Hospitals In Denmark Research Articles

Effect of single versus multiple prophylactic antibiotic doses on prosthetic joint infections following primary total hip arthroplasty in patients with osteoarthritis at public and private hospitals in Denmark: protocol for a nationwide cross-over, cluster randomised, non-inferiority trial [The Pro-Hip-Quality Trial]

IntroductionA feared complication after total hip arthroplasty (THA) is prosthetic joint infection (PJI), associated with high morbidity and mortality. Prophylactic antibiotics can reduce the risk of PJI. However, there is...

Perioperative optimization and profitability (POP) in a high-volume bariatric surgery center.

Currently, bariatric surgery is the most effective long-term treatment of obesity. Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the primary types of bariatric surgery performed worldwide. To minimize the risks of surgical complications and optimize cost-effectiveness, it is essential to develop fast-track protocols and patient logistics. At Aleris Hospitals in Denmark, a fast-track methodology in bariatric surgery has been implemented and continuously optimized over the last 15years. The main objective was to demonstrate timelines recorded during one consecutive year in a fast-track, high-volume bariatric surgery setting after logistic optimization. This study included 949 consecutive patients who had undergone primary bariatric surgery in 2021. The primary outcomes were length of hospital stay and perioperative timeline recordings that were prospectively collected. The secondary outcomes were mortality, complication rates, and weight loss data. The vast majority of our patients (99.1%) were discharged from the hospital within the day after surgery. The median total surgery time was 30min, after 12min of patient preparation and with a turnover time between patients of seven min. The median knife-to-knife time in one operating room was 56min. Mortality was zero, 30-day reoperation rate was 1.2%, and 30-day readmission rate was 0.8%. SG and RYGB patients had an excess weight loss after four months of 45.6% and 57.9%, respectively. Implementation of fast-track principles in the clinical practice of bariatric surgery allows for an optimized, cost-effective surgical organization supporting the quality of procedures and patient safety.

Prevalence and risk factors for hand eczema among professional hospital cleaners in Denmark: A cross-sectional questionnaire-based study.

Professional cleaners are commonly affected by hand eczema (HE) due to wet work and exposure to cleaning products in the work environment. To investigate (1) the prevalence of HE in a group of professional hospital cleaners, (2) the association of HE with various comorbidities and self-reported signs/symptoms of skin lesions and (3) the association of HE with various occupational and personal risk factors in the same population. A cross-sectional questionnaire-based study including all cleaners working in three hospitals in Denmark. The questionnaire was composed of 35 questions. Prevalence is reported using proportions with 95% confidence intervals and compared using difference of proportions and Fisher's exact test. A total of 122 out of 180 cleaners (response rate = 68%) participated in this study. The self-reported lifetime prevalence of HE among the cleaners was 30.3%, while the 1-year prevalence was 18.9%. HE was significantly associated with a history of atopic diseases. There was a significant correlation between having HE, and self-reported redness and itch of the hands in the last 12 months, as well as the use of hydrochloric acid ≥4 days/week during the last 12 months. Logistic regression analysis found HE significantly associated with washing hands ≥20 times during a working day and a history of atopic dermatitis. Cleaners are at an elevated risk of developing HE. More focus on education/information regarding the prevention and treatment of HE is necessary for the cleaning profession. Self-reported redness and itching of the hands may be a useful prediction of HE in cleaners.

Prospective Observational Study Evaluating Systemic Hormones and Corneal Crosslinking Effects in Keratoconus

