Using BCG Vaccine to Enhance Nonspecific Protection of Health Care Workers During the COVID-19 Pandemic: A Randomized Controlled Trial.

BACKGROUND: The BCG (Bacillus Calmette-Guérin) vaccine can induce nonspecific protection against unrelated infections. We aimed to test the effect of BCG on absenteeism and health of Danish health care workers (HCWs) during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: A single-blinded randomized controlled trial included 1221 HCWs from 9 Danish hospitals. Participants were randomized 1:1 to standard dose BCG or placebo. Primary outcome was days of unplanned absenteeism. Main secondary outcomes were incidence of COVID-19, all-cause hospitalization, and infectious disease episodes. RESULTS: There was no significant effect of BCG on unplanned absenteeism. Mean number of days absent per 1000 workdays was 20 in the BCG group and 17 in the placebo group (risk ratio, 1.23; 95% credibility interval, 0.98-1.53). BCG had no effect on incidence of COVID-19 or all-cause hospitalization overall. In secondary analyses BCG revaccination was associated with higher COVID-19 incidence (hazard ratio [HR], 2.47; 95% confidence interval [CI], 1.07-5.71), but also reduced risk of hospitalization (HR, 0.28; 95% CI, .09-.86). The incidence of infectious disease episodes was similar between randomization groups (HR, 1.09; 95% CI, .96-1.24). CONCLUSIONS: In this relatively healthy cohort of HCWs, there was no overall effect of BCG on any of the study outcomes. CLINICAL TRIALS REGISTRATION: NCT0437329 and EU Clinical Trials Register (EudraCT number 2020-001888-90).

The perception of patients, mothers and healthcare professionals regarding introduction of home visits for adolescents with type 1 diabetes.

BACKGROUND AND OBJECTIVES: Despite advancements in diabetes management, a subgroup of patients does not achieve an acceptable level of metabolic control. To achieve treatment goals for high-risk patients, a higher frequency of contact with healthcare professionals is essential. However, socioeconomic challenges often lead to nonattendance at the outpatient clinic. Therefore, home visits were introduced as a supplement/an alternative to consultations at the paediatric diabetes clinic. The aim of this study was to uncover the perception of patients, mothers and healthcare professionals regarding home visits versus consultations at the outpatient clinic in order to being able to improve the services offered. METHODS: Semistructured interviews with patients, mothers and healthcare professionals were conducted to explore the experiences and perspectives of the concept at two paediatric diabetes clinics in Denmark. Paired t tests were used to compare the glycated hemoglobin A1c (HbA1c) levels at the start of the intervention with HbA1c 1 year before and HbA1c at the end of the intervention. RESULTS: Both patients, mothers and healthcare professionals found consultations in familiar surroundings to result in stronger relationships between healthcare professionals and families, creating greater opportunities to discuss personal issues aimed at improving the outcome of diabetes. Furthermore, home visits facilitated finding alternative methods of helping patients and the families integrating diabetes into everyday life. CONCLUSION: Overall, home visits were found to contribute toward creating a more constructive relationship. However, it was still a challenge to keep the scheduled appointments, and during this short study, no improvement in metabolic control could be observed.

Warming Prior to Heel Stick: Blood Sample Quality and Infant Comfort-A Randomized Controlled Trial.

