic sclerosis.

OBJECTIVE: To our knowledge, no studies have investigated the association of pruritus, which is present in almost half of patients with systemic sclerosis (SSc; scleroderma), with quality of life (QOL) and disability. The objective of this study was to investigate the association of pruritus with QOL and disability in SSc. METHODS: We performed a cross-sectional, multicenter study of 578 SSc patients ≥1 year post-enrollment in the Canadian Scleroderma Research Group Registry. Patients reported whether they experienced pruritus during the past month on most days and underwent clinical histories and medical examinations. QOL was measured using the mental and physical component summary scores of the Short Form 36, and disability was measured with the Health Assessment Questionnaire disability index. The association of pruritus with QOL and disability was estimated using linear regression, controlling for sociodemographic and disease variables. RESULTS: A total of 248 patients (43%) reported pruritus on most days. Patients with pruritus had significantly worse mental (Hedges's g = -0.43; 95% confidence interval [95% CI] -0.59, -0.26) and physical function (Hedges's g = -0.51; 95% CI -0.68, -0.34) and greater disability (Hedges's g = 0.46; 95% CI 0.29, 0.63) than patients without pruritus. In multivariate analyses, controlling for age, sex, marital status, education, disease duration, skin score, number of tender joints, gastrointestinal symptoms, breathing problems, Raynaud's phenomenon, and finger ulcers, pruritus was independently associated with mental (P = 0.017) and physical function (P = 0.003), but not disability (P = 0.112). CONCLUSION: Pruritus is common and associated with QOL in SSc. More attention to pruritus in SSc is needed, including its measurement, etiology, trajectory, and potential methods for intervention.

Prevalence and clinical correlates of pruritus in patients with systemic sclerosis.

OBJECTIVE: There are no studies of pruritus prevalence or clinical correlates in systemic sclerosis (SSc). The objectives of this study were to document the proportion of SSc patients with pruritus on most days, to determine when in the course of the disease pruritus is most prevalent, and to identify clinical correlates. METHODS: We performed a cross-sectional, multicenter study of 400 SSc patients from the Canadian Scleroderma Research Group Registry > or =1 year after Registry enrollment. Patients indicated whether they experienced pruritus during the past month on most days and underwent clinical histories and medical examinations. Multiple logistic regression was used to assess the association between sociodemographic and clinical variables and pruritus. RESULTS: A total of 179 patients (45%) reported pruritus on most days, including 69% (11 of 16) among patients 1.0-1.9 years from onset of non-Raynaud's symptoms, 41% (38 of 93) for 2.0-4.9 years, 47% (44 of 94) for 5.0-9.9 years, 43% (60 of 140) for 10.0-19.9 years, and 46% (26 of 57) for > or =20 years. In post hoc analysis, patients 1.0-1.9 years from disease onset were significantly more likely to report pruritus (P = 0.049). Patients with pruritus had significantly more skin involvement (P = 0.029), more gastrointestinal (GI) symptoms (P < 0.001), worse breathing problems (P = 0.001), worse Raynaud's symptoms (P = 0.002), and more severe finger ulcers (P = 0.009). Only the number of GI symptoms predicted pruritus in multiple logistic regression analysis (odds ratio 1.25, 95% confidence interval 1.13-1.37; P < 0.001). CONCLUSION: Pruritus is common in SSc and is independently associated with GI symptoms. Focused research on sources of pruritus and its management in SSc is needed.