bluuebunny/crossref_metadata_2025 huggingface dataset:
Making it “work”: mothers’ perceptions of workplace breastfeeding and pumping at Dutch universities
Authors: Hentges Maike , Pilot Eva
Published: November 2021

Background

Dutch breastfeeding rates are below World Health Organization’s recommendations and targets despite the benefits for individuals and society. Increasing the rates is complex due to multiple breastfeeding determinants, of which maternal education and employment are dominant. This study aimed to identify the perceptions and experiences of mothers employed at Dutch universities regarding barriers and enablers to workplace breastfeeding and pumping.

Methods

The study adopted a descriptive, qualitative research design. Thirteen semi-structured online interviews, underpinned by the Social Ecological Model, were conducted in 2020 with three experts and ten academic employees from five universities who had breastfed or pumped at work within the past five years. Qualitative data were examined through a thematic analysis.

Results

Four main themes were identified: physical work environment, social support, work culture and organisation, policies and legal rights. Most mothers had more negative than positive experiences combining breastfeeding with work. They were unable to exercise their rights as a breastfeeding employee due to inappropriate and inaccessible lactation rooms, a lack of communication and information-provision, other people’s lack of awareness, inflexible working hours and unadjusted workloads, especially for teaching positions. All participants found the duration of Dutch maternity leave too short.

Conclusions

Universities need to increase institutional efforts at multiple levels and meet their legal obligations to support breastfeeding employees. Workplace interventions should be combined with more political commitment to normalise breastfeeding, monitor compliance with maternity protection provisions at work and prolong parental leave to encourage breastfeeding continuation.
Alcohol use during pregnancy in post-conflict northern Uganda: pregnant women’s experiences and provider perceptions
Authors: Agiresaasi Apophia , Tumwesigye Nazarius Mbona , Nabiwemba Elizabeth , Kiguli Juliet , Maina Gakenia Wamuyu , Nassanga Goretti
Published: November 2021

Background

Alcohol use during pregnancy has been associated with several birth defects and developmental disabilities generally known as Fetal Alcohol Spectrum Disorders (FASD). Contextual in-depth understanding on why women drink while pregnant is scarce. For this reason, we explored pregnant women’s experiences, knowledge, attitudes as well as provider perceptions regarding prenatal alcohol consumption to inform interventions meant to address alcohol-exposed pregnancies in post-conflict settings.

Methods

In the months of May and June 2019, 30 in-depth interviews were conducted with pregnant mothers who reported maternal alcohol use during pregnancy. In addition 30 Key informant interviews were carried out with health workers providing Antenatal Care services (ANC) in health facilities in Gulu, Kitgum and Pader districts in Northern Uganda. Data was recorded, transcribed and subjected to thematic content analysis.

Results

Women reported diverse views regarding maternal alcohol use during pregnancy. Whereas some felt it was favourable, others had misgivings about it. There was marked variability in knowledge on dangers of drinking during pregnancy. In this study, women reported that they found themselves in alluring situations that predisposed them to drinking alcohol. These included brewing alcohol as a source of livelihood, pregnancy-induced craving for alcohol, and participation in cultural festivities that are characterised by eating and drinking alcohol. Nonetheless, women who consume alcohol during pregnancy were not held in high esteem in the Acholi communities. Various prevention interventions reportedly existed in communities to address alcohol use during pregnancy including ANC health education, public debates, radio talk shows, community health worker group and individual counselling, and local council by laws.

Conclusions and recommendations

Pregnant mothers in post-conflict northern Uganda regard alcohol as a remedy to some of the social, economic and health challenges they face. Hence they continue drinking even during pregnancy because of the existing socio-cultural norms that promote it. The findings of this study demonstrate a need for sensitising communities in which pregnant women live so they can provide a supportive environment for mothers to abstain from alcohol consumption during pregnancy. Health care providers should ensure pregnant women consistently receive accurate and honest messages on the dangers of drinking during pregnancy so they can make informed decisions.
An explainable artificial intelligence approach for decoding the enhancer histone modifications code and identification of novel enhancers in Drosophila
Authors: Wolfe Jareth C. , Mikheeva Liudmila A. , Hagras Hani , Zabet Nicolae Radu
Published: November 2021

Background

Enhancers are non-coding regions of the genome that control the activity of target genes. Recent efforts to identify active enhancers experimentally and in silico have proven effective. While these tools can predict the locations of enhancers with a high degree of accuracy, the mechanisms underpinning the activity of enhancers are often unclear.

Results

Using machine learning (ML) and a rule-based explainable artificial intelligence (XAI) model, we demonstrate that we can predict the location of known enhancers in Drosophila with a high degree of accuracy. Most importantly, we use the rules of the XAI model to provide insight into the underlying combinatorial histone modifications code of enhancers. In addition, we identified a large set of putative enhancers that display the same epigenetic signature as enhancers identified experimentally. These putative enhancers are enriched in nascent transcription, divergent transcription and have 3D contacts with promoters of transcribed genes. However, they display only intermediary enrichment of mediator and cohesin complexes compared to previously characterised active enhancers. We also found that 10–15% of the predicted enhancers display similar characteristics to super enhancers observed in other species.

