Burden of late effects in a nationwide sample of long-term breast cancer survivors.

BACKGROUND: Long-term breast cancer survivors (BCSs) may experience several late effects (LEs) simultaneously. This study aimed to identify subgroups of 8-year BCSs with higher burden of LEs who could benefit from closer survivorship care, explore variables associated with higher symptom burden, and describe how symptom burden may affect general functioning. METHODS: All Norwegian women aged 20 to 65 years when diagnosed with stage I-III breast cancer in 2011 and 2012 were invited (n = 2803). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire/BR23, the Fatigue Questionnaire, Assessment of Survivor Concerns, and Scale for Chemotherapy Induced Long-term Neurotoxicity were used to assess 10 common LEs and general functioning. Using latent class analysis, subgroups of BCSs with similar burden of LEs were identified. Multinominal regression analysis were performed to examine variables associated with higher symptom burden. RESULTS: The final sample consisted of 1353 BCSs; 46% had low, 37% medium, and 17% high symptom burden. Younger age, short education, axillary dissection, higher systemic treatment burden, higher body mass index, and physical inactivity were associated with higher symptom burden. General functioning scores were lower, and the proportion on disability pension were higher among BCSs in the two most burdened subgroups compared with those in the low burden subgroup. CONCLUSION: More than half of long-term BCSs suffered from medium or high symptom burden and experienced impaired general functioning compared with BCS with low symptom burden. Younger age and systemic treatment were important risk factors for higher symptom burden. BCSs at risk of higher symptom burdens should be identified and offered closer and extended survivorship care.

Evaluation of sex inequity in lung-cancer-specific survival.

BACKGROUND: Whether sex is an independent prognostic factor in lung cancer survival is the subject of ongoing debate. Both large national registries and single hospital studies have shown conflicting findings. In this study, we explore the impact of sex on lung-cancer-specific survival in an unselected population that is well-characterized with respect to stage and other covariates. MATERIAL AND METHODS: All patients diagnosed with lung cancer at a single hospital serving a whole and defined region in Southern Norway during the 10 years 2007-2016 were included. Follow-up data were available for at least 56 months for all patients. Analyses were adjusted for stage, treatment, performance status, smoking, age, histology, epidermal growth factor receptor/anaplastic lymphoma kinase/immunotherapy treatment and period. Differences in lung-cancer-specific survival by sex were explored using restricted mean survival times (RMST). RESULTS: Of the 1,261 patients diagnosed with lung cancer, 596 (47%) were females and 665 (53%) males, with mean ages of 68.5 and 69.5 years, respectively. The observed 5-year lung-cancer-specific survival rate was 27.4% (95% CI 23.7, 31.2) in females and 21.4% (95% CI 18.2, 24.8) in males. However, after adjustment for covariates, no significant differences by sex were observed. The 5-year RMST was 0.9 months shorter (95% CI -2.1, 0.31, p = 0.26) in males compared to females. INTERPRETATION: In this cohort, sex was not associated with a difference in lung-cancer-specific survival after adjusting for clinical and biological factors. Imbalance in stage at diagnosis was the main contributor to the observed difference in lung-cancer-specific survival by sex.

PCM4EU and PRIME-ROSE: Collaboration for implementation of precision cancer medicine in Europe.

BACKGROUND: In the two European Union (EU)-funded projects, PCM4EU (Personalized Cancer Medicine for all EU citizens) and PRIME-ROSE (Precision Cancer Medicine Repurposing System Using Pragmatic Clinical Trials), we aim to facilitate implementation of precision cancer medicine (PCM) in Europe by leveraging the experience from ongoing national initiatives that have already been particularly successful. PATIENTS AND METHODS: PCM4EU and PRIME-ROSE gather 17 and 24 partners, respectively, from 19 European countries. The projects are based on a network of Drug Rediscovery Protocol (DRUP)-like clinical trials that are currently ongoing or soon to start in 11 different countries, and with more trials expected to be established soon. The main aims of both the projects are to improve implementation pathways from molecular diagnostics to treatment, and reimbursement of diagnostics and tumour-tailored therapies to provide examples of best practices for PCM in Europe. RESULTS: PCM4EU and PRIME-ROSE were launched in January and July 2023, respectively. Educational materials, including a podcast series, are already available from the PCM4EU website (http://www.pcm4eu.eu). The first reports, including an overview of requirements for the reimbursement systems in participating countries and a guide on patient involvement, are expected to be published in 2024. CONCLUSION: PCM4EU and PRIME-ROSE were launched in January and July 2023, respectively. Educational materials, including a podcast series, are already available from the PCM4EU website (http://www.pcm4eu.eu). The first reports, including an overview of requirements for the reimbursement systems in participating countries and a guide on patient involvement, are expected to be published in 2024. CONCLUSION: European collaboration can facilitate the implementation of PCM and thereby provide affordable and equitable access to precision diagnostics and matched therapies for more patients.

