Economic evaluation of the Very Early Rehabilitation in SpEech (VERSE) intervention.

INTRODUCTION: There is limited evidence on the costs and outcomes of patients with aphasia after stroke. The aim of this study was to estimate costs in patients with aphasia after stroke according to the aphasia therapies provided. METHODS: A three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment trial conducted in Australia and New Zealand. Usual ward-based care (Usual Care) was compared to additional usual ward-based therapy (Usual Care Plus) and a prescribed and structured aphasia therapy program in addition to Usual Care (the VERSE intervention). Information about healthcare utilization and productivity were collected to estimate costs in Australian dollars for 2017-18. Multivariable regression models with bootstrapping were used to estimate differences in costs and outcomes (clinically meaningful change in aphasia severity measured by the WAB-R-AQ). RESULTS: Overall, 202/246 (82%) participants completed follow-up at 26 weeks. Median costs per person were $23,322 (Q1 5,367, Q3 52,669, n = 63) for Usual Care, $26,923 (Q1 7,303, Q3 76,174, n = 70) for Usual Care Plus and $31,143 (Q1 7,001. Q3 62,390, n = 69) for VERSE. No differences in costs and outcomes were detected between groups. Usual Care Plus was inferior (i.e. more costly and less effective) in 64% of iterations, and in 18% was less costly and less effective compared to Usual Care. VERSE was inferior in 65% of samples and less costly and less effective in 12% compared to Usual Care. CONCLUSION: There was limited evidence that additional intensively delivered aphasia therapy within the context of usual acute care provided was worthwhile in terms of costs for the outcomes gained.

Understanding Organisms Using Ecological Observatory Networks.

Human activities are rapidly changing ecosystems around the world. These changes have widespread implications for the preservation of biodiversity, agricultural productivity, prevalence of zoonotic diseases, and sociopolitical conflict. To understand and improve the predictive capacity for these and other biological phenomena, some scientists are now relying on observatory networks, which are often composed of systems of sensors, teams of field researchers, and databases of abiotic and biotic measurements across multiple temporal and spatial scales. One well-known example is NEON, the US-based National Ecological Observatory Network. Although NEON and similar networks have informed studies of population, community, and ecosystem ecology for years, they have been minimally used by organismal biologists. NEON provides organismal biologists, in particular those interested in NEON's focal taxa, with an unprecedented opportunity to study phenomena such as range expansions, disease epidemics, invasive species colonization, macrophysiology, and other biological processes that fundamentally involve organismal variation. Here, we use NEON as an exemplar of the promise of observatory networks for understanding the causes and consequences of morphological, behavioral, molecular, and physiological variation among individual organisms.

Clinical implantation of 92 VACStents in the upper gastrointestinal tract of 50 patients-applicability and safety analysis of an innovative endoscopic concept.

Introduction: Endoscopic vacuum therapy (EVT) has emerged as a promising treatment option for upper gastrointestinal wall defects, offering benefits such as evacuation of secretions and removal of wound debris by suction, and reduction and healing of wound cavities to improve clinical outcomes. In contrast, covered stents have a high rate of migration and lack functional drainage, while endoluminal EVT devices obstruct the GI tract. The VACStent is a novel device that combines the benefits of EVT and stent placement. Its design features a fully covered Nitinol-stent within a polyurethane sponge cylinder, enabling EVT while maintaining stent patency. Methods: This study analyzes the pooled data from three different prospective study cohorts to assess the safe practicality of VACStent placement, complete leak coverage, and effective suction-treatment of esophageal leaks. By pooling the data, the study aims to provide a broader base for analysis. Results: In total, trans-nasal derivation of the catheter, suction and drainage of secretion via vacuum pump were performed without any adversity. In the pooled study cohort of 92 VACStent applications, the mean stent indwelling time was 5.2 days (range 2-8 days) without any dislocation of the device. Removal of the VACStent was done without complication, in one case the sponge was lost but subsequently fully preserved. Minor local erosions and bleeding and one subsequent hemostasis were recorded unfrequently during withdrawal of the device (5.4%, 5/92) but no perforation or pressure ulcer. Despite a high heterogeneity regarding primary disease and pretreatments a cure rate of 76% (38/50 patients) could be achieved. Discussion: In summary, insertion and release procedure was regarded as easy and simple with a low potential of dislocation. The VACStent was well tolerated by the patient while keeping the drainage function of the sponge achieving directly a wound closure by continuous suction and improving the healing process. The implantation of the VACStent provides a promising new procedure for improved clinical treatment in various indications of the upper gastrointestinal wall, which should be validated in larger clinical studies.Clinical Trial Registration: Identifier [DRKS00016048 and NCT04884334].

