Standard Course Research Articles

Modified FOLFIRINOX (mFOLFIRINOX) as neoadjuvant therapy and 'salvage' in patients with high risk locally advanced rectal cancers - tolerance and early outcomes.

There is limited data with regard to the use of modified 5-fluoroural-leucovorin-irinotecan-oxaliplatin (mFOLFIRINOX) in terms of tolerance and enabling total mesorectal excision (TME) of locally advanced rectal adenocarcinomas (LARC) with high-risk characteristics (T4b status, signet ring histology etc) post standard neoadjuvant long course chemoradiation (NACTRT) or short course radiation (SCRT) and chemotherapy. Patients with LARC from January 2018 to December 2020 receiving mFOLFIRINOX post NACTRT/SCRT to facilitate TME were evaluated. The primary endpoint was assessment of grade 3 and grade 4 treatment related toxicity and TME rates. Event free survival (EFS), where event was defined as disease progression or recurrence post resection after mFOLFIRINOX, was calculated by Kaplan Meier method. Forty-seven patients were evaluated with a median age of 33 years (Range:18-59), 45% T4b status, 96% radiological circumferential margin (CRM) involved (79% CRM positive post NACTRT/SCRT), 43% extramural venous invasion (n=33) and 36% signet ring histology. 62% had received prior NACTRT and 38% had received SCRT with chemotherapy before receiving mFOLFIRINOX. The most common grade 3 and grade 4 treatment related side effects included diarrhoea (7%), anaemia (4%) and infections (4%). Intended duration of mFOLFIRINOX or beyond was completed in 94% of patients. 60% of patients underwent curative local resection with R0 resection rates of 100% (n=28) and pathological complete response rates of 21%. The most common surgeries done were exenterations and abdominoperineal in 22% and 17% patients respectively. With a median follow up of 19 months, 24 patients had recurred or progressed for a median EFS of 20 months [95% confidence interval (CI): 15-24]. Locally advanced rectal cancers with high-risk characteristics are a niche group of cancers with less-than-optimal outcomes post standard neoadjuvant strategies. mFOLFIRINOX appears to be well tolerated and enables TME in a significant proportion of these patients.

Efficacy of a Relaxation Scenario in Virtual Reality for the Comorbid Symptoms of Anxiety and Asthenia in a General Hospital Setting: A Pilot Comparative Randomized Open-Label Study.

Patients in general hospitals often display concomitant signs of mental maladjustment: low mood, anxiety, apathy, asthenia, all of which can have a negative impact on the course of the underlying disease and the recovery process. One of the non-pharmacological approaches that has gained wider acceptance in medical practice in recent years is the use of procedures based on virtual reality. Assess the efficacy of the new domestic, virtual reality application Flow as relates to symptoms of anxiety and asthenia in patients undergoing inpatient treatment. The study was open-label and had a comparison group; the patients were assigned to the experimental or control group using a randomization table. The patients were assessed using the Spielberger State Anxiety Inventory; the Fatigue Symptom Rating Scale; the Well-being, Activity, Mood questionnaire; the Depression Anxiety Stress Scale; and the Clinical Global Impression Scale. Physical parameters were measured before and after each virtual reality session. The obtained data were statistically processed. The study involved 60 patients. In 40 patients, the treatment program included a course of five daily relaxation sessions in virtual reality; the control group consisted of 20 patients, who were treated in accordance with the usual practice of the institution. The addition of virtual reality sessions to the standard treatment course yielded significant advantage in terms of affective symptoms reduction in patients both after a single session and as a result of undergoing the full course, and several days after its completion. The patients in the experimental group also showed a significant decrease in blood pressure after the sessions, and this was most pronounced in individuals who initially had elevated and high blood pressure. The use of relaxation program courses in the virtual reality application Flow is an effective and promising means of non-pharmacological care for non-psychiatric inpatients showing symptoms of anxiety, apathy, depressive mood, as well as hypertension.

The learning curve for gasless transaxillary posterior endoscopic thyroidectomy for thyroid cancer: a cumulative sum analysis.