IMPRESS-Norway: improving public cancer care by implementing precision medicine in Norway; inclusion rates and preliminary results.

BACKGROUND AND PURPOSE: In Norway, comprehensive molecular tumour profiling is implemented as part of the public healthcare system. A substantial number of tumours harbour potentially targetable molecular alterations. Therapy outcomes may improve if targeted treatments are matched with actionable genomic alterations. In the IMPRESS-Norway trial (NCT04817956), patients are treated with drugs outside the labelled indication based on their tumours molecular profile. PATIENTS AND METHODS: IMPRESS-Norway is a national, prospective, non-randomised, precision cancer medicine trial, offering treatment to patients with advanced-stage disease, progressing on standard treatment. Comprehensive next-generation sequencing, TruSight Oncology 500, is used for screening. Patients with tumours harbouring molecular alterations with matched targeted therapies available in IMPRESS-Norway, are offered treatment. Currently, 24 drugs are available in the study. Primary study endpoints are percentage of patients offered treatment in the trial, and disease control rate (DCR) defined as complete or partial response or stable disease in evaluable patients at 16 weeks (W16) of treatment. Secondary endpoint presented is DCR in all treated patients. RESULTS: Between April 2021 and October 2023, 1,167 patients were screened, and an actionable mutation with matching drug was identified for 358 patients. By the data cut off 186 patients have initiated treatment, 170 had a minimum follow-up time of 16 weeks, and 145 also had evaluable disease. In patients with evaluable disease, the DCR was 40% (58/145). Secondary endpoint analysis of DCR in all treated patients, showed DCR of 34% (58/170). INTERPRETATION: Precision cancer medicine demonstrates encouraging clinical effect in a subset of patients included in the IMPRESS-Norway trial.

Haemodynamic effects of remifentanil during induction of general anaesthesia with propofol. A randomised trial.

BACKGROUND: Remifentanil may have a dose-dependent haemodynamic effect during the induction of general anaesthesia combined with propofol. Our objective was to investigate whether systolic arterial blood pressure (SAP) was reduced to a greater extent when the remifentanil dose was increased. METHODS: This randomised, double-blind, dose-controlled study was conducted at the Day Surgery Unit of Haugesund Hospital, Norway. Ninety-nine healthy women scheduled for gynaecological surgery were randomly allocated in a 1:1:1 ratio to receive remifentanil induction with a low, medium or high dose corresponding to maximum effect-site concentrations (Ce) of 2, 4 and 8 ng/mL. The induction dose of propofol was 1.8 mg/kg, with a Ce of 2.9 µg/mL. Anaesthesia was induced using target-controlled infusion. After 150 s of sedation, a bolus of remifentanil and propofol was administered. Baseline was defined as 55-5 s before the bolus dose, and the total observation time was 450 s. We used beat-to-beat haemodynamic monitoring with LiDCOplus. The primary outcome variable was the maximum decrease in SAP within 5 min after bolus administration of remifentanil and propofol. Absolute and relative changes from baseline to minimal values and the area under the curve (AUC) were used as effect measures. Comparisons of groups were performed using analysis of variance (ANOVA). RESULTS: Median remifentanil doses were 0.75, 1.5 and 3.0 µg/kg in the low-, medium- and high-dose groups, respectively. The absolute changes (mean ± standard deviation) in SAP in the low-, medium- and high-dose groups of remifentanil were -39 ± 9.6 versus -43 ± 9.1, and -41 ± 10 mmHg, respectively. No difference (95% confidence interval) in the absolute change in SAP was observed between the groups (ANOVA, p = .29); medium versus low dose 3.7 (-2.0, 9.4) mmHg, and high versus medium dose -2.2 (-8.0; 3.5) mmHg. The relative changes from baseline to minimum SAP values were -30% versus -32% versus -32% (p = .52). The between-group differences in the AUC were not statistically significant. Relative changes in heart rate (-20% vs. -21% vs. -21%), stroke volume (-19% vs. -16% vs. -16%), cardiac output (-32% vs. -32% vs. -32%), systemic vascular resistance (-24% vs. -27% vs. -28%), and AUC were not statistically significant. CONCLUSION: This trial demonstrated major haemodynamic changes during the induction of anaesthesia with remifentanil and propofol. However, we did not observe any statistically significant differences between low, medium or high doses of remifentanil when using continuous invasive high-accuracy beat-to-beat monitoring.

Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice.

Patient-reported outcomes (PROs) are increasingly used in single-arm cancer studies. We reviewed 60 papers published between 2018 and 2021 of single-arm studies of cancer treatment with PRO data for current practice on design, analysis, reporting, and interpretation. We further examined the studies' handling of potential bias and how they informed decision making. Most studies (58; 97%) analysed PROs without stating a predefined research hypothesis. 13 (22%) of the 60 studies used a PRO as a primary or co-primary endpoint. Definitions of PRO objectives, study population, endpoints, and missing data strategies varied widely. 23 studies (38%) compared the PRO data with external information, most often by using a clinically important difference value; one study used a historical control group. Appropriateness of methods to handle missing data and intercurrent events (including death) were seldom discussed. Most studies (51; 85%) concluded that PRO results supported treatment. Conducting and reporting of PROs in cancer single-arm studies need standards and a critical discussion of statistical methods and possible biases. These findings will guide the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Data in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) in developing recommendations for the use of PRO-measures in single-arm studies.

Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit-risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change. This Policy Review presents international stakeholder views on the need for SISAQOL-IMI, the agreed on and prioritised set of PRO objectives, and a roadmap to ensure that international consensus recommendations are achieved.

High neuroticism is associated with common late adverse effects in a nationwide sample of long-term breast cancer survivors.

PURPOSE: Neuroticism is a basic personality trait characterized by negative emotions triggered by stress such as a breast cancer diagnosis and its treatment. Due to lack of relevant research, the purpose of this study was to examine if high neuroticism is associated with seven common late adverse effects (LAEs) in long-term (≥ 5 years) breast cancer survivors (BCSs). METHODS: All female Norwegian BCSs aged 20-65 years when diagnosed with stage I-III breast cancer in 2011 or 2012 were invited to a questionnaire study in 2019 (N = 2803), of whom 48% participated (N = 1355). Neuroticism was self-rated using the abridged version of the Eysenck Personality Questionnaire, and scores dichotomized into high and low neuroticism. LAEs were defined by categorization of ratings on the EORTC QLQ-C30 (cognitive function, pain, and sleep problems) and QLQ-BR23 (arm problems) questionnaires, and categorizations of scale scores on mental distress, fatigue, and neuropathy. Associations between high neuroticism and LAEs were explored using multivariate logistic regression analyses. RESULTS: High neuroticism was found in 40% (95%CI 37-42%) of BCSs. All LAEs were significantly more common among BCSs with high compared to low neuroticism. In multivariable analyses, high neuroticism was positively associated with all LAEs except neuropathy. Systemic treatment, somatic comorbidity, and not being in paid work were also significantly associated with all LAEs. CONCLUSIONS: High neuroticism is prevalent and associated with increased risks of LAEs among BCSs. Identification of high neuroticism could improve the follow-up care of BCSs as effective interventions for the condition exist.

Sexual health in long-term breast cancer survivors: a comparison with female population controls from the HUNT study.

PURPOSE: Sexual health is an important aspect of quality of life. Knowledge concerning sexual health in long-term breast cancer survivors (BCSs) is limited. This study compared sexual health in BCSs 8 years after diagnosis with similarly aged controls and examined the impact of menopausal status at diagnosis and systemic breast cancer treatments on sexual health. METHODS: Women aged 20-65 years when diagnosed with stage I-III breast cancer in 2011-2012 were identified by the Cancer Registry of Norway (n = 2803) and invited to participate in a nationwide survey. Controls were women from the Trøndelag Health Study (HUNT4). Sexual functioning and sexual enjoyment were measured by the EORTC QLQ-BR23 subscales scored from 0 to 100, and sexual discomfort by the Sexual Activity Questionnaire scored from 0 to 6. Linear regression analyses with adjustments for sociodemographic and health-related variables were performed to compare groups. Differences of ≥ 10% of range score were considered clinically significant. RESULTS: The study samples consisted of 1241 BCSs and 17,751 controls. Sexual enjoyment was poorer (B - 13.1, 95%CI - 15.0, - 11.2) and discomfort higher (B 0.9, 95%CI 0.8, 1.0) among BCSs compared to controls, and larger differences were evident between premenopausal BCSs and controls (B - 17.3, 95%CI - 19.6, - 14.9 and B 1.2, 95%CI 1.0, 1.3, respectively). BCSs treated with both endocrine- and chemotherapy had lower sexual functioning (B - 11.9, 95%CI - 13.8, - 10.1), poorer sexual enjoyment (B - 18.1, 95%CI - 20.7, - 15.5), and more sexual discomfort (B 1.4, 95% 1.3, 1.6) than controls. CONCLUSION: Sexual health impairments are more common in BCSs 8 years after diagnosis compared to similar aged population controls. During follow-up, attention to such impairments, especially among women diagnosed at premenopausal age and treated with heavy systemic treatment, is warranted.