Conclusions

Here, we applied an explainable AI model to predict enhancers with high accuracy. Most importantly, we identified that different combinations of epigenetic marks characterise different groups of enhancers. Finally, we discovered a large set of putative enhancers which display similar characteristics with previously characterised active enhancers.
HOME DM-BAT: home-based diabetes-modified behavioral activation treatment for low-income seniors with type 2 diabetes—study protocol for a randomized controlled trial
Authors: Egede Leonard E. , Davidson Tatiana M. , Knapp Rebecca G. , Walker Rebekah J. , Williams Joni S. , Dismuke Clara E. , Dawson Aprill Z.
Published: November 2021

Background

About 13% of African Americans and 13% of Hispanics have diabetes, compared to 8% of non-Hispanic Whites (NHWs). This is more pronounced in the elderly where about 25–30% of those aged 65 and older have diabetes. Studies have found associations between social determinants of health (SDoH) and increased incidence, prevalence, and burden of diabetes; however, few interventions have accounted for the context in which the elderly live by addressing SDoH. Specifically, psychosocial factors (such as cognitive dysfunction, functional impairment, and social isolation) impacting this population may be under-addressed due to numerous medical concerns addressed during the clinical visit. The long-term goal of the project is to identify strategies to improve glycemic control and reduce diabetes complications and mortality in African Americans and Hispanics/Latinos with type 2 diabetes.

Methods

This is a 5-year prospective, randomized clinical trial, which will test the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with type 2 diabetes mellitus (T2DM) (HOME DM-BAT). Two hundred, aged 65 and older and with an HbA1c ≥8%, will be randomized into one of two groups: (1) an intervention using in-home, nurse telephone-delivered diabetes education, and behavioral activation or (2) a usual care group using in-home, nurse telephone-delivered, health education/supportive therapy. Participants will be followed for 12 months to ascertain the effect of the intervention on glycemic control, blood pressure, and low-density lipoprotein (LDL) cholesterol. The primary hypothesis is low-income, minority seniors with poorly controlled type 2 diabetes randomized to HOME DM-BAT will have significantly greater improvements in clinical outcomes at 12 months of follow-up compared to usual care.

Discussion

Results from this study will provide important insight into the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with uncontrolled type 2 diabetes mellitus and inform strategies to improve glycemic control and reduce diabetes complications in minority elderly with T2DM.

Trial registration

ClinicalTrials.govNCT04203147). Registered on December 18, 2019, with the National Institutes of Health Clinical Trials Registry.
Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)
Authors: Pourrat Xavier , Berthy Elise , Dupuis Antoine , Barbier Louise , Buchler Matthias , Guillon Leslie Grammatico , Monmousseau Fanny , Ruspini Eric , Salamé Ephrem , Houdard Solène Brunet , Giraudeau Bruno
Published: November 2021

Background

Nowadays, the main challenge of transplantation is the improvement of long-term care, aiming at reducing treatment-related complications and at decreasing rejection rates. Patients’ adherence to both treatment and hygienic-dietary measures is mandatory to achieve these objectives. Adherence to immunosuppressive drugs is estimated to be only 70%. We hypothesized that the implementation of a personalized pharmaceutical plan (PPP) would increase adherence and therefore graft survival.

Methods/design

This study is a stepped-wedge cluster randomized trial with transplantation units defining clusters. Twelve clusters from 10 university hospitals were recruited. All centres started on the same day in the control phase. Every 7 weeks, one centre will switch to the intervention phase and remain there until the end of inclusions. We plan to recruit 1716 kidney and/or liver transplant patients. The intervention phase consists in setting up the PPP: development of the patient’s hospital and community pharmaceutical follow-up. In the hospital, the pharmacist will carry out drug reconciliation upon admission, daily pharmaceutical follow-up of prescriptions and pharmaceutical interviews with the patient in order to explain the modalities of taking immunosuppressive drugs and hygienic-dietary measures. After hospitalization, during the post-transplantation year, pharmaceutical meetings will take place, prior to medical consultations in order to check the patient’s understanding of the prescription, his adherence, to remind them of hygienic-dietary measures and to look for adverse effects. The hospital pharmacist will also be in charge of establishing a close link with the community pharmacist (CP) and general practitioner, especially providing discharge medication reconciliation, an e-learning and a checklist. Moreover, prior to each pharmaceutical consultation, the hospital pharmacist will contact the CP to discuss patient adherence.

The primary outcome is adherence to immunosuppressive treatments 1 year post-transplantation assessed by using the BAASIS questionnaire and the health insurance data from the national health data system. A medico-economic study will measure the efficiency of this plan.

Discussion

GRePH aims to increase adherence of liver and/or kidney transplant patients to their immunosuppressive therapies in order to reduce transplant rejections. To this end, a new clinical pharmacy model, the PPP, will be set up in 10 university hospitals.