To evaluate associations between hormone levels and corneal parameters in patients with keratoconus (KC), before and after photooxidative corneal collagen crosslinking (CXL). Prospective, observational cohort study. Twenty-eight patients with KC who were scheduled for CXL at Aarhus University Hospital in Denmark. Androgen (dehydroepiandrosterone sulfate [DHEA-S]) and estrogen (estrone and estriol) plasma levels were measured and clinical assessments were performed before CXL and 2 to 3 months post-CXL, comparing the CXL eye with the control eye from the same participant. Associations between hormone levels and maximum corneal curvature (Kmax) and minimum central corneal thickness (CCtmin) before and after CXL. Corneal collagen crosslinking was associated with a 2% reduction in Kmax values in the CXL eye, post-CXL, from baseline (median, 56.8 diopters [D]; 95% confidence interval [CI], 50.4-60.3) to the second visit (55.7 D; 95% CI, 50.4-58.8; P < 0.001). Systemic DHEA-S levels were 5 to 6 orders of magnitude higher than estriol or estrone concentrations in plasma. Importantly, estriol levels, rather than DHEA-S or estrone levels, were more closely correlated with Kmax before CXL (Spearman's r= 0.55, P= 0.01). Post-CXL Kmax and CCtmin were not associated with DHEA-S, estrone, or estriol plasma levels at the same timepoint. This study provides supporting evidence based on a KC clinical population that systemic estrogen levels may influence corneal parameters (curvature and thickness) pre-CXL. Further studies evaluating the interplay between the therapeutic benefits of CXL and systemic hormone distributions are needed to determine if perturbation of the local corneal microenvironment influences endocrine function. The authors have no proprietary or commercial interest in any materials discussed in this article.

Uneven Between-Hospital Distribution of Patient-Related Risk Factors for Adverse Outcomes of Colorectal Cancer Treatment: A Population-Based Register Study.

The purpose of this study was to elucidate between-hospital variation in the prevalence at the time of diagnosis of patient-related risk factors for adverse outcomes of colorectal cancer (CRC) treatment. A register-based national cohort of 44,471 patients diagnosed with CRC and registered in the Danish Colorectal Cancer Group database in 2009-2018 was included in the study. Patient-related risk factors present at diagnosis were collected from national Danish registers within the areas of demography, lifestyle factors, comorbidity, participation in screening, disease-related factors and socioeconomic factors. Prediction models of short-term postoperative outcomes and mortality were modelled to examine the potential aggregated impact of patient-related risk factors on outcomes, and variations between hospitals were examined. The most conspicuous variations found were for old age (75+ years), ranging from 31% (95% confidence interval (95% CI): 29-33%) to 46% (95% CI: 43-48%), Union for International Cancer Control Stage I ranging from 12% (95% CI: 10-14%) to 21% (95% CI: 19-22%), Stage IV ranging from 23% (95% CI: 21-25%) to 35% (95% CI: 34-37%) and American Society of Anesthesiologists score ≥III ranging from 18% (95% CI: 16-19%) to 40% (95% CI: 37-43%). Clinically significant variations were found in predicted probability of 30-day surgical complications which varied from 17% (95% CI: 16-17%) to 23% (95% CI: 22-23%) and 90-day postoperative mortality which varied between 3.2% (95% CI: 3-3.4%) and 5.5% (95% CI: 4.9-6%). Marked variation in the prevalence of patient-related risk factors for adverse outcomes of colorectal cancer treatment exists between hospitals in Denmark. It seems reasonable to take these differences into account when comparing outcomes between hospitals.

Confined placental mosaicism: placental size and function evaluated on magnetic resonance imaging.