Self-reported lower extremity lymphedema and quality of life after surgical staging of endometrial carcinoma: A population based cross-sectional study.

OBJECTIVES: Sentinel lymph node biopsy (SLN) has replaced lymphadenectomy in staging of endometrial carcinoma. The aims of the study were to explore the prevalence of self-reported lymphedema (LEL), identify factors associated with LEL, compare quality of life (QoL) scores using thresholds of clinical importance, and assess correlation between different questionnaires. METHODS: Women who underwent staging for endometrial carcinoma from 2006 to 2021 were invited to complete the Lower Extremity Lymphedema Screening Questionnaire (LELSQ), EORTC QLQ-C30, QLQ-EN24 and EQ-5D-5L. RESULTS: Of 2156 invited survivors, 61% participated in the study, whereof 1127 were evaluable by LELSQ. The LEL prevalence was 51%, 36% and 40% after lymphadenectomy, SLN and hysterectomy, respectively (p < 0.001). Higher BMI, undergoing lymphadenectomy and receiving adjuvant chemotherapy were associated with LEL; odds ratios 1.07 (95% CI 1.05-1.09), 1.42 (95% CI 1.03-1.97) and 1.43 (95% CI 1.08-1.89) respectively. QoL was lower for women with LEL compared to those without. In women with musculoskeletal complaints the prevalence of LEL was 59%, 50% and 53% after lymphadenectomy, SLN and hysterectomy (p = 0.115), respectively, compared to 39%, 17% and 18% (p < 0.001) in women without musculoskeletal complaints. Spearman's correlation was moderate to strong between the questionnaires. CONCLUSION: SLN implementation is not associated with increased LEL prevalence compared to hysterectomy alone, but is associated with a significantly lower prevalence compared to lymphadenectomy. LEL is associated with lower QoL. Our study demonstrates moderate to strong correlation between self-reported LEL and QoL scores. Available questionnaires may not distinguish between symptoms caused by LEL and musculoskeletal disease.

Fear of cancer recurrence eight years after early-stage breast cancer - results from a national survey.

BACKGROUND: Fear of cancer recurrence (FCR) in breast cancer survivors (BCSs) is common, associated with reduced quality of life and effective interventions exist. There are knowledge gaps concerning FCR among long-term, early-stage BCSs and its associations with other late effects. Within a national cohort, we explored these knowledge gaps, with the ultimate aim of improved care for BCSs experiencing long-term FCR. METHODS: In this cross-sectional study, all BCSs aged 20-65 years with early-stage breast cancer in 2011-2012 (n = 2803), were identified by the Cancer Registry of Norway in 2019 and mailed a survey including the Assessment of Survivor Concerns used to measure FCR. Factors associated with moderate/high FCR (defined as a sum score of ≥ 6 of a possible range 3-12, or a single score on one of the items of ≥ 3) were explored using a three-block regression analyses including relevant sociodemographic-, health- and cancer-related variables. RESULTS: In total, 1311 BCSs were included (47%). Median age at survey was 60 years. Fifty-six % reported moderate-to-high FCR, associated with younger age (OR 0.96, 95% CI 0.95-0.97) and receiving chemo- and endocrine therapy (OR 1.59, 95% CI 1.15-2.20). After adding late effects into the model, FCR remained significantly associated with these variables, in addition to sleep disturbances (OR 1.58, 95% CI 1.18-2.10). In the final block, adding mental distress, FCR remained significantly associated with younger age (OR 0.97, 95% CI 0.96-0.99), receiving chemo- and endocrine therapy (OR 1.14, 95% CI 1.00-1.97), sleep disturbances (OR 1.44, 95% CI 1.08-1.94) and anxiety (OR 2.67, 95% CI 1.38-5.19). CONCLUSIONS: FCR was prevalent eight years after early-stage breast cancer. Being younger, receiving intensive treatment, experiencing sleep disturbances and/or anxiety were associated with moderate/high FCR. Addressing FCR should be part of standard follow-up care of long-term BCSs.

