Coeliac disease in the Trøndelag Health Study (HUNT), Norway, a population-based cohort of coeliac disease patients.

PURPOSE: Coeliac disease (CD) is a common disorder and affects about 1% of the population worldwide. CD in the Trøndelag Health Study (HUNT) is a population-based cohort study which was established to provide new knowledge about CD that can improve the diagnostics and management, prevent the onset or progression and expand the knowledge about the role of genetics of the disease. PARTICIPANTS: The cohort is based on the fourth wave of the population-based HUNT study (HUNT4), Norway, performed during 2017-2019, also including linkage to hospital records and the Norwegian Patient Registry (NPR). A total of 54 541 HUNT4 participants with available sera were screened for CD by serology. All seropositive participants were invited to a clinical assessment, including endoscopy with duodenal biopsies, during 2019-2023. FINDINGS TO DATE: A total of 1107 HUNT4 participants (2%) were seropositive for CD and 1048 were eligible for clinical assessment, including biopsy. Of these, 724 participants attended the clinical assessment and 482 were identified with CD. In addition, 371 participants with CD were identified through the hospital records and NPR. In total, 853 participants in HUNT4 with biopsy-verified CD diagnosis were identified. FUTURE PLANS: All participants in the study will be invited to a follow-up assessment after at least 1 year, including repeated standard serological testing, endoscopy and tissue sampling. The collected data and material will be used to establish the true population-based prevalence of CD. The consequences of CD, including symptoms, deficiencies and comorbidity, will be investigated and possible triggers and predictors, will be studied. With access to serum samples from the previous HUNT surveys in HUNT Biobank, serological signs of CD in prediagnostic samples of seropositive individuals will be used. Genetic studies will identify new CD markers, assess genotype-phenotype links and explore gene-environment correlations. REGISTRATION: clinicaltrials.gov identifier: NCT04041622.

Risk of Cancer in Patients With Crohn's Disease 30 Years After Diagnosis (the IBSEN Study).

Background: Patients with Crohn's disease (CD) are most often diagnosed as young adults; therefore, long-term studies are needed to assess the risk of cancer over their lifetime. Thus, the aims of the present study were to determine the risk of cancer in a Norwegian population-based cohort (the Inflammatory Bowel South Eastern Norway [IBSEN] study), 30 years after diagnosis, and to assess whether patients with CD were at an increased risk of specific cancer types. Methods: The IBSEN cohort prospectively included all incident patients diagnosed between 1990 and 1993. Data on cancer incidence were obtained from the Cancer Registry of Norway. Overall and cancer-specific hazard ratios (HRs) for CD patients compared with age- and sex-matched controls were modeled using Cox regression. Standardized incidence ratios (SIRs) were estimated compared to the general population. Results: In total, the cohort included 237 patients with CD, and 36 of them were diagnosed with cancer. Compared to the general Norwegian population, patients with CD had an increased overall risk of cancer (HR = 1.56, 95% CI: 1.06-2.28), particularly male patients (HR = 1.85, 95% CI: 1.08-3.16). The incidence of lung cancer and nonmelanoma skin cancer was increased; however, the difference was not statistically significant (SIR = 2.29, 95% CI: 0.92-4.27 and SIR = 2.45, 95% CI: 0.67-5.37, respectively). Conclusions: After 30 years of follow-up, the risk of all cancers in patients with CD was increased compared to the general population.

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.

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.

Fatigue in Patients with Newly Diagnosed Inflammatory Bowel Disease: Results from a Prospective Inception Cohort, the IBSEN III Study.

