bluuebunny/crossref_metadata_2025 huggingface dataset:
Nasal Symptoms Following Laryngectomy: A Cross-sectional Analysis
Authors: Ayoub Noel , Kearney Ann , Sayyid Zahra N. , Erickson-DiRenzo Elizabeth , Jeffrey Caroline , Hwang Peter H.
Published: January 2020

Background

After total laryngectomy, the severe reduction in nasal airflow alters the function and physiology of the nasal cavity. These anatomic and physiologic changes may in turn impact sinonasal quality of life.

Objective

This study sought to characterize the degree of postoperative sinonasal symptoms experienced by laryngectomees.

Methods

Two groups of subjects were recruited in this cross-sectional analysis: patients who previously underwent laryngectomy with or without chemoradiation for laryngeal or hypopharyngeal cancer and a comparison group treated with radiation but not laryngectomy. Patients underwent assessment of sinonasal symptoms using the Reflective Total Nasal Symptom Score (rTNSS), 22-item Sinonasal Outcome Test (SNOT-22), and visual analog scales (VASs). Patients also underwent nasal endoscopy recorded and graded by blinded reviewers using the Modified Lund–Kennedy (MLK) scale.

Results

Thirty-six laryngectomees and 12 controls were enrolled. The total SNOT-22 was similar between the 2 groups (27.3 vs 20.3, P = .16), but the laryngectomy cohort had higher rhinologic ( P < .01), extranasal ( P = .01), and ear/face ( P = .01) subdomain scores. VAS scores were worse in the laryngectomy group for nasal congestion ( P < .01), rhinorrhea ( P < .01), postnasal drip ( P < .01), and smell ( P < .01) but not for nasal fullness ( P = .11). rTNSS (4.7 vs 2.8, P = .04) and MLK scores (2.8 vs 0.8, P < .01) were higher in the laryngectomy group. In addition, 44% and 83% of patients in the laryngectomy and nonlaryngectomy groups, respectively, subjectively reported well-controlled nasal symptoms.

Conclusion

Laryngectomees are likely to experience a higher degree of subjective and objective nasal disease than nonlaryngectomized patients. Postlaryngectomy nasal dysfunction may be an important aspect of quality of life impairment in the laryngectomee population.
The Role of Hypertension in Cartilage Restoration: Increased Failure Rate After Autologous Chondrocyte Implantation but Not After Osteochondral Allograft Transplantation
Authors: Merkely Gergo , Ackermann Jakob , Gomoll Andreas H.
Published: January 2020

Objectives. The purpose of this study was to examine whether patients with diagnosed hypertension have an increased risk of graft failure following cartilage repair with either autologous chondrocyte implantation (ACI) or osteochondral allograft transplantation (OCA). We hypothesized that hypertension is related to higher ACI and OCA graft failure. Design. Patients who underwent ACI or OCA transplantation between February 2009 and December 2016 were included in this study. Inclusion criteria were (1) at least 2 years’ follow-up, (2) available information related to the living habits (smoking and medication status), and (3) available information related to the presence of hypertension, diabetes mellitus, or hyperlipidemia. To identify potential independent risk factors of graft failure, univariate screening was performed and factors with significance at a level of P < 0.1 were entered in multivariate logistic regression models. Results. A total of 368 patients (209 ACI and 159 OCA) were included into our study. In the ACI group, 61 patients’ (29.1%) graft failed. Univariate screening identified older age, female gender, defect size, higher prevalence of hypertension, and smoking as a predictor of graft failure. Following, multivariate logistic regression revealed female gender (odds ratio [OR] 1.02, P = 0.048), defect size (OR 1.07, P = 0.035), and hypertension (OR 3.73, P = 0.023) as significant independent risk factors predicting graft failure after ACI. In the OCA group, 29 patients’ (18.2%) graft failed and none of the included factors demonstrated to be a potential risk factor for graft failure. Conclusion. Hypertension, defect size, and female gender seem to predict ACI graft failure but not OCA failure.
Biological Mechanisms for Cartilage Repair Using a BioCartilage Scaffold: Cellular Adhesion/Migration and Bioactive Proteins
Authors: Commins Jacqueline , Irwin Rebecca , Matuska Andrea , Goodale Margaret , Delco Michelle , Fortier Lisa
Published: January 2020

Objective. BioCartilage is a desiccated, particulated cartilage allograft used for repair of focal cartilage defects. It is mixed with a biologic such as bone marrow concentrate (BMC), pressed into a contained defect, and sealed with fibrin glue. The objective of this study was to assess if BioCartilage could serve as a bioactive scaffold by affecting cellular adhesion, cellular migration, or the release interleukin-1 receptor antagonist protein (IL-1RA), and to identify its full proteomic makeup. Design. Cartilage explants were used to model confined defects. BioCartilage was mixed with BMC, grafted into defects, and sealed with 1 of 5 fibrin glues. Constructs were cultured for 24 or 48 hours and then processed for live/dead microscopy. Chondrocyte and mesenchymal stem cell (MSC) adhesion on BioCartilage was assessed using scanning electron microscopy. Conditioned medium from cultures and the biologics used in the study were assayed for IL-1RA. The protein footprint of BioCartilage was determined using bottom-up proteomics. Results. BioCartilage supported chondrocyte and MSC attachment within 24 hours, and cell viability was retained in all constructs at 24 and 48 hours. Fibrin glue did not inhibit cell attachment. BMC had the highest concentration of IL-1RA. Proteomics yielded 254 proteins, including collagens, proteoglycans, and several bioactive proteins with known anabolic roles including cartilage oligomeric matrix protein. Conclusions. This study suggests that BioCartilage has the chemical composition and architecture to support cell adherence and migration and to provide bioactive proteins, which together should have biologics advantages in cartilage repair beyond its role as a scaffold.
Demographics of traumatic brain injury and outcomes of continuous chain of early rehabilitation in Singapore
Authors: Lui Siew Kwaon , Fook-Chong Stephanie Man Chung , Teo Qiao Qi
Published: January 2020

