bluuebunny/crossref_metadata_2025 huggingface dataset:
Anatomic Repair of a Lateral Collateral Ligament and Anterolateral Capsular Complex Injury With Internal Brace Augmentation
Authors: Schoell Kyle , Haratian Aryan , Fathi Amir , Bolia Ioanna K. , Hasan Laith K. , Petrigliano Frank A. , Weber Alexander E. , Hatch George F. “Rick“
Published: July 2022

Background:

Lateral collateral ligament (LCL) injuries are implicated in varus instability of the knee. Often, these accompany other ligamentous injuries including anterior cruciate ligament (ACL), posterior cruciate ligament (PCL) tears, and injury to the anterolateral capsular complex (ALCC). Use of internal brace augmentation with anatomic repair is an alternative to reconstruction to improve patient outcomes and facilitate early range of motion and weight bearing.

Indications:

We present a case of an anatomic repair of a LCL and an ALCC injury with internal brace augmentation.

Technique Description:

A curvilinear incision centered over the lateral epicondyle is used. The avulsed LCL and biceps tendon was exposed and a placed #5 FiberWire was placed into the distal LCL, biceps tendon, and the popliteofibular ligament. A split was made in the iliotibial (IT) band and a second #5 FiberWire was placed proximally in the LCL/biceps tendon for additional fixation. A tunnel was made in the fibular head and tibia using a 2.4-mm beath pin and the two #5 FiberWires were passed to the anteromedial tibia. The FiberWires were fixed to the tibia using a 14-mm attachable button system (ABS) manhole cover for suspensory fixation. Repair and internal bracing of the anterolateral capsular complex was accomplished with 2 interlocked TightRopes and a #2 FiberTape. This fixation method achieved repair by compressing the anterolateral capsular complex onto its tibial origin. The suture devices also served to augment the repair and were fixed proximally to the femur using another 14-mm ABS manhole cover. The FiberTape was fixed to the anterolateral tibia distally with a 4.5 mm SwiveLock. The TightRopes were passed through a tunnel to the anterolateral tibia and secured using an ABS Dog Bone. The construct was tensioned in near full extension and gapping was matched fluoroscopically to the contralateral knee.

Results:

Patient was cleared for full return to sports 9 months postoperatively. At the final follow up visit, the patient had excellent strength, stability, and 135° range of motion on the operative knee. Patient had returned to exercise at home but was unable to return to sports due to COVID-19 restrictions.

Conclusion:

Anatomic repair of the LCL and the ALCC with internal brace augmentation can serve as an effective alternative to reconstruction and demonstrates excellent patient outcomes regarding restoring stability, ROM, and return to preoperative sports.
An analytical model for 2D seismic tunnel-aboveground structure interaction with considering the influence of tunnel longitudinal shear deformation
Authors: Jin Liguo , Du Liting , Xie Junju , Li Xiaojun
Published: July 2022

The influence of tunnel longitudinal shear deformation on the response of its adjacent ground building is investigated based on a 2D analytical model considering a flexible circular tunnel and a shear wall standing on a semi-circular rigid foundation under SH-waves excitation. Soil-tunnel relative stiffness is introduced, and a closed-form analytical solution is presented for the system response. Tunnel stiffness significantly affects the foundation impedance function of the building. Rayleigh scattering frequency can accurately predict the position of the fluctuation peaks of the foundation impedance function. At locations where the tunnel–building interaction is strong, the tunnel cannot be considered as rigid even if the tunnel relative stiffness to the soil reaches 100. At locations where constructive and destructive wave interference occurs, the building relative response increases or decreases accordingly. Considering the influence of tunnel relative stiffness, the amplitude of the building relative response can be amplified by 27.0% or reduced by approximately 28.0%, respectively. This analytical model is also used to qualitatively predict the amplitude of the relative response transfer function of the Hollywood Storage Building under the influence of the tunnel longitudinal shear deformation, and its accuracy is verified.
Evaluating methods for Lasso selective inference in biomedical research: a comparative simulation study
Authors: Kammer Michael , Dunkler Daniela , Michiels Stefan , Heinze Georg
Published: July 2022

Background

Variable selection for regression models plays a key role in the analysis of biomedical data. However, inference after selection is not covered by classical statistical frequentist theory, which assumes a fixed set of covariates in the model. This leads to over-optimistic selection and replicability issues.

Methods

We compared proposals for selective inference targeting the submodel parameters of the Lasso and its extension, the adaptive Lasso: sample splitting, selective inference conditional on the Lasso selection (SI), and universally valid post-selection inference (PoSI). We studied the properties of the proposed selective confidence intervals available via R software packages using a neutral simulation study inspired by real data commonly seen in biomedical studies. Furthermore, we present an exemplary application of these methods to a publicly available dataset to discuss their practical usability.

Results

Frequentist properties of selective confidence intervals by the SI method were generally acceptable, but the claimed selective coverage levels were not attained in all scenarios, in particular with the adaptive Lasso. The actual coverage of the extremely conservative PoSI method exceeded the nominal levels, and this method also required the greatest computational effort. Sample splitting achieved acceptable actual selective coverage levels, but the method is inefficient and leads to less accurate point estimates.

The choice of inference method had a large impact on the resulting interval estimates, thereby necessitating that the user is acutely aware of the goal of inference in order to interpret and communicate the results.