Translation and cross-cultural adaptation of the Gynecologic Cancer Lymphedema Questionnaire and the Lower Extremity Lymphedema Screening Questionnaire.

OBJECTIVE: There is a paucity of international data regarding self-reported lower extremity lymphedema and quality of life after surgery for gynecological cancer. Validated questionnaires are emerging, but translated versions are lacking. Cross-cultural adaptation is important to reduce the risk of introducing bias into a study. OBJECTIVE: To translate and culturally adapt the Gynecologic Cancer Lymphedema Questionnaire and the Lower Extremity Lymphedema Screening Questionnaire for a Norwegian population. METHODS: Permission to use the original English versions of the Gynecologic Cancer Lymphedema Questionnaire and the Lower Extremity Lymphedema Screening Questionnaire for translation was obtained. The questionnaires were translated using a procedure based on standard guidelines, including forward translation by native speakers of the target language, synthesis, back translation, and review. Seventeen patients from the Norwegian Radium Hospital gynecological cancer outpatient clinic, all expected to have stable disease, were invited for questionnaire test-retest by completing the same questionnaires twice at 3-4-week intervals. Internal consistency was assessed by calculating Cronbach's alpha. Test-retest reliability was assessed using an intra-class correlation coefficient. RESULTS: Twelve patients completed the questionnaires twice. Cronbach's alpha was 0.75 for the Gynecologic Cancer Lymphedema Questionnaire and 0.89 for the Lower Extremity Lymphedema Screening Questionnaire. The intra-class correlation coefficient was 0.86 for the Gynecologic Cancer Lymphedema Questionnaire and 0.91 for the Lower Extremity Lymphedema Screening Questionnaire. CONCLUSIONS: Translation and cross-cultural adaptation of these internationally validated patient-reported outcomes questionnaires for survivors of lower extremity lymphedema in gynecological cancer was feasible. The Norwegian translation of the Gynecologic Cancer Lymphedema Questionnaire and the Lower Extremity Lymphedema Screening Questionnaire showed acceptable internal consistency and the test-retest reliability was excellent.

A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire.

PURPOSE: To develop and validate a health-related quality of life (HRQoL) questionnaire for patients with current or previous coronavirus disease (COVID-19) in an international setting. METHODS: This multicenter international methodology study followed standardized guidelines for a four-phase questionnaire development. Here, we report on the pretesting and validation of our international questionnaire. Adults with current or previous COVID-19, in institutions or at home were eligible. In the pretesting, 54 participants completed the questionnaire followed by interviews to identify administration problems and evaluate content validity. Thereafter, 371 participants completed the revised questionnaire and a debriefing form to allow preliminary psychometric analysis. Validity and reliability were assessed (correlation-based methods, Cronbach's α, and intra-class correlation coefficient). RESULTS: Eleven countries within and outside Europe enrolled patients. From the pretesting, 71 of the 80 original items fulfilled the criteria for item-retention. Most participants (80%) completed the revised 71-item questionnaire within 15 min, on paper (n = 175) or digitally (n = 196). The final questionnaire included 61 items that fulfilled criteria for item retention or were important to subgroups. Item-scale correlations were > 0.7 for all but nine items. Internal consistency (range 0.68-0.92) and test-retest results (all but one scale > 0.7) were acceptable. The instrument consists of 15 multi-item scales and six single items. CONCLUSION: The Oslo COVID-19 QLQ-W61© is an international, stand-alone, multidimensional HRQoL questionnaire that can assess the symptoms, functioning, and overall quality of life in COVID-19 patients. It is available for use in research and clinical practice. Further psychometric validation in larger patient samples will be performed.

Exploring trends of severe postpartum haemorrhage: a hospital-based study.