Background:

Evidence shows that early initiation of a continuous chain of rehabilitation is associated with better functional outcomes in traumatic brain injured patients. The Department of Rehabilitation Medicine initiated early screening and review of patients with all traumatic brain injury (TBI) severity within 72 hours of acute admission, followed by direct transfer of suitable patients to acute inpatient rehabilitation (AIR).

Objectives:

This study aim to document the demographics and clinical characteristics of all TBI patients admitted to the local acute hospital; determine the characteristics of patients with TBI who are directly transferred to AIR following early screening and review; and determine clinical predictors affecting functional outcomes of patients of all TBI severity.

Methods:

A total of 491 patients were screened and reviewed; 116 patients were directly transferred to AIR.

Results:

The median age of the screened cohort was 67.0 years (interquartile range 50.0–77.0 years). Falls were the leading mechanism of TBI. Infection (odds ratio (OR)=2.95, 95% confidence interval (CI) 1.59–5.49) and neurosurgical intervention (OR=2.18, 95% CI 1.24–3.81) increased the odds of transfer to AIR. The Functional Independence Measure (FIM) gain after receiving AIR was significant ( p<0.001). Increased age, complications, high motor admission FIM (AFIM) and long rehabilitation length of stay (RLOS) were negatively associated with FIM gain and FIM efficiency.

Conclusions:

Our study demonstrated that falls were the leading mechanism of TBI, with the majority of patients being older. Infection and neurosurgical intervention increased the likelihood of transfer to AIR. There was functional improvement after AIR. Age, complications, motor AFIM and RLOS were negatively associated with FIM gain and FIM efficiency. Further local research is warranted to confirm these findings.
Awareness about radiation hazards and knowledge about radiation protection among healthcare personnel: A quaternary care academic center–based study
Authors: Khamtuikrua Chaowanan , Suksompong Sirilak
Published: January 2020

Background:

The use of medical radiation in diagnosis and procedural and surgical treatment is increasing. Therefore, healthcare personnel should be adequately aware and knowledgeable about radiation hazards to protect themselves and their patients from its adverse effects. The objective of this study was to examine awareness about radiation hazards and knowledge about protection methods among the anesthesia personnel and surgical subspecialists of a quaternary care academic center.

Methods:

A validated questionnaire was completed by anesthetic personnel and surgical subspecialists. It consisted of questions that required demographic information and assessed awareness about radiation hazards. In addition, 15 multiple-choice questions assessed knowledge about radiation across the following domains: the main principle of radiation protection, personal annual radiation dose, personal protection equipment, safe distance from an X-ray machine, and susceptible organs.

Results:

A total of 270 potential participants were emailed and invited to respond to an online questionnaire, and the response rate was 79.3%. Of the 214 participants, 69.2% were women; the mean age of the sample was 34.8 years. Most of the participants (63.1%) considered radiation exposure that occurs as a part of daily work to be very harmful; 86.4% and 78.5% reported that they always wore a lead apron and a thyroid shield when working in an environment that entails radiation exposure, respectively. The mean score for knowledge about radiation hazards and protection was 6.4 ± 2.0 (maximum possible score = 15) Therefore, there is a need to improve anesthetic personnel and surgical subspecialists’ knowledge about radiation protection, especially with regard to the use of lead goggles and harmful doses of radiation.

Conclusion:

The present findings suggest that there is a reasonable level of awareness but a relative lack of knowledge about radiation hazards and protection among anesthesia personnel and surgical subspecialists. Therefore, continuing medical education on radiation hazards and protection must be mandated.
Personal and societal costs of multiple sclerosis in the UK: A population-based MS Registry study
Authors: Nicholas Richard S , Heaven Martin L , Middleton Rodden M , Chevli Manoj , Pulikottil-Jacob Ruth , Jones Kerina H , Ford David V
Published: January 2020

Objectives

To investigate through survey and data linkage, healthcare resource use and costs (except drugs), including who bears the cost, of multiple sclerosis in the United Kingdom by disease severity and type.

Methods

The United Kingdom Multiple Sclerosis Register deployed a cost of illness survey, completed by people with multiple sclerosis and linked this with data within the United Kingdom Multiple Sclerosis Register and from their hospital records. Resource consumption was categorised as being medical or non-medical and costed by National Health Service and social services estimates for 2018.

Results

We calculated £509,003 in non-medical costs over a year and £435,488 in medical costs generated over 3 months. People with multiple sclerosis reported self-funding 75% of non-medical costs with non-medical interventions having long-term potential benefits. Costs increased with disability as measured by patient-reported Expanded Disability Status Score and Multiple Sclerosis Impact Scale, with Multiple Sclerosis Impact Scale physical being a more powerful predictor of costs than the patient-reported Expanded Disability Status Score. Two distinct groups were identified: medical and non-medical interventions ( n = 138); and medical interventions only ( n = 399). The medical and non-medical group reported increased disease severity and reduced employment but incurred 80% more medical costs per person than the medical-only group.

