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OBJECTIVE: To determine, only for those who improved, the rate per day of improvement expected for outpatients with low back pain and to identify factors influencing pain improvement: pain duration before assessment, pain and physical functioning levels before assessment, age, sex, and affective factors. It was presupposed that affective factors would have an appreciable effect. DESIGN: The LIFEware System database was used. Analysis was performed on 1292 records for the Painfree measure and 1562 records for the LIFEware System Visual Analog Scale. Measures for pain, physical functioning, and affective well-being were analyzed for 0-30 days vs. >30 days of pain duration before assessment using classification and regression trees analysis. RESULTS: In both Painfree and LIFEware System Visual Analog Scale, 73% improved and 27% did not improve. Of those who improved, outpatients with 0-30 days of pain duration before assessment had higher per day rates of improvement than the >30 days group. Factors affecting improvement were, in descending order, more initial pain, younger age, and positive affective well-being; physical functioning did not affect rate of improvement. Factors affecting improvement for outpatients with >30 days since onset were, in descending order, more initial pain and better initial physical functioning; age and affective well-being were not factors. For all, neither sex nor the 'satisfaction with life in general' question affected low back pain rate of improvement. CONCLUSION: Findings may be useful for clinical application because the actual rate of improvement may be compared with the expected rate. There was only a weak relationship shown between affective factors and pain improvement. [ABSTRACT FROM AUTHOR]

Goals: To identify potential mechanisms by which childhood trauma may lead to the adult development of abdominal symptoms in patients with irritable bowel syndrome (IBS)., Background: Patients with IBS frequently report a history of childhood trauma. The pathophysiology by which abdominal pain arises in patients with IBS is multidimensional, consisting of both peripheral factors, such as altered motility, inflammation, and bacterial overgrowth, as well as central factors, such as psychological distress and neuro-hormonal dysregulation., Study: Adult psychological factors (anxiety, depression, and somatization) were examined to determine if they mediate the relationship between retrospective reports of childhood trauma and current adult IBS abdominal symptoms in a study of 436 patients (M age=41.6, 79% F) meeting Rome III diagnosis criteria. Childhood trauma was measured using retrospective questions assessing physical and sexual abuse. Psychological factors in adulthood were measured with the subscales of the Brief Symptom Inventory-18. Outcome variables included adult IBS symptoms of abdominal pain, bloating, and satisfaction with bowel habits from the IBS Symptoms Severity Scale., Results: Results indicated that somatization mediated the relationship between childhood abuse and abdominal pain and bloating but not bowel satisfaction., Conclusions: This study provides insight into the multifactorial nature of IBS-associated abdominal pain in patients with a history of childhood trauma, elucidating the need for a trauma-informed treatment approach for patients with histories of abuse., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The role of nonspecific factors, such as treatment credibility, treatment expectancy, and symptom expectancy, may shape the outcomes of the nonoperative treatment of degenerative meniscal tears (DMTs)., Purpose/hypothesis: The purpose of this study was to characterize treatment credibility and expectancy, symptom expectancy, and patient and clinical correlates of these factors among participants before undergoing 4 nonoperative treatment programs for DMTs. It was hypothesized that (1) treatment credibility scores would be similar across patient and baseline clinical subgroups and (2) treatment expectancy and symptom expectancy scores would be lower in older patients and among those reporting a longer pain duration or greater pain intensity., Study Design: Cohort study; Level of evidence, 3., Methods: In 126 participants, validated scales were administered before treatment to assess the credibility of the assigned treatment (possible score of 1-9) as well as the expectations of treatment outcomes (0-100) and symptom improvement (1-5). Patient and clinical characteristics associated with these variables were examined., Results: On average, participants (mean age, 58 years [range, 45-75 years]; 51% female; 94% White) expected the treatment to improve their symptoms by a mean of 68% and expected their symptoms to be "very likely" to improve. Participants with a body mass index (BMI) ≥30 kg/m 2 had lower mean treatment credibility (6.09 ± 1.81) and treatment expectancy (64.53 ± 25.16) scores on bivariate analyses than those with a BMI <30 kg/m 2 (6.73 ± 1.69 [ P = .045] and 72.86 ± 19.20 [ P = .039], respectively). Participants reporting a pain duration ≥3 months also had lower mean treatment expectancy (63.85 ± 23.83) and symptom expectancy (3.70 ± 0.85) scores compared to those reporting a pain duration <3 months (75.52 ± 18.93 [ P = .003] and 4.16 ± 0.67 [ P = .001], respectively)., Conclusion: Most patients about to undergo physical therapy for DMTs considered it to be between "somewhat" and "very" credible and believed that their symptoms, on average, were "very likely" to improve. Although not supported by most evidence, patients with a BMI ≥30 kg/m 2 believed physical therapy to be less credible and had lower treatment and symptom expectations, and those with symptoms present for ≥3 months had lower treatment and symptom expectations as well. Whether these nonspecific factors influence outcomes should be considered for further research., Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: This study was partially funded by the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant No. U01AR071658; principal investigator: J.N.K.). L.J.B. has received hospitality payments from Arthrex. J.N.K. has received honoraria from Pfizer. K.B.F. has received education payments from Pinnacle and Medical Device Business Services. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto., (© The Author(s) 2024.)

Background & Aims: Some brain-gut behavioral treatments (BGBTs) are beneficial for global symptoms in irritable bowel syndrome (IBS). United States management guidelines suggest their use in patients with persistent abdominal pain, but their specific effect on this symptom has not been assessed systematically., Methods: We searched the literature through December 16, 2023, for randomized controlled trials (RCTs) assessing efficacy of BGBTs for adults with IBS, compared with each other or a control intervention. Trials provided an assessment of abdominal pain resolution or improvement at treatment completion. We extracted data as intention-to-treat analyses, assuming dropouts to be treatment failures and reporting pooled relative risks (RRs) of abdominal pain not improving with 95% confidence intervals (CIs), ranking therapies according to the P score., Results: We identified 42 eligible randomized controlled trials comprising 5220 participants. After treatment completion, the BGBTs with the largest numbers of trials and patients recruited demonstrating efficacy for abdominal pain, specifically, included self-guided/minimal contact cognitive behavioral therapy (CBT) (RR, 0.71; 95% CI, 0.54-0.95; P score, 0.58), face-to-face multicomponent behavioral therapy (RR, 0.72; 95% CI, 0.54-0.97; P score, 0.56), and face-to-face gut-directed hypnotherapy (RR, 0.77; 95% CI, 0.61-0.96; P score, 0.49). Among trials recruiting only patients with refractory global IBS symptoms, group CBT was more efficacious than routine care for abdominal pain, but no other significant differences were detected. No trials were low risk of bias across all domains, and there was evidence of funnel plot asymmetry., Conclusions: Several BGBTs, including self-guided/minimal contact CBT, face-to-face multicomponent behavioral therapy, and face-to-face gut-directed hypnotherapy may be efficacious for abdominal pain in IBS, although none was superior to another., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

One of the greatest challenges worldwide is containing the spread of problematic microorganisms. A promising approach is the use of antimicrobial coatings (AMCs). The antimicrobial potential of certain metals, including copper and zinc, has already been verified. In this study, polyethylene terephthalate and aluminum (PET-Al) foils were coated with copper, zinc, and a combination of these two metals, known as core-shell particles, respectively. The resistance of the three different types of coatings to mechanical and chemical exposure was evaluated in various ways. Further, the bacteria Staphylococcus aureus and the bacteriophage ϕ6 were used to assess the antimicrobial efficacy of the coatings. The best efficacy was achieved with the pure copper coating, which was not convincing in the abrasion tests. The result was a considerable loss of copper particles on the surfaces and reduced effectiveness against the microorganisms. The core-shell particles demonstrated better adhesion to the surfaces after abrasion tests and against most chemical agents. In addition, the antimicrobial efficiency remained more stable after the washability treatment. Thus, the core-shell particles had several benefits over the pure copper and zinc coatings. In addition, the best core-shell loading for durability and efficacy was determined in this study.

