bluuebunny/crossref_metadata_2025 huggingface dataset:
Influenza co-infection associated with severity and mortality in COVID-19 patients
Authors: Alosaimi Bandar , Naeem Asif , Hamed Maaweya E. , Alkadi Haitham S. , Alanazi Thamer , Al Rehily Sanaa Saad , Almutairi Abdullah Z. , Zafar Adnan
Published: June 2021

Background

In COVID-19 patients, undetected co-infections may have severe clinical implications associated with increased hospitalization, varied treatment approaches and mortality. Therefore, we investigated the implications of viral and bacterial co-infection in COVID-19 clinical outcomes.

Methods

Nasopharyngeal samples were obtained from 48 COVID-19 patients (29% ICU and 71% non-ICU) and screened for the presence of 24 respiratory pathogens using six multiplex PCR panels.

Results

We found evidence of co-infection in 34 COVID-19 patients (71%). Influenza A H1N1 (n = 17), Chlamydia pneumoniae (n = 13) and human adenovirus (n = 10) were the most commonly detected pathogens. Viral co-infection was associated with increased ICU admission (r = 0.1) and higher mortality (OR 1.78, CI = 0.38–8.28) compared to bacterial co-infections (OR 0.44, CI = 0.08–2.45). Two thirds of COVID-19 critically ill patients who died, had a co-infection; and Influenza A H1N1 was the only pathogen for which a direct relationship with mortality was seen (r = 0.2).

Conclusions

Our study highlights the importance of screening for co-infecting viruses in COVID-19 patients, that could be the leading cause of disease severity and death. Given the high prevalence of Influenza co-infection in our study, increased coverage of flu vaccination is encouraged to mitigate the transmission of influenza virus during the on-going COVID-19 pandemic and reduce the risk of severe outcome and mortality.
It’s not my fault although it might be: chiropractic practice and vicarious liability
Authors: Simpson J. Keith , Innes Stanley
Published: June 2021

Background

While chiropractic care is most commonly provided within a private practice context, the ‘traditional’ solo practice is now uncommon. Chiropractors, manual therapists and related health professionals commonly work within the same practice bringing obvious advantages to both the practitioners and their patients. However, multi-practitioner, multi-disciplinary clinics also carry often unrecognized liabilities. We refer here to vicarious liability and non-delegable duties. Vicarious liability refers to the strict liability imposed on one person for the negligent acts of another person. The typical example is an employer being held vicariously liable to the negligent acts of an employee. However, vicarious liability can arise outside of the employer-employee relationship. For example, under non-delegable duty provisions, an entity owing a non-delegable duty can be liable for an independent contractor’s wrongdoing.

After a plain English explanation of this complex area of law, we provide seven scenarios to demonstrate how vicarious liability can envelop practice principals when things go wrong. We also make suggestions for risk mitigation.

Conclusion

Practice owners may unexpectedly find themselves legally liable for another’s actions with dire consequences. A knowledge of vicarious liability along with implementing risk mitigation strategies has the potential to minimize the likelihood of this unwanted event. Recommendations are made to this end.
A novel external beam radiotherapy method for cervical cancer patients using virtual straight or bending boost areas; an in-silico feasibility study
Authors: Cozzi Luca , Beriwal Sushil , Kuusela Esa , Chopra Supriya , Burger Hester , Joubert Nanette , Fogliata Antonella , Agarwal Jai Prakash , Kupelian Pat
Published: June 2021

Aim

To investigate the potential role of a novel spatially fractionated radiation therapy (SFRT) method where heterogeneous dose patterns are created in target areas with virtual rods, straight or curving, of variable position, diameter, separation and alignment personalised to a patient’s anatomy. The images chosen for this study were CT scans acquired for the external beam part of radiotherapy.

Methods

Ten patients with locally advanced cervical cancer were retrospectively investigated with SFRT. The dose prescription was 30 Gy in 5 fractions to 90% target volume coverage. Peak-and-valley (SFRT_1) and peak-only (SFRT_2) strategies were applied to generate the heterogeneous dose distributions. The planning objectives for the target (CTV) were D90% ≥ 30 Gy, V45Gy ≥ 50–55% and V60Gy ≥ 30%. The planning objectives for the organs at risk (OAR) were: D2cm3 ≤ 23.75 Gy, 17.0 Gy, 19.5 Gy, 17.0 Gy for the bladder, rectum, sigmoid and bowel, respectively. The plan comparison was performed employing the quantitative analysis of the dose-volume histograms.

Results

The D2cm3 was 22.4 ± 2.0 (22.6 ± 2.1) and 13.9 ± 2.9 (13.2 ± 3.0) for the bladder and the rectum for SFRT_1 (SFRT_2). The results for the sigmoid and the bowel were 2.6 ± 3.1 (2.8 ± 3.0) and 9.1 ± 5.9 (9.7 ± 7.3), respectively. The hotspots in the target volume were V45Gy = 43.1 ± 7.5% (56.6 ± 5.6%) and V60Gy = 15.4 ± 5.6% (26.8 ± 6.6%) for SFRT_1 (SFRT_2). To account for potential uncertainties in the positioning, the dose prescription could be escalated to D90% = 33–35 Gy to the CTV without compromising any constraints to the OARs

Conclusion

In this dosimetric study, the proposed novel planning technique for boosting the cervix uteri was associated with high-quality plans, respecting constraints for the organs at risk and approaching the level of dose heterogeneity achieved with routine brachytherapy. Based on a sample of 10 patients, the results are promising and might lead to a phase I clinical trial.
Efficacy and safety of a self-developed home-based enhanced knee flexion exercise program compared with standard supervised physiotherapy to improve mobility and quality of life after total knee arthroplasty: a randomized control study
Authors: Xu Tianyang , Yang Dong , Liu Kaiyuan , Gao Qiuming , Lu Hengli , Qiao Yue , Zhu Chunyan , Li Guodong
Published: June 2021

Background

This randomized controlled study compared standard supervised physiotherapy (SPT) with a self-developed, home-based, enhanced knee flexion exercise program involving a low stool (KFEH) in patients who underwent total knee arthroplasty (TKA).

