Publications by authors named "Søren Møller"

315 Publications

Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: Overlapping Mechanisms.

Semin Liver Dis 2021 May 15. Epub 2021 May 15.

Department of Clinical Medicine, University of Copenhagen, Denmark.

Nonalcoholic fatty liver disease (NAFLD) denotes a condition with excess fat in the liver. The prevalence of NAFLD is increasing, averaging > 25% of the Western population. In 25% of the patients, NAFLD progresses to its more severe form: nonalcoholic steatohepatitis and >25% of these progress to cirrhosis following activation of inflammatory and fibrotic processes. NAFLD is associated with obesity, type 2 diabetes, and the metabolic syndrome and represents a considerable and increasing health burden. In the near future, NAFLD cirrhosis is expected to be the most common cause for liver transplantation. NAFLD patients have an increased risk of developing cardiovascular disease as well as liver-related morbidity. In addition, hepatic steatosis itself appears to represent an independent cardiovascular risk factor. In the present review, we provide an overview of the overlapping mechanisms and prevalence of NAFLD and cardiovascular disease.
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http://dx.doi.org/10.1055/s-0041-1725022DOI Listing
May 2021

Prophylactic Negative Pressure Wound Therapy in Obese Women Undergoing Caesarean Section: a Commentary on New Evidence that Fuels the Debate.

BJOG 2021 May 14. Epub 2021 May 14.

Department of Obstetrics and Gynaecology, Odense University Hospital, University of Southern Denmark, 5000, Odense, Denmark.

Further debate about the effect of incisional negative pressure wound therapy (iNPWT) versus standard wound dressing on surgical-site infection (SSI) in obese women after caesarean section (CS) has resurfaced. This is because of a study published in JAMA that was stopped early on the grounds of "futility". This was counterintuitive to us having published a systematic review, a randomised controlled trial (RCT) and a health economic evaluation on the same subject, the latter two of which were published in BJOG.
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http://dx.doi.org/10.1111/1471-0528.16750DOI Listing
May 2021

Trends in Incidence of Intracerebral Hemorrhage and Association With Antithrombotic Drug Use in Denmark, 2005-2018.

JAMA Netw Open 2021 May 3;4(5):e218380. Epub 2021 May 3.

Research Unit for Neurology, Odense University Hospital, Odense, Denmark.

Importance: Spontaneous (nontraumatic) intracerebral hemorrhage (ICH) is the most severe complication of antithrombotic drug use.

Objectives: To estimate the strength of association between use of antithrombotic drugs and risk of ICH and to examine major changes in the incidence of ICH in the general population.

Design, Setting, And Participants: This case-control study of patients with a first-ever ICH from January 1, 2005, to December 31, 2018, matched by age, sex, and calendar year with general population controls (1:40 ratio), assessed case and control patients 20 to 99 years of age in population-based nationwide registries in Denmark (population of 5.8 million).

Exposures: Use of low-dose aspirin, clopidogrel, a vitamin K antagonist (VKA), or a direct oral anticoagulant (DOAC).

Main Outcomes And Measures: Association of ICH with antithrombotic drug use, annual age- and sex-standardized incidence rate of ICH, and prevalence of treatment with antithrombotic drugs. Conditional logistic regression models estimated adjusted odds ratios (aORs) (95% CIs) for the association of antithrombotic drugs with ICH.

Results: Among 16 765 cases with ICH (mean [SD] age, 72.8 [13.1] years; 8761 [52.3%] male), 7473 (44.6%) were exposed to antithrombotic medications at the time of ICH onset. The association with ICH was weakest for current use of low-dose aspirin (cases: 28.7%, controls: 22.6%; aOR, 1.51; 95% CI, 1.44-1.59) and clopidogrel (cases: 6.2%, controls: 3.4%; aOR, 1.65; 95% CI, 1.47-1.84) and strongest with current use of a VKA (cases: 12.0%, controls: 5.0%; aOR, 2.76; 95% CI, 2.58-2.96). The association with ICH was weaker for DOACs (cases: 3.0%, controls: 1.8%; aOR, 1.83; 95% CI, 1.61-2.07) than for VKAs. Compared with 2005, the prevalence of use of oral anticoagulants among general population controls in 2018 was higher (3.8% vs 11.1%), predominantly because of increased use of DOACs (DOACs: 0% vs 7.0%; VKA: 3.8% vs 4.2%). Antiplatelet drugs were used less frequently (24.7% vs 21.4%) because of decreased use of low-dose aspirin (24.3% vs 15.3%), whereas clopidogrel use increased (1.0% vs 6.8%). The age- and sex-standardized incidence rate of ICH decreased from 33 per 100 000 person-years in 2005 to 24 per 100 000 person-years in 2018 (P < .001 for trend).

Conclusions And Relevance: In Denmark from 2005 to 2018, use of antithrombotic drugs, especially VKAs, was associated with ICH. Although use of oral anticoagulation increased substantially during the study period, the incidence rate of ICH decreased.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.8380DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8100864PMC
May 2021

Identification of a clinical signature predictive of differentiation fate of human bone marrow stromal cells.

Stem Cell Res Ther 2021 May 3;12(1):265. Epub 2021 May 3.

Department of Endocrinology, Odense University Hospital, Odense, Denmark.

Background: Transplantation of human bone marrow stromal cells (hBMSCs) is a promising therapy for bone regeneration due to their ability to differentiate into bone forming osteoblastic cells. However, transplanted hBMSCs exhibit variable capacity for bone formation resulting in inconsistent clinical outcome. The aim of the study was to identify a set of donor- and cell-related characteristics that detect hBMSCs with optimal osteoblastic differentiation capacity.

Methods: We collected hBMSCs from 58 patients undergoing surgery for bone fracture. Clinical profile of the donors and in vitro characteristics of cultured hBMSCs were included in uni- and multivariable analysis to determine their predictive value for osteoblastic versus adipocytic differentiation capacity assessed by quantification of mineralized matrix and mature adipocyte formation, respectively.

Results: We identified a signature that explained > 50% of variation in osteoblastic differentiation outcome which included the following positive predictors: donor sex (male), absence of osteoporosis diagnosis, intake of vitamin D supplements, higher fraction of CD146+, and alkaline phosphate (ALP+) cells. With the exception of vitamin D and ALP+ cells, these variables were also negative predictors of adipocytic differentiation.

Conclusions: Using a combination of clinical and cellular criteria, it is possible to predict differentiation outcome of hBMSCs. This signature may be helpful in selecting donor cells in clinical trials of bone regeneration.
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http://dx.doi.org/10.1186/s13287-021-02338-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091554PMC
May 2021

Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial.

Ann Rheum Dis 2021 Apr 29. Epub 2021 Apr 29.