BACKGROUND: Over the past two decades several high-income countries have reported increased rates of postpartum haemorrhage (PPH). Many of the studies are registry studies with limited access to detailed information. We aimed to explore trends of severe PPH in the largest labour ward in Norway during a 10-year period with a hospital based study. Our population constituted all women who gave birth after week 22 at Oslo University Hospital between 2008 and 2017. The main outcome measure was severe PPH, defined as registered blood loss greater than 1500 ml, or transfusion of blood products due to PPH. METHODS: We estimated the incidence of severe PPH and blood transfusions, and performed temporal trend analysis. We performed Poisson regression analysis to investigate associations between pregnancy characteristics and severe PPH, presented using crude incidence rate ratios (IRR) with 95% confidence intervals (CI)s. We also estimated annual percentage change of the linear trends. RESULTS: Among 96 313 deliveries during the 10-year study period, 2621 (2.7%) were diagnosed with severe PPH. The incidence rate doubled from 17.1/1000 to 2008 to 34.2/1000 in 2017. We also observed an increased rate of women receiving blood transfusion due to PPH, from 12.2/1000 to 2008 to 27.5/1000 in 2017. The rates of invasive procedures to manage severe PPH did not increase, and we did not observe a significant increase in the number of women defined with maternal near miss or massive transfusions. No women died due to PPH during the study period. CONCLUSION: We found a significant increasing trend of severe PPH and related blood transfusions during the 10-year study period. We did not find an increase in massive PPH, or in invasive management, and we suspect that the rise can be at least partly explained by increased awareness and early intervention contributing to improved registration of severe PPH.

The impact of recommending iron supplements to women with depleted iron stores in early pregnancy on use of supplements, and factors associated with changes in iron status from early pregnancy to postpartum in a multi-ethnic population-based cohort.

BACKGROUND: We aimed to evaluate the impact of recommending supplementation to pregnant women with serum ferritin (SF) < 20 µg/L in early pregnancy on use of supplements, and to explore which factors were associated with changes in iron status by different iron indicators to 14 weeks postpartum. METHODS: A multi-ethnic population-based cohort study of 573 pregnant women examined at mean gestational week (GW) 15 (enrolment), at mean GW 28 and at the postpartum visit (mean 14 weeks after delivery). Women with SF < 20 µg/L at enrolment were recommended 30-50 mg iron supplementation and supplement use was assessed at all visits. Change of SF, soluble transferrin receptor and total body iron from enrolment to postpartum were calculated by subtracting the concentrations at the postpartum visit from that at enrolment. Linear and logistic regression analyses were performed to assess associations between use of supplements in GW 28 and changes in iron status and postpartum iron deficiency/anaemia. Change of iron status was categorized into 'steady low', 'improvement', 'deterioration', and 'steady high' based on SF status at enrolment and postpartum. Multinomial logistic regression analyses were performed to identify factors associated with change of iron status. RESULTS: At enrolment, 44% had SF < 20 µg/L. Among these women (78% non-Western European origin), use of supplements increased from 25% (enrolment) to 65% (GW 28). Use of supplements in GW 28 was associated with improved iron levels by all three indicators (p < 0.05) and with haemoglobin concentration (p < 0.001) from enrolment to postpartum, and with lower odds of postpartum iron deficiency by SF and TBI (p < 0.05). Factors positively associated with 'steady low' were: use of supplements, postpartum haemorrhage, an unhealthy dietary pattern and South Asian ethnicity (p ≤ 0.01 for all); with 'deterioration': postpartum haemorrhage, an unhealthy dietary pattern, primiparity and no use of supplements (p < 0.01 for all), and with 'improvement': use of supplements, multiparity and South Asian ethnicity (p < 0.03 for all). CONCLUSIONS: Both supplement use and iron status improved from enrolment to the postpartum visit among women recommended supplementation. Dietary pattern, use of supplements, ethnicity, parity and postpartum haemorrhage were identified as factors associated with change in iron status.

Hemodynamic effects of a low versus a high dose of propofol during induction of anesthesia. A randomized trial.