Long-term placement of facial implants requires avoiding the formation of fibrous tissue capsules around the artificial material by creating osteoconductive properties of the surface. Most promising approach is the deposition coatings made of materials very similar to bone mineral components, that is, calcium phosphates such as hydroxyapatite (HAp). As part of the research work, an innovative, cost-effective atmospheric pressure plasma deposition (APPD) system was used as a low-temperature coating technology for generating the HAp coatings deposition. Full microstructural characterisation of the coatings using SEM and TEM techniques was carried out in the work. It has been shown that the fully crystalline HAp powder undergoes a transformation during the coatings deposition and the material had a quasi-sintered structure after deposition. The crystalline phase content increased at the coating/substrate interface, while the surface of the HAp was amorphous. This is a very beneficial phenomenon due to the process of bioresorption. The amorphous phase undergoes much faster biodegradation than the crystalline one. In order to increase the bioactivity of the HAp, Zn particles were introduced on the surface of the coating. The TEM microstructural analysis in conjunction with the qualitative analysis of the EDS chemical composition showed that the binding of the Zn particles within the HAp matrix had diffusive character, which is very favourable from the point of view of the quality of the adhesion and the bioactivity of the coating. In the case of such a complex structure and due to its very porous nature, micromechanical analysis was carried out in situ in SEM, that is, by microhardness measurements of both the HAp matrix and the Zn particle. It was shown that the average value of HAp microhardness was 4.395 GPa ± 0.08, while the average value of Zn microhardness was 1.142 GPa ± 0.02., (© 2024 Royal Microscopical Society.)

Introduction: Latino individuals are underrepresented in the disorders of the gut-brain interaction (DGBI) literature, and no work has explored how disorders of the gut-brain interaction affect health and well-being in this group., Methods: This study sought to explore how disorders of the gut-brain interaction affect health factors in a sample of Latino individuals (N = 292; 80.80% female; M age = 37.65 years, SD = 11.98) with (n = 60) and without (n = 232) a disorder of the gut-brain interaction based on current Rome Foundation diagnostic criteria (Rome IV)., Results: DGBI was associated with increased pain intensity, pain disability, cardiovascular risk, depressive symptoms, and anxiety/panic symptoms and lower physical health-related quality of life and mental health-related quality of life controlling for age, sex, and nativity., Discussion: Better understanding mental health and treatment-seeking behaviors among Latino individuals may help clinical gastroenterologists engage their Latino patients to a greater extent and thus provide higher quality of care., (Copyright © 2023 by The American College of Gastroenterology.)

Purpose: Urologic chronic pelvic pain syndrome (UCPPS), which encompasses interstitial cystitis/bladder pain syndrome in women and men and chronic prostatitis/chronic pelvic pain syndrome in men, is a common, often disabling urological disorder that is neither well understood nor satisfactorily treated with medical treatments. The past 25 years have seen the development and validation of a number of behavioral pain treatments, of which cognitive behavioral therapy (CBT) is arguably the most effective. CBT combines strategies of behavior therapy, which teaches patients more effective ways of behaving, and cognitive therapy, which focuses on correcting faulty thinking patterns. As a skills-based treatment, CBT emphasizes "unlearning" maladaptive behaviors and thoughts, and replacing them with more adaptive ones that support symptom self-management., Materials and Methods: This review describes the rationale, technical procedures, and empirical basis of CBT., Results: While evidence supports CBT for treatment-refractory chronic pain disorders, there is limited understanding of why or how CBT might work, for whom it is most beneficial, or the specific UCPPS symptoms (eg, pain, urinary symptoms) it effectively targets. This is the focus of EPPIC (Easing Pelvic Pain Interventions Clinical Research Program), a landmark NIH trial examining the efficacy of low-intensity, home-based CBT for UCPPS relative to a nonspecific comparator featuring self-care recommendations of AUA guidelines., Conclusions: Systematic efforts to increase both the efficiency of CBT and the way it is delivered (eg, home-based treatments) are critical to scaling up CBT, optimizing its therapeutic potential, and reducing the public health burden of UCPPS.

The aim of the experiment was to evaluate the biocompatibility of four 3D-printed biomaterials planned for use in the surgical treatment of finger amputees: Ti-6Al-4 V (Ti64), ZrO 2 -Al 2 O 3 ceramic material (ATZ20), and osteoconductive (anodized Ti64) and antibacterial (Hydroxyapatite, HAp) coatings that adhere well to materials dedicated to finger bone implants. The work concerns the correlation of mechanical, microstructural, and biological properties of dedicated materials. Biological tests consisted of determining the overall cytotoxicity of the organism on the basis of in vivo tests carried out in accordance with the ISO 10993-6 and ISO 10993-11 standards. Clinical observations followed by diagnostic examinations, histopathological evaluation, and biochemical characterization showed no significant differences between control and tested groups of animals. The wound healed without complication, and no pathological effects were found. The wear test showed the fragility of the hydroxyapatite thin layer and the mechanical stability of the zirconia-based ceramic substrate. Electron microscopy observations revealed the layered structure of tested substrates and coatings.

Background and Aims: Placebo response impedes the development of novel irritable bowel syndrome (IBS) therapies and the interpretability of randomized clinical trials. This study sought to characterize the magnitude, timing, and durability of IBS symptom relief in patients undergoing a non-drug placebo-like control., Methods: One hundred forty-five Rome III-diagnosed patients (80% F, M age = 42 years) were assigned to education/nondirective support delivered over a 10-week acute phase. Treatment response was based on the IBS version of the Clinical Global Improvement Scale completed 2 weeks after treatment ended. Candidate predictors were assessed at baseline (eg, emotion regulation, pain catastrophizing, distress, neuroticism, stress, somatization, gastrointestinal-specific anxiety) or clinically relevant points during treatment (patient-provider relationship, treatment expectancy/credibility)., Results: Midtreatment response was associated with lower levels of stress and somatization at baseline and greater patient-provider agreement on treatment tasks ( P < .001). Treatment response was associated with baseline gastroenterologist-rated IBS severity, anxiety, ability to reappraise emotions to reduce their impact [cognitive reappraisal], and agreement that provider and patient shared goals from provider perspective ( P < .001). The day-to-day ability to reappraise emotions at baseline distinguished rapid from delayed placebo responders ( P = .011)., Conclusion: Patient beliefs (eg, perceived stress, cognitive reappraisal) impacted the magnitude, timing, and persistence of placebo response measured at midway point of acute phase and 2 weeks after treatment discontinuation. Baseline beliefs that patients could alter the impact of stressful events by rethinking their unpleasantness distinguished rapid vs delayed placebo responders. Collaborative agreement between doctor and patient around shared tasks/goals from the clinician perspective predicted placebo response., Competing Interests: Conflicts of Interest: The authors disclose no conflicts.

The versatility of sol-gel systems makes them ideal for functional coatings in industry. However, existing coatings are either too thin or take too long to cure. To address these issues, this paper proposes using an atmospheric pressure plasma source to fully cure and functionalize thicker sol-gel coatings in a single step. The study explores coating various substrates with sol-gel layers to make them scratch-resistant, antibacterial, and antiadhesive. Microparticles like copper, zinc, or copper flakes are added to achieve antibacterial effects. The sol-gel system can be sprayed on and quickly functionalized on the substrate. The study focuses on introducing and anchoring particles in the sol-gel layer to achieve an excellent antibacterial effect by changing the penetration depth. Overall, this method offers a more efficient and effective approach to sol-gel coatings for industrial applications. In order to achieve a layer thickness of more than 100 µm, the second part of the study proposes a multilayer system comprising 15 to 30 µm thick monolayers that can be modified by introducing fillers (such as TiO 2 ) or scratch-resistant chemicals like titanium isopropoxide. This system also allows for individual plasma functionalization of each sol-gel layer. For instance, the top layer can be introduced with antibacterial particles, while another layer can be enhanced with fillers to increase wear resistance. The study reveals the varying antibacterial effects of spherical particles versus flat flakes and the different scratch hardnesses induced by changes in pH, number of layers, and particle introduction.

