Time trends in human papillomavirus prevalence and genotype distribution in vulvar carcinoma in Norway.

INTRODUCTION: Approximately 25%-43% of all vulvar carcinomas are associated with human papillomavirus (HPV). In many countries, vulvar carcinoma incidence rates are increasing, possibly due to greater HPV exposure. However, studies exploring changes in HPV prevalence and genotype distribution in vulvar carcinoma over time are scarce. Our aim was to evaluate time trends in HPV prevalence and genotype distribution in vulvar squamous cell carcinoma in an unselected, nationwide sample of Norwegian women. Further, we explored clinical and histopathological aspects in relation to HPV status and investigated whether HPV status was associated with survival. MATERIAL AND METHODS: All vulvar squamous cell carcinoma cases from 1970-1975 and 2000-2005 were extracted from the Cancer Registry of Norway and corresponding tissue blocks were retrieved. After detailed histology review, HPV testing was conducted using real-time TaqMan PCR. Overall survival rates were calculated using the Kaplan-Meier method. Multivariable Cox regression analysis was performed to estimate hazard ratios adjusted for age at diagnosis, stage and diagnostic period. RESULTS: Histological review was performed on 352 vulvar squamous cell carcinoma cases. We were able to obtain valid HPV analysis results for 282 cases, Overall, 29.8% (95% CI 24.5%-35.5%) of cases were high-risk HPV (hrHPV)-positive. When comparing the two periods, we found that the percentage of hrHPV-positive tumors increased significantly from 23% (95% CI 16.0%-31.4%) in 1970-1975 to 35.3% (95% CI 27.8%-43.3%) in 2000-2005 (P = 0.025). The predominant genotypes were HPV 16 (73%), HPV 33 (21%), and HPV 18 (6%), with similar distributions in both periods. In the more recent cohort, several additional genotypes were detected: HPV 6, 11, 39, 45, 52, 58 and 66 were found in smaller percentages, ranging from 1.8% to 3.6%. In univariate analysis, patients with HPV-positive tumors showed improved overall survival compared with patients with HPV-negative tumors (hazard ratio [HR] 0.65, 95% CI 0.48-0.86). CONCLUSIONS: The prevalence of HPV in vulvar squamous cell carcinomas in Norway was significantly higher in 2000-2005 than in 1970-1975. The three predominant genotypes were HPV 16, 33 and 18 in both time periods. However, several other HPV genotypes have emerged over the last decades. HPV-positivity was associated with better overall survival.

Post-traumatic stress symptoms six months after ICU admission with COVID-19: Prospective observational study.

AIMS AND OBJECTIVES: The aim of this study was to investigate the prevalence of post-traumatic stress symptoms, and to identify possible predictive factors in Norwegian intensive care unit survivors, 6 months after admission to the intensive care unit with COVID-19. BACKGROUND: The SARS CoV-2 virus causing COVID-19 has spread worldwide since it was declared a pandemic in March 2020. The most severely ill patients have been treated in the intensive care due to acute respiratory failure and also acute respiratory distress syndrome. It is well documented that these severe conditions can lead to complex and long-lasting symptoms, such as psychological distress, and was, therefore, investigated for the specific COVID-19 population. DESIGN: Prospective observational study. METHODS: Clinical data and patient reported outcome measures were collected by the Norwegian Intensive Care and Pandemic Registry and by the study group 6 months after admission to an intensive care unit. RESULTS: Among 222 COVID-19 patients admitted to Norwegian intensive care units between 10 March and 6 July 2020, 175 survived. The study sample consisted of 131 patients who responded to at least one patient reported outcome measure at 6 months following admission. The primary outcome was self-reported post-traumatic stress symptoms, using the Impact of Event Scale-6 (n = 89). Of those, 22.5% reported post-traumatic stress symptoms 6 months after admission. Female gender, younger age and having a high respiratory rate at admission were statistically significant predictive factors for reporting post-traumatic stress symptoms. CONCLUSIONS: The result is in accordance with previously published research with comparable populations, suggesting that for many COVID-19 survivors psychological distress is a part of the post-acute sequelae. Results from the present study should be replicated in larger datasets. RELEVANCE TO CLINICAL PRACTICE: This project provides important insight to post-acute sequelae after COVID-19 that patients may experience after critical illness.

Prevalence of and predictive factors associated with high levels of post-traumatic stress symptoms 3 months after intensive care unit admission: A prospective study.