BACKGROUND: Capillary blood sampling (heel stick) in infants is commonly performed in neonatal care units. Before the procedure, warming the infant's heel is often a customary practice, but no consensus exists on the most effective heel-warming method. PURPOSE: To compare the effects of routinely used warming methods (glove, gel pack, or blanket) applied prior to heel stick on blood sample quality and infant's comfort. METHODS: This prospective, double-blind, randomized controlled trial conducted in the neonatal intensive care unit included infants (postmenstrual age of ≥28 + 0 weeks and ≤43 + 6 weeks) who were computer-randomized to 1 of 3 warming methods.The primary outcome was blood flow velocity at sampling. Secondary outcomes were hemolysis index, infant COMFORTneo score, and frequency of postprocedure skin injuries. In addition, irrespective of the warming method used, the correlation between heel skin temperature and postprocedure heel skin injury was analyzed. RESULTS: A total of 176 heel warmings were successfully randomized, and 173 were analyzed. Despite a significant difference in obtained heel skin temperature after warming between the 3 warming methods ( P = .001), no difference in blood flow velocity ( P = .91), hemolysis index ( P = .99), or COMFORTneo score ( P = .76) was found. Baseline skin temperatures above 37.0°C were associated with higher incidences of skin injury, and skin temperatures after warming were significantly higher in skin-injured heels ( P = .038). IMPLICATIONS FOR PRACTICE AND RESEARCH: All 3 warming methods had similar effects on blood sample quality and infant's comfort. However, excessive warming of the heel should be avoided to prevent skin injuries.

Developing and Implementing a Father-Friendly Neonatal Intensive Care Unit Improved Nurses' Self-Efficacy.

BACKGROUND: The need for paternal support is rarely addressed in neonatal intensive care units (NICUs). Neonatal nurses often primarily focus on the needs of the mother and infant and may not be trained in support of fathers. PURPOSE: To investigate nurses' self-efficacy (SE) in guiding and supporting fathers after implementing a father-friendly NICU. METHODS: Nurses from the intervention NICU and 13 control NICUs were included in a before-and-after intervention study. Questionnaires measuring nurses' SE regarding support of fathers and mothers were obtained when starting the development process, before and 18 months after the implementation. The primary outcome was the difference between nurses' SE scores for father and mother questions in the intervention group compared with the control group. RESULTS: In total, 294, 330, and 288 nurses responded to the first, second, and third questionnaires, respectively. From the first to third questionnaires, the intervention group showed a significantly higher increase in SE scores for father questions compared with the control group (0.53 vs 0.20, P = .005) and a nonsignificantly higher increase for mother questions (0.30 vs 0.09, P = .13). In the third questionnaire, the intervention group showed a higher SE score for father questions compared with the control group (9.02 vs 8.45, P = .002) and the first questionnaire (9.02 vs 8.49, P = .02). IMPLICATIONS FOR PRACTICE AND RESEARCH: By implementing a father-friendly NICU, nurses' SE for providing support to fathers increased significantly. Training in a father-friendly approach increases nurses' ability to support both parents.

Parents' Perception of Staff Support in a Father-Friendly Neonatal Intensive Care Unit.

Healthcare professionals, especially nurses, play a central role in supporting parents during their stay in neonatal intensive care units (NICUs). Fathers often have their own support needs; however, studies have shown that these needs are rarely met to the same degree as those of the mothers. We developed a "father-friendly NICU" with the aim of providing good-quality care to the entire family. To evaluate the impact of this concept, we adopted a quasi-experimental design; using the Nurse Parent Support Tool (NPST), we investigated the differences in the fathers' (n = 497) and mothers' (n = 562) perception of the nursing support received on admission and discharge between before and after the intervention. In the historical control and intervention groups, the fathers' median NPST scores at admission were 4.3 (range, 1.9-5.0) and 4.0 (range, 2.5-4.8), respectively (p < 0.0001); at discharge, these scores were 4.3 (range, 1.6-5.0) and 4.4 (range, 2.3-5.0), respectively (difference not significant). In the historical control and intervention groups, the mothers median NPST scores at admission were 4.5 (range, 1.9-5.0) and 4.1 (range, 1.0-4.8), respectively (p < 0.001); at discharge, these scores were 4.4 (range, 2.7-5.0) and 4.4 (range, 2.6-5), respectively (difference not significant). The parental perception of support did not increase after the intervention; however, the parents reported a high level of staff support both before and after the intervention. Further studies should focus on parental support needs during the different phases of hospitalization (i.e., admission, stabilization, and discharge).

