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Purpose It is well-known that revision rates after primary knee arthroplasty vary widely. However, it is uncertain whether hospital revision rates are reliable indicators of general surgical quality as defined by patients. The SPARK study compared primary knee arthroplasty surgery at three high-volume hospitals whose revision rates differed for unknown reasons. Methods This prospective observational study included primary knee arthroplasty patients (total, medial/lateral unicompartmental and patellofemoral) in two low-revision hospitals (Aarhus University Hospital and Aalborg University Hospital Farsø) and one high-revision hospital (Copenhagen University Hospital Herlev-Gentofte). Patients were followed from preoperatively (2016–17) to 1-year postoperatively with patient-reported outcome measures including Oxford Knee Score (OKS), EQ-5D-5L and Copenhagen Knee ROM (range of motion) Scale. The surgical outcomes were compared across hospitals for patients with comparable grades of radiographic knee osteoarthritis and preoperative OKS. Statistical comparisons (parametric and non-parametric) included all three hospitals. Results 97% of the 1452 patients who provided baseline data (89% of those included and 56% of those operated) responded postoperatively (90% at 1 year) . Hospitals’ utilization of unicompartmental knee arthroplasties differed (Aarhus 49%, Aalborg 14%, and Copenhagen 22%, p  < 0.001). 28 patients had revision surgery during the first year (hospital independent, p  = 0.1) and were subsequently excluded. 1-year OKS (39 ± 7) was independent of hospital ( p  = 0.1), even when adjusted for age, sex, Body Mass Index, baseline OKS and osteoarthritis grading. 15% of patients improved less than Minimal Important Change (8 OKS) (Aarhus 19%, Aalborg 13% and Copenhagen 14%, p  = 0.051 unadjusted). Patients with comparable preoperative OKS or osteoarthritis grading had similar 1-year results across hospitals (OKS and willingness to repeat surgery, p  ≥ 0.087) except for the 64 patients with Kellgren–Lawrence grade-4 (Aarhus 4–6 OKS points lower). 86% of patients were satisfied, and 92% were “willing to repeat surgery”, independent of hospital ( p  ≥ 0.1). Hospital revision rates differences diminished during the study period. Conclusions Patients in hospitals with a history of differing revision rates had comparable patient-reported outcomes 1 year after primary knee arthroplasty, supporting that surgical quality should not be evaluated by revision rates alone. Future studies should explore if revision rate variations may depend as much on revision thresholds and indications as on outcomes of primary surgery. Level of evidence Level II (Prospective cohort study).

Patients with severe COVID-19 have overwhelmed healthcare systems worldwide. We hypothesized that machine learning (ML) models could be used to predict risks at different stages of management and thereby provide insights into drivers and prognostic markers of disease progression and death. From a cohort of approx. 2.6 million citizens in Denmark, SARS-CoV-2 PCR tests were performed on subjects suspected for COVID-19 disease; 3944 cases had at least one positive test and were subjected to further analysis. SARS-CoV-2 positive cases from the United Kingdom Biobank was used for external validation. The ML models predicted the risk of death (Receiver Operation Characteristics—Area Under the Curve, ROC-AUC) of 0.906 at diagnosis, 0.818, at hospital admission and 0.721 at Intensive Care Unit (ICU) admission. Similar metrics were achieved for predicted risks of hospital and ICU admission and use of mechanical ventilation. Common risk factors, included age, body mass index and hypertension, although the top risk features shifted towards markers of shock and organ dysfunction in ICU patients. The external validation indicated fair predictive performance for mortality prediction, but suboptimal performance for predicting ICU admission. ML may be used to identify drivers of progression to more severe disease and for prognostication patients in patients with COVID-19. We provide access to an online risk calculator based on these findings.