BACKGROUND: Post-traumatic stress symptoms (PTSS) following intensive care unit (ICU) treatment may increase morbidity and mortality. Therefore, it is important to identify patients at risk of suffering from such symptoms. OBJECTIVES: The objective of this study was to describe the prevalence and identify possible predictive factors associated with high levels of PTSS 3 months after ICU admission. METHODS: A multicentre, observational study was carried out in six ICUs in Norway. Patients aged ≥18 years were included. The Impact of Event Scale-Revised measured PTSS 3 months after ICU admission. The impacts of pre-ICU measures; demographic and clinical measures; and daily measures of pain, agitation, and delirium were analysed using univariate and multivariate logistic regression models. RESULTS: In total, of the 273 patients included, the prevalence rate of high levels of PTSS was 19.8% (n = 54) 3 months after ICU admission (95% confidence interval [CI]: [15.2, 25.0]). Female gender, age, pre-ICU unemployment, a minimum of one episode of agitation or delirium, and pre-ICU level of functioning in daily living were all significantly associated with high levels of PTSS in univariate logistic analyses. In the multivariate logistic regression, two models were analysed. In model 1, episodes of agitation during ICU stay (odds ratio [OR] = 4.73; 95% CI: [1.17, 19.0]), pre-ICU unemployment (OR = 3.33; 95% CI: [1.26, 8.81]), and pre-ICU level of functioning in daily living (OR = 0.78; 95% CI: [0.63, 0.96]) (implying lower level) increased the odds of reporting high levels of PTSS. In model 2, pre-ICU unemployment (OR = 2.70; 95% CI: [1.05, 6.93]) and pre-ICU level of functioning in daily living (OR = 0.77; 95% CI: [0.62, 0.95]) (implying lower level) increased the odds of reporting high levels of PTSS. CONCLUSIONS: Healthcare personnel are suggested to be aware of ICU patients' pre-ICU employment status, pre-ICU functioning in daily living, and agitation during ICU stay to identify those at risk of PTSS after discharge.

Clinical and biochemical impact of vitamin B6 deficiency in primary sclerosing cholangitis before and after liver transplantation.

BACKGROUND AND AIMS: We previously demonstrated that people with primary sclerosing cholangitis (PSC) had reduced gut microbial capacity to produce active vitamin B6 (pyridoxal 5'-phosphate [PLP]), which corresponded to lower circulating PLP levels and poor outcomes. Here, we define the extent and biochemical and clinical impact of vitamin B6 deficiency in people with PSC from several centers before and after liver transplantation (LT). METHODS: We used targeted liquid chromatography-tandem mass spectrometry to measure B6 vitamers and B6-related metabolic changes in blood from geographically distinct cross-sectional cohorts totaling 373 people with PSC and 100 healthy controls to expand on our earlier findings. Furthermore, we included a longitudinal PSC cohort (n = 158) sampled prior to and serially after LT, and cohorts of people with inflammatory bowel disease (IBD) without PSC (n = 51) or with primary biliary cholangitis (PBC) (n = 100), as disease controls. We used Cox regression to measure the added value of PLP to predict outcomes before and after LT. RESULTS: In different cohorts, 17-38% of people with PSC had PLP levels below the biochemical definition of a vitamin B6 deficiency. The deficiency was more pronounced in PSC than in IBD without PSC and PBC. Reduced PLP was associated with dysregulation of PLP-dependent pathways. The low B6 status largely persisted after LT. Low PLP independently predicted reduced LT-free survival in both non-transplanted people with PSC and in transplant recipients with recurrent disease. CONCLUSIONS: Low vitamin B6 status with associated metabolic dysregulation is a persistent feature of PSC. PLP was a strong prognostic biomarker for LT-free survival both in PSC and recurrent disease. Our findings suggest that vitamin B6 deficiency modifies the disease and provides a rationale for assessing B6 status and testing supplementation. IMPACT AND IMPLICATIONS: We previously found that people with PSC had reduced gut microbial potential to produce essential nutrients. Across several cohorts, we find that the majority of people with PSC are either vitamin B6 deficient or have a marginal deficiency, which remains prevalent even after liver transplantation. Low vitamin B6 levels strongly associate with reduced liver transplantation-free survival as well as deficits in biochemical pathways dependent on vitamin B6, suggesting that the deficiency has a clinical impact on the disease. The results provide a rationale for measuring vitamin B6 and to investigate whether vitamin B6 supplementation or modification of the gut microbial community can help improve outcomes for people with PSC.

Incidence of cancer in patients with ulcerative colitis 30 years after diagnosis (the IBSEN study).

OBJECTIVES: Patients with ulcerative colitis (UC) have shown an increased risk for colorectal cancer, hepatobiliary, hematologic, and skin cancers, but updated long-term data is needed. This study aimed to estimate the risk of cancer in patients with UC compared to the general Norwegian population, in a population-based cohort (the IBSEN study), 30 years after diagnosis; and to identify possible risk factors associated with cancer. METHODS: The IBSEN cohort prospectively included all incident patients between 1990 and 1993. Cancer incidence data were obtained from the Cancer Registry of Norway. The overall and cancer-specific hazard ratios (HR) were modelled using Cox regression. Standardized incidence ratios were estimated compared to the general population. RESULTS: In total, the cohort included 519 patients, and 83 cases were diagnosed with cancer. There was no statistically significant difference in the overall cancer risk (HR = 1.01, 95% CI: [0.79-1.29]) and colorectal cancer risk (HR = 1.37, 95% CI: [0.75-2.47]) between patients and controls. The incidence of biliary tract cancer was higher than expected (SIR = 9.84, 95%CI: [3.19-20.15]), especially when UC patients suffered from primary sclerosing cholangitis. Male UC patients were also more at risk of being diagnosed with hematologic malignancies (HR = 3.48, 95% CI: [1.55-7.82]). Being prescribed thiopurines was associated with a higher risk of cancer (HR = 2.03, 95% CI: [1.02-4.01]). CONCLUSIONS: At 30 years after diagnosis, the risk of all cancer in patients with UC was not significantly increased compared with the general population. However, the risks of biliary tract cancer and hematologic cancers were increased, particularly in male patients.

