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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.)

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.

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.

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.)

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.

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).)

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.

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.

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.

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.)

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 & 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.)

Background: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and alterations in bowel habits. Three subtypes are defined on the basis of stool patterns: diarrhea-predominant IBS, constipation-predominant IBS, and alternating or mixed IBS., Objectives: To develop patient-reported outcome measures for qualification by the Food and Drug Administration to support product approvals and labeling in IBS; the article focuses on the qualitative research that provided the foundation for the new measures., Methods: Forty-nine concept elicitation and 42 cognitive debriefing interviews were conducted with subjects meeting Rome III criteria; additional criteria were imposed to yield a sample representative of the target patient population., Results: Although incomplete bowel movements, abnormal stool frequency and consistency, and abdominal pain, discomfort, and bloating were reported most frequently across concept elicitation interviews, the relative importance of specific symptoms varied by subtype. Among their five symptoms most important to treat, diarrhea-predominant and alternating or mixed IBS subjects frequently identified urgency, loose/watery stools, abdominal pain, and cramping, whereas constipation-predominant IBS subjects commonly included infrequent and incomplete bowel movements, bloating, and abdominal pain. The cognitive debriefing interviews facilitated refinement of each item set, supported minor modifications following translatability assessment, and suggested improvements to the electronic interface. Furthermore, subjects reported that every item was relevant and no concepts of importance were missing., Conclusions: Results support the content validity of the IBS patient-reported outcome measures. A pilot study was recently initiated to inform item reduction, develop scoring algorithms, and provide preliminary psychometric information. Comprehensive psychometric evaluation and responder definition development will follow., (Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

In this paper, we provide a general framework for understanding the functional gastrointestinal disorders (FGID) from a biopsychosocial perspective. More specifically, we provide an overview of the recent research on how the complex interactions of environmental, psychological, and biological factors contribute to the development and maintenance of the FGID. We emphasize that considering and addressing all these factors is a conditio sine qua non for appropriate treatment of these conditions. First, we provide an overview of what is currently known about how each of these factors - the environment, including the influence of those in an individual's family, the individual's own psychological states and traits, and the individual's (neuro)physiological make-up - interact to ultimately result in the generation of FGID symptoms. Second, we provide an overview of commonly used assessment tools which can assist clinicians in obtaining a more comprehensive assessment of these factors in their patients. Finally, the broader perspective outlined earlier is applied to provide an overview of centrally acting treatment strategies, both psychological and pharmacological, which have been shown to be efficacious to treat FGID., (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: A wireless motility capsule is a new method for ambulatory assessment of transit times and motility throughout the gastrointestinal tract. The objective of this study was to evaluate the ability of a wireless motility capsule to detect drug effects on gastric emptying time (GET) and gastric contractility., Methods: 15 healthy adults were administered in random order saline, erythromycin IV 150 mg, or morphine IV 0.05 mg/kg BW. Subjects ate a standard meal after each infusion, and subsequently ingested the motility capsule. Data were recorded for 8 hours, and the results were analyzed using the manufacturer's software., Results: GET was significantly faster after erythromycin than either saline or morphine. Morphine tended to delay emptying of the capsule compared to saline. There was a trend toward a greater frequency of gastric contractions with erythromycin and a reduced frequency of gastric contractions with morphine that did not reach statistical significance., Conclusions: A wireless motility capsule successfully detected acceleration of gastric emptying induced by erythromycin, and retardation of gastric motility caused by morphine. These results indicate that a wireless motility capsule is a promising technique to assess pharmacologic effects on gastric transit and contractility and aid in development of drugs for gastric motor disorders.