Evidence regarding placental function in pregnancies complicated by confined placental mosaicism (CPM) is conflicting. We aimed to compare placental function between CPM and non-CPM pregnancies prenatally and at birth. A secondary objective was to evaluate the relationship between placental function and chromosomal subtype of CPM. This was a retrospective study of pregnancies with CPM and control pregnancies delivered at a tertiary hospital in Denmark between 2014 and 2017. Placental volume and placental transverse relaxation time (T2*) were estimated on magnetic resonance imaging (MRI), fetal weight and uterine artery pulsatility index (UtA-PI) were estimated on ultrasound and fetoplacental ratio was assessed on MRI and at birth. These estimates of placental function were adjusted for gestational age and compared between groups using the Wilcoxon rank-sum test. Within the group of CPM pregnancies, measures of placental function were compared between those at high risk (chromosome numbers 2, 3, 7, 13 and 16) and those at low risk (chromosome numbers 5, 18 and 45X). A total of 90 pregnancies were included, of which 12 had CPM and 78 were controls. MRI and ultrasound examinations were performed at a median gestational age of 32.6 weeks (interquartile range, 24.7-35.3 weeks). On MRI assessment, CPM placentae were characterized by a lower placental T2* Z-score (P = 0.004), a lower fetoplacental ratio (P = 0.03) and a higher UtA-PI Z-score (P = 0.03), compared with non-CPM placentae. At birth, the fetoplacental ratio was significantly lower (P = 0.02) and placental weight Z-score was higher (P = 0.01) in CPM pregnancies compared with non-CPM pregnancies. High-risk CPM pregnancies showed a reduced placental T2* Z-score (P = 0.003), lower birth-weight Z-score (P = 0.041), earlier gestational age at delivery (P = 0.019) and higher UtA-PI Z-score (P = 0.028) compared with low-risk CPM pregnancies. Low-risk CPM pregnancies did not differ in any of these parameters from non-CPM pregnancies. CPM pregnancies are characterized by an enlarged and dysfunctional placenta. Placental function was highly related to the chromosomal type of CPM; placental dysfunction was seen predominantly in high-risk CPM pregnancies in which chromosomes 2, 3, 7, 13 or 16 were involved. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Patient perspectives on home-based rehabilitation exercise and general physical activity after total hip arthroplasty: A qualitative study (PHETHAS-2)

Background: Home-based rehabilitation exercise following Total Hip Arthroplasty (THA) shows similar outcomes compared to supervised outpatient rehabilitation exercise. Little is known about patients' experiences with home-based rehabilitation, and this study aimed to investigate how patients perceived home-based rehabilitation exercise and general physical activity after THA, focusing on facilitators and barriers. Methods: Semi-structured interviews of qualitative design were conducted with 22 patients who had undergone THA and who had performed home-based rehabilitation exercise. The study took place in a regional hospital in Denmark between January 2018 and May 2019. Data were analyzed using an interpretive thematic analysis approach, with theoretical underpinning from the concept ‘conduct of everyday life’. The study is embedded within the Pragmatic Home-Based Exercise Therapy after Total Hip Arthroplasty-Silkeborg trial (PHETHAS-1). Results: The main theme, ‘wishing to return to the well-known everyday life’, and four subthemes were identified. Generally, participants found the home-based rehabilitation exercise boring but were motivated by the goal of returning to their well-known everyday life and performing their usual general physical activities, though some lacked contact to physiotherapist. Participants enrolled in the PHETHAS-1 study used the enrollment as part of their motivation for doing the exercises. Both pain and the absence of pain were identified as barriers for doing home-based rehabilitation exercise. Pain could cause insecurity about possible medical complications, while the absence of pain could lead to the rehabilitation exercise being perceived as pointless. Conclusions: The overall goal of returning to the well-known everyday life served as a facilitator for undertaking home-based rehabilitation exercise after THA along with the flexibility regarding time and place for performing exercises. Boring exercises as well as both pain and no pain were identified as barriers to the performance of home-based rehabilitation exercise. Participants were motivated towards performing general physical activities which were part of their everyday life.

Surgical trends and regional variation in Danish patients diagnosed with lumbar spinal stenosis between 2002 and 2018: a retrospective registry-based study of 83,783 patients

