bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial
Authors: Terhorst Yannik , Braun Lina , Titzler Ingrid , Buntrock Claudia , Freund Johanna , Thielecke Janika , Ebert David , Baumeister Harald 
Published: September 2020

IntroductionChronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).Methods and analysisA two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups.Ethics and disseminationThis study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17—FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences.Trial registration numberGerman Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.
Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK: a retrospective quantitative analysis
Authors: O'Sullivan Lydia , Sukumar Prasanth , Crowley Rachel , McAuliffe Eilish , Doran Peter 
Published: September 2020

ObjectivesThe first aim of this study was to quantify the difficulty level of clinical research Patient Information Leaflets/Informed Consent Forms (PILs/ICFs) using validated and widely used readability criteria which provide a broad assessment of written communication. The second aim was to compare these findings with best practice guidelines.DesignRetrospective, quantitative analysis of clinical research PILs/ICFs provided by academic institutions, pharmaceutical companies and investigators.SettingPILs/ICFs which had received Research Ethics Committee approval in the last 5 years were collected from Ireland and the UK.InterventionNot applicable.Main outcome measuresPILs/ICFs were evaluated against seven validated readability criteria (Flesch Reading Ease, Flesh Kincaid Grade Level, Simplified Measure of Gobbledegook, Gunning Fog, Fry, Raygor and New Dale Chall). The documents were also scored according to two health literacy-based criteria: the Clear Communication Index (CCI) and the Suitability Assessment of Materials tool. Finally, the documents were assessed for compliance with six best practice metrics from literacy agencies.ResultsA total of 176 PILs were collected, of which 154 were evaluable. None of the PILs/ICFs had the mean reading age of <12 years recommended by the American Medical Association. 7.1% of PILs/ICFs were evaluated as ‘Plain English’, 40.3%: ‘Fairly Difficult’, 51.3%: ‘Difficult’ and 1.3%: ‘Very Difficult’. No PILs/ICFs achieved a CCI >90. Only two documents complied with all six best practice literacy metrics.ConclusionsWhen assessed against both traditional readability criteria and health literacy-based tools, the PILs/ICFs in this study are inappropriately complex. There is also evidence of poor compliance with guidelines produced by literacy agencies. These data clearly evidence the need for improved documentation to underpin the consent process.
Identifying research priorities in cardiac surgery: a report from the James Lind Alliance Priority Setting Partnership in adult heart surgery
Authors: Lai Florence Y , Abbasciano Riccardo G , Tabberer Bethany , Kumar Tracy , Murphy Gavin J 
Published: September 2020

ObjectiveTo identify research priorities that address the needs of people affected by cardiac surgery and those who support and care for them.DesignJames Lind Alliance (JLA) process—two surveys and a consensus workshop guided by an independent JLA adviser.SettingThe UK with international participation.ParticipantsThree stakeholder groups—heart surgery patients, carers and healthcare professionals involved in care delivery.MethodsThe initial survey was set to collect potential research questions in cardiac surgery as identified by stakeholders. Submitted questions were summarised into indicative questions. The existing evidence was searched to verify that these indicative questions had not been answered. In the second survey, stakeholders then voted for their top 10 from the list of unanswered questions. The top voted questions were taken forward for final ranking in a workshop.ResultsIn the initial survey, 629 respondents (28% patients/carers, 62% healthcare professionals) submitted 1082 potential questions. Of these, 797 in-scope questions were summarised into 49 indicative questions and of which 45 had not been answered by existing research. In the second survey, 492 respondents (43% patients/carers, 49% healthcare professionals) cast their votes with the top 12 from each of the three stakeholder groups totalling 21 questions advancing to the final priority setting workshop. The workshop attended by 25 delegates (10 patients/carers and 15 healthcare professionals) agreed on the top 10 research questions including long-term outcomes (quality of life), and aspects from preoperative personalised care (prehabilitation, frailty, comorbidities), intraoperative management (minimally invasive techniques), to prevention and management of postoperative complications (organ injury, atrial fibrillation, infection).ConclusionsThis Priority Setting Partnership (PSP) identified the priorities and unmet needs of patients and clinicians in cardiac surgery. The next step is to disseminate and implement the PSP results to ensure that these priorities shape future research and improve clinical services.
Gender disparity in care-seeking behaviours and treatment outcomes for dehydrating diarrhoea among under-5 children admitted to a diarrhoeal disease hospital in Bangladesh: an analysis of hospital-based surveillance data
Authors: Mahmud Imteaz , Das Subhasish , Khan Soroar Hossain , Faruque A S G , Ahmed Tahmeed 
Published: September 2020