Gasless transaxillary posterior endoscopic thyroidectomy (GTPET) is a new approach for thyroid cancer. It allows en bloc resection of the thyroid and central lymph nodes. Few studies have reported on the learning curve for GTPET.We examined the learning curve of GTPET for thyroid cancer by cumulative sum (CUSUM) analysis by retrospectively analyzing patients who underwent hemithyroidectomy with ipsilateral central neck dissection between December 2020 and September 2021 at a tertiary medical center, including the first patient. Moving average analysis and sequential time-block analysis were used for validation. Data on the clinical factors between the two periods were compared. In the overall cohort, the average time for GTPET for thyroid cancer was 113.25min to harvest an average of 6.4 central lymph nodes. The CUSUM curve of the operative time indicated an inflection point after 38 patients. Moving average analysis and sequential time-block analysis validated the number of procedures needed for GTPET proficiency. (124.05min vs. 107.63min for the unproficient period vs. proficient period, respectively; P < 0.001) The number of retrieved lymph nodes was not associated with a certain level of proficiency per the learning curve. The main complication during the surgeon's unproficient period was transient hoarseness (3/38), which was similar to that in their proficient period (2/73, p = 0.336). Proficiency in GTPET is associated with performing more than 38 procedures. Standard course training and instruction on careful management are required prior to introducing the procedure.

Development of Vaccines in Celiac Disease Therapies

In Western countries, celiac disease is a relatively common genetic immune disorder. When a patient ingests foods containing gluten, the gluten protein acts as an allergen and can cause the patient to develop the disease. The disease is not directly fatal, but its onset can be very uncomfortable for the patient, and its complications may lead to an increased chance of developing certain cancers. A lifetime gluten-free diet has already been the standard course to prevent celiac disease symptoms, but it can be challenging. In past studies, researchers have attempted to prevent patients from developing or mitigating their condition through vaccines as a treatment. However, with research stagnating and clinical trials being canceled, the production of a celiac disease vaccine is currently experiencing a bottleneck. Fortunately, the treatment of celiac disease is not the only way to build tolerance through vaccines; other therapies under investigation as well as new vaccine design ideas may be effective in treating celiac disease. This review systematically summarizes the scientific status of the celiac disease and discusses the potential of vaccine as a promising treatment for celiac disease.

Safer cycling in older age (SiFAr): effects of a multi-component cycle training. a randomized controlled trial

BackgroundThe risk of older adults being injured or killed in a bicycle accident increases significantly due to the age-related decline of physical function. Therefore, targeted interventions for older adults to improve safe cycling competence (CC) are urgently needed.MethodsThe “Safer Cycling in Older Age” (SiFAr) randomized controlled trial investigated if a progressive multi-component training program related to cycling improves CC of older adults. Between June 2020 and May 2022, 127 community-dwelling persons living in the area Nürnberg-Fürth-Erlangen, Germany aged 65 years and older were recruited, who are either (1) beginners with the e-bike or (2) feeling self-reported unsteadiness when cycling or (3) uptaking cycling after a longer break. Participants were either randomized 1:1 to an intervention group (IG; cycling exercise program, 8 sessions within 3 months) or an active control group (aCG; health recommendations). The CC as primary outcome was tested not blinded in a standardized cycle course prior and after the intervention period and after 6–9 months, which consists of variant tasks requiring skills related to daily traffic situations. Regression analyses with difference of errors in the cycling course as dependent variable and group as independent variable adjusted for covariates (gender, number of errors at baseline, bicycle type, age and cycled distance) were performed.Results96 participants (73.4 ± 5.1 years; 59.4% female) were analyzed for primary outcome. Compared to the aCG (n = 49), the IG (n = 47) made an average of 2.37 fewer errors in the cycle course after the 3 months intervention period (p = 0.004). People with more errors at baseline had higher potential for improvement (B=-0.38; p < 0.001). Women on average made 2.31 (p = 0.016) more errors than men, even after intervention. All other confounders had no significant effect on the difference in errors. The intervention effect was very stable until 6–9 months after the intervention (B=-3.07, p = 0.003), but decreased with a higher age at baseline in the adjusted model (B = 0.21, p = 0.0499).ConclusionThe SiFAr program increases cycling skills among older adults with self-perceived needs for improvement in CC and could easily be made available to a broad public due to its standardized structure and a train-the-trainer approach.Trial RegistrationThis study was registered with clinicaltrials.gov: NCT04362514 (27/04/2020), https://clinicaltrials.gov/ct2/show/NCT04362514.

