Burnout among intensive care nurses, physicians and leaders during the COVID-19 pandemic: A national longitudinal study.

BACKGROUND: Burnout is frequent among intensive care unit (ICU) healthcare professionals and may result in medical errors and absenteeism. The COVID-19 pandemic caused additional strain during working hours and also affected off-duty life. The aims of this study were to survey burnout levels among ICU healthcare professionals during the first year of COVID-19, describe those who reported burnout, and analyse demographic and work-related factors associated with burnout. METHODS: This was a national prospective longitudinal cohort study of 484 nurses, physicians and leaders working in intensive care units with COVID-19 patients in Norway. Burnout was measured at 6- and 12-month follow-up, after a registration of baseline data during the first months of the COVID epidemic. The Copenhagen Burnout Inventory (CBI), was used (range 0-100), burnout caseness defined as CBI ≥50. Bi- and multivariable logistic regression analyses were performed to examine baseline demographic variables and work-related factors associated with burnout caseness at 12 months. RESULTS: At 6 months, the median CBI score was 17, increasing to 21 at 12 months (p = .037), with nurses accounting for most of the increase. Thirty-two per cent had an increase in score of more than 5, whereas 25% had a decrease of more than 5. Ten per cent reported caseness of burnout at 6 months and 14% at 12 months (n.s.). The participants with burnout caseness were of significantly lower age, had fewer years of experience, reported more previous anxiety and/or depression, more moral distress, less perceived hospital recognition, and more fear of infection in the bivariate analyses. Burnout was the single standing most reported type of psychological distress, and 24 out of 41 (59%) with burnout caseness also reported caseness of anxiety, depression and/or post-traumatic stress disorder (PTSD) symptoms. Multivariate analysis showed statistically significant associations of burnout caseness with fewer years of professional experience (p = .041) and borderline significance of perceived support by leader (p = .049). CONCLUSION: In Norway, a minority of ICU nurses, physicians and leaders reported burnout 1 year into the pandemic. A majority of those with burnout reported anxiety, depression and/or PTSD symptoms combined. Burnout was associated with less years of professional experience.

Implementation of an algorithm for tapering analgosedation reduces iatrogenic withdrawal syndrome in pediatric intensive care.

BACKGROUND: Proper analgosedation is a cornerstone in the treatment of critically ill patients in Pediatric Intensive Care Units (PICUs). Medications, such as fentanyl, morphine, and midazolam, are essential to safe and respectful care. The use of these medications over time may lead to side effects such as iatrogenic withdrawal syndrome (IWS) in the tapering phase. The aim of the study was to test an algorithm for tapering analgosedation to reduce the prevalence of IWS in two Norwegian PICUs at Oslo University Hospital. METHODS: A cohort of mechanically ventilated patients from newborn to 18 years with continuous infusions of opioids and benzodiazepines for 5 days or more were included consecutively from May 2016 to December 2021. A pre- and posttest design, with an intervention phase using an algorithm for tapering analgosedation after the pretest, was used. The ICU staffs were trained in using the algorithm after the pretest. The primary outcome was a reduction in IWS. The Withdrawal Assessment Tool-1 (WAT-1) was used to identify IWS. A WAT-1 score ≥3 indicates IWS. RESULTS: We included 80 children, 40 in the baseline group, and 40 in the intervention group. Age and diagnosis did not differ between the groups. The prevalence of IWS was 95% versus 52.5% in the baseline group versus the intervention group, and the peak WAT-1 median was 5.0 (IQR 4-6.8) versus 3.0 (IQR 2.0-6.0) (p = .012). Based on SUM WAT-1 ≥ 3, which describes the burden over time better, we demonstrated a reduction of IWS, from a median of 15.5 (IQR 8.25-39) to a median of 3 (IQR 0-20) (p = <.001). CONCLUSION: We suggest using an algorithm for tapering analgosedation in PICUs since the prevalence of IWS was significantly lower in the intervention group in our study.

Improving Health Knowledge Through Provision of Free Digital Health Education to Rural Communities in Iringa, Tanzania: Nonrandomized Intervention Study.