Irritable bowel syndrome (IBS) is the most common gastrointestinal (GI) condition treated by GI and primary care physicians. Although IBS symptoms (abdominal pain, bowel problems) are generally refractory to medical therapies, consistent research has shown that they improve following cognitive-behavioral therapy (CBT). Notwithstanding empirical support for CBT, there is less research explicating the reasons for why or how it works. Like other pain disorders, the focus on change mechanisms for behavioral pain treatments has focused on pain-specific cognitive-affective processes that modulate pain experience, few of which are more important than pain catastrophizing (PC). The fact that PC changes are seen across treatments of differing theoretical and technical orientation, including CBT, yoga, and physical therapy, suggests that it may be a nonspecific (vs. theory-based) change mechanism akin to therapeutic alliance and treatment expectancy. Therefore, the current study examined change in PC as a concurrent mediator of IBS symptoms severity, global GI symptom improvement, and quality of life among 436 Rome III-diagnosed IBS patients enrolled in a clinical trial undergoing two dosages of CBT versus a nonspecific comparator emphasizing education and support. Results from structural equation modeling parallel process mediation analyses suggest that reduction in PC during treatment are significantly associated with improvement in IBS clinical outcomes through 3-month follow-up. Results from the current study provide evidence that PC may be an important, albeit nonspecific change mechanism, during CBT for IBS. Overall, reducing the emotional unpleasantness of pain through cognitive processes is associated with improved outcomes for IBS., (Copyright © 2023 Association for Behavioral and Cognitive Therapies. Published by Elsevier Ltd. All rights reserved.)

Background: Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that is thought to involve alterations in the gut microbiome, but robust microbial signatures have been challenging to identify. As prior studies have primarily focused on composition, we hypothesized that multi-omics assessment of microbial function incorporating both metatranscriptomics and metabolomics would further delineate microbial profiles of IBS and its subtypes., Methods: Fecal samples were collected from a racially/ethnically diverse cohort of 495 subjects, including 318 IBS patients and 177 healthy controls, for analysis by 16S rRNA gene sequencing (n = 486), metatranscriptomics (n = 327), and untargeted metabolomics (n = 368). Differentially abundant microbes, predicted genes, transcripts, and metabolites in IBS were identified by multivariate models incorporating age, sex, race/ethnicity, BMI, diet, and HAD-Anxiety. Inter-omic functional relationships were assessed by transcript/gene ratios and microbial metabolic modeling. Differential features were used to construct random forests classifiers., Results: IBS was associated with global alterations in microbiome composition by 16S rRNA sequencing and metatranscriptomics, and in microbiome function by predicted metagenomics, metatranscriptomics, and metabolomics. After adjusting for age, sex, race/ethnicity, BMI, diet, and anxiety, IBS was associated with differential abundance of bacterial taxa such as Bacteroides dorei; metabolites including increased tyramine and decreased gentisate and hydrocinnamate; and transcripts related to fructooligosaccharide and polyol utilization. IBS further showed transcriptional upregulation of enzymes involved in fructose and glucan metabolism as well as the succinate pathway of carbohydrate fermentation. A multi-omics classifier for IBS had significantly higher accuracy (AUC 0.82) than classifiers using individual datasets. Diarrhea-predominant IBS (IBS-D) demonstrated shifts in the metatranscriptome and metabolome including increased bile acids, polyamines, succinate pathway intermediates (malate, fumarate), and transcripts involved in fructose, mannose, and polyol metabolism compared to constipation-predominant IBS (IBS-C). A classifier incorporating metabolites and gene-normalized transcripts differentiated IBS-D from IBS-C with high accuracy (AUC 0.86)., Conclusions: IBS is characterized by a multi-omics microbial signature indicating increased capacity to utilize fermentable carbohydrates-consistent with the clinical benefit of diets restricting this energy source-that also includes multiple previously unrecognized metabolites and metabolic pathways. These findings support the need for integrative assessment of microbial function to investigate the microbiome in IBS and identify novel microbiome-related therapeutic targets. Video Abstract., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Introduction: Medication nonadherence in patients with ulcerative colitis (UC) can result in frequent relapses, severe disease, and higher risk of colorectal cancer. Behavioral models relying on motivation and perceived competence, like the self-determination theory (SDT), have been implicated in nonadherence; however, the SDT has not been evaluated in the adult UC population. We sought to examine the association between adherence to oral medications in patients with UC and psychological distress, relationship with health care providers, motivation, and competence., Methods: We performed a cross-sectional study within the Inflammatory Bowel Disease (IBD) Partners online registry in which participants completed a baseline survey including demographic information, IBD history, symptoms, medication adherence, and psychosocial factors. Members of the registry with a diagnosis of UC received an online follow-up survey that included baseline questionnaires and assessment of competence, motivation, and patient-physician relationship. Logistic regression models were performed to determine the relationship between psychosocial factors, adherence modifiers, and medication adherence., Results: Of the 410 UC patients included, 29% had low adherence to their medications, 36% had medium adherence, and 34% had high adherence. In the multivariable analysis, younger patients, those with a lower perceived competence, and those with worse relationship with their providers were more likely to have lower adherence to their medications., Conclusions: Poor adherence to oral medications in UC was associated with lower perceived competence and worse relationship with providers. Further interventions based on the SDT can potentially improve adherence and optimize patient care., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: The research was focused on determining basic mechanical properties, surface, and phase structure taking into consideration basic cytotoxicity analysis towards human cells., Methods: Biological tests were performed on human C-12302 fibroblasts cells using 3D-printed Ti6Al4V alloy (Ti64), produced by laser-based powder bed fusion (LB-PBF) and Alumina Toughened Zirconia 20 (ATZ20), produced by lithography-based ceramic manufacturing (LCM). Surface modifications included electropolishing and hydroxyapatite or hydroxyapatite/zinc coating. Structure analysis was carried out using a variety of techniques such as X-Ray diffraction, scanning electron microscopy (SEM), transmission electron microscopy (TEM) and confocal laser scanning microscopy (CLSM), followed by mechanical properties evaluation using nanoindentation testing., Results: Samples subjected to surface modifications showed diversity among surface and phase structure and mechanical properties. However, the cytotoxicity towards tested cells was not significantly higher than the control. Though, a trend was noted among the materials analysed, indicating that HAp/Zn coating on Ti64 and ATZ20 resulted in the best biological performance increasing cell survivability by more than 10%., Conclusions: Hydroxyapatite coating on Ti64 and ATZ20 resulted in the best biological properties. Tested materials are suitable for in vivo toxicity testin.

As a result of loading with an external force during the wear process, coating deforms uniformly. After a certain limit load is exceeded, coating deformation is localised through the formation of the so-called shear bands. It has been showed experimentally the process of shear bands formation. The microstructural characterisation before and after the mechanical tests was performed using scanning and transmission electron microscopy (SEM and TEM) on cross-sections of the samples. The analysis indicated that in the case of multilayer coatings where the ratio of the metallic to the ceramic phase is 1:1, the shear bands are formed at an angle of 45°. With a greater proportion of the ceramic phase to metallic (ratio 1:2), the shear band changed the shear angle from ∼45° to ∼90°. Mechanical in situ tests were carried out in the chambers of SEM and TEM. The scratch tests in the SEM were done with the simultaneous observation of the phenomena occurring on the surface of the tested materials showed that at a scratch force of 0.04 N, the additional outer a-C:H layer was damaged, which was shown in the form of a fault in the force-displacement diagram, and in the form of splits visible in the SEM image. However, the application of this additional layer had a positive effect on the wear mechanism of the entire coating structure. The test also indicated that in the case of coatings with phases ratio 1:2 and 1:4 (metallic to ceramic), the characteristics of the brittle material were demonstrated, unlike the coating with a 1:1 phase ratio, where plastic properties predominated. However, for the 1:2 phase ratio coating, the chip was more ductile than for the chip formed when testing a 1:4 phase ratio coating. For in situ mechanical testing in the TEM, a straining holder was used. The test showed that the shear band angle for a 1:1 ratio coating has changed from 45° to 90° due to the different direction of force interaction., (© 2022 Royal Microscopical Society.)

