Search

Background Infant crying may cause concerns among new parents and is a frequent reason for seeking help from their general practitioner (GP). The etiology of crying problems in infancy is not fully understood, but recent studies have found associations with maternal mental factors. It is well-established that postpartum depression is related to infant crying problems while the influence of maternal mental problems in pregnancy on infant crying is less investigated. We aimed to explore whether maternal depressive symptoms or maternal anxiety during pregnancy were related to crying problems by the newborn child. Methods In this prospective cohort study, 1290 pregnant women and their newborn children were followed throughout pregnancy until 8 weeks postpartum. Depressive symptoms and anxiety symptoms were assessed three times during pregnancy and again 8 weeks postpartum with the Major Depressive Inventory (MDI) and the Anxiety Symptoms Scale (ASS). Eight weeks postpartum the mothers were also asked whether their child cried in a way they found problematic. Multivariable regression was used to assess the association between depressive and anxiety symptoms during pregnancy and crying problems, and to adjust for potential confounders. Results We found statistically significant associations between high scores of depressive symptoms and anxiety symptoms in pregnancy and infant crying problems. Previously reported strong associations postpartum between depressive symptoms, anxiety symptoms and infant crying problems were also observed in the present data. Conclusion These results indicate that mental problems during pregnancy are associated with having a child with crying problems after birth. If more focus is given to maternal mental problems during pregnancy, the healthcare system might be able to detect and help these women, which would be beneficial for both mother and child.

Content validity is the most important property of PROMs. The COSMIN initiative has published guidelines for evaluating the content validity of PROMs, but they have only sparsely been applied to relevant PROMs for musculoskeletal conditions. The aim of this study was to use the COSMIN Risk of Bias checklist to evaluate the content validity of five PROMs, that are highly relevant in musculoskeletal research and used by the arthroscopic surgery community: the modified Harris’ Hip Score (mHHS), the Copenhagen Hip and Groin Outcome Score (HAGOS), the International Knee Documentation Committee Subjective Knee evaluation Form (IKDC-SKF), the Knee injury and Osteoarthritis Outcome Score (KOOS) and the Knee Numeric-Entity Evaluation Score ACL (KNEES-ACL). The development articles for the five PROMs were identified through searches in PubMed and SCOPUS. A literature search was performed to identify additional studies assessing content validity of the PROMs. Additional information, necessary for the assessments, was obtained from the PROM developers after direct request. To evaluate the quality of the development studies and rate the content validity, the COSMIN Risk of Bias checklist was applied to all studies. All five development studies were identified. Three subsequent content validity studies were identified, all evaluating KOOS and one also IKDC. One content validity study was of inadequate quality and excluded from further analysis. The development of mHHS, IKDC-SKF, and KOOS was rated inadequate and possess insufficient content validity for their target populations. Due to the irrelevance of multiple items, KOOS was in particular inappropriate to evaluate patients with an ACL injury. The development of HAGOS was also rated inadequate, although the insufficiency aspects can be regarded as minor. KNEES-ACL possessed sufficient content validity. Out of five PROMs, only KNEES-ACL possessed sufficient content validity. Particularly, KOOS should not be used as an outcome for patients with an ACL injury. There is an urgent need for condition-specific PROMs for musculoskeletal conditions, developed with adequate methods. III.

This study aimed to describe prescription of antibiotics to the elderly population in general practice in Denmark from 2010–2017. This is a national register-based observational study. General practice, Denmark The main outcome measure was prescriptions/1,000 inhabitants/day (PrID) in relation to year, age and sex, indication, and antibiotic agent. In this study, we included inhabitants of Denmark, ≥65 years of age between 01st July 2010–30th June 2017. A total of 5,168,878 prescriptions were included in the study. Antibiotic prescriptions decreased from 2.2 PrID to 1.7 (-26.9%, CI95% [-31.1;-22.4]) PrID during the study. The decrease in PrID was most noticeable among 65–74-year-olds (-25%). The ≥85-year-olds were exposed to twice as many PrID than the 65–74-year-olds, but only accounted for 20% of the total use. Urinary tract infection (UTI) was the most common indication for antibiotic prescription and increased with advancing age. The most commonly prescribed antibiotics were pivmecillinam and phenoxymethylpenicillin. Prescribing with no informative indication was present in one third of all cases. The prescription of antibiotics in the elderly population in general practice decreased from 2010 to 2017. The oldest age group was exposed twice as frequently to antibiotic prescriptions as the 65–74-year-olds. The smallest reduction was observed for the ≥85-year-olds, suggesting targeting interventions at this group.Key PointsHigh antibiotic use among elderly is well known and studies indicate mis- and overuse within this population. Our study shows.The prescription rate is decreasing within all age groups of the elderly population.The ≥85-year-olds receive twice as many prescriptions/1000/day as the 65–74-years-olds. High antibiotic use among elderly is well known and studies indicate mis- and overuse within this population. Our study shows. The prescription rate is decreasing within all age groups of the elderly population. The ≥85-year-olds receive twice as many prescriptions/1000/day as the 65–74-years-olds.