Trial registration

ClinicalTrials.gov NCT04295928. Registered on 5 March 2020
A new cluster of rhabdovirus detected in field-caught sand flies (Diptera: Psychodidae: Phlebotominae) collected from southern Thailand
Authors: Phumee Atchara , Wacharapluesadee Supaporn , Petcharat Sininat , Siriyasatien Padet
Published: November 2021

Background

The distribution of phlebotomine sand flies is changing rapidly due to climate change. This issue has implications for the epidemiology of sand fly-borne diseases, especially sand fly-associated viruses. Few studies concerning sand fly-associated viruses have been conducted in Thailand. Therefore, this study aimed to perform a molecular survey of groups of pathogenic RNA viruses belonging to the Orbivirus, Phlebovirus, and Flavivirus genera and family Rhabdoviridae in sand fly samples collected from southern Thailand.

Methods

Sand flies were collected at two locations in Trang and Songkhla provinces of southern Thailand, and individual sand fly samples were processed for species identification and virus detection. The Orbivirus, Phlebovirus, and Flavivirus genera and family Rhabdoviridae molecular determination was performed by RT-PCR, and positive samples were identified by cloning and sequencing, cell culture inoculation, and phylogenetic analysis.

Results

The results presented in this study were based on the analysis of a total of 331 female sand flies. This molecular study revealed evidence of Rhabdoviridae family virus presence in Phlebotomus papatasi (3/331, 0.9%). The findings demonstrated a new cluster of rhabdovirus that was closely related to Bactrocera dorsalis sigmavirus strain BDSV.abc5 and the lineages of insect-specific Rhabdoviridae. In addition, the Bayesian tree suggested that the common ancestor of this group was the dimarhabdovirus clade. It was assumed that the virus may have switched hosts during its evolution. However, the detection of Orbivirus, Phlebovirus, and Flavivirus genera using specific primers for RT-PCR was negative in the collected sand flies.

Conclusions

There is limited knowledge on the genetic diversity and ecology of Rhabdoviridae in Thailand. This is the first data regarding the circulation of Rhabdoviridae in Ph. papatasi from Thailand. We found a new cluster of rhabdoviruses that was close to the new B. dorsalis sigmavirus. It is possible that there is a great deal of diversity in this family yet to be discovered, and a more extensive survey for new rhabdoviruses may uncover viruses from a wide diversity of host taxa and broaden our understanding of the relationships among the Rhabdoviridae.

Graphical abstract
First-year follow-up of children with chronic nonbacterial osteomyelitis—an analysis of the German National Pediatric Rheumatologic Database from 2009 to 2018
Authors: Reiser Christiane , Klotsche Jens , Hospach Anton , Berendes Rainer , Schnabel Anja , Jansson Annette F. , Hufnagel Markus , Grösch Nadine , Niewerth Martina , Minden Kirsten , Girschick Hermann
Published: November 2021

Objective

To assess the first-year features of patients with chronic nonbacterial osteomyelitis (CNO).

Methods

Patients with a diagnosis of CNO, disease duration of under 13 months, and first registration in the German National Pediatric Rheumatologic Database (NPRD) between 2009 and 2018 were included in this cross-sectional analysis.

Results

Of 774 documented patients, 62.8% were female, and all patients had a median age of 11 years. The most affected clinical sites were the tibia (29.7%), pelvis (28.0%), and femur (27.8%). HLA-B27 was positive in 48 of 314 analyzed patients (15.3%). In 406 patients, an X-ray was performed at the first visit; X-ray results showed osteosclerosis/−lysis in 34.0% and hyperostosis in 14.5% of the patients. MRI scans (focal and whole-body scans) were performed in 648 patients, and 81.5% showed a positive TIRM/STIR signal. A total of 84.7% of the patients were administered nonsteroidal anti-inflammatory drugs, 9.6% were administered oral glucocorticoids, 10.8% were administered disease-modifying anti-rheumatic drugs (DMARDs), and 6.1% were administered bisphosphonates. An evaluation of the patient’s questionnaire showed an overall well-being (NRS 0–10) of 2.0. The PedCNO disease “activity” score revealed a 70% improvement in variables in 43% of patients in the initial 1-year follow-up. Copresentation with diagnostic criteria of pediatric enthesitis-related arthritis was rare.

Conclusion

To our knowledge, the NPRD cohort seemed to be the largest cohort of children and adolescents suffering from CNO worldwide. Most patients were treated effectively with NSAIDs, and only a small group of patients was administered additional medication. The patient-defined measures of disease activity had a moderate impact on patients’ daily lives.

Trial registration

Not applicable.
Analysis of Stokes system with solution-dependent subdifferential boundary conditions
Authors: Zhao Jing , Migórski Stanisław , Dudek Sylwia
Published: November 2021

We study the Stokes problem for the incompressible fluid with mixed nonlinear boundary conditions of subdifferential type. The latter involve a unilateral boundary condition, the Navier slip condition, a nonmonotone version of the nonlinear Navier–Fujita slip condition, and the threshold slip and leak condition of frictional type. The weak form of the problem leads to a new class of variational–hemivariational inequalities on convex sets for the velocity field. Solution existence and the weak compactness of the solution set to the inequality problem are established based on the Schauder fixed point theorem.
Allometric equations for estimating on-farm fuel production of Gliricidia sepium (Gliricidia) shrubs and Cajanus cajan (pigeon pea) plants in semi-arid Tanzania
Authors: Hafner J. M. , Steinke J. , Uckert G. , Sieber S. , Kimaro A. A.
Published: November 2021

Background

Fuelwood is considered to be the primary source of cooking energy in Tanzania and, due to ongoing deforestation, access to fuelwood is becoming more cumbersome. On-farm agroforestry systems can reduce dependency on off-farm fuel; however, the output of on-farm produced fuel is typically uncertain as production potentials are often not known. In this paper, we have developed allometric equations to model the above-ground woody biomass (AGWB) production from intercropped Gliricidia sepium (Jacq.) Kunth ex Walp (Gliricidia) shrubs and Cajanus cajan (L.) Millsp. (pigeon pea) plants.