Purpose Revision rates following primary knee arthroplasty vary by country, region and hospital. The SPARK study was initiated to compare primary surgery across three Danish regions with consistently different revision rates. The present study investigated whether the variations were associated with differences in the primary patient selection. Methods A prospective observational cohort study included patients scheduled Sep 2016 Dec 2017 for primary knee arthroplasty (total, medial/lateral unicompartmental or patellofemoral) at three high-volume hospitals, representing regions with 2-year cumulative revision rates of 1, 2 and 5%, respectively. Hospitals were compared with respects to patient demographics, preoperative patient-reported outcome measures, motivations for surgery, implant selection, radiological osteoarthritis and the regional incidence of primary surgery. Statistical tests (parametric and non-parametric) comprised all three hospitals. Results Baseline data was provided by 1452 patients (89% of included patients, 56% of available patients). Patients in Copenhagen (Herlev-Gentofte Hospital, high-revision) were older (68.6 ± 9 years) than those in low-revision hospitals (Aarhus 66.6 ± 10 y. and Aalborg (Farsø) 67.3 ± 9 y., p  = 0.002). In Aalborg, patients who had higher Body Mass Index (mean 30.2 kg/m 2 versus 28.2 (Aarhus) and 28.7 kg/m 2 (Copenhagen), p  < 0.001), were more likely to be male (56% versus 45 and 43%, respectively, p  = 0.002), and exhibited fewer anxiety and depression symptoms (EQ-5D-5L) (24% versus 34 and 38%, p  = 0.01). The preoperative Oxford Knee Score (23.3 ± 7), UCLA Activity Scale (4.7 ± 2), range of motion (Copenhagen Knee ROM Scale) and patient motivations were comparable across hospitals but varied with implant type. Radiological classification ≥ 2 was observed in 94% (Kellgren-Lawrence) and 67% (Ahlbäck) and was more frequent in Aarhus (low-revision) ( p  ≤ 0.02), where unicompartmental implants were utilized most (49% versus 14 (Aalborg) and 23% (Copenhagen), p  < 0.001). In the Capital Region (Copenhagen), the incidence of surgery was 15–28% higher ( p  < 0.001). Conclusion Patient-reported outcome measures prior to primary knee arthroplasty were comparable across hospitals with differing revision rates. While radiographic classifications and surgical incidence indicated higher thresholds for primary surgery in one low-revision hospital, most variations in patient and implant selection were contrary to well-known revision risk factors, suggesting that patient selection differences alone were unlikely to be responsible for the observed variation in revision rates across Danish hospitals. Level of evidence II, Prospective cohort study.

Prediction of neurological outcome is a crucial part of post cardiac arrest care and prediction in patients remaining unconscious and/or sedated after rewarming from targeted temperature management (TTM) remains difficult. Current guidelines suggest the use of serial measurements of the biomarker neuron-specific enolase (NSE) in combination with other predictors of outcome in patients admitted after out-of-hospital cardiac arrest (OHCA). This study sought to investigate the ability of NSE to predict poor outcome in patients remaining unconscious at day three after OHCA. In addition, this study sought to investigate if serial NSE measurements add incremental prognostic information compared to a single NSE measurement at 48 hours in this population. This study is a post-hoc sub-study of the TTM trial, randomizing OHCA patients to a course of TTM at either 33°C or 36°C. Patients were included from sites participating in the TTM-trial biobank sub study. NSE was measured at 24, 48 and 72 hours after ROSC and follow-up was concluded after 180 days. The primary end point was poor neurological function or death defined by a cerebral performance category score (CPC-score) of 3 to 5. A total of 685 (73%) patients participated in the study. At day three after OHCA 63 (9%) patients had died and 473 (69%) patients were not awake. In these patients, a single NSE measurement at 48 hours predicted poor outcome with an area under the receiver operating characteristics curve (AUC) of 0.83. A combination of all three NSE measurements yielded the highest discovered AUC (0.88, p = .0002). Easily applicable combinations of serial NSE measurements did not significantly improve prediction over a single measurement at 48 hours (AUC 0.58-0.84 versus 0.83). NSE is a strong predictor of poor outcome after OHCA in persistently unconscious patients undergoing TTM, and NSE is a promising surrogate marker of outcome in clinical trials. While combinations of serial NSE measurements may provide an increase in overall prognostic information, it is unclear whether actual clinical prognostication with low false-positive rates is improved by application of serial measurements in persistently unconscious patients. The findings of this study should be confirmed in another prospective cohort. NCT01020916.