The research was focused on alternative treatment techniques, separating immediate and long-term reconstruction stages. The work involved development of ceramic materials dedicated to reconstruction of the temporomandibular joint area. They were based on alumina (aluminum oxide) and characterized by varying porosities. A broad spectrum of studies was conducted to test the proposed material and determine its suitability for mandibular reconstruction. They compared the effects of substrate properties of ceramic materials in terms of biocompatibility, microbiology and systemic toxicity in in vivo studies. Finally it was concluded that Alumina LithaLox 350D is best suited for jawbone implants., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Atrial fibrillation (AF), the most common abnormal heart rhythm, places a considerable burden on patients, providers, and the US healthcare system., Objective: The purpose of this qualitative study was to compare patients' and providers' interpretations and responses to AF symptoms and to identify where treatment can be improved to better address patient needs and well-being., Design: Qualitative design using focus groups with patients (3 groups) and providers (3 groups)., Participants: Patients with physician-confirmed AF (n=29) and cardiologists, primary care physicians, and cardiac nurses (n=24)., Approach: Focus groups elicited patient and provider perspectives regarding the symptom experience of AF, treatment goals, and gaps in care. Patient and provider transcripts were analyzed separately, using a thematic content analysis approach, and then compared., Key Results: While patients and providers described similar AF symptoms, patients' illness experiences included a wider range of symptoms that elicited anxiety and impacted quality of life (QOL) across many biopsychosocial domains. Patients and providers prioritized different treatment goals. Providers tended to focus on controlling symptoms congruent with objective findings, minimizing stroke risk, and restoring sinus rhythm. Patients focused on improving QOL by reducing medication use or procedures. Both patients and providers struggled with patients' cardiac-related anxiety. Patients expressed an unmet need for education and support., Conclusion: Patients with AF experience a range of symptoms and QOL issues. While guidelines recommend shared-decision making, discordance between patient and provider perspectives on the importance, priority, and impact of patients' perceived AF symptoms and consequent cardiac anxiety may result in differing treatment priorities. Starting from a perspective that contextualizes AF in the broader context of patients' lives, prioritizes QOL, and addresses symptom-specific anxiety as a prime concern may better address patients' unmet needs., (© 2021. The Author(s) under exclusive licence to Society of General Internal Medicine.)

Background: Urologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly, diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are poorly understood and inadequately treated with conventional medical therapies. Behavioral strategies, recommended as a first-line treatment for managing symptoms, are largely inaccessible, time and labor intensive, and technically complex. The Easing Pelvic Pain Interventions Clinical Research Program (EPPIC) is a clinical trial examining the efficacy of low-intensity cognitive behavioral therapy (Minimal Contact CBT or MC-CBT) for UCPPS and its durability 3 and 6 months post treatment. Additional aims include characterizing the operative processes (e.g., cognitive distancing, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT-induced symptom relief and pre-treatment patient variables that moderate differential response., Methods: UCPPS patients (240) ages 18-70 years, any gender, ethnicity, and race, will be randomized to 4-session MC-CBT or a credible, non-specific education comparator (EDU) that controls for the generic effects from simply going to treatment. Efficacy assessments will be administered at pre-treatment, 2 weeks, and 3 and 6 months post treatment-week acute phase. A novel statistical approach applied to micro-analytic mediator assessment schedule will permit the specification of the most effective CBT component(s) that drive symptom relief., Discussion: Empirical validation of a low-intensity self-management therapy transdiagnostic in scope has the potential to improve the health of chronic pelvic pain patients refractory to medical therapies, reduce social and economic costs, conserve health care resources, as well as inform evidence-based practice guidelines. Identification of change mechanisms and moderators of treatment effects can provide proactive patient-treatment matching fundamental to goals of personalized medicine., Trial Registration: Clinicaltrials.gov NCT05127616. Registered on 9/19/21., (© 2022. The Author(s).)

This study tested the novel hypothesis that CBT-treated IBS patients who learn to self-manage painful GI symptoms by targeting rigid cognitive style show improvement in cognitive flexibility, GI symptoms (e.g., abdominal pain), and quality of life. Participants included 130 Rome-III diagnosed IBS patients (M age = 40.3, F = 83%) with moderate-to-severe symptoms randomly assigned to either cognitive behavioral therapy (CBT; N = 86) or a nonspecific education/support (EDU) comparator (N = 44). Participants completed an assessment battery at baseline and post-treatment 2 weeks after 10-week acute treatment phase. Measures included cognitive flexibility, psychological flexibility, emotion regulation strategies, IBS symptom severity, quality of life (QOL), and distress. CBT but not EDU patients showed significant GI sympton improvement from baseline to post-treatment in cognitive flexibility. For CBT patients, changes in cognitive flexibility were significantly associated with changes in IBS symptom severity, abdominal pain, and IBS QOL. Neither condition showed significant changes in psychological flexibility (Acceptance and Action Questionnaire-II) or use of emotion regulation strategies (Emotion Regulation Questionnaire). The ability to self-manage painful IBS symptoms refractory to conventional medical and dietary treatments is related to the ability to respond flexibly across shifting contexts using cognitive change procedures featured in CBT for IBS., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Treatment guidelines identify cognitive behavioral therapy (CBT) as a treatment of choice for irritable bowel syndrome (IBS). As a learning-based treatment, homework assignments are regarded as important for optimizing outcomes for CBT-treated patients. However, their actual benefit for IBS is unknown. This study examined whether homework completion corresponds with immediate and sustained treatment response in IBS patients enrolled in CBT treatment. Subjects were 358 IBS patients receiving clinic-based CBT (10 session), home-based CBT (4 session), or a 4 session, non-specific IBS education comparator as part of a large NIH trial. Homework completion was rated by clinician at each session. IBS symptom improvement was measured with the Clinician Global Improvement Scale at treatment week 5, post-treatment (week 12), and at follow-ups (weeks 22, 34, 46, 62). Homework completion rates over the 10-week acute phase corresponded with greater IBS symptom improvement and patient satisfaction at post-treatment. Early treatment homework completion did not predict early treatment response. Contrary to expectations, homework compliance rates were not greater among in-clinic session patients than home-based patients. Data lend empirical support to the clinical value of homework in teaching patients how to self-manage painful GI symptoms refractory to conventional medical and dietary therapies., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: There is growing recognition that bidirectional signaling between the digestive tract and the brain contributes to irritable bowel syndrome (IBS). We recently showed in a large randomized controlled trial that cognitive behavioral therapy (CBT) reduces IBS symptom severity. This study investigated whether baseline brain and gut microbiome parameters predict CBT response and whether response is associated with changes in the brain-gut-microbiome (BGM) axis., Methods: Eighty-four Rome III-diagnosed IBS patients receiving CBT were drawn from the Irritable Bowel Syndrome Outcome Study (IBSOS; ClinicalTrials.gov NCT00738920) for multimodal brain imaging and psychological assessments at baseline and after study completion. Fecal samples were collected at baseline and post-treatment from 34 CBT recipients for 16S rRNA gene sequencing, untargeted metabolomics, and measurement of short-chain fatty acids. Clinical measures, brain functional connectivity and microstructure, and microbiome features associated with CBT response were identified by multivariate linear and negative binomial models., Results: At baseline, CBT responders had increased fecal serotonin levels, and increased Clostridiales and decreased Bacteroides compared to non-responders. A random forests classifier containing 11 microbial genera predicted CBT response with high accuracy (AUROC 0.96). Following treatment, CBT responders demonstrated reduced functional connectivity in regions of the sensorimotor, brainstem, salience, and default mode networks and changes in white matter in the basal ganglia and other structures. Brain changes correlated with microbiome shifts including Bacteroides expansion in responders., Conclusions: Pre-treatment intestinal microbiota and serotonin levels were associated with CBT response, suggesting that peripheral signals from the microbiota can modulate central processes affected by CBT that generate abdominal symptoms in IBS. CBT response is characterized by co-correlated shifts in brain networks and gut microbiome that may reflect top-down effects of the brain on the microbiome during CBT. Video abstract., (© 2021. The Author(s).)