BACKGROUND AND AIMS: Although fatigue is common in inflammatory bowel disease [IBD], its pathogenesis remains unclear. This study aimed to determine the prevalence of fatigue and its associated factors in a cohort of patients newly diagnosed with IBD. METHODS: Patients ≥18 years old were recruited from the Inflammatory Bowel Disease South-Eastern Norway [IBSEN III] study, a population-based, observational inception cohort. Fatigue was assessed using the Fatigue Questionnaire and compared with data from a Norwegian general population. Univariate and multivariate linear and logistic regression analyses were performed to evaluate the associations of total fatigue [TF; continuous score] and substantial fatigue [SF; dichotomized score ≥4] with sociodemographic, clinical, endoscopic, laboratory, and other relevant patient data. RESULTS: In total, 983/1509 [65.1%] patients with complete fatigue data were included (ulcerative colitis [UC], 68.2%; Crohn's disease [CD], 31.8%). The prevalence of SF was higher in CD [69.6%] compared with UC [60.2%] [p < 0.01], and in both diagnoses when compared to the general population [p < 0.001]. In multivariate analyses, depressive symptoms, pain intensity, and sleep disturbances were associated with increased TF for both diagnoses. In addition, increased clinical disease activity and Mayo endoscopic score were significantly associated with TF in UC, whereas all disease-related variables were insignificant in CD. Similar findings were observed for SF, except regarding the Mayo endoscopic score. CONCLUSIONS: SF affects approximately two-thirds of patients newly diagnosed with IBD. Fatigue was associated with depressive symptoms, sleep disturbances, and increased pain intensity in both diagnoses, while clinical and endoscopic activity were associated factors only in UC.

Health-related quality of life in patients with newly diagnosed inflammatory bowel disease: an observational prospective cohort study (IBSEN III).

PURPOSE: This unselected, population-based cohort study aimed to determine the level of health-related quality of life (HRQoL) in patients with Crohn's disease (CD) and ulcerative colitis (UC) at the time of diagnosis compared with a reference population and identify the demographic factors, psychosocial measures, and disease activity markers associated with HRQoL. METHODS: Adult patients newly diagnosed with CD or UC were prospectively enrolled. HRQoL was measured using the Short Form 36 (SF-36) and Norwegian Inflammatory Bowel Disease Questionnaires. Clinical significance was assessed using Cohen's d effect size and further compared with a Norwegian reference population. Associations between HRQoL and symptom scores, demographic factors, psychosocial measures, and disease activity markers were analyzed. RESULTS: Compared with the Norwegian reference population, patients with CD and UC reported significantly lower scores in all SF-36 dimensions, except for physical functioning. Cohen's d effect sizes for men and women in all SF-36 dimensions were at least moderate, except for bodily pain and emotional role for men with UC and physical functioning for both sexes and diagnoses. In the multivariate regression analysis, depression subscale scores ≥ 8 on the Hospital Anxiety and Depression Scale, substantial fatigue, and high symptom scores were associated with reduced HRQoL. CONCLUSION: Patients newly diagnosed with CD and UC reported statistically and clinically significantly lower scores in seven of the eight SF-36 dimensions than the reference population. Symptoms of depression, fatigue, and elevated symptom scores were associated with poorer HRQoL.

Associations between unit workloads and outcomes of first extubation attempts in extremely premature infants below a gestational age of 26 weeks.

Objective: The objective was to explore whether high workloads in neonatal intensive care units were associated with short-term respiratory outcomes of extremely premature (EP) infants born <26 weeks of gestational age. Methods: This was a population-based study using data from the Norwegian Neonatal Network supplemented by data extracted from the medical records of EP infants <26 weeks GA born from 2013 to 2018. To describe the unit workloads, measurements of daily patient volume and unit acuity at each NICU were used. The effect of weekend and summer holiday was also explored. Results: We analyzed 316 first planned extubation attempts. There were no associations between unit workloads and the duration of mechanical ventilation until each infant's first extubation or the outcomes of these attempts. Additionally, there were no weekend or summer holiday effects on the outcomes explored. Workloads did not affect the causes of reintubation for infants who failed their first extubation attempt. Conclusion: Our finding that there was no association between the organizational factors explored and short-term respiratory outcomes can be interpreted as indicating resilience in Norwegian neonatal intensive care units.

The Role of Procalcitonin as an Antimicrobial Stewardship Tool in Patients Hospitalized with Seasonal Influenza.

BACKGROUND: Up to 60% of the antibiotics prescribed to patients hospitalized with seasonal influenza are unnecessary. Procalcitonin (PCT) has the potential as an antimicrobial stewardship program (ASP) tool because it can differentiate between viral and bacterial etiology. We aimed to explore the role of PCT as an ASP tool in hospitalized seasonal influenza patients. METHODS: We prospectively included 116 adults with seasonal influenza from two influenza seasons, 2018-2020. All data was obtained from a single clinical setting and analyzed by descriptive statistics and regression models. RESULTS: In regression analyses, we found a positive association of PCT with 30 days mortality and the amount of antibiotics used. Influenza diagnosis was associated with less antibiotic use if the PCT value was low. Patients with a low initial PCT (<0.25 µg/L) had fewer hospital and intensive care unit (ICU) days and fewer positive chest X-rays. PCT had a negative predictive value of 94% for ICU care stay, 98% for 30 days mortality, and 88% for bacterial coinfection. CONCLUSION: PCT can be a safe rule-out test for bacterial coinfection. Routine PCT use in seasonal influenza patients with an uncertain clinical picture, and rapid influenza PCR testing, may be efficient as ASP tools.