Conclusions

Despite violating nominal coverage levels in some scenarios, selective inference conditional on the Lasso selection is our recommended approach for most cases. If simplicity is strongly favoured over efficiency, then sample splitting is an alternative. If only few predictors undergo variable selection (i.e. up to 5) or the avoidance of false positive claims of significance is a concern, then the conservative approach of PoSI may be useful. For the adaptive Lasso, SI should be avoided and only PoSI and sample splitting are recommended. In summary, we find selective inference useful to assess the uncertainties in the importance of individual selected predictors for future applications.
Challenges in the cross-sectoral collaboration on vulnerable pregnant women: a qualitative study among Danish general practitioners
Authors: Brygger Venø L. , Pedersen L. B. , Søndergaard J. , Ertmann R. K. , Jarbøl D. E.
Published: July 2022

Background

Vulnerable pregnant women, defined as women threatened by social, psychological, or physical risk factors, need special support during pregnancy to prevent complications in pregnancy, birth, and childhood. Proper cross-sectoral collaboration in antenatal care is paramount to delivering sufficient supportive care to these women. General practitioners (GPs) often face barriers when assessing vulnerable pregnant women and may; as a result, under-identify and underreport child abuse. Little is known about how the cross-sectoral collaboration in antenatal care affects the GP’s opportunities of managing vulnerable pregnant women. This study explores GPs’ perceived barriers and facilitators in the antenatal care collaboration on vulnerable pregnant women and in the reporting of these women to social services.

Methods

A qualitative study with semi-structured focus group interviews among twenty GPs from the Region of Southern Denmark. A mixed inductive and deductive analytic strategy was applied, structured according to the Theoretical Domains Framework (TDF).

Results

Three themes emerged: I) collaborative experience, II) motivation, and III) organizational working conditions. Barriers were lacking experience, i.e. knowledge, skills, and attention to antenatal care collaboration and reporting, inadequate organizational working contexts, i.e. insufficient pathways for communication between health care and social care systems, and laws restricting feedback on the consequences of reporting. This decreased the GPs motivation, i.e. poor confidence in navigating the system, fear of breaking the patient alliance when collaborating in antenatal care and reporting with the social services. GPs motivation to collaborate and report was increased by knowing the working contexts of their collaborative partners in the antenatal care and social services system and by a strong doctor-patient relationship enabling them to describe the vulnerability to collaborators.

Conclusions

GPs experience system-related barriers to collaborating and reporting on vulnerable pregnant women within the health care sector and in the interplay with the social services sector. Organizational development of cross-sectoral antenatal care collaboration should imply user involvement of all collaborative partners. Results suggest that health authorities should consider establishing accessible communication pathways between the GPs and the social services to improve options for proper cross-sectoral communication and feedback to GPs, thereby improving care trajectories of vulnerable pregnant women.
Chronic kidney disease awareness among the general population: tool validation and knowledge assessment in a developing country
Authors: Younes Samar , Mourad Nisreen , Safwan Jihan , Dabbous Mariam , Rahal Mohamad , Al Nabulsi Marah , Sakr Fouad
Published: July 2022

Introduction

Good knowledge and early identification of chronic kidney disease (CKD) can help in preventing disease progression in its early stages and reducing undesired outcomes. The aim of the current study was to assess the level of public knowledge about CKD, determine predictors of better knowledge, and to construct and validate a CKD knowledge scale for public health assessment and research use.

Methods

A community-based cross-sectional study was conducted using an electronic self-administered questionnaire. All people living in Lebanon and being 18 years of age and above were considered eligible for recruitment. CKD knowledge was assessed by a 37-item scale that was constructed by principal component analysis and then validated. The score of the CKD knowledge scale was computed from the extracted factors. A multivariable binomial logistic regression model evaluated the sociodemographic and clinical predictors of the knowledge score.

Results

A total of 1308 participants were included. The scale items converged over 9 factors with Eigenvalue greater than 1 and explaining 53.26% of the total variance, and the total scale had a high Cronbach’s alpha of 0.804. All items of the scale significantly correlated with the full scale with correlation coefficients ranging from 0.082 to 0.558. The ROC curve analysis determined an optimal cutoff point of better knowledge at 47.5 with 70.6% sensitivity and 44.2% specificity. The CKD knowledge score had a median of 51.00 (IQR 47.00–55.00). Higher knowledge score was significantly associated with old age (ORa = 1.018, 95% CI 1.006–1.030, P = 0.003),, occupation (ORa = 3.919, 95% CI 2.107–7.288, P <  0.001), and recent renal function assessment (ORa = 2.314, 95% CI 1.532–3.495, P <  0.001). However, a lower knowledge score was significantly associated with lower level of education (ORa = 0.462, 95% CI 0.327–0.653, P <  0.001).

Conclusion

A reliable tool to assess public knowledge and awareness about CKD was developed and validated. The overall knowledge was good, however, important gaps in CKD awareness were detected in some areas and subpopulations. Therefore, public health stakeholders need to implement targeted CKD educational activities to minimize the disease burden.
Prevalence and predictors of depression among women attending antenatal care in Moshi, Tanzania: a cross-sectional study
Authors: Ngocho James S. , Minja Linda M. , Mwamba Rimel N. , Knettel Brandon A. , Kisigo Godfrey A. , Mmbaga Blandina T. , Watt Melissa H.
Published: July 2022

Introduction

Antenatal depression in low-and middle-income countries is under-diagnosed and leads to poorer outcomes in the pregnancy and postpartum periods. The aim of this study was to quantify depressive symptoms among pregnant women in Moshi, Tanzania, and identify factors associated with probable depression.