In this study, assessment of the antimicrobial activity of a novel, plasma-cured 2.5% ( w / v ) Cu(NO 3 ) 2 -containing sol-gel surface was performed. In contrast to state-of-the-art sol-gel coatings, the plasma curing led to a gradient in cross-linking with the highest values at the top of the coating. As a result, the coating behaved simultaneously hard, scratch-resistant, and tough, the latter due to the more flexible bulk of the coating toward the substrate. Further, the diffusion and permeation through the coating also increased toward the substrate. In our study, tests according to ISO 22196 showed antibacterial activity of the 2.5% ( w / v ) Cu(NO 3 ) 2 -containing sol-gel surface against all bacterial strains tested, and we expanded the testing further using a "dry" evaluation without an aqueous contact phase, which confirmed the antimicrobial efficacy of the 2.5% ( w / v ) Cu(NO 3 ) 2 -containing sol-gel surface. However, further investigation under exposure to soiling with the addition of 0.3% albumin, used to simulate organic load, led to a significant impairment in the antibacterial effect under both tested conditions. Furthermore, re-testing of the surface after disinfection with 70% ethanol led to a total loss of antibacterial activity. Our results showed that besides the mere application of an antimicrobial agent to a surface coating, it is also necessary to consider the future use of these surfaces in the experimental phase combining industry and science. Therefore, a number of tests corresponding to the utilization of the surface should be obligative on the basis of this assessment.

Background: Irritable bowel syndrome (IBS) is a common, often disabling gastrointestinal (GI) disorder for which there is no satisfactory medical treatment but is responsive to cognitive behavior therapy (CBT)., Purpose: To evaluate the costs and cost-effectiveness of a minimal contact version of CBT (MC-CBT) condition for N = 145 for IBS relative to a standard, clinic-based CBT (S-CBT; N = 146) and a nonspecific comparator emphasizing education/support (EDU; N = 145)., Method: We estimated the per-patient cost of each treatment condition using an activity-based costing approach that allowed us to identify and estimate costs for specific components of each intervention as well as the overall total costs. Using simple means analysis and multiple regression models, we estimated the incremental effectiveness of MC-CBT relative to S-CBT and EDU. We then evaluated the cost-effectiveness of MC-CBT relative to these alternatives for selected outcomes at immediate posttreatment and 6 months posttreatment, using both an intent-to-treatment and per-protocol methodology. Key outcomes included scores on the Clinical Global Impressions-Improvement Scale and the percentage of patients who positively responded to treatment., Results: The average per-patient cost of delivering MC-CBT was $348, which was significantly less than the cost of S-CBT ($644) and EDU ($457) (p < .01). Furthermore, MC-CBT produced better average patient outcomes at immediate and 6 months posttreatment relative to S-CBT and EDU (p < .01). The current findings indicated that MC-CBT is a cost-effective option relative to S-CBT and EDU., Conclusion: As predicted, MC-CBT was delivered at a lower cost per patient than S-CBT and performed better over time on the primary outcome of global IBS symptom improvement., (© Society of Behavioral Medicine 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

This paper presents the results of biocompatibility testing performed on several biomaterial variants for manufacturing a newly designed petal valve intended for use in a pulsatile ventricular assist device or blood pump. Both physical vapor deposition (PVD) and plasma-enhanced chemical vapor deposition (PECVD) were used to coat titanium-based substrates with hydrogenated tetrahedral amorphous carbon (ta-C:H) or amorphous hydrogenated carbon (a-C:H and a-C:H, N). Experiments were carried out using whole human blood under arterial shear stress conditions in a cone-plate analyzer (ap. 1800 1/s). In most cases, tested coatings showed good or very good haemocompatibility. Type a-C:H, N coating proved to be superior in terms of activation, risk of aggregation, and the effects of generating microparticles of apoptotic origin, and also demonstrated excellent mechanical properties. Therefore, a-C:H, N coatings were selected for further in vivo studies. In vivo animal studies were carried out according to the ISO 10993 standard. Intradermal reactivity was assessed in three rabbits and sub-acute toxicity and local effects after implantation were examined in 12 rabbits. Based on postmortem examination, no organ failure or wound tissue damage occurred during the required period of observation. In summary, our investigations demonstrated high biocompatibility of the biomaterials in relation to thrombogenicity, toxicity, and wound healing. Prototypes of the petal valves were manufactured and mounted on the pulsatile ventricular assist device. Hydrodynamic features and impact on red blood cells (hemolysis) as well as coagulation (systemic thrombogenicity) were assessed in whole blood., (© 2021. The Author(s).)

The goal of the work was to develop materials dedicated to spine surgery that minimized the potential for infection originating from the transfer of bacteria during long surgeries. The bacteria form biofilms, causing implant loosening, pain and finally, a risk of paralysis for patients. Our strategy focused both on improvement of antibacterial properties against bacteria adhesion and on wear and corrosion resistance of tools for spine surgery. Further, a ~35% decrease in implant and tool dimensions was expected by introducing ultrahigh-strength titanium alloys for less-invasive surgeries. The tested materials, in the form of thin, multi-layered coatings, showed nanocrystalline microstructures. Performed direct-cytotoxicity studies (including lactate dehydrogenase activity measurement) showed that there was a low probability of adverse effects on surrounding SAOS-2 ( Homo sapiens bone osteosarcoma) cells. The microbiological studies (e.g., ISO 22196 contact tests) showed that implanting Ag nanoparticles into Ti/Ti x N coatings inhibited the growth of E. coli and S. aureus cells and reduced their adhesion to the material surface. These findings suggest that Ag-nanoparticles present in implant coatings may potentially minimize infection risk and lower inherent stress.