Methods

Patients were recruited from July 2014 to December 2015 and randomly assigned to one of two groups: KFEH (n= 60) and SPT (n= 59). Outcomes (joint function) were evaluated according to the Knee Society Score (KSS), visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and range of motion (ROM) assessment at selected time points (preoperatively; 1 week; 1, 3, and 6 months; and 1 year after surgery).

Results

Pain and functional improvement were observed in both groups. Non-inferiority of KFEH was evident 12 months postoperatively; however, patients in the KFEH group exhibited better ROM at 1 month (P< 0.01). Absolute WOMAC and KSS scores were slightly better in the KFEH group, although the difference was not statistically significant. There was no difference in VAS scores and complication rates between the two groups. Additionally, the home program would save patient time and decrease the economic burden associated with in-hospital SPT.

Conclusion

Considering rehabilitation and economic efficiency as well as the COVID pandemic, a home-based enhanced knee flexion exercise program for TKA rehabilitation is recommended.
Patellar retraction versus eversion on functional outcomes in total knee replacement: a randomized controlled study protocol
Authors: Wang Zhao , Ji Yong , Bao Hongwei , Hou Jingzhao , Cheng Yan-xiao
Published: June 2021

Background

Patellar mobilization technique during total knee replacement (TKR) has been debated, with some suggesting that lateral retraction, rather than eversion, of the patella may be beneficial. This randomized controlled trial was to investigate the effects of patellar eversion on functional outcomes in TKR.

Methods and analysis

This single-center, prospective, randomized controlled test will be conducted in Jingjiang People's Hospital. Primary end-stage osteoarthritis patients that prepared for unilateral TKR were randomized to one of two patellar exposure techniques during the primary total knee arthroplasty: lateral retraction or eversion. The informed consent will be acquired in each patient. The primary outcome was operation time, length of hospital stay, and straight leg raising time. Second outcomes including Insall-Salvati ratio; range of motion at 1 month, 3 months, and 1 year following TKR; visual analog scale (VAS) at 1 month, 3 months; and Knee Society Score (KSS) score at 1 year following TKR. The significance level was defaulted as P < .05.

Results

Results will be published in relevant peer-reviewed journals.

Conclusion

Our study aims to systematically assess the functional outcomes of patellar eversion for TKR patients, which will provide clinical guidance for TKR patients.
Expression of VEGF-A Signaling Pathway in Cartilage of ACLT-induced Osteoarthritis Mouse Model
Authors: Qian Jia-jia , Xu Qi , Xu Wei-min , Cai Ren , Huang Gui-cheng
Published: June 2021

Background

Anterior cruciate ligament transection surgery (ACLT)-induced OA model was often used to investigate the molecular mechanism of knee osteoarthritis (KOA). Researches have shown that vascular endothelial growth factor (VEGF) played an important role in OA. The present study aimed to investigate the pathological changes after ACLT surgery and reveal the expression characteristics of the VEGF-A/VEGFR2 signaling pathway in this model.

Methods

Moderate KOA model was established by ACLT, and 1, 2, 4, 8, and 12 weeks after surgery, hematoxylin-eosin (HE) and Safranin-O(S-O) staining were used to detect the pathological changes in mouse knee cartilage, and the matrix biomarkers A Disintegrin and Metalloproteinase with Thrombospondin Motifs 5(ADAMTS5), Collagen II (COL-II) were detected using immunohistochemistry (IHC), CD31 was detected by immunofluorescence (IF) to show the vascular invasion in cartilage, and proteins expression of VEGF-A pathway were detected by Western blot (WB). Meanwhile, the inflammatory biomarkers cyclooxygenase-2 (COX-2) and inducible nitric oxide synthase (iNOS) in cartilage were detected by WB.

Results

ACLT surgery can lead to degeneration of cartilage in mice, and the characteristics of the lesion were time-dependent. The ADAMTS5-positive cells increased while COL-II decreased in OA cartilage with time, and new blood vessels labeled by CD31 can be seen from 1 week in OA cartilage, and increased in 8 and 12 weeks. The expression of VEGF-A, VEGFR2, COX-2, and iNOS were higher than control groups, which were basically consistent with the degree of osteoarthritis.

Conclusions

The degenerative degree of articular cartilage was time-dependent; angiogenesis and inflammation were important pathological changes of cartilage in KOA. The expression of the VEGF-A/VEGFR2 signaling pathway was basically correlated with the degree of KOA.
The effect of postoperative complications on health-related quality of life and survival 12 years after coronary artery bypass grafting – a prospective cohort study
Authors: Hokkanen Matti , Huhtala Heini , Laurikka Jari , Järvinen Otso
Published: June 2021

Background

Despite the steady improvements in survival and operative safety, postoperative complications still remain a significant cause of morbidity and mortality after coronary artery bypass grafting (CABG). However, less is known on the impact of postoperative complications on health-related quality of life (QoL). The main objective of our study was to investigate the impact of postoperative complications on long-term QoL and survival after CABG surgery.