Methods

Between March and December 2019, we enrolled 1039 pregnant women attending their first antenatal care appointment at two government health facilities to complete an audio computer-assisted self-interview. Depressive symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS), with a score > 13 indicating probable depression. A log-binomial regression model was used to identify factors associated with probable antenatal depression.

Results

A total of 11.5% (119/1033) met criteria for probable depression. Depression was more common among women who were not married (16.5% vs. 7.9%, PrR = 1.5, 95% CI 1.0, 2.1) and women who reported a lifetime history of violence (22.6% vs. 5.3%, PrR = 3.3, 95% CI 2.2, 5.0). Depression was less common among women who reported more partner-specific support (PrR = 0.92, 95% CI 0.87, 0.96).

Conclusions

Screening pregnant women for depressive symptoms is an essential component of evidence-based maternity care and should be accompanied by appropriate support and resources. Women who are not married, have limited support from a partner, or have experienced violence are especially vulnerable to depressive symptomatology during pregnancy.
Prevalence and implications of the presence of intraocular silicone oil droplets in patients treated with intravitreal injections of anti-VEGF
Authors: García Sandra Banderas , Garrell-Salat Xavier , Trejo-Velasco Fernando , Aragón-Roca David , Zapata Miguel Ángel , García-Arumí José
Published: July 2022

Background

To determine the percentage of patients who have silicone droplets in the vitreous after treatment with different anti-Vascular Endothelial Growth Factor (anti-VEGF) intravitreal injections (IVI) and how symptomatic they are.

Methods

One hundred fifty-two eyes of 140 patients who had at least received an IVI were recruited for this study. Data collection included the number and type of IVI (aflibercept, ranibizumab and bevacizumab) and the follow-up time. A complete ophthalmologic examination was carried out and patients were classified in four groups according to the amount of silicone droplets found in dilated fundoscopy (nonexistent, scarce, moderate and abundant). Measurement of intraocular pressure (IOP) was also carried out. An interview was conducted to report the presence and intensity of the symptomatology.

Results

Silicone oil droplets were reported in 109 eyes (71.7%). A positive correlation was found between the number of IVIs received and the quantity of droplets found, especially when aflibercept was used. Posterior vitreous detachment (PVD) was present in 65.8% of the patients, showing a positive correlation with the number of bubbles. Regarding the symptomatology, 60 eyes (39.5%) had floaters and the disturbance was reported to be 4 out of 10. The group with a moderate amount of silicone droplets had the highest percentage of floaters (60%). No statistical differences in the IOP were found between groups, although the group with abundant droplets had a higher mean IOP.

Conclusion

A high prevalence of silicone droplets in vitreous of patients who undergo IVI treatment was found. It appears to have little impact on symptomatology and rise of IOP.
Changes in ideal cardiovascular health among Iranian adolescents: 2007–2008 to 2015–2017
Authors: Asghari Golaleh , Mirmiran Parvin , Rezaeemanesh Alireza , Mahdavi Maryam , Azizi Fereiodoun , Hadaegh Farzad
Published: July 2022

Background

Assessment of both behavior and factors of health as ideal cardiovascular health (iCVH) in adolescence could contribute to cardiovascular disease prevention in adulthood.

Aims

To explore the changes in the prevalence of iCVH and its components during a decade among Tehranian adolescents.

Methods

The 12–19 years old adolescents were selected from the Tehran Lipid and Glucose Study(TLGS). The iCVH score was calculated in the study period 1 (2007–2008; n = 267) and 2 (2015–2017; n = 336). To calculate iCVH, body mass index(BMI), systolic and diastolic blood pressure (BP), total cholesterol, fasting plasma glucose (FPG), physical activity, smoking status, and dietary intakes were measured by standard protocols. The changes in iCVH components between the two study periods were reported by prevalence (95% confidence interval). A logistic regression model was conducted to test the effects of study periods, sex, and age groups on the iCVH(≥ 6 scores).

Results

Overall, there was a reduction in the prevalence of ideal FPG (97.4 vs. 91.1%) and ideal BP(91.8 vs. 82.7%). Girls had a decrease in the prevalence of ideal BP(91.2 vs. 79.4%) as well as an increase in non-smoking status(77.6 vs. 89.7%). However, the prevalence of ideal FPG (96.5 vs. 88.5%) and ideal BP(92.2 vs 85.0%) decreased in boys. Study period 2, compared to period 1 was associated with lower odds of having iCVH. Furthermore, boys were 1.57 folds more likely to have ideal CVH factors than girls.

Conclusion

There was a decrease in the prevalence of ideal CVD metrics, including FPG and BP, after one decade. Generally, adolescent boys had higher odds of having ideal CVH compared to girls.
A new approach to skin extravasation injury management during the neonatal period
Authors: Sagheb Setareh , Mohseni Sayyed Ourmazd , Lamsehchi Ameneh
Published: July 2022

Background

To identify a standard protocol for managing extravasation injuries in neonates.