Symptoms and symptom clusters in patients newly diagnosed with inflammatory bowel disease: results from the IBSEN III Study.

BACKGROUND: Patients with inflammatory bowel disease report multiple symptoms, but the relationships among co-occurring symptoms are poorly understood. This study aimed to examine the prevalence of symptoms and explore symptom clusters and possible associations between symptom clusters and socio-demographic and clinical variables in patients newly diagnosed with inflammatory bowel disease. METHODS: The IBSEN III study is a prospective population-based inception cohort of patients with inflammatory bowel disease. This study used patient data from the three largest hospitals in the study catchment area. The Memorial Symptom Assessment Scale was used to assess the prevalence of symptoms. Symptom clusters were identified using principal component analysis. Possible associations between socio-demographic and clinical variables and symptom cluster membership were estimated using regression analysis. RESULTS: Of the 573 patients (age, ≥18 years) diagnosed with inflammatory bowel disease, 350 (61.1%) completed the questionnaire (responders). Eleven symptoms were reported by >50% of the responders. The three most prevalent symptoms were bloating (84%), drowsiness (81%), and lack of energy (81%). Three symptom clusters were identified: psychological (56% of the patients), impaired energy (28%), and physical (16%) clusters. Multinomial regression analysis revealed that vitamin D deficiency was significantly associated with the impaired energy cluster (odds ratio=2.49, 95% confidence interval [1.00-6.2], p=0.05). CONCLUSIONS: We found high symptom prevalence in patients newly diagnosed with inflammatory bowel disease. Three distinct symptom clusters were identified, and the psychological cluster includes >50% of the patients. Vitamin D deficiency is the only factor associated with cluster membership, namely the impaired energy cluster.

The impact of restrictions on psychological outcomes in patients with inflammatory bowel disease on biological treatment during the coronavirus pandemic in Norway.

PURPOSE: The coronavirus (COVID-19) pandemic restrictions have led to changes in the follow-up routine of patients in outpatient clinics at hospitals in Norway. The purpose of this study was to assess possible associations between psychological health and concerns regarding COVID-19 societal and hospital restrictions in patients with inflammatory bowel disease on biological therapy. METHODS: Patients with IBD (≥ 18 years) undergoing biological treatment (TNF-alpha inhibitor, ustekinumab, vedolizumab) for IBD were recruited from an IBD outpatient clinic in Norway. Data were collected through self-report, including questions covering concerns regarding their disease, medical therapy, and follow-up during the pandemic, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 questionnaire (GAD-7). Multiple logistic regression with backward conditional selection was fitted to examine associations between patients' depression and anxiety levels and their concerns about COVID-19 restrictions, controlled for sociodemographic and disease-related factors. RESULTS: Five-hundred and six patients were included in this study. General condition, self-isolation, employment status, fear of visiting the hospital, and changes to patients' appointments made by the hospital were independently associated with higher levels of depression. Female gender, experiencing symptoms of COVID-19, self-isolation, experiencing an increased risk of COVID-19 because of IBD, being afraid to visit the hospital because of COVID-19 restrictions, and having their appointment cancelled due to COVID-19 were independently associated with higher anxiety levels. CONCLUSION: Concerns about physical health and societal and hospital restrictions were associated with anxiety and depression in patients with IBD undergoing biological treatment. The findings will help facilitate healthcare services for patients with IBD in outpatient clinics and develop guidelines for follow-up.

Quality of life in Norwegian pregnant women and men with pregnant partners, and association with perception of sleep and depressive symptoms: a cross-sectional study.

BACKGROUND: Pregnant women and men with pregnant partners experience variations in quality of life (QoL) during pregnancy, a period characterized by physical, psychological, and social changes. Pregnancy is associated with reduced QoL, depressive symptoms, and sleep problems. This study aimed to: (1) determine whether Norwegian pregnant women and men with pregnant partners differed in QoL levels in the third trimester of pregnancy; (2) determine whether the relationship between perception of sleep and QoL is moderated by depressive symptoms, when analyzed separately in pregnant women and men with pregnant partners; and (3) determine whether selected possible predictive factors were associated with QoL when stratified by level of depressive symptoms, in pregnant women and men with pregnant partners separately. METHODS: A cross-sectional study conducted between October 2018 and January 2020 included 228 pregnant women and 197 men with pregnant partners in the third trimester of pregnancy. The age range was 22-50 years. QoL was assessed using the World Health Organization Quality of Life Questionnaire brief version, depressive symptoms using the Edinburgh Postnatal Depression Scale, and perception of sleep by a single item. Data were analyzed in SPSS version 28 using descriptive statistics, the PROCESS macro for moderation analyses, and multivariate linear regression. The level of statistical significance was p < 0.05. RESULTS: Pregnant women reported significantly lower QoL scores on the physical health and psychological domains than the men with pregnant partners. Our data did not reveal any moderating effect of depressive symptoms on the relationship between the perception of sleep and QoL. Depressive symptoms in the pregnant women were found to be a significant predictor of lower QoL in all domains. In the men with pregnant partners, getting enough sleep was a significant predictor of higher QoL in all domains. In the pregnant women without depressive symptoms, higher QoL in the physical health domain was significantly associated with the perception of getting enough sleep. CONCLUSION: Women in the final trimester of pregnancy experience poor QoL compared to the men with pregnant partners. Pregnant women with depressive symptoms have lower QoL compared to those without depressive symptoms. The perception of getting enough sleep was associated with better QoL.