Conclusions

The importance of disability in driving costs is illustrated with balance between medical and non-medical costs consistent with the United Kingdom health environment. People with multiple sclerosis and their families fund a considerable proportion of non-medical costs but non-medical interventions with longer term impact could affect future medical costs.
Effects of tourniquet application on enhanced recovery after surgery (ERAS) and ischemia-reperfusion post-total knee arthroplasty: Full- versus second half-course application
Authors: Cao Qinggang , He Zhiwei , Fan Yongfei , Meng Jia , Yuan Tao , Zhao Jianning , Bao Nirong
Published: January 2020

Purpose:

Pneumatic tourniquets are used in total knee arthroplasty (TKA) for surgical field visualization and improved cementation; however, their use is controversial. This study aimed to assess the effects of tourniquet application on enhanced recovery post-TKA.

Methods:

A prospective randomized single-blinded trial assessed tourniquet’s effects on postoperative pain, swelling, and early outcome in TKA. One-hundred and two patients with knee osteoarthritis were randomized to full-course (FC) and second half-course (SHC) application ( n = 51/group). Tumor necrosis factor-alpha (TNF-α), C-C motif chemokine ligand 2(CCL-2), pentraxin-3 (PTX-3), prostaglandin E-2 (PGE-2), superoxide dismutase-1 (SOD-1), and myoglobin (Mb) were assessed by enzyme-linked immunosorbent assay, while the visual analog scale (VAS), range of motion (ROM), and thigh circumference growth rate were recorded.

Results:

Average tourniquet duration significantly differed between the SHC (37.5 ± 5.1 min) and FC (66.4 ± 7.2 min) groups ( p < 0.01); VAS and thigh circumference growth rate in the SHC group were much lower compared with the FC group, while ROM was higher within 48 h of tourniquet removal ( p < 0.01). Blood TNF-α, PTX3, CCL2, PGE2, SOD-1, and Mb were lower in the SHC group than the FC group ( p < 0.01). Additionally, intraoperative blood loss was significantly elevated in the SHC group than the FC group ( p < 0.01), with lower postoperative blood loss in the drain ( p = 0.001). Postoperative drainage volume was reduced in the SHC group compared with the FC group ( p < 0.01); five and two patients in the FC and SHC groups required blood transfusion, respectively ( p = 0.025). Hospital stay tended to be shorter in the SHC group ( p = 0.023), and no tourniquet-related complications were recorded.

Conclusion:

Improved therapeutic outcome was observed in the SHC group, indicating patients should routinely undergo TKA with SHC tourniquet application.
Influence of Occupational Factors on the Job Satisfaction Among Licensed Periodontist in Kingdom of Saudi Arabia: A Cross-Sectional Study
Authors: Al-Shibani Nouf , Labban Nawaf , Alshehri Fahad Ali , Al-Kattan Reem , Al-Otaibi Hanan , Alfadda Sara , Albarakati Sahar Faisal
Published: January 2020

Aim:

To evaluate the overall job satisfaction among periodontists, highlighting the significance of intrinsic and extrinsic factors and their satisfaction level with patients, facilities, and workplace when working in the Kingdom of Saudi Arabia.

Materials and Methods:

An interview-type questionnaire-based cross-sectional study was formulated and consisted of total 38 questions in 8 domains. Contact details of registered periodontists were taken and a weblink containing details of the questionnaire using the tool SurveyMonkey was sent to periodontist from the office of Saudi Dental Society. A single investigator was done to minimize bias evaluated with all the responses. Statistical Package for the Social Sciences software version 21 (SPSS Inc., Chicago, IL, USA) was used for tabulation of descriptive analysis. Standard deviation, percentages and means were calculated.

Results:

Out of the total 75 emails sent to the periodontists, 65 (86%) responses were received. 63 (96.9%) of the respondents were Saudi nationals, whereas the rest 2 (3.1%) were non‑Saudis. 40 (61.5%) respondents were males, whereas 25 (38.5%) were females. Majority of the respondents were dentists 43 (66.2%). 32.3% reported better professional growth as the main reason for choosing periodontal profession. However, a vast majority of the respondents, 56.9% stated that working as a periodontist was their first choice. 49.3% of the respondents affirmed that they were pleased with the working environment as it was conductive and professional. Approximately, 73.9% of the periodontist were of the view that they had good relations with their patients.

Conclusion:

Job satisfaction among periodontists working in the Kingdom of Saudi Arabia was adequate as majority of them displayed a positive attitude toward working environment, their profession, peers, and intrinsic and extrinsic factors related to periodontal profession.

Clinical Significance:

Job satisfaction plays a vital role in delivering standard quality health care. Dissatisfaction in job may lead to stress, anxiety, and/or depression leading to compromised health care facilities and patient satisfaction.
Hip and Groin Injuries in National Collegiate Athletic Association Women’s Soccer Players
Authors: Ralston Bridget , Arthur Jaymeson , Makovicka Justin L. , Hassebrock Jeff , Tummala Sailesh , Deckey David G. , Patel Karan , Chhabra Anikar , Hartigan David
Published: January 2020

Background:

Hip and groin injuries are common in competitive soccer players and have been shown to be significant sources of time loss. There are few studies describing the epidemiology of hip and groin injuries in female National Collegiate Athletic Association (NCAA) soccer players.