Methods

We recruited all the neonates with extravasation wounds from the neonatal intensive care unit of Shariati hospital, Tehran, Iran, between October 2018 and October 2020. Sixteen patients with grade 3–4 extravasation were evaluated in this retrospective study. All grade 3 and 4 extravasation wounds were injected with hyaluronidase at 5 points of the wound circle; the procedure was repeated every 5 min at different points in a smaller circle to the core. The wound was then covered with a warm compress for 24 h. Twenty-four hours after injection, the cover was changed twice a day with normal saline irrigation. Fibrinolysin ointment was applied on top of the wound. The ulcer was then dressed with phenytoin ointment until healing.

Results

Out of 16 neonates who were followed up, 10 of them were male, with the average birth weight being 1.37 (range 1.05–3.75) kg. The mean (± SD) wound healing duration was 13.12 (± 6) (range: 7–29) days. Factors including the cannulation duration before the appearance of the lesion (R:0.2, P = 0.2), birth weight (R = -.37, P = 015), and extravasated substances (p = 0.2) were not associated with the duration of hospital stay. The only exception to this trend is the wound size factor of 7.31(± 7.45) (R = .83, P < 0.001). Continuous and categorical variables were summarized as mean (SD) and proportions, respectively, and the Kruskal–Wallis test and Spearman correlation coefficients were used.

Conclusions

Limited evidence exists on the effects of different protocols on extravasation management in neonates in the NICU. We recommend our method as a standard protocol in NICU for high-stage extravasated lesions because of the shorter duration of healing, non-invasive nature of this procedure, and lack of side effects or surgical involvement.
Cluster B personality disorders and its associated factors among psychiatric outpatients in Southwest Ethiopia: institutional-based cross-sectional study
Authors: Jemal Muzeyen , Tessema Worknesh , Agenagnew Liyew
Published: July 2022

Background

Diagnosis of co-occurring personality disorders, particularly the most comorbid cluster B personality disorders in psychiatric patients is clinically important because of their association with the duration, recurrence, and outcome of the comorbid disorders. The study aimed to assess the prevalence of cluster B personality disorders and associated factors among psychiatric outpatients in Jimma Medical Center.

Methods

An institution-based cross-sectional study was conducted among 404 patients with mental illnesses at Jimma Medical Center from July 15 to September 14, 2021. A systematic random sampling method was used to recruit the participants. Personality disorder questionnaire four (PDQ-4) was used to assess the prevalence of cluster B personality disorders through a face-to-face interview. Data were entered into Epi Data Version 4.6 and exported to SPSS Version 26 for analysis. Logistic regression analysis was done and variables with a p-value less than 0.05 with a 95% confidence interval in the final fitting model were declared as independent predictors of cluster B personality disorders.

Result

Amongst 401 respondents with response rate of 99.3%, slightly less than one-fourth (23.19%, N = 93) were found to have cluster B personality disorders. Unable to read and write(AOR = 3.28, 95%CI = 1.43—7.51), unemployment(AOR = 2.32, 95%CI = 1.19—4.49), diagnosis of depressive (AOR = 3.72, 95%CI = 1.52–9.10) and bipolar-I disorders (AOR = 2.94, 95%CI = 1.37—6.29), longer duration of illness (AOR = 2.44, 95%CI = 1.33—4.47), multiple relapses (AOR = 2.21, 95%CI = 1.18–4.15)), history of family mental illnesses (AOR = 2.05, 95%CI = 1.17—3.62), recent cannabis use (AOR = 4.38, 95%CI = 1.61—11.95), recent use of alcohol (AOR = 2.86, 95%CI = 1.34—6.10), starting to use substance at earlier age (AOR = 4.42, 95%CI = 1.51 -12.96), and suicidal attempt (AOR = 2.24, 95%CI = 1.01—4.96), were the factors significantly associated with cluster B personality disorders.

Conclusion

The prevalence of cluster B personality disorders was high among mentally ill outpatients and found to be important for mental health professionals working in the outpatient departments to screen for cluster B personality disorders as part of their routine activities, particularly those who have mood disorders, longer duration of illness, multiple relapses, history of family mental illnesses, suicidal attempt and are a current user of alcohol and cannabis.
Predictors for the restoration of the sagittal spinal malalignment in patients with lumbar stenosis after short-segment decompression and fusion surgery
Authors: Huang Rufeng , Pan Fumin , Zhu Weiguo , Kong Chao , Lu Shibao
Published: July 2022

Background

To explore the predictors for the restoration of the sagittal spinal malalignment in the elderly patients with lumbar spinal stenosis (LSS) after short-segment decompression and fusion surgery.

Methods

We retrospectively reviewed 82 LSS patients with sagittal malalignment (SVA ≥ 50 mm or PT ≥ 20° or PI-LL ≥ 20°) who underwent short-segment decompression and fusion surgery between January 2019 and March 2021. Patients’ characteristic, radiographic and paravertebral muscle parameters were assessed. The patients were divided into group A (postoperative malalignment) and B (postoperative alignment) according to whether the postoperative restoration of the sagittal alignment was achieved.

Results

There existed more males in group B than in group A (p = 0.002). The age of group A (73.36 ± 8.02) was greater than that of group B (69.08 ± 6.07, p = 0.009). Preoperative PT in group A (27.40 ± 5.82) was greater than that in group B (19.30 ± 7.32, p < 0.001). The functional cross-sectional area (fCSA) in group A (28.73 ± 4.23) was lower than that in group B (36.94 ± 7.81, p < 0.001). And the fatty infiltration rate (FI) of group A (27.16% ± 5.58%) was higher than that of group B (22.61% ± 5.81%, p = 0.001). The fCSA was negatively correlated with the postoperative PT and PTr (p < 0.05).