Rehabilitation of Social Communication Skills in Patients With Acquired Brain Injury With Intensive and Standard Group Interactive Structured Treatment: A Randomized Controlled Trial.

OBJECTIVE: To determine the efficacy of group interactive structured treatment (standard GIST) for improving social communication difficulties in a wider acquired brain injury (ABI) population compared to a waitlist control (WL). Secondary objectives were to (a) explore GIST across delivery formats by comparing the results to an intensive inpatient version of GIST (intensive GIST) and (b) compare the within-subject results for WL and intensive GIST. DESIGN: Randomized controlled trial with WL and repeated measures (pre- and posttraining, 3- and 6-month follow-ups). SETTING: Community and rehabilitation hospital. PARTICIPANTS: Forty-nine persons (27-74 years) with ABI and social communication difficulties (26.5% traumatic brain injury, 44.9% stroke, 28.6% other), minimum 12 months postinjury. INTERVENTION: Standard GIST (n=24) consisted of 12 weekly outpatient interactive group sessions (2.5 hours/session) and follow-up. Intensive GIST (n=18) consisted of 4 weeks with daily 4-hour inpatient group sessions (2 × 3 d/wk, 2 × 4 d/wk) and follow-up. MAIN OUTCOME MEASURES: La Trobe Questionnaire, a self-report questionnaire measuring social communication. Secondary measures: Social Communication Skills Questionnaire-Adapted, Goal Attainment Scale, Mind in the Eyes test, and questionnaires addressing mental and cognitive health, self-efficacy, and quality of life. RESULTS: When comparing the standard GIST and WL results, a trend of improvement was found for the main outcome, La Trobe Questionnaire, and a statistically significant improvement was found for the secondary outcome Social Communication Skills Questionnaire-Adapted. Comparing standard GIST and intensive GIST, improvement in social communication skills after both treatments was detected and maintained at 6-month follow-up. No statistically significant difference was found between groups. Goal attainment was achieved and maintained during follow-up for both standard and intensive GIST. CONCLUSIONS: Social communication skills were improved after both standard and intensive GIST, indicating that GIST can be delivered across treatment formats and to a wider ABI population.

The impact of New Families home visiting program on first-time mothers' quality of life and its association with social support: a non-randomized controlled study.

BACKGROUND: The transition to motherhood is characterized by physical, psychological, social, and relational changes. Quality of life (QoL) changes substantially during this transition. Higher QoL is associated with social support, essential for coping with the challenges and changes of becoming a mother. An early universal home visiting program (New Families) is developed to strengthen and support families. The study aims to evaluate the impact of New Families on first-time mothers' QoL and to investigate the association between their QoL, social support, and selected possible predictive factors. METHODS: A prospective non-randomized controlled study with parallel group design. Child Health Services in five city districts of Oslo were matched in intervention and control groups. First-time mothers were allocated based on the residential area and assessed at pregnancy week 28 (N = 228), six weeks postpartum (N = 184), and three months postpartum (N = 167). Measures of the World Health Organization Quality of Life brief, Perinatal Infant Care Social Support Scale, and background variables were collected from October 2018 to June 2020. Multivariate linear regression models were applied to examine intervention impact and assess associations. RESULTS: Our data did not reveal a significant association between New Families intervention and the QoL levels of first-time mothers at three months postpartum. Thus, we analyzed the whole sample together. Emotional support was significantly associated with higher QoL levels in the physical health (B = 0.19, 95%CI [0.04 to 0.34]) and social relationships (B = 0.40, 95%CI [0.20 to 0.60]) domains. Appraisal support was significantly associated with higher QoL levels in the psychological (B = 0.34, 95%CI [0.18 to 0.50]) and environment (B = 0.33, 95%CI [0.19 to 0.48]) domains. QoL levels in pregnancy were significantly associated with QoL levels postpartum, showing small to medium effect size (ES = 0.30 to 0.55), depending on the domain. CONCLUSIONS: Further research, including qualitative interviews, could provide more insights into the impact of New Families on QoL. A positive association between QoL levels in pregnancy and postpartum suggests that postnatal interventions targeting improved QoL could potentially improve postpartum QoL. Emotional and appraisal support seems beneficial for first-time mothers' QoL and could be provided and facilitated by public health nurses. TRIAL REGISTRATION: clinicaltrial.gov NCT04162626.

Sleep duration in schooldays is associated with health-related quality of life in norwegian adolescents: a cross-sectional study.