BackgroundLumbar spinal stenosis (LSS) is the most common reason for spine surgery in older people. However, surgery rates vary widely both internationally and nationally. This study compared patient and sociodemographic characteristics, geographical location and comorbidity between surgically and non-surgically treated Danish patients diagnosed with LSS from 2002 to 2018 and described variations over time.MethodsDiagnostic ICD-10 codes identifying patients with LSS and surgical procedure codes for decompression with or without fusion were retrieved from the Danish National Patient Register. Patients ≥ 18 years who had been admitted to private or public hospitals in Denmark between 2002 and 2018 were included. Data on age, sex, income, retirement status, geographical region and comorbidity were extracted. A multivariable logistic regression model was used to calculate the relative risk for surgically versus non-surgically treated LSS patients using the total population and subsequently divided into three time periods. Variations over time were displayed graphically.ResultsA total of 83,783 unique patients with an LSS diagnosis were identified, and of these, 38,362 (46%) underwent decompression surgery. Compared to those who did not receive surgery, the surgically treated patients were more likely to be aged 65–74 years, were less likely to have comorbidities, had higher income and were more likely to reside in the northern part of Denmark. Patients aged 65–74 years remained more likely to receive surgery over time, although the difference between age groups eventually diminished, as older patients (aged ≥ 75) were increasingly more likely to undergo surgery. Large variations and differences in the relative risk of surgery were observed within and between the geographical regions. The likelihood of receiving surgery varied up to threefold between regions.ConclusionDanish patients with LSS who receive surgery differ in a number of respects from those not receiving surgery. Patients aged 65 to 74 years were more likely to receive surgery than other age groups, and LSS surgical patients were healthier, more often retired and had higher incomes than those not undergoing surgery. There were considerable variations in the relative risk of surgery between and within geographical regions.

#3193 PERFORMANCE OF THE RACE-FREE CKD-EPI CREATININE-BASED EGFR EQUATION IN A DANISH COHORT WITH CHROMIUM-51-EDTA CLEARANCE MEASUREMENTS

Abstract Background and Aims In 2021, an updated estimated glomerular filtration rate (eGFR) equation based on serum creatinine, age, and sex, but without a coefficient for race (CKD-EPI21) was developed and recommended for clinical use. However, the performance of the new equation has yet to be examined among specific groups such as patients with cancer. Method We compared the performances of the CKD-EPI21 equation and the original creatinine-based eGFR equation assuming non-Black race (CKD-EPI09-NB) in patients ≥18 years of age with measured GFR ascertained by chromium-51-EDTA plasma clearance at Aarhus University Hospital in Denmark during 2010–2018. We examined bias, accuracy, precision (defined as the interquartile range of the absolute bias), and correct classification of chronic kidney disease (CKD) stages (GFR ≥60, 30–59, and &amp;lt;30 ml/min/1.73 m2) using the chromium-51-EDTA clearance as the reference standard. Furthermore, we assessed the performance of the equations in the total cohort while stratifying by CKD stage. We assessed the performance in the total cohort and in cohorts of cancer patients and potential living kidney donors. Results In this predominantly White population, the CKD-EPI21 equation performed slightly better than the CKD-EPI09-NB equation, both when examining the total cohort (N = 4,668) and when examining cohorts of cancer patients (N = 3,313) and potential living kidney donors (N = 239). In the total cohort, the CKD-EPI21 equation demonstrated lower median absolute bias (−0.2 versus −4.4 ml/min/1.73 m2), higher accuracy (72% versus 70%) as well as equal precision (25 versus 25 ml/min/1.73 m2) and correct classification of CKD stages (86% versus 85%) when compared with the CKD-EPI09-NB equation. When we stratified by CKD stage, the CKD-EPI09-NB equation performed slightly better than the CKD-EPI21 equation among patients with a GFR &amp;lt; 60 ml/min/1.73 m2. Conclusion In a selected cohort of Danish patients with measured GFR, the CKD-EPI21 equation performed slightly better than the CKD-EPI21-NB equation except for patients with a GFR &amp;lt; 60 ml/min/1.73 m2.

Development of a dynamic prediction model for unplanned ICU admission and mortality in hospitalized patients.