Conclusion

Stronger lumbar paravertebral muscles, smaller preoperative PI, PT or PI-LL, male and younger age are the predictors for the restoration of the sagittal spinal malalignment in the elderly LSS patients after short-segment decompression and fusion surgery.
Performance of Tönnis triple osteotomy in older children with developmental dysplasia of the hip (DDH) assisted by a 3D printing navigation template
Authors: Liu Fei , Tang Kai , Zheng Peng-fei , Zhang Zhi-qun , Ling Gang , Lou Yue
Published: July 2022

Background

The objective of this study is to investigate the preparation of a navigation template via a computer-aided design (CAD) and 3D printing (3DP) in order to improve the effectiveness of Tönnis triple osteotomy in older children with developmental dysplasia of the hip (DDH).

Method

Thirty-eight older children who received Tönnis triple osteotomy were included in this study. Among them, 20 were categorized as the 3DP navigation template group (3DP group), and the remaining 18 were categorized as the conventional surgery group (CS group). Data, including preoperative and postoperative pelvic sharp angle (SA), lateral center-edge angle (LCEA), acetabular roof angle (ARA), acetabular head index (AHI), crossover sign (COS), ischial spine sign (ISS), operation time (OT), intraoperative blood loss (IBL), and number of radiation exposures (NORE) were recorded for both groups. In addition, the therapeutic effect was evaluated at the last follow-up, according to the McKay criteria and Severin’s criteria.

Results

In the 3DP and CS groups, the mean OT was 126.6 ± 17.6 min and 156.0 ± 18.6 min, respectively; the mean IBL was 115.0 ± 16.9 ml and 135.7 ± 26.5 ml, respectively; the NORE were 3.3 ± 0.8 times and 8.6 ± 1.3 times, respectively. There were significant differences in the OT, IBL, and NORE between the two groups (P = 0.03, 0.05, < 0.001, respectively). At the last follow-up, the 3DP and CS groups displayed SA of 41.8 ± 2.3° and 42.6 ± 3.1°, respectively; LCEA of 35.6 ± 4.2° and 37.1 ± 2.8°, respectively; ARA of 6.9 ± 1.8° and 9.8 ± 2.6°, respectively; and AHI of 86.6 ± 4.1% and 84.3 ± 2.8%, respectively; COS(+) of 5 hips and 4 hips, respectively; ISS(+) of 6 hips and 7 hips. We observed no statistical differences in the SA, LCEA, ARA, AHI, COS and ISS between the two groups (P = 0.918, 0.846, 0.643, 0.891, 0.841, 0.564, respectively). According to the McKay criteria, the 3DP group had 10 excellent, 6 good, and 4 general hips, whereas, the CS group had 12 excellent, 4 good, and 2 general hip. There was no statistical difference between the two groups (P = 0.698). In 3DP group the postoperative Severin’s grading included 13 hips in grade I, 4 in grade II, 3 in grade III. Alternately, in the CS group, the postoperative Severin’s grading included 11 hips in grade I, 5 in grade II, 2 in grade III. The Severin ‘s criteria also showed no statistical difference between the two groups (P = 0.945).

Conclusions

Base on our analysis, our CAD-3DP-fabricated navigation template assisted Tönnis triple osteotomy in older DDH children, it reduced operation time and number of radiation exposures. However, no significant differences in radiological assessment and functional outcomes were observed when an experienced surgeon performs the surgery. Therefore, Surgeons who have less experience in triple osteotomy profit more from the application of this technology.
Drug cost avoidance analysis of cancer clinical trials in Spain: a study on cost contributors and their impact
Authors: Sánchez Martínez Domingo Antonio , Salas-Lucia Federico , Jiang Hanzi , Ruiz-Carreño Paula , Alonso Romero José Luis
Published: July 2022

Objective

Analyze the cost contributors and their impact on the drug cost avoidance (DCA) resulting from cancer clinical trials over the period of 2015–2020 in a tertiary-level hospital in Spain (HCUVA).

Methods

We performed a cross-sectional, observational, retrospective study of a total of 53 clinical trials with 363 patients enrolled. We calculated the DCA from the price of the best standard of care (i.e.: drugs that the institution would otherwise fund). A linear regression model was used to determine cost contributors and estimate their impact.

Results

The total DCA was ~ 4.9 million euros (31 clinical trials; 177 enrollees), representing ~ 30% and ~ 0,05% approximately of the annual pharmaceutical expenditures at the HCUVA and for the Spanish Health System, respectively. Cancer type analysis showed that lung cancer had the highest average DCA by trial, indicating that treatments in these trials were the most expensive. Linear regression analysis showed that the number of patients in a trial did not significantly affect that trial's DCA. Instead, cancer type, phase trials, and intention of treatment were significant cost contributors to DCA. Compared to digestive cancer trials, breast and lung trials were significantly more expensive, (p < 0.05 and p < 0.1, respectively). Phase III trials were more expensive than Phase II (p < 0.01) and adjuvant trials were less expensive than palliative (p < 0.05).