BACKGROUND: Insufficient sleep is commonly reported in adolescence and is negatively associated with a wide range of health outcomes. A way to grasp the complicated challenge of how sleep impact different aspects of the adolescents´ everyday life is by examining the relationship between sleep duration in schooldays and weekends on different health-related quality of life (HRQOL) subscales. Furthermore, to expand the understanding of possible underlying mechanisms between sleep and HRQOL, testing for self-efficacy as a possible mediator is of importance. METHODS: A cross-sectional study was performed among 696 adolescents aged 13-15 years from a school-based setting. All participants completed an electronic survey in their respective classrooms. The survey included demographic data, the School Sleep Habits Survey, the KIDSCREEN-27 questionnaire measuring HRQOL, and the General Perceived Self-Efficacy Scale. Statistical analyses were conducted using SPSS Statistics software including PROCESS macro by Andrew Hayes. RESULTS: Our findings revealed overall similar sleep patterns in boys and girls including longer sleep duration in the study sample during weekends (10:09 h) than in schooldays (08:36 h). Regression analyses revealed that sleep duration in schooldays was positively and statistically associated with HRQOL subscales psychological well-being (95% CI [0.44 to 1.33]), autonomy and parents (95% CI [0.12 to 1.06]), school environment (95% CI [0.47 to 1.40]), and self-efficacy (95% CI [0.01 to 0.47]). Sleep duration in weekends revealed no associations with the HRQOL subscales, except for the HRQOL subscale psychological well-being (95% CI [0.09 to 0.85]). Mediation analyses revealed that sleep duration in schooldays explained most of the associations (64 - 75%) in 4 out 5 HRQOL subscales, except in the association with the HRQOL subscale physical well-being revealing an indirect effect of 71.9%. CONCLUSIONS: This cross-sectional study described sleep among Norwegian adolescents and demonstrated that sleep durations in weekends and schooldays impact HRQOL and self-efficacy, revealing overall better outcome in HRQOL and self-efficacy with sufficient sleep during schooldays. These findings support the regularity of sleep and highlight the importance of sufficient sleep during schooldays, especially in a school-based sample of adolescents.

Gastric Bypass Versus Sleeve Gastrectomy in Type 2 Diabetes: Effects on Hepatic Steatosis and Fibrosis : A Randomized Controlled Trial.

BACKGROUND: Weight loss improves fatty liver disease. No randomized trial has compared the effects of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) on liver fat content and fibrosis. OBJECTIVE: To compare the 1-year effects of SG and RYGB on hepatic steatosis and fibrosis. DESIGN: Single-center, randomized, controlled trial (Oseberg [ObesitySurgery in Tønsberg]). (ClinicalTrials.gov: NCT01778738). SETTING: Tertiary care obesity center in Norway. PARTICIPANTS: 100 patients (65% female; mean age, 47.5 years; mean body mass index, 42 kg/m2) with type 2 diabetes mellitus (T2DM). INTERVENTION: From January 2013 to February 2018, patients were randomly assigned (1:1 ratio) to SG or RYGB. MEASUREMENTS: The primary outcome was remission of T2DM (previously published). Predefined secondary outcomes in the present study were hepatic steatosis and fibrosis assessed by magnetic resonance imaging (liver fat fraction), enhanced liver fibrosis (ELF) test, noninvasive indices, and liver enzymes. RESULTS: Liver fat fraction declined similarly after SG (-19.7% [95% CI, -22.5% to -16.9%]) and RYGB (-21.5% [CI, -24.3% to -18.6%]) from surgery to 1-year follow-up, and almost all patients (SG, 94%; RYGB, 100%) had no or low-grade steatosis at 1 year. The ELF score category remained stable in 77% of patients, but 18% experienced worsening of fibrosis at 1 year, with no substantial between-group difference. LIMITATIONS: Single-center study, short follow-up time, and lack of power for secondary outcomes. CONCLUSION: With an almost complete clearance of liver fat 1 year after surgery, RYGB and SG were both highly effective in reducing hepatic steatosis. Bariatric surgery had less influence on degree of fibrosis in the short term, but assessment of long-term progression is warranted. PRIMARY FUNDING SOURCE: Vestfold Hospital Trust and the South-Eastern Norway Regional Health Authority.

Infant colic and abdominal pain; associations with infant multimorbidity and maternal perceived stress up to 3 months postpartum-A cross-sectional/cohort study in the PreventADALL study.