Methods

Data of 508 patients, who underwent isolated CABG was prospectively collected. The RAND-36 Health Survey (RAND-36) was used to evaluate patients’ QoL status preoperatively, 1 year and 12 years after the surgery. Predefined postoperative complications were reported during primary and secondary hospital stay. QoL and survival analysis were performed primarily on three patient groups: patients with and without complications and patients with major adverse cardiac and cerebrovascular events (MACCE).

Results

In total 205(40%) of 508 patients had at least one postoperative complication and 73 (14%) experienced MACCE. Patients’ thirty-day, 1-year and 10-year survival rates were, 99, 98, 84% without complications, 97, 95, 72% with complications, and 90, 89, 64% with MACCE, respectively (log-rank p < 0.001). Patients without complications showed significant(p < 0.05) improvements in seven and patients with complications in five out of eight RAND-36 QoL dimensions. All patient groups showed significant improvements in RAND-36 summary scores compared with preoperative values. Patients with complications and especially with MACCE had more profound decline in their RAND-36 summary scores while patients without complications maintained their health status best.

Conclusions

Despite the constant deterioration, both patients with and without complications showed improvements even 12 years after CABG compared with preoperative state. Postoperative complications and especially MACCE were associated with impaired long-term QoL.
Development of a new sternal dehiscence prediction scale for decision making in sternal closure techniques after cardiac surgery
Authors: Nooh Ehab , Griesbach Colin , Rösch Johannes , Weyand Michael , Harig Frank
Published: June 2021

Background

After sternotomy, the spectrum for sternal osteosynthesis comprises standard wiring and more complex techniques, like titanium plating. The aim of this study is to develop a predictive risk score that evaluates the risk of sternum instability individually. The surgeon may then choose an appropriate sternal osteosynthesis technique that is risk- adjusted as well as cost-effective.

Methods

Data from 7.173 patients operated via sternotomy for all cardiovascular indications from 2008 until 2017 were retrospectively analyzed. Sternal dehiscence occurred in 2.5% of patients (n = 176). A multivariable analysis model examined pre- and intraoperative factors. A multivariable logistic regression model and a backward elimination based on the Akaike Information Criterion (AIC) a logistic model were selected.

Results

The model showed good sensitivity and specificity (area under the receiver-operating characteristic curve, AUC: 0.76) and several predictors of sternal instability could be evaluated. Multivariable logistic regression showed the highest Odds Ratios (OR) for reexploration (OR 6.6, confidence interval, CI [4.5–9.5], p < 0.001), obesity (body mass index, BMI > 35 kg/m2) (OR 4.23, [CI 2.4–7.3], p < 0.001), insulin-dependent diabetes mellitus (IDDM) (OR 2.2, CI [1.5–3.2], p = 0.01), smoking (OR 2.03, [CI 1.3–3.08], p = 0.001). After weighting the probability of sternum dehiscence with each factor, a risk score model was proposed scaling from − 1 to 5 points. This resulted in a risk score ranging up to 18 points, with an estimated risk for sternum complication up to 74%.

Conclusions

A weighted scoring system based on individual risk factors was specifically created to predict sternal dehiscence. High-scoring patients should receive additive closure techniques.
Survival of patients with rare diseases: a population-based study in Tuscany (Italy)
Authors: Gorini Francesca , Coi Alessio , Mezzasalma Lorena , Baldacci Silvia , Pierini Anna , Santoro Michele
Published: June 2021

Background

Rare diseases (RDs) encompass a heterogeneous group of life-threatening or chronically debilitating conditions that individually affect a small number of subjects but overall represent a major public health issue globally. There are still limited data on RD burden due to the paucity of large population-based epidemiological studies. The aim of this research was to provide survival estimates of patients with a RD residing in Tuscany, Italy.

Methods

Cases collected in the Rare Diseases Registry of Tuscany with diagnosis between 1st January 2000 and 31th December 2018 were linked to the regional health databases in order to retrieve information on mortality of all subjects. Survival at 1, 5 and 10 years from diagnosis with 95% confidence intervals (CI) was estimated by sex, age class, nosological group and subgroup using the Kaplan–Meier method. The effect of sex, age and period of diagnosis (years 2000–2009 or 2010–2018) on survival was estimated using Cox proportional hazards regression.

Results

Survival at 1, 5 and 10 years from diagnosis was 97.3%, 88.8% and 80.8%, respectively. Respiratory diseases and peripheral and central nervous system disorders were characterized by the lowest survival at 5 and 10 years. Despite a modest higher prevalence of RDs among females (54.0% of the total), male cases had a significant increased risk of death (hazard ratio, HR 1.48, 95% CI 1.38–1.58). Cases diagnosed during 2010–2018 period had a risk of death significantly lower than those diagnosed during 2000–2009 (HR 0.81, 95% CI 0.82–0.96), especially for immune system disorders (HR 0.48, 95% CI 0.26–0.87), circulatory system diseases (HR 0.61, 95% CI 0.45–0.84) and diseases of the musculoskeletal system and connective tissue (HR 0.64, 95% CI 0.49–0.84).