Conclusion

We studied cost contributors that significantly impacted the estimated DCA from cancer clinical trials. Our work provides the groundwork to explore DCA contributors with potential to enhance public relations material and serve as a negotiating tool for budgeting, thus playing an important role to inform decisions about resource allocation.
Correlation analysis of serum reproductive hormones and metabolites during multiple ovulation in sheep
Authors: Xu Quanzhong , Wang Chunwei , Wang Lequn , Feng Rui , Guo Yulin , Feng Shuang , Zhang Liguo , Zheng Zhong , Su Guanghua , Fan Lifen , Bian Chao , Zhang Li , Su Xiaohu
Published: July 2022

Background

The establishment of non-invasive diagnostic method for multiple ovulation prediction is helpful to improve the efficiency of multiple ovulation. The blood hormones and metabolites would be suitable indexes for this subject.

Methods

In this study, 86 estrus ewes (65 of induced estrus (IE) and 21 of spontaneous estrus (SE)) were selected and the blood samples were collected at the day before follicle-stimulating hormone (FSH) injection (1st) and before artificial insemination (2nd). The serum reproductive hormones ofFSH, luteinizing hormone (LH), 17β-Estradiol (E2), progesterone (P4) and anti-Mullerian hormone (AMH) were measured through enzyme linked immunosorbent assay (ELISA) and the untargeted metabolomics analysis was processed through LC–MS/MS. The embryos were collected after 6.5 days of artificial insemination.

Results

In total, 975 and 406 embryos were collected in IE and SE group, respectively. The analysis of reproductive hormones showed that concentrations of FSH, E2 and AMH were positive correlated with the embryo yield while concentrations of LH and P4 were negative correlated in both group at 1stdetection. At 2nddetection, the trends of reproductive hormones were similar with 1stexcept P4, which was positive correlated with embryo yield. The metabolomics analysis showed that 1158 metabolites (721 in positive iron mode and 437 in negative iron mode) were detected and 617 were annotated. In 1stcomparation of high and low embryonic yield populations, 56 and 53 differential metabolites were identified in IE and SE group, respectively. The phosphatidyl choline (PC) (19:0/20:5) and PC (18:2/18:3) were shared in two groups. In 2ndcomparation, 48 and 49 differential metabolites were identified in IE and SE group, respectively. The PC (18:1/18:2) and pentadecanoic acid were shared. Most differential metabolites were significantly enriched in amino acid, fatty acid metabolism, digestive system secretion and ovarian steroidogenesis pathways.

Conclusions

This study showed that FSH, P4, AMH, the PC relevant metabolites and some anomic acids could be potential biomarkers for embryonic yield prediction in ovine multiple ovulation. The results would help to explain the relation between blood material and ovarian function and provide a theoretical basis for the multiple ovulation prediction.
Label-free detection and quantification of ultrafine particulate matter in lung and heart of mouse and evaluation of tissue injury
Authors: Hameed Saira , Pan Kun , Su Wenhua , Trupp Miles , Mi Lan , Zhao Jinzhuo
Published: July 2022

While it is known that air borne ultrafine particulate matter (PM) may pass through the pulmonary circulation of blood at the alveolar level between lung and heart and cross the air-blood barrier, the mechanism and effects are not completely clear. In this study the imaging method fluorescence lifetime imaging microscopy is adopted for visualization with high spatial resolution and quantification of ultrafine PM particles in mouse lung and heart tissues. The results showed that the median numbers of particles in lung of mice exposed to ultrafine particulate matter of diameter less than 2.5 µm was about 2.0 times more than that in the filtered air (FA)-treated mice, and about 1.3 times more in heart of ultrafine PM-treated mice than in FA-treated mice. Interestingly, ultrafine PM particles were more abundant in heart than lung, likely due to how ultrafine PM particles are cleared by phagocytosis and transport via circulation from lungs. Moreover, heart tissues showed inflammation and amyloid deposition. The component analysis of concentrated airborne ultrafine PM particles suggested traffic exhausts and industrial emissions as predominant sources. Our results suggest association of ultrafine PM exposure to chronic lung and heart tissue injuries. The current study supports the contention that industrial air pollution is one of the causative factors for rising levels of chronic pulmonary and cardiac diseases.
Optimizing PO2 during peripheral veno-arterial ECMO: a narrative review
Authors: Winiszewski Hadrien , Guinot Pierre-Grégoire , Schmidt Matthieu , Besch Guillaume , Piton Gael , Perrotti Andrea , Lorusso Roberto , Kimmoun Antoine , Capellier Gilles
Published: July 2022

During refractory cardiogenic shock and cardiac arrest, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is used to restore a circulatory output. However, it also impacts significantly arterial oxygenation. Recent guidelines of theExtracorporeal Life Support Organization(ELSO) recommend targeting postoxygenator partial pressure of oxygen (PPOSTO2) around 150 mmHg. In this narrative review, we intend to summarize the rationale and evidence for this PPOSTO2target recommendation. Because this is the most used configuration, we focus on peripheral VA-ECMO. To date, clinicians do not know how to set the sweep gas oxygen fraction (FSO2). Because of the oxygenator’s performance, arterial hyperoxemia is common during VA-ECMO support. Interpretation of oxygenation is complex in this setting because of the dual circulation phenomenon, depending on both the native cardiac output and the VA-ECMO blood flow. Such dual circulation results in dual oxygenation, with heterogeneous oxygen partial pressure (PO2) along the aorta, and heterogeneous oxygenation between organs, depending on the mixing zone location. Data regarding oxygenation during VA-ECMO are scarce, but several observational studies have reported an association between hyperoxemia and mortality, especially after refractory cardiac arrest. While hyperoxemia should be avoided, there are also more and more studies in non-ECMO patients suggesting the harm of a too restrictive oxygenation strategy. Finally, setting FSO2to target strict normoxemia is challenging because continuous monitoring of postoxygenator oxygen saturation is not widely available. The threshold of PPOSTO2around 150 mmHg is supported by limited evidence but aims at respecting a safe margin, avoiding both hypoxemia and severe hyperoxemia.
DCSO: towards an ontology for machine-actionable data management plans
Authors: Cardoso João , Castro Leyla J. , Ekaputra Fajar J. , Jacquemot Marie C. , Suchánek Marek , Miksa Tomasz , Borbinha José
Published: July 2022