Face mask use during the COVID-19 pandemic was associated with breathing difficulties in adolescent patients with asthma.

AIM: Face masks have been used to prevent severe acute respiratory syndrome coronavirus-2 transmission. We investigated the impact of face mask use on paediatric patients with asthma. METHODS: Between February 2021 and January 2022, we surveyed adolescents aged 10-17 attending the paediatric outpatient clinic at the Lillebaelt Hospital, Kolding, Denmark with asthma, other breathing problems or no breathing problems. RESULTS: We recruited 408 participants (53.4% girls) with a median age of 14 years: 312 in the asthma group, 37 in the other breathing problems group and 59 in the no breathing problems group. Most participants experienced mask-related breathing impairment. The relative risk (RR) of experiencing severe breathing problems, compared to no problems, was more than four times as high for adolescents with asthma (RR 4.6, 95% CI 1.3-16.8, p = 0.02) than adolescents with no breathing problems. More than a third (35.9%) of the asthma group experienced mild asthma and 3.9% had severe asthma. Girls experienced more mild (RR 1.9, 95% CI 1.2-3.1, p < 0.01) and severe (RR 6.6, 95% CI 3.1-13.8, p < 0.01) symptoms than boys. Age had no effect. Adequate asthma control minimised negative effects. CONCLUSION: Face masks caused significant breathing impairment in most adolescents, particularly in those with asthma.

Patient Care Boards - A tool to promote patient participation during hospital ward rounds.

Objective: This pre-post intervention study investigated the effectiveness of the Patient Care Board (PCB) as a tool to increase the participation of patients and relatives during hospital ward rounds. Methods: Using The Activity Barometer (TAB), we rated 121 video-recorded rounds to compare participation before and after implementing the PCB into clinical practice. Associations between scores for the extent to which patients ask questions or express preferences and concerns were tested with multiple linear regression. Results: TAB-scores tended to be higher after implementing the PCB, especially for the relatives. However, no significant differences were found. The greatest impact on participation was time spent on rounds (p < 0.001). Preparing questions in advance of the round, as well as using anatomical drawings for explanations, increased patient participation (p = 0.041, 0.024). Furthermore, the implementation of the PCB led to higher nurse attendance (p = 0.003). Conclusion: Although we found tendencies towards higher participation, the study could not confirm a significant impact of the overall intervention. Innovation: Our results suggest that further research is needed, to ensure a higher degree of preparation among the patients, better opportunities for relatives to participate as well as integration of visual information in the rounds.

Seasonal variation of diarrhoeal pathogens among Guinea-Bissauan children under five years of age.

BACKGROUND: Diarrhoea remains a major cause of childhood morbidity and mortality in low-income countries (LICs). The frequency of diarrhoeal episodes may vary by season, yet few prospective cohort studies have examined seasonal variation among various diarrhoeal pathogens using multiplex qPCR to analyse bacterial, viral and parasitic pathogens. METHODS: We combined our recent qPCR data of diarrhoeal pathogens (nine bacterial, five viral and four parasitic) among Guinea-Bissauan children under five years old with individual background data, dividing by season. The associations of season (dry winter and rainy summer) and the various pathogens were explored among infants (0-11 months) and young children (12-59 months) and those with and without diarrhoea. RESULTS: Many bacterial pathogens, especially EAEC, ETEC and Campylobacter, and parasitic Cryptosporidium, prevailed in the rainy season, whereas many viruses, particularly the adenovirus, astrovirus and rotavirus proved common in the dry season. Noroviruses were found constantly throughout the year. Seasonal variation was observed in both age groups. CONCLUSION: In childhood diarrhoea in a West African LIC, seasonal variation appears to favour EAEC, ETEC, and Cryptosporidium in the rainy and viral pathogens in the dry season.

Facilitators and Barriers to a Hospital-Based Communication Skills Training Programme: An Interview Study.