Background: Several studies show that psychological treatments relieve symptoms for patients suffering from irritable bowel syndrome (IBS). However, there are no consistent findings that show what patient characteristics make a psychological treatment more or less likely to result in improvement. We have previously conducted a study of a newly developed internet-delivered cognitive behavioral therapy (ICBT) that emphasized exposure to IBS symptoms and IBS-related situations and reduced symptom-related avoidance. The study showed that the treatment led to improvement in IBS symptoms compared to a waiting list and that treatment gains were maintained over a 15-18 month follow-up period. The aim of the present study was to investigate several possible predictors of short- and long-term treatment outcome in terms of symptom improvement, based on data collected in the previously conducted treatment trial., Methods: Demographics, comorbid psychological distress, IBS-related fear and avoidance behaviors, and IBS-related disability were investigated as predictors of treatment outcome in the sample consisting of 79 participants diagnosed with IBS who had undergone 10 weeks of ICBT. Predictors that were significantly correlated with symptom levels at post-treatment and follow-up were entered into multiple regression analyses that controlled for pre-treatment symptom levels., Results: There were measures within each domain, i.e., comorbid psychological distress, IBS-related fear and avoidance behaviors, and IBS-related disability, with the exception of demographic data, that were correlated with the symptom levels at post-treatment and follow-up. However, when these were entered into a multiple regression analyses that controlled for pre-treatment levels, none remained a significant predictor of the post-treatment and follow-up symptomatic status., Conclusions: The study did not find any individual characteristics that made patients more or less likely to respond to the exposure-based ICBT. The finding that comorbid psychological distress did not predict outcome is in accordance with previous studies. Reliable predictors for response to any type of psychological treatment for IBS remain to be established.

Background & Aims: Irritable bowel syndrome (IBS) has significant mental and physical comorbidities. However, little is known about the day-to-day burden these comorbidities place on quality of life (QOL), physical and mental function, distress, and symptoms of patients., Methods: We collected cross-sectional data from 175 patients with IBS, which was diagnosed on the basis of Rome III criteria (median age, 41 years; 78% women), who were referred to 2 specialty care clinics. Patients completed psychiatric interviews, a physical comorbidity checklist, the IBS Symptom Severity Scale, the IBS-QOL instrument, the Brief Symptom Inventory, the abdominal pain intensity scale, and the Short Form-12 Health Survey., Results: Patients with IBS reported an average of 5 comorbidities (1 mental, 4 physical). Subjects with more comorbidities reported worse QOL after adjusting for confounding variables. Multiple linear regression analyses indicated that comorbidity type was more consistently and strongly associated with illness burden indicators than disease counts. Of 10,296 possible physical-mental comorbidity pairs, 6 of the 10 most frequent dyads involved specific conditions (generalized anxiety, depression, back pain, agoraphobia, tension headache, and insomnia). These combinations were consistently associated with greater illness and symptom burdens (QOL, mental and physical function, distress, more severe symptoms of IBS, and pain)., Conclusions: Comorbidities are common among patients with IBS. They are associated with distress and reduced QOL. Specific comorbidities are associated with more severe symptoms of IBS., (Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Biomimetic design of new materials uses nature as antetype, learning from billions of years of evolution. This work emphasizes the mechanical and tribological properties of skin, combining both hardness and wear resistance of its surface (the stratum corneum) with high elasticity of the bulk (epidermis, dermis, hypodermis). The key for combination of such opposite properties is wrinkling, being consequence of intrinsic stresses in the bulk (soft tissue): Tribological contact to counterparts below the stress threshold for tissue trauma occurs on the thick hard stratum corneum layer pads, while tensile loads smooth out wrinkles in between these pads. Similar mechanism offers high tribological resistance to hard films on soft, flexible polymers, which is shown for diamond-like carbon (DLC) and titanium nitride thin films on ultrasoft polyurethane and harder polycarbonate substrates. The choice of these two compared substrate materials will show that ultra-soft substrate materials are decisive for the distinct tribological material. Hierarchical wrinkled structures of films on these substrates are due to high intrinsic compressive stress, which evolves during high energetic film growth. Incremental relaxation of these stresses occurs by compound deformation of film and elastic substrate surface, appearing in hierarchical nano-wrinkles. Nano-wrinkled topographies enable high elastic deformability of thin hard films, while overstressing results in zigzag film fracture along larger hierarchical wrinkle structures. Tribologically, these fracture mechanisms are highly important for ploughing and sliding of sharp and flat counterparts on hard-coated ultra-soft substrates like polyurethane. Concentration of polyurethane deformation under the applied normal loads occurs below these zigzag cracks. Unloading closes these cracks again. Even cyclic testing do not lead to film delamination and retain low friction behavior, if the adhesion to the substrate is high and the initial friction coefficient of the film against the sliding counterpart low, e.g. found for DLC.