The concept of Data Management Plan (DMP) has emerged as a fundamental tool to help researchers through the systematical management of data. The Research Data Alliance DMP Common Standard (DCS) working group developed a set of universal concepts characterising a DMP so it can be represented as a machine-actionable artefact, i.e., machine-actionable Data Management Plan (maDMP). The technology-agnostic approach of the current maDMP specification: (i) does not explicitly link to related data models or ontologies, (ii) has no standardised way to describe controlled vocabularies, and (iii) is extensible but has no clear mechanism to distinguish between the core specification and its extensions.This paper reports on a community effort to create the DMP Common Standard Ontology (DCSO) as a serialisation of the DCS core concepts, with a particular focus on a detailed description of the components of the ontology. Our initial result shows that the proposed DCSO can become a suitable candidate for a reference serialisation of the DMP Common Standard.
Characterization of task response time in fog enabled networks using queueing theory under different virtualization modes
Authors: Mohamed Ismail , Al-Mahdi Hassan , Tahoun Mohamed , Nassar Hamed
Published: July 2022

Much research has focused on task offloading in fog-enabled IoT networks. However, there is an important offloading issue that has hardly been addressed—the impact of different virtualization modes on task response (TR) time. In the present article, we bridge this gap, introducing three virtualization modes, and characterizing the TR time under each. In each mode the virtual machines (VM) at the fog are customized differently, leveraging VM elasticity. In the perfect virtualization mode, the VM is customized to match exactly the computational load of the incoming task. This ensures that each task, regardless of which VM it goes to, will have the same service time. In the semiperfect virtualization mode, a less stringent, thus more practical, alternative, the VM is customized to match roughly the computational load of the incoming task. This results in a uniformly distributed task service time. Finally, in the baseline virtualization mode, the VM is customized to just be fast, with no regard to the computational load of the incoming task. This mode, which just re-scales the processing time of the task, is the default in existing research, and is re-introduced here for only comparison purposes. We characterize the TR time for the three modes leveraging M/G/1 and M/G/m queueing models, with the queueing stability condition identified for each mode. The obtained analytical results are successfully validated by discrete event Monte Carlo simulation. The numerical results show that the first mode results in the shortest TR time, followed by the second mode, then the third mode. That is, if virtualization is managed adequately, significant improvement in TR time can be gained.
ES-PPDA: an efficient and secure privacy-protected data aggregation scheme in the IoT with an edge-based XaaS architecture
Authors: Chen Quan , Wu Liangshun , Jiang Congshi
Published: July 2022

In an Internet of Things (IoT) system based on an anything as a service (XaaS) architecture, data are uploaded from heterogeneous nodes in a nonstandardized format and aggregated on the server side. Within this data-intensive architecture, privacy preservation is one of the most important issues. In response to this concern, there are numerous privacy-protection data aggregation (PPDA) solutions available for various IoT applications. Because of the limited resources of intelligent IoT devices, traditional PPDA cannot meet practical privacy and performance needs. To tackle this challenge, we provide a more efficient and secure PPDA solution that guarantees data security and integrity through Paillier homomorphic encryption and online/offline signing technology. Detailed security analysis shows that our system is unpredictable under a chosen message attack, and the data integrity may be guaranteed under the assumption of q-strong Diffie-Hellman (Q-SDH). We choose an M/G/1 priority queue model to maximize system performance. M/G/1 enhances queuing efficiency and accelerates channel access, thus reducing waiting time and increasing reliability. The experimental results show that our data aggregation scheme is reliable with low latency.
Exploring spatiotemporal patterns of COVID-19 infection in Nagasaki Prefecture in Japan using prospective space-time scan statistics from April 2020 to April 2022
Authors: Lu Yixiao , Cai Guoxi , Hu Zhijian , He Fei , Jiang Yixian , Aoyagi Kiyoshi
Published: July 2022

Background

Up to April 2022, there were six waves of infection of coronavirus disease 2019 (COVID-19) in Japan. As the outbreaks continue to grow, it is critical to detect COVID-19’s clusters to allocate health resources and improve decision-making substantially. This study aimed to identify active clusters of COVID-19 in Nagasaki Prefecture and form the spatiotemporal pattern of high-risk areas in different infection periods.

Methods

We used the prospective space-time scan statistic to detect emerging COVID-19 clusters and examine the relative risk in five consecutive periods from April 1, 2020 to April 7, 2022, in Nagasaki Prefecture.