Research on the Application of Language Input and Interaction Hypothesis in HSK Personalized Tutoring

This paper briefly introduces three hypotheses in the theory of language input and interaction, and some related researches. Guided by the theories of comprehensible input, semantic negotiation and effective output, we carried out a teaching experiment aimed at improving the primary teaching of HSK standard course through two teaching observations and reflections. The teaching experiment proves that the improved teaching design can promote learners to learn Chinese more effectively. At the same time, the author also points out the problems in the teaching of Chinese as a foreign language by applying the principles of comprehensible input and semantic negotiation, and that the theory should be applied to promote the innovation of the method of teaching Chinese as a foreign language.

Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis (RECORDS): study protocol for a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial

IntroductionCorticosteroids affect variably survival in sepsis trials, suggesting heterogeneity in patients’ response to corticosteroids. The RECORDS (Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis) trial aimed at defining endotypes associated...

Congenital hand malformations in an anatomical donor: a potential case of brachydactyly type B

This study investigates the anatomy of a cadaveric hand presenting with a rare malformation that we identified as a form of brachydactyly. We performed a layer-by-layer dissection of the affected cadaveric hand and documented both the normal and variant anatomical compositions that were present. The osteology revealed complete aplasia of the proximal and middle phalanges of the second, third, fourth, and fifth digits along with truncated distal phalanges of the fourth and fifth digits. The radius, ulna, carpal bones, and the first digit were unremarkable. Neurovasculature followed standard anatomical courses. Normal development of surrounding musculature was observed. Congenital hand malformations are infrequently observed in the anatomy lab and provide a unique learning opportunity for students and faculty alike. While hand deformities are frequently imaged through noninvasive techniques such as X-rays and CT imaging, they are infrequently dissected. Through dissection, clinicians and anatomists may be able to adopt a more tangible appreciation for the underlying anatomy of this condition.

Occupational exposure to blood and body fluids among prehospital emergency medical services workers in Mashhad, Northeast of Iran

This study aimed to assess occupational exposure to blood and body fluids (BBFs) and the use of protective equipment among prehospital emergency medical services (EMS) workers in Mashhad, Iran. This cross-sectional questionnaire survey-based study was conducted from July 2020 to March 2021 in Mashhad. All prehospital EMS workers of Mashhad were invited to participate in the study using the census technique. The questionnaire was about occupational exposure to BBFs, infection control, protective measures, health program, and demographic information. In total, 442 participants answered the questionnaire (response rate: 82.77%). Based on the findings, 420 (95.2%) and 402 (91.2%) participants had been exposed to BBFs as prehospital EMS workers. Moreover, 31.5% and 38.5% of these exposures were caused by contaminated needles and lancets, respectively. The BBFs incidents have occurred despite 98% of the EMS workers reporting there is a needle safety disposable box in the ambulance. The relationship between awareness of precaution measures after exposure to BBFs and training course completion was significant (P < .0001). This study demonstrated the high prevalence of occupational exposures to BBFs among prehospital EMS workers. Considering the significant relationship between the completion of standard precautions courses and awareness of BBFs' postexposure measures, it is recommended to consider multi-faceted strategies for continuous monitoring, training, and follow-up of prehospital EMS workers.

Evaluación del entrenamiento visual sobre habilidades físicas y funciones visuales en adultos mayores de Bucaramanga, Colombia

Introduction: Visual training has been used to improve locomotion fall risk in older adults. Objective: This study evaluates the effects of visual training on physical abilities and visual functions of older adults from Bucaramanga, Colombia. Methodology: A quasi-experimental study of older adults who underwent visual evaluation and assessment of physical abilities through the Senior Fitness Test, a standardized obstacle course, and the eye-hand coordination test. For 10 weeks, all adults attended daily recreational physical activities. Additionally, those assigned to the experimental group received a weekly session of visual training. Results: A total of 52 adults with a median age of 68.5 years were enrolled. Of the participants, 84.21% (48) were female and 93.94% were obese. Normal values were presented for aerobic resistance and lower and upper limb strength. Overall, 91.3% (21) had no ocular pathologies impacting visual acuity. Those who received visual training showed statistically significant improvements in the time it took to run the obstacle course and on the eye-hand coordination test. Conclusions:Visual training has a positive effect on hand-eye coordination, vision-mediated locomotion, and balance in older adults. These results suggest that virtual reality may enhance reaction speed, balance, and coordination.