Purpose:

To describe the epidemiology of hip and groin injuries in women’s collegiate soccer players.

Study Design:

Descriptive epidemiology study.

Methods:

The NCAA Injury Surveillance System/Program (ISS/ISP) was analyzed from 2004 through 2014 for data related to hip and groin injuries in female collegiate soccer players. Injuries and athlete-exposures (AEs) were reported by athletic trainers. Data were stratified by time of season, event type, injury type, treatment outcome, time loss, and player field position.

Results:

Between 2004 and 2014, there were 439 recorded hip or groin injuries in female soccer players and an overall rate of injury of 0.57 per 1000 AEs. Injuries were 12.0 times more likely to occur during the preseason (4.41/1000 AEs) as opposed to during the regular season (0.37/1000 AEs) (injury rate ratio [IRR], 12.01; 95% confidence interval [CI], 9.92-14.55) or postseason (0.38/1000 AEs) (IRR, 11.55; 95% CI, 7.06-18.91). Rates of injury were similar during the regular season and postseason (IRR, 0.96; 95% CI, 0.59-1.58). Rates of injury were higher during competition (0.69/1000 AEs) than during practice (0.52/1000 AEs) (IRR, 1.33; 95% CI, 1.08-1.63). Most injuries were new (87.5%; n = 384) and unlikely to recur (12.5%; n = 55).

Conclusion:

Hip and groin injuries in female NCAA soccer players are uncommon, and fortunately, most players return to play quickly without recurrence. Future prospective studies should evaluate the effectiveness of strength and conditioning programs in preventing these injuries.
Causes of Death in Childhood Acute Lymphoblastic Leukemia at Hue Central Hospital for 10 Years (2008-2018)
Authors: Kiem Hao Tran , Nhu Hiep Pham , Kim Hoa Nguyen Thi , Van Ha Chau
Published: January 2020

Aim. To analyze the common cause of death in childhood acute lymphoblastic leukemia patients. Methods and Materials. A retrospective descriptive study on children with acute lymphoblastic leukemia who died at Hue Central Hospital between 2008 and 2018. All the patients were treated with the same protocol of modified Children’s Cancer Group 1882 and 1881. Results. A total of 238 children with acute lymphoblastic leukemia who were cared for at our center were enrolled. Of these, there were 74 deaths. Among the death group, the male-to-female ratio was 2.7:1. Twenty-six (35.1%) occurred in maintenance phase, 18 (24.3%) occurred in induction phase, and 9 (12.2%) occurred in delayed intensification. Infection was responsible for deaths in 32 of 74 (43.2%) cases. Pseudomonas aeruginosa was found in 3 of 32 infected cases (9.4%) and resistance to almost all antibiotics in our hospital. Relapse, abandonment, and bleeding were documented in 20 (27.0%), 7 (9.5%), and 6 (8.1%) cases, respectively. Twenty-seven (84.3%) patients had absolute neutrophil count <500/µL. Of 32 infectious deaths, pneumonia occurred in 40.6%. Regarding 20 relapse death, bone marrow was the major site of relapse and it occurred in 13 (65%) cases. And there were 65% patients with very early relapse. Conclusions. Infection is the major cause of mortality in acute lymphoblastic leukemia patients in our study. To improve outcome, we should improve supportive care, especially prevention and control infection.
Virtual Reality Relaxation to Decrease Dental Anxiety: Immediate Effect Randomized Clinical Trial
Authors: Lahti S. , Suominen A. , Freeman R. , Lähteenoja T. , Humphris G.
Published: January 2020

Introduction:

Dental anxiety is common and causes symptomatic use of oral health services.

Objectives:

The aim was to study if a short-term virtual reality intervention reduced preoperative dental anxiety.

Methods:

A randomized controlled single-center trial was conducted with 2 parallel arms in a public oral health care unit: virtual reality relaxation (VRR) and treatment as usual (TAU). The VRR group received a 1- to 3.5-min 360° immersion video of a peaceful virtual landscape with audio features and sound supporting the experience. TAU groups remained seated for 3 min. Of the powered sample of 280 participants, 255 consented and had complete data. Total and secondary sex-specific mixed effects linear regression models were completed for posttest dental anxiety (Modified Dental Anxiety Scale [MDAS] total score) and its 2 factors (anticipatory and treatment-related dental anxiety) adjusted for baseline (pretest) MDAS total and factor scores and age, taking into account the effect of blocking.

Results:

Total and anticipatory dental anxiety decreased more in the VRR group than the TAU group (β = −0.75, P < .001, for MDAS total score; β = −0.43, P < .001, for anticipatory anxiety score) in patients of a primary dental care clinic. In women, dental anxiety decreased more in VRR than TAU for total MDAS score (β = −1.08, P < .001) and treatment-related dental anxiety (β = −0.597, P = .011). Anticipatory dental anxiety decreased more in VRR than TAU in both men (β = −0.217, P < .026) and women (β = −0.498, P < .001).

Conclusion:

Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).