Methods

We used a destructive sampling approach, for measuring the dendrometric characteristics, such as the root collar diameter at a 20 cm stem height (RCD20) and the stem height to estimate the AGWB production. The models are based on 112 Gliricidia and 80 pigeon pea observations from annually pruned plants. Seven allometric equations were fitted to derive the best-fit models for the AGWB production.

Results

We found that using a natural log-transformed linear model with RCD20 as a single predictor variable provides the highest explanatory value to estimate the AGWB production (Gliricidia: R2 = 95.7%, pigeon pea: R2 = 91.4%) while meeting Ordinary Least Square (OLS) estimator requirements. Adding stem height as an additional variable to predict the AGWB production does not improve model accuracy enough to justify the extra work for including it.

Conclusions

While on-farm pigeon pea plants produced a stable amount of woody biomass per annum, annual fuelwood production from Gliricidia shrubs increased over the years. Compared to the annual fuelwood consumption data from the literature, our results show that on-farm produced fuelwood can substantially offset the demand for off-farm fuel, potentially resulting in household fuelwood autarky.
The determinants of survival among adults with cystic fibrosis—a cohort study
Authors: Durda-Masny Magdalena , Goździk-Spychalska Joanna , John Aleksandra , Czaiński Wojciech , Stróżewska Weronika , Pawłowska Natalia , Wlizło Jolanta , Batura-Gabryel Halina , Szwed Anita
Published: November 2021

Background

Cystic fibrosis (CF) is one of the most common autosomal recessive diseases. Factors contributing to disease exacerbations and survival rate of CF patients are type of mutation in the CFTR gene, poor nutritional status, lung failure, and infection development by Pseudomonas aeruginosa. The study aimed to evaluate the relationship between the severity of mutation, nutritional status, lung function, and Pseudomonas aeruginosa prevalence and survival rate in adult patients with cystic fibrosis.

Methods

A study of 124 (68 ♀ and 56 ♂) adults with CF aged 18–51 years were evaluated for (a) type of mutation in the CFTR gene, (b) nutritional status (BMI), (c) lung function (FEV1%), and (d) Pseudomonas aeruginosa prevalence. For statistical calculations, Kaplan-Meier analysis of survival, chi-squared test for multiple samples, and logistic regression were used.

Results

The type of mutation (χ2 = 12.73, df = 3, p = 0.005), FEV1% (χ2 = 15.20, df = 2, p = 0.0005), Pseudomonas aeruginosa prevalence (χ2 = 11.48, df = 3, p = 0.009), and BMI (χ2 = 31.08, df = 4, p < 0.000) significantly differentiated the probability of survival of patients with CF. The shortest life expectancy was observed in patients with a severe type of mutation on both alleles, FEV1% < 40, subjects in whom Pseudomonas culture was extensively drug-resistant or pandrug-resistant, and patients whose BMI was lower than 18.5 kg/m2. The period from 30 to 40 years of age was the most critical in CF adults’ lifespan. The risk of adults with CF death doubled with Pseudomonas aeruginosa prevalence (OR = 2.06, 95% CI 1.29; 2.28) and eightfold when the bacteria acquired antibiotic resistance (OR = 8.11, 95% CI 1.67; 38.15).

Conclusions

All factors included in the study were significantly related to the survival rate of patients with cystic fibrosis.
The power of feeling seen: perspectives of individuals with eating disorders on receiving validation
Authors: Geller Josie , Fernandes A. , Srikameswaran S. , Pullmer R. , Marshall S.
Published: November 2021

Background

A common complaint of individuals suffering from mental health conditions is feeling invalidated or misunderstood by care providers. This is notable, given that non-collaborative care has been linked to poor engagement, low motivation and treatment non-adherence. This study examined how receiving validation from care providers is experienced by individuals who have an eating disorder (ED) and the impact of receiving validation on the recovery journey.

Methods

Eighteen individuals who had an eating disorder for an average duration of 19.1 years (two identifying as male, 16 identifying as female), participated in semi-structured interviews on barriers and facilitators to self-compassion. Seven were fully recovered, and 11 were currently participating in recovery-focused residential treatment. Thematic analysis focused on the meaning and impact of receiving validation to participants.

Results

Five care provider actions were identified: (i) making time and space for me, (ii) offering a compassionate perspective, (iii) understanding and recognizing my treatment needs, (iv) showing me I can do this, and (v) walking the runway. These were associated with four key experiences (feeling trust, cared for, empowered, and inspired), that participants described as supportive of their recovery.