Mortality in Patients with Inflammatory Bowel Disease: Results from 30 Years of Follow-up in a Norwegian Inception Cohort (the IBSEN study).

BACKGROUND AND AIMS: Patients with longstanding inflammatory bowel disease [IBD] may be at an increased risk of death compared to the general population, especially elderly patients. The Inflammatory Bowel South-Eastern Norway [IBSEN] study has previously detected a small but not statistically significant increase in mortality 20 years after diagnosis. The aim of this study was to evaluate the overall and cause-specific mortality at 30 years of follow-up. METHODS: The IBSEN cohort included 519 incident patients with ulcerative colitis [UC] and 237 patients with Crohn's disease [CD] between 1990 and 1993, each matched with five controls. Death certificate data were obtained from the Norwegian Cause of Death Registry. The underlying causes of death were categorized into five groups: all cancers, gastrointestinal cancers, cardiovascular diseases, infections and all other causes. Hazard ratios [HRs] were modelled using Cox regression. RESULTS: There was no statistically significant difference in the overall mortality rates. However, in patients with CD, male sex (HR = 1.65 [95% CI: 1.04-2.62]), onset after 40 years of age (HR = 1.72 [1.19-2.48]), colonic disease (HR = 1.57 [1.05-2.35]) and penetrating behaviour (HR = 3.3 [1.41-7.76]) were clinical factors associated with an increased mortality. IBD patients were at a higher risk of death due to cardiovascular disease: HR = 1.51 [1.10-2.08] for UC and 2.04 [1.11-3.77] for CD. When taking into account both the underlying and the immediate cause of death, infection was more frequent in patients with IBD. CONCLUSIONS: Overall, all-cause mortality rates were similar between patients with IBD and controls. However, clinicians should remain alert to cardiovascular diseases and infections, particularly in specific subgroups of CD patients.

Health-related quality of life in inflammatory bowel disease: a comparison of patients receiving nurse-led versus conventional follow-up care.

BACKGROUND: Inflammatory bowel disease (IBD), consisting of Crohn's disease (CD) and ulcerative colitis (UC), is a chronic disorder with a considerable negative impact on health-related quality of life (HRQoL). During the past decade, IBD nurse specialists have been increasingly involved in follow-up care of IBD outpatients, in a consultative and coordinating role, closely cooperating with gastroenterologists. Whether patients' HRQoL differs between nurses' follow-up care (NF) and conventional follow-up care (CF) has not been widely researched and the aim of this study was to compare two different follow-up regimes with respect to patients' HRQoL. METHODS: This cross-sectional, multicenter study involved seven centers; five organized as CF, two as NF. RESULTS: A total of 304 patients aged 18-80 years, 174 females and 130 males, were included, of whom 140 received care under the NF model and 164 under the CF model. Participants in the NF group had a statistically significant higher median total score on the Inflammatory Bowel Disease Questionnaire (IBDQ) (p-value < .001). This pattern could also be seen in the sub-scores of the different IBDQ domains. Despite a trend of higher IBDQ score in all domains in the NF model, the overall result in our study did not reach the limit of 16 points, defined as clinically significant. A higher proportion of NF patients had IBDQ scores defined as remission, as well as a statistically significant higher frequency of outpatient check-ups during a two-year follow-up period. CONCLUSIONS: Nurse-led models are not inferior to conventional models with regards to patient reported HRQoL except in the social domain where the model showed to be clinically significant better. Further studies are needed to advance efforts to implement these models and increase access to IBD care.

Predictors of extubation success: a population-based study of neonates below a gestational age of 26 weeks.