Results

The densely inhabited districts (DIDs) in Nagasaki City have remained the most affected areas since December 2020. Most of the confirmed cases in the early period of each wave had a history of travelling to other prefectures. Community-level transmissions are suggested by the quick expansion of spatial clusters from urban areas to rural areas and remote islands. Moreover, outbreaks in welfare facilities and schools may lead to an emerging cluster in Nagasaki Prefecture’s rural areas.

Conclusions

This study gives an overall analysis of the transmission dynamics of the COVID-19 pandemic in Nagasaki Prefecture, based on the number of machi-level daily cases. Furthermore, the findings in different waves can serve as references for subsequent pandemic prevention and control. This method helps the health authorities track and investigate outbreaks of COVID-19 that are specific to these environments, especially in rural areas where healthcare resources are scarce.
The impact of tracheostomy delay in intensive care unit patients: a two-year retrospective cohort study
Authors: Sindi Anees
Published: July 2022

Background

Aims

This study was undertaken to evaluate our tracheostomy service and identify reasons for any delays.

Methods

A retrospective study in an academic tertiary-care hospital in Jeddah, Saudi Arabia. Inclusion criteria were any patients in ICU who required a surgical tracheostomy over a 2-year period (January 2014 to December 2015). The primary outcome was delayed tracheostomy referral and secondary outcomes included the number of days between referral and consultation, days between consultation and tracheostomy placement, and mortality rates.

Results

Ninety-nine patients had a tracheostomy between January 2014 to December 2015 and could be analysed, mean age of 52.7 years, 44.5% females. The average duration from referral to tracheostomy was 5.12 days (SD 6.52). Eighteen patients (18.2%) had delayed tracheostomy (> 7 days from referral). The main reasons for the delay were the patient’s medical condition (50%, n = 9), followed by low haemoglobin (38.9%, n = 7). Administrative reasons were recorded in 5 cases only (28%); 2 due to operating room lack of time, 2 due to multidisciplinary issues, and 1 due to family refusal. Laboratory-confirmed low haemoglobin, a prescription of anti-platelets, or a prescription of anti-coagulation were not associated with a longer duration between referral and tracheostomy placement. An increase of 1 day in the time between referral and tracheostomy corresponded to an increase in delay in discharge from ICU of 1.24 days (95% CI 0.306 to 2.18).

Conclusion

Although most delays related to the clinical condition of the patient, administrative and multidisciplinary factors also play a role. Early tracheostomy (less than 14 days) from intubation increases the survival rates of patients and improves their clinical outcomes. Further prospective evaluation is needed to confirm the impact of delay in performing surgical tracheostomy among ICU patients whose bedside percutaneous tracheostomy is contraindicated.
Small biomarkers with massive impacts: PI3K/AKT/mTOR signalling and microRNA crosstalk regulate nasopharyngeal carcinoma
Authors: LI Hai-Long , Deng Nian-Hua , He Xiu-Sheng , Li Yue-Hua
Published: July 2022

Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumours of the head and neck in Southeast Asia and southern China. The Phosphatidylinositol 3-kinase/protein kinase B (AKT)/mammalian target of rapamycin (mTOR) signalling pathway is involved in processes related to tumour initiation/progression, such as proliferation, apoptosis, metastasis, and drug resistance, and is closely related to the clinicopathological features of NPC. In addition, key genes involved in the PI3K/AKT/mTOR signalling pathway undergo many changes in NPC. More interestingly, a growing body of evidence suggests an interaction between this signalling pathway and microRNAs (miRNAs), a class of small noncoding RNAs. Therefore, in this review, we discuss the interactions between key components of the PI3K/AKT/mTOR signalling pathway and various miRNAs and their importance in NPC pathology and explore potential diagnostic biomarkers and therapeutic targets.
Murine Thyroid IL-4 Expression Worsens Hypothyroidism on Iodine Restriction and Mitigates Graves Disease Development
Authors: Merakchi Karima , Djerbib Sami , Soleimani Manoocher , Dumont Jacques-Emile , Miot Françoise , De Deken Xavier
Published: July 2022

Cytokines are known to perturb thyroid function and the role of interleukin-4 (IL-4) in the pathogenesis of Graves disease (GD) remains controversial. In our mouse model overexpressing IL-4 in thyrocytes (Thyr-IL4), we have reported that adult mice preserved normal serum thyroxine despite an iodide uptake defect. In the present work, we evaluated if iodine restriction could uncover the thyroid deficiency in Thyr-IL4 animals as well as the role of pendrin overexpression as a compensatory mechanism. Moreover, using an experimental model of GD we investigated the effect of a local expression of IL-4 on the incidence of hyperthyroidism. Thyr-IL4 mice developed more rapidly elevated serum thyrotropin under low-iodine supply with thyroid enlargement and classical histological modifications. These hallmarks of hypothyroidism were all enhanced in Thyr-IL4 mice with complete pendrin invalidation. Following immunization, a lower proportion of Thyr-IL4 animals developed hyperthyroidism. Surprisingly, immunized Thyr-IL4 animals presented numerous leukocyte infiltrates, associated with increased intrathyroidal expression of IFN-γ. We have demonstrated that thyroid deficiency in Thyr-IL4 mice is partially compensated for by the excessive iodide content of the standard chow and the overexpression of pendrin in these animals. Furthermore, we have shown that the local expression of IL-4 in the thyroid attenuates GD progression, which was associated with enhanced thyroid infiltration by immune cells that could negatively affect thyroid function.