Background: In the absence of a satisfactory medical or dietary treatment, the quality of the therapeutic alliance between irritable bowel syndrome (IBS) patients and their provider is deemed critical to managing refractory IBS. Surprisingly, little research has been conducted on the nature of the therapeutic alliance, factors that influence it, or practical strategies to improve it. This study sought to identify actionable variables that impact therapeutic alliance in patients with refractory IBS., Methods: Subjects included a total of 436 Rome III-diagnosed IBS patients (80% female, mean age=41.39 y) who completed a battery of clinical measures at the beginning of the acute treatment phase of an National Institutes of Health (NIH) behavioral trial. Pretreatment candidate predictor variables were organized into 4 categories: sociodemographic, extraintestinal, interpersonal, clinical (eg, symptom severity, pain intensity), cognitive (eg, treatment motivation, expectancy for improvement). Alliance was assessed by patient and clinician-rated measures of the Working Alliance Inventory after first treatment session., Results: Patient reports of alliance were most strongly and consistently predicted by patient access to interpersonal support [β=0.16; 95% confidence interval (CI)=0.07-0.25], motivation for IBS symptom improvement (β=0.12; 95% CI=0.02-0.21), and expectancy of IBS symptom improvement (β=0.35; 95% CI=0.25-0.44). Therapist ratings of alliance also were predicted by patient expectancy of IBS symptom improvement (β=0.16; 95% CI=0.05-0.26)., Conclusion: When managing IBS, a focus on dynamic factors of treatment motivation, social support, and treatment expectancy may be useful in improving the quality of the therapeutic alliance between patient and clinical gastroenterologist., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: This study sought to characterize change mechanisms that underlie gastrointestinal (GI) symptom improvement in IBS patients undergoing two dosages of CBT for IBS as compared to a nondirective education/support (EDU) condition. Method: Data were collected in the context of a large clinical trial that randomized 436 Rome III-diagnosed IBS patients ( M age = 41, 80 % female) to standard, clinic-based CBT (S-CBT), a largely home-based version with minimal therapist contact (MC-CBT) or Education/Support that controlled for nonspecific effects. Outcome was measured with the IBS-version of the Clinical Global Improvement scale that was administered at Week 5 and 2-week posttreatment (Week 12). Potential mediators (IBS Self-efficacy (IBS-SE), pain catastrophizing, fear of GI symptoms, and treatment alliance were assessed at Weeks 3, 5, and 8 during treatment with the exception of treatment expectancy that was measured at the end of Session 1. Results: IBS-SE, a positive treatment expectancy for symptom improvement, and patient-therapist agreement on tasks for achieving goals mediated effects of CBT early in treatment (rapid response, RR) and at posttreatment. Notwithstanding their different intensities, both CBT conditions had comparable RR rates (43%-45%) and significantly greater than the EDU RR rate of 22%. While pain catastrophizing, fear of GI symptoms, and patient-therapist emotional bonding related to posttreatment symptom improvement, none of these hypothesized mediators explained differences between CBT and EDU, thereby lacking the mechanistic specificity of IBS-SE, task agreement, and treatment expectancy. Conclusion: Findings suggest that CBT-induced GI symptom improvement may be mediated by a constellation of CBT-specific (IBS-SE) and nonspecific (task agreement, treatment expectancy) processes that reciprocally influence each other in complex ways to catalyze, improve, and sustain IBS symptom relief. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

The main purpose of the work was to assess the haemocompatible properties of polyurethane discs with a modified surface dedicated to cardiovascular system regeneration. They were coated with acrylic acid-based material to inhibit the activation of the blood coagulation cascade. This coating improved the wettability of the material, leading to the prevention of protein adsorption on the surface. The blood-material interaction was analyzed in dynamic conditions with a specially designed tester, which helps to control blood-material interaction under high shear stress conditions. The corresponding numerical model of the tester was also developed by finite volume method (FVM). The 3D FVM model allows the determination of shear stresses applying different flow and boundary conditions representing blood-material interactions. The haemocompatibility analyses were performed through in vitro tests using a blood flow simulator. They revealed a low probability of activation of blood coagulation and low leukocyte activation. The original mechanical set-up to test the blood-material interaction helped to prove that acrylic acid-based coatings expressed good haemocompatible properties., (Copyright © 2021 Elsevier B.V. All rights reserved.)

The paper presents an influence of the surface mechanical properties of thin-film materials on blood cell adhesion under shear stress conditions. Physical vapour deposited (PVD) coatings i.e. hydrogenated amorphous carbon (a-C:H) doped with nitrogen or silicon have been investigated. The mechanical properties of materials, namely their microhardness and Young's modulus were measured using indentation test with Rockwell indenter. The adhesion efficiency of blood cells in dynamic conditions were analysed using a radial flow chamber. Red blood cells (RBC) were used as representative cells to analyse cell-material interactions. The biomaterial examinations were performed under physiological flow conditions at the single-cell level. The 3D FVM (finite volume method) model of multi-phase radial flow test was developed to reproduce the physical test and to predict distributions of shear stresses and velocity during blood washout with PBS. Cell-material interactions were found to be strongly associated with the mechanical properties of the thin-film material. The decrease in the hardness of the coatings translated into a weaker cell - material interactions., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Minimizing of the life-threatening thrombo-emboli formation in pulsatile heart assist devices by a new biomimetic heart valve design is presently one of the most important problems in medicine. As part of this work, an original valve structure was proposed intended for pneumatic, extracorporeal ventricular assist devices. The valve design allows for direct integration with other parts of the pulsating blood pump. Strengthening in the form of the titanium or steel frame has been introduced into the polyurethane lagging, which allows for maintaining material continuity and eliminating the risk of blood clotting. The prototype of the valve was made by the injection molding method assisted by numerical simulation of this process. The prototype was introduced into a modified pulsating, extracorporeal heart assist pump ReligaHeart EXT (developed for tilting disc valves) and examined in-vitro using the "artificial patient" model in order to determine hydrodynamic properties of the valve in the environment similar to physiological conditions. Fundamental blood tests, like hemolysis and thrombogenicity have been carried out. Very low backflow through the closed valve was observed despite their slight distortion due to pressure. On the basis of immunofluorescence tests, only slight activation of platelets was found on the inlet valve and slight increased risk of clotting of the outlet valve commissures as a result of poor valve leaflets assembling in the prototype device. No blood hemolysis was observed. Few of the clots formed only in places where the valve surfaces were not smooth enough.

Objective: Recent evidence indicates that interventions designed to improve emotional awareness reduce pain in irritable bowel syndrome. This preliminary study sought to determine whether trait emotional awareness is associated with typical pain in patients with irritable bowel syndrome., Methods: Healthy volunteers ( n  =   66) and irritable bowel syndrome patients ( n  =   50) were asked to self-report their typical levels of pain intensity and complete both the Levels of Emotional Awareness Scale and the Somatization Scale of the Brief Symptom Inventory., Results: Levels of Emotional Awareness Scale scores in irritable bowel syndrome patients did not differ from scores in healthy participants; however, higher Levels of Emotional Awareness Scale scores in irritable bowel syndrome patients predicted lower levels of typical pain intensity ( r (45) = -.36, p  = .01, 95% CI [-.59, -.08]) and lower levels of somatization ( r (45)= -.31, p  = .03, 95% CI [-.55, -.02])., Conclusions: This inverse relationship between emotional awareness and both pain and somatization symptoms is consistent with evidence that irritable bowel syndrome patients experience reduced pain from therapies designed to improve emotional awareness. The Levels of Emotional Awareness Scale could potentially be used to identify patients who could benefit from such therapy and could potentially be a moderator of response to efficacious psychological therapies.