OBJECTIVE: The aim of the study was to investigate first extubation attempts among extremely premature (EP) infants and to explore factors that may increase the quality of clinical judgement of extubation readiness. DESIGN AND METHOD: A population-based study was conducted to explore first extubation attempts for EP infants born before a gestational age (GA) of 26 weeks in Norway between 1 January 2013 and 31 December 2018. Eligible infants were identified via the Norwegian Neonatal Network database. The primary outcome was successful extubation, defined as no reintubation within 72 hours after extubation. RESULTS: Among 482 eligible infants, 316 first extubation attempts were identified. Overall, 173 (55%) infants were successfully extubated, whereas the first attempt failed in 143 (45%) infants. A total of 261 (83%) infants were extubated from conventional ventilation (CV), and 55 (17%) infants were extubated from high-frequency oscillatory ventilation (HFOV). In extubation from CV, pre-extubation fraction of inspired oxygen (FiO2) ≤0.35, higher Apgar score, higher GA, female sex and higher postnatal age were important predictors of successful extubation. In extubation from HFOV, a pre-extubation FiO2 level ≤0.35 was a relevant predictor of successful extubation. CONCLUSIONS: The correct timing of extubation in EP infants is important. In this national cohort, 55% of the first extubation attempts were successful. Our results suggest that additional emphasis on oxygen requirement, sex and general condition at birth may further increase extubation success when clinicians are about to extubate EP infants for the first time.

Antitumour necrosis factor alpha treatment in Crohn's disease: long-term efficacy, side effects and need for surgery.

OBJECTIVES: To examine the long-term efficacy and side effects of antitumour necrosis factor alpha (anti-TNF) therapy in patients with Crohn's disease (CD), the need for surgery and the clinical outcome after discontinuing anti-TNF therapy. MATERIAL AND METHODS: Data were collected from the inflammatory bowel disease (IBD)-TNF register at Østfold Hospital Trust. Clinical and sociodemographic data were recorded for patients initiating anti-TNF therapy from January 2000 until December 2011. Follow-up was conducted until December 2017. RESULTS: Complete remission (CR) was achieved in 40/154 (26%) patients at the last follow-up (median follow-up time 10 years). A total of 40 (26%) patients had to discontinue treatment due to serious side effects, and malignancy was recorded in 10 (6.5%) patients. Surgical resection was performed in 55 (36%) patients during follow-up. Patients with Montreal phenotype B2 before anti-TNF therapy were estimated to have a 2.54-fold greater risk of surgery than patients with phenotype B1 (p = .001). Of those with phenotype B1 before anti-TNF therapy, 19 (24%) of them developed stenosis in need of surgical resection ('phenotype migration'). In patients followed up after discontinuing anti-TNF therapy (n = 89, median observational time six years), CR was achieved in most patients. CONCLUSIONS: Long-term complete remission was achieved in only one in four patients receiving anti-TNF therapy, and one in four patients had to discontinue therapy due to side effects. Despite anti-TNF therapy, one in four patients with a baseline luminal disease phenotype needed subsequent surgical resection.

Integrating simulation training during clinical practice in nursing homes: an experimental study of nursing students' knowledge acquisition, self-efficacy and learning needs.

BACKGROUND: Limited access to supervision, feedback and quality learning experiences pose challenges to learning in the clinical setting for first-year nursing students who are beginning their clinical experiences. Prior studies have indicated that simulation training, as a partial replacement of clinical practice hours, may improve learning. However, there has been little research on simulation training integrated as a partial replacement during first-year students' clinical practice in nursing homes. The primary aim of this study was to examine first-year nursing students' knowledge acquisition and self-efficacy in integrating a partial replacement of clinical hours in nursing homes with simulation training. Its secondary aim was to examine perceptions of how learning needs were met in the simulated environment compared with the clinical environment. DESIGN: The primary aim was addressed using an experimental design that included pre- and post-tests. The secondary aim was investigated using a descriptive survey-based comparison. METHODS: First-year students at a Norwegian university college (n = 116) were asked to participate. Those who agreed (n = 103) were randomly assigned to the intervention group (n = 52) or the control group (n = 51). A knowledge test, the General Self-efficacy Scale and the Clinical Learning Environment Comparison Survey were used to measure students' outcomes and perceptions. The data were analysed using independent samples t-tests, chi-square tests and paired samples t-tests. RESULTS: Knowledge scores from pre- to post-tests were significantly higher in the intervention group than in the control group with a medium to large effect size (p < 0.01, Hedges' g = 0.6). No significant differences in self-efficacy were identified. Significant differences (p <  0.05) were observed between the simulated and the clinical environment with regard to meeting learning needs; effect sizes ranged from small and medium to large (Cohen's d from 0.3 to 1.0). CONCLUSION: Integrating the partial replacement of clinical hours in nursing homes with simulation training for first-year nursing students was positively associated with knowledge acquisition and meeting learning needs. These findings are promising with regard to simulation as a viable partial replacement for traditional clinical practice in nursing homes to improve learning.