Rheumatology Research Unit, Department of Rheumatology, Odense University Hospital, Odense, Denmark

Objectives: Although causality remains to be established, targeting dysbiosis of the intestinal microbiota by faecal microbiota transplantation (FMT) has been proposed as a novel treatment for inflammatory diseases. In this exploratory, proof-of-concept study, we evaluated the safety and efficacy of FMT in psoriatic arthritis (PsA).

Methods: In this double-blind, parallel-group, placebo-controlled, superiority trial, we randomly allocated (1:1) adults with active peripheral PsA (≥3 swollen joints) despite ongoing treatment with methotrexate to one gastroscopic-guided FMT or sham transplantation into the duodenum. Safety was monitored throughout the trial. The primary efficacy endpoint was the proportion of participants experiencing treatment failure (ie, needing treatment intensification) through 26 weeks. Key secondary endpoints were change in Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR20) response at week 26.

Results: Of 97 screened, 31 (32%) underwent randomisation (15 allocated to FMT) and 30 (97%) completed the 26-week clinical evaluation. No serious adverse events were observed. Treatment failure occurred more frequently in the FMT group than in the sham group (9 (60%) vs 3 (19%); risk ratio, 3.20; 95% CI 1.06 to 9.62; p=0.018). Improvement in HAQ-DI differed between groups (0.07 vs 0.30) by 0.23 points (95% CI 0.02 to 0.44; p=0.031) in favour of sham. There was no difference in the proportion of ACR20 responders between groups (7 of 15 (47%) vs 8 of 16 (50%)).

Conclusions: In this first preliminary, interventional randomised controlled trial of FMT in immune-mediated arthritis, we did not observe any serious adverse events. Overall, FMT appeared to be inferior to sham in treating active peripheral PsA.

Trial Registration Number: NCT03058900.
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http://dx.doi.org/10.1136/annrheumdis-2020-219511DOI Listing
April 2021

Is greater patient involvement associated with higher satisfaction? Experimental evidence from a vignette survey.

BMJ Qual Saf 2021 Apr 22. Epub 2021 Apr 22.

Department of Clinical Research, University of Southern Denmark, DK-5000 Odense, Denmark.

Background: Patient-centredness is an essential quality parameter of modern healthcare. Accordingly, involving patients in decisions about care is required by international laws and an increasing number of medical codes and standards. These directives are based on ethical principles of autonomy. Still, there is limited empirical knowledge about the influence of patient involvement on satisfaction with care.

Objective: In a large national vignette survey, we aimed to empirically test healthcare users' satisfaction with healthcare given different degrees of patient involvement, choices made and outcomes.

Methods: A web-based cross-sectional survey distributed to a randomised sample of men in Denmark aged 45-70 years. Case vignettes used prostate-specific antigen (PSA) screening for early detection of prostate cancer as a clinical model. Using a 5-point Likert scale, we measured respondents' satisfaction with care in scenarios which differed in the amount of patient involvement (ranging from no involvement, through involvement with neutral or nudged information, to shared decision-making), the decision made (PSA test or no PSA test) and clinical outcomes (no cancer detected, detection of treatable cancer and detection of non-treatable cancer).

Results: Participating healthcare users tended to be more satisfied with healthcare in scenarios illustrating greater levels of patient involvement. Participants were positive towards nudging in favour of the intervention but patient involvement through shared decision-making obtained the highest satisfaction ratings (Likert rating 3.81 without any involvement vs 4.07 for shared decision-making, p<0.001). Greater involvement also had an ameliorating effect on satisfaction if a non-treatable cancer was later diagnosed.

Conclusion: Our study provides empirical support for the hypothesis that greater patient involvement in healthcare decision-making improves satisfaction with care irrespective of decisions made and clinical outcomes. Overall satisfaction with the care illustrated was highest when decisions were reached through shared decision-making.
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http://dx.doi.org/10.1136/bmjqs-2020-012786DOI Listing
April 2021

Burden and prevalence of risk factors for severe COVID-19 in the ageing European population - a SHARE-based analysis.

Z Gesundh Wiss 2021 Apr 11:1-10. Epub 2021 Apr 11.

Unit of Epidemiology, Biostatistics and Biodemography, Department of Public Health, University of Southern Denmark, J.B. Winsløws Vej 9B, 5000 Odense, Denmark.

Aim: International health authorities suggest that individuals aged 65 years and above and people with underlying comorbidities such as hypertension, chronic lung disease, cardiovascular disease, cancer, diabetes, and obesity are at increased risk of severe Coronavirus Disease 2019 (COVID-19); however, the prevalence of risk factors is unknown in many countries. Therefore, we aimed to describe the distribution of these risk factors across Europe.

Subject And Methods: Prevalence of risk factors for severe COVID-19 was identified based on interviews from 73,274 Europeans aged 50+ participating in the Survey of Health, Ageing and Retirement in Europe (SHARE) in 2017. Burden of disease was estimated using population data from Eurostat.

Results: A total of 75.3% of the study population (corresponding to approx. 60 million European men and 71 million women) had at least one risk factor for severe COVID-19, 45.9% (approx. 36 million men and 43 million women) had at least two factors, and 21.2% (approx. 17 million men and 20 million women) had at least three risk factors. The prevalence of underlying medical conditions ranged from 4.5% for cancer to 41.4% for hypertension, and the region-specific prevalence of having at least three risk factors ranged from 18.9% in Northern Europe to 24.6% in Eastern Europe.

Conclusions: Information about the prevalence of risk factors might help authorities to identify the most vulnerable subpopulations with multiple risk factors of severe COVID-19 and thus to decide appropriate strategies to mitigate the pandemic.

Supplementary Information: The online version contains supplementary material available at 10.1007/s10389-021-01537-7.
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http://dx.doi.org/10.1007/s10389-021-01537-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8036158PMC
April 2021

History of healthcare use and disease burden in older adults with different levels of alcohol use. A register-based cohort study.

Alcohol Clin Exp Res 2021 Apr 16. Epub 2021 Apr 16.

Unit of Clinical Alcohol Research, Institute of Clinical Research, University of Southern Denmark, Odense C, Denmark.

Background: Only a minority of individuals with problematic alcohol use ever seek alcohol treatment. Knowledge of general help-seeking behavior in the healthcare system can identify possibilities for prevention and intervention.

Method: The current study describes healthcare use, burden of disease, and prior morbidities over a 15-year period by current alcohol use behavior among Danish adults aged 60-70. The Danish National Health Survey 2013 and the baseline assessment of the Elderly Study (2014-2016) were linked to Danish national registers to collect annual information on healthcare use and morbidity for the 15 years prior to inclusion. Participants from the 3 largest Danish municipalities were divided into 4 groups with varying drinking patterns and no recent treatment [12-month abstinent (n = 691), low-risk drinkers (n = 1978), moderate-risk drinkers (n = 602), and high-risk drinkers (n = 467)], and a group of treatment-seeking individuals with a 12-month DSM-5 alcohol use disorder (AUD; n=262). Negative binomial regression models were utilized to compare rates of healthcare use and logistic regressions were used to compare odds of diagnoses.

