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Existing data demonstrate reduced delta power during sleep in patients with depression and chronic pain. However, there has been little examination of the relationship between delta power and pain-reports, or pain-catastrophizing. We recruited female participants (n = 111) with insomnia and temporomandibular disorder, and measured nocturnal and daytime measures of pain and pain catastrophizing, and calculated relative nocturnal delta (0.5-4 Hz) power during sleep. We fit linear regression models, and further examined the moderating effect of depressive symptom severity. Lower relative delta power across the whole night was significantly associated with greater nocturnal pain (B = -20.276, P = .025, R

Introduction Existing data demonstrate reduced delta power during sleep in chronic pain and depressed patients. However, there has been little examination of the relationship between delta power and next-day reports of pain. We tested the extent to which nocturnal (during the concurrent sleep period) and daytime pain reports are associated with delta power during sleep, as well as the extent to which this association is moderated by depressive symptoms. We hypothesised that reduced delta power and SWS would be associated with increased pain, pain catastrophising, and pain sensitivity. Methods 149 female participants with insomnia and temporomandibular joint pain (TMD) were recruited. We examined nocturnal and daytime measures of pain (pain severity, average pain), pain catastrophizing, and objective pain sensitivity (obtained through quantitative sensory testing (QST)), and calculated relative nocturnal delta (0.5-3.4 Hz) power using polysomnography. We fit linear regression models correcting for depressive symptom severity, age, and total sleep time, and further examined the moderating effect of depression severity on these measures. Results reduced delta power was associated with increased average nocturnal pain (Unstandardized β = -17.67, p= 0.02), morning pain (Unstandardized β = -15.67, p=0.02), and average next-day pain (Unstandardized β = -16.74, p= 0.03). Depression severity did not moderate these relationships. Delta power was not significantly associated with objective pain-sensitivity, nocturnal, or daytime pain catastrophising. However the association between nocturnal pain catastrophising and delta power was moderated by depressive symptom severity (p = 0.04). Simple slopes analysis revealed that when participants had low depressive symptoms ( Discussion These findings demonstrate that delta power during sleep is associated with both nocturnal and daytime experience of pain in patients with TMD. In patients with TMD and low depressive symptoms, reduced delta power was associated with increased nocturnal pain catastrophising.

Introduction There is an established link between tinnitus (an auditory symptom affecting sound in the ear or head, in the absence of auditory stimulus) and depression in adults. However, there is a lack of research into the effect of tinnitus on sleep architecture in this depression. Methods Female participants (n=149) with sleep disturbance and temporomandibular joint (TMJD) pain were recruited as part of a treatment trial. Data were used to identify a cohort of participants with clinically significant depressive symptoms (CES-D >16), with and without tinnitus. We examined the pre-randomization polysomnography (PSG) dataset, and calculated sleep architecture, and relative spectral power (Alpha, beta, theta, delta). We compared cohorts using independent t-tests, testing for differences in architectural and spectral sleep parameters, controlling for anxiety symptoms. Results 14 females (mean age = 41.76) reporting current tinnitus were age and depression severity matched with 14 females reporting no tinnitus (mean age = 41.27). Groups did not differ significantly in age (p = 0.91), BMI (p = 0.868), race (p = 0.328) or severity of depressive symptoms (CES-D: 23.93 No tinnitus vs 25.07 Tinnitus, p = 0.540), but the tinnitus group reported significantly higher anxiety (GAD-7: 9.43 no tinnitus vs 13.36 Tinnitus, p = 0.016). Data indicated TMJD patients with tinnitus had greater N2 sleep percentage (24.243% no tinnitus vs 57.200% Tinnitus, p = 0.033) compared with controls. There were no significant differences in N1% (4.2% No tinnitus vs 3.7% Tinnitus, p = 0.874), SWS% (23.164% No tinnitus vs 17.236% Tinnitus, p = 0.217) or REM% (26.386% No Tinnitus vs 21.88% Tinnitus, p = 0.238) between groups. Analysis of spectral data showed no significant differences in relative alpha (0.129 No tinnitus, 0.143 Tinnitus, p = 0.099), beta (0.186 No tinnitus vs 0.188 Tinnitus, p = 0.814), theta (0.123 No Tinnitus vs 0.125 Tinnitus, p = 0.069), or delta power (0.360 Tinnitus vs 0.346 Tinnitus, p = 0.399). Conclusion Our results indicate an association between tinnitus and increased N2% in TMJD participants reporting sleep disturbance and depressive symptoms. The effect of tinnitus on objective sleep parameters, in the context of depressive symptoms warrants further study. Support (If Any) This research study was supported financially by the NIH Grant R01 DE019731 (Haythornthwaite, JA and Smith, MT).[MR1] [MR1]Don’t include this in the main body, it’ll use too many words. If there’s a section on the submission portal to include this, add it. If not can just put the grant reference (as one word) in brackets after “treatment trial”