Factors Affecting Antibiotic Prescription among Hospital Physicians in a Low-Antimicrobial-Resistance Country: A Qualitative Study.

Antimicrobial resistance (AMR) is a threat to hospital patients. Antimicrobial stewardship programs (ASPs) can counteract AMR. To optimize ASPs, we need to understand what affects physicians' antibiotic prescription from several contexts. In this study, we aimed to explore the factors affecting hospital physicians' antibiotic choices in a low-resistance country to identify potential targets for future ASPs. We interviewed 14 physicians involved in antibiotic prescription in a Norwegian hospital. The interviews were audiotaped, transcribed verbatim, and analyzed using thematic analysis. The main factors affecting antibiotic prescription were a high work pressure, insufficient staff resources, and uncertainties regarding clinical decisions. Treatment expectations from patients and next of kin, benevolence towards the patients, suboptimal microbiological testing, and limited time for infectious disease specialists to offer advisory services also affected the antibiotic choices. Future ASP efforts should evaluate the system organization and prioritizations to address and manage potential time-pressure issues. To limit the use of broad-spectrum antibiotics, improving microbiology testing and the routines for consultations with infectious disease specialists seems beneficial. We also identified a need among the prescribing physicians for a debate on ethical antibiotic questions.

The multidimensional fatigue inventory (MFI-20): psychometrical testing in a Norwegian sample of inflammatory bowel disease (IBD) patients.

OBJECTIVES: To evaluate the psychometric properties of the Norwegian version of the multidimensional fatigue inventory (MFI-20) in patients with inflammatory bowel disease. METHODS: Participants were recruited from nine hospitals in the southeastern and western parts of Norway. Clinical and sociodemographic data were collected, and participants completed the MFI-20, as well as the Fatigue Questionnaire (FQ). In addition to a confirmatory factor analysis, validity, reliability, test-retest and responsiveness were evaluated. RESULTS: In total, 410 patients were included. The Norwegian MFI-20 had an acceptable model fit when compared to the original five-dimensional structure. A positive correlation was observed between the dimensions of MFI-20 and the FQ. MFI-20 scores increased according to subjective disease activity, but no differences were observed when using a calprotectin cut-off < or > =250 µg/g mg/kg. All MFI-20 dimensions except 'reduced motivation' in both ulcerative colitis (UC) and Crohn's disease (CD) patients had alpha Cronbach alpha values ≥70, and test-retest reliability revealed good to excellent values. Merely one dimension (Reduced activity) in UC patients reporting improvement did not reach the threshold for acceptable responsiveness according to Guyatt statistics. CONCLUSIONS: The Norwegian version of MFI-20 is valid, reliable and responsive. The instrument can safely be used in studies using fatigue as an endpoint.

Cross-cultural adaptation and validation of the Norwegian version of the Leicester Cough Questionnaire in chronic obstructive pulmonary disease.

BACKGROUND: Cough is a common symptom among patients with chronic obstructive pulmonary disease (COPD), but there are currently no patient-reported outcome measures (PROM) for subjective cough symptoms in Norwegian. OBJECTIVE: The objective was to translate and validated the most widely used PROM for chronic cough, the Leicester Cough Questionnaire (LCQ) from English to Norwegian (NLCQ) using established guidelines. METHODS: Forward and backward translations were performed using external translators. All phases were discussed in an expert workgroup until consensus was achieved. Ten patients were interviewed about the pre-final version to assess understandability and ease to complete. The final NLCQ was externally proofread and tested for content and construct validity, internal consistency, test-retest reliability and measurement error. RESULTS: Mean (SD) age was 67 (7.9) years, and 62% of the sample were female (n = 56/89). According to GOLD stages, 10% had mild, 27% moderate, 35% severe and 22% very severe COPD, respectively. GOLD stages were missing for five patients (6%). The NLCQ showed acceptable accordance with the original, acceptable understandability and ease to complete, satisfactory content reliability, total score construct validity, internal consistency and test-retest reliability. Test-retest bias was low, but measurement error was larger than previously reported. The standard error of measurement and smallest detectable change were 1.56 and 4.32, respectively. Construct validity and factor analysis raised concerns regarding the three subdomains. CONCLUSION: The present cross-cultural adaptation of the NLCQ showed satisfactory reliability and overall validity. Due to concerns for the validity of the three domains, we suggest use should be restricted to the NLCQ total score until these are reassessed.