Results: Low-, moderate-, and high-risk drinkers had similar rates of past healthcare utilization (low-risk mean yearly number of contacts for primary care 7.50 (yearly range 6.25-8.45), outpatient care 0.80 (0.41-1.32) and inpatient care 0.13 (0.10-0.21)). Higher rates were observed for both the 12-month abstinent group (adjusted RR = 1.16-1.26) and the group with AUD (ARR = 1.40-1.60) compared to the group with low-risk alcohol consumption. Individuals with AUD had higher odds of previous liver disease (adjusted OR = 6.30), ulcer disease (AOR = 2.83), and peripheral vascular disease (AOR 2.71). Twelve-month abstinence was associated with higher odds of diabetes (AOR = 1.97) and ulcer disease (AOR = 2.10).

Conclusions: Looking back in time, we found that older adults had regular healthcare contacts, with those who received treatment for AUD having had the highest contact frequency and prevalence of alcohol-related diseases. Thus, healthcare settings are suitable locations for efforts at AUD prevention and intervention.
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http://dx.doi.org/10.1111/acer.14615DOI Listing
April 2021

[Alcohol-related liver cirrhosis and related complications].

Ugeskr Laeger 2021 Apr;183(14)

Alcohol is still the dominating cause of liver cirrhosis in Denmark. Only a minor fraction of individuals with alcohol abuse develop cirrhosis, and the pathophysiological mechanisms are only partly understood. About 50% of patients are diagnosed, when complications such as ascites, renal failure, or oesophageal varices occur. Treatment of alcohol-related cirrhosis is mainly symptomatic, and a summary is given in this review. It is, however, anticipated, that improved focus on nutrition, prevention of complications and therapeutic agents directed towards hepatic fibrogenesis will improve life and health of patients with alcohol-related cirrhosis.
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April 2021

Frailty screening for predicting rapid functional decline, rapid progressive disease, and shorter overall survival in older patients with gastrointestinal cancer receiving palliative chemotherapy - a prospective, clinical study.

J Geriatr Oncol 2021 May 21;12(4):578-584. Epub 2020 Oct 21.

Department of Oncology, Odense University Hospital, Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark.

Objectives: A growing number of older patients with cancer require well-founded clinical decision-making. Frailty screening is suggested as a service to improve outcomes in vulnerable older patients with cancer. This prospective study examined the value of frailty screening to predict rapid functional decline, rapid progressive disease (PD) and shorter overall survival (OS) in older patients with gastrointestinal cancer receiving palliative chemotherapy.

Materials And Methods: Patients aged ≥70 years were screened for frailty in an oncologic department after clinical decision but before starting palliative chemotherapy. Screening was repeated at first response evaluation after approximately two months of chemotherapy. Frailty screening tools included performance status (PS), Charlson Comorbidity Index, G-8 using two different cut-offs (G8,G8), VES-13, Timed-Up-and-Go, Handgrip strength and falls.

Results: A total of 170 patients were included, median age was 75.5 (70-88) years and 65.9% were male. The frequency of frailty varied from 14% to 74% according to the chosen frailty tool. In multivariate analysis G8 predicted OS (HR 1.5; 95%CI 1.0-2.4), whereas G8 predicted PD (OR 2.4; 1.1-5.6) and OS (HR 2.1; 1.4-2.9). VES-13 predicted functional decline (OR 3.5; 1.0-11.6), PD (OR 3.5; 1.5-8.4) and OS (HR 1.7; 1.2-2.4). Timed-Up-and-Go predicted OS (HR 1.8; 1.1-2.7). Handgrip strength and falls predicted functional decline (OR 4.5; 1.1-19 and OR 6.1; 1.4-25.8, respectively). PS predicted PD (OR 6.2; 2.6-14.7) and OS (HR 2.2; 1.5-3.2).

Conclusion: VES-13 was useful for predicting all three endpoints of interest. Frailty tools covering domains of functioning and nutrition are suggested for older patients with advanced gastrointestinal cancer.
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http://dx.doi.org/10.1016/j.jgo.2020.10.007DOI Listing
May 2021

Possible Relevance of Soluble Luteinizing Hormone Receptor during Development and Adulthood in Boys and Men.

Cancers (Basel) 2021 Mar 16;13(6). Epub 2021 Mar 16.

Group of Skeletal, Mineral and Gonadal Endocrinology, University Department of Growth and Reproduction, Rigshospitalet, 2100 Copenhagen, Denmark.

Luteinizing hormone (LH) and human chorionic gonadotropin (hCG) are agonists for the luteinizing hormone receptor (LHCGR) which regulates male reproductive function. LHCGR may be released into body fluids. We wish to determine whether soluble LHCGR is a marker for gonadal function. Cross-sectional, longitudinal, and intervention studies on 195 healthy boys and men and 396 men with infertility, anorchia, or Klinefelter Syndrome (KS) were used to correlate LHCGR measured in serum, seminal fluid, urine, and hepatic/renal artery and vein with gonadal function. LHCGR was determined in fluids from in vitro and in vivo models of human testicular tissue and cell lines, xenograft mouse models, and human fetal kidney and adrenal glands. Western blot showed LHCGR fragments in serum and gonadal tissue of similar size using three different antibodies. The LHCGR-ELISA had no species cross-reactivity or unspecific reaction in mouse serum even after human xenografting. Instead, sLHCGR was released into the media after the culture of a human fetal kidney and adrenal glands. Serum sLHCGR decreased markedly during puberty in healthy boys ( = 0.0001). In healthy men, serum sLHCGR was inversely associated with the Inhibin B/FSH ratio (β -0.004, = 0.027). In infertile men, seminal fluid sLHCGR was inversely associated with serum FSH (β 0.006, = 0.009), sperm concentration (β -3.5, = 0.003) and total sperm count (β -3.2, = 0.007). The injection of hCG lowered sLHCGR in serum and urine of healthy men ( < 0.01). In conclusion, sLHCGR is released into body-fluids and linked with pubertal development and gonadal function. Circulating sLHCGR in anorchid men suggests that sLHCGR in serum may originate from and possibly exert actions in non-gonadal tissues. (ClinicalTrials: NTC01411527, NCT01304927, NCT03418896).
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http://dx.doi.org/10.3390/cancers13061329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7999540PMC
March 2021

Validation of the Fracture Risk Evaluation Model (FREM) in predicting major osteoporotic fractures and hip fractures using administrative health data.

Bone 2021 Jun 20;147:115934. Epub 2021 Mar 20.