This study aimed to investigate the facilitators and barriers experienced by the department management (DMs) and communication skills trainers (trainers) during the implementation of a 3-day communication skills training (CST) programme for healthcare professionals (HCPs). Thus, we conducted semi-structured interviews with 23 DMs and 10 trainers from 11 departments concurrently implementing the CST programme. Thematic analysis was undertaken to elucidate the themes across the interviews. Five themes were developed: resource consumption; obstacles; management support; efforts and outcomes; and a lack of systematic follow-up. Although the DMs and trainers were largely in agreement, the theme of a lack of systematic follow-up was derived exclusively from the trainers, as were two of the subthemes within obstacles: (b) seniority, profession, and cultural differences, and (c) the trainers' competencies. The greatest perceived barrier was resource consumption. In addition, DMs found planning and staff resistance to be a challenge. However, the HCPs' resistance diminished or even changed to satisfaction after participating. The mandatory approach served as both a facilitator and a barrier; DMs' support was an essential facilitator. Explicit communication related to resource demands, planning, and participation is crucial, as is management support and the allocation of resources.

Dysfunctional breathing and its impact on asthma control in children and adolescents.

BACKGROUND: Dysfunctional breathing (DB) has been shown to negatively affect asthma control in adults, but for children and adolescents, the knowledge is scarce. DB is among others characterized by dyspnea and hyperventilation. The Nijmegen Questionnaire (NQ) is often used as a marker for DB. We conducted a cross-sectional survey to estimate the prevalence of DB in patients with asthma in a pediatric outpatient clinic and to determine the impact of DB on asthma control. METHODS: Patients between 10 and 17 years were invited to complete the NQ and the Asthma Control Questionnaire (ACQ) and report the use of beta2 agonist (ß2). Spirometry data and prescribed asthma medications were noted from the patient record. RESULTS: Three hundred and sixty-three patients (180 boys) completed the survey. Sixty-seven patients (18%) scored ≥23 points in the NQ predicting DB. The DB group was older (median (range)) 15.6 (10.5-17.9) vs. 13.7 (10.0-17.9) years) (p < .01), and girls were overrepresented (84%) (p < .01). FEV1% exp. was higher in the DB group (mean (SD)) (89.4 (9.0) vs. 85.7 (11.8)) (p < .02). ACQ score (median (range)) (2.0 (0-4) vs. 0.6 (0-3.4)) (p < .01) and the use of ß2 (median (range)) (2 (0-56) vs. 0 (0-20) puffs/week) (p < .01) were higher. Inhaled corticosteroid dose (mean (SD) (416 (160) vs. 420 (150) mcg) and the use of a second controller were equal between the groups. CONCLUSION: Dysfunctional breathing was a frequent comorbidity, especially in adolescent girls. DB correlated with poorer asthma control and higher use of ß2 and may be an important cofactor in difficult-to-treat asthma.

Parents' comfort and staffs' working-environment when infants are sitting skin-to-skin: a randomised controlled trial comparing a recliner and a hospital bed.

Skin-to-skin contact between parents and preterm infants is recommended because it has proven to be valuable for the infants' development and healing. However, it can be difficult to comply with this guideline and still ensure a good working environment for the staff.This randomised controlled trial compared a new recliner developed in collaboration with parents and staff with a hospital bed for use in neonatal and maternity care using parents' rating of own comfort/discomfort, self-reliance, and felt security, and the chair's/bed's functionality at two different days (Q1 and Q2) of hospitalisation. The physical work-environment was evaluated through a questionnaire to the staff.Ninety-seven parents and 53 health professionals participated. Parents had significantly lower discomfort, in the recliner at Q1 compared to the hospital bed. The staff had to twist and/or bend their back significantly less often when working at the recliner as compared to the hospital bed. Practitioner summary: Due to poor working environment, a participatory design project developed a new recliner that improved the possibility of infants having skin-to-skin contact with their parents. The recliner provided a better working-environment for the staff while focussing on improving comfort and self-reliance of the parents, as compared to a hospital bed. Abbreviations: NICU: Neonatal Intensive Care Unit; VELA: Vermund Larsen.