Knowledge Transfer Statement:

Dental anxiety, which is a common problem, can be reduced with short application of virtual reality relaxation applied preoperatively in the waiting room. Findings of this study indicate that it is a feasible and effective procedure to help patients with dental anxiety in normal public dental care settings.
Prediction of cutting force in micro-end-milling by a combination of analytical and FEM method
Authors: Roushan Ashutosh , Rao U. S. , Vijayaraghavan L.
Published: January 2020

Mechanical micro-machining, in general, and micro-end-milling, in particular, has become a very good technique for fabricating 3D micro-features in a variety of materials. To optimize and control the process, prediction of the cutting force accurately is very important. In this work, a force prediction model is developed by a combination of analytical method and finite element (FE) simulations. The model predicts the cutting force components for micro-end-milling process successfully which is compared with experimental force signal obtained by using Al2024-T3 and AISI 4340 as workpiece materials. The predicted and experimental cutting forces are in very good agreement for both the amplitude and trend of the cutting force. The percentage deviation of the predicted force from the experimental force values for both feed force ( Fx) and transverse force ( Fy) is around 15% (except one case) for Al2024-T3. For the AISI 4340 material, the percentage deviation for Fx is around 25% and for Fy is approximately 10%. The methodology followed here is general in nature and it can be applied to any other machining process as well.
Utilization of Technology to Improve Efficiency in Investigational Drug Management Processes
Authors: Mudaranthakam Dinesh Pal , Cernik Colin , Curtis Leslie , Griffith Blake , Hu Jinxiang , Wick Jo , Thompson Jeffrey , Gajewski Byron , Koestler Devin , Jensen Roy A. , Mayo Matthew S.
Published: January 2020

Background: Background: An investigational pharmacy is responsible for all tasks related to receiving, storing, and dispensing of any investigational drugs. Traditional methods of inventory and protocol tracking on paper binders are very tedious and could be error-prone. Objective: To evaluate the utilization of the IDS to efficiently manage the inventory within an investigational Pharmacy. We hypothesize that the IDS will reduce the drug processing time. Methods: Our pharmacy tracked the drug processing time before and after using the IDS including the receiving, dispensing, and inventory. As part of the receiving the study drug pharmacists tracked the time it took a pharmacist to complete the tasks of logging the study drug before and after the implementation of the IDS system. In addition, the pharmacy also timed the process for drug dispensing and a full investigational drug inventory check. Wilcoxon signed-rank test was used to compare the difference in the meantime of total processing before and after the IDS. Results: Utilization of the IDS system showed significant reduction in processing time, and improvement of efficiency in inventory management. Additionally, the usability survey of the IDS demonstrated that the IDS system helped pharmacists capture data consistently across every clinical trial. Conclusion: Our results demonstrates how technology helps pharmacists to focus on their actual day to day medication-related tasks rather than worrying about other operational aspects. Informatics team continues to further enhance the features such as monitor portal, and features related to finance – generation of invoices, billing reconciliation, etc.
A telehealth approach to improving clinical trial access for infants with tuberous sclerosis complex
Authors: Hyde Carly , Pizzano Maria , McDonald Nicole M. , Nelson Charles A. , Kasari Connie , Thiele Elizabeth A. , Jeste Shafali S.
Published: January 2020

Background

Research in rare genetic syndromes associated with ASD is often hampered by the wide geographic distribution of families and the presence of medical comorbidities, such as epilepsy, that may preclude travel to clinical sites. These challenges can limit the sample size and generalizability of the cohorts included in both natural history studies and clinical trials. Tuberous sclerosis complex (TSC) is a rare genetic syndrome that confers an elevated risk for autism spectrum disorder (ASD), with social communication delays identified in this population as early as 12 months of age. Early identification of risk necessitates parallel testing of early intervention, prompting the first randomized controlled clinical trial of behavioral intervention for infants with TSC (NCT03422367). However, considerable early recruitment challenges have mandated the systematic identification of enrollment barriers followed by modification of the study design to address these barriers.

Methods

Caregivers were interviewed regarding barriers to enrollment (phase 1). Adaptations to the intervention were made to address these barriers (phase 2). Outcomes based on this modification to the study design were defined by enrollment rate and participant demographics.

Results

Qualitative reports from caregivers indicated that distance and time were the primary barriers to clinical trial enrollment. The intervention was then modified to a remote model, with at-home, parent-delivered intervention, and weekly video conferencing with interventionists at the study sites. Enrollment increased 10-fold (from 3 to 30 participants) within 1 year and included a more diverse and clinically representative cohort of infants.

Conclusion

The design and implementation of more scalable methods to disseminate research remotely can substantially improve access to clinical trials in rare neurodevelopmental disorders. The lessons learned from this trial can serve as a model for future studies not only in rare conditions, but in other populations that lack adequate access, such as families with limited financial or clinical resources. Continued efforts will further refine delivery methods to enhance efficiency and ease of these delivery systems for families.
Abnormal cisatracurium pharmacodynamics and pharmacokinetics among patients with severe aortic regurgitation during anesthetic induction
Authors: Huang Xiaocong , Chen Lei , Cai Yujing , Wei Jinfeng , Lin Lina , Sun Jie , Peng Xuemei , Wang Sheng
Published: January 2020

Background

This study was designed to examine whether severe aortic regurgitation will affect the pharmacodynamics (PD) and pharmacokinetics (PK) of cisatracurium during anesthetic induction.

Methods

A total of 32 patients were divided into two groups: the AR group (n = 16) and the control group (n = 16). Arterial blood samples were drawn before and at 1, 2, 4, 6, 8, 10, 16 and 20 min after intravenous injection of 0.15 mg/kg cisatracurium. TOF tests were applied to determine the onset time of maximal muscle relaxation. The concentration of cisatracurium in plasma was determined by high-performance liquid chromatography.