OPEN - Open Patient data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Heden 16, DK-5000 Odense C, Denmark. Electronic address:

Background: Prevention of osteoporotic fractures remains largely insufficient, and effective means to identify patients at high, short-term fracture risk are needed. The FREM tool is available for automated case finding of men and women aged 45 years or older at high imminent (1-year) risk of osteoporotic fractures, based on administrative health data with a 15-year look-back. The aim of this study was to validate the performance of FREM, and the effect of applying a shorter look-back period. We also evaluated FREM for 5-year fracture risk prediction.

Methods: Using Danish national health registers we generated consecutive general population cohorts for the years 2014 through 2018. Within each year and across the full time period we estimated the individual fracture risk scores and determined the actual occurrence of major osteoporotic fractures (MOF) and hip fractures. Risk scores were calculated with 15- and 5-year look-back periods. The discriminative ability was evaluated by area under the receiver operating curve (AUC), and negative predictive value (NPV) and positive predictive value (PPV) were estimated applying a calculated risk cut-off of 2% for MOF and 0.3% for hip fractures.

Results: Applying a 15-year look-back, AUC was around 0.75-0.76 for MOF and 0.84-0.87 for hip fractures in 2014, with minor decreases in the subsequent fracture cohorts (2015 to 2018). Applying a 5-year look-back generated similar results, with only marginally lower AUC. In the 5-year risk prediction setting, AUC-values were 0.70-0.72 for MOF and 0.81-0.84 for hip fractures. Generally, PPVs were low, while NPVs were very high.

Conclusion: FREM predicts the 1- and 5-year risk of MOF and hip fractures with acceptable vs excellent discriminative power, respectively, when applying both a 15- and a 5-year look-back. Hence, the FREM tool may be applied to improve identification of individuals at high imminent risk of fractures using administrative health data.
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http://dx.doi.org/10.1016/j.bone.2021.115934DOI Listing
June 2021

Prognostic scoring models in parotid gland carcinoma.

Head Neck 2021 Mar 18. Epub 2021 Mar 18.

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Odense University Hospital, Odense, Denmark.

Background: The aim was to identify prognostic factors and test three prognostic scoring models that predicted the risk of recurrence in patients with parotid gland carcinoma.

Methods: All Danish patients with parotid gland carcinoma, treated with curative intent, from 1990 to 2015 (n = 726) were included. Potential prognostic factors were evaluated using Cox regression and competing risk analyses. The concordance of each prognostic model was estimated using Harrel's C index.

Results: The study population consisted of 344 men and 382 women, with a median age of 63 years. Age above 60 years, high grade histology, T3/T4 tumor, regional lymph node metastases, and involved surgical margins were all associated with a significant reduction in recurrence-free survival. The prognostic model that agreed best with actual outcomes had a C-index of 0.76.

Conclusion: Prognostic scoring models may improve individualized follow-up strategies after curatively intended treatment for patients with parotid gland carcinoma.
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http://dx.doi.org/10.1002/hed.26672DOI Listing
March 2021

Arm lean mass determined by dual-energy X-ray absorptiometry is superior to characterize skeletal muscle and predict sarcopenia-related mortality in cirrhosis.

Am J Physiol Gastrointest Liver Physiol 2021 May 17;320(5):G729-G740. Epub 2021 Mar 17.

Center of Functional Imaging and Research, Department of Clinical Physiology and Nuclear Medicine, Hvidovre University Hospital, Copenhagen, Denmark.

Sarcopenia worsens survival in patients with advanced liver disease including cirrhosis. In this study, we aimed to characterize skeletal muscle status by dual-energy X-ray absorptiometry (DXA) in patients with cirrhosis and examine the association between different skeletal muscle compartments and mortality. We included 231 men and 84 women (, , and ) with cirrhosis and 315 healthy matched controls (231 men and 84 women). Body composition was assessed with DXA. Appendicular skeletal muscle index (ASMI), arms index (AI), and legs index (LI) were calculated by normalizing lean mass to height squared. Low ASMI was defined as ASMI < 7.0 kg/m in men and <5.5 kg/m in women. Biochemical and hemodynamic data were recorded for cirrhotic patients and mortality data retrieved from registers. Low ASMI was more prevalent in both men (49%) and women (43%) with cirrhosis compared with healthy men (8%) and women (5%) ( < 0.001). ASMI and LI were lowest in , whereas AI decreased gradually with advancing Child class. ASMI was inversely associated with mortality in men [HR = 0.74 (0.59-0.93), < 0.01], and this was mainly driven by AI [HR = 0.37 (0.18-0.71), < 0.01]. AI showed closer association than ASMI or LI to both the severity of liver disease and to mortality, which may be due to increasing prevalence of leg edema with disease progression in this population. Determination of arm lean mass may add information on survival in patients with cirrhosis. Sarcopenia increases mortality in patients with end-stage liver disease. We show that arm lean mass determined by dual-energy X-ray absorptiometry is a better marker than the traditional appendicular skeletal muscle mass when predicting sarcopenia-related mortality in patients with cirrhosis of different severity. The findings add to the dispute about the optimal method for repeated assessments of skeletal muscle status in patients with cirrhosis and may have implications for clinical decision making.
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http://dx.doi.org/10.1152/ajpgi.00478.2020DOI Listing
May 2021

A Prognostic Model for Glioblastoma Patients Treated With Standard Therapy Based on a Prospective Cohort of Consecutive Non-Selected Patients From a Single Institution.

Front Oncol 2021 25;11:597587. Epub 2021 Feb 25.

Department of Radiation Biology, The Finsen Center, Rigshospitalet, Copenhagen, Denmark.

Background: Glioblastoma patients administered standard therapies, comprising maximal surgical resection, radiation therapy with concomitant and adjuvant temozolomide, have a variable prognosis with a median overall survival of 15-16 months and a 2-year overall survival of 30%. The aim of this study was to develop a prognostic nomogram for overall survival for glioblastoma patients treated with standard therapy outside clinical trials.

Methods: The study included 680 consecutive, non-selected glioblastoma patients administered standard therapy as primary treatment between the years 2005 and 2016 at Rigshospitalet, Copenhagen, Denmark. The prognostic model was generated employing multivariate Cox regression analysis modeling overall survival.

Results: The following poor prognostic factors were included in the final prognostic model for overall survival: Age (10-year increase: HR = 1.18, 95% CI: 1.08-1.28, p < 0.001), ECOG performance status (PS) 1 vs. 0 (HR = 1.30, 95% CI: 1.07-1.57, p = 0.007), PS 2 vs. 0 (HR = 2.99, 95% CI: 1.99-4.50, p < 0.001), corticosteroid use (HR = 1.42, 95% CI: 1.18-1.70, p < 0.001), multifocal disease (HR = 1.63, 95% CI: 1.25-2.13, p < 0.001), biopsy vs. resection (HR = 1.35, 95% CI: 1.04-1.72, p = 0.02), un-methylated promoter of the MGMT (O-methylguanine-DNA methyltransferase) gene (HR = 1.71, 95% CI: 1.42-2.04, p < 0.001). The model was validated internally and had a concordance index of 0.65.