Conclusions

An earlier diagnosis as well as the improvement in the efficacy of treatment resulted in a decreased risk of death over the years for specific RDs. The linkage between a population-based registry and other regional databases exploited in this study provides a large and accurate mass of data capable of estimating patients’ life-expectancy and increasing knowledge on the collective burden of RDs.
The whole is greater than the sum of its parts: profiles of multiple mental health risk factors using Latent class analysis
Authors: Göbel Kristin , Cohrdes Caroline
Published: June 2021

Background

The exposure to an accumulation of various risk factors during childhood and adolescence relative to a single risk is associated with poorer mental health. Identification of distinct constellations of risk factors is an essential step towards the development of effective prevention strategies of mental disorders. A Latent class analysis (LCA) extracts different combinations of risk factors or subgroups and examines the association between profiles of multiple risk and mental health outcomes.

Methods

The current study used longitudinal survey data (KiGGS) of 10,853 German children, adolescents and young adults. The LCA included 27 robust risk and protective factors across multiple domains for mental health.

Results

The LCA identified four subgroups of individuals with different risk profiles: abasic-risk (51.4%), high-risk (23.4%), parental-risk (11.8%) and social-risk class (13.4%).Multiple risk factors of the family domain, in particular family instability were associated with negative mental health outcomes (e.g. mental health problems, depression, ADHD) and predominately comprised late adolescent girls. The social environment represented a more common risk domain for young males.

Conclusion

The understanding of multiple risk and different risk “profiles” helps to understand and adjust targeted interventions with a focus on vulnerable groups.
Awake prone positioning in patients with hypoxemic respiratory failure due to COVID-19: the PROFLO multicenter randomized clinical trial
Authors: Rosén Jacob , von Oelreich Erik , Fors Diddi , Jonsson Fagerlund Malin , Taxbro Knut , Skorup Paul , Eby Ludvig , Campoccia Jalde Francesca , Johansson Niclas , Bergström Gustav , Frykholm Peter ,   the PROFLO Study Group, Gradin Anna , Ali Mustafa , Lennborn Ulrica , Bogdanovic Darko , Roos Andreas , Modie Matilda , Giesecke Julia
Published: June 2021

Background

The effect of awake prone positioning on intubation rates is not established. The aim of this trial was to investigate if a protocol for awake prone positioning reduces the rate of endotracheal intubation compared with standard care among patients with moderate to severe hypoxemic respiratory failure due to COVID-19.

Methods

We conducted a multicenter randomized clinical trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO2/FiO2ratio ≤ 20 kPa were randomly assigned to a protocol targeting 16 h prone positioning per day or standard care. The primary endpoint was intubation within 30 days. Secondary endpoints included duration of awake prone positioning, 30-day mortality, ventilator-free days, hospital and intensive care unit length of stay, use of noninvasive ventilation, organ support and adverse events. The trial was terminated early due to futility.

Results

Of 141 patients assessed for eligibility, 75 were randomized of whom 39 were allocated to the control group and 36 to the prone group. Within 30 days after enrollment, 13 patients (33%) were intubated in the control group versus 12 patients (33%) in the prone group (HR 1.01 (95% CI 0.46–2.21),P = 0.99). Median prone duration was 3.4 h [IQR 1.8–8.4] in the control group compared with 9.0 h per day [IQR 4.4–10.6] in the prone group (P = 0.014). Nine patients (23%) in the control group had pressure sores compared with two patients (6%) in the prone group (difference − 18% (95% CI − 2 to − 33%);P = 0.032). There were no other differences in secondary outcomes between groups.

Conclusions

The implemented protocol for awake prone positioning increased duration of prone positioning, but did not reduce the rate of intubation in patients with hypoxemic respiratory failure due to COVID-19 compared to standard care.

Trial registration

ISRCTN54917435. Registered 15 June 2020 (https://doi.org/10.1186/ISRCTN54917435).
Breath-holding as a novel approach to risk stratification in COVID-19
Authors: Messineo Ludovico , Perger Elisa , Corda Luciano , Joosten Simon A. , Fanfulla Francesco , Pedroni Leonardo , Terrill Philip I. , Lombardi Carolina , Wellman Andrew , Hamilton Garun S. , Malhotra Atul , Vailati Guido , Parati Gianfranco , Sands Scott A.
Published: June 2021

Background

Despite considerable progress, it remains unclear why some patients admitted for COVID-19 develop adverse outcomes while others recover spontaneously. Clues may lie with the predisposition to hypoxemia or unexpected absence of dyspnea (‘silent hypoxemia’) in some patients who later develop respiratory failure. Using a recently-validated breath-holding technique, we sought to test the hypothesis that gas exchange and ventilatory control deficits observed at admission are associated with subsequent adverse COVID-19 outcomes (composite primary outcome: non-invasive ventilatory support, intensive care admission, or death).

Methods

Patients with COVID-19 (N = 50) performed breath-holds to obtain measurements reflecting the predisposition to oxygen desaturation (mean desaturation after 20-s) and reduced chemosensitivity to hypoxic-hypercapnia (including maximal breath-hold duration). Associations with the primary composite outcome were modeled adjusting for baseline oxygen saturation, obesity, sex, age, and prior cardiovascular disease. Healthy controls (N = 23) provided a normative comparison.

Results

The adverse composite outcome (observed in N = 11/50) was associated with breath-holding measures at admission (likelihood ratio test, p = 0.020); specifically, greater mean desaturation (12-fold greater odds of adverse composite outcome with 4% compared with 2% desaturation, p = 0.002) and greater maximal breath-holding duration (2.7-fold greater odds per 10-s increase, p = 0.036). COVID-19 patients who did not develop the adverse composite outcome had similar mean desaturation to healthy controls.