Conclusions

This research provides insight into patient perspectives of validation and strategies care providers can use, such as compassionate reframing of difficult life experiences, matching interventions to patient readiness, and modeling vulnerability.
Techno-economic analysis of a new downstream process for the production of astaxanthin from the microalgae Haematococcus pluvialis
Authors: Bauer Andreas , Minceva Mirjana
Published: November 2021

The biotechnological production of the carotenoid astaxanthin is done with the microalgae Haematococcus pluvialis (H. pluvialis). Under nutrient deficiency and light stress, H. pluvialis accumulates astaxanthin intracellularly and forms a resistant cyst cell wall that impedes direct astaxanthin extraction. Therefore, a complex downstream process is required, including centrifugation, mechanical cell wall disruption, drying, and supercritical extraction of astaxanthin with CO2. In this work, an alternative downstream process based on the direct extraction of astaxanthin from the algal broth into ethyl acetate using a centrifugal partition extractor (CPE) was developed. A mechanical cell wall disruption or germination of the cysts was carried out to make astaxanthin accessible to the solvent. Zoospores containing astaxanthin are released when growth conditions are applied to cyst cells, from which astaxanthin can directly be extracted into ethyl acetate. Energy-intensive unit operations such as spray-drying and extraction with supercritical CO2 can be replaced by directly extracting astaxanthin into ethyl acetate. Extraction yields of 85% were reached, and 3.5 g of oleoresin could be extracted from 7.85 g homogenised H. pluvialis biomass using a CPE unit with 244 mL column volume. A techno-economic analysis was done for a hypothetical H. pluvialis production facility with an annual biomass output of 8910 kg. Four downstream scenarios were examined, comparing the novel process of astaxanthin extraction from homogenised cyst cells and germinated zoospores via CPE extraction with the conventional industrial process using in-house or supercritical CO2 extraction via an external service provider. After 10 years of operation, the highest net present value (NPV) was determined for the CPE extraction from germinated zoospores.
Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study
Authors: Forde Colin , Haddad Mark , Hirani Shashivadan P. , Keene David J.
Published: November 2021

Background

Lateral patellar dislocations mainly affect active teenagers and young adults. To help people recover, non-surgical exercise-based treatment is often recommended but the optimal exercise-based treatment is unknown. Currently, treatment outcomes after this injury are variable. Common problems include recurrent dislocation, reduced activity levels, and later surgery. A programme of intense leg resistance exercises, and dynamic exercises related to participants’ activity-related goals, has rationale, but has not been previously reported. In line with the Medical Research Council guidance, this study aimed to assess the acceptability of a novel evidence-based exercise programme for adults after acute lateral patellar dislocation and the feasibility of future research evaluating this treatment.

Methods

A single-group prospective study was conducted at the John Radcliffe Hospital, Oxford, UK. Participants were 16 years or older with an acute first-time or recurrent lateral patellar dislocation. Participants received up to six face-to-face, one-to-one, physiotherapy sessions, over a maximum of 3 months, and performed intensive home exercises independently at least three times per week. Strategies to increase exercise adherence were used. Primary objectives were to determine the number of eligible patients, the recruitment rate (proportion of eligible patients that provided written informed consent), participant adherence to scheduled physiotherapy sessions and self-reported adherence to prescribed exercise, and intervention acceptability to participants measured by attrition and a study-specific questionnaire. Data were analysed using descriptive statistics.

Results

Fifteen of 22 (68%) patients with a lateral patellar dislocation were eligible. All eligible (100%) were recruited. Two of 15 (13%) participants provided no outcome data, 2/15 (13%) provided partial outcome data, and 11/15 (73%) provided all outcome data. Questionnaire responses demonstrated high intervention acceptability to participants. Participants attended 56/66 (85%) physiotherapy sessions and 10/11 (91%) participants reported they ‘always’ or ‘often’ completed the prescribed exercise. One participant redislocated their patella; another experienced knee pain or swelling lasting more than one week after home exercise on three occasions.

Conclusion

The intervention appeared acceptable to adults after acute lateral patellar dislocation, and a future randomised pilot trial is feasible. This future pilot trial should estimate attrition with increased precision over a longer duration and assess participants’ willingness to be randomised to different treatments across multiple centres.

Trial registration

ClinicalTrials.govNCT03798483, registered on January 10, 2019
Quality of life, burden of treatment, safety, and avoidance of future events (QBSAfe) protocol: a pilot study testing an intervention to shift the paradigm of diabetes care
Authors: Clark Jennifer E. , Boehmer Kasey R. , Breslin Maggie , Haider Shanzay , Pasciak Weronika , Gravholt Derek , Sanchez Brianna B. , Hartasanchez Sandra A. , El Kawkgi Omar M. , Montori Victor , Lipska Kasia J.
Published: November 2021

Background

Diabetes care has been traditionally focused on targeting certain levels of glycemic control. This narrow emphasis may impose burdens on patients, including high treatment costs, illness-related work, or side effects from medications, while leaving other patient needs and goals under-addressed. The authors aim to shift the paradigm of care for people with diabetes, to focus on quality of life, burden of treatment, safety, and avoidance of future events: the QBSAfe domains.