Introduction Most cardiac arrest survivors are classified with mild to moderate cognitive impairment; roughly, 50% experience long-term neurocognitive impairment. Postarrest challenges complicate participation in society and are associated with social issues such as failure to resume social activities and impaired return to work. The effectiveness of rehabilitation interventions for out-of-hospital cardiac arrest survivors are sparsely described, but the body of evidence describes high probabilities of survivors not returning to work, returning to jobs with modified job descriptions, returning to part-time employment, and often in combination with extensive unmet rehabilitation needs. Hence, there is a need to develop and test a pragmatic individual targeted intervention to facilitate return to work (RTW) in survivors of OHCA. The overall aim of the ROCK trial is to evaluate the effectiveness of a comprehensive individually tailored multidisciplinary rehabilitation intervention for survivors of OHCA on RTW compared to usual care. Methods and analysis The ROCK trial is a two-arm parallel group multicentre investigator-initiated pragmatic randomized controlled superiority trial with primary endpoint measured 12 months after the cardiac arrest. Adult survivors who were part of the labour force prior to the OCHA and had at least 2 years until they are qualified to receive retirement state pensions are eligible for inclusion. Survivors will be randomized 1:1 to usual care group or usual care plus a comprehensive tailored rehabilitation intervention focusing on supporting RTW. After comprehensive assessment of individual rehabilitation needs, the intervention is ongoingly coordinated within a multidisciplinary rehabilitation team, and the intervention can be delivered for up until 12 months. Data for the primary outcome will be obtained from the national register on social transfer payments. The primary outcome will be analysed using logistic regression assessing RTW status at 12 months adjusting for the intervention and age at OHCA, sex, marital status, and occupation prior to OHCA. Discussion The ROCK trial is the first RCT to investigate the effectiveness of a rehabilitation intervention focusing on return to work after cardiac arrest. Trial registration ClinicalTrials.gov NCT05173740. Registered on May 2018

Background Early diagnosis of alcohol-related liver disease (ALD) can improve survival if it leads to alcohol abstention or very light consumption. It is possible to screen for liver fibrosis, an asymptomatic condition of ALD that can lead to cirrhosis, by an easy and non-invasive approach called transient elastography. It has not yet been established whether screening for liver fibrosis reduces alcohol consumption among individuals with alcohol use disorders compared to standard treatment. In addition, it is important to address whether receiving a screening result indicating no ALD could lead to increased alcohol consumption (the certificate-of-health effect). This paper describes a study protocol aiming to evaluate alcohol drinking outcomes after screening for liver fibrosis among individuals receiving community-based treatment for alcohol use disorder. Methods The study follows a randomized, controlled trial design (RCT) with concealed allocation in a 2:1 ratio to the intervention group or the control group. Blinded outcome assessments will be conducted for both parallel groups. A total of 408 participants will be randomized to receive both transient elastography and blood tests (intervention group, n  = 272) or standard of care consisting of a blood test (control group, n  = 136). Participants are adults receiving outpatient treatment for alcohol use disorder at three specialized centres in Denmark with no known liver disease. The primary outcome is abstinence or light consumption (≤ 10 units/week, 1 unit = 12 g alcohol) throughout the last 30 days, evaluated 6 months after randomization using the validated timeline follow-back method, supplemented by review of electronic health records. Secondary outcomes include quality of life and motivation to reduce alcohol intake. Qualitative studies will explore emotional impacts of screening on participants’ and health professionals’ barriers to the implementation of screening. Discussion This study has the potential to offer important insights into the effect of screening for liver fibrosis on alcohol consumption among individuals who are attending treatment for alcohol use disorder. Furthermore, the study will provide insights into user and health professionals’ experiences related to screening. Findings may have implications for the implementation of non-invasive screening for chronic liver disease in individuals receiving alcohol use disorder treatment. Trial registration ClinicalTrials.gov NCT05855031. Registered on the 20th of April 2023.