Objectives: Patient-reported outcomes assessing multiple gastrointestinal symptoms are central to characterizing the therapeutic benefit of novel agents for irritable bowel syndrome (IBS). Common approaches that sum or average responses across different illness components must be unidimensional and have small unique variances to avoid aggregation bias and misinterpretation of clinical data. This study sought to evaluate the unidimensionality of the IBS Symptom Severity Scale (IBS-SSS) and to explore person-centered cluster analytic methods for characterizing multivariate-based patient profiles., Methods: Ninety-eight Rome-diagnosed patients with IBS completed the IBS-SSS and a single, global item of symptom severity (UCLA Symptom Severity Scale) at pretreatment baseline of a clinical trial funded by the National Institutes of Health. k-means cluster analyses were performed on participants' symptom severity scores., Results: The IBS-SSS was not unidimensional. Exploratory cluster analyses revealed four common symptom profiles across five items of the IBS-SSS. One cluster of patients (25%) had elevated scores on pain frequency and bowel dissatisfaction, with less elevated but still high scores on life interference and low pain severity ratings. A second cluster (19%) was characterized by intermediate scores on both pain dimensions but more elevated scores on bowel dissatisfaction. A third cluster (18%) had elevated scores across all IBS-SSS subcomponents. The fourth and the most common cluster (37%) had relatively low scores on all dimensions except bowel dissatisfaction and life interference due to IBS symptoms., Conclusions: Patient-reported outcome end points and research on IBS more generally relying on multicomponent assessments of symptom severity should take into account the multidimensional structure of symptoms to avoid aggregation bias and to optimize the sensitivity of detecting treatment effects., (Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Biocompatibility improvements for blood contacting materials are of increasing interest for implanted devices and interventional tools. The current study focuses on inorganic (titanium, titanium nitride, titanium oxide) as well as diamond-like carbon (DLC) coating materials on polymer surfaces (thermoplastic polyurethane), deposited by magnetron sputtering und pulsed laser deposition at room temperature. DLC was used pure (a-C:H) as well as doped with silicon, titanium, and nitrogen + titanium (a-C:H:Si, a-C:H:Ti, a-C:H:N:Ti). In-vitro testing of the hemocompatibility requires mandatory dynamic test conditions to simulate in-vivo conditions, e.g., realized by a cone-and-plate analyzer. In such tests, titanium- and nitrogen-doped DLC and titanium nitride were found to be optimally anti-thrombotic and better than state-of-the-art polyurethane polymers. This is mainly due to the low tendency to platelet microparticle formation, a high content of remaining platelets in the whole blood after testing and low concentration of platelet activation and aggregation markers. Comparing this result to shear-flow induced cell motility tests with e.g., Dictostelium discoideum cell model organism reveals similar tendencies for the investigated materials.

Background & Aims: Cognitive behavior therapy (CBT) is an empirically validated treatment for irritable bowel syndrome (IBS), yet it is unclear for whom and under what circumstances it is most effective. We investigated whether patients who achieved a positive response soon after CBT onset (by week 4), termed rapid responders (RRs), maintain treatment gains compared with non-rapid responders. We also characterized the psychosocial profile of RRs on clinically relevant variables (eg, health status, IBS symptom severity, distress)., Methods: The study included 71 individuals (age, 18-70 y) whose IBS symptoms were consistent with Rome II criteria and were of at least moderate severity. Patients were assigned randomly to undergo a wait list control; 10 weekly 1-hour sessions of CBT; or four 1-hour CBT sessions over 10 weeks. RRs were classified as patients who reported adequate relief of pain, adequate relief of bowel symptoms, and a decrease in total IBS severity scores of 50 or greater by week 4., Results: Of patients undergoing CBT, 30% were RRs; 90% to 95% of the RRs maintained gains at the immediate and 3-month follow-up examinations. Although the RRs reported more severe IBS symptoms at baseline, they achieved more substantial, sustained IBS symptom reduction than non-rapid responders. Both dosages of CBT had comparable rates of RR., Conclusions: A significant proportion of IBS patients treated with CBT have a positive response within 4 weeks of treatment; these patients are more likely to maintain treatment gains than patients without a rapid response. A rapid response is not contingent on the amount of face-to-face contact with a clinician., (Copyright (c) 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Wireless pH and pressure motility capsule (wireless motility capsule) technology provides a method to assess regional gastrointestinal transit times., Aims: To analyse data from a multi-centre study of gastroparetic patients and healthy controls and to compare regional transit times measured by wireless motility capsule in healthy controls and gastroparetics (GP)., Methods: A total of 66 healthy controls and 34 patients with GP (15 diabetic and 19 idiopathic) swallowed wireless motility capsule together with standardized meal (255 kcal). Gastric emptying time (GET), small bowel transit time (SBTT), colon transit time (CTT) and whole gut transit time (WGTT) were calculated using the wireless motility capsule., Results: Gastric emptying time, CTT and WGTT but not SBTT were significantly longer in GP than in controls. Eighteen percent of gastroparetic patients had delayed WGTT. Both diabetic and idiopathic aetiologies of gastroparetics had significantly slower WGTT (P < 0.0001) in addition to significantly slower GET than healthy controls. Diabetic gastroparetics additionally had significantly slower CTT than healthy controls (P = 0.0054)., Conclusions: In addition to assessing gastric emptying, regional transit times can be measured using wireless motility capsule. The prolongation of CTT in gastroparetic patients indicates that dysmotility beyond the stomach in GP is present, and it could be contributing to symptom presentation.