Methods

We describe a single-arm pilot study to assess the feasibility and acceptability of using the QBSAfe agenda setting kit (ASK) during routine clinical visits. The set of 14 conversation aid cards was co-developed with patients, family caregivers, and clinicians. The ASK will be used in the context of a clinic visit, which will be recorded by members of the study team to identify patterns of clinician-patient conversations. Feasibility will be measured by the number of participants recruited, time to goal accrual, and completeness of data collection; acceptability will be assessed using post-visit surveys of patients and clinicians. A subgroup of patients will be invited to participate in post-visit qualitative semi-structured interviews for additional feedback. This study will be conducted across three medical centers in the Midwest and East Coast of the USA.

Discussion

Current healthcare infrastructure and associated demands and pressures on clinicians make changes in care difficult. However, this intervention has the potential to shift conversations during clinical encounters so they can address and directly respond to patient needs, symptoms, and capacity. As part of the QBSAfe ASK, the authors are also actively collaborating with a variety of stakeholders to create tools to help clinicians respond more effectively to patient concerns as they are raised during the clinical encounters. Additional insights about the use of the QBSAfe approach in the virtual space will be gathered during the process of our study due to restrictions imposed upon face to face visit during the COVID-19 pandemic.

Trial registration

ClinicalTrials.gov, NCT04514523. Registered 17 August 2020—retrospectively registered.
Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study
Authors: Alkaabi Salem A. , Kalla Diandra Sabrina Natsir , Alsabri Ghamdan A. , Fauzi Abul , Jansen Nova , Tajrin Andi , Nurrahma Rifaat , Müller Werner , Schröder Heinz C. , Xiaohong Wang , Forouzanfar Tymour , Helder Marco N. , Ruslin Muhammad
Published: November 2021

Background

Bone grafting is an important surgical procedure to reconstruct alveolar bone defects in patients with cleft lip and palate. Polyphosphate (PolyP) is a physiological polymer present in the blood, primarily in platelets. PolyP plays a role as a phosphate source in bone calcium phosphate deposition. Moreover, the cleavage of high-energy bonds to release phosphates provides local energy necessary for regenerative processes. In this study, polyP is complexed with calcium to form Calcium polyP microparticles (Ca-polyP MPs), which were shown to have osteoinductive properties in preclinical studies. The aim of this study was to evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs, alone or in combination with BCP, in a first-in-human clinical trial.

Methods

This single-blinded, parallel, prospective clinical pilot study enrolled eight adolescent patients (mean age 18.1: range 13–34 years) with residual alveolar bone cleft. Randomization in two groups (four receiving Ca-polyP MPs only, four a combination of Ca-polyP MPs and biphasic calcium phosphate (BCP)) was performed. Patient follow-up was 6 months. Outcome parameters included safety parameters and close monitoring of possible adverse effects using radiographic imaging, regular blood tests, and physical examinations. Osteoinductivity evaluation using histomorphometric analysis of biopsies was not possible due to COVID restrictions.

Results

Due to surgical and feasibility reasons, eventually, only 2 patients received Ca-polyP MPs, and the others the combination graft. All patients were assessed up to day 90. Four out of eight were able to continue with the final assessment day (day 180). Three out of eight were unable to reach the hospital due to COVID-19 restrictions. One patient decided not to continue with the study.

None of the patients showed any allergic reactions or any remarkable local or systematic side effects. Radiographically, patients receiving Ca-polyP MPs only were scored grade IV Bergland scale, while patients who got the BCP/Ca-polyP MPs combination had scores ranging from I to III.

Conclusions

Our results indicate that Ca-polyP MPs and the BCP/Ca-polyP MPs combination appear to be safe graft materials; however, in the current setting, Ca-polyP MPs alone may not be a sufficiently stable defect-filling scaffold to be used in alveolar cleft repair.

Trial registration

Indonesian Trial Registry under number INA-EW74C1N by the ethical committee of Faculty of Medicine, Hasanuddin University, Makassar, Indonesia with code number 1063/UN4.6.4.5.31/PP36/2019.
Posterior and postero-lateral incidental durotomy during lumbar spine surgery: primary repair versus augmented primary repair
Authors: Makia Mansour A. , Alawamry Ahmed , Elsharkawy Ahmad M.
Published: November 2021

Background

Incidental durotomy (ID) during lumbar spine surgery is a frequent complication of lumbar spine surgical procedures. Many surgical techniques were described in literature for repair of durotomy, however it is a matter of debate if one technique is a gold standard method of repair. Our study described two groups with posterior and postero-lateral ID that occurred during lumbar spine surgery: group A with 34 cases with a mean age of 49.85 years repaired by primary water tight closure using prolene or silk sutures, and group B with 34 cases with a mean age of 47.18 years treated with augmented primary repair (sutures augmented with a graft from lumbar fascia and tissue sealant "Fibrin glue"). Patients were evaluated for risk factors for durotomy, post-operative clinical outcome, and need for revision surgery.