Confronting a post-pandemic new-normal-threats and opportunities to trust-based relationships in natural resource science and management.

Natural resource governance is inherently complex owing to the socio-ecological systems in which it is embedded. Working arrangements have been fundamentally transformed throughout the COVID-19 pandemic with potential negative impacts on trust-based social networks foundational to resource management and transboundary governance. To inform development of a post-pandemic new-normal in resource management, we examined trust relationships using the Laurentian Great Lakes of North America as a case study. 82.9% (n = 97/117) of Great Lakes fishery managers and scientists surveyed indicated that virtual engagement was effective for maintaining well-established relationships during the pandemic; however, 76.7% (n = 89/116) of respondents indicated in-person engagement to be more effective than virtual engagement for building and maintaining trust. Despite some shortcomings, virtual or remote engagement presents opportunities, such as: (1) care and nurturing of well-established long-term relationships; (2) short-term (1-3 years) trust maintenance; (3) peer-peer or mentor-mentee coordination; (4) supplemental communications; (5) producer-push knowledge dissemination; and, if done thoughtfully, (6) enhancing diversity, equity, and inclusion. Without change, pre-pandemic trust-based relationships foundational to cooperative, multinational, resource management are under threat.

The VACStent trial: combined treatment of esophageal leaks by covered stent and endoscopic vacuum therapy.

BACKGROUND: Endoscopic treatment of esophageal leaks, mostly by covered stents or endoscopic vacuum therapy (EVT), has largely improved the clinical outcome in the last decade. However, both techniques suffer from significant limitations. Covered stents are hampered by a high rate of migration and missing functional drainage, whereas endoluminal EVT devices are limited by obstruction of the GI tract. The new design of the VACStent makes it a fully covered stent within a polyurethane sponge cylinder, allowing EVT while stent passage is still open. Initial clinical applications have demonstrated the fundamental concept of the VACStent. METHOD: A prospective multicenter open-label study was performed with the primary endpoint safe practicality, complete leak coverage, and effective suction-treatment of esophageal leaks. Secondary endpoints were prevention of septic conditions, successful leak healing, and complications, in particular stent-migration, local erosions and bleeding. RESULTS: Fifteen patients with different, mostly postoperative anastomotic leaks were enrolled in three centers. A total of 41 VACStents were implanted. The mean number of VACStents per patient was 2.7, with a mean duration of VACStent treatment of 15 days. The primary endpoint was met in all VACStent applications (41/41 implants), resulting in a leak healing rate of 80% (12/15 patients). Septic episodes were prevented in 93% (14/15 patients) and there was no mortality. There were no severe device-related adverse events (SADE) nor significant local bleeding or erosion. Minor stent-dislocation and migration, respectively, was observed in 7%. Oral intake of liquids or food was documented in 87% (13/15 patients). One anastomotic stenosis was seen during follow-up. CONCLUSIONS: VACStent treatment is a safe and effective treatment in esophageal leaks which can be covered by the sponge cylinder. Its application was described as easy and resembling that of conventional GI stents, with an impressive clinical success rate comparable to EVT outcomes. The VACStent offers a new option for clinical treatment of critical situations in esophageal perforations and anastomotic sutureline failures.

Self-rated health in individuals with and without disease is associated with multiple biomarkers representing multiple biological domains.

