Sleep disturbances in systemic sclerosis: evidence for the role of gastrointestinal symptoms, pain and pruritus.

OBJECTIVE: SSc is a rare autoimmune CTD characterized by thickening and fibrosis of skin and internal organs. There is significant mortality and no cure. Sleep disturbance has been identified as an important contributor to poor quality of life. The objective was to investigate socio-demographic and medical factors potentially associated with sleep disturbance in SSc. METHODS: The sample consisted of patients from the Canadian Scleroderma Research Group's (CSRG) 15-centre, pan-Canadian Registry assessed with the 8-item Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance scale short form, version 1.0. Pearson's correlations were used to assess bivariate association of socio-demographic and medical variables with PROMIS sleep scores. The independent association of PROMIS sleep disturbance scores and factors previously identified as associated with sleep disturbance in the general population, in SSc and other rheumatic diseases, was assessed using multiple linear regression. RESULTS: Among 397 patients in the study (88% female, mean age 57.5 years), 25% (n = 98) had diffuse cutaneous SSc. Mean duration since onset of non-RP symptoms was 10.6 years. Number of gastrointestinal symptoms (standardized regression coefficient ß = 0.19, P = 0.001), pain severity (ß = 0.21, P < 0.001) and pruritus severity (ß = 0.13, P = 0.024) were independently associated with more severe sleep disturbance. CONCLUSION: Gastrointestinal symptoms, pain and pruritus were associated with sleep disturbance in SSc. Additional research is needed on sleep in SSc so that well-informed sleep interventions can be developed and tested.

Effects of screening for psychological distress on patient outcomes in cancer: a systematic review.

OBJECTIVE: Several practice guidelines recommend routine screening for psychological distress in cancer care. The objective was to evaluate the effect of screening cancer patients for psychological distress by assessing the (1) effectiveness of interventions to reduce distress among patients identified as distressed; and (2) effects of screening for distress on distress outcomes. METHODS: CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO, and SCOPUS databases were searched through April 6, 2011 with manual searches of 45 relevant journals, reference list review, citation tracking of included articles, and trial registry reviews through June 30, 2012. Articles in any language on cancer patients were included if they (1) compared treatment for patients with psychological distress to placebo or usual care in a randomized controlled trial (RCT); or (2) assessed the effect of screening on psychological distress in a RCT. RESULTS: There were 14 eligible RCTs for treatment of distress, and 1 RCT on the effects of screening on patient distress. Pharmacological, psychotherapy and collaborative care interventions generally reduced distress with small to moderate effects. One study investigated effects of screening for distress on psychological outcomes, and it found no improvement. CONCLUSION: Treatment studies reported modest improvement in distress symptoms, but only a single eligible study was found on the effects of screening cancer patients for distress, and distress did not improve in screened patients versus those receiving usual care. Because of the lack of evidence of beneficial effects of screening cancer patients for distress, it is premature to recommend or mandate implementation of routine screening.

Depression screening and patient outcomes in cancer: a systematic review.

BACKGROUND: Several practice guidelines recommend screening for depression in cancer care, but no systematic reviews have examined whether there is evidence that depression screening benefits cancer patients. The objective was to evaluate the potential benefits of depression screening in cancer patients by assessing the (1) accuracy of depression screening tools; (2) effectiveness of depression treatment; and (3) effect of depression screening, either alone or in the context of comprehensive depression care, on depression outcomes. METHODS: Data sources were CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO and SCOPUS databases through January 24, 2011; manual journal searches; reference lists; citation tracking; trial registry reviews. Articles on cancer patients were included if they (1) compared a depression screening instrument to a valid criterion for major depressive disorder (MDD); (2) compared depression treatment with placebo or usual care in a randomized controlled trial (RCT); (3) assessed the effect of screening on depression outcomes in a RCT. RESULTS: There were 19 studies of screening accuracy, 1 MDD treatment RCT, but no RCTs that investigated effects of screening on depression outcomes. Screening accuracy studies generally had small sample sizes (median = 17 depression cases) and used exploratory methods to set sample-specific cutoff scores that varied substantially across studies. A nurse-delivered intervention for MDD reduced depressive symptoms moderately (effect size = 0.37). CONCLUSIONS: The one treatment study reviewed reported modest improvement in depressive symptoms, but no evidence was found on whether or not depression screening in cancer patients, either alone or in the context of optimal depression care, improves depression outcomes compared to usual care. Depression screening in cancer should be evaluated in a RCT in which all patients identified as depressed, either through screening or via physician recognition and referral in a control group, have access to comprehensive depression care.

Reporting of conflicts of interest in meta-analyses of trials of pharmacological treatments.

CONTEXT: Disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships is sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals. Authors of meta-analyses, however, are not required to report COIs disclosed in original reports of included RCTs. OBJECTIVE: To investigate whether meta-analyses of pharmacological treatments published in high-impact biomedical journals report COIs disclosed in included RCTs. DATA SOURCES AND STUDY SELECTION: We selected the 3 most recent meta-analyses of patented pharmacological treatments published January 2009 through October 2009 in each general medicine journal with an impact factor of at least 10; in high-impact journals in each of the 5 specialty medicine areas with the greatest 2008 global therapeutic sales (oncology, cardiology, respiratory medicine, endocrinology, and gastroenterology); and in the Cochrane Database of Systematic Reviews. DATA EXTRACTION: Two investigators independently extracted data on disclosed study funding, author-industry financial ties, and author employment from each meta-analysis, from RCTs included in each meta-analysis, and on whether meta-analyses reported disclosed COIs of included RCTs. RESULTS: Of 29 meta-analyses reviewed, which included 509 RCTs, only 2 meta-analyses (7%) reported RCT funding sources; and 0 reported RCT author-industry ties or employment by the pharmaceutical industry. Of 318 meta-analyzed RCTs that reported funding sources, 219 (69%) were industry funded; and 91 of 132 (69%) that reported author financial disclosures had 1 or more authors with pharmaceutical industry financial ties. In 7 of the 29 meta-analyses reviewed, 100% of included RCTs had at least 1 form of disclosed COI (pharmaceutical industry funding, author-industry financial ties, or employment), yet only 1 of these 7 meta-analyses reported RCT funding sources, and 0 reported RCT author-industry ties or employment. CONCLUSION: Among a group of meta-analyses of pharmacological treatments published in high-impact biomedical journals, information concerning primary study funding and author COIs for the included RCTs were only rarely reported.

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.