Results

Eleven cases of group A and nine cases of group B had previous spine surgery. The dural tear was < 2 cm in 41.7% of group A and 83.3% of group B. Better outcome was achieved in 32 patients of group A and 30 patients of group B. Among our study cases 2 patients from group A and 4 patients from group B needed revision surgery due to CSF leak which failed to stop with conservative management and percutaneous blood patch.

Conclusions

Dural closure technique after ID does not seem to influence revision surgery rates due to cerebrospinal fluid (CSF) leakage and its complications. Durotomies that were immediately recognized and treated did not lead to any significant consequences.
The impact of education through nurse-led telephone follow-up (telenursing) on the quality of life of COVID-19 patients
Authors: Raesi Rasoul , Shaye Zahra Abbasi , Saghari Sam , Sheikh Beig Goharrizi Mohammad Ali , Raei Mehdi , Hushmandi Kiavash
Published: November 2021

Abstracts

Background

The widespread prevalence of COVID-19 has disrupted the social life, physical function, and daily activities of patients, leading to reduced quality of their lives. Because of the nature of this disease and its comprehensive impact on patients’ lives, a follow-up based on the conditions of these patients is necessary. This study was conducted to determine the impact of nurse education and telephone follow-up (telenursing) on the quality of life of COVID-19 patients.

Methods

This quasi-experimental study included 120 COVID-19 patients discharged from 22nd-Bahman Hospital in Khaf city and was conducted over 6 months from July 20, 2020, to December 20, 2020. The participants were selected by convenience sampling method and were assigned into two matching groups. The training was delivered through telenursing based on the quality of life criteria for 1 month in the intervention group. The controls did not receive any intervention. Both groups completed the 36-item SF health survey before and 1 month after the intervention.

Results

The two groups were not significantly different regarding the quality of life mean scores at baseline (p = 0.61). However, after the intervention, the mean and standard deviation of the total life quality score was significantly different between the control and intervention groups (63.62 ± 3.93 versus 72.62 ± 3.51, p <0.001).

Conclusions

Telenursing improves the life quality of COVID-19 patients. Through appropriate policies, health managers may put on the agenda the implementation of telenursing for COVID-19 patients.
Centering social-technical relations in studying platform urbanism: intersectionality for just futures in European cities
Authors: Webster Natasha A. , Zhang Qian
Published: November 2021

Platform-based services are rapidly transforming urban work, lives and spaces around the world. The rise of platforms dependent on largely expendable labour relations, with significant migrant involvement, must be seen as connected, and as replicating larger social processes rather than merely technological changes. This perspective paper urgently calls for an intersectional perspective to better understand social-technical relations crossing the digital-urban interface of platform urbanism in contemporary European cities. Critics of platforms and gig work, to date, have mainly focused on algorithms-based social control, degraded working conditions, problematic employment relations and precariousness of gig work. The ongoing Covid-19 pandemic has both disrupted and amplified these issues, intensifying the vulnerability of gig workers. For example, in Sweden, migrant groups and gig workers were separately identified as being hardest hit by Covid, but with little attention to the interconnectivity between these categories, nor to how these groups are co-positioned vis-a-vis larger socio-economic inequalities. Thus, we argue for a deeper understanding of the social processes underlying platforms and for active investigation of how inequalities are being produced and/or maintained in/by these processes. Urban planners, designers and policy makers will need to actively address the hybrid (digital and physical) urban spaces produced in platform urbanism in order to prevent spatial and economic inequalities. We argue for a stronger recognition of interrelated and overlapping social categories such as gender and migrant status as central to the construction of mutually constitutive systems of oppression and discrimination produced in and through the platform urbanism.
Development of an accurate lateral flow immunoassay for PEDV detection in swine fecal samples with a filter pad design
Authors: Zou Siyi , Wu Lei , Li Gan , Wang Juan , Cao Dongni , Xu Tao , Jia Aiqing , Tang Yong
Published: November 2021

Porcine epidemic diarrhea virus (PEDV), as the main causative pathogen of viral diarrhea in pigs, has been reported to result in high morbidity and mortality in neonatal piglets and cause significant economic losses to the swine industry. Rapid diagnosis methods are essential for preventing outbreaks and transmission of this disease. In this study, a paper-based lateral flow immunoassay for the rapid diagnosis of PEDV in swine fecal samples was developed using stable color-rich latex beads as the label. Under optimal conditions, the newly developed latex bead-based lateral flow immunoassay (LBs-LFIA) attained a limit of detection (LOD) as low as 103.60 TCID50/mL and no cross-reactivity with other related swine viruses. To solve swine feces impurity interference, by adding a filtration unit design of LFIA without an additional pretreatment procedure, the LBs-LFIA gave good agreement (92.59%) with RT-PCR results in the analysis of clinical swine fecal samples (n = 108), which was more accurate than previously reported colloidal gold LFIA (74.07%) and fluorescent LFIA (86.67%). Moreover, LBs-LFIA showed sufficient accuracy (coefficient of variance [CV] < 15%) and stable (room temperature storage life > 56 days) performance for PEDV detection, which is promising for on-site analysis and user-driven testing in pig production system.
Communication Priorities and Experiences of Caregivers of Children With Cancer in Guatemala
Authors: Graetz Dylan E. , Rivas Silvia Elena , Wang Huiqi , Vedaraju Yuvanesh , Fuentes Ana Lucia , Caceres-Serrano Annie , Antillon-Klussmann Federico , Devidas Meenakshi , Metzger Monika L. , Rodriguez-Galindo Carlos , Mack Jennifer W.
Published: November 2021

PURPOSE

Although > 90% of children with cancer live in low- and middle-income countries, little is known about communication priorities and experiences of families in these settings. We examined communication priorities and the quality of information exchange for Guatemalan caregivers of children with cancer during diagnostic communication.