Objective: We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a study describing the assessment and reporting AEs in clinical trials. Study Design and Setting: We examined 21 trials of gabapentin for neuropathic pain (52 sources) and seven trials of quetiapine for bipolar depression (80 sources) using data from the Multiple Data Sources study. We extracted and compared information about nonsystematic AEs (i.e., AEs that were not assessed for every participant), including AEs categorized as “serious.” We recorded whether AEs were grouped by anatomic or physiological system. Results: Trials of the same drug reported information about different AEs. Information in public sources was inadequate for decision-making. No public source reported all AEs, or all serious AEs, identified in nonpublic sources about the same trial. Of trials with only public sources, 2/15 (13%) gabapentin and 0/3 (0%) quetiapine trials grouped AEs by anatomic or physiological system. Conclusion: Public sources contained little information about nonsystematic AEs, including serious AEs. Grouping might make nonsystematic AEs easier to detect; however, most public sources did not report grouped AEs. Standards are needed to improve the collection and reporting of nonsystematic AEs so that stakeholders can use trials to assess the balance of potential benefits and harms.

Background Systematic reviews should provide trustworthy guidance to decision-makers, but their credibility is challenged by the selective reporting of trial results and outcomes. Some trials are not published, and even among clinical trials that are published partially (e.g., as conference abstracts), many are never published in full. Although there are many potential sources of published and unpublished data for systematic reviews, there are no established methods for choosing among multiple reports or data sources about the same trial. Methods We will conduct systematic reviews of the effectiveness and safety of two interventions following the Institute of Medicine (IOM) guidelines: (1) gabapentin for neuropathic pain and (2) quetiapine for bipolar depression. For the review of gabapentin, we will include adult participants with neuropathic pain who do not require ventilator support. For the review of quetiapine, we will include adult participants with acute bipolar depression (excluding mixed or rapid cycling episodes). We will compare these drugs (used alone or in combination with other interventions) with placebo or with the same intervention alone; direct comparisons with other medications will be excluded. For each review, we will conduct highly sensitive electronic searches, and the results of the searches will be assessed by two independent reviewers. Outcomes, study characteristics, and risk of bias ratings will be extracted from multiple reports by two individuals working independently, stored in a publicly available database (Systematic Review Data Repository) and analyzed using commonly available statistical software. In each review, we will conduct a series of meta-analyses using data from different sources to determine how the results are affected by the inclusion of data from multiple published sources (e.g., journal articles and conference abstracts) as well as unpublished aggregate data (e.g., “clinical study reports”) and individual participant data (IPD). We will identify patient-centered outcomes in each report and identify differences in the reporting of these outcomes across sources. Systematic review registration CRD42015014037, CRD42015014038