Bile acid diarrhea (BAD) is a socially debilitating disease with frequent bowel movements, urgency, and fecal incontinence as the main symptoms. It is caused by excessive bile acid levels in the colon and is most commonly treated with bile acid sequestrants. It is estimated that 1-2% of the population suffers from the disease, but only a fraction of these are properly diagnosed with the gold standard ⁷⁵selenium-homotaurocholic acid (SeHCAT) test. Here, we use nationwide registries to describe the demographic characteristics of individuals suffering from BAD in Denmark. Since the International Classification of Diseases diagnosis code for BAD was not used until 2021, we identified the BAD population by referral to SeHCAT testing followed by a prescription of a bile acid sequestrant (colestyramine, colestipol or colesevelam) within 365 days. The study period was from 2003 to 2021. During the study period, a total of 5264 individuals with BAD were identified with large differences between the five regions in Denmark. The number of prescriptions of colestyramine and colesevelam, the number of SeHCAT tests, and the number of individuals diagnosed with BAD increased during the study period. The BAD population had more co-morbidities and more health care contacts as well as lower levels of education and income compared with age- and sex-matched controls from the general population. Using the Danish registries, we identified a BAD population, which seems to be inferior in health care and socio-economic parameters compared with the Danish general population.

Background Alcohol-related liver disease is a preventable disease with high mortality. If individuals with alcohol-related liver disease were to be diagnosed earlier by screening and they reduced their alcohol consumption, lives lost to alcohol-related liver disease might be saved. A liver stiffness measurement (FibroScan©) is a key tool to screen for alcohol-related liver disease in asymptomatic individuals. No randomized controlled trials have been conducted to test if screening for liver disease reduces alcohol consumption in individuals with alcohol use disorders, in addition to what can be obtained by motivational interventions. We aimed to assess the feasibility of a randomized controlled trial of a screening for liver disease on the prevalence of alcohol abstinence or light consumption after 6 months in individuals attending outpatient treatment for alcohol use disorder. Methods We used an interdisciplinary approach to develop the format of the randomized controlled trial. Individuals were recruited from one outpatient treatment facility for alcohol use disorders. Study participants were randomized 1:1 to receive a) a liver stiffness measurement in addition to usual care (intervention) or b) usual care (control). Follow-up on alcohol consumption was assessed by telephone interview after 6 months and corroborated by data from records from public hospitals and the alcohol treatment facility. Feasibility was assessed by probabilities of recruitment, retention, and completion and estimated by the exact binominal test, with success defined as > 50% participation for each endpoint. The study design was evaluated at interdisciplinary meetings with staff and researchers from the outpatient alcohol treatment facility and the hospital clinic. Results Forty of 57 invited individuals agreed to participate in the study (recruitment = 70% (95% CI: 57–82)); 19 of 20 participants randomized to the intervention showed up for the screening (retention = 95% (95% CI: 75–100)). Follow-up telephone interviews succeeded for 33 of 39 reachable participants (completion = 85% (95% CI: 69–94)). Treatment records indicated that the 6 participants who were lost to follow-up for the telephone interview had not achieved alcohol abstinence or light consumption. There was no evidence that the intervention increased abstinence or light alcohol consumption at follow-up: 45% (95% CI: 23–68) in the intervention group and 65% (95% CI: 41–85) in the control group had a alcohol consumption below 10 standard drinks/week at 6 months. The main obstacle regarding study feasibility was to avoid disappointment in individuals randomized as controls. Conclusions This feasibility study developed a study design to test the influence of screening for liver disease on abstinence or light alcohol consumption in individuals attending treatment for alcohol use disorder. Trial registration ClinicalTrials.gov identifier: NCT05244720; registered on February 17, 2022.