Conclusions

Breath-holding offers a novel method to identify patients with high risk of respiratory failure in COVID-19. Greater breath-hold induced desaturation (gas exchange deficit) and greater breath-holding tolerance (ventilatory control deficit) may be independent harbingers of progression to severe disease.
Can patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design
Authors: Bhattacharya Indrani S. , Haviland Joanne S. , Turner Lesley , Stobart Hilary , Balasopoulou Ada , Stones Liba , Kirby Anna M. , Kirwan Cliona C. , Coles Charlotte E. , Bliss Judith M. ,   on behalf of the PRIMETIME Trialists
Published: June 2021

Background

For patients with early breast cancer considered at very-low risk of local relapse, risks of radiotherapy may outweigh the benefits. Decisions regarding treatment omission can lead to patient uncertainty (decisional conflict), which may be lessened with patient decision aids (PDA). PRIMETIME (ISRCTN 41579286) is a UK-led biomarker-directed study evaluating omission of adjuvant radiotherapy in breast cancer; an embedded Study Within A Trial (SWAT) investigated whether PDA reduces decisional conflict using a cluster stepped-wedge trial design.

Methods

PDA diagrams and a video explaining risks and benefits of radiotherapy were developed in close collaboration between patient advocates and PRIMETIME trialists. The SWAT used a cluster stepped-wedge trial design, where each cluster represented the radiotherapy centre and referring peripheral centres. All clusters began in the standard information group (patient information and diagrams) and were randomised to cross-over to the enhanced information group (standard information plus video) at 2, 4 or 6 months. Primary endpoint was the decisional conflict scale (0–100, higher scores indicating greater conflict) which was assessed on an individual participant level. Multilevel mixed effects models used a random effect for cluster and a fixed effect for each step to adjust for calendar time and clustering. Robust standard errors were also adjusted for the clustering effect.

Results

Five hundred twenty-one evaluable questionnaires were returned from 809 eligible patients (64%) in 24 clusters between April 2018 and October 2019. Mean decisional conflict scores in the standard group (N = 184) were 10.88 (SD 11.82) and 8.99 (SD 11.82) in the enhanced group (N = 337), with no statistically significant difference [mean difference − 1.78, 95%CI − 3.82–0.25, p = 0.09]. Compliance with patient information and diagrams was high in both groups although in the enhanced group only 121/337 (36%) reported watching the video.

Conclusion

The low levels of decisional conflict in PRIMETIME are reassuring and may reflect the high-quality information provision, such that not everyone required the video. This reinforces the importance of working with patients as partners in clinical trials especially in the development of patient-centred information and decision aids.
Effects of seated lumbar rotation manipulation in treating degenerative lumbar instability: a protocol for a randomized controlled trial
Authors: Xie Rui , Liang Long , Li Kaiming , Yu Jie , Feng Minshan , Zhan Jiawen , Wei Xu , Yang Kexin , Jin Zhefeng , Yin He , Chen Xin , Yin Xunlu , Liu Zhiwei , Dai Wenkang , Zhu Liguo
Published: June 2021

Background

Degenerative lumbar instability (DLI) is a common disease that causes low back pain (LBP) in clinic. It is difficult to completely recover from DLI, and it occurs repeatedly, which seriously affects the quality of life of patients. The epidemiological survey showed that 20–30% of low back pain was related to lumbar instability. Increasing evidence shows that seated lumbar rotation manipulation can effectively improve the clinical symptoms of patients with low back pain. The primary aim of this clinical trial is to observe the intervention effect of seated lumbar rotation manipulation on DLI patients.

Method/design

A total of 60 participants with DLI will be recruited and randomly allocated into the seated lumbar rotation manipulation group (the intervention group) or lumbar traction in supine position group (the control group) in this prospective, outcome assessor-blind, two-arm randomized controlled clinical trial. The treatment of the two groups lasted for 3 weeks, and the manipulation of the intervention group would be carried out once every other day, three times a week, a total of 9 times; the control group would be given lumbar traction once a day, five times a week, a total of 15 times. JOA (Japanese Orthopaedic Association) and VAS (Visual Analogue Scales) scores will be recorded as the primary outcomes before the treatment and at the 1st, 3rd, 5th, 8th, 10th, 12th, 15th, 17th, and 19th days after treatment and follow-up visit at the first, third, and sixth months. JOA efficacy evaluation standard will be used to evaluate the overall efficacy as the secondary outcomes.

Discussion

The results of this prospective, randomized controlled trial will provide a clinical evidence for the treatment of DLI with seated lumbar rotation manipulation.

Trial registration

Chinese Clinical Trial Registry ChiCTR2000032017. Registered on 18 April 2020, Prospective registration.
Short-term effects of synchronized vs. non-synchronized NIPPV in preterm infants: study protocol for an unmasked randomized crossover trial
Authors: Cresi Francesco , Chiale Federica , Maggiora Elena , Borgione Silvia Maria , Ferroglio Mattia , Runfola Federica , Maiocco Giulia , Peila Chiara , Bertino Enrico , Coscia Alessandra
Published: June 2021

Background

Non-invasive ventilation (NIV) has been recommended as the best respiratory support for preterm infants with respiratory distress syndrome (RDS). However, the best NIV technique to be used as first intention in RDS management has not yet been established.

Nasal intermittent positive pressure ventilation (NIPPV) may be synchronized (SNIPPV) or non-synchronized to the infant’s breathing efforts.