BACKGROUND: Community health education is one of the most effective measures to increase health literacy worldwide and can contribute to the achievement of specific targets of the Sustainable Development Goal 3. Digitalized health education materials can improve health knowledge as a dimension of health literacy and play an important role in disease prevention in rural sub-Saharan settings. OBJECTIVE: The objective of this research is to assess the effect of a digital health education intervention on the uptake and retention of knowledge related to HIV/AIDS, tuberculosis (TB), and Taenia solium (neuro)cysticercosis and taeniosis in rural communities in Iringa, Tanzania. METHODS: We conducted a nonrandomized intervention study of participants aged 15 to 45 years, randomly selected from 4 villages in Iringa, Tanzania. The intervention consisted of 2 parts. After the baseline assessment, we showed the participants 3 animated health videos on a tablet computer. After a period of 6 months, free access to community information spots (InfoSpots) with an integrated digital health education platform was provided to the intervention villages. Participants in the control group did not receive the intervention. The primary outcome was the difference in disease knowledge between the intervention and control groups, 12 months after baseline. Data were collected using an open-ended questionnaire, with correct or incorrect answers before and after intervention. RESULTS: Between April and May 2019, a total of 600 participants were recruited into the intervention (n=298, 49.7%) or control (n=302, 50.3%) groups. At baseline, no statistically significant differences in knowledge of the target diseases were observed. At 12 months after intervention, knowledge about HIV/AIDS, TB, and T. solium (neuro)cysticercosis and taeniosis was 10.2% (95% CI 5.0%-15.4%), 12% (95% CI 7.7%-16.2%), and 31.5% (95% CI 26.8%-36.2%) higher in the intervention group than in the control group, respectively. In all 4 domains (transmission, symptoms, treatment, and prevention), an increase in knowledge was observed in all the 3 diseases, albeit to varying degrees. The results were adjusted for potential confounders, and the significance of the primary results was maintained in the sensitivity analysis to assess dropouts. The participants who reported using the InfoSpots in the 12-month assessment further increased their knowledge about the target diseases by 6.8% (HIV/AIDS), 7.5% (TB), and 13.9% higher mean proportion of correct answers compared with the participants who did not use the InfoSpots. CONCLUSIONS: Digital health education based on animated health videos and the use of free InfoSpots has significant potential to improve health knowledge, especially in rural areas of low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT03808597; https://clinicaltrials.gov/ct2/show/NCT03808597. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25128.

Quality of life and emotional vulnerability in a national cohort of adolescents living with Fontan circulation.

INTRODUCTION: To investigate quality of life and mental health after Fontan completion, we aimed to characterise outcomes in a representative group of adolescent patients. The study was part of the pre-transition clinical work-up in adolescents with Fontan-type palliation of univentricular CHD. The programme covers the entire paediatric Fontan patient population in Norway. METHODS: Our cross-sectional study included 42 adolescents with Fontan circulation aged 15-18. We recruited a control group of 29 healthy peers. Quality of life was measured by the Pediatric Quality of Life Inventory Questionnaire, while mental health was assessed with the Strength and Difficulties Questionnaire. RESULTS: Fontan patients scored lower than healthy controls on the Pediatric Quality of Life Inventory total (p = 0.004), the physical (p < 0.001) and social (p = 0.001) functioning subscale, and the Strength and Difficulties Questionnaire subscale of emotional symptoms (p = 0.035). Compared to two of the healthy teens (7%), seven patients (16%) in the Fontan group scored as having impaired mental health (p = 0.224). The female/male ratio for individuals with impaired health was 7:2 (p = 0.003). CONCLUSIONS: Compared to healthy controls, adolescents after Fontan-type palliation in Norway have good health-related quality of life and mental health, despite having slightly lower score than healthy individuals, mainly in physical domains and school functioning. Compared to healthy controls and healthy teenagers, these adolescents have somewhat more emotional problems, and compared to male patients, female patients more often have impaired mental health.

Music therapy as an adjunct in cardiac device lead extraction procedures: A randomized controlled trial.