Comparison of Benefits and Risks Associated with Anti-T-Lymphocyte Globulin (ATLG) Serotherapy in Methotrexate (MTX)- versus Mycophenolate Mofetil (MMF)-Based Hematopoietic Stem Cell Transplantation

Background: Serotherapy with anti-T lymphocyte globulin (ATLG, Grafalon, formerly ATG-Fresenius) is established for the prevention of severe graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation (HSCT). The evidence from prospective studies is predominantly derived from a setting where methotrexate (MTX) and a calcineurin inhibitor (CNI) are used as the backbone of GVHD prophylaxis. The efficacy of ATLG in combination with CNI and mycophenolate mofetil (MMF) has not been investigated as much, particularly in terms of a direct comparison with its effects when combined with CNI/MTX. A total of 401 HSCTs from two Austrian transplant centers were retrospectively evaluated. We included peripheral blood transplants from early- or intermediate-stage (excluding advanced/refractory) hematological diseases from matched siblings or 10/10 or 9/10 matched unrelated donors with CNI/MTX or CNI/MMF prophylaxis, either without (n = 219) or with ATLG (n = 182). Overall, ATLG significantly reduced the risk for all-cause mortality by multivariate Cox analysis (HR 0.53; p = 0.002). Stratification by postgrafting prophylaxis type revealed a significant survival advantage for ATLG in the CNI/MMF cohort (HR 0.49; p = 0.001; n = 193), while its effect on survival in the CNI/MTX cohort was not significant (HR 0.87; p = 0.56; n = 208). In unrelated HSCT with CNI/MMF prophylaxis, ATLG exhibited its greatest survival benefit (HR 0.34; p = 0.001; n = 104). In the context of CNI/MMF, ATLG may provide even greater benefits than in the setting of CNI/MTX for post-grafting immunosuppression. Future prospective studies on ATLG should therefore focus on CNI/MMF-based transplants, which are widely performed in elderly or comorbid patients not expected to tolerate a standard course of MTX.

Needs Analysis of Aircraft Mechanics’ English Language Skills

English is used in all parts of aviation, especially in aircraft maintenance, where all documentation and various manuals are written in this language. However, there are no formal requirements for aircraft mechanics to have a certain level of English. Nevertheless, aircraft mechanics must master their English language skills, since they are needed for managing their work tasks. This study deals with the issue of insufficiency of standardized English courses, and determines the English language needs of aircraft maintenance in the Slovak Republic, using a triangular approach. The gathered data from 80 respondents for this paper were subjected to descriptive and inferential statistics, which were calculated by the means of Jamovi statistical software. The results revealed that aircraft mechanics engage most often in communication situations that require their knowledge of the reading skill. The importance of all language skills (reading, writing, listening, speaking) is proven by the determination of the most-common communication activities of aircraft mechanics, which should be included in specialized English courses. The results of this study are useful in the creation of language courses which increase the level of English in aircraft maintenance, thus, increasing safety in aviation.

A Phase 1b/2 Study of Atezolizumab with or Without Bacille Calmette-Guérin in Patients with High-risk Non–muscle-invasive Bladder Cancer