The aim of the study is to evaluate the short-term effects of SNIPPV vs. NIPPV on the cardiorespiratory events, trying to identify the best ventilation modality for preterm infants at their first approach to NIV ventilation support.

Methods

An unmasked randomized crossover study with three treatment phases was designed. All newborn infants < 32 weeks of gestational age with RDS needing NIV ventilation as first intention or after extubation will be consecutively enrolled in the study and randomized to the NIPPV or SNIPPV arm. After stabilization, enrolled patients will be alternatively ventilated with two different techniques for two time frames of 4 h each. NIPPV and SNIPPV will be administered with the same ventilator and the same interface, maintaining continuous assisted ventilation without patient discomfort.

During the whole duration of the study, the patient’s cardiorespiratory data and data from the ventilator will be simultaneously recorded using a polygraph connected to a computer.

The primary outcome is the frequency of episodes of oxygen desaturation. Secondary outcomes are the number of the cardiorespiratory events, FiO2 necessity, newborn pain score evaluation, synchronization index, and thoracoabdominal asynchrony. The calculated sample size was of 30 patients.

Discussion

It is known that NIPPV produces a percentage of ineffective acts due to asynchronies between the ventilator and the infant’s breaths. On the other hand, an ineffective synchronization could increase work of breathing. Our hypothesis is that an efficient synchronization could reduce the respiratory work and increase the volume per minute exchanged without interfering with the natural respiratory rhythm of the patient with RDS. The results of this study will allow us to evaluate the effectiveness of the synchronization, demonstrating whether SNIPPV is the most effective non-invasive ventilation mode in preterm infants with RDS at their first approach to NIV ventilation.

Trial registration

ClinicalTrials.gov NCT03289936. Registered on September 21, 2017.
Metabolic profiling of liver and faeces in mice infected with echinococcosis
Authors: Zhu Mingxing , Du Xiancai , Xu Hongxia , Yang Songhao , Wang Chan , Zhu Yazhou , Zhang Tingrui , Zhao Wei
Published: June 2021

Background

Echinococcosis is a severe zoonotic parasitic disease which severely affects the health of the hosts. The diagnosis of echinococcosis depends mainly on imaging examination. However, the patient is often in the late stage of the disease when the symptoms appear, thus limiting the early diagnosis of echinococcosis. The treatment and prognosis of the patients are hampered because of long-term asymptomatic latency. Metabolomics is a new discipline developed in the late 1990s. It reflects a series of biological responses in pathophysiological processes by demonstrating the changes in metabolism under the influence of internal and external factors. When the organism is invaded by pathogens, the alteration in the characteristics of metabolites in cells becomes extremely sensitive. Here, we used a metabolomics approach involving liquid chromatography coupled with tandem mass spectrometry (LC–MS/MS) to determine the molecular mechanism of cystic echinococcosis (CE) and to develop an effective method for CE diagnosis.

Methods

Twenty 8-week-old female BALB/c mice were divided into normal and Echinococcus granulosus infection groups. To develop the E. granulosus infection model, mice were infected with protoscoleces. Six weeks later, the abdomens of the mice showed significant bulging. An LC–MS/MS system-based metabolomics approach was used to analyse the liver and faeces to reveal the metabolic profiles of mice with echinococcosis.

Results

We found that the metabolism of nucleotides, alkaloids, amino acids, amides, and organic acids in mice is closely interrelated with E. granulosus infection. In the liver, the metabolic pathways of tyrosine and tryptophan biosynthesis; phenylalanine, valine, leucine and isoleucine biosynthesis; and phenylalanine metabolism were notably associated with the occurrence and development of hydatid disease, and in the faeces, pantothenate and CoA biosynthesis are thought to be closely associated with the development of CE.

Conclusion

The metabolomics approach used in this study provides a reference for a highly sensitive and specific diagnostic and screening method for echinococcosis.

Graphical Abstract
Predictors of unacceptable pain with and without low inflammation over 5 years in early rheumatoid arthritis—an inception cohort study
Authors: Eberhard Anna , Bergman Stefan , Mandl Thomas , Olofsson Tor , Rydholm Maria , Jacobsson Lennart , Turesson Carl
Published: June 2021

Objectives

Pain is a major symptom in patients with rheumatoid arthritis (RA). In early RA, pain is usually due to synovitis, but can also persist despite effective anti-inflammatory treatment. The objective of this study was to investigate the pain course over time and predictors of unacceptable pain and unacceptable pain with low inflammation, in patients with early RA.

Methods

An inception cohort of 232 patients with early RA, recruited in 1995–2005, was followed in a structured programme for 5 years. Pain was assessed using a visual analogue scale (VAS; 0–100). Unacceptable pain was defined as VAS pain > 40 based on the patient acceptable symptom state (PASS) and low inflammation as CRP < 10 mg/l. Baseline predictors of unacceptable pain were evaluated using logistic regression analysis.

Results

Pain improved significantly during the first 6 months, but then remained basically unchanged. Thirty-four per cent of the patients had unacceptable pain 5 years after inclusion. Baseline predictors of unacceptable pain after 5 years were lower swollen joint counts [odds ratio (OR) 0.71 per standard deviation (95% confidence interval (CI) 0.51–0.99)] and higher VAS for pain and global assessment of disease activity. Unacceptable pain with low inflammation after 5 years was negatively associated with anti-CCP antibodies [OR 0.50 (95% CI 0.22–0.98)].

