Virtual Reality intervention to improve quality of care during Colonoscopy: A hybrid type 1 randomized controlled trial.

BACKGROUND AND AIMS: Effective management of patients' pain, anxiety, and discomfort during colonoscopy is crucial for successful completion of the procedure, patient adherence to follow-up examinations, and patient satisfaction. Virtual Reality (VR) interventions, as a nonpharmacological and innovative solution, have demonstrated promising results in managing these outcomes. Nevertheless, there is limited evidence on their effectiveness and implementation. This trial aimed to test clinical effectiveness and identify factors to facilitate the implementation of VR during colonoscopy. METHODS: A hybrid type 1 effectiveness-implementation, parallel randomized controlled, open-label trial was conducted. Fifty patients were randomized (1:1) to a VR or a control group. The effectiveness (pain, anxiety, discomfort, medication usage, and satisfaction) and implementation (reach, adoption, implementation, and maintenance) outcomes were assessed before, during, and after colonoscopy. RESULTS: Patients in the VR group reported significantly lower pain (p=0.043) and discomfort (p<0.0001) during colonoscopy, had a higher number of completed colonoscopy without sedation (p=0.003), and showed higher satisfaction (p=0.032). The major barrier to the implementation and maintenance of the VR intervention was inadequate VR content design. Staff were most worried about altered patient communications, unclear responsibilities, increasing workload, and patient safety. Patients expressed willingness to reuse VR glasses and to suggest them to other patients. CONCLUSION: VR can be used as a nonpharmacological method for pain management and for overcoming anxiety and discomfort during colonoscopy. VR can improve patients' satisfaction and diminish the need for sedative medications; accordingly, it has the potential to promote cooperation and compliance among patients and increase screening colonoscopy rates. CLINICALTRIALS: gov NCT05723861.

Virtual reality interventions to reduce psychological distress during colonoscopy: a rapid review.

INTRODUCTION: Colonoscopy can cause psychological distress in patients, consequently discouraging patients from undergoing an unpleasant procedure or reducing compliance with follow-up examinations. This rapid review aimed to assess the feasibility and efficacy of Virtual Reality (VR) interventions during colonoscopy on patients' perceived psychological distress and procedure satisfaction. AREAS COVERED: We searched PubMed, CINAHL, ProQuest/All Databases, and Cochrane Library databases on 1 December 2022, with a date limiter of 2002-2022 for articles that investigated the effect and feasibility of any type of immersive VR-based intervention on patients' pain, anxiety, discomfort, and procedure satisfaction immediately before, during, and/or post-procedure of colonoscopy. EXPERT OPINION: Initially, 118 articles were identified, of which seven were eligible and included in this rapid review. Our findings demonstrate that VR interventions during colonoscopy were feasible, significantly reduced participant pain and anxiety, and significantly increased participant satisfaction with the procedure. VR interventions appear to be an effective alternative for patients who prefer to avoid analgetic medications or as an adjunct to routine sedation during colonoscopy. Directions of research design should focus on an optimized blinding process, using the high-end technology of 3-dimensional devices, considering an audiovisual distracting intervention, and designing multicenter and high-quality Randomized Controlled Trials.

Surgical Strategy for Contralateral Groin Management in Patients Scheduled for Unilateral Inguinal Hernia Repair: An International Web-Based Surveymonkey® Questionnaire: Strategy for Contralateral Groin Management during Inguinal Hernia Repair.

BACKGROUND: A contralateral occult inguinal hernia is frequently observed in patients planned for a unilateral laparoscopic inguinal hernia repair. Surgical strategy for contralateral groin management in patients scheduled for an endo-laparoscopic unilateral inguinal hernia repair is controversial and based on questionable evidence. This study aimed to gather international opinion concerning the surgical strategy for the contralateral asymptomatic side when no hernia or lipoma is clinically evident at the preoperative examination or anamnesis. METHODS: An international Internet-based questionnaire was sent to all the members of the European Hernia Society, the Americas Hernia Society, and the Asia Pacific Hernia Society. The clinical scenario for responders was a patient with a unilateral symptomatic inguinal hernia planned for endo-laparoscopic repair with no preoperative symptoms/lump on the contralateral side. RESULTS: A total of 640 surgeons replied (response rate = 26%), of whom 506 were included for analysis. Most surgeons had performed > 300 repairs. The preferred surgical technique was evenly distributed between laparoscopic total extraperitoneal repair and laparoscopic transabdominal preperitoneal repair. In total, 54% preferred to implant a prophylactic mesh on the contralateral side when an occult hernia was found, 47% when a lipoma was found, and 6% when no occult hernia/lipoma was identified. CONCLUSIONS: Mesh implementation was preferred by half of the endo-laparoscopic hernia surgeons for a contralateral occult hernia and/or lipoma. Although not supported by strong evidence, mesh implantation on the asymptomatic contralateral side might be cost-effective and perhaps beneficial in the long term but could be offset by increased risk of chronic pain and sexual dysfunction.