Conclusion: A nomogram for overall survival was established. This model can be used for risk stratification and treatment planning, as well as improve enrollment criteria for clinical trials.
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http://dx.doi.org/10.3389/fonc.2021.597587DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7946965PMC
February 2021

Disentangling the relationship between bone turnover and glucose homeostasis: A prospective, population-based twin study.

Bone Rep 2021 Jun 5;14:100752. Epub 2021 Feb 5.

Department of Endocrinology, Odense University Hospital, Denmark.

Background: Biochemical markers of bone turnover are lower in patients with type 2 diabetes, which may be explained by genetic variants being associated with type 2 diabetes and bone turnover as well as environmental factors. We hypothesized that bone turnover markers associate with and predict changes in glucose homeostasis after control for genetics and shared environment.

Methods: 1071 healthy, non-diabetic (at baseline, 1997-2000) adult mono- and dizygotic twins participating in the prospective study GEMINAKAR were reassessed between 2010 and 2012 with clinical evaluation, biochemical tests and oral glucose tolerance test. Fasting bone turnover markers (CTX, P1NP and osteocalcin) were measured. The association between bone turnover, glucose homeostasis and the ability of bone turnover markers to predict changes in glucose homeostasis were assessed in cross-sectional and longitudinal analyses. Analyses were performed both at an individual level and adjusted for shared environmental and genetic factors.

Results: Glucose levels increased with age, and 33 (3%) participants had developed type 2 diabetes at follow-up. In women, bone turnover markers increased with age, whereas for men only osteocalcin increased with age. Bone turnover markers were not associated with fasting glucose, insulin, or HOMA-IR at baseline or follow-up before or after adjustment for age, sex, BMI, smoking, and use of medication at baseline. Variation in bone turnover markers was mainly explained by unique environmental factors, 70%, 70% and 55% for CTX, P1NP and osteocalcin, respectively, whereas additive genetic factors explained 7%, 13% and 45% of the variation in CTX, P1NP and osteocalcin.

Conclusions: Bone turnover markers were not associated with baseline plasma glucose levels and did not predict changes in glucose homeostasis. Variation in bone turnover markers is mainly explained by environmental factors, however, compared to CTX and P1NP, genetic factors have a larger impact on osteocalcin levels.
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http://dx.doi.org/10.1016/j.bonr.2021.100752DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900018PMC
June 2021

The PROMova study comparing active and passive use of patient-reported outcome measures in ovarian cancer follow-up: effect on patient-perceived involvement, satisfaction with care, and usefulness.

Acta Oncol 2021 Apr 2;60(4):434-443. Epub 2021 Mar 2.

Department of Oncology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.

Background: Patients with ovarian cancer often experience substantial health problems and side effects resulting in reduced quality of life (QoL). Different models of using patient-reported outcome measures (PROMs) during follow-up may improve the quality of care. This national, multicenter observational study investigated the effect of active use of PROMs on patient-perceived involvement, satisfaction with care, unmet needs, and QoL during follow-up of ovarian cancer.

Material And Methods: Ovarian cancer patients were recruited at the end of primary treatment at eight centers in Denmark. During 18 months of follow-up patients repeatedly completed European Organization for Research and Treatment of Cancer (EORTC) questionnaires covering health related QoL and symptoms. At the sites using PROMs actively (ACT), the clinician had access to an overview of the patient's scores during the clinical encounter. Clinicians using PROMs passively were alerted in case of severe development of symptoms. Following each encounter, patients evaluated their health service experience by completing the CollaboRATE scale of involvement in decision making, the Patient Experience Questionnaire, and ad hoc questions covering patient-perceived usefulness of the PROMs.

Results: A total of 223 patients were enrolled, i.e., 168 (75.3%) at five sites using ACT and 53 (23.8%) at three sites using them passively. We found no statistically significant difference in involvement in the decision making, satisfaction with care, unmet needs, and QoL between the two groups. The majority of patients found it useful to complete the PROMs, although it did not seem to significantly support them in raising issues with the oncologist.

Conclusion: Active use of PROMs did not improve patients' experience of involvement in follow-up care as compared to passive use.
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http://dx.doi.org/10.1080/0284186X.2021.1891281DOI Listing
April 2021

Characteristics of culprit lesion in patients with non-ST-elevation myocardial infarction and improvement of diagnostic utility using dual energy cardiac CT.

Int J Cardiovasc Imaging 2021 May 27;37(5):1781-1788. Epub 2021 Jan 27.

Department of Medical Research, OUH Svendborg Hospital, Institute of Regional Health Research, Valdemarsgade 53, 5700, Svendborg, Denmark.

Aims: The aim of the study was to identify the characteristics of the culprit lesions compared to non-culprit lesions in patients with non-ST-elevation-myocardial infarction using dual energy computed tomography (DECT).

Methods And Results: In 29 patients, we identified 29 culprit lesions and 227 non-culprit lesions. Quantitative values such as the effective atomic number (effective-Z) and Hounsfield Units (HU) values were measured. Furthermore, all the lesions were characterised using characteristics such as composition (non-calcified, predominantly-non-calcified, predominantly-calcified, or calcified), presence of spotty calcification, remodelling index, and napkin ring sign. The mean effective-Z and HU values were significantly lower in culprit lesions than in non-culprit lesions (8.99 ± 1.21 vs 9.79 ± 1.52; p = 0.0066 and 87.41 ± 84.97 vs. 154.45 ± 176.13; p = 0.0447). The culprit lesions had a higher frequency of non-calcified plaques and predominantly non-calcified plaques, and were with a greater presence of napkin ring signs in comparison with non-culprit lesions. There were no differences in the presence of spotty calcification or remodelling index. By adding effective-Z to plaque characteristics such as non-calcified, positive remodelling, spotty calcification, and napkin rings we observed a significant increased sensitivity of detecting culprit lesions (65.5% vs.44.8%), but no significant changes in area under curve (AUC).

Conclusion: The use of DECT adds new information of the plaque composition expressed by the effective-Z, which differs significantly in culprit lesions in comparison with non-culprit lesions. The use of the effective-Z improves the diagnostic sensitivity in detection of culprit lesions.
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http://dx.doi.org/10.1007/s10554-020-02141-8DOI Listing
May 2021

Confidence Limits of Word Identification Scores Derived Using Nonlinear Quantile Regression.

Trends Hear 2021 Jan-Dec;25:2331216520983110

Department of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark.