Frequent assessment of the severity of illness for hospitalized patients is essential in clinical settings to prevent outcomes such as in-hospital mortality and unplanned admission to the intensive care unit (ICU). Classical severity scores have been developed typically using relatively few patient features. Recently, deep learning-based models demonstrated better individualized risk assessments compared to classic risk scores, thanks to the use of aggregated and more heterogeneous data sources for dynamic risk prediction. We investigated to what extent deep learning methods can capture patterns of longitudinal change in health status using time-stamped data from electronic health records. We developed a deep learning model based on embedded text from multiple data sources and recurrent neural networks to predict the risk of the composite outcome of unplanned ICU transfer and in-hospital death. The risk was assessed at regular intervals during the admission for different prediction windows. Input data included medical history, biochemical measurements, and clinical notes from a total of 852,620 patients admitted to non-intensive care units in 12 hospitals in Denmark's Capital Region and Region Zealand during 2011-2016 (with a total of 2,241,849 admissions). We subsequently explained the model using the Shapley algorithm, which provides the contribution of each feature to the model outcome. The best model used all data modalities with an assessment rate of 6 hours, a prediction window of 14 days and an area under the receiver operating characteristic curve of 0.898. The discrimination and calibration obtained with this model make it a viable clinical support tool to detect patients at higher risk of clinical deterioration, providing clinicians insights into both actionable and non-actionable patient features.

PATHPOD – A loop-mediated isothermal amplification (LAMP)-based point-of-care system for rapid clinical detection of SARS-CoV-2 in hospitals in Denmark

Sensitive and rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a vital goal in the ongoing COVID-19 pandemic. We present in this comprehensive work, for the first time, detailed fabrication and clinical validation of a point of care (PoC) device for rapid, onsite detection of SARS-CoV-2 using a real-time reverse-transcription loop-mediated isothermal amplification (RT-LAMP) reaction on a polymer cartridge. The PoC system, namely PATHPOD, consisting of a standalone device (weight less than 1.2 kg) and a cartridge, can perform the detection of 10 different samples and two controls in less than 50 min, which is much more rapid than the golden standard real-time reverse-transcription Polymerase Chain Reaction (RT-PCR), typically taking 16–48 h. The novel total internal reflection (TIR) scheme and the reactions inside the cartridge in the PoC device allow monitoring of the diagnostic results in real-time and onsite. The analytical sensitivity and specificity of the PoC test are comparable with the current RT-PCR, with a limit of detection (LOD) down to 30–50 viral genome copies. The robustness of the PATHPOD PoC system has been confirmed by analyzing 398 clinical samples initially examined in two hospitals in Denmark. The clinical sensitivity and specificity of these tests are discussed.

Predicting Short-Term Mortality in Older Patients Discharged from Acute Hospitalizations Lasting Less Than 24 Hours.

Over coming decades, a rise in the number of short, acute hospitalizations of older people is to be expected. To help physicians identify high-risk patients prior to discharge, we aimed to develop a model capable of predicting the risk of 30-day mortality for older patients discharged from short, acute hospitalizations and to examine how model performance changed with an increasing amount of information. This registry-based study included acute hospitalizations in Denmark for 2016-2018 lasting ≤24 hours where patients were permanent residents, ≥65 years old, and discharged alive. Utilizing many different predictor variables, we developed random forest models with an increasing amount of information, compared their performance, and examined important variables. We included 107,132 patients with a median age of 75 years. Of these, 3.3% (n=3575) died within 30 days of discharge. Model performance improved especially with the addition of laboratory results and information on prior acute admissions (AUROC 0.835), and again with comorbidities and number of prescription drugs (AUROC 0.860). Model performance did not improve with the addition of sociodemographic variables (AUROC 0.861), apart from age and sex. Important variables included age, dementia, number of prescription drugs, C-reactive protein, and eGFR. The best model accurately estimated the risk of short-term mortality for older patients following short, acute hospitalizations. Trained on a large and heterogeneous dataset, the model is applicable to most acute clinical settings and could be a useful tool for physicians prior to discharge.

Early intensive mobilization after acute high-risk abdominal surgery: a nonrandomized prospective feasibility trial.