AIMS AND OBJECTIVES: The primary aim was to explore whether infants with pain symptoms (colic, abdominal pain and visit to healthcare provider with pain or other discomforts) had increased multimorbidity (common infections, eczema and food sensitivity) compared with infants without these conditions. Secondarily, we aimed to determine whether infant pain symptoms were associated with maternal perceived stress in pregnancy and 3 months postpartum. BACKGROUND: Infant colic and abdominal pain are common concerns in early infancy. Nevertheless, to our knowledge, little research exists on the relationship between infant pain and common infant infections, eczema and food sensitization as comorbidities, and the impact of infant pain on the development of maternal perceived stress from pregnancy to infancy is inconsistent. DESIGN: This study was cross-sectional and partly prospective. METHODS: The sample consisted of mother-infant pairs (N = 1852); information regarding infant pain and multimorbidity was collected from the 3-month questionnaire and postpartum visits in the PreventADALL prospective cohort study. Chi-square tests and regression analyses were conducted. The STROBE checklist was followed. RESULTS: Our results showed a statistically significant higher proportion of respiratory and other infections in infants with pain symptoms. The odds of infant pain were higher for infants with multimorbidity compared to those with no comorbidity. Mothers of infants with colic and of infants visiting healthcare with pain and other discomforts reported statistically significant higher perceived stress by 3 months compared with mothers of infants with no reported pain. CONCLUSION: Our results indicate an association between infant pain symptoms and the presence of infections. Mothers of infants with colic and visiting healthcare had higher perceived stress compared to the no pain group. IMPLICATIONS FOR PRACTICE: Our study indicates that infant pain is associated with infant multimorbidity and maternal perceived stress, which may be useful when planning diagnostic, treatment and coping strategies in infant and family care. PATIENT OR PUBLIC CONTRIBUTION: The PreventADALL is a collaborative study with governmental and patient organisation representation. Selected infants with parents were also contributing during calibrating courses on eczema assessment for the data collectors. TRIAL REGISTRATION: The study was approved by the Regional Committee in Norway (2014/518) and Sweden (2014/2242-31/4) and registered at clinicaltrial.gov (NCT02449850). Link for clinical trials: https://clinicaltrials.gov/ct2/show/NCT02449850.

Stress, pain, and work affiliation are strongly associated with health-related quality of life in parents of 14-15-year-old adolescents.

BACKGROUND: For many adults, their role as a parent is a vital part of their lives. This role is likely to be associated with a parent's health-related quality of life (HRQOL). The aim of this study was to explore the associations between gender, demographic and psychosocial variables, pain, and HRQOL in parents of 14-15-year-old adolescents. METHODS: This was a cross-sectional study that included 561 parents. Data on demographic, psychosocial variables and pain were collected using validated instruments. HRQOL was assessed using the RAND-36. Data were analysed using univariate and hierarchical multiple linear regression analyses. RESULTS: Four hundred and thirty-six (78%) mothers and 125 (22%) fathers with a mean age of 45 (SD = 5) years were included. Eighty-one per cent were married/cohabiting, 74% worked full time, and 50% had university education of more than 4 years. Almost one-third reported daily or weekly pain, and more than half (58%) reported using pain analgesics during the previous 4 weeks. Mothers reported significantly lower scores on self-efficacy, self-esteem and for all RAND-36 domains, including the physical component summary (PCS) and mental component summary (MCS) and experienced greater stress than fathers. Hierarchical regression analyses showed that working part-time (beta = 0.40) or full time (beta = 0.52) (reference: not working) had the strongest positive effect on PCS. Absence from work for > 10 days (beta = -0.24) (reference: no absence), short-term pain (beta = -0.14), chronic pain (beta = -0.37) (reference: no pain), and stress (beta = -0.10) had the strongest negative effects on PCS. High self-esteem (beta = 0.11) had the strongest positive effect, whereas stress (beta = -0.58) and absence from work for > 10 days (beta = -0.11) (reference: no absence) had the strongest negative effects on MCS. CONCLUSION: Mothers reported significantly lower scores on self-efficacy, self-esteem, and HRQOL, and experienced greater stress than the fathers. A high proportion of parents reported pain. Pain, stress, and low work affiliation were strongly associated with decreased HRQOL in parents. We recommend that parents of adolescents should be provided guidance about coping with pain and stress, and facilitation of a strong work affiliation because these seem to be important to parents' HRQOL.

The relationship between stress and health-related quality of life and the mediating role of self-efficacy in Norwegian adolescents: a cross-sectional study.

BACKGROUND: During the transitional phase from childhood to adulthood, adolescents encounter many changes and challenges. Stress is associated with reduced health-related quality of life (HRQOL) in adolescents and, thus, impacts all aspects of their life. Adolescents' thoughts and beliefs in their capacity may be essential with regard to their subjective perception of stress and coping with it. Insights into the complexity of stress and exploration of the possible underlying mechanisms in adolescence are needed. We sought to describe stress, HRQOL, and self-efficacy and explore the association between stress and HRQOL by testing for self-efficacy as a possible mediator in adolescents. METHODS: In total, 696 school-based adolescents aged 14-15 years participated in this study. Participants were recruited from 22 schools in the Eastern and Southern parts of Norway. All participants completed an electronic survey in their respective classrooms. The survey included demographic data, the Perceived Stress Questionnaire, the KIDSCREEN-27 questionnaire measuring HRQOL, and the General Perceived Self-Efficacy Scale. Statistical analyses were conducted using the PROCESS macro for SPSS Statistics software by Andrew Hayes model 4. RESULTS: Descriptive analyses revealed overall low levels of stress with a score of 0.29 (SD, 0.15). Nevertheless, stress was negatively associated with all HRQOL subscales: physical well-being (B = - 25.60), psychological well-being (B = - 38.43), autonomy and parents (B = - 28.84), social support and peers (B = - 21.05), and school environment (B = - 30.28). Furthermore, these respective associations were all mediated by self-efficacy, which explained approximately one-fifth of the reduction in HRQOL. The highest degree of mediation and, thus, the largest indirect effect was estimated for the HRQOL subscale physical well-being (31.7%). CONCLUSIONS: Our findings extend prior research on the mechanisms underlying the relationship between perceived stress and HRQOL in adolescents. They demonstrated that perceived stress explained most of the reduction in the HRQOL after adjusting for the effect of self-efficacy. Hence, stress itself appears to be an important target for future interventions to enhance HRQOL, rather than purely focusing on increasing self-efficacy to enhance the HRQOL in adolescents. Our findings highlight the importance of a better understanding of the underlying mechanisms to develop strategic and accurate interventions for adolescents.