Conclusion

Over one third of the patients had unacceptable pain 5 years after inclusion. Lower swollen joint count was associated with unacceptable pain at 5 years. The results may be explained by the positive effects of treatment on pain related to inflammation. Non-inflammatory long-lasting pain appears to be a greater problem in anti-CCP-negative patients.
Impact of COVID-19 pandemic on athletes with disabilities preparing for the Paralympic Games in Tokyo
Authors: Urbański Piotr , Szeliga Łukasz , Tasiemski Tomasz
Published: June 2021

Objective

The main aim of the study was to assess the impact of COVID-19 pandemic on athletes preparing for the Tokyo 2021 Paralympic Games during 1 month of lockdown in Poland. The study involved 166 athletes (106 male, 66 female), members of either the Polish Paralympic Committee or the Polish Sports Association for the Disabled’Start’, two organizations responsible for managing and regulating sports played by persons with disabilities in Poland.

Results

Athletes with disabilities have been strongly affected by the pandemic and the resultant lockdown. The majority of respondents reported that they trained at home (88.6%), whereas 60.2% of athletes trained outdoors, and 12% suspended their training regimens altogether. Only 5.4% of athletes had some access to sport facilities. The athletes reduced their weekly training time by almost half (9.4 h/week vs. 5.3 h/week), a statistically significant difference (t = 16.261, p < 0.001).
Computer-aided clinical image analysis for non-invasive assessment of tumor thickness in cutaneous melanoma
Authors: Papadakis Marios , Paschos Alexandros , Manios Andreas , Lehmann Percy , Manios Georgios , Zirngibl Hubert
Published: June 2021

Objective

Computerized clinical image analysis is shown to improve diagnostic accuracy for cutaneous melanoma but its effectiveness in preoperative assessment of melanoma thickness has not been studied. The aim of this study, is to explore how melanoma thickness correlates with computer-assisted objectively obtained color and geometric variables. All patients diagnosed with cutaneous melanoma with available clinical images prior to tumor excision were included in the study. All images underwent digital processing with an automated non-commercial software. The software provided measurements for geometrical variables, i.e., overall lesion surface, maximum diameter, perimeter, circularity, eccentricity, mean radius, as well as for color variables, i.e., range, standard deviation, coefficient of variation and skewness in the red, green, and blue color space.

Results

One hundred fifty-six lesions were included in the final analysis. The mean tumor thickness was 1.84 mm (range 0.2–25). Melanoma thickness was strongly correlated with overall surface area, maximum diameter, perimeter and mean lesion radius. Thickness was moderately correlated with eccentricity, green color and blue color. We conclude that geometrical and color parameters, as objectively extracted by computer-aided clinical image processing, may correlate with tumor thickness in patients with cutaneous melanoma. However, these correlations are not strong enough to reliably predict tumor thickness.
Embryo transfer can be performed in either uterine horn. Two successive pregnancies in a patient with uterus didelphys: a case report
Authors: Khrait Zakwan
Published: June 2021

Background

Uterus didelphys results from a failure in Mullerian duct fusion and may be associated with complete or partial vaginal septa. Most cases of uterus didelphys are discovered incidentally during the workup of infertility or recurrent miscarriage. The incidence of uterus didelphys has been reported to be 0.2% in the infertile population.

Case presentation

A 35-year-old white Arab woman, gravida 0, parity 0, with a history of primary infertility of 8 years (a well-known male factor) presented to our infertility center. She was diagnosed as having uterus didelphys with severe male factor. The patient had three previous failed in vitro fertilization/intracytoplasmic sperm injection cycles outside our center.

This is a case report of an infertile woman with uterus didelphys who conceived twice following single embryo transfer in both uterine horns successively. After the first successful pregnancy in the left uterine horn, the initial decision was to transfer the embryo to the same horn (left) because of the previous successful transfer. The very deep and long vagina forced us to reach one of the cervices, in which the embryo was placed in the right uterine horn, followed by the second successful pregnancy in the other, smaller horn. The patient gave her informed consent, both verbal and written, to use her information and images for medical publication.

Conclusion

Pregnancy is possible in women with uterus didelphys using single embryo transfer in in vitro fertilization/intracytoplasmic sperm injection cycles. It is recommended that both horns be given a chance.
Accuracy comparison of various quantitative [99mTc]Tc-DPD SPECT/CT reconstruction techniques in patients with symptomatic hip and knee joint prostheses
Authors: Braun Martin , Cachovan Michal , Kaul Felix , Caobelli Federico , Bäumer Markus , Hans Vija A. , Pagenstert Geert , Wild Damian , Kretzschmar Martin
Published: June 2021

Background

There is a need for better diagnostic tools that identify loose total hip and knee arthroplasties. Here, we present the accuracy of different 99mTc-dicarboxypropandiphosphate ([99mTc]Tc-DPD) SPECT/CT quantification tools for the detection of loose prostheses in patients with painful hip and knee arthroplasties.

Methods

Quantitative reconstruction of mineral phase SPECT data was performed using Siemens xSPECT-Quant and xSPECT-Bone, with and without metal artefact reduction (iMAR) of CT-data. Quantitative data (SUVmax values) were compared to intraoperative diagnosis or clinical outcome after at least 1 year as standard of comparison. Cut-off values and accuracies were calculated using receiver operator characteristics. Accuracy of uptake quantification was compared to the accuracy of visual SPECT/CT readings, blinded for the quantitative data and clinical outcome.