BackgroundBacille Calmette-Guérin (BCG) is the standard therapy after transurethral resection of bladder tumour for high-risk non–muscle-invasive bladder cancer (NMIBC). However, post-BCG recurrence/progression occurs frequently, and noncystectomy options are limited. ObjectiveTo evaluate the safety and clinical activity of atezolizumab ± BCG in high-risk BCG-unresponsive NMIBC. Design, setting, and participantsThis phase 1b/2 GU-123 study (NCT02792192) treated patients with BCG-unresponsive NMIBC who had carcinoma in situ with atezolizumab ± BCG. InterventionPatients in cohorts 1A and 1B received atezolizumab 1200 mg IV q3w for ≤96 wk. Those in cohort 1B also received standard BCG induction (six weekly doses) and maintenance courses (three doses weekly starting at month 3) with optional maintenance at 6, 12, 18, 24, and 30 mo. Outcome measurements and statistical analysisCoprimary endpoints were safety and 6-mo complete response (CR) rate. Secondary endpoints included 3-mo CR rate and duration of CR; 95% confidence intervals were calculated using the Clopper-Pearson method. Results and limitationsAt data cut-off (September 29, 2020), 24 patients were enrolled (cohort 1A, n = 12; cohort 1B, n = 12), and the recommended BCG dose was 50 mg in cohort 1B. Four patients (33%) had adverse events (AEs) leading to BCG dose modification/interruption. Three patients (25%) in cohort 1A reported atezolizumab-related grade 3 AEs; cohort 1B had no atezolizumab- or BCG-related grade ≥3 AEs. No grade 4/5 AEs were reported. The 6-mo CR rate was 33% in cohort 1A (median duration of CR, 6.8 mo) and 42% in cohort 1B (median duration of CR, not reached [≥12 mo]). These results are limited by the small sample size of GU-123. ConclusionsIn this first report of the atezolizumab-BCG combination in NMIBC, atezolizumab ± BCG was well tolerated, with no new safety signals or treatment-related deaths. Preliminary results suggested clinically meaningful activity; the combination favoured a longer duration of response. Patient summaryWe studied atezolizumab with and without bacille Calmette-Guérin (BCG) to determine whether this combination was safe and had clinical activity in patients with high-risk noninvasive bladder cancer (high-grade bladder tumours that affect the outermost lining of the bladder wall) that has previously been treated with BCG and is still present or occurred again. Our results suggest that atezolizumab with or without BCG was generally safe and could be used to treat patients unresponsive to BCG.

Prevention of recurrence of bacterial vaginosis using lactobacilli-containing vaginal tablets among women with HIV: a randomized, placebo-controlled, double-blinded phase IV trial

ObjectivesThe effectiveness of lactobacilli-containing vaginal tablets (VT) in bacterial vaginosis (BV) recurrence prevention among women infected with HIV treated with standard oral metronidazole in Pune, India was studied. MethodsWomen infected with HIV with confirmed BV diagnosis (Nugent score ≥7 and Amsel criteria >3) were enrolled in a 12-month, double-blind, randomized, placebo-controlled, phase IV study between 2018 and 2021. After a standard course of oral metronidazole for 7 days (400 mg three times a day), women were randomly assigned to either lactobacilli-containing or placebo VT arms to receive VTs for 4 months. BV recurrence was assessed after the initial cure from BV. ResultsOf the 464 women infected with HIV, 80 women with confirmed BV were enrolled. The retention was affected due to the COVID-19 pandemic (6-month retention rates 78%). The cure was seen in 85% and 93.5% of participants from the treatment and placebo arms, respectively, after four VT cycles. BV recurrence was seen in 41.4% and 44.8% in the treatment and placebo arm, respectively, with no significant difference in the two groups. ConclusionThe lactobacilli-containing VT was acceptable and safe; however, the addition of VT over standard oral metronidazole did not show any additional benefit in the prevention of BV recurrence in women infected with HIV, indicating the need for long-term randomized trials among them. Registered at Clinical Trials Registry- India, (CTRI) Number: CTRI/2018/04/013298

The Short versus Long Antibiotic Course for Pleural Infection Management (SLIM) randomised controlled open-label trial.