Changes in health-related quality of life in adolescents and the impact of gender and selected variables: a two-year longitudinal study.

BACKGROUND: Increased knowledge about factors that can impact changes in adolescents' health-related quality of life (HRQOL) is needed. The present study aimed to investigate possible HRQOL changes in adolescents at 14 and 16 years, and assess the impact of sociodemographic factors, gender, pain, self-esteem, self-efficacy, loneliness, and stress on HRQOL changes over time. Further, to assess HRQOL stratified by gender. METHODS: A longitudinal study involving 211 adolescents was conducted. Sociodemographic variables, pain, self-esteem, self-efficacy, loneliness, and stress were all assessed with well-validated instruments. KIDSCREEN-27 was used to measure HRQOL. Data were analyzed using independent t-tests, paired samples t-tests, and linear mixed models for repeated measures. RESULTS: When all variables were added to the linear mixed models, stress, loneliness, and pain were significantly, independently associated with a reduction in HRQOL change scores for four of the five KIDSCREEN subscales. Time was significantly associated with a reduction in physical and psychological well-being. Self-efficacy and self-esteem were significantly associated with an increase in HRQOL change scores for four and two subscales, respectively. Male gender was significantly negatively associated with changes in social support and peers compared to female gender. CONCLUSION: Our results demonstrated a significant decline in adolescents' HRQOL regarding physical and psychological well-being for the age range 14-16 years. Furthermore, we found that stress, loneliness, and pain have a significant negative impact on HRQOL changes, whereas self-esteem and self-efficacy have a significant positive impact. Our results highlight the importance of increased understanding regarding factors associated with changes in adolescents' HRQOL to enable accurate and strategic interventions.

Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial.

BACKGROUND: Aerobic exercise is an important part of obesity treatment and may improve health-related quality of life (HRQOL). The objective of this study was to compare the effect of two different exercise programs on health-related quality of life in patients with severe obesity. METHODS: This was a single-center, open-label, randomized, parallel-group study comparing the effects of a 24-week moderate-intensity continuous training (MICT) program and a combined high-intensity interval training program with MICT (HIIT/MICT). The primary objective (specified secondary outcome) was to assess HRQOL by using the general health dimension of the Short Form Health Survey (SF-36). The secondary objectives were to assess other dimensional SF-36 scores, the impact of weight on the physical and psychosocial aspects of quality of life (IWQOL-Lite), and the burden of obesity-specific weight symptoms (WRSM). RESULTS: 73 patients were enrolled and reported patient reported outcome measures, with 71 patients (55% females) allocated to either MICT (n = 34) or HIIT/MICT (n = 37). In the intention-to-treat analysis, general health scores increased between baseline and 24-week follow-up in both the HIIT/MICT group and the MICT group, with a mean change of 13 (95% CI 6-21) points and 11 (95% CI 5-17) points, respectively, with no difference between the groups. The effect sizes of these changes were moderate. The vitality and social functioning scores of SF-36, and the physical function and self-esteem scores of IWQOL-Lite increased moderately in both groups, with no difference between groups. The tiredness, back pain, and physical stamina scores based on WRSM showed moderate to strong changes in both the groups. CONCLUSIONS: Patients who had completed a combined HIIT/MICT program did not experience larger improvements in general health compared with those completing a clean 24-week MICT program. Exercise may confer general health benefits independent of intensity. TRIALS REGISTRATION: Regional Committees for Medical and Health Research Ethics south east, Norway, October 23, 2013 (identifier: 2013/1849) and ClinicalTrials.gov December 8, 2014 (identifier: NCT02311738).

Symptomatic or asymptomatic recurrence of ovarian cancer: does it influence survival?