BACKGROUND: Evidence of music therapy as an effective supportive therapy in invasive cardiac procedures is increasing, but more research is needed. AIMS: To evaluate the impact of music therapy on stress responses during cardiac device lead extraction procedures performed in local anaesthesia. METHODS: Sixty-four patients undergoing cardiac implantable electronic device lead extraction at Oslo University Hospital Ulleval from March 2018 to September 2019 were randomized to music therapy (n = 32) or control (n = 32). Primary endpoints were patient satisfaction with pain management and average pain intensity during the procedure. Secondary endpoints were average anxiety intensity, need for analgesic/anxiolytic drugs, blood pressure, heart and respiration rate. RESULTS: All patients in the music therapy group completed the intervention. Patient satisfaction with pain management was 10.00 (8.00, 10.00) in the music therapy vs. 10.00 (9.00, 10.00) in the control group (p = 0.85), and average level of pain 0.89 (0.22, 1.13) vs. 0.96 (0.36, 1.58), respectively (p = 0.38). Average anxiety score was 1.00 (0.33, 2.17) in the music therapy vs 1.67 (0.71, 3.35) in the control group (p = 0.056). The use of analgesic/anxiolytic drugs and physiological parameters were similar across groups. CONCLUSIONS: In this study of music therapy during cardiac device lead extractions, no effect was found on patient satisfaction with pain management or average pain level. A decrease in patient anxiety of borderline significance was observed in the music therapy group. More studies with more sensitive measures of pain and anxiety are needed to determine the value of music therapy in invasive cardiac procedures.

Effects of nutrition and hygiene education on oral health and growth among toddlers in rural Uganda: follow-up of a cluster-randomised controlled trial.

OBJECTIVE: To examine the effect of a nutrition and hygiene education intervention on oral health behaviour and whether early onset of caries was related to child growth in rural Uganda. METHODS: Follow-up study of a cluster-randomised controlled trial conducted between October 2013 and January 2015. Data were available from 399 mother/child pairs (203 in the intervention and 198 in the control group) of the original trial (78%) when the children were 36 months old. Oral health behaviour was evaluated using questionnaires. Photographs of the maxillary anterior teeth were examined for unmistakably carious lesions, and 115 water samples from the study area were analysed for fluoride concentration. RESULTS: The frequency of cleaning of the child's teeth at 36 months was about twice as high in the intervention as in the control group (84.3% vs. 46.6%; P = 0.0001). Cavitated carious lesions occurred more frequently in the control than the intervention group (27.8% vs. 18.2%; P = 0.04). Extraction of 'false teeth' (ebiino), a painful and crude traditional operation, was profoundly reduced in the intervention group (8.9% vs. 24.7%; P = 0.001). There was no evidence of association between the occurrence of caries and child growth. CONCLUSIONS: The education intervention improved oral hygiene practices and reduced the development and progression of caries and extraction of ebiino. Early childhood caries was not clearly associated with child growth.

Pregabalin Has Analgesic, Ventilatory, and Cognitive Effects in Combination with Remifentanil.

BACKGROUND: Pregabalin is widely used perioperatively. The authors explored the effects of pregabalin, remifentanil, and their combination on experimental pain, ventilatory, and cognitive function. METHODS: In a randomized, double-blinded crossover study, 12 volunteers received (1) pregabalin + placebo, (2) placebo + remifentanil, (3) pregabalin + remifentanil, and (4) placebo + placebo. Pregabalin 150 mg/placebo was administered twice orally. After baseline, remifentanil/placebo was given as effect-site target-controlled infusion (TCI): 0.6, 1.2, and 2.4 ng/ml. Pain during cold pressor test was scored on visual analog scale (0 to 100 mm). Ventilation was measured by spirometry and cognition tested with Color-Word Interference and Rapid Information Processing tests. RESULTS: Pain intensity after placebo was (mean) 72 mm (95% CI, 62 to 83). Pregabalin reduced pain score by -10 mm (-14 to -7, P < 0.001). Remifentanil had dose-dependent analgesic effect, reducing pain score by -47 mm (-54 to -39, P < 0.001) on highest TCI level, whereas pregabalin + remifentanil exerted additive effect, reducing pain score by -57 mm (-64 to -50, P < 0.001). Respiratory depression was potentiated by adding pregabalin to remifentanil; end-tidal carbon dioxide was 39.3 mmHg (37.2 to 41.3) with placebo, increased 1.8 mmHg (-0.9 to 4.6, P = 0.4) with pregabalin, 10.1 mmHg (4.9 to 15.4, P < 0.001) with remifentanil, and 16.4 mmHg (11.3 to 21.5, P < 0.001) with pregabalin + remifentanil on highest TCI level. The combination pregabalin + remifentanil, but not either drug alone, adversely affected all cognitive tests. CONCLUSIONS: The combination of pregabalin and remifentanil had additive analgesic effects, pregabalin potentiated remifentanil ventilatory depression, and the combination adversely affected cognition. These results question the clinical benefit of the combination compared with higher doses of opioids.