Results

In this prospective study, 30 consecutive patients with 33 symptomatic hip and knee prostheses underwent [99mTc]Tc-DPD SPECT/CT. Ten arthroplasties were diagnosed loose and 23 stable. Mean-SUVmax was significantly higher around loose prostheses compared to stable prostheses, regardless of the quantification method (P = 0.0025–0.0001). Quantification with xSPECT-Bone-iMAR showed the highest accuracy (93.9% [95% CI 79.6–100%]) which was significantly higher compared to xSPECT-Quant-iMAR (81.8% [67.5–96.1%], P = 0.04) and xSPECT-Quant without iMAR (77.4% [62.4–92.4%], P = 0.02). Accuracies of clinical reading were non-significantly lower compared to quantitative measures (84.8% [70.6–99.1%] (senior) and 81.5% [67.5–96.1%] (trainee)).

Conclusion

Quantification with [99mTc]Tc-DPD xSPECT-Bone-iMAR discriminates best between loose and stable prostheses of all evaluated methods. The overall high accuracy of different quantitative measures underlines the potential of [99mTc]Tc-DPD-quantification as a biomarker and demands further prospective evaluation in a larger number of prosthesis.
Diversity and metagenome analysis of a hydrocarbon-degrading bacterial consortium from asphalt lakes located in Wietze, Germany
Authors: Eze Michael O. , Hose Grant C. , George Simon C. , Daniel Rolf
Published: June 2021

The pollution of terrestrial and aquatic environments by petroleum contaminants, especially diesel fuel, is a persistent environmental threat requiring cost-effective and environmentally sensitive remediation approaches. Bioremediation is one such approach, but is dependent on the availability of microorganisms with the necessary metabolic abilities and environmental adaptability. The aim of this study was to examine the microbial community in a petroleum contaminated site, and isolate organisms potentially able to degrade hydrocarbons. Through successive enrichment of soil microorganisms from samples of an historic petroleum contaminated site in Wietze, Germany, we isolated a bacterial consortium using diesel fuel hydrocarbons as sole carbon and energy source. The 16S rRNA gene analysis revealed the dominance of Alphaproteobacteria. We further reconstructed a total of 18 genomes from both the original soil sample and the isolated consortium. The analysis of both the metagenome of the consortium and the reconstructed metagenome-assembled genomes show that the most abundant bacterial genus in the consortium, Acidocella, possess many of the genes required for the degradation of diesel fuel aromatic hydrocarbons, which are often the most toxic component. This can explain why this genus proliferated in all the enrichment cultures. Therefore, this study reveals that the microbial consortium isolated in this study and its dominant genus, Acidocella, could potentially serve as an effective inoculum for the bioremediation of sites polluted with diesel fuel or other organic contaminants.
Asymptotic behavior of random coupled Ginzburg–Landau equation driven by colored noise on unbounded domains
Authors: Chen Zhang , Li Lingyu , Yang Dandan
Published: June 2021

In this paper, a random coupled Ginzburg–Landau equation driven by colored noise on unbounded domains is considered, in which the nonlinear term satisfies a local Lipschitz condition. It is shown that the random attractor of such a coupled Ginzburg–Landau equation is a singleton set, and the components of solutions are very close when the coupling parameter becomes large enough.
Linking the International English Language Competency Assessment suite of examinations to the Common European Framework of Reference
Authors: Hidri Sahbi
Published: June 2021

The study investigated the alignment process of the International English Language Competency Assessment (IELCA) suite examinations’ four levels, B1, B2, C1 and C2, onto the Common European Framework of Reference (CEFR) by explaining and discussing the five linking stages (Council of Europe (CoE 2009). Unlike previous studies, this study used the five linking stages altogether to make fair judgements and informed decisions about the practical consequences and validity arguments of this mapping task. Findings indicated that the useful and in-depth discussions of the relevant CEFR descriptors resulted in a deeper awareness of establishing succinct re-familiarisations and re-definitions of the salient features of the different skills and items, thus making them more specific to reflect the CEFR descriptors. The ample alignment activities provided fertile ground for dependable results. For instance, teacher estimates confirmed the cut scores with high agreement percentages, ranging from 74.4 to 99.34. Also, the FACETS analyses showed a good global model fit with a high reliability value of the judgement process, only after undergoing rater training sessions. Specifically, the majority of item difficulty estimates were within the typical range, thus indicating that the IELCA examinations were measuring the underlying construct traits; however, the empirical validation called for additional data and further implementation practices regarding other judgements on the levels’ boundary for IELCA examinations. Further mapping challenges, implications, and future research were also discussed.
DaLiF: a data lifecycle framework for data-driven governments
Authors: Shah Syed Iftikhar Hussain , Peristeras Vassilios , Magnisalis Ioannis
Published: June 2021

The public sector, private firms, business community, and civil society are generating data that is high in volume, veracity, velocity and comes from a diversity of sources. This kind of data is known as big data. Public Administrations (PAs) pursue big data as “new oil” and implement data-centric policies to transform data into knowledge, to promote good governance, transparency, innovative digital services, and citizens’ engagement in public policy. From the above, the Government Big Data Ecosystem (GBDE) emerges. Managing big data throughout its lifecycle becomes a challenging task for governmental organizations. Despite the vast interest in this ecosystem, appropriate big data management is still a challenge. This study intends to fill the above-mentioned gap by proposing a data lifecycle framework for data-driven governments. Through a Systematic Literature Review, we identified and analysed 76 data lifecycles models to propose a data lifecycle framework for data-driven governments (DaliF). In this way, we contribute to the ongoing discussion around big data management, which attracts researchers’ and practitioners’ interest.