Systematic reviews should provide trustworthy guidance to decision-makers, but their credibility is challenged by the selective reporting of trial results and outcomes. Some trials are not published, and even among clinical trials that are published partially (e.g., as conference abstracts), many are never published in full. Although there are many potential sources of published and unpublished data for systematic reviews, there are no established methods for choosing among multiple reports or data sources about the same trial.We will conduct systematic reviews of the effectiveness and safety of two interventions following the Institute of Medicine (IOM) guidelines: (1) gabapentin for neuropathic pain and (2) quetiapine for bipolar depression. For the review of gabapentin, we will include adult participants with neuropathic pain who do not require ventilator support. For the review of quetiapine, we will include adult participants with acute bipolar depression (excluding mixed or rapid cycling episodes). We will compare these drugs (used alone or in combination with other interventions) with placebo or with the same intervention alone; direct comparisons with other medications will be excluded. For each review, we will conduct highly sensitive electronic searches, and the results of the searches will be assessed by two independent reviewers. Outcomes, study characteristics, and risk of bias ratings will be extracted from multiple reports by two individuals working independently, stored in a publicly available database (Systematic Review Data Repository) and analyzed using commonly available statistical software. In each review, we will conduct a series of meta-analyses using data from different sources to determine how the results are affected by the inclusion of data from multiple published sources (e.g., journal articles and conference abstracts) as well as unpublished aggregate data (e.g., "clinical study reports") and individual participant data (IPD). We will identify patient-centered outcomes in each report and identify differences in the reporting of these outcomes across sources.CRD42015014037 , CRD42015014038.

To assess disparities in the quality of healthcare provider communication experienced by African-American adults with and without sickle cell disease (SCD) in the U.S.Poor provider communication was assessed by the Provider Communication subscale of the Consumer Assessment of Healthcare Plans and Systems survey. The SCD sample was obtained from participants in a multicenter observational study of healthcare experiences. The national African-American sample data was obtained from published national estimates.The SCD sample was more likely than the national sample to report poor communication in 3 out of 4 communication domains: listening (22.3% vs. 11.5%, p0.0001); showing respect (26.1% vs. 9.5%, p0.0001); and spending enough time (38.3% vs. 16.2%, p0.0001). Differences were consistent in young, but not old, patients and showed some variation by self-reported health status and education.The communication difficulties experienced by persons with SCD do not appear reducible to their predominantly African-American race, but may result from more disease-specific factors.Healthcare providers should take particular care in recognizing and demonstrating recommended communication skills with SCD patients as these patients may be particularly vulnerable to, and cognizant of, poor quality interactions.

Adults with sickle cell disease (SCD) report experiencing discriminatory behavior from some healthcare providers. The impact of discrimination on health outcomes in SCD, including adherence to physician recommendations, is not known.Our aim was to evaluate the association between perceived discrimination from healthcare providers and nonadherence to physician recommendations among persons with SCD, and to test the potentially mediating role of patient trust.Patients with SCD (age 15 years and older) participating in the Improving Patient Outcomes with Respect and Trust (IMPORT) Study.Perceived discrimination from healthcare providers and reported adherence to physician recommendations were assessed by patient self-report using items from the 2001 Commonwealth Fund Health Survey. Interpersonal trust in medical professionals was assessed using the short form of the Wake Forest Trust in Medical Professionals instrument.We used a cross-sectional analysis of IMPORT participant data. Multivariable Poisson regression models were used to test the independent association of discrimination with adherence and to test patient trust as a potential mediator.Among 273 SCD patients with complete data on all variables of interest, patients reporting experiences of discrimination in the healthcare system were 53% more likely to also report being nonadherent to physician recommendations. Trust in medical professionals appeared to mediate the discrimination/nonadherence relationship, accounting for 50% of the excess prevalence of nonadherence among those experiencing discrimination.SCD patient perceptions of discriminatory experiences from healthcare providers are associated with greater nonadherence to physician recommendations, and may be a potential factor contributing to disparities in health and health quality among this patient population. Perceived discrimination appears to affect adherence behaviors through the pathway of patient trust. Improving relationships between healthcare providers and SCD patients may improve the trust that SCD patients have in medical professionals, which in turn may improve other outcomes among this underserved patient population.