BACKGROUND: Hypotension is common after anesthesia induction with propofol and is associated with increased morbidity. It is important to examine the effects of the proposed interventions to limit preventable hypotension, as suggested by the reduction in the dose of propofol. Our objective was to investigate whether a high dose of propofol is inferior to a low dose with respect to changes in systolic arterial blood pressure (SAP). METHODS: This randomized, double-blind, dose-controlled, non-inferiority study included 68 healthy women scheduled for gynecological surgery at the Day Surgery Unit, Haugesund Hospital, Norway. The patients were randomly allocated 1:1 to a low or high dose (1.4 mg/kg total body weight (TBW) versus 2.7 mg/kg TBW of propofol corresponding to maximal effect site concentrations (Ce) of 2.0 µg/mL versus 4.0 µg/mL. The dose of remifentanil was 1.9-2.0 µg/kg TBW, with maximal Ce of 5.0 ng/mL. The patients were observed for 450 s from the start of the infusions. The first 150 s was the sedation period, after which a bolus of propofol and remifentanil was administered. Baseline was defined as 55-5 s before the bolus doses. LiDCOplus was used for invasive beat-to-beat hemodynamic monitoring of changes in SAP, heart rate (HR), cardiac output (CO), stroke volume (SV), and systemic vascular resistance (SVR). A difference of 10 mmHg in the change in SAP was considered to be clinically important. RESULTS: The SAP change difference for low versus high dose was -2.9 mmHg (95% CI -9.0-3.1). The relative changes for low versus high dose were SAP -31% versus -36%, (p < .01); HR -24% versus -20%, (p = .09); SVR -20% versus -31%, (p < .001); SV -16% versus -20%, (p = .04); and CO -35% versus -32%, (p = .33). CONCLUSION: A high dose of propofol was not inferior to a low dose, and a reduction in the dose of propofol did not result in clinically important attenuation of major hemodynamic changes during induction in healthy women. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03861364, January 3, 2019.

Intrapartum pudendal nerve block analgesia and childbirth experience in primiparous women with vaginal birth: A cohort study.

BACKGROUND: A negative childbirth experience has short- and long-term consequences for both mother and child. This study aimed to investigate the association between intrapartum pudendal nerve block (PNB) analgesia and childbirth experience. METHODS: Primiparous women with a singleton cephalic vaginal live births at term at Oslo University Hospital from January 1, 2017, to June 1, 2019, were eligible for inclusion. The main outcome was total score on a childbirth experience questionnaire (range 1.0-4.0, higher score indicates better childbirth experience). An absolute risk difference of 0.10 was considered clinically relevant. Propensity score matching was used to adjust for differences in baseline characteristics between women with and without PNB. The analyses were stratified by spontaneous vs instrumental birth. Subanalyses of the questionnaire's domains (own capacity, professional support, perceived safety, and participation) were performed. RESULTS: Of 979 participating women, mean age was 32 years. Childbirth experience did not differ between women with and without PNB, either in spontaneous (absolute risk difference of the mean: -0.05, P value 0.36) or in instrumental birth (absolute risk difference of the mean: 0.03, P value 0.61). There were no statistically significant differences between PNB group scores for the separate domains. CONCLUSIONS: Women's childbirth experiences did not differ between birthing people with or without PNB, either in spontaneous or in instrumental births. The clinical implications of our study should be interpreted in light of the pain-relieving effects of PNB.PNB should be provided on clinical indication, including for individuals with severe labor pain.

Factors associated with changes in students' self-reported nursing competence after clinical rotations: a quantitative cohort study.

BACKGROUND: The quality of nursing care in different healthcare contexts can be associated with the level of available nursing competence. Physical assessment skills are vital in nurses' assessment of patient care needs. However, in nursing education, using physical assessment skills is challenging for nursing students who struggle to apply these skills comprehensively in a clinical rotation. Therefore, this study explores changes in nursing competence, factors associated with changes after clinical rotations, and whether a Suite of Mobile Learning Tools supports changes in confident use of basic physical assessment skills. METHODS: A quantitative cohort study with an explorative pre-and post-test design. During autumn 2019 and spring 2020, 72 s-year nursing students and 99 third-year students participated in the study. The Nurse Professional Competence scale short form was used to investigate students' self-reported changes in nursing competence, and a study-specific questionnaire was used to investigate students' confidence concerning performing physical assessments. The students voluntarily used the Suite of Mobile Learning Tools for the learning of physical assessment. Linear regression analysis was used to identify factors associated with changes in nursing competence after clinical rotation. The STROBE guidelines for cohort studies were followed for study reporting. RESULTS: After the clinical rotation, both student groups reported changes in nursing competence and confidence in performing physical assessment skills, with statistically significant moderate or large changes in all areas. The Suite of Mobile Learning Tools was evaluated as being useful for learning physical assessment. The regression analysis showed that confidence in performing physical assessment skills, the usefulness of the Suite of Mobile Learning Tools, and a higher nursing competence at the start of clinical rotation were positively associated with overall nursing competence. CONCLUSION: Basic physical assessment skills are an important component of nursing competence and can be considered one of the pillars of person-centered care, as proposed by the Fundamentals of Care framework. Spaced repetition and access to digital resources are suggested pedagogical approaches to enhance student confidence in the use of assessment skills within academic and clinical contexts.