IntroductionDespite economic development and augmented literacy rates, Bangladeshi households are still discriminating against girls when it comes to seeking medical care. We examined gender disparities in diarrhoeal disease severity and the treatment outcomes of under-5 children.SettingA tertiary level diarrhoeal disease hospital in Dhaka, Bangladesh.Participants13 361 under-5 children admitted to the hospital between January 2008 and December 2017.Outcome variables and methodsThe primary outcome of interest was severity of diarrhoea, defined as ‘dehydrating diarrhoea’ or ‘non-dehydrating diarrhoea’. Multivariable logistic regression analyses were performed to assess the association between ‘gender’ and admission to hospital for dehydrating diarrhoea.ResultsData on 13 321 children under 5 years of age were analysed, of whom 61.5% were male and 38.5% were female. The mean (±SD) age of children with diarrhoea was 5.63 (±3.49) months. The median distance travelled to come to the hospital for admission was 10 miles (IQR: 6–25) and was significantly higher for boys (10 miles, IQR: 6–25) than girls (9.5 miles, IQR: 6–23) (p<0.001). Girls had 1.11 times higher odds (adjusted OR: 1.11, 95% CI 1.03 to 1.20, p=0.007) of presenting with dehydrating diarrhoea than boys at the time of hospital admission. Almost 20% of children received two or more medications during the period of hospital admission and this did not differ by gender. The median duration of hospital stay was 11 hours and was similar in both sexes. No gender-based disparity was observed in the management of diarrhoea and in the hospital outcome of children.ConclusionWe found that girls were more likely to have dehydrating diarrhoea when they were presented to the Dhaka hospital of International Centre for Diarrhoeal Disease Research, Bangladesh. No gender-based disparity was observed in the hospital outcome of children.
Administration of label and off-label drugs by the subcutaneous route in palliative care: an observational cohort study
Authors: Jensen Jesper Jørgen , Sjøgren Per 
Published: September 2020

BackgroundThe marketing authorisation for many injectable drugs used in palliative care does not cover the frequently preferred subcutaneous route. Consequently, subcutaneous off-label drug administration is often practised.AimTo assess the use, safety and tolerability of subcutaneous label and subcutaneous off-label drug administration in a Danish hospice.Material and methodsRetrospective data from hospice inpatient records registered with subcutaneous drug administration. Prospective data of subcutaneous drug administration registered to hospice inpatients over a period of 2 months.ResultsDrugs were administered subcutaneously to 90% of patients in both studied cohorts. Thirty different drugs were administered subcutaneously. Ten (33%) drugs were authorised for subcutaneous administration, 14 (47%) for intramuscular and 6 (20%) for intravenous administration only. A search in major palliative literature and scientific publications revealed that 11 of the 20 subcutaneous off-labelled drugs were administered with little to no support from these sources. In seven patients, 11 adverse drug reactions (ADRs) were registered. ADRs were all minor local reactions and led to drug discontinuation in two patients only.ConclusionSubcutaneous drug administration was frequently used in the hospice. Two-thirds of the drugs were administered subcutaneously off-label. The findings of only a few and minor ADRs indicate that the drugs identified in this study, although often subcutaneously off-label and with little support from palliative literature, were administered with acceptable safety and tolerability. Off-label treatment practised in the clinic should be identified, reported and serve as inspiration for future scientific research and incentives for extension of marketing authorisations.
Use of three-dimensional printing for simulation in ultrasound education: a scoping review
Authors: Gallagher Patrick , Smith Ryan , Sheppard Gillian 
Published: September 2020