OBJECTIVE: The survival benefit of monitoring CA125 in ovarian cancer patients after primary treatment is debated due to findings varying from insignificant survival differences to prolonged median overall survival in favor of asymptomatic patients. Hence we aimed to compare ovarian cancer patients with and without symptoms at the time of the first diagnosed recurrence in terms of post-recurrence survival and overall survival, and to explore time to recurrence and common symptoms at recurrence. METHODS: We included 421 women with ovarian cancer from a prospective multi-institutional Norwegian study of first recurrence of gynecological cancer over the period from March 2012 to April 2016. Patients were interviewed by clinicians at participating hospitals, and patient reported and clinical variables were recorded in a standardized questionnaire. The Kaplan-Meier method and the multivariate Cox model were used to evaluate post-recurrence survival and overall survival. RESULTS: Of the 406 patients included, 183 (45%) patients were diagnosed with asymptomatic recurrence, and 223 (55%) patients had symptoms at recurrence. Asymptomatic patients had their recurrence detected 2 months later than symptomatic patients (14 vs 12 months, respectively, p=0.17). Median post-recurrence survival was significantly longer in asymptomatic patients compared with patients with symptoms at recurrence (33.9 vs 26.2 months, respectively, p=0.002). The post-recurrence survival rate remained higher for symptomatic patients in the adjusted analysis (hazard ratio (HR)=1.42, p=0.001). Median overall survival was 47.8 months for asymptomatic patients versus 44.0 months for symptomatic patients in the unadjusted analyses (p=0.056). Asymptomatic patients had a significantly longer survival in the adjusted analysis (HR=1.24, p=0.046). Pain was the most common symptom at recurrence (54%). CONCLUSION: Patients with asymptomatic recurrence had a better prognosis based on post-recurrence data and the multivariate Cox regression analysis of overall survival. However, a closer exploration of differences in development of recurrence is needed as these results may give rise to more individualized follow-up for ovarian cancer patients.

Factors associated with maternal overall quality of life six months postpartum: a cross sectional study from The Norwegian Mother, Father and Child Cohort Study.

BACKGROUND: Having good Quality of Life (QoL) is essential, particularly for women after childbirth. However, little is known about the factors associated with maternal QoL after giving birth. We aimed to investigate the relationship between characteristics of the mother (socio-demographic variables), selected symptoms (depression and joy/anger), health perception (perception of birth) and possible characteristics of the environment (infant temperament, colic, sleep, parental relationship), with mothers' overall quality of life when the child is 6 months of age. METHODS: This study is based on the Norwegian Mother, Father and Child Cohort Study (MoBa), conducted at the Norwegian Institute of Public Health from June 1999 to December 2008, which included a total of 86,724 children. Maternal QoL was assessed by the Satisfaction With Life Scale. Joy and anger were measured using the Differential Emotional Scale, mothers' mental health was assessed using the Edinburgh Postnatal Depression Scale and satisfaction with relationship was measured using the Relationship Satisfaction Scale. Child temperament was measured using the Infant Characteristics Questionnaire and colic, sleep duration and feelings related to childbirth were assessed by mothers' reports. The associations between life satisfaction and selected variables were analysed using stepwise multiple linear regression models, and the results are presented as effect sizes (ES). RESULTS: Maternal feelings of joy of having a baby (ES = 0.35), high relationship satisfaction (ES = 0.32), as well as having a baby with normal sleep (ES = 0.31), are factors associated with higher maternal overall QoL. Postnatal depression was negatively associated with mothers' QoL, and infant colic or child's temperament (fussiness) showed no such association with mothers' QoL. CONCLUSIONS: Health professionals and clinicians should focus on infants sleep but also on supporting joy of motherhood and strengthening relationships of the new parents when they develop health interventions or provide counselling to new mothers and their families.

Safe Pregnancy intervention for intimate partner violence: a randomised controlled trial in Norway among culturally diverse pregnant women.

BACKGROUND: Intimate partner violence (IPV) during pregnancy is a global health problem with adverse consequences for mothers, infants and families. We hypothesise that information about IPV and safety behaviours during pregnancy has the potential to increase quality of life and the use of safety behaviours and prevent IPV. METHODS: A multicentre randomised controlled trial among culturally diverse pregnant women in Norway, to test the effect of a tablet-based video intervention about IPV and safety behaviours. Women attending routine antenatal check-ups alone (baseline) were screened for violence (Abuse Assessment Screen) by responding to questions on a tablet, and randomised (1:1) by computer to receive an intervention or a control video. The intervention video presented information about IPV and safety behaviours. The controls viewed a video promoting healthy pregnancy in general. Outcome measures were assessed three months post-partum: The World Health Organization Quality of Life-BREF, the Composite Abuse Scale on violence during the last 12 months and use of safety behaviours based on a 15-item checklist. A general linear model for repeated measures was used to examine the intervention's effect. The analyses were conducted by intention to treat. RESULTS: Among 1818 eligible women, 317 reported IPV and were randomised to an intervention (157) or a control group (160). A total of 251 (79.2%) women completed the follow-up questionnaire: 120 (76.4%) in the intervention group and 131 (81.9%) in the control group. At follow-up, 115 (45.8%) women reported a history of IPV. Few women (n = 39) reported IPV during the last 12 months. No differences in quality-of-life domains and overall quality of life and health were found between the intervention and the control groups. We detected no differences between the use of safety behaviours or IPV frequency and severity during the last 12 months. CONCLUSION: Our intervention did not improve women's quality of life, use of safety behaviours or exposure to violence. Nevertheless, a tablet-based tool may motivate women experiencing IPV to seek help and support. More research is needed regarding tablet-based interventions for women experiencing IPV, particularly culturally sensitive interventions. TRIAL REGISTRATION: NCT03397277 registered in clinicaltrials.gov on 11/01/2018.