Mobilization after emergency abdominal surgery is considered essential to facilitate rehabilitation and reduce postoperative complications. The aim of this study was to evaluate the feasibility of early intensive mobilization after acute high-risk abdominal (AHA) surgery. We conducted a nonrandomized, prospective feasibility trial of consecutive patients after AHA surgery at a university hospital in Denmark. The participants followed a predefined, interdisciplinary protocol for early intensive mobilization during the first 7 postoperative days (PODs) of their hospital admission. We evaluated feasibility in accordance with the percentage of patients who mobilized within 24 hours after surgery, mobilized at least 4 times per day and achieved daily goals of time out of bed and walking distance. We included 48 patients with a mean age of 61 (standard deviation 17) years (48% female). Within 24 hours after surgery, 92% of the patients were mobilized and 82% or more were mobilized at least 4 times per day over the first 7 PODs. On PODs 1-3, 70%-89% of the participants achieved the daily goals of mobilization; participants still in hospital after POD 3 were less able to achieve the daily goals. Patient reported that the primary factors limiting their level of mobilization were fatigue, pain and dizziness. Participants not mobilized independently on POD 3 (28%) had significantly (p ≤ 0.04) fewer hours out of bed (4 v. 8 h), were less able to achieve the goals of time out of bed (45% v. 95%) and walking distance (62% v. 94%) and had longer hospital stays (14 v. 6 d) than participants mobilized independently on POD 3. The early intensive mobilization protocol seems feasible for most patients after AHA surgery. For nonindependent patients, however, alternative mobilization strategies and goals should be investigated.

Utilisation and time to performance of diagnostic imaging in patients admitted to Danish emergency departments: a nationwide register-based study from 2007 to 2017

ObjectivesTo describe the development of diagnostic imaging utilisation in Denmark from 2007 to 2017, coinciding with a major national reform of the emergency healthcare system.DesignNationwide descriptive register-based study.SettingAll public hospitals...

Impact of COVID-19 Restrictions on Acute Gastroenteritis in Children: A Regional, Danish, Register-Based Study.

This study aimed to evaluate the impact of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) restrictions such as social distancing on the occurrence of acute gastroenteritis (AGE) among children. This study is a register-based study, including every child seen in the departments of paediatrics with the initial diagnosis of AGE in three neighbouring hospitals in Denmark, from March 2018 through February 2021. The study also included every positive stool sample for AGE-causing pathogens analysed in these three hospitals from children during the same period. The Wilcoxon rank-sum test was used to determine differences between the period during the SARS-CoV-2 restrictions and before. In all, 222,157 children were seen in the three paediatric departments during this period. Of these, 3917 children were diagnosed with AGE. We found a decrease of 46.6% in AGE-related visits per month after the SARS-CoV-2 restrictions were introduced compared to before (p-value < 0.001). Positive stool samples decreased by 38.2% (p-value = 0.008) during the restrictions. This study found that cases of paediatric AGE decreased significantly the during COVID-19 restrictions, suggesting that studies should be conducted to determine whether this reduction was a result of good hand hygiene and social distancing or just a result of altered health-seeking behaviour among children.

The impact of caring on caregivers of patients with life-threatening organ failure.

This study aimed at characterizing 3 populations of family/friend caregivers of patients with different life-threatening organ failure regarding health-related quality of life, caregiver burden, and dyadic coping. Three cross-sectional (population) studies were conducted at a tertiary hospital in Denmark (2019-2020). Patients with renal failure (RF), cystic fibrosis (CF), and intestinal failure (IF) were asked to designate the closest person with ≥18years old involved in the care (caregiver) to participate in this study. Number of caregivers included were RF=78, CF=104, and IF=73. Electronic questionnaires were filled in by caregivers to assess health-related quality of life and caregiver burden and by caregivers and respective patients to assess dyadic coping. The 3 caregiver groups had self-perception of poor health and energy; however, caregivers of CF patients perceived their physical role functioning better than those caregiving for RF and IF patients (p=0.002). The level of caregiver burden was reported as not high, but caregivers used in average 13hours/day for caring. Moreover, cleaning tasks (p=0.005) and personal care (p=0.009) were more demanding in RF and IF patients. Caregivers also did not differ regarding dyadic coping. When comparing patients and caregivers, stress communication by oneself and the partner differed (p<0.001). Caregivers spent many hours in the care role, they reported poor health, and dyadic coping may be improved. Interventions in caregivers of patients with life-threatening organ failure could help to improve care management at home, caregiver's health, and dyadic coping between caregiver and patient and consequently reduce caregiver burden.