BackgroundThere is a significant learning curve when teaching ultrasonography to medical trainees; task trainers can help learners to bridge this gap and develop their skills. Three-dimensional printing technology has the potential to be a great tool in the development of such simulators.
ObjectiveThis scoping review aimed to identify what 3D-printed models have been used in ultrasound education to date, how they were created and the pros and limitations involved.DesignResearchers searched three online databases to identify 3D-printed ultrasound models used in medical education.ResultsTwelve suitable publications were identified for inclusion in this review. The models from included articles simulated largely low frequency and/or high stakes events, with many models simulating needle guidance procedures. Most models were created by using patient imaging data and a computer-aided design software to print structures directly or print casting molds. The benefits of 3D-printed educational trainers are their low cost, reproducibility, patient specificity and accuracy. The current limitations of this technology are upfront investments and a lack of optimisation of materials.ConclusionsThe use of 3D-printed ultrasound task trainers is in its infancy, and more research is needed to determine whether or not this technology will benefit medical learners in the future.
Simulation versus live tissue training randomised trial for ECMO proficiency: is one better than the other?
Authors: Mu Thornton , Garcia-Choudary Tricia , Staudt Amanda , Tyree Melissa , Valdez-Delgado Krystal , Caldwell Nicole , Carr Nicholas , Borgman Matthew , Delaney Heather 
Published: September 2020

IntroductionExtracorporeal membrane oxygenation (ECMO) is a classic low-volume high-risk procedure that requires just in time and/or refresher training through animal or simulation modalities. This manuscript evaluated the performance of ECMO personnel trained with both modalities to determine which is better suited for ECMO skills training.MethodsParticipants (physicians, nurses and respiratory/medical technicians) completed a series of ECMO scenarios with synthetic tissue cannulation task trainer as well as a live tissue model. Objective performance quality was based on task completion using a validated ECMO skills assessment tool.ResultsThirty-eight individuals completed this study. Participants completed individual scenario tasks 3 min faster using the simulator (26 min vs 29 min; p=0.03). No differences were seen in percentage of individual tasks completed. In the group scenarios, participants completed a higher percentage of critical tasks using the simulator (97%) versus the animal model (91%; p=0.05), but no differences were seen in task completion times. Additionally, no differences were seen in either lab-based or participants’ prelab cognitive scores.ConclusionsRegardless of their self-assessment or experience, participants’ objective performances were similar among both animal and simulation labs. Task completion times were quicker with simulation model. The distinction between simulation versus animal model may be less important as both demonstrate benefit in development of and/or maintaining skill competency. In the era of questioning the need for and costs of live tissue training, expanding the role of simulation may achieve similar training goals.
Metabolic disease testing on farms: epidemiological principles
Authors: Mann Sabine , McArt Jessica , Abuelo Ãngel 
Published: September 2020

BackgroundAlthough many clinical metabolic diseases have been successfully controlled in modern dairy herds, subclinical metabolic diseases are often prevalent and associated with significant economic losses. Given the absence of easily identifiable clinical signs, their diagnosis often requires testing for metabolic markers in blood, urine, or milk. On‐farm testing with point‐of‐care devices can facilitate the acceptance of a metabolic screening programme that is economically feasible and delivers a high quality of information. The goal of such a screening programme is to establish a baseline, set goals for an acceptable herd‐level prevalence, and supervise the success or failure of any management changes required to attain these goals.Aim of the articleThe article discusses the practical aspects of metabolic disease testing with examples of results and their interpretation.
MultiSense
Authors: Zeng Youwei , Wu Dan , Xiong Jie , Liu Jinyi , Liu Zhaopeng , Zhang Daqing 
Published: September 2020

In recent years, we have seen efforts made to simultaneously monitor the respiration of multiple persons based on the channel state information (CSI) retrieved from commodity WiFi devices. Existing approaches mainly rely on spectral analysis of the CSI amplitude to obtain respiration rate information, leading to multiple limitations: (1) spectral analysis works when multiple persons exhibit dramatically different respiration rates, however, it fails to resolve similar rates; (2) spectral analysis can only obtain the average respiration rate over a period of time, and it is unable to capture the detailed rate change over time; (3) they fail to sense the respiration when a target is located at the "blind spots" even the target is close to the sensing devices.
To overcome these limitations, we propose MultiSense, the first WiFi-based system that can robustly and continuously sense the detailed respiration patterns of multiple persons even they have very similar respiration rates and are physically closely located. The key insight of our solution is that the commodity WiFi hardware nowadays is usually equipped with multiple antennas. Thus, each individual antenna can receive a different mix copy of signals reflected from multiple persons. We successfully prove that the reflected signals are linearly mixed at each antenna and propose to model the multi-person respiration sensing as a blind source separation (BSS) problem. Then, we solve it using independent component analysis (ICA) to separate the mixed signal and obtain the reparation information of each person. Extensive experiments show that with only one pair of transceivers, each equipped with three antennas, MultiSense is able to accurately monitor respiration even in the presence of four persons, with the mean absolute respiration rate error of 0.73 bpm (breaths per minute).
Checking Invariant Confluence, In Whole or In Parts
Authors: Whittaker Michael , Hellerstein Joseph M. 
Published: September 2020

