Evolution and risk factors of anal incontinence during the first 6 years after first delivery: a prospective cohort study

Complicated vaginal delivery, age and bowel emptying problems increase the risk of long-term anal incontinence.publishedVersio

Nurse-led ultrasound-guided femoral nerve block: A randomised controlled trial of two different patient flow systems in an emergency department

Introduction: Elderly with hip fractures present complex challenges. Effective pain management is crucial for recovery and quality of life. However, pain control can be difficult and requires customized care. Methods: We conducted an unblinded, randomised controlled trial investigating the effects of ultrasound-guided femoral nerve block in patients with hip fracture performed by specially trained nurses (Group Nurse) compared to anaesthesiologists (Group Anaesthesiologist). The hypothesis was that a single shot ultrasound-guided femoral nerve block would result in a total summarized lower dynamic numeric rating scale score for pain intensity during the first 120 min after admission for patients in Group Nurse compared to Group Anaesthesiologist measured in five timepoints. The primary outcome was measured by a cumulative numeric rating scale score for dynamic pain (with flexion of the hip until maximum 30◦ from bed surface) during the first 120 min after admission to the emergency department. Results: From February 2020 to June 2021, 263 patients were screened, of which 42 (16.0%) consented and were randomly allocated; 21 in each arm. The primary outcome was not different between groups (p = 0.24), and displayed no substantial superiority of specially trained nurses over anaesthesiologist. No complications or adverse effects were observed in either group. The use of systemic analgesics and the development of delirium was similar between the two groups. In the Nurse Group, patients were administered their ultrasound-guided femoral nerve block earlier. Conclusion: Our study did not demonstrate a statistically significant beneficial effect of specially trained nurses over anaesthesiologist on cumulative pain in performing ultrasound-guided femoral nerve blocks, while no side- effects/complications or adverse effects were observed in either group.publishedVersio

Changes in Health Literacy during the first year following a kidney transplantation: Using the Health Literacy Questionnaire

Objectives The study aimed to identify changes in health literacy (HL) and associated variables during the first year following a kidney transplantation. Methods A total of 196 transplant recipients were included in a prospective follow-up study. The patients answered the Health Literacy Questionnaire (HLQ) at 5 days, 8 weeks, 6 and 12 months following the kidney transplantation. Mixed linear models were used to analyze changes in HL and backward elimination was used to identify variables associated with HL. Results Two main patterns of change were identified: a) HL increased during the first 8 weeks of close follow-up and b) in several domains, the positive increase from 5 days to 8 weeks flattened out from 5 days to 6 and 12 months. Self-efficacy, transplant-related knowledge, and general health were core variables associated with HL. Conclusions Overall, HL increased during the 8 weeks of close follow-up following the kidney transplantation, while 6 months seem to be a more vulnerable phase. Furthermore, low self-efficacy, less knowledge, and low self-perceived health may represent vulnerable characteristics in patients. Practical implications Future kidney transplant care should take into account patients’ access to and appraisal of health information and social support, and draw attention to potentially vulnerable groups.publishedVersio

Differences in rates and odds for emergency caesarean section in six Palestinian hospitals: A population-based birth cohort study

Objective To assess the differences in rates and odds for emergency caesarean section among singleton pregnancies in six governmental Palestinian hospitals. Design A prospective population-based birth cohort study. Setting Obstetric departments in six governmental Palestinian hospitals. Participants 32 321 women scheduled to deliver vaginally from 1 March 2015 until 29 February 2016. Methods To assess differences in sociodemographic and antenatal obstetric characteristics by hospital, χ2 test, analysis of variance and Kruskal-Wallis test were applied. Logistic regression was used to estimate differences in odds for emergency caesarean section, and ORs with 95% CIs were assessed. Main outcome measures The primary outcome was the adjusted ORs of emergency caesarean section among singleton pregnancies for five Palestinian hospitals as compared with the reference (Hospital 1). Results The prevalence of emergency caesarean section varied across hospitals, ranging from 5.8% to 22.6% among primiparous women and between 4.8% and 13.1% among parous women. Compared with the reference hospital, the ORs for emergency caesarean section were increased in all other hospitals, crude ORs ranging from 1.95 (95% CI 1.42 to 2.67) to 4.75 (95% CI 3.49 to 6.46) among primiparous women. For parous women, these differences were less pronounced, crude ORs ranging from 1.37 (95% CI 1.13 to 1.67) to 2.99 (95% CI 2.44 to 3.65). After adjustment for potential confounders, the ORs were reduced but still statistically significant, except for one hospital among parous women. Conclusion Substantial differences in odds for emergency caesarean section between the six Palestinian governmental hospitals were observed. These could not be explained by the studied sociodemographic or antenatal obstetric characteristics.publishedVersio