METHODS

A cross-sectional survey including items used in pediatric communication studies from high-income countries and novel questions was verbally administered to 100 caregivers of children with cancer in Guatemala.

RESULTS

Guatemalan caregivers prioritized communication functions of exchanging information (99%), fostering healing relationships (98%), decision making (97%), enabling self-management (96%), and managing uncertainty (94%) over responding to emotions (66%) and cultural awareness (48%). Almost all caregivers wanted as many details as possible about their child's diagnosis and treatment (96%), likelihood of cure (99%), and late effects (97%). Only 67% were always given the information they needed without asking for it, and most caregivers sometimes (56%) or always (18%) had questions they wanted to discuss but did not. Approximately half of the caregivers (54%) correctly identified their child's diagnosis, primary site, disease extent (localized v metastatic), proposed treatment length, and treatment intent (curative v palliative). Caregivers of children with leukemia were more likely to correctly identify all attributes than those whose children had solid tumors ( P < .001).

CONCLUSION

Caregivers in Guatemala prioritize many of the same aspects of diagnostic communication as parents in the United States, and experience similar challenges. Shared communication values offer potential for adaptation of communication interventions across settings with varying resources and diverse cultures.
Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification
Authors: Jameel Feroz , Alexeenko Alina , Bhambhani Akhilesh , Sacha Gregory , Zhu Tong , Tchessalov Serguei , Sharma Puneet , Moussa Ehab , Iyer Lavanya , Luthra Sumit , Srinivasan Jayasree , Tharp Ted , Azzarella Joseph , Kazarin Petr , Jalal Mehfouz
Published: November 2021

This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qualification and continued process verification. The goal of the study is to show the cutting edge of lyophilization validation based on the integrated community-based opinion and the industrial perspective. This study presents best practices for batch size determination and includes the effect of batch size on drying time, process parameters selection strategies, and batch size overage to compensate for losses during production. It also includes sampling strategies to demonstrate batch uniformity as well as the use of statistical models to ensure adequate sampling. Based on the LyoHUB member organizations survey, the best practices in determining the number of PPQ runs are developed including the bracketing approach with minimum and maximum loads. Standard practice around CQA and CPP selection is outlined and shows the advantages of using control charts and run charts for process trending and quality control. The case studies demonstrating the validation strategy for monoclonal antibody and the impact of the loading process on the lyophilization cycle and product quality as well as the special case of lyophilization for dual-chamber cartridge system are chosen to illustrate the process validation. The standard practices in the validation of the lyophilization process, special lyophilization processes, and their impact on the validation strategy are discussed.

Graphical Abstract
Autoantibodies to N-terminally Truncated GAD65(96-585): HLA Associations and Predictive Value for Type 1 Diabetes
Authors: Pöllänen Petra M , Härkönen Taina , Ilonen Jorma , Toppari Jorma , Veijola Riitta , Siljander Heli , Knip Mikael
Published: November 2021

Objective

To evaluate the role of autoantibodies to N-terminally truncated glutamic acid decarboxylase GAD65(96-585) (t-GADA) as a marker for type 1 diabetes (T1D) and to assess the potential human leukocyte antigen (HLA) associations with such autoantibodies.

Design

In this cross-sectional study combining data from the Finnish Pediatric Diabetes Register, the Type 1 Diabetes Prediction and Prevention study, the DIABIMMUNE study, and the Early Dietary Intervention and Later Signs of Beta-Cell Autoimmunity study, venous blood samples from 760 individuals (53.7% males) were analyzed for t-GADA, autoantibodies to full-length GAD65 (f-GADA), and islet cell antibodies. Epitope-specific GAD autoantibodies were analyzed from 189 study participants.

Results

T1D had been diagnosed in 174 (23%) participants. Altogether 631 (83%) individuals tested positive for f-GADA and 451 (59%) for t-GADA at a median age of 9.0 (range 0.2-61.5) years. t-GADA demonstrated higher specificity (46%) and positive predictive value (30%) for T1D than positivity for f-GADA alone (15% and 21%, respectively). Among participants positive for f-GADA, those who tested positive for t-GADA carried more frequently HLA genotypes conferring increased risk for T1D than those who tested negative for t-GADA (77% vs 53%; P < 0.001).

Conclusions

Autoantibodies to N-terminally truncated GAD improve the screening for T1D compared to f-GADA and may facilitate the selection of participants for clinical trials. HLA class II-mediated antigen presentation of GAD(96–585)-derived or structurally similar peptides might comprise an important pathomechanism in T1D.