Is allergy immunotherapy with birch sufficient to treat patients allergic to pollen of tree species of the birch homologous group?

Pollen from various Fagales tree species prolongs the season and makes tree pollen allergy a major health problem. Despite involving the same causative allergens, allergy immunotherapy (AIT) treatment habits differ significantly across different geographical regions. Diagnosis and treatment with AIT in patients allergic to tree pollen were discussed by a group of German medical experts who give practical recommendations based on the available data. Regulatory perspective: According to current guidelines on allergen products, birch pollen are the representative allergen source of the birch homologous group including several Fagales trees based on sequence and structural similarity of their allergen proteins. Immunological perspective: A high level of IgE cross-reactivity towards allergens from the birch homologous group has been observed in basic research and clinical trials. Clinical perspective: Clinical trial data show that the efficacy of birch pollen AIT is not only related to birch pollen allergy but extends to pollen from other trees, especially alder, hazel and oak. In order to optimize diagnosis and treatment of tree pollen allergy, the experts recommend to focus diagnosis and respective treatment with AIT primarily to birch as the representative allergen of the Fagales tree homologous group, but further diagnostics may be needed for some patients to determine adequate treatment.

Brain swelling during dialysis: A randomized trial comparing low-flux hemodialysis with pre-dilution hemodiafiltration
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Osmotic changes in plasma are assumed to cause cerebral swelling in hemodialysis patients. We investigated the acute effect of low-flux hemodialysis (HD) (removal of small molecules) and pre-dilution hemodiafiltration (pre-HDF) (additional removal of larger molecules) on cerebral compartment volumes using quantitative magnetic resonance imaging (MRI) in chronic uremic patients. Twelve patients underwent a session of HD and pre-HDF in a randomized crossover study with equal ultrafiltration. MRI was performed immediately before and after dialysis. A linear correlation was found between changes in gray matter and plasma osmolarity (HD: r2 = 0.83; HDF: r2 = 0.73) but not between changes in white matter volume and plasma osmolarity (HD: r2 = 0.02; HDF: r2 = 0.004). Total brain volume increased by 1.8 ± 1.7% (18.7 ± 17.4 mL) (mean ± SD) during HD and 2.0 ± 0.9% (22.3 ± 10.7 mL) during pre-HDF. Gray matter volume increased: HD 3.8% (from -3.6 to 9.7) and pre-HDF 4.2% (from -2.8 to 14.3). White matter volume did not change significantly. Reduction ratio of urea (molecular weight (MW) 0.06 kDa) (HD: 68%; pre-HDF: 69.7%) and ß2-microglobulin (MW 11.7 kDa) (HD: -13.7%; pre-HDF: 67.2%) separated the treatments. This study showed that HD and pre-HDF caused equal acute cerebral swelling of the grey matter. This appeared to be driven by small solute change in plasma interacting linearly with gray matter volume regardless of additional removal of larger molecules or ultrafiltration.
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Increased Risk of Gallstone Disease Following Colectomy for Ulcerative Colitis.

OBJECTIVES: Biochemical studies suggest that patients who have had a colectomy or restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) are at an increased risk of developing gallstone disease, but epidemiological studies are lacking. We evaluated the risk of gallstone disease following colectomy and IPAA. METHODS: Individuals who had a colectomy were identified from a national cohort of patients with ulcerative colitis (UC), and controls without colectomy were sampled from within the same cohort, matching on gender, calendar year, and year of birth. We used Cox regression to examine the effect of colectomy on the hazard rates of gallstone disease and cholecystectomy, adjusting for alcoholism, stroke, chronic obstructive pulmonary disease, cancer, cardiac disease, diabetes mellitus, hypothyroidism, hyperlipidemia, cirrhosis, obesity, renal failure, and transient ischemic attacks. The effect of an IPAA was determined for patients who had colectomy by including the procedure as a time-dependent variable. RESULTS: We identified 4548 patients and matched these to 44 372 controls without colectomy. During a median follow-up of 11.9 years, 1963 patients were hospitalized for gallstone disease. Patients who had a colectomy were at an increased risk (adjusted hazard ratio (HR)=1.63 (1.39-1.91)), and sensitivity analyses of the risk of undergoing cholecystectomy revealed a similar association (adjusted HR=1.55 (1.22-1.98)). An IPAA did not affect the risk of developing gallstones among patients who had a colectomy (adjusted HR=1.03 (0.77-1.37)). CONCLUSION: The risk of gallstone disease increases following colectomy for UC.