Based on expert opinion, the length of antibiotic treatment for pleural infection in adults is typically recommended to be a minimum of 4 weeks. This clinical trial aimed to assess whether shorter antibiotic courses lead to more treatment failures than standard longer courses. In an open-label randomised controlled trial, adult patients with pleural infection who were medically treated and stabilised within 14 days of admission were randomised to either a short antibiotic course (total course 14-21 days) or a long antibiotic course (total course 28-42 days). Patients were excluded if their baseline RAPID score was >4 (high-risk category). The primary outcome was the incidence of treatment failure by 6 weeks post-admission. Secondary outcomes were total length of antibiotic treatment, proportion of patients who resumed normal activity levels within 6 weeks post-admission, time from discharge to resuming normal activity levels and incidence of antibiotic-related adverse reactions. Between September 2020 and October 2021, 50 patients (mean±sd age 46±13.7 years; 35 (70%) males) were recruited to the trial and randomly assigned to the short course group (n=25) or the long course group (n=25), with outcome data available for 24 patients in each study group. Treatment failure occurred in four (16.7%) patients in the short course group and three (12.5%) patients in the long course group. In the intention-to-treat analysis the OR for treatment failure in the long course group was 0.714 (95% CI 0.142-3.600; p=0.683). The median (interquartile range) duration of antibiotic treatment in the short course group was 20.5 (18-22.5) days compared with 34.5 (32-38) days in the long course group (p<0.001). There were no statistically significant differences in the other outcomes. In medically treated adult patients with pleural infection a long course of antimicrobial therapy did not lead to fewer treatment failures compared with a shorter course. These findings need to be confirmed in a larger multicentre trial.

Cost and Prescriber and Patient Characteristics of Cenegermin Use in the Medicare Population

To assess the cost and prescriber and patient characteristics associated with the early use of cenegermin (OXERVATE) after its approval among Medicare beneficiaries to better define resource use and areas for improvement in the treatment of neurotrophic keratopathy. Retrospective, cross-sectional study. Medicare Part D claims data of all cenegermin prescriptions from January 1, 2019, to December 31, 2020, were identified using its National Drug Code. Patients younger than 65 years and those with missing demographic characteristics were excluded. Information on patient and prescriber demographic characteristics, quantity of cenegermin prescription, gross drug costs, and patient out-of-pocket costs were extracted from each claim. In 2019-2020, a total of 2410 Medicare beneficiaries aged 65 years or older were prescribed cenegermin. The mean (standard deviation [SD]) age of these patients was 77.3 (7.6) years. Most patients were female (63.6%), White (87.3%), and lived in urban areas (86.9%). The majority (72%) received a standard 8-week course. A total of 1025 clinicians prescribed cenegermin. Most were male (68.2%), in an urban setting (90.8%). The median (interquartile range [IQR]) duration of cenegermin therapy prescribed per patient by each clinician was 8 (7.5-8) weeks. Total gross drug cost of all cenegermin therapy over the study period was $287 million. Median (IQR) out-of-pocket patient cost was $5791 (180-7179). Despite the clinical benefits of cenegermin therapy, the associated significant cost warrants further analysis of its cost-effectiveness in patient care, especially in comparison with alternative novel management options.

Molecular classification and therapeutics in diffuse large B-cell lymphoma.

Diffuse large B-cell lymphoma (DLBCL) encompasses a wide variety of disease states that have to date been subgrouped and characterized based on immunohistochemical methods, which provide limited prognostic value to clinicians and no alteration in treatment regimen. The addition of rituximab to CHOP therapy was the last leap forward in terms of treatment, but regimens currently follow a standardized course when disease becomes refractory with no individualization based on genotype. Research groups are tentatively proposing new strategies for categorizing DLBCL based on genetic abnormalities that are frequently found together to better predict disease course following dysregulation of specific pathways and to deliver targeted treatment. Novel algorithms in combination with next-generation sequencing techniques have identified between 4 and 7 subgroups of DLBCL, depending on the research team, with potentially significant and actionable genetic alterations. Various drugs aimed at pathways including BCR signaling, NF-κB dysfunction, and epigenetic regulation have shown promise in their respective groups and may show initial utility as second or third line therapies to patients with recurrent DLBCL. Implementation of subgroups will allow collection of necessary data to determine which groups are significant, which treatments may be indicated, and will provide better insight to clinicians and patients on specific disease course.