Preoperative magnetic resonance imaging for detecting uni- and bilateral extraprostatic disease in patients with prostate cancer.

OBJECTIVE: The objective of the study was to evaluate the diagnostic accuracy of preoperative magnetic resonance imaging (MRI) for detecting uni- and bilateral extraprostatic disease (T3) in patients with prostate cancer (PCa). MATERIALS AND METHODS: This prospective study included 199 patients with biopsy-proven PCa who underwent MRI prior to radical prostatectomy from December 2009 to July 2012. Extraprostatic extension and seminal vesicle invasion represented T3 disease, and was classified as uni- (right or left) or bilateral. MRI detection of T3 disease was assessed by descriptive statistics and odds ratio (OR). Whole-mount histopathology was used as the reference standard. RESULTS: The overall prevalence of pT3 was 105/199 (53 %), unilateral in 81/105 (77 %) and bilateral in 24/105 (23 %). The sensitivity of MRI for predicting pT3 was 76/105 (72 %), specificity 61/94 (65 %), accuracy 137/199 (69 %), and OR 4.8 (95 % CI 2.7-8.8). A complete match with respect to the laterality of pT3 was found in 52/105 (50 %), and the side-specific accuracy was 113/199 (57 %). When unilateral pT3 was found, MRI falsely suggested contralateral T3 in 4/81 (5 %) and bilateral in 8/81 (10 %). When bilateral pT3 was found, MRI falsely suggested unilateral T3 in 12/24 (50 %). CONCLUSION: Magnetic resonance imaging (MRI) detected 72 % of all patients with T3 disease, and the accuracy dropped from 69 to 57 % when considering the laterality of T3. Thus far, the MRI technique is not yet adequate to meet the increasing demands of accurate diagnosis of locally advanced disease, and the contemporary MRI staging should be careful.

Intraoperative ligament laxity influences functional outcome 1 year after total knee arthroplasty.

PURPOSE: To find out if there is an association between ligament laxity measured intraoperatively and functional outcome 1 year after total knee arthroplasty (TKA). METHODS: Medial and lateral ligament laxities were measured intraoperatively in extension and in 90° of flexion in 108 patients [122 knees; median age 70 (range 42-83) years]. Mechanical axes were measured preoperatively and at 1-year follow-up. Outcome measures were the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Knee Society Clinical Rating System, the Oxford Knee Score and patient satisfaction. The relationships between laxity and outcome scores were examined by median regression analyses. RESULTS: Post-operative mechanical axis had a significant effect on the association between ligament laxity and KOOS. Therefore, the material was stratified on post-operative mechanical axis. In perfectly aligned and valgus-aligned TKAs, there was a negative correlation between medial laxity and all subscores in KOOS. The most important regression coefficient (ß) was recorded for the effect of medial laxity in extension on activities of daily living (ADLs) (ß = -7.32, p < 0.001), sport/recreation (ß = -6.9, p = 0.017) and pain (ß = -5.9, p = 0.006), and for the effect of medial laxity in flexion on ADLs (ß = -3.11, p = 0.023) and sport/recreation (ß = -4.18, p = 0.042). CONCLUSIONS: In order to improve the functional results after TKA, orthopaedic surgeons should monitor ligament laxity and mechanical axis intraoperatively and avoid medial laxity more than 2 mm in extension and 3 mm in flexion in neutral and valgus-aligned knees. LEVEL OF EVIDENCE: II.

Morbidity associated with primary high intensity focused ultrasound and redo high intensity focused ultrasound for localized prostate cancer.