In case of benign and malignant tumours affecting the maxillofacial region, the resection of jawbone reflects the standard therapy in more than 5.000 cases per year within the European Union. The resulting large bone defects lead to scarred, mangled facial appearance, loss of mastication and probably speech, requiring aesthetic and functional surgery as a basis for physical and physiological rehabilitation. Although autologous vascularized bone autografts reflect the current golden standard, the portion of bone available for the procedure is limited and subsequent high-dose anti-cancer chemo-/radiotherapy can lead to local tissue necrosis. Autologous vascularized bone from fibular or iliac-crest autografts is current golden standard in jawbone resection post-treatment, however, the portion of transplantable bone is limited and subsequent high-dose anti-cancer chemo-/radiotherapy often results in tissue necrosis Our research focuses on alternative treatment techniques: tissue reconstruction via novel patient-specifically manufactured maxillofacial implant that stimulates bone tissue growth. The planned neoformation of vascularized bone in such implants within the patient's own body as "bioreactor" is the safest approach in tissue engineering. The works described herein included the design of the metallic substrate of the implant with the use of computed tomography basing on real patients scans and then 3D-printing the substrates from the Ti6Al7Nb powder. The metal core was then evaluated in terms of structural characteristic, cytotoxicity and gene expression through the in vitro tests. Further experiments were focused on fabrication of the biocompatible coating for outer surface of the bone implant that would enhance the healing process and accelerate the tissue growth. Functional polymeric granulate dedicated for osteoconductive, osteoinductive and osteogenesis properties were elaborated. Another approach including the coating for the implant surface with two-phase biocompatible layer including polymeric microspheres and hydrogel carrier, which would provide long-time release of bone and cartilage growth factors around the implant were also done. The polymeric granulate containing βTCP improved bone cells growth, but it some modification has to be done in order to improve structural pores to ensure for better osteoconductivity. The biocompatible coating including PVP hydrogel and polymeric microspheres is still in the development process., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Introduction: Irritable bowel syndrome is a common, painful, and often disabling GI disorder for which there is no satisfactory medical or dietary treatment. The past 10 years have seen the development and validation of a number of psychological treatments of which CBT is arguably the most effective based on two recently conducted multiple site trials from two investigative teams in the UK and USA., Areas Covered: The purpose of this review is to describe the principles, processes, procedures, and empirical basis supporting CBT and distinguish it from other psychological treatments available to clinical GE whose patients suffer from refractory IBS., Expert Opinion: The efficacy of CBT in treating refractory IBS patients is well established but there is limited understanding of why it works and for whom it is most beneficial. Further, its availability is generally limited to tertiary care settings which may undermine its value proposition if improved self-management is not accompanied by other health-care efficiencies. Systematic efforts to increase both the efficiency of CBT and the way it is delivered (e.g. digital therapeutics, integration into primary care) is critical to optimizing CBT's potential and reducing the public health burden IBS imposes.

The process of modern cardiovascular device fabrication should always be associated with an investigation of how surface properties modulate its hemocompatibility through plasma protein adsorption as well as blood morphotic element activation and adhesion. In this work, a package of novel assays was used to correlate the physicochemical properties of thin ceramic coatings with hemocompatibility under dynamic conditions. Different variants of carbon-based films were prepared on polymer substrates using the magnetron sputtering method. The microstructural, mechanical, and surface physicochemical tests were performed to characterize the coatings, followed by investigation of whole human blood quality changes under blood flow conditions using the "Impact R" test, tubes' tester, and radial flow chamber assay. The applied methodology allowed us to determine that aggregate formation on hydrophobic and hydrophilic carbon-based coatings may follow one of the two different mechanisms dependent on the type and conformational changes of adsorbed blood plasma proteins.

Competing Interests: Competing interests: None declared.

Background & Aims: Among patients with irritable bowel syndrome (IBS), it would be helpful to identify those most likely to respond to specific treatments, yet few factors have been identified that reliably predict positive outcome. We sought to identify pretreatment baseline characteristics that associate with gastrointestinal symptom improvement in patients who received empirically validated regimens of cognitive behavior therapy (CBT) or IBS education., Methods: We analyzed data from the IBS Outcome Study, in which 436 patients with IBS (average age, 41 years; 80%, female) were randomly assigned to groups that received 4 or 10 sessions of cognitive behavior therapy or education over 10 weeks. Baseline data were collected from all participants on sociodemographic and clinical features and comorbidities. Interaction analyses used a modified linear probability model with Huber-White robust estimators to identify baseline factors that moderated as a function of treatment condition GI symptom improvement based on the IBS-version of the Clinical Global Impressions-Improvement Scale., Results: Whether the primary outcome of IBS symptom improvement was rated by patients or physician assessors blind to treatment 2 weeks after it ended, higher percentages of patients had symptom improvement after CBT compared with EDU among those with low levels of trait anxiety (71.3% vs 34.9%; P < .05) or anxiety sensitivity (71.7% vs 38.6%; P < .05) and for those with baseline typical levels of trait anxiety (66.0% vs 47.1%; P < .05) or anxiety sensitivity (66.3% vs 47.1%; P < .05). For patients with high trait anxiety or anxiety sensitivity, the difference in percentage of responders to CBT vs EDU was non-significant for trait anxiety (60.6% vs 59.2%) and anxiety sensitivity (60.9% vs 55.9%). If patients scored at or below 22 on the Trait Anxiety Inventory, CBT had a statistically significant advantage over EDU. If patients scored at or below 29 on the Anxiety Sensitivity Inventory, there was a statistically significant advantage for CBT vs EDU., Conclusions: In analyses of outcomes of patients with treatment-refractory IBS, baseline levels of trait anxiety and anxiety sensitivity (fear of arousal symptoms) were associated with improved gastrointestinal symptoms following CBT compared to IBS education. These findings and approaches might be used to optimize selection of treatment for patients with IBS., (Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: There is a need for safe and effective IBS treatments that provide immediate and sustained improvement of IBS symptoms, particularly among more severe patients. The aim was to assess long-term clinical response of cognitive behavioral therapy (CBT) with reference to IBS education., Methods: A total of 436 Rome III-diagnosed IBS patients (80% F, M age = 41 years) were randomized to: 4 session home-based CBT (minimal contact (MC-CBT)), 10 session clinic-based CBT (standard (S-CBT)), or 4 session IBS education (EDU). Follow-up occurred at 2 weeks and 3, 6, 9, and 12 months following treatment completion. Treatment response was based a priori on the Clinical Global Improvement Scale (global IBS symptom improvement) and IBS Symptom Severity Scale (IBS-SSS)., Results: Post-treatment CGI gains were generally maintained by MC-CBT patients at quarterly intervals through 12-month follow-up with negligible decay. For MC-CBT and S-CBT, 39 and 33% of respondents maintained treatment response at every follow-up assessment. The corresponding percent for EDU was 19%, which was significantly lower (p < 0.05) than for the CBT groups. On the IBS-SSS, therapeutic gains also showed a pattern of maintenance with trends towards increased efficacy over time in all conditions, with the mean unit reductions between baseline and follows-up being approximately -76 at immediate and approximately -94 at 12 months (-50 = clinically significant)., Conclusions: For treatment-refractory IBS patients, home- and clinic-based CBT resulted in substantial and enduring relief of multiple IBS symptoms that generally extended to 12-month post treatment.

Purpose:: The main goal of this work was to develop haemocompatibile thin film materials dedicated to novel flexible mechanical heart valves intended for pulsatile ventricle assist devices., Methods:: The studies performed have led to the selection of a material for the surface modification of the metallic scaffold. Haemocompatible, biofunctional, ultra-elastic, thin carbon-based coatings were proposed. The surface was designed to eliminate thrombogenic and microbial construction by a reduction in turbulence and sufficient washing of the biofunctional-adapted surfaces, thus allowing for extended use for temporary heart support. The article presents the influence of the mechanical properties of coatings and their influence on the haemocompatibility. In this study, we investigated a simplified model of the whole blood shear stress based on a cone and plate rotational viscometer. Several indices of platelet activation were analysed, including platelet and granulocyte-platelet aggregates, platelet activation markers and platelet-derived microparticles., Results:: The shear stress induced a platelet aggregate count in the range from 2% to 30% of the CD61 positive cells. For polyurethane (PU), the average value of platelet aggregates was on the level of 7%. The analyses have demonstrated that the cytometric methods of the direct determination of platelet-derived microparticles in plasma are reproducible and reliable. Considering the generation of microparticles on the tested coatings under hydrodynamic conditions, the best properties were observed for the coating a-C:H,N., Conclusion:: The results indicate that a-C:H-based coatings with the thickness of 110 nm do not induce an immune response and do not influence the origin of platelet microparticle formation; thus, these type of coatings are the most promising for the parts which are planned to withstand blood contact under the high value of shear stress.