Sexual activity and functioning in long-term breast cancer survivors; exploring associated factors in a nationwide survey.

PURPOSE: Sexual health is a key quality of life issue. Knowledge concerning sexual health in long-term breast cancer survivors (BCSs) is limited. Within a nationwide sample, we aimed to assess the prevalence of sexual inactivity and to explore factors associated with sexual inactivity and reduced sexual functioning among long-term BCSs. METHODS: Long-term BCSs aged 20-65 years when diagnosed with early-stage breast cancer in 2011-2012 were identified by the Cancer Registry of Norway in 2019 (n = 2803) and invited to participate in a nationwide survey. Sexual health was measured using the multidimensional Sexual Activity Questionnaire. Factors associated with sexual inactivity and reduced sexual functioning were explored using multivariable logistic- and linear regression analyses with adjustments for relevant sociodemographic, health-, and cancer-related variables. RESULTS: The final sample consisted of 1307 BCSs with a mean age of 52 years at diagnosis. Fifty-two percent of the BCSs were sexually inactive. Lack of interest was the most common reason for sexual inactivity. Treatment with aromatase inhibitor (OR 1.73, 95% CI 1.23, 2.43) and poor body image (OR 0.99, 95% CI 0.99, 0.995) were associated with sexual inactivity. Among sexually active BCSs, depression (B - 1.04, 95% CI - 2.10, - 0.02) and physical inactivity (B - 0.61, 95% CI - 1.21, - 0.02) were inversely related to sexual pleasure. Treatment with aromatase inhibitor (B 0.61, 95% CI 0.20, 1.01), sleep problems (B 0.37, 95% CI 0.04, 0.70), breast symptoms (B 0.01, 95% CI 0.003, 0.02), and chronic fatigue (B 0.43, 95% CI 0.05, 0.81) were associated with sexual discomfort. Chemotherapy (OR 1.91, 95% CI 1.23, 2.97), current endocrine treatment (OR 1.98, 95% CI 1.21, 3.25), and poor body image (OR 0.98, 95% CI 0.98, 0.99) were associated with less sexual activity at present compared to before breast cancer. CONCLUSION: Treatment with aromatase inhibitor seems to affect sexual health even beyond discontinuation. Several common late effects were associated with sexual inactivity and reduced sexual functioning. To identify BCSs at risk of sexual dysfunction, special attention should be paid to patients treated with aromatase inhibitor or suffering from these late effects.

Quality of life among women with symptomatic, screen-detected, and interval breast cancer, and for women without breast cancer: a retrospective cross-sectional study from Norway.

PURPOSE: Breast cancers detected at screening need less aggressive treatment compared to breast cancers detected due to symptoms. The evidence on the quality of life associated with screen-detected versus symptomatic breast cancer is sparse. This study aimed to compare quality of life among Norwegian women with symptomatic, screen-detected and interval breast cancer, and women without breast cancer and investigate quality adjusted life years (QALYs) for women with breast cancer from the third to 14th year since diagnosis. METHODS: This retrospective cross-sectional study was focused on women aged 50 and older. A self-reported questionnaire including EQ-5D-5L was sent to 11,500 women. Multivariable median regression was used to analyze the association between quality of life score (visual analogue scale 0-100) and detection mode. Health utility values representing women's health status were extracted from EQ-5D-5L. QALYs were estimated by summing up the health utility values for women stratified by detection mode for each year between the third and the 14th year since breast cancer diagnosis, assuming that all women would survive. RESULTS: Adjusted regression analyses showed that women with screen-detected (n = 1206), interval cancer (n = 1005) and those without breast cancer (n = 1255) reported a higher median quality of life score using women with symptomatic cancer (n = 1021) as reference; 3.7 (95%CI 2.2-5.2), 2.3 (95%CI 0.7-3.8) and 4.8 (95%CI 3.3-6.4), respectively. Women with symptomatic, screen-detected and interval cancer would experience 9.5, 9.6 and 9.5 QALYs, respectively, between the third and the 14th year since diagnosis. CONCLUSION: Women with screen-detected or interval breast cancer reported better quality of life compared to women with symptomatic cancer. The findings add benefits of organized mammographic screening.