PURPOSE: High intensity focused ultrasound may have a role as an alternative to standard radical therapies for localized prostate cancer. An attribute of high intensity focused ultrasound is that it can be repeated. We determined morbidity after primary and redo high intensity focused ultrasound. MATERIALS AND METHODS: We performed an academic lead analysis of United Kingdom registry data on high intensity focused ultrasound treatments at 3 centers using patient reported continence and sexual function outcomes. Validated questionnaires were completed before and after each ultrasound treatment. RESULTS: A total of 359 patients received 1 whole gland high intensity focused ultrasound treatment for localized prostate cancer from October 2004 to June 2012, of whom 130 (36.2%) received re-treatment. Median followup was 27 months (range 3 to 81) after re-treatment. When analyzing adverse events, 10.8% of patients experienced urinary tract infection after the first treatment compared to 3.9% after re-treatment (p=0.009). Urethral dilatation was required in 13.8% and 14.0% of patients after first and redo ultrasound treatments (p=0.7), and bladder neck incision was required in 9.2% and 11.6%, respectively (p=0.2). Before and after re-treatment 73.3% and 55.1% of patients had no leak, and 2.7% and 9.0% used daily pads (p<0.001 and p=0.07, respectively). Analysis of erectile function showed that 56.2% and 56.0% of patients were potent before and after re-treatment, respectively (p=0.9). CONCLUSIONS: Redo high intensity focused ultrasound is associated with an increase in urinary side effects but sexual side effects do not appear to be significantly increased. The number of adverse events seems to be equivalent after first and redo treatments. Meticulous patient selection is of paramount importance when selecting men for redo high intensity focused ultrasound.

The relationships between demographic and clinical characteristics and quality of life during and after radiotherapy: in women with breast cancer.

PURPOSE: The purpose of this longitudinal study was to investigate quality of life (QOL) before, during, and after the course of radiotherapy (RT) and to identify risk factors for diminished QOL in women with breast cancer. METHODS: Patients (N = 188) completed the short-form 12 (SF-12), the Karnofsky Performance Status Scale, Memorial Symptom Assessment Scale, and the Self-Administrated Comorbidity Questionnaire 1 week prior to the start of RT. To assess changes in QOL, patients also completed the SF-12 1, 2, 3, and 6 months after the baseline. A random-intercept and slope model (mixed model) for each patient was used to estimate linear trends for the mental component score and physical component score of QOL (five time points for each patient). Descriptive statistics were used to analyze demographic and clinical characteristics. RESULTS: The physical component score (PCS) did not change significantly (p = 0.078) during the course of RT in women with breast cancer. An increase in the number of symptoms and a higher comorbidity profile was negatively related to the PCS. The mental component score (MCS) did not change from the start of RT until the 2-month assessment, but increased significantly after 2 months (p = 0.044). An increase in the number of symptoms was negatively related to the MCS. CONCLUSION: The MCS and PCS of QOL remained stable at a diminished level except for the MCS which improved between 2 and 6 months after the start of RT. The total number of symptoms was the only variable that was negatively associated with both component scores (MCS and PCS) during the 6 months.

Normal range and risk factors for deviating body temperatures during the first 24 hours in term-born infants under standardised care: an observational study.

OBJECTIVE: Body temperature for a known ambient temperature is not known for infants born at term. We aimed to determine the normal range and the incidences of hypothermia and hyperthermia during the first 24 hours of life in healthy term-born infants nursed according to WHO recommendations. DESIGN: Prospective observational study. SETTING: Norwegian single centre district hospital. Infants were observed during skin-to-skin care or when dressed in cots. PARTICIPANTS: Convenience sample of 951 healthy infants born at term. METHODS: Delivery room temperature was aimed at 26-30°C and rooming-in temperature at 24°C. We measured rectal and room temperatures at 2, 4, 8, 16 and 24 hours of age. MAIN OUTCOME MEASURES: Percentile curves for rectal temperature. Proportions and risk factors for hypothermia and hyperthermia. RESULTS: The mean (SD) room temperature was 24.0°C (1.1), 23.8°C (1.0), 23.8°C (1.0)., 23.7°C (0.9) and 23.8°C (0.9). The median (2.5, 97.5 percentile) rectal temperature was 36.9°C (35.7-37.9), 36.8°C (35.9-37.5), 36.9°C (36.1-37.5), 37.0°C (36.4-37.7) and 37.1°C (36.5-37.7). Hypothermia (<36.5°C) occurred in 28% of the infants, 82% of incidents during the first 8 hours. Risk factors for hypothermia were low birth weight (OR 3.1 (95% CI, 2.0 to 4.6), per kg), male sex, being born at night and nursed in a cot versus skin to skin. Hyperthermia (>37.5°C) occurred in 12% and most commonly in large infants after 8 hours of life. Risk factors for hyperthermia were high birth weight (OR 2.2 (95% CI, 1.4 to 3.5), per kg), being awake, nursed skin to skin and being born through heavily stained amniotic fluid. CONCLUSIONS: Term-born infants were at risk of hypothermia during the first hours after birth even when nursed in an assumed adequate thermal environment and at risk of hyperthermia after 8 hours of age.