Self-rated health (SRH) is one of the most frequently used indicators in health and social research. Its robust association with mortality in very different populations implies that it is a comprehensive measure of health status and may even reflect the condition of the human organism beyond clinical diagnoses. Yet the biological basis of SRH is poorly understood. We used data from three independent European population samples (N approx. 15,000) to investigate the associations of SRH with 150 biomolecules in blood or urine (biomarkers). Altogether 57 biomarkers representing different organ systems were associated with SRH. In almost half of the cases the association was independent of disease and physical functioning. Biomarkers weakened but did not remove the association between SRH and mortality. We propose three potential pathways through which biomarkers may be incorporated into an individual's subjective health assessment, including (1) their role in clinical diseases; (2) their association with health-related lifestyles; and (3) their potential to stimulate physical sensations through interoceptive mechanisms. Our findings indicate that SRH has a solid biological basis and it is a valid but non-specific indicator of the biological condition of the human organism.

Applying Best Practices from Health Communication to Support a University's Response to COVID-19.

Higher education institutions face profound communication challenges managing risks for university communities during the ongoing pandemic. This commentary shares 1) findings from our study involving analysis of 17 focus groups of students, faculty, staff, and parents of students to explore effective COVID-19 messages about campus safety, and 2) insights into the process of integrating the expertise of a university health communication center into campus-wide responses to COVID-19. Key focus group takeaways highlight the importance of communicating empathetically, acknowledging those who are made vulnerable through their work on campus, and that promises to return to normal would be perceived as unrealistic. Bringing the evidence base of health communication to the typical work of professional communicators on campus allowed us to create a communication toolkit for consistent messaging, and in turn, learn about the vital role health communication scholars can play in university crisis messaging.

Application of Theory in Studies of Healthcare Built Environment Research.

We aimed to examine the nature and extent of theory application in studies of built environment attributes and impact on adults in healthcare facilities. Many varied theories are described when providing the rationale for research into built environments in healthcare. Uncertainty exists around the right theory to frame a research question, alignment with measurement tools, and whether healthcare setting makes a difference. This poses challenges to researchers seeking to build the evidence base for built environment design that benefits patients and staff. Our multidisciplinary review team scoped the literature to determine how theories are used to inform research investigating the impact of the built environment of healthcare on adults. When researchers recorded theory at development of the study question, in data collection, and in data analysis/interpretation, we called this explicitly theory-based application. Synthesis occurred using a narrative approach. Overall, we found 17 diverse theories named in studies. Explicitly theory-based use occurred with eight theories, comprising 47% of all theories used. Five theories were named more frequently in studies out of all theories identified. In 20% of studies, theory was not used explicitly during the research inquiry. We argue that researchers must continue to strive toward explicit use of theories, similar to development of other health interventions that employ multifactorial components.

[Surgical management for early stage gastric cancer]. / Chirurgische Strategie bei Frühkarzinomen des Magens.

BACKGROUND: In the last decade the implementation of the new technique of endoscopic submucosal dissection (ESD) and the rapid progression of laparoscopic gastric cancer (LAG) resection with an adequate lymphadenectomy (LAD) have played an increasing role in the treatment of patients with early stage gastric cancer (EGC). OBJECTIVE: A systematic review of the currently available data in the literature was carried out to evaluate the contemporary surgical management for treatment of EGC. RESULTS: Endoscopic resection (ER) of mucosal T1 gastric cancer (T1m) in accordance with the German guidelines on resection criteria is a widely accepted treatment option, if a definitive R0 resection can be achieved. Excellent en bloc and R0 results in more than 90% of these cases have been shown particularly for ESD. In contrast to T1m gastric carcinomas with a low risk of lymph node metastases (approximately 3%), nodal involvement reaches more than 20% for submucosal infiltrated EGC (T1sm). For this reason, a surgical resection with adequate LAD is further recommended in all cases of non-curative ER or any T1sm gastric cancer. In seven randomized controlled trials and a series of meta-analyses including high-quality non-randomized trials, significant benefits in short-term postoperative outcome have been demonstrated for LAG in comparison to open gastrectomy (OG) in the treatment of EGC. The general morbidity was also significantly lower in LAG than in OG. The 30-day mortality and long-term survival outcome were comparable between the two groups. CONCLUSION: The use of ESD should be the standard treatment for T1m EGC within the guidelines criteria. For non-curative ESD and T1sm gastric cancer, surgical resection with LAD is recommended. The LAG is a technically safe, feasible, and favorable approach in terms of faster recovery compared to OG. The long-term survival outcome is comparable between LAG and OG for EGC.