Patient-Related Characteristics Associated with Treatment Modifications and Suboptimal Relative Dose Intensity of Neoadjuvant Chemotherapy in Patients with Breast Cancer-A Retrospective Study.

Reduced relative dose intensity (RDI) of neoadjuvant chemotherapy (NACT) in patients with breast cancer may compromise treatment outcome and survival. We examined patient-related characteristics associated with treatment modifications and suboptimal RDI and tumour response in patients with breast cancer. In this observational study, electronic medical records were reviewed retrospectively for female patients with breast cancer scheduled for NACT at a university hospital in Denmark between 2017 and 2019. The RDI (ratio of delivered dose intensity in relation to standard dose intensity) was calculated. Multivariate logistic regression analyses examined associations of sociodemographics, general health and clinical cancer characteristics with dose reductions, dose delays, discontinuation of NACT and suboptimal RDI < 85%. Among 122 included patients, 43%, 42% and 28% experienced dose reductions, dose delays ≥3 days and discontinuation, respectively. A total of 25% received an RDI < 85%. Comorbidity, taking long-term medications and being overweight were statistically significantly associated with treatment modifications, while age ≥ 65 years and comorbidity were associated with RDI < 85%. Around one third of all patients had radiologic (36%) or pathologic (35%) complete tumour response, with no statistically significant differences by RDI < or ≥85% irrespective of breast cancer subtype. While most patients had RDI ≥85%, still one out of four patients received an RDI < 85%. Further investigations of possible supportive care initiatives to improve patients' treatment tolerability are needed, particularly among subgroups of older age or with comorbidity.

Patient and public involvement to inform the protocol of a clinical trial comparing total hip arthroplasty with exercise: an exploratory qualitative case study

ObjectiveTo explore patient, clinician and decision-maker perceptions on a clinical trial evaluating the effectiveness of total hip arthroplasty (THA) compared with exercise to inform the trial protocol.DesignThis is an exploratory...

Clinical characteristics of hospitalized patients with paracetamol poisoning before and after restrictions of over-the-counter sale of paracetamol

Introduction Paracetamol poisoning is a frequent cause of hospitalization in Denmark. On 30 September 2013, the Danish authorities restricted packages available without a prescription in pharmacy outlets to contain a maximum of 10 g of paracetamol. We aimed to investigate the effects of this regulation. Methods This was a cross-sectional study of two groups of patients admitted consecutively to a Danish University Hospital due to poisoning with paracetamol in 365 days in 2012–13 before 30 September 2013, and a corresponding 365-day period in 2017–18. Data were extracted from patient records. Results In 2012–2013 and 2017–18, 156 and 92 admissions in 127 and 78 unique patients, respectively, were identified. Ingestion of more than 20 g paracetamol occurred in a significantly higher proportion of cases in 2012–13 compared to 2017–18 (29% vs 13%, P < 0.01). In accordance, there were no cases of international normalized ratio >1.5 or alanine aminotransferase activity >1000 U/L in the post-legislation period, and seven and five cases in the pre-legislation period, respectively. Females accounted for 80% and 78% of patients in the two periods, respectively, and were considerably younger than males (median [interquartile range]: 22 [17–40] vs. 47 [30–56], P < 0.01 in 2012–13, and 23 [18–46] vs. 43 [27–49] years, P = 0.02 in 2017–18). Furthermore, in 2012-13, intentional poisonings occurred in a higher proportion of females than males 2012–13 (97% vs 85%, P < 0.01). Conclusions The present study demonstrated a lower number of paracetamol poisonings, a decreased proportion of poisonings involving ingestion of more than 20 g of paracetamol, and a lower occurrence of hepatotoxicity after the regulation. However, circumstances other than pack size restrictions, such as increased public awareness of the danger of paracetamol poisonings, may affect these associations. Furthermore, the study showed that females and males constitute two distinct groups in terms of age and intentional poisoning.