Results

The onset time to maximal neuromuscular block was prolonged from 2.07 ± 0.08 min to 4.03 ± 0.14 min, which indicated that the PD responses to cisatracurium were significantly delayed in the AR group (P < 0.05) compared to the control group.

A conventional two-compartment PK model showed a higher plasma concentration of cisatracurium among the AR group with markedly reduced intercompartment transfer rate (K12 = 0.19 ± 0.02 and K21 = 0.11 ± 0.01 in the AR group vs. K12=0.26 ± 0.01 and K21 = 0.19 ± 0.01 in the control group,P < 0.01) compared to the control group.

Conclusion

Backward blood flow during diastole in severe AR impaired distribution of cisatracurium from the central compartment to the peripheral compartment, which accounted for the lagged PD responses.

Findings in this study underlie the importance of muscular blockade monitoring among patients with severe aortic regurgitation during anesthetic induction.

Registration

Name of the registry: Abnormal Cisatracurium Pharmacodynamics and Pharmacokinetics among Patients with Severe Aortic Regurgitation during Anesthetic Induction. Trial registration number:ChiCTR1800019654. Date of registration: November 20th 2018.
HIV testing, test results and factors influencing among infants born to HIV positive mothers in public hospitals of Mekelle City, North Ethiopia: a cross-sectional study
Authors: Ebuy Hiluf , Bekele Alemayehu , Redae Getachew
Published: January 2020

Background

Timely infant testing for HIV is critical to ensure optimal treatment outcomes among exposed infants. While world health organization recommends HIV exposed infants to be tested between 4 to 6 weeks of age, in developing countries like Ethiopia, access to timely infant testing is still very limited. The study is intended to assess timely infant testing, testing for HIV at the 18th month, test results and factors influencing HIV positivity among infants born to HIV positive mothers in public hospitals of Mekelle, Ethiopia.

Methods

A cross-sectional study design was employed on 558 HIV exposed infants, using consecutive sampling technique. A checklist was used to extract 4 years (January 2014–December 2017) secondary data, collected from January–April 2018. Data were analyzed using SPSS version 20, and binary logistic regression model was used to examine the association of independent variables with the outcome variables.

Results

Timely infant testing for HIV accounted for 346(62.0%). Mothers who attended antenatal care (AOR: 2.77; 95% CI: 1.17, 6.55) and who were counselled on feeding options (AOR: 2.01; 95% CI: 1.11, 3.65) were strongly associated with timely infant testing. Poor maternal adherence status was associated with infants’ HIV positivity at the 18th month of antibody test (AOR: 15.93; 95% CI: 2.21, 94.66). Being rural resident (AOR: 4.0; 95% CI: 1.23, 13.04), being low birth weight (AOR: 5.64; 95% CI: 2.00, 16.71) and not receiving ARV prophylaxis (AOR: 4.70; 95% CI: 1.15, 19.11) were positively associated with the overall HIV positivity.

Conclusions

A considerable proportion of exposed infants did not undergo timely testing for HIV. Antenatal care follow-up and counselling on feeding options were associated with timely infant testing. Mother’s poor adherence status was associated with infant’s HIV positivity at the 18th month of antibody testing. Being rural resident, being low birth weight, and not receiving ARV prophylaxis were the factors that enhance the overall HIV positivity. Timely infant testing, counselling on feeding options and adherence should be intensified, and prevention of mother-to-child transmission program in rural settings need to be strengthened.
Intrafractional vaginal dilation in anal cancer patients undergoing pelvic radiotherapy (DILANA) – a prospective, randomized, 2-armed phase-II-trial
Authors: Arians Nathalie , Häfner Matthias , Krisam Johannes , Lang Kristin , Wark Antje , Koerber Stefan A. , Hommertgen Adriane , Debus Jürgen
Published: January 2020

Background

The incidence of anal cancer is rising in the last decades and more women are affected than men. The prognosis after chemoradiation is very good with complete remission rates of 80–90%. Thus, reducing therapy-related toxicities and improving quality of life are of high importance. With the development of new radiotherapy techniques like IMRT (Intensity-modulated radiotherapy), the incidence of acute and chronic gastrointestinal toxicities has already been reduced. However, especially in female anal cancer patients genital toxicities like vaginal fibrosis and stenosis are of great relevance, too. Up to now, there are no prospective data reporting incidence rates, techniques of prevention or impact on quality of life. The aim of the DILANA trial is to evaluate the incidence and grade of vaginal fibrosis, to optimize radiotherapy by reducing dose to the vaginal wall to minimize genital toxicities and improve quality of life of anal cancer patients.

Methods

The study is designed as a prospective, randomized, two-armed, open, single-center phase-II-trial. Sixty patients will be randomized into one of two arms, which differ only in the diameter of a tampon used during treatment. All patients will receive standard (chemo) radiation with a total dose of 45–50.4 Gy to the pelvic and inguinal nodes with a boost to the anal canal up to 54–60 Gy. The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo) radiation depending on the extent of vaginal dilation. Secondary endpoints are toxicities according to the CTC AE version 5.0 criteria, assessment of clinical feasibility of daily use of a tampon, assessment of compliance for the use of a vaginal dilator and quality of life.