Background & Aims: Colonic transit time (CTT) traditionally is assessed with radiopaque markers (ROMs), which requires radiation and is hindered by lack of standardization and compliance. We assessed regional and CTT with the SmartPill (SmartPill Corporation, Buffalo, NY), a new wireless pH and pressure recording capsule, in constipated and healthy subjects and compared this with ROM., Methods: Seventy-eight constipated (Rome II) and 87 healthy subjects ingested a 260-kcal meal, a ROM capsule, and the SmartPill. Subjects wore a data receiver and kept daily stool diaries for 5 days. SmartPill recordings assessed CTT, whole-gut transit time (WGTT), small-bowel transit time, and gastric emptying time. Abdominal radiographs on days 2 and 5 assessed ROM transit. Sensitivity/specificity and receiver operating characteristics (ROCs) of each technique and utility were compared., Results: Gastric emptying time, CTT, and WGTT were slower (P < .01) in constipated subjects than controls. CTT was slower in women than men (P = .02). Day 2 and day 5 ROM transits were slower (P < .001) in constipated subjects. Correlation of the SmartPill CTT with ROMs expelled on day 2/day 5 was r = 0.74/r = 0.69 in constipation, and r = 0.70/r = 0.40 in controls, respectively. The diagnostic accuracy of the SmartPill CTT to predict constipation from ROC was 0.73, with a specificity of 0.95. These were comparable with those of day 5 ROM (ROC, 0.71; specificity, 0.95)., Conclusions: The SmartPill is a novel ambulatory technique of assessing regional (gastric, small bowel, colonic) and WGTT without radiation. It reveals hitherto unrecognized gender differences and upper-gut dysfunction in constipation. It correlates well with ROM and offers a standardized method of discriminating normal from slow colonic transit.

Background & Aims: Given the limitations of conventional therapies and restrictions imposed on newer pharmacologic agents, there is an urgent need to develop efficacious and efficient treatments that teach patients behavioral self-management skills for relieving irritable bowel syndrome (IBS) symptoms and associated problems., Methods: Seventy-five Rome II diagnosed IBS patients (86% female) without comorbid gastrointestinal disease were recruited from local physicians and the community and randomized to either 2 versions of cognitive behavior therapy (CBT) (10-session, therapist-administered CBT vs 4-session, patient-administered CBT) or a wait list control (WLC) that controlled for threats to internal validity. Final assessment occurred 2 weeks after the 10-week treatment phase ended. Outcome measures included adequate relief from pain and bowel symptoms, global improvement of IBS symptoms (CGI-Improvement Scale), IBS symptom severity scale (IBS SSS), quality of life (IBSQOL), psychological distress (Brief Symptom Inventory), and patient satisfaction (Client Satisfaction Scale)., Results: At week 12, both CBT versions were significantly (P < .05) superior to WLC in the percentage of participants reporting adequate relief (eg, minimal contact CBT, 72%; standard CBT, 60.9%; WLC, 7.4%) and improvement of symptoms. CBT-treated patients reported significantly improved quality of life and IBS symptom severity but not psychological distress relative to WLC patients (P < .0001)., Conclusions: Data from this pilot study lend preliminary empirical support to a brief patient-administered CBT regimen capable of providing short-term relief from IBS symptoms largely unresponsive to conventional therapies.