The relation between degree of sensorineural hearing loss and maximum speech identification scores (PB) is commonly used in audiological diagnosis and rehabilitation. It is important to consider the relation between the degree of hearing loss and the lower boundary of PB, as the PB varies largely between subjects at a given degree of hearing loss. The present study determines the lower boundary by estimating the lower limit of the one-tailed 95% confidence limit (CL) for a Dantale I, word list, in a large group of young and older subjects with primarily sensorineural hearing loss. PB scores were measured using Dantale I, at 30 dB above the speech reception threshold or at the most comfortable level from 1,961 subjects with a wide range of pure-tone averages. A nonlinear quantile regression approach was applied to determine the lower boundary (95% CL) of PB scores. At a specific pure-tone average, if the measured PB is poorer than the lower boundary (95% CL) of PB, it may be considered poor.
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http://dx.doi.org/10.1177/2331216520983110DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841653PMC
April 2021

Intended and unintended changes in length of stay following reconfiguration of emergency care departments.

Int J Qual Health Care 2021 Feb;33(1)

Department of Emergency Medicine, Hospital of South West Jutland, Finsensgade 35, Esbjerg 6700, Denmark.

Background: The Danish health-care system has witnessed noticeable changes in the acute hospital care organization. The reconfiguration includes closing hospitals, centralizing acute care functions and investing in new buildings and equipment.

Objective: To examine the impact on the length of stay (LOS) and the proportion of overnight stays for hospitalized acute care patients.

Methods: This nationwide interrupted time series examined trend changes in LOS and overnight stay. Admissions were stratified based on admission time (weekdays/weekends and time of day), age and the level of co-morbidity.

Results: In 2007-2016, the global average LOS declined 2.9% per year (adjusted time ratio [CI (confidence interval) 95%] 0.971 [0.970-0.971]). The reconfiguration was overall not associated with change in trend of LOS (time ratio [CI 95%] 1.001 [1.000-1.002]). When admissions were stratified for either weekdays or weekends, the reconfiguration was associated with reduction of the underlying downward trend for weekdays (time ratio [CI 95%] 1.004 [1.003-1.005]) and increased downward trend for weekend admissions (time ratio [CI 95%] 0.996 [0.094-0.098]). Admissions at night were associated with a 0.7% trend change in LOS (time ratio [CI 95%] 0.993 [0.991-0.996]). The reconfiguration was not associated with trend changes for overnight stays.

Conclusion: The nationwide reconfiguration of acute hospital care was overall not associated with change in trend for the registered LOS and no change in trend for overnight stays. However, the results varied according to hospitalization time, where admissions during weekends and nights after the reconfiguration were associated with shortened LOS.
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http://dx.doi.org/10.1093/intqhc/mzab008DOI Listing
February 2021

Needle aspiration treatment vs. incision of acute simple perianal abscess: randomized controlled study.

Int J Colorectal Dis 2021 Mar 15;36(3):581-588. Epub 2021 Jan 15.

Research Unit for Surgery, Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense C, Denmark.

Purpose: Needle aspiration of an acute simple perianal abscess may be an alternative to conventional incision drainage with potential advantages in wound healing, functional outcome, and quality of life. The aim and objectives of the study are to compare the outcome of needle aspiration and postoperative antibiotics with that of conventional surgical incision drainage of acute perianal abscess. The primary outcome was abscess recurrence. Secondary outcomes were fistula formation, wound healing, quality of life, and fecal continence.

Methods: This is a three-center randomized controlled trial, including adults with acute perianal abscess. The needle aspiration group received clindamycin for one week postoperatively. All included patients were scheduled for a follow-up at 2, 12, and 52 weeks postoperatively including physical examination, quality of life assessment (SF 36 questionnaire), and fecal continence (Wexner score).

Results: A total of 98 patients were included. The recurrence rate was 41% in needle aspiration and 15% in incision drainage, with HR of 3.033 (p = 0.014). Fistula formation was 15% without significant difference between the groups. There was no significant difference in wound healing, quality of life, or fecal incontinence scores.

Conclusion: Needle aspiration with postoperative antibiotics cannot be recommended as an alternative for surgical incision in the treatment of acute perianal abscess.

Trial Registration Number: ClinicalTrials.org with identification number NCT02585141, initial release on 15 October 2015.
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http://dx.doi.org/10.1007/s00384-021-03845-6DOI Listing
March 2021

Chronic Inflammatory Diseases - Diabetes Mellitus, Rheumatoid Arthritis, Coeliac Disease, Crohn's Disease, and Ulcerative Colitis Among the Offspring of Affected Parents: A Danish Population-Based Registry Study.

Clin Epidemiol 2021 7;13:13-20. Epub 2021 Jan 7.

Open Patient Data Explorative Network (OPEN), Department of Clinical Research, Odense University Hospital and University of Southern Denmark, Odense, Denmark.

Background: Chronic inflammatory diseases (CIDs) may share aetiological factors across diseases. We used registry data to evaluate the risk of developing five common childhood CIDs dependent on the parents' disease status.

Methods: We performed a national population-based registry study by linking data from the national Danish health registers from January 1973 to March 2016 to evaluate any potential associations between parents' disease and development of CIDs among the offspring. Results were adjusted for parental age at birth, the decade of birth, gender of the child, and type of birth. A cohort of 2,699,449 liveborn children was established for investigating the primary outcome measures: diabetes mellitus (DM), rheumatoid arthritis (RA), coeliac disease, Crohn's disease (CD), and ulcerative colitis (UC) and all diseases combined (CID).

Results: Children with one CID affected parent (Hazard ratio (HR), 95% confidence interval (95% CI)=1.75 (1.72-1.79, p<0.001)), one multiple CID affected parent (HR=2.23 (2.11-2.34), p<0.001), and both parents affected (HR=3.10 (2.98-3.22), p<0.001) were at higher risk than children without CID affected parents. Children with DM, RA, and COE affected parents were at increased risk of three specific diseases (DM, RA and COE), whereas children with CD and UC affected parents were at increased risk of two specific diseases (CD and UC).

Conclusion: Children with CID affected parents were at increased risk of the same CID as their parents as well as other specific CIDs dependent on the parents' CID. Future studies should address the aetiology underlying these findings to support the development of new strategies for prevention, treatment, and cure.
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http://dx.doi.org/10.2147/CLEP.S286623DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7800432PMC
January 2021

ePRO-based individual follow-up care for women treated for early breast cancer: impact on service use and workflows.

J Cancer Surviv 2021 Jan 7. Epub 2021 Jan 7.

Department of Oncology, Lillebaelt Hospital, University Hospital of Southern Denmark, Beriderbakken 4, DK-7100, Vejle, Denmark.