Rifaximin-α for liver fibrosis in patients with alcohol-related liver disease (GALA-RIF): a randomised, double-blind, placebo-controlled, phase 2 trial

Alcohol is the leading cause of liver-related mortality worldwide. The gut-liver axis is considered a key driver in alcohol-related liver disease. Rifaximin-α improves gut-barrier function and reduces systemic inflammation in patients with cirrhosis. We aimed to compare the efficacy and safety of rifaximin-α with placebo in patients with alcohol-related liver disease. GALA-RIF was an investigator-initiated, randomised, double-blind, placebo-controlled, single-centre, phase 2 trial done at Odense University Hospital in Denmark. Eligible participants were adults (aged 18-75 years) who had current or previous alcohol overuse (at least 1 year with ≥24 g of alcohol per day for women and ≥36 g of alcohol per day for men), biopsy-proven alcohol-related liver disease, and no previous hepatic decompensation. Patients were randomly allocated (1:1) through a web-based randomisation system to receive oral rifaximin-α (550 mg) twice daily or matched placebo for 18 months. Randomisation was done in blocks of four and stratified according to fibrosis stage and alcohol abstinence. Participants, sponsor, investigators, and nurses involved in the study were masked to the randomisation outcome. The primary endpoint was a histological decrease from baseline to 18-month treatment of at least one fibrosis stage, according to the Kleiner fibrosis score. We also assessed the number of patients with progression by at least one fibrosis stage from baseline to 18 months. Primary analyses were done in the per-protocol and modified intention-to-treat populations; safety was assessed in the full intention-to-treat population. The per-protocol population was defined as all randomly assigned patients who did not present serious protocol violations, who ingested at least 75% of the treatment, and who were not withdrawn from the study due to non-adherence (interruption of treatment for 4 weeks or more). Participants receiving at least one dose of the intervention were included in the modified intention-to-treat analyses. This completed trial is registered with EudraCT, number 2014-001856-51. Between March 23, 2015, and Nov 10, 2021, we screened 1886 consecutive patients with a history of excessive alcohol consumption and no previous hepatic decompensation, of whom 136 were randomly assigned to either rifaximin-α (n=68) or placebo (n=68). All patients were White (100%), 114 (84%) were men, and 22 (16%) were women. 133 (98%) patients received at least one dose of the intervention and were included in the modified intention-to-treat analysis; 108 (79%) completed the trial per protocol. In the per-protocol analysis, 14 (26%) of 54 patients in the rifaximin-α group and 15 (28%) of 54 patients in the placebo group had a decrease in fibrosis stage after 18 months (odds ratio 1·10 [95% CI 0·45-2·68]; p=0·83). In the modified intention-to-treat analysis, 15 (22%) of 67 patients in the rifaximin-α group and 15 (23%) of 66 patients in the placebo group had a decrease in fibrosis stage at 18 months (1·05 [0·45-2·44]; p=0·91). In the per-protocol analysis, increase in fibrosis stage occurred in 13 (24%) patients in the rifaximin-α group and 23 (43%) patients in the placebo group (0·42 [0·18-0·98]; p=0·044). In the modified intention-to-treat analysis, increase in fibrosis stage occurred in 13 (19%) patients in the rifaximin-α group and 23 (35%) patients in the placebo group (0·45 [0·20-1·02]; p=0·055). The number of patients with adverse events (48 [71%] of 68 patients in the rifaximin-α group; 53 [78%] of 68 in the placebo group) and serious adverse events (14 [21%] in the rifaximin-α group; 12 [18%] in the placebo group) was similar between the groups. No serious adverse events were deemed related to treatment. Three patients died during the trial, but none of the deaths were considered treatment related. In patients with alcohol-related liver disease, rifaximin-α might reduce progression of liver fibrosis. These findings warrant confirmation in a multicentre phase 3 trial. The EU Horizon 2020 Research and Innovation Program and The Novo Nordisk Foundation.