Diabetes susceptibility in ethnic minority groups from Turkey, Vietnam, Sri Lanka and Pakistan compared with Norwegians - the association with adiposity is strongest for ethnic minority women.

BACKGROUND: The difference in diabetes susceptibility by ethnic background is poorly understood. The aim of this study was to assess the association between adiposity and diabetes in four ethnic minority groups compared with Norwegians, and take into account confounding by socioeconomic position. METHODS: Data from questionnaires, physical examinations and serum samples were analysed for 30-to 60-year-olds from population-based cross-sectional surveys of Norwegians and four immigrant groups, comprising 4110 subjects born in Norway (n = 1871), Turkey (n = 387), Vietnam (n = 553), Sri Lanka (n = 879) and Pakistan (n = 420). Known and screening-detected diabetes cases were identified. The adiposity measures BMI, waist circumference and waist-hip ratio (WHR) were categorized into levels of adiposity. Gender-specific logistic regression models were applied to estimate the risk of diabetes for the ethnic minority groups adjusted for adiposity and income-generating work, years of education and body height used as a proxy for childhood socioeconomic position. RESULTS: The age standardized diabetes prevalence differed significantly between the ethnic groups (women/men): Pakistan: 26.4% (95% CI 20.1-32.7)/20.0% (14.9-25.2); Sri Lanka: 22.5% (18.1-26.9)/20.7% (17.3-24.2), Turkey: 11.9% (7.2-16.7)/12.0% (7.6-16.4), Vietnam: 8.1% (5.1-11.2)/10.4% (6.6-14.1) and Norway: 2.7% (1.8-3.7)/6.4% (4.6-8.1). The prevalence increased more in the minority groups than in Norwegians with increasing levels of BMI, WHR and waist circumference, and most for women. Highly significant ethnic differences in the age-standardized prevalence of diabetes were found for both genders in all categories of all adiposity measures (p < 0.001). The Odds Ratio (OR) for diabetes adjusted for age, WHR, body height, education and income-generating work with Norwegians as reference was 2.9 (1.30-6.36) for Turkish, 2.7 (1.29-5.76) for Vietnamese, 8.0 (4.19-15.14) for Sri Lankan and 8.3 (4.37-15.58) for Pakistani women. Men from Sri Lanka and Pakistan had identical ORs (3.0 (1.80-5.12)). CONCLUSIONS: A high prevalence of diabetes was found in 30-to 60-year-olds from ethnic minority groups in Oslo, with those from Sri Lanka and Pakistan at highest risk. For all levels of adiposity, a higher susceptibility for diabetes was observed for ethnic minority groups compared with Norwegians. The association persisted after adjustment for socioeconomic position for all minority women and for men from Sri Lanka and Pakistan.

Meditative-based diaphragmatic breathing vs. vagus nerve stimulation in the treatment of fibromyalgia-A randomized controlled trial: Body vs. machine.