An opportunistic study evaluating pharmacokinetics of sildenafil for the treatment of pulmonary hypertension in infants.

OBJECTIVE: The objective of this study is to assess sildenafil and N-desmethyl sildenafil (DMS) exposure in infants receiving sildenafil for the treatment of pulmonary hypertension (PH). STUDY DESIGN: Data were collected from six infants receiving sildenafil for the treatment of PH and plasma samples were collected at the time of routine laboratory blood draws. The echocardiography results were assessed for improvement in right ventricular (RV) hypertension following sildenafil treatment. RESULT: The median (range) sildenafil and DMS concentrations were 27.4 ng ml(-1) (2.6 to 434.0) and 105.5 ng ml(-1) (3.6 to 314.0), respectively. The median metabolite-to-parent ratio was higher in infants receiving co-medications that can induce cytochrome P450 (CYP) enzymes (5.2 vs 0.7). The echocardiography results showed improvement in RV hypertension for the majority of infants (5/6). CONCLUSION: The concentrations of sildenafil and DMS were within the previously observed ranges. Our results suggest that caution may be warranted when CYP-related co-medications are administered during sildenafil treatment for PH.

Representation of people with aphasia in randomized controlled trials of acute stroke interventions.

BACKGROUND: Aphasia affects up to a third of the stroke population and is associated with poor social participation and quality of life. Yet people with aphasia may be excluded from some types of stroke research due to challenges in informing, consenting, and conducting follow-up in this population. AIMS AND/OR HYPOTHESIS: We described the representation of those with aphasia in acute stroke clinical research, the level of inclusion across international trial sites, and whether there have been improvements in the inclusion of this population in recent clinical trials. METHODS: We conducted a retrospective analysis of clinical trial data from the Virtual International Stroke Trials Archive (VISTA), defining aphasia using the Best Language (item 9) domain of the National Institutes of Health Stroke Scale. We used proportional odds modeling, adjusting for age, gender, ethnicity, stroke severity, medical history, hemisphere affected by stroke, and trial eligibility criteria, to examine the associations between year, location of enrollment, inclusion, and attrition of those with aphasia. RESULTS: Data were available for 8904 patients from 10 trials; no trials listed aphasia as an exclusion criterion. At baseline, aphasia was present in 4039 (45·4%); severe/global aphasia was present in 2688 (30·2%). We observed no geographic or longitudinal disparity in the attrition of these patients at three-months. Centers in the Philippines recruited fewer people [P = 0·05, odds ratio = 0·5, 95% confidence interval (0·2, 1·0)], while centers in Central and South America included more people with severe/global aphasia [P = 0·0004, odds ratio = 2·4, 95% confidence interval (1·3, 4·3)], when compared with centers in the USA and Canada. CONCLUSIONS: Acute stroke trials have demonstrated the feasibility of including people with aphasia in stroke research; we observed geographic variations that were not entirely explained by case mix or trial eligibility criteria. Similar levels of inclusion should be sought in nonemergency stroke trials to improve the applicability of research findings to this population.

Montreal Cognitive Assessment and Mini-Mental State Examination are both valid cognitive tools in stroke.

OBJECTIVE: To determine the validity of the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE) as screening tools for cognitive impairment after stroke. MATERIALS AND METHODS: Cognitive assessments were administered over 2 sessions (1 week apart) at 3 months post-stroke. Scores on the MoCA and MMSE were evaluated against a diagnosis of cognitive impairment derived from a comprehensive neuropsychological battery (the criterion standard). RESULTS: Sixty patients participated in the study [mean age 72.1 years (SD = 13.9), mean education 10.5 years (SD = 3.9), median acute NIHSS score 5 (IQR 3-7)]. The MoCA yielded lower scores (median = 21, IQR = 17-24; mean = 20.0, SD = 5.4) than the MMSE (median = 26, IQR = 22-27; mean = 24.2, SD = 4.5). MMSE data were more skewed towards ceiling than MoCA data (skewness = -1.09 vs -0.73). Area under the receiver operator curve was higher for MoCA than for MMSE (0.87 vs 0.84), although this difference was not significant (χ(2) = 0.48, P = 0.49). At their optimal cut-offs, the MoCA had better sensitivity than the MMSE (0.92 vs 0.82) but poorer specificity (0.67 vs 0.76). CONCLUSIONS: The MoCA is a valid screening tool for post-stroke cognitive impairment; it is more sensitive but less specific than the MMSE. Contrary to the prevailing view, the MMSE also exhibited acceptable validity in this setting.