The aim of this article is to review the pathophysiology and clinical role of serotonin receptor modulators used in the treatment of irritable bowel syndrome. Serotonin is an important monoamine neurotransmitter that plays a key role in the initiation of peristaltic and secretory refl exes, and in modulation of visceral sensations. Several serotonin receptor subtypes have been characterized, of which 5HT3, 5HT4, and 5HT1b are the most important for GI function. 5HT4 agonists (eg, tegaserod) potentiate peristalsis initiated by 5HT1 receptor stimulation. 5HT4 agonists are therefore useful in constipation predominant form of IBS and in chronic constipation. 5HT3 antagonists (Alosetron and Cilansetron) prevent the activation of 5HT3 receptors on extrinsic afferent neurons and can decrease the visceral pain associated with IBS. These agents also retard small intestinal and colonic transit, and are therefore useful in diarrhea-predominant IBS. Tegaserod has been demonstrated in several randomized, placebo controlled trials to relieve global IBS symptoms as well as individual symptoms of abdominal discomfort, number of bowel movements and stool consistency. Several randomized, controlled trials have shown that alosetron relieves pain, improves bowel function, and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome. However, ischemic colitis and severe complications of constipation have been major concerns leading to voluntary withdrawal of Alosetron from the market followed by remarketing with a comprehensive risk management program.

Background: Gastric emptying scintigraphy (GES) using a radio-labelled meal is used to measure gastric emptying. A nondigestible capsule, SmartPill, records luminal pH, temperature, and pressure during gastrointestinal transit providing a measure of gastric emptying time (GET)., Aims: To compare gastric emptying time and GES by assessing their correlation, and to compare GET and GES for discriminating healthy subjects from gastroparetics., Methods: Eighty-seven healthy subjects and 61 gastroparetics enrolled with simultaneous SmartPill and GES. Fasted subjects were ingested capsule and [(99m)Tc]-SC radio-labelled meal. Images were obtained every 30 min for 6 h. Gastric emptying time and percentage of meal remaining at 2/4 h were determined for each subject. The sensitivity/specificity and receiver operating characteristic analysis of each measure were determined for each subject., Results: Correlation between GET and GES-4 h was 0.73 and GES-2 h was 0.63. The diagnostic accuracy from the receiver operating characteristic curve between gastroparetics and healthy subjects was GET = 0.83, GES-4 h = 0.82 and GES-2 h = 0.79. The 300-min cut-off time for GET gives sensitivity of 0.65 and specificity of 0.87 for diagnosis of gastroparesis. The corresponding sensitivity/specificity for 2 and 4 h standard GES measures were 0.34/0.93 and 0.44/0.93, respectively., Conclusion: SmartPill GET correlates with GES and discriminates between healthy and gastroparetic subjects offering a nonradioactive, standardized, ambulatory alternative to scintigraphy.

Background and Aims: Although multiple clinical trials support the efficacy of psychological treatments for reducing irritable bowel syndrome (IBS) symptoms, the mechanisms responsible for symptomatic improvement are unknown. One hypothesis is that psychological treatments work by alleviating comorbid psychological distress implicated in the worsening of bowel symptoms and quality of life. An alternative hypothesis assumes that changes in distress are not strictly a cause but a consequence of IBS that will decrease with symptomatic improvement., Methods: We evaluated these 2 hypotheses by applying structural equation modeling (SEM) to the data set of a large number (n = 147) of Rome II diagnosed participants randomized to CBT, psychoeducation, or wait list. Per Rome guidelines, the primary end point was global improvement of gastrointestinal (GI) symptoms measured 2 weeks after a 10-week regimen. Secondary end points were distress and quality of life (QOL)., Results: SEM analyses lend support to a model in which CBT is associated with improvements in IBS symptoms, but that therapeutic gains do not depend on changes in patients' overall level of psychological distress. Symptom severity, but not clinical status (pain catastrophizing, predominant bowel habits, symptom duration, abuse, diagnosable psychiatric disorder) or relevant sociodemographic variables (eg, gender, age), moderated treatment outcome., Conclusion: CBT has a direct effect on global IBS symptom improvement independent of its effects on distress. Improvement in IBS symptoms is associated with improvements in the QOL, which may lower distress. Symptom improvements are not moderated by variables reflecting the mental well-being of IBS patients.