Extensive IgE cross-reactivity towards the Pooideae grasses substantiated for a large number of grass-pollen-sensitized subjects.

BACKGROUND: Allergy to taxonomically related species is a common phenomenon caused by the same immunological receptor cross-reacting to homologous allergens from different species. Knowledge of patterns of cross-reactivity is crucial for the selection of optimal products for diagnosis and for specific immunotherapy. The objective of this study was to investigate patterns of serum IgE cross-reactivity towards pollens from various grass species. METHODS: With grass group 1 allergens as the representative group, amino acid sequence alignment, structural modelling and comparison of 3D surface characteristics were performed to exemplify the molecular basis of IgE cross-reactivity. IgE binding to extracts from ten different grass species was determined (total number of data pairs >19,000), and IgE inhibition experiments using Phleum pratense were performed. RESULTS: Analysis of surface topography for group 1 grass allergens demonstrated ample space for IgE binding epitopes in surface areas conserved among Pooideae grasses. Significant correlation was observed between the serum IgE response to P. pratense extract and extracts from the other Pooideae grasses analyzed. P. pratense extract was demonstrated to inhibit the binding of IgE to the allergens in all of the extracts included in the investigation, indicating patient IgE to be primarily directed towards common epitopes. CONCLUSION: Extensive IgE cross-reactivity was observed towards the allergens of the Pooideae grasses, meaning that the immune system does not appear to distinguish based on the IgE level between the different species of this subfamily. The data suggest equal effect upon use of any of the Pooideae species for diagnostic as well as therapeutic purposes.

The association between atopy and factors influencing folate metabolism: is low folate status causally related to the development of atopy?

BACKGROUND: Deficiency of folate has been associated with several disorders characterized by enhanced activation of the cellular immune system (non-allergic th1 type immune response). Whether folate status is also associated with atopic disease (allergic th2 type immune response) is unknown. We aimed at examining the association between atopy and markers of impaired folate metabolism, i.e. MTHFR(C677T) genotype, plasma total homocysteine, and dietary intakes of methionine, folates, and vitamins B12, B6, and B2. METHODS: Cross-sectional population-based study of 1,671 male and female residents of Copenhagen County, Denmark, aged 30-60 years participating in a health examination during 1999-2001. Atopy was defined as positive levels of specific IgE against a panel of inhalant allergens. MTHFR(C677T) genotype was determined by PCR followed by restriction fragment length polymorphism analyses. Total homocysteine was measured by fluorescent polarization immunoassay. Dietary vitamin intakes were estimated from a semi-quantitative food frequency questionnaire. RESULTS: The prevalence of atopy was associated with MTHFR(C677T) genotype. TT individuals had a significantly higher risk of atopy compared with CC/CT individuals [odds ratio 1.76, 95% confidence interval (95% CI) 1.19-2.60]. Additionally, gene-diet interaction effects were identified. Dietary markers were negatively associated with risk of atopy in persons with the TT genotype. Total homocysteine was not related to atopy (odds ratio per 5 mumol/l = 1.12, 95% CI 0.98-1.29). CONCLUSIONS: The results suggest that an impaired folate metabolism may be causally related to the development of atopy.

Sublingual immunotherapy with once-daily grass allergen tablets: a randomized controlled trial in seasonal allergic rhinoconjunctivitis.

BACKGROUND: Specific immunotherapy is the only treatment modality that has the potential to alter the natural course of allergic diseases. Sublingual immunotherapy has been developed to facilitate access to this form of treatment and to minimize serious adverse events. OBJECTIVE: To investigate the efficacy and safety of sublingual grass allergen tablets in seasonal allergic rhinoconjunctivitis. METHODS: A multinational, multicenter, randomized, placebo-controlled trial conducted during 2002 and 2003. Fifty-five centers in 8 countries included 855 participants age 18 to 65 years who gave a history of grass pollen-induced allergic rhinoconjunctivitis and had a positive skin prick test and elevated serum allergen-specific IgE to Phleum pratense. Participants were randomized to 2500, 25,000, or 75,000 SQ-T grass allergen tablets (GRAZAX; ALK-Abelló, Hørsholm, Denmark) or placebo for sublingual administration once daily. Mean duration of treatment was 18 weeks. RESULTS: Average rhinoconjunctivitis scores during the season showed moderate reductions of symptoms (16%) and medication use (28%) for the grass allergen tablet 75,000 SQ-T (P = .0710; P = .0470) compared with placebo. Significantly better rhinoconjunctivitis quality of life scores (P = .006) and an increased number of well days (P = .041) were also observed. Efficacy was increased in the subgroup of patients who completed the recommended preseasonal treatment of at least 8 weeks before the grass pollen season (symptoms, 21%, P = .0020; and medication use, 29%, P = .0120). No safety concerns were observed. CONCLUSION: This study confirms dose-dependent efficacy of the grass allergen tablet. Although further studies are required, the greater tolerability of the tablet may permit immunotherapy to be available to a much broader group of patients with impaired quality of life caused by grass pollen allergy. CLINICAL IMPLICATIONS: For patients with grass pollen allergy, sublingual immunotherapy is well tolerated and can reduce symptoms and improve quality of life.