Goals: The goal of this study is to assess: (1) the relative contribution of patient factors to satisfaction ratings in irritable bowel syndrome (IBS) patients and (2) the relationship between patient satisfaction (PS) and the number of diagnostic tests patients underwent prior to receiving IBS diagnosis., Background: Although PS is regarded as an important indicator of quality of care, little is known about its determinants., Study: A total of 448 Rome III-diagnosed patients (M age=41 y; 79% F), whose GI symptoms were at least moderate in severity completed patient-reported outcome measures as part of pretreatment evaluation of an NIH-funded clinical trial. PS was measured with the 11-point Hospital Consumer Assessment of Healthcare Providers and Systems global rating scale modified to assess for IBS treatments. A series of multiple regression analyses were conducted for demographic, IBS-specific, general physical health, and psychological predictors before running a final model of significant predictors from each domain., Results: The final regression model was significant, F6,419=6.34, P<0.001, R=0.08, with race, insurance, number of diagnostic tests, and lower neuroticism predicting PS. Medical tests were rendered nonsignificant when history of seeking care from a gastroenterologist was introduced into the equation., Conclusions: Contrary to hypotheses, neither the IBS symptom severity nor quality of life impairment predicted PS. Patient factors such as a neurotic personality style and sociodemographic profile had a significant but modest impact on PS. Pattern of regression analyses suggests that patients may turn to their gastroenterologist for testing for reassurance, which may in the long-term fuel demand for more testing.

Background & Aims: There is an urgent need for safe treatments for irritable bowel syndrome (IBS) that relieve treatment-refractory symptoms and their societal and economic burden. Cognitive behavior therapy (CBT) is an effective treatment that has not been broadly adopted into routine clinical practice. We performed a randomized controlled trial to assess clinical responses to home-based CBT compared with clinic-based CBT and patient education., Methods: We performed a prospective study of 436 patients with IBS, based on Rome III criteria, at 2 tertiary centers from August 23, 2010, through October 21, 2016. Subjects (41.4 ± 14.8 years old; 80% women) were randomly assigned to groups that received the following: standard-CBT (S-CBT, n = 146, comprising 10 weekly, 60-minute sessions that emphasized the provision of information about brain-gut interactions; self-monitoring of symptoms, their triggers, and consequences; muscle relaxation; worry control; flexible problem solving; and relapse prevention training), or 4 sessions of primarily home-based CBT requiring minimal therapist contact (MC-CBT, n = 145), in which patients received home-study materials covering the same procedures as S-CBT), or 4 sessions of IBS education (EDU, n = 145) that provided support and information about IBS and the role of lifestyle factors such as stress, diet, and exercise. The primary outcome was global improvement of IBS symptoms, based on the IBS-version of the Clinical Global Impressions-Improvement Scale. Ratings were performed by patients and board-certified gastroenterologists blinded to treatment allocation. Efficacy data were collected 2 weeks, 3 months, and 6 months after treatment completion., Results: A higher proportion of patients receiving MC-CBT reported moderate to substantial improvement in gastrointestinal symptoms 2 weeks after treatment (61.0% based on ratings by patients and 55.7% based on ratings by gastroenterologists) than those receiving EDU (43.5% based on ratings patients and 40.4% based on ratings by gastroenterologists) (P < .05). Gastrointestinal symptom improvement, rated by gastroenterologists, 6 months after the end of treatment also differed significantly between the MC-CBT (58.4%) and EDU groups (44.8%) (P = .05). Formal equivalence testing applied across multiple contrasts indicated that MC-CBT is at least as effective as S-CBT in improving IBS symptoms. Patients tended to be more satisfied with CBT vs EDU (P < .05) based on immediate posttreatment responses to the Client Satisfaction Questionnaire. Symptom improvement was not significantly related to concomitant use of medications., Conclusions: In a randomized controlled trial, we found that a primarily home-based version of CBT produced significant and sustained gastrointestinal symptom improvement for patients with IBS compared with education. Clinicaltrials.gov no.: NCT00738920., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Goals: To assess the relationship between pain, psychological processes, and quality of life (QOL) in chronic pancreatitis (CP)., Background: CP is a progressive inflammatory disorder of the pancreas characteristically resulting in abdominal pain and impairing QOL. Pain due to CP is poorly understood and frequently difficult to treat. This pain has historically been understood as a peripheral process originating from the pancreas itself, but a growing body of literature is revealing an important role offered by central influences. Viewed through the perspective of the biopsychosocial model of illness, cognitive variables strongly influence QOL. However, there is little understanding of variables that influence QOL in CP., Study: Patients with CP from the University of Alabama at Birmingham were administered a 165-question test battery which was comprised of questionnaires evaluating pain beliefs, disease-specific QOL, psychological distress, pain sensation, pain affect, and long-term suffering., Results: Sixty-eight subjects completed the question battery between February 28, 2011 and January 16, 2014. Almost all (91.2%) reported taking pain medication. QOL was significantly associated with reported levels of pain intensity (r=-0.52, P<0.01) as well as perceived self-blame., Conclusions: The significant predictors of QOL impairment in CP are pain intensity and perceived self-blame for pain. Further research is needed to elucidate this relationship while also evaluating the effectiveness of systematic modification of these variables in an attempt to improve pain and QOL in CP.

Background: Current clinical guidelines identify several psychological treatments for irritable bowel syndrome (IBS). IBS patients, however, have elevated trauma, life stress, relationship conflicts, and emotional avoidance, which few therapies directly target. We tested the effects of emotional awareness and expression training (EAET) compared to an evidence-based comparison condition-relaxation training-and a waitlist control condition., Methods: Adults with IBS (N=106; 80% female, Mean age=36 years) were randomized to EAET, relaxation training, or waitlist control. Both EAET and relaxation training were administered in three, weekly, 50-minute, individual sessions. All patients completed the IBS Symptom Severity Scale (primary outcome), IBS Quality of Life, and Brief Symptom Inventory (anxiety, depressive, and hostility symptoms) at pretreatment and at 2 weeks posttreatment and 10 weeks follow-up (primary endpoint)., Key Results: Compared to waitlist controls, EAET, but not relaxation training, significantly reduced IBS symptom severity at 10-week follow-up. Both EAET and relaxation training improved quality of life at follow-up. Finally, EAET did not reduce psychological symptoms, whereas relaxation training reduced depressive symptoms at follow-up (and anxiety symptoms at posttreatment)., Conclusions & Inferences: Brief emotional awareness and expression training that targeted trauma and emotional conflicts reduced somatic symptoms and improved quality of life in patients with IBS. This emotion-focused approach may be considered an additional treatment option for IBS, although research should compare EAET to a full cognitive-behavioral protocol and determine which patients are best suited for each approach. Registered at clinicaltrials.gov (NCT01886027)., (© 2017 John Wiley & Sons Ltd.)

Functional dyspepsia is one of the most prevalent functional gastrointestinal disorders. Functional dyspepsia comprises three subtypes with presumed different pathophysiology and aetiology: postprandial distress syndrome (PDS), epigastric pain syndrome (EPS) and a subtype with overlapping PDS and EPS features. Functional dyspepsia symptoms can be caused by disturbed gastric motility (for example, inadequate fundic accommodation or delayed gastric emptying), gastric sensation (for example, sensations associated with hypersensitivity to gas and bloating) or gastric and duodenal inflammation. A genetic predisposition is probable but less evident than in other functional gastrointestinal disorders, such as irritable bowel syndrome (IBS). Psychiatric comorbidity and psychopathological state and trait characteristics could also play a part, although they are not specific to functional dyspepsia and are less pronounced than in IBS. Possible differential diagnoses include Helicobacter pylori infection and peptic ulceration. Pharmacological therapy is mostly based on the subtype of functional dyspepsia, such as prokinetic and fundus-relaxing drugs for PDS and acid-suppressive drugs for EPS, whereas centrally active neuromodulators and herbal drugs play a minor part. Psychotherapy is effective only in a small subset of patients, whereas quality of life can be severely affected in nearly all patients. Future therapies might include novel compounds that attempt to treat the underlying gastric and duodenal inflammation.