More outcomes than trials: a call for consistent data collection across stroke rehabilitation trials.

Stroke survivors experience complex combinations of impairments, activity limitations, and participation restrictions. The essential components of stroke rehabilitation remain elusive. Determining efficacy in randomized controlled trials (RCTs) is challenging; there is no commonly agreed primary outcome measure for rehabilitation trials. Clinical guidelines depend on proof of efficacy in RCTs and meta-analyses. However, diverse trial aims, differing methods, inconsistent data collection, and use of multiple assessment tools hinder comparability across trials. Consistent data collection in acute stroke trials has facilitated meta-analyses to inform trial design and clinical practice. With few exceptions, inconsistent data collection has hindered similar progress in stroke rehabilitation research. There is an urgent need for the routine collection of a core dataset of common variables in rehabilitation trials. The European Stroke Organisation Outcomes Working Group, the National Institutes of Neurological Disorders and Stroke Common Data Elements project, and the Collaborative Stroke Audit and Research project have called for consistency in data collection in stroke trials. Standardizing data collection can decrease study start up times, facilitate data sharing, and inform clinical guidelines. Although achieving consensus on which outcome measures to use in stroke rehabilitation trials is a considerable task, perhaps a feasible starting point is to achieve consistency in the collection of data on demography, stroke severity, and stroke onset to inclusion times. Longer term goals could include the development of a consensus process to establish the core dataset. This should be endorsed by researchers, funders, and journal editors in order to facilitate sustainable change.

Stroke management: updated recommendations for treatment along the care continuum.

The Australian Clinical Guidelines for Stroke Management 2010 represents an update of the Clinical Guidelines for Stroke Rehabilitation and Recovery (2005) and the Clinical Guidelines for Acute Stroke Management (2007). For the first time, they cover the whole spectrum of stroke, from public awareness and prehospital response to stroke unit and stroke management strategies, acute treatment, secondary prevention, rehabilitation and community care. The guidelines also include recommendations on transient ischaemic attack. The most significant changes to previous guideline recommendations include the extension of the stroke thrombolysis window from 3 to 4.5 h and the change from positive to negative recommendations for the use of thigh-length antithrombotic stockings for deep venous thrombosis prevention and the routine use of prolonged positioning for contracture management.

Pure NOTES sigmoid resection in an animal survival model.

INTRODUCTION: The potential to use single-site transluminal access to perform major surgical procedures is limited. In the current study, a pure natural orifice transluminal endoscopic surgery (NOTES) technique was developed for sigmoid resection, with combined transgastric and transvaginal access to the abdominal cavity and assisted by colonoscopy. METHODS: This experimental study was conducted on a porcine model. Transgastric access was achieved by needle-knife incision and balloon dilation. Colonoscopy was used to maneuver the colon and expose the colic mesentery. Mesocolic dissection close to the bowel was carried out gastroscopically using a coagulating forceps. To prepare the anastomosis, a circular stapler anvil was introduced endoluminally. Subsequently, sigmoid resection was performed using a roticulating linear stapler inserted transvaginally. Bowel extraction was performed by invagination transrectally. After extracorporeal distal linear stapling of the sigmoid, colorectal anastomosis was completed by application of a circular stapling device transrectally. Gastric access closure was achieved using the over-the-scope clipping system (OTSC). RESULTS: The procedure was successful in all animals, with the operation time ranging from 150 to 270 minutes. The first animal died at postoperative day 5 from peritonitis due to an infected hematoma following spleen injury by an observation trocar. All other animals gained weight postoperatively. Animals were sacrificed after postoperative day 35. The work-up showed complete anastomotic healing and healed gastric closure. The OTSC clip was still in situ in all animals. CONCLUSION: The presented study shows that pure NOTES resection and anastomosis of the large bowel are feasible. Intraluminal organ manipulation provided excellent organ exposition and rendered one additional access site unnecessary. Transgastric preparation was shown to be safe and effective.