Discussion

Prospective studies are needed evaluating the incidence and grade of vaginal fibrosis after (chemo) radiation in female anal cancer patients. Furthermore, the assessment of techniques to reduce the incidence of vaginal fibrosis like intrafractional vaginal dilation as well as other radiotherapy-independent methods like using a vaginal dilator are essential. Additionally, implementation of a systematic assessment of vaginal stenosis is necessary to grant reproducibility and comparability of future data.

Trial registration

The trial is registered with clinicaltrials.gov (NCT04094454, 19.09.2019).
Validation and human factor analysis study of an infant weight estimation device
Authors:   on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network, Abdel-Rahman Susan M. , Paul Ian M. , Delmore Paula , Chen Jia-Yuh , Mills Mary , Greenberg Rachel G.
Published: January 2020

Background

Weight is critical for the medical management of infants; however, scales can be unavailable or inaccessible in some practice settings. We recently developed and validated a robust infant weight estimation method based on chest circumference (CC) and head circumference (HC). This study was designed to determine the human factors (HF) experience with, and predictive performance of, an infant weight estimation device that implements this method.

Methods

Prospective, multi-center, observational, masked study of 486 preterm and term infants (0–90 days) assessed by 15 raters. Raters measured the infant using calibrated scales/measures and masked versions of the device. Raters also evaluated critical tasks associated with device use. Mean error (ME) and mean percentage error (MPE) were used to assess predictive performance.

Result

Among 486 infants enrolled (36.8 ± 4.0 weeks gestational age, 31.5 ± 28.6 days postnatal age), predicted weight correlated highly with actual weight (r = 0.97, ME: − 69 ± 257 g, MPE: − 1.3 ± 6.9%). Predicted weight was within 10 and 15% of actual weight in 86 and 99%, of infants. HF errors were low, 0.1–0.8% depending on task. In all cases raters were confident or very confident in their measurements.

Conclusion

The device was statistically equivalent to the method on which it was based and approximated weight with acceptable variance from the true weight. HF data suggest the device is easy to use. This device can be used to estimate weight in infants when calibrated scales are impractical or unavailable.
Prevalence and factors associated with intestinal parasites among children of age 6 to 59 months in, Boricha district, South Ethiopia, in 2018
Authors: Tsegaye Berhan , Yoseph Amanuel , Beyene Hunachew
Published: January 2020

Background

Intestinal parasites are the commonest cause of childhood diarrhea and malnutrition in Ethiopia. Information about intestinal parasites is the first fundamental step for designing intervention strategies against them. Hence, health planners can maximize their efforts. Information is scarce about intestinal parasites among children of under-five years of age in Boricha district. Therefore, this study aimed at assessing prevalence and factors associated with intestinal parasites among children of age 6 to 59 months in Boricha district, South Ethiopia.

Methods

A community based analytical cross sectional study was conducted among 624 children of age 6 to 59 months from January 1 to 30; in 2018. We have utilized two stage stratified sampling method. Firstly, simple random sampling was used to select sample Kebeles. Secondly, systematic random sampling method was used to select the study participants. Structured and interviewer administrated questionnaire was used to collect data. Parasitological examination of children’s stool was conducted microscopically. Data were entered into Epi-info, exported and analyzed by SPSS version 22. Logistic regression analysis was conducted to identify association between explanatory variables and outcome variable. Adjusted Odds Ratio (AOR) with 95% confidence interval (95%CI) was computed, and P-value < 0.05 was considered as statistically significant. Descriptive statistics was presented using texts, tables and figures.

Result

A total of 622 participants were included in the analysis which makes a response rate of 99.9%. Prevalence of intestinal parasites was 48.7% (95%CI, 44.8–52.6) in this study. Higher family size (AOR = 2.7, 95%CI = 1.5–5.0), medium family size (AOR = 2.3,95%CI,1.3–4.2), absence of laterine facility in the household (AOR = 2.9, 95% CI = 1.6–5.3), unable to put on shoes (AOR = 3.5,95%CI = 2.2–5.7), and eating raw vegetables (AOR = 2.6,95%CI = 1.6–4.7) were factors positively associated with intestinal parasites in this study.

Conclusion

Overall prevalence of intestinal parasites was almost high. Latrine facility, family size, shoes wearing habit and eating raw vegetables were significantly associated with intestinal parasites. Family planning service, sanitation and hygiene practices should be intensified through community education. Activate support of deworming program should be considered. Moreover, policy makers should give priority on creating awareness to prevent intestinal parasite.
Study protocol of the Healthy High School study: a school-based intervention to improve well-being among high school students in Denmark
Authors: Bonnesen Camilla Thørring , Toftager Mette , Madsen Katrine Rich , Wehner Stine Kjær , Jensen Marie Pil , Rosing Johanne Aviaja , Laursen Bjarne , Rod Naja Hulvej , Due Pernille , Krølner Rikke Fredenslund
Published: January 2020

Background

The prevalence of low well-being, perceived stress and unhealthy behaviours is high among high school students, but few interventions have addressed these problems. The aim of this paper is to present a study protocol of a cluster randomised controlled trial evaluating the Healthy High School (HHS) intervention programme. The intervention programme is designed to improve well-being (primary outcome) by preventing 1) stress and promoting 2) sleep, 3) sense of community, 4) physical activity (PA) and 5) regular and healthy meals among high school students in Denmark.