Exploring low grade inflammation by soluble urokinase plasminogen activator receptor levels in schizophrenia: a sex-dependent association with depressive symptoms

Background - There is evidence of increased low grade inflammation (LGI) in schizophrenia patients. However, the inter-individual variation is large and the association with demographic, somatic and psychiatric factors remains unclear. Our aim was to explore whether levels of the novel LGI marker soluble urokinase plasminogen activator receptor (suPAR) were associated with clinical factors in schizophrenia and if such associations were sex-dependent. Method - In this observational study a total of 187 participants with schizophrenia (108 males, 79 females) underwent physical examination and assessment with clinical interviews (Positive and Negative Syndrome Scale (PANSS), Calgary Depression Scale for Schizophrenia (CDSS), Alcohol Use Disorder Identification Test (AUDIT), and Drug Use Disorder Identification Test (DUDIT)). Blood levels of suPAR, glucose, lipids, and high sensitivity C-reactive protein (hsCRP) were determined and body mass index (BMI) calculated. Multivariable linear regression analyses were used adjusting for confounders, and sex interaction tested in significant variables. Results - Adjusting for sex, age, current tobacco smoking and BMI, we found that levels of hsCRP and depressive symptoms (CDSS) were positively associated with levels of suPAR (p  Conclusion - Our findings indicate that increased suPAR levels are associated with depressive symptoms in females with schizophrenia, suggesting aberrant immune activation in this subgroup. Our results warrant further studies, including longitudinal follow-up of suPAR levels in schizophrenia and experimental studies of mechanisms

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 recent publications of single-arm studies of cancer treatment involving PRO data for current practice on design, analysis, reporting, and interpretation. We further examined their handling of potential bias and how they informed decision-making. Most studies (97%) analyzed PROs without stating a predefined research hypothesis. Thirteen studies (22%) used a PRO as a (co)primary endpoint. Definitions of PRO objectives, study population, endpoints, and strategies of handling missing data varied widely. Twenty-three studies (38%) compared the PRO data to external information, most often by using a clinically important difference value; one study used a historical control group. Appropriateness of methods to handle missingness and intercurrent events including death were seldom discussed. Most studies (85%) concluded that PRO results supported treatment. Conducting and reporting of PROs in cancer single-arm studies lacks 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

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.publishedVersio

Health-related quality of life issues, including symptoms, in patients with active COVID-19 or post COVID-19; a systematic literature review

Purpose This systematic review was performed to identify all relevant health-related quality of life (HRQoL) issues associated with COVID-19. Methods A systematic literature search was undertaken in April 2020. In four teams of three reviewers each, all abstracts were independently reviewed for inclusion by two reviewers. Using a pre-defined checklist of 93 criteria for each publication, data extraction was performed independently by two reviewers and subsequently compared and discussed. If necessary, a third reviewer resolved any discrepancies. The search was updated in February 2021 to retrieve new publications on HRQoL issues including issues related to the long-term consequences of COVID-19. Results The search in April 2020 identified 3342 potentially relevant publications, and 339 publications were selected for full-text review and data extraction. We identified 75 distinct symptoms and other HRQoL issues categorized into 12 thematic areas; from general symptoms such as fever, myalgia, and fatigue, to neurological and psychological issues. The updated search revealed three extra issues experienced during active disease and long-term problems with fatigue, psychological issues and impaired cognitive function. Conclusion This first comprehensive systematic review provides a detailed overview of the wide range of HRQoL issues experienced by patients with COVID-19 throughout the course of the disease. It demonstrates the devastating impact of the disease and provides critically important information for clinicians, to enable them to better recognize the disease and to provide knowledge important for treatment and follow-up. The results provided the foundation for the international development of a COVID-19 specific patient-reported HRQoL questionnaire