Neonatal Bacillus Calmette-Guérin Vaccination to Prevent Early-Life Eczema: A Systematic Review and Meta-analysis.

ABSTRACT: Increasing evidence suggests that early-life bacillus Calmette-Guérin (BCG) vaccine could prevent atopic eczema through its beneficial off-target effects. In this meta-analysis, 3 randomized control trials with similar methods were included and enabled robust estimations with low heterogeneity, involving a total of 5655 children randomized to early-life BCG Denmark (n = 2832) or no BCG (n = 2823). Meta-analyses suggest a beneficial effect of BCG to prevent eczema (risk ratio [RR], 0.89; 95% confidence interval [CI], 0.82-0.98). In subgroup analyses, BCG was more beneficial in boys (RR, 0.84; 95% CI, 0.74-0.95) and in children born to 2 atopic parents (RR, 0.81; 95% CI, 0.68-0.97). The NNT to prevent one case of eczema among children of 1 or 2 atopic parent was 20 (95% CI, 12-50). Bacillus Calmette-Guérin Denmark leads to an 11% reduction in the risk of eczema in early life. A greater effect was observed with increasing predisposition. Given its well-established safety profile, neonatal BCG vaccination should be considered for children of atopic parents.

Chloroquine-susceptible and -resistant Plasmodium falciparum strains survive high chloroquine concentrations by becoming dormant but are eliminated by prolonged exposure.

BACKGROUND: Plasmodium falciparum strains that are resistant to standard-dose chloroquine can be treated by higher chloroquine concentrations maintained for a longer time in vivo. OBJECTIVES: To determine the relative importance of chloroquine concentrations versus exposure time for elimination of chloroquine-susceptible and -resistant P. falciparum in vitro. METHODS: Chloroquine-susceptible (3D7) and -resistant (FCR3) strains were exposed in vitro to 1, 2, 4, 8, 16 or 32 times their respective 90% inhibitory chloroquine concentrations for 3, 5, 7 or 14 days and then followed until recrudescence, or not, by 42 days after the end of exposure. RESULTS: Exposure to chloroquine appeared to eliminate susceptible and resistant parasites, leaving small pyknotic apparently dead parasites. Chloroquine-susceptible and -resistant parasites recrudesced after 3 and 5 days of chloroquine exposure. Recrudescence occurred in one out of four 7 day exposure series but not after 14 days exposure. The median time to recrudescence was 13 to 28 days with a range of 8 to 41 days after the end of exposure. Time to recrudescence after the end of exposure increased with duration of exposure for susceptible and resistant strains (P < 0.001). Time to recrudescence did not correlate with concentrations greater than 1× IC90. CONCLUSIONS: Chloroquine-susceptible and -resistant P. falciparum probably become dormant. Elimination of dormant parasites is primarily dependent upon the duration of chloroquine exposure. Exposure to effective drug concentrations for 7 days eliminates most parasites in vitro. The results support in vivo data indicating that elimination of chloroquine-resistant P. falciparum correlates with Day 7 chloroquine concentrations.

The impact of COVID-19 lockdown on glycaemic control and use of health services among children followed at a Danish diabetes clinic.