Methods

The development of the HHS study was guided by the Intervention Mapping protocol. The intervention comprises four components: 1) a teaching material, 2) a smartphone app, 3) a catalogue focusing on environmental changes, and 4) a peer-led innovation workshop aiming at inspiring students to initiate and participate in various movement activities. The HHS study employs a cluster-randomised controlled trial design. Thirty-one high schools across Denmark were randomly allocated to intervention (16 schools) or control (15 schools) groups. The study included all first-year students (~ 16 years of age) (n = 5976 students). Timeline: Intervention: August 2016 – June 2017. Collection of questionnaire data: Baseline (August 2016), 1st follow-up (May 2017) and 2nd follow-up (April 2018). All students were invited to participate in a monthly sub-study about perceived stress using text messages for data collection (September 2016 – June 2017). PA was objectively assessed among a sub-sample of students using accelerometers (Axivity, AX3) in August 2016 and May 2017. Primary outcome measures: Student well-being measured by the Cantril Ladder and the five item World Health Organisation Well-being Index (individual level outcomes). Secondary outcome measures: Stress (10-item Perceived Stress Scale), sleep (quantity and quality), PA (hours of moderate-to-vigorous PA per week, hours of daily sedentary time and average daily PA), meal habits (daily intake of breakfast, lunch, snacks and water), and strong sense of community in class and at school, respectively (individual level outcomes). The study encompasses process and effect evaluation as well as health economic analyses.

Trial registration

ISRCTN ISRCTN43284296, 28 April 2017, retrospectively registered.
Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial
Authors: Vargas-Ortiz Katya , Lira-Mendiola Georgina , Gómez-Navarro Claudia M. , Padilla-Estrada Katya , Angulo-Romero Fabiola , Hernández-Márquez José M. , Villa-Martínez Ana K. , González-Mena Jessica N. , Macías-Cervantes Maciste H. , Reyes-Escogido Maria de Lourdes , Guardado-Mendoza Rodolfo
Published: January 2020

Background

Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients´ family. The aim of this study was to compare the impact of an interdisciplinary family (FI) Vs individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic β-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families’ metabolic risk.

Methods

Randomized Clinical Trial (RCT) to compare the impact of FI and II on IR and pancreatic β-cell function in subjects with prediabetes. There were 122 subjects with prediabetes (and 101 family members) randomized to FI or II. Data were collected in 2015–2016 and analyzed in 2017–2018. FI group had the support of their family members, who also received personalized diet and exercise recommendations; patients and their family members attended monthly a lifestyle enhancement program. II group received personalized diet and exercise recommendations. The follow-up was for 12 months. Glucose, IR, pancreatic β-cell function and secondary outcomes (body composition and lipid profile) were assessed at baseline, 6 and 12 months.

Results

FI group improved area under the glucose curve (AUC) (from 18,597 ± 2611 to 17,237 ± 2792, p = 0.004) and the Matsuda index (from 3.5 ± 2.3 to 4.7 ± 3.5, p = 0.05) at 12 months. II group improved Disposition Index (from 1.5 ± 0.4 to 1.9 ± 0.73, p < .0001) at 12 months.

The improvements achieved in weight and lipids at 6 months, were lost in II group at 12 moths, whereas in FI persisted. Adherence up to 12 months was not different between the study groups (FI 56% Vs II 60%).

Conclusions

FI intervention was more effective by improving glucose AUC, insulin sensitivity and lipid profile, besides that, metabolic risk in family members of the FI group was maintained, while the risk of II group was increased.

Trial registration

This study was retrospectively registered at clinicaltrials.gov on December 15, 2015 (NTC026365646).
The prevalence of mental distress and the association with education: a cross-sectional study of 18-49-year-old citizens of Yangon Region, Myanmar
Authors: Aye Win Thuzar , Lien Lars , Stigum Hein , Win Hla Hla , Oo Tin , Bjertness Espen
Published: January 2020

Background

Poor mental health is an important contributor to the global burden of disease. Mental health problems are often neglected in communities, and are scarcely studied in developing countries, including Myanmar. This study estimates the prevalence of mental distress by socio-demographic and health related factors, and the association between education and mental distress. As far as the authors are aware, this is the first population-based study in Myanmar estimating the prevalence of mental distress.

Methods

Between October and November 2016, a cross sectional study was conducted using a multi-stage sampling design with face-to-face interviews using the Hopkins Symptom Checklist (HSCL-10) for mental distress (symptoms of depression and anxiety). The multivariable analysis strategy was based on Directed Acyclic Graphs (DAGs), to identify confounders, mediators and colliders. Pearson’s chi-square was used for testing differences between proportions and multiple linear regression analysis was applied to explore the association between education (years at school) and mental distress (HSCL score).

Results

A random sample of 2391 (99.6% response) men and women aged 18–49 years participated in the study. The prevalence of mental distress was 18.0% (95% confidence interval (CI): 14.7–21.9), being higher among women (21.2%; 95% (CI): 16.6–26.6) than men (14.9%; 95% (CI): 11.4–19.2). Older-age, being separated or divorced and having a higher number of children were associated with increased mental distress. In linear regression analyses, adjusted for confounders (age, marital status and income), there was a significant negative association between years at school and mental distress among women and older men (> 30 years), but not among the youngest men.

Conclusions

The prevalence of mental distress is high, and there is an association between HSCL-10 score and education. Due to the scarcity of mental health services in Myanmar, the findings indicate a need for a mental health policy to handle the burden of mental health problems in Yangon, a burden which is probably high within the country.