N-terminal pro-B-type natriuretic (NT-proBNP) is expressed in the heart and brain, and serum levels are elevated in acute heart and brain diseases. We aimed to assess the possible association between serum levels and neurological outcome and death in comatose patients resuscitated from out-of-hospital cardiac arrest (OHCA). Of the 939 comatose OHCA patients enrolled and randomized in the Targeted Temperature Management (TTM) trial to TTM at 33°C or 36°C for 24 hours, 700 were included in the biomarker substudy. Of these, 647 (92%) had serum levels of NT-proBNP measured 24, 48, and 72 hours after return of spontaneous circulation (ROSC). Neurological outcome was evaluated by the Cerebral Performance Category (CPC) score and modified Rankin Scale (mRS) at 6 months. Six hundred thirty-eight patients (99%) had serum NT-proBNP levels ≥125 pg/ml. Patients with TTM at 33°C had significantly lower NT-proBNP serum levels (median 1,472 pg/ml) than those in the 36°C group (1,914 pg/ml) at 24 hours after ROSC, p <0.01 but not at 48 and 72 hours. At 24 hours, an increase in NT-proBNP quartile was associated with death (Plogrank <0.0001). In addition, NT-proBNP serum levels > median were independently associated with poor neurological outcome (odds ratio, ORCPC 2.02, CI 1.34 to 3.05, p <0.001; ORmRS 2.28, CI 1.50 to 3.46, p <0.001) adjusted for potential confounders. The association was diminished at 48 and 72 hours after ROSC. In conclusion, NT-proBNP serum levels are increased in comatose OHCA patients. Furthermore, serum NT-proBNP levels are affected by level of TTM and are associated with death and poor neurological outcome.

Background: The BREATHE study is a cross-sectional study of real-life patients with asthma and/or COPD in Denmark and Sweden aiming to increase the knowledge across severities and combinations of obstructive airway disease. Design: Patients with suspicion of asthma and/or COPD and healthy controls were invited to participate in the study and had a standard evaluation performed consisting of questionnaires, physical examination, FeNO and lung function, mannitol provocation test, allergy test, and collection of sputum and blood samples. A subgroup of patients and healthy controls had a bronchoscopy performed with a collection of airway samples. Results: The study population consisted of 1403 patients with obstructive airway disease (859 with asthma, 271 with COPD, 126 with concurrent asthma and COPD, 147 with other), and 89 healthy controls (smokers and non-smokers). Of patients with asthma, 54% had moderate-to-severe disease and 46% had mild disease. In patients with COPD, 82% had groups A and B, whereas 18% had groups C and D classified disease. Patients with asthma more frequently had childhood asthma, atopic dermatitis, and allergic rhinitis, compared to patients with COPD, asthma + COPD and Other, whereas FeNO levels were higher in patients with asthma and asthma + COPD compared to COPD and Other (18 ppb and 16 ppb vs 12.5 ppb and 14 ppb, p < 0.001). Patients with asthma, asthma + COPD and Other had higher sputum eosinophilia (1.5%, 1.5%, 1.2% vs 0.75%, respectively, p < 0.001) but lower sputum neutrophilia (39.3, 43.5%, 40.8% vs 66.8%, p < 0.001) compared to patients with COPD. Conclusions: The BREATHE study provides a unique database and biobank with clinical information and samples from 1403 real-life patients with asthma, COPD, and overlap representing different severities of the diseases. This research platform is highly relevant for disease phenotype- and biomarker studies aiming to describe a broad spectrum of obstructive airway diseases.