Purpose: The increasing population of breast cancer survivors highlights the need to (re)consider how we utilize available services for survivorship care in oncology clinics. Electronic Patient-Reported Outcomes (ePROs) can be used to identify patients' individual care needs and triage them to the right services. We examined the impact on service use, workflow and workload following the introduction of an ePRO-based individual follow-up (PIFU) for women treated for early breast cancer.

Methods: A multi-method approach was used. In a pilot randomized controlled trial, the use of consultations, telephone calls, and specialist referrals were systematically recorded. Comparison was done between PIFU and standard follow-up care (SFU). Focus group interviews with nurse navigators evaluated the impact on workflow and workload qualitatively.

Results: The 64 women randomized to attend SFU used a mean of 3.8 (95% CI: 3.5-4.1) planned consultations during the 2-year study period compared with a mean of 1.9 consultations (95% CI: 1.4-2.4) for the 60 women randomized to PIFU (P < 0.001). Urgent appointments were more frequent in SFU (mean of 0.47 vs 0.22 per patient, P = 0.03). No statistically significant differences were observed in the use of telephone calls and specialist referrals. The nurse navigators did not experience an increase in their workload, but implementation of PIFU may require a re-structured workflow.

Conclusions: The ePRO-based individual follow-up could change organization of care and re-allocate services for those in need of it.

Implications For Cancer Survivors: ePRO-based individual follow-up could potentially ensure more time for those most in need of face-to-face care.
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http://dx.doi.org/10.1007/s11764-020-00942-3DOI Listing
January 2021

Health-related quality of life in patients with multiple myeloma participating in a multidisciplinary rehabilitation program.

Ann Hematol 2021 Jan 6. Epub 2021 Jan 6.

REHPA - The Danish Knowlegde Centre for Rehabilitation and Palliative Care, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.

Patients with multiple myeloma (MM) report high symptom burden and functional disabilities resulting in impaired health-related quality of life (HRQoL). Effective evidence-based rehabilitation guidelines are needed for patients with MM to improve HRQoL. The primary aim of this study was to investigate HRQoL in patients with rehabilitation needs living their everyday life. Patients with MM in remission attended a 12-week multidisciplinary rehabilitation program including a 5-day residential course, home-based exercise and a 2-day follow-up course. The patients were referred by the treating haematologist and completed a booklet of validated HRQoL questionnaires at baseline and before arriving for the 2-day follow-up course. The proportion of participants with moderate to severe symptoms and functional problems were assessed at the two time points and multivariate logistic regression was used to investigate explaining factors of impaired HRQoL at baseline. Ninety-two patients participated with a follow-up compliance rate of 90%. Median age was 67 years and median time since diagnosis was 26 months (ranged 5 months to 15.6 years). The most frequently reported symptoms were global quality of life, role functioning, fatigue, pain, peripheral neuropathy and physical functioning. Pain and fatigue were both highly coherent with impairment in physical functioning and those two symptoms explained most HRQoL impairments. Overall, the participants reported no change in HRQoL after the 12-week rehabilitation program. The study supports the need for an evidence-based guideline for rehabilitation and palliative care to patients with MM in remission living their everyday life.
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http://dx.doi.org/10.1007/s00277-020-04356-0DOI Listing
January 2021

The Psychometric Hepatic Encephalopathy Syndrome score does not correlate with blood ammonia, endotoxins or markers of inflammation in patients with cirrhosis.

Transl Gastroenterol Hepatol 2021 5;6. Epub 2021 Jan 5.

Gastrounit, Medical Division, University Hospital Hvidovre, Hvidovre, Denmark.

Background: The pathogenesis of hepatic encephalopathy (HE) remains unclear but impaired clearance of gut-derived neurotoxins and increased systemic inflammation are thought to play key roles. The diagnosis is based on detection of neurophysiological and neuropsychometric abnormalities. The Psychometric Hepatic Encephalopathy Score (PHES) have been found to correlate with markers of systematic inflammation including interleukin 6, C-reactive protein (CRP) and tumor necrosis factor-α (TNF-α). This study explores the associations between the PHES score and systemic inflammation, endotoxins and disease severity using baseline data from a trial involving patients with cirrhosis and minimal or no HE (NCT01769040).

Methods: Arterial blood was obtained during hepatic vein catheterization, from 54 patients [median age 55 (range, 33-70) years; 83% men] with decompensated but stable cirrhosis. None had clinical evidence of HE but 34 (55.6%) had an abnormal PHES score indicating the presence of minimal HE. Relationships were sought between the PHES score and markers of systemic inflammation, high sensitivity-CRP, cytokines (SDF-1α, TGF-b1, IP-10, IL-6, 10 and 18, and TNF-α; lipopolysaccharide (LPS), the lipopolysaccharide binding protein (LBP) and soluble CD14 (sCD14); and the blood ammonia.

Results: No significant relationships were found between the PHES score and any of the variables tested with the single exception of the correlation with serum IL-6 (r=-0.29, 95% confidence interval, -0.53 to -0.02, P=0.031). No independent predictors of the PHES score were identified in regression analyses.

Conclusions: No predictive associations were identified between the PHES scores and circulating blood ammonia, endotoxins, or markers of systemic inflammation in this patient population.
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http://dx.doi.org/10.21037/tgh.2020.02.14DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724176PMC
January 2021

Associations of Empagliflozin With Left Ventricular Volumes, Mass, and Function in Patients With Heart Failure and Reduced Ejection Fraction: A Substudy of the Empire HF Randomized Clinical Trial.

JAMA Cardiol 2021 Jan 6. Epub 2021 Jan 6.

Research Unit of Cardiology, Department of Cardiology, Odense University Hospital, Odense, Denmark.

Importance: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) improve outcomes in patients with heart failure and a reduced ejection fraction (HFrEF). The association with cardiac remodeling has not been investigated.

Objective: To investigate the outcome of the SGLT2i empagliflozin, compared with placebo, on cardiac remodeling in patients with HFrEF.

Design, Setting, And Participants: This exploratory post hoc analysis included participants with stable HFrEF and ejection fractions of 40% or less, who were randomly enrolled in an investigator-initiated, multicenter, double-blind, placebo-controlled randomized clinical trial in Denmark. Enrollment commenced on June 29, 2017, and continued through September 10, 2019, with the last participant follow-up on December 20, 2019.

Interventions: Randomization (1:1) to empagliflozin (10 mg once daily) or matching placebo in addition to recommended heart failure therapy for 12 weeks.

Main Outcomes And Measures: Efficacy measures were changes from baseline to week 12 in left ventricular end-systolic and end-diastolic volume indexes, left atrial volume index, and left ventricular ejection fraction adjusted for age, sex, type 2 diabetes, and atrial fibrillation. Secondary efficacy measures included changes in left ventricular mass index, global longitudinal strain, and relative wall thickness.