Importance: Vagus nerve innervation via electrical stimulation and meditative-based diaphragmatic breathing may be promising treatment avenues for fibromyalgia. Objective: Explore and compare the treatment effectiveness of active and sham transcutaneous vagus nerve stimulation (tVNS) and meditative-based diaphragmatic breathing (MDB) for fibromyalgia. Design: Participants enrolled from March 2019-October 2020 and randomly assigned to active tVNS (n = 28), sham tVNS (n = 29), active MDB (n = 29), or sham MDB (n = 30). Treatments were self-delivered at home for 15 min/morning and 15 min/evening for 14 days. Follow-up was at 2 weeks. Setting: Outpatient pain clinic in Oslo, Norway. Participants: 116 adults aged 18-65 years with severe fibromyalgia were consecutively enrolled and randomized. 86 participants (74%) had an 80% treatment adherence and 107 (92%) completed the study at 2 weeks; 1 participant dropped out due to adverse effects from active tVNS. Interventions: Active tVNS is placed on the cymba conchae of the left ear; sham tVNS is placed on the left earlobe. Active MDB trains users in nondirective meditation with deep breathing; sham MDB trains users in open-awareness meditation with paced breathing. Main outcomes and measures: Primary outcome was change from baseline in ultra short-term photoplethysmography-measured cardiac-vagal heart rate variability at 2 weeks. Prior to trial launch, we hypothesized that (1) those randomized to active MDB or active tVNS would display greater increases in heart rate variability compared to those randomized to sham MDB or sham tVNS after 2-weeks; (2) a change in heart rate variability would be correlated with a change in self-reported average pain intensity; and (3) active treatments would outperform sham treatments on all pain-related secondary outcome measures. Results: No significant across-group changes in heart rate variability were found. Furthermore, no significant correlations were found between changes in heart rate variability and average pain intensity during treatment. Significant across group differences were found for overall FM severity yet were not found for average pain intensity. Conclusions and relevance: These findings suggest that changes in cardiac-vagal heart rate variability when recorded with ultra short-term photoplethysmography in those with fibromyalgia may not be associated with treatment-specific changes in pain intensity. Further research should be conducted to evaluate potential changes in long-term cardiac-vagal heart rate variability in response to noninvasive vagus nerve innervation in those with fibromyalgia. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03180554, Identifier: NCT03180554.

SARS-CoV-2 antibody persistence after five and twelve months: A cohort study from South-Eastern Norway.

OBJECTIVES: To assess total antibody levels against Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS CoV-2) spike protein up to 12 months after Coronavirus Disease (COVID-19) infection in non-vaccinated individuals and the possible predictors of antibody persistence. METHODS: This is the first part of a prospective multi-centre cohort study. PARTICIPANTS: The study included SARS-CoV-2 real-time polymerase chain reaction (RT-PCR) positive and negative participants in South-Eastern Norway from February to December 2020. Possible predictors of SARS-CoV-2 total antibody persistence was assessed. The SARS-CoV-2 total antibody levels against spike protein were measured three to five months after PCR in 391 PCR-positive and 703 PCR-negative participants; 212 PCR-positive participants were included in follow-up measurements at 10 to 12 months. The participants completed a questionnaire including information about symptoms, comorbidities, allergies, body mass index (BMI), and hospitalisation. PRIMARY OUTCOME: The SARS-CoV-2 total antibody levels against spike protein three to five and 10 to 12 months after PCR positive tests. RESULTS: SARS-CoV-2 total antibodies against spike protein were present in 366 (94%) non-vaccinated PCR-positive participants after three to five months, compared with nine (1%) PCR-negative participants. After 10 to 12 months, antibodies were present in 204 (96%) non-vaccinated PCR-positive participants. Of the PCR-positive participants, 369 (94%) were not hospitalised. The mean age of the PCR-positive participants was 48 years (SD 15, range 20-85) and 50% of them were male. BMI ≥ 25 kg/m2 was positively associated with decreased antibody levels (OR 2.34, 95% CI 1.06 to 5.42). Participants with higher age and self-reported initial fever with chills or sweating were less likely to have decreased antibody levels (age: OR 0.97, 95% CI 0.94 to 0.99; fever: OR 0.33, 95% CI 0.13 to 0.75). CONCLUSION: Our results indicate that the level of SARS-CoV-2 total antibodies against spike protein persists for the vast majority of non-vaccinated PCR-positive persons at least 10 to 12 months after mild COVID-19.

Efficacy and safety of short-term genistein intervention in patients with localized prostate cancer prior to radical prostatectomy: a randomized, placebo-controlled, double-blind Phase 2 clinical trial.

We conducted a placebo-controlled, block-randomized double-blind Phase 2 study to examine the effect of 30 mg synthetic genistein daily on serum and tissue biomarkers in patients with localized prostate cancer (CaP). Fifty-four study subjects were recruited and randomized to treatment with genistein (n = 23) or placebo (n = 24) for 3 to 6 wk prior to prostatectomy. Seven study subjects were noncompliant to the study protocol. Adverse events were few and mild. Serum prostate specific antigen (PSA) decreased by 7.8% in the genistein arm and increased by 4.4% in the placebo arm (P = 0.051). The PSA level was reduced in tumor tissue compared to normal tissue in the placebo arm. In the genistein arm, the PSA level in tumor and normal tissue was comparable. Total cholesterol was significantly lower in the genistein arm (P = 0.013). There were no significant effects on thyroid or sex hormones. Plasma concentrations of total genistein were on average 100-fold higher in the genistein arm after treatment (P < 0.001). Genistein at a dose that can be easily obtained from a diet rich in soy reduced the level of serum PSA in patients with localized CaP, without any effects on hormones. It was well tolerated and had a beneficial effect on blood cholesterol.