Strongly consistent distributed systems are easy to reason about but face fundamental limitations in availability and performance. Weakly consistent systems can be implemented with very high performance but place a burden on the application developer to reason about complex interleavings of execution. Invariant confluence provides a formal framework for understanding when we can get the best of both worlds. An invariant confluent object can be efficiently replicated with no coordination needed to preserve its invariants. However, actually determining whether or not an object is invariant confluent is challenging.
In this paper, we establish conditions under which a commonly used sufficient condition for invariant confluence is both necessary and sufficient, and we use this condition to design a general-purpose interactive invariant confluence decision procedure. We then take a step beyond invariant confluence and introduce a generalization of invariant confluence, called segmented invariant confluence, that allows us to replicate non-invariant confluent objects with a small amount of coordination. We implement these formalisms in a prototype called Lucy and find that our decision procedures efficiently handle common real-world workloads including foreign keys, escrow transactions, and more.
PD1 Blockade Enhances ICAM1-Directed CAR T Therapeutic Efficacy in Advanced Thyroid Cancer
Authors: Gray Katherine D. , McCloskey Jaclyn E. , Vedvyas Yogindra , Kalloo Olivia R. , Eshaky Steve El , Yang Yanping , Shevlin Enda , Zaman Marjan , Ullmann Timothy M. , Liang Heng , Stefanova Dessislava , Christos Paul J. , Scognamiglio Theresa , Tassler Andrew B. , Zarnegar Rasa , Fahey Thomas J. , Jin Moonsoo M. , Min Irene M. 
Published: September 2020

AbstractPurpose:Advanced thyroid cancers, including poorly differentiated and anaplastic thyroid cancer (ATC), are lethal malignancies with limited treatment options. The majority of patients with ATC have responded poorly to programmed death 1 (PD1) blockade in early clinical trials. There is a need to explore new treatment options.Experimental Design:We examined the expression of PD-L1 (a ligand of PD1) and intercellular adhesion molecule 1 (ICAM1) in thyroid tumors and ATC cell lines, and investigated the PD1 expression level in peripheral T cells of patients with thyroid cancer. Next, we studied the tumor-targeting efficacy and T-cell dynamics of monotherapy and combination treatments of ICAM1-targeting chimeric antigen receptor (CAR) T cells and anti-PD1 antibody in a xenograft model of ATC.Results:Advanced thyroid cancers were associated with increased expression of both ICAM1 and PD-L1 in tumors, and elevated PD1 expression in CD8+ T cells of circulating blood. The expression of ICAM1 and PD-L1 in ATC lines was regulated by the IFNγ–JAK2 signaling pathway. ICAM1-targeted CAR T cells, produced from either healthy donor or patient T cells, in combination with PD1 blockade demonstrated an improved ability to eradicate ICAM1-expressing target tumor cells compared with CAR T treatment alone. PD1 blockade facilitated clearance of PD-L1 high tumor colonies and curtailed excessive CAR T expansion, resulting in rapid tumor clearance and prolonged survival in a mouse model.Conclusions:Targeting two IFNγ-inducible, tumor-associated antigens—ICAM1 and PD-L1—in a complementary manner might be an effective treatment strategy to control advanced thyroid cancers in vivo.
Statins as Anticancer Agents in the Era of Precision Medicine
Authors: Longo Joseph , van Leeuwen Jenna E. , Elbaz Mohamad , Branchard Emily , Penn Linda Z. 
Published: September 2020

AbstractStatins are widely prescribed cholesterol-lowering drugs that inhibit HMG-CoA reductase (HMGCR), the rate-limiting enzyme of the mevalonate metabolic pathway. Multiple lines of evidence indicate that certain cancers depend on the mevalonate pathway for growth and survival, and, therefore, are vulnerable to statin therapy. However, these immediately available, well-tolerated, and inexpensive drugs have yet to be successfully repurposed and integrated into cancer patient care. In this review, we highlight recent advances and outline important considerations for advancing statins to clinical trials in oncology.