P513 Prospective study on patients’ satisfaction and impact on quality of life of corticosteroid therapy in patients with Inflammatory Bowel Disease

Abstract Background Corticosteroids (Cs) remain the first-line therapy for moderate-to-severe flares in patients with inflammatory bowel disease (IBD), both Crohn’s disease (CD) and ulcerative colitis (UC). On the other hand, their use has been associated to multiple adverse events (AEs) in randomized controlled trials and registries. Nevertheless, recent studies have repeatedly observed that the use of Cs has not decreased in spite of the increasing availability of biological agents and new small molecules licensed for IBD. The impact of Cs therapy on patients’ quality of life (QoL) and the patients’ perception on Cs have not been properly assessed in IBD. The purpose of this study was to assess the impact of a standard Cs course on the patients’ QoL and their satisfaction with treatment. Methods A prospective, longitudinal and observational study was conducted in adult IBD. All subjects received the same standard Cs regimen: starting dose of 1mg/kg/day (maximum 60mg/day) and tapering after 14 days with 10mg per week until reach 20mg/day, thereafter reduction was 5mg per week. QoL was assessed by the IBDQ-9 questionnaire at baseline, week 4 and at the end of Cs. Treatment satisfaction was assessed by the TSQM1.4 questionnaire at week 4 and at the end of Cs. Results Sixty-three patients were included in the study (54% CD and 43% UC; mean age 38.5±14.9 years; 46%females). Cs therapy failed in 41% of cases (active disease upon Cs discontinuation or need for rescue therapy). AEs attributable to Cs were reported in 84.1%, the most frequent were dermatologic (acne and moon face) (60.3%), hypokalemia (44.8%) and poor quality of sleep (40%). Serious AEs were reported in 20,6%, mostly mild or moderate infections that resolved without sequelae. IBDQ-9 scores increased 12.4 and 13.5 points at 4 weeks and at the end of Cs, respectively (p&amp;lt;0.05). Improvement in QoL was not associated with any of the analysed factors (gender, age, type of IBD, response to treatment and AEs). The overall degree of satisfaction with Cs was 68.5 over 100 points, with the highest score related to satisfaction with adverse events (82/100). Satisfaction with treatment was only associated with the achievement of clinical remission or development of steroid dependence. Conclusion A standard Cs course significantly increases the QoL of patients with IBD. Furthermore, a high satisfaction with treatment was perceived by patients.

The HEADS: UP Development Study: Working with Key Stakeholders to Adapt a Mindfulness-Based Stress Reduction Course for People with Anxiety and Depression after Stroke.

Following stroke, rates of mood disorder are and remain high at five years (anxiety 34.4%; depression 23%). Structured mindfulness-based stress reduction (MBSR) courses are effective in a range of health conditions, but stroke survivors find adherence challenging. We aimed to adapt a standard MBSR course specifically for people affected by stroke. We recruited stroke survivors and family members with symptoms of anxiety and/or depression to take part in a co-development study comprising two rounds of MBSR 'taster' sessions, followed by focus groups in which views were sought on the practices sampled. Data were collected in October 2017 and May 2018 and were analysed using framework analysis, informed adaptations to mindfulness materials and delivery. Twenty-eight stroke survivors and seven family members participated. Nineteen (76%) stroke survivors had anxiety; 15 (60%) had depression. Five (71.4%) family members reported anxiety; n = 4 (57.1%) depression. Thirty participants attended the first round of taster sessions and focus groups; twenty (66%) the second and three (10%) were unable to attend either round. Framework analysis informed adaptations to course delivery, practices, and materials, ultimately resulting in a stroke-specific MBSR course, HEADS: UP (Helping Ease Anxiety and Depression after Stroke). HEADS: UP may provide a feasible, appropriate, and meaningful self-management intervention to help alleviate symptoms of mood disorder.

Hardware methods for dynamic stereotype gait training in patients of older age groups

Purpose of the study: to evaluate the effectiveness of the hardware biofeedback video gait reconstruction for training balance and dynamic stereotype in patients of the older age group, in order to prevent the risk of falls. The study included 40 participants, aged 78.2±9.4 years. The patients were divided into two groups: group 1, main (n=20), and group 2, control (n=32). All patients received a standard course of treatment, including group therapeutic exercises and massage according to the relaxing method of the classical therapeutic collar zone massage. The duration of the rehabilitation course in a round-the-clock hospital was 10 days. In addition to the basic course of rehabilitation, the patients of the main group had training using the C–Mill biofeedback sensor treadmill. As a result of the study, a significant improvement in the submetric indicators of the dynamic gait stereotype and the degree of mobility was noted in the patients of the main group, compared to the control group. The obtained results of the effective use of the method of hardware balance training indicate the prospect of including this technology in the rehabilitation programs for elderly patients to improve the dynamic stereotype and increase stability during walking.