Effect of bariatric surgery on sulphur amino acids and glutamate.

Plasma total cysteine (tCys) concentrations are associated with BMI. To study the relationship between tCys and BMI, we monitored the changes in serum concentrations of tCys and metabolically related compounds in sixty obese patients (BMI 50-60 kg/m(2)) from before to 1 year after either gastric bypass surgery (mean 30 % weight loss) or duodenal switch surgery (mean 41 % weight loss). A total of fifty-eight healthy persons (BMI 17-31 kg/m(2)) served as controls. Before surgery, obese patients had modestly (approximately 17 %) higher mean serum tCys, and markedly (>2-fold) higher glutamate concentrations, than controls (P ≤ 0·001 for both). Serial examinations after surgery revealed that gastric bypass patients had no change in tCys concentrations (P = 0·22), while duodenal switch patients showed a modest (approximately 12 %) but significant decrease in tCys (P < 0·001). Total homocysteine concentrations increased in duodenal switch patients but not in gastric bypass patients. Independent of surgery type, serum concentrations of methionine and cystathionine decreased (P < 0·05 for both), while serum glutathione and taurine remained stable. Glutamate concentrations declined, as did γ-glutamyltransferase activity (P < 0·001 for both). These results show that despite 30 % weight loss, and decreases in methionine, cystathionine and glutamate, there was no significant change in serum tCys in patients after gastric bypass surgery. The decrease in tCys in patients undergoing duodenal switch could be related to malabsorption. The present findings do not suggest that BMI is a causal determinant of plasma tCys.

Heart rate during the first 24 hours in term-born infants.

OBJECTIVE: Heart rate (HR) is an important clinical parameter in newborn infants, but normal ranges are poorly defined. Our aim was to establish normal reference ranges and individual variations in HR as obtained by auscultation in healthy term-born infants during the first 24 hours of life. DESIGN: Observational study. SETTING: Single hospital in Norway. METHODS: HR was assessed by auscultation for 30 s at 2, 4, 8, 16 and 24 hours of age. Auscultation was validated against ECG recordings. SUBJECTS: Healthy term-born infants who were asleep or awake in a quiet resting state. MAIN OUTCOME MEASURES: Construction of percentile curves for resting HR. RESULTS: The study included 953 infants. The 50th percentile was 126 beats per minute (bpm) at age 2 hours and thereafter 120-122 bpm. The respective 2nd and 98th percentiles were 102 (thereafter 96-100) bpm and 162 (thereafter 150-156) bpm. The mean HR was 5.6 bpm higher when awake than asleep, 4.9 bpm higher when on the mother's chest than in the cot, 1.6 bpm higher in girls than in boys, and increased by 0.5 bpm per 0.1°C increase in rectal temperature. Mode of delivery, meconium staining, birth weight and maternal smoking during pregnancy were of no significance. For each infant, HR varied considerably during the first 24 hours (intraclass correlation 0.21 (95% CI 0.18 to 0.24), coefficient of variation 9.2%). CONCLUSIONS: The HR percentiles allow for a scientifically based use of HR when assessing newborn infants born at term.

Three-month follow-up effects of a medication management program on nurses' knowledge.

This quasi-experimental study examined the effects of a medication management program on nurses knowledge of medication management, three months after program completion. Fifty-seven nurses took a multiple-choice test both immediately after the program and three months later. Changes in test performance were assessed using McNemar's test and generalized estimating equations for binary outcomes. Test results were generally consistent from immediately post-program to three months later, though four items differed significantly. From immediately post-program to three months later, fewer nurses correctly answered the items: documenting no medication administration (98.2 vs 86.6, p = 0.04); documenting opioid administration (56.1 vs 33.3, p = 0.01); and observation after opioid administration (35.1 vs 19.3, p = 0.08. Significantly more nurses correctly answered the item concerning the pharmacology of medication administered with food (64.9 vs 77.2, p = 0.09). We recommend both continuous medication management training and focusing on the correspondence between theory-based knowledge and clinical practice routines.