AIM: During COVID-19 restrictions, the paediatric clinic only accepted essential outpatient visits, schools closed, sports activities and social life were limited. Most employees worked at home. This quasi-experiment evaluates how this affected glycaemic control and use of health services among children with diabetes. METHODS: Paired t-tests were used to compare HbA1c-values before, during and after lockdown. Sub-analyses were stratified by pre-lockdown HbA1c-values. RESULTS: Overall mean HbA1c decreased from 58.3 to 56.9 mmol/mol (p = 0.025) from pre- to post-lockdown, a decrease also seen during the same season the previous year. HbA1c decreased by -4.2 mmol/mol (p = 0.002) for patients with pre-lockdown HbA1c > 59 mmol/mol, but increased slightly by 0.8 mmol/mol (p = 0.176) for patients with HbA1c < 52 mmol/mol. HbA1c measured 8 months post-lockdown increased again, most pronounced for patients with lowest HbA1c. During lockdown, virtual contacts increased from 0.1 to 0.5 contacts/patient/month and stayed post-lockdown at 0.3 contacts/patient/month. CONCLUSION: Compared to 2019, overall the COVID-19 restrictions did not influence the glycaemic control negatively. However, patients with pre-lockdown HbA1c < 52 mmol/mol experienced a deterioration, whereas those with HbA1c > 59 mmol/mol experienced an improvement. Less stress and more contact with parents may contribute to the last-mentioned finding. The lockdown enforced more virtual contacts between patients and the clinic.

Reactivation of BCG vaccination scars after vaccination with mRNA-Covid-vaccines: two case reports.

BACKGROUND: From May 2020 to January 2021, we enrolled 1233 health care workers (HCW) from Danish Hospitals in a randomized trial evaluating whether Bacille Calmette-Guérin (BCG) provides protection against COVID-19. Participants were randomized 1:1 to BCG vs saline and followed for 6 months. From December 2020, Covid-19 vaccines were offered to the HCW. In most cases, BCG vaccination results in a characteristic scar. Reactivation of the BCG scar has been described in children during viral infections and following influenza vaccination, but is mostly associated to Kawasaki's disease, a disease entity with pathogenesis likely similar to the child Covid-19 complication MIS-C: Multi-System Inflammatory Syndrome. Reactivation of scars after neonatal BCG vaccination has recently been described in four women after Covid-19 mRNA vaccination. Two of our trial participants experienced reactivation of their novel BCG scars after receiving mRNA Covid-19 vaccination 6 to 8 months post-BCG. CASE PRESENTATIONS: Two female HCW participants that had been randomly allocated to BCG in the BCG-DENMARK-COVID trial, spontaneously reported itching and secretion at the BCG scar site after having received mRNA Covid-19 vaccination (Moderna and Pfizer-BioNTech) 6 to 8 months following inclusion and BCG vaccination. One participant, who had a larger BCG skin reaction, noticed re-appearing symptoms after both the first and the second COVID-vaccine dose, while the other participant only noted symptoms after the second dose. Both had been BCG vaccinated during childhood, and no reactivation was noted in the older scars. No treatment was needed or provided. CONCLUSIONS: The reactivation of the BCG scar after receiving mRNA vaccine might have been caused by cross-reactivity between BCG and SARS-CoV-2. In both cases, the symptoms were bothersome, but self-limiting and left no sequelae. The risk of reactivation at the scar site is thus not a reason to avoid vaccination with either vaccine.

Communication Skills Training: A Means to Promote Time-Efficient Patient-Centered Communication in Clinical Practice.

PURPOSE: We hypothesized that health care providers would behave in a more patient-centered manner after the implementation of communication skills training, without causing the consultation to last longer. METHODS: This study was part of the large-scale implementation of a communication skills training program called "Clear-Cut Communication With Patients" at Lillebaelt Hospital in Denmark. Audio recordings from real-life consultations were collected in a pre-post design, with health care providers' participation in communication skills training as the intervention. The training was based on the Calgary-Cambridge Guide, and audio recordings were rated using the Observation Scheme-12. RESULTS: Health care providers improved their communication behavior in favor of being more patient-centered. Results were tested using a mixed-effect model and showed significant differences between pre- and postintervention assessments, with a coefficient of 1.3 (95% Cl: 0.35-2.3; P=0.01) for the overall score. The consultations did not last longer after the training. CONCLUSIONS: Health care providers improved their communication in patient consultations after the implementation of a large-scale patient-centered communication skills training program based on the Calgary-Cambridge Guide. This did not affect the length of the consultations.