Translating the use of an enriched environment poststroke from bench to bedside: study design and protocol used to test the feasibility of environmental enrichment on stroke patients in rehabilitation.

RATIONALE: Environmental enrichment, a paradigm investigated extensively in animal models, is an intervention, which by design facilitates motor, sensory, social, and cognitive activity. It has been shown to improve poststroke motor and cognitive function in animal models of stroke. This is the first study to attempt to translate this intervention from the laboratory to the clinical setting. AIMS: The overall aim of this pilot study is to test the feasibility of using environmental enrichment with stroke patients in a rehabilitation setting. The aim is to enrich the environment of stroke survivors in a rehabilitation ward and measure changes in their activity (physical, cognitive, and social activity). DESIGN: Prospective nonrandomized block design intervention study. STUDY: In the control phase we will determine the change in activity levels of patients treated in a usual rehabilitation environment over time. In the intervention phase structured observational techniques (behavioural mapping) will be used to quantify the change in activity levels of patients exposed to environmental enrichment. OUTCOMES: The primary outcome is change in activity level. Additional data collected on entry to and exit from the study will include: cognitive function using a battery of cognitive tests, general function using the Functional Independence Measure, mood using the Patient Health Questionnaire 9 and boredom using the Stroke Rehabilitation Boredom Survey. Quality of life will be assessed using the Assessment of Quality of Life 1 month postdischarge from rehabilitation. Australian New Zealand Clinical Trials Registry# ACTRN12611000629932.

[Minimally invasive gastric surgery]. / Minimal-invasive Magenchirurgie.

The interest in minimally invasive surgery (MIS) for the treatment of gastric carcinoma has increased in recent years worldwide. In particular, for early gastric carcinoma (EGC) many retrospective comparative trials and some prospective randomized trials have confirmed that laparoscopy-assisted distal gastrectomy shows a better short-term outcome in terms of lower morbidity, less pain, faster recovery and shorter hospital stay in contrast to open surgery. In this group of selected patients MIS is safe and feasible but at present not widely accepted because of a limited evaluation in oncologic long-term follow-up. In cases of EGC limited to the mucosal layer and under the condition that endoscopic resection is not suitable, laparoscopic local wedge resection or intragastric resection can be an alternative option with good results in long-term follow-up. The data for laparoscopic total gastrectomy and MIS for advanced gastric cancer have confirmed that both are technically feasible and extended lymph node dissection can also be laparoscopically performed. However, laparoscopic total gastrectomy is much more complex and even in expert hands more complications and a higher morbidity have been observed in contrast to laparoscopic distal resections.

Very early mobilisation and complications in the first 3 months after stroke: further results from phase II of A Very Early Rehabilitation Trial (AVERT).

BACKGROUND: Interventions that may reduce the number and severity of potentially harmful post-stroke complications are desirable. This study explored whether very early and frequent mobilisation (VEM) affected complication type (immobility/stroke related), number and severity. METHODS: Secondary analysis from phase II, randomised controlled trial. Patients admitted within 24 h of stroke, whose physiological parameters fell within set limits, were randomised to either VEM, commencing <24 h, or standard care. Complications to 3 months were recorded by a blinded assessor and classified by a neurologist. Analysis was intention to treat. RESULTS: Seventy-one patients were recruited (standard care 33; VEM 38).There were no significant group differences in the number, type or severity of complications by 3 months, and most patients (81.6%) experienced one or more complications. Falls were common, while depression was absent. The multivariate analysis showed older age (OR 1.10, 95% CI: 1.02-1.18, p = 0.009) and longer length of stay (OR 1.18, 95% CI: 1.06-1.32, p = 0.002) were associated with experiencing an immobility-related complication. CONCLUSION: Interventions that promote recovery and reduce complications may consequently reduce length of stay. The larger phase III trial currently underway may shed light on whether increasing mobilisation reduces complications after stroke.