Results: A total of 190 patients were randomized (95 each receiving empagliflozin and placebo), with a mean (SD) age of 64 (11) years; 162 were men (85.3%), 97 (51.1%) had ischemic HFrEF, 24 (12.6%) had type 2 diabetes, and the mean (SD) latest recorded left ventricular ejection fraction was 29% (8%). Of the 190, 186 completed the study. Empagliflozin significantly reduced left ventricular end-systolic volume index (-4.3 [95% CI, -8.5 to -0.1] mL/m2; P = .04), left ventricular end-diastolic volume index (-5.5 [95% CI, -10.6 to -0.4] mL/m2; P = .03), and left atrial volume index (-2.5 [95% CI, -4.8 to -0.1] mL/m2; P = .04) compared with placebo at 12 weeks' follow-up, with no change in left ventricular ejection fraction (1.2% [95% CI, -1.2% to 3.6%]; P = .32). These findings were consistent across subgroups. Of secondary efficacy measures, left ventricular mass index was significantly reduced by empagliflozin (-9.0 [95% CI, -17.2 to -0.8] g/m2; P = .03).

Conclusions And Relevance: In this small, randomized, short-term study, empagliflozin was associated with modest reductions in left ventricular and left atrial volumes with no association with ejection fraction. Effects beyond 12 weeks of SGLT2i use require further study.

Trial Registration: ClinicalTrials.gov Identifier: NCT03198585.
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http://dx.doi.org/10.1001/jamacardio.2020.6827DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788505PMC
January 2021

An Extension of the Bland-Altman Plot for Analyzing the Agreement of More than Two Raters.

Diagnostics (Basel) 2021 Jan 1;11(1). Epub 2021 Jan 1.

Department of Clinical Research, University of Southern Denmark, 5000 Odense C, Denmark.

The Bland-Altman plot is the most common method to analyze and visualize agreement between raters or methods of quantitative outcomes in health research. While very useful for studies with two raters, a limitation of the classical Bland-Altman plot is that it is specifically used for studies with two raters. We propose an extension of the Bland-Altman plot suitable for more than two raters and derive the approximate limits of agreement with 95% confidence intervals. We validated the suggested limit of agreement by a simulation study. Moreover, we offer suggestions on how to present bias, heterogeneity among raters, as well as the uncertainty of the limits of agreement. The resulting plot could be utilized to investigate and present agreement in studies with more than two raters.
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http://dx.doi.org/10.3390/diagnostics11010054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824071PMC
January 2021

Similar lipid level changes in early rheumatoid arthritis patients following 1-year treat-to-target strategy with adalimumab plus methotrexate versus placebo plus methotrexate: secondary analyses from the randomised controlled OPERA trial.

Rheumatol Int 2021 Mar 2;41(3):543-549. Epub 2021 Jan 2.

Faculty of Health Sciences, Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, J.B. Winsløws Vej 4, Indgang 96, 1. Sal, 5000, Odense, Denmark.

To compare changes in low-density lipoprotein cholesterol and other lipids in patients with rheumatoid arthritis (RA) randomised to a 1-year treat-to-target strategy with either adalimumab plus methotrexate or placebo plus methotrexate. Prespecified secondary analyses from the OPERA trial, where 180 early and treatment-naïve RA patients received methotrexate 20 mg once weekly in combination with either placebo or subcutaneous adalimumab 40 mg every other week. Serum lipid levels were measured at baseline and after 1 year. Changes in lipid levels were analysed using mixed linear models based on the intention-to-treat (ITT) population. Overall, 174 patients were included in the ITT population (adalimumab plus methotrexate n = 86; placebo plus methotrexate n = 88). Differences between changes in lipid levels were low-density lipoprotein cholesterol 0.18 mmol/l [95% CI - 0.05 to 0.42], total cholesterol 0.27 mmol/l [- 0.002 to 0.54], high-density lipoprotein cholesterol 0.05 mmol/l [- 0.06 to 0.15], triglycerides 0.11 mmol/l [- 0.08 to 0.29], very-low-density lipoprotein cholesterol 0.03 mmol/l [- 0.05 to 0.12], and non-high-density lipoprotein cholesterol 0.22 mmol/l [- 0.02 to 0.46]. In early RA patients treated to tight control of inflammation over a period of 1 year with either adalimumab plus methotrexate or placebo plus methotrexate, changes in lipid levels were similar. Trial registration number: NCT00660647.
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http://dx.doi.org/10.1007/s00296-020-04756-5DOI Listing
March 2021

Variability Matters.

Int J Environ Res Public Health 2020 12 28;18(1). Epub 2020 Dec 28.

Department of Clinical Research, University of Southern Denmark, Winsløwsvej 9B, 5000 Odense, Denmark.

Much of science, including public health research, focuses on means (averages). The purpose of the present paper is to reinforce the idea that variability matters just as well. At the hand of four examples, we highlight four classes of situations where the conclusion drawn on the basis of the mean alone is qualitatively altered when variability is also considered. We suggest that some of the more serendipitous results have their origin in variability.
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http://dx.doi.org/10.3390/ijerph18010157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7795489PMC
December 2020

The effect of compression therapy on post-surgical swelling and pain after total knee arthroplasty.

Int J Orthop Trauma Nurs 2020 Aug 28:100815. Epub 2020 Aug 28.

OPEN Open Patient data Explorative Network, Odense University Hospital, Denmark.

Background: We hypothesized that the use of a graduated medical elastic thigh compression stocking for 14 days after total knee arthroplasty would reduce swelling by 2 cm and reduce pain among patients with a BMI ≥30 kg/m. The aim of this pilot study was to provide preliminary data and information about feasibility. The specified objectives were to investigate: 1) the level of post-surgical swelling and, 2) the level of post-surgical pain, 14 days after surgery.

Methods: In a randomized controlled pilot study, 44 patients were allocated to a graduated medical elastic thigh compression stocking or standard treatment for 14 days after total knee arthroplasty. Outcome measures were knee, calf, and ankle swelling and pain. Study feasibility included acceptable rates of written consent and compliance with the use of the compression stocking. Data was analyzed using two-sample t-test for equality of mean.

Results: Overall, 68.8% of eligible patients gave written consent to participate in the study and 41.2% complied with use of the graduated medical elastic thigh compression stocking for 14 days post-surgery. No significant difference was found between the groups regarding knee, calf and ankle swelling or pain.

Interpretation: Knee swelling was reduced in both groups after 14 days, but was slightly more in the intervention group. The result is not statistically significant but indicates that a graduated medical elastic thigh compression stocking may have a positive effect on reduction of swelling after total knee arthroplasty. Initiating a larger scale randomized controlled study to determine effectiveness requires a higher level of compliance.
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http://dx.doi.org/10.1016/j.ijotn.2020.100815DOI Listing
August 2020