Prevalence of diarrhoeal pathogens among children under five years of age with and without diarrhoea in Guinea-Bissau.

BACKGROUND: Childhood diarrhoea, a major cause of morbidity and mortality in low-income regions, remains scarcely studied in many countries, such as Guinea-Bissau. Stool sample drying enables later qPCR analyses of pathogens without concern about electricity shortages. METHODS: Dried stool samples of children under five years treated at the Bandim Health Centre in Bissau, Guinea-Bissau were screened by qPCR for nine enteric bacteria, five viruses, and four parasites. The findings of children having and not having diarrhoea were compared in age groups 0-11 and 12-59 months. RESULTS: Of the 429 children- 228 with and 201 without diarrhoea- 96.9% and 93.5% had bacterial, 62.7% and 44.3% viral, and 52.6% and 48.3% parasitic pathogen findings, respectively. Enteroaggregarive Escherichia coli (EAEC; 60.5% versus 66.7%), enteropathogenic E. coli (EPEC; 61.4% versus 62.7%), Campylobacter (53.2% versus 51.8%), and enterotoxigenic E. coli (ETEC; 54.4% versus 44.3%) were the most common bacterial pathogens. Diarrhoea was associated with enteroinvasive E. coli (EIEC)/Shigella (63.3%), ETEC (54.4%), astrovirus (75.0%), norovirus GII (72.6%) and Cryptosporidium (71.2%). The only pathogen associated with severe diarrhoea was EIEC/Shigella (p<0.001). EAEC was found more frequent among the infants, and EIEC/Shigella, Giardia duodenalis and Dientamoeba fragilis among the older children. CONCLUSIONS: Stool pathogens proved common among all the children regardless of them having diarrhoea or not.

Intestinal protozoan infections shape fecal bacterial microbiota in children from Guinea-Bissau.

Intestinal parasitic infections, caused by helminths and protozoa, are globally distributed and major causes of worldwide morbidity. The gut microbiota may modulate parasite virulence and host response upon infection. The complex interplay between parasites and the gut microbiota is poorly understood, partly due to sampling difficulties in remote areas with high parasite burden. In a large study of children in Guinea-Bissau, we found high prevalence of intestinal parasites. By sequencing of the 16S rRNA genes of fecal samples stored on filter paper from a total of 1,204 children, we demonstrate that the bacterial microbiota is not significantly altered by helminth infections, whereas it is shaped by the presence of both pathogenic and nonpathogenic protozoa, including Entamoeba (E.) spp. and Giardia (G.) lamblia. Within-sample diversity remains largely unaffected, whereas overall community composition is significantly affected by infection with both nonpathogenic E. coli (R2 = 0.0131, P = 0.0001) and Endolimax nana (R2 = 0.00902, P = 0.0001), and by pathogenic E. histolytica (R2 = 0.0164, P = 0.0001) and G. lamblia (R2 = 0.00676, P = 0.0001). Infections with multiple parasite species induces more pronounced shifts in microbiota community than mild ones. A total of 31 bacterial genera across all four major bacterial phyla were differentially abundant in protozoan infection as compared to noninfected individuals, including increased abundance of Prevotella, Campylobacter and two Clostridium clades, and decreased abundance of Collinsella, Lactobacillus, Ruminococcus, Veillonella and one Clostridium clade. In the present study, we demonstrate that the fecal bacterial microbiota is shaped by intestinal parasitic infection, with most pronounced associations for protozoan species. Our results provide insights into the interplay between the microbiota and intestinal parasites, which are valuable to understand infection biology and design further studies aimed at optimizing treatment strategies.

The effectiveness of a person-centred communication skills training programme for the health care professionals of a large hospital in Denmark.