Performance evaluation of a specific IgE assay developed for the ADVIA centaur immunoassay system.

OBJECTIVE: To develop and evaluate a liquid phase immunoassay for accurate determination of allergen-specific IgE (sIgE) as a useful tool in the diagnosis of allergy patients. DESIGN AND METHODS: A fully automated, quantitative sIgE assay was developed for the ADVIA Centaur technology platform using a unique calibration method based on a recombinant reference allergen. Compared to most other IgE-assays, the assay employs a reverse sandwich architecture using monoclonal mouse anti-human IgE antibody covalently bound to paramagnetic particles in the solid phase and capturing the sample IgE. Bound sIgE reacts with liquid biotin-labeled allergen, which is detected as chemiluminescence using acridiniumester-labeled streptavidin. RESULTS: The ADVIA Centaur sIgE assay (Centaur assay) has exclusive reactivity to human IgE and performs with excellent linearity in the assay range 0.35-100 kU/L and high precision (imprecision within-run <2.6%, between-run <4.9%, and total imprecision <7.1%). The analytical sensitivity is <0.10 kU/L. Using Pharmacia CAP system FEIA (CAP) as a comparative method, positive/negative concordance was 94% at 0.35 kU/L cut-off, and the Centaur assay has a sensitivity of 90% and a specificity of 98%. Validation of the assay in a general population sample (The Copenhagen allergy study) revealed that sIgE was highly associated with a clinical diagnosis of inhalation allergy. CONCLUSIONS: The Centaur assay is an allergen-specific assay for measurement of IgE without interference from other types of immunoglobulins or nonspecific IgE. The assay performs with a linear reaction, high assay range, and good reproducibility. The assay correlates well with the CAP system and is in agreement with clinical diagnosis.

Effect of nutritional support on clinical outcome in patients at nutritional risk.

BACKGROUND & AIMS: Undernourished patients have an increased risk of complications and a prolonged hospital stay, compared to those who are not undernourished. The aim of this study was to evaluate the effect of nutritional intervention in a random sample of hospitalized patients at nutritional risk. METHODS: A randomized, controlled trial of nutritional intervention in 212 patients. Intervention consisted of a specialized nutritional team (nurse and dietician) who attended patients and staff for motivation, detailed a nutritional plan, assured delivery of prescribed food and gave advice on enteral or parenteral nutrition when appropriate. The control group received the standard regime used in the department. The primary endpoint was the part of the length of stay (LOS) that was considered to be sensitive to nutritional support, designated LOSNDI. The nutritional discharge index (NDI) consists of three objective criteria: (1) the patient is able to manage toilet visits without assistance, reflecting mobilization; (2) the patient is without fever (tp < 38 degrees C), reflecting absence of infection; and (3) the patient has no intravenous access, reflecting absence of complications in general. On the day when all three criteria were fulfilled, hospital stay was no longer considered to be sensitive to nutritional support. Actual LOS is also reported. Incidence and severity of complications were recorded to explain LOSNDI findings. As a secondary endpoint, quality of life was evaluated by the Short Form 36 (SF-36) questionnaire. RESULTS: Intervention led to an intake of > or = 75% of requirements in 62% of the intervention patients, as compared to 36% of the control patients. Rates of complications, mean LOSNDI and LOS were not significantly different between the two study groups. However, among patients with complications a difference in LOSNDI between intervention patients (14 +/- 2 days, mean +/- SE) and control patients (20 +/- 2 days) was statistically significant (P = 0.015). In the same patients, LOS was 17 +/- 2 days in the intervention group and 22 +/- 2 days in the control group (P = 0.028). The SF-36 questionnaire did not show a significant effect of treatment. CONCLUSIONS: Protein and energy intake of nutritionally at-risk patients was increased which resulted in shortening of the part of the length of stay that was considered to be sensitive to nutritional support (LOSNDI) and shorter length of stay (LOS) among patients with complications.