Health-related quality-of-life questionnaires for deep vein thrombosis and pulmonary embolism: A systematic review on questionnaire development and methodology.

To improve the quality and accuracy of the patient-reported outcome measures that assess health-related quality of life (HRQoL), guidelines have been developed to standardize the development and validation process. Considering the increasing importance of HRQoL questionnaires in research, we set out to review the literature and evaluate whether existing questionnaires developed for deep vein thrombosis (DVT) and pulmonary embolism (PE) fulfill state-of-the-art requirements. The literature search was conducted in March 2019 and updated in September 2020. Seven databases were searched. No time limit was set for the search to include all available questionnaires. The inclusion criteria were original publications describing the development of disease-specific HRQoL questionnaires specific to DVT or PE in adults and available in English. The questionnaires were assessed to determine whether they fulfill the requirements in the latest guidelines. A total of 3826 references were identified. After the exclusion process, 15 papers were reviewed in full, of which 7 were included. Four questionnaires were developed for chronic venous disease, two were specific to DVT, and one was specific to PE. Most questionnaires we found in this review, fulfilled some but none fulfilled all recommendations in existing guidelines. Because the development of current available HRQoL questionnaires specific to DVT or PE do not fulfil all recommendations of existing guidelines, there is room for improvements within this field. Such improvements could likely enhance the quality associated with the use of these end points in clinical trials and practice.

Psychometric properties of the Norwegian version of the clinical learning environment comparison survey.

AIM: To translate The Clinical Learning Environment Comparison Survey (CLECS) into Norwegian and to evaluate the psychometric properties of the Norwegian version. DESIGN: A cross-sectional survey including a longitudinal component. METHODS: The CLECS was translated into Norwegian following the World Health Organization guidelines, including forward translation, expert panel, back-translation, pre-testing and cognitive interviewing. Nursing students at a Norwegian university college were invited to participate in the study (psychometrical testing) based on informed consent. Reliability and validity of the translated version of CLECS were investigated using a confirmatory factor analysis (CFA), Cronbach's alpha and test-retest analysis. RESULTS: A total of 122 nursing students completed the questionnaire and Cronbach alphas for the CLECS subscales ranged from 0.69 to 0.89. CFA goodness-of-fit indices (χ2 /df = 1.409, CFI = 0.915, RMSEA = 0.058) showed acceptable model fit. Test-retest ICC ranged from 0.55 to 0.75, except for two subscales with values below 0.5.

Hospital physicians' experiences with procalcitonin - implications for antimicrobial stewardship; a qualitative study.

BACKGROUND: Procalcitonin is an inflammatory biomarker that is sensitive for bacterial infections and a promising clinical decision aid in antimicrobial stewardship programs. However, there are few studies of physicians' experiences concerning the use of PCT. The objective of this study was to investigate whether hospital physicians' experience with procalcitonin after 18 months of use can inform the PCT implementation in antimicrobial stewardship programs. MATERIALS/METHODS: We deployed a qualitative approach using semi-structured interviews with 14 hospital physicians who had experience with procalcitonin in clinical practice. Interviews were audio-taped, transcribed verbatim and analysed using thematic analysis. RESULTS: Physicians reported a knowledge gap, which made them uncertain about the appropriate procalcitonin use, interpretation, and trustworthiness. Simultaneously, the physicians experienced procalcitonin as a useful clinical decision aid but emphasised that their clinical evaluation of the patient was the most important factor when deciding on antibiotic treatment. CONCLUSIONS: Procalcitonin was regarded a helpful clinical tool, but the physicians called for more knowledge about its appropriate uses. Active implementation of unambiguous procalcitonin algorithms and physician education may enhance the utility of the test as an antimicrobial stewardship adjunct.