OBJECTIVE: As a part of an evaluation of a large-scale communication skills training (CST) programme, this study aimed to investigate the effect on health care professionals' (HCPs) self-efficacy (SE) and perceived importance (PI) of the skills taught. METHODS: A pre-post intervention design was used, and 1647 HCPs responded to the SE-12 questionnaire. Changes in self-efficacy were examined at an item and scale level. RESULTS: The responses of 74% of the HCPs who replied to at least two of the three questionnaires were analysed. A significant increase in the SE-12 scale scores by 12.45 points between Q1 (baseline) and Q2 (immediately after the intervention) across all professions was found. There was a small albeit statistically significant decrease in the SE-12 scale scores by 2.06 points between Q2 and Q3 (24 weeks after the intervention). CONCLUSION: The implementation of the CST course significantly improved the self-efficacy of HCPs. The findings were supported by an increase in the number of HCPs who considered the skills that they had acquired to be very important. PRACTICE IMPLICATIONS: The findings suggest that the large-scale implementation of evidence-based CST programmes can yield the same outcomes that have been observed in smaller and better controlled studies.

Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark.

OBJECTIVES: The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID-19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism.The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with SARS-CoV-2, and to reduce the number of hospital admissions among HCW during the COVID-19 pandemic. HYPOTHESIS: BCG vaccination of HCW will reduce absenteeism by 20% over a period of 6 months. TRIAL DESIGN: Placebo-controlled, single-blinded, randomised controlled trial, recruiting study participants at several geographic locations. The BCG vaccine is used in this study on a different indication than the one it has been approved for by the Danish Medicines Agency, therefore this is classified as a phase III study. PARTICIPANTS: The trial will recruit 1,500 HCW at Danish hospitals.To be eligible for participation, a subject must meet the following criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week.A potential subject who meets any of the following criteria will be excluded from participation in this study: Known allergy to components of the BCG vaccine or serious adverse events to prior BCG administration Known prior active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species Previous confirmed COVID-19 Fever (>38 C) within the past 24 hours Suspicion of active viral or bacterial infection Pregnancy Breastfeeding Vaccination with other live attenuated vaccine within the last 4 weeks Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1) b) subjects with solid organ transplantation c) subjects with bone marrow transplantation d) subjects under chemotherapy e) subjects with primary immunodeficiency f) subjects under treatment with any anti-cytokine therapy within the last year g) subjects under treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months h) Active solid or non-solid malignancy or lymphoma within the prior two years Direct involvement in the design or the execution of the BCG-DENMARK-COVID trial Intervention and comparator: Participants will be randomised to BCG vaccine (BCG-Denmark, AJ Vaccines, Copenhagen, Denmark) or placebo (saline). An adult dose of 0.1 ml of resuspended BCG vaccine (intervention) or 0.1 ml of sterile 0.9% NaCl solution (control) is administered intradermally in the upper deltoid area of the right arm. All participants will receive one injection at inclusion, and no further treatment of study participants will take place. MAIN OUTCOMES: Main study endpoint: Days of unplanned absenteeism due to illness within 180 days of randomisation.Secondary study endpoints: The cumulative incidence of documented COVID-19 and the cumulative incidence of hospital admission for any reason within 180 days of randomisation.Randomisation: Randomisation will be done centrally using the REDCap tool with stratification by hospital, sex and age groups (+/- 45 years of age) in random blocks of 4 and 6. The allocation ratio is 1:1.Blinding (masking): Participants will be blinded to treatment. The participant will be asked to leave the room while the allocated treatment is prepared. Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.The physicians administering the treatment are not blinded.Numbers to be randomised (sample size): Sample size: N=1,500. The 1,500 participants will be randomised 1:1 to BCG or placebo with 750 participants in each group.Trial Status: Current protocol version 5.1, from July 6, 2020.Recruitment of study participants started on May 18, 2020 and we anticipate having finished recruiting by the end of December 2020. TRIAL REGISTRATION: The trial was registered with EudraCT on April 16, 2020, EudraCT number: 2020-001888-90, and with ClinicalTrials.gov on May 1, 2020, registration number NCT04373291.Full protocol: The full protocol is attached as an additional file, accessible from the Trialswebsite (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.