Aims: Maternal mental distress in pregnancy can be damaging to the mother’s and child’s physical and mental health. This study aimed to provide an insight into mental well-being of pregnant women in Denmark during COVID-19 by assessing symptoms of depression and anxiety. Methods: Data from two cohorts of pregnant women recruited from Danish general practice were compared. A COVID-19 lockdown cohort ( N=330) completed questionnaires between 8 April and 6 May. Responses were compared to those from a control cohort of women from 2016 ( N=1428). Mental well-being was measured with the Major Depression Inventory (MDI) and the Anxiety Symptom Scale (ASS). Results: Questionnaires were returned by 83% of the COVID-19 lockdown cohort and by 93% of the control cohort. Multivariable analysis controlling for age, cohabitation status, occupation, smoking, alcohol use, chronic disease, fertility treatment, parity and children living at home showed no difference in depressive symptoms (MDI). Anxiety symptoms (ASS) were slightly worse in the COVID-19 lockdown cohort (mean difference=1.4 points), mainly driven by questions concerning general anxiety. The largest differences in anxiety were seen in first trimester (adjusted mean difference=4.0 points). Conclusions: Pregnant women questioned during the COVID-19 pandemic showed no change in symptoms of depression and only a modest elevation of anxiety when compared to pregnant women questioned during a non-pandemic period in 2016.

Results by patient-reported outcome measures (PROMs) from randomized controlled trials (RCTs) in musculoskeletal research often influence healthcare strategies. We aimed to evaluate to which extent these RCTs use adequate PROMs, and how this influences the results and conclusions. We identified RCTs of sports research relevance with PROMs as primary outcomes published in 13 preselected journals between January 1, 2008, and November 1, 2019; all journals regularly publish results from musculoskeletal research. Five journals have a high impact factor (>15), and eight with lower impact factors are widely read journals. It was assessed whether the RCTs had used PROMs with high content validity and whether the most adequate PROMs were used (ie, the most well developed and well validated for the patients enrolled in the study). We registered journal impact factor, year of publication, existence of a registered protocol, and whether the study showed significant difference between interventions. A total of 54 RCTs with 56 primary outcomes comprising 26 different PROMs were identified. For 13 RCTs (24%), a protocol was not published. In only 24 of RCTs (44%), the most appropriate PROM had been used as primary outcome, independent of a registered protocol, ranking of the journal, and year of publication. In seven cases, PROMs were used to evaluate a condition that they had not been developed for. RCTs that used the most adequate PROM showed significantly more often (46%) difference in outcomes in contrast to RCTs that used inadequate PROMs (22%) (P = 0.0483). In conclusion, in the majority of RCTs, the most adequate PROM had not been used. Studies, in which the most adequate PROM had been used as outcome, were significantly more likely to show significant difference between interventions. The extent to which protocols were not available was surprisingly high. Journals should request that adequate PROMs are used in RCTs, and if this is not the case that it is discussed how it might influence the results and conclusions. Likewise, it should be requested that a protocol is published or registered.

BACKGROUND: To curb future antibiotic resistance it is important to monitor and investigate current prescription patterns of antibiotics.OBJECTIVES: To examine trends in antibiotic prescription to children aged 0-6 years old and the association with socioeconomic status of municipalities in the Capital region of Denmark between 2009 and 2018.METHODS: This is a register-based study combining data on antibiotic treatments from 2009 to 2018, inhabitant-data and socioeconomic municipality scores. Subjects were children aged 0-6 years, residing in the Capital Region of Denmark. The study quantifies the use of antibiotics as number of antibiotic treatments/1000 inhabitants/year (TIY), inhabitants defined as children aged 0-6. Socioeconomic status of the municipalities is evaluated by a score from 3 to 12.RESULTS: The average TIY of the municipalities decreased from 741.2 [95%CI 689.3-793.2] in 2009 to 348.9 [329.4-368.4] in 2018. The difference between the highest and lowest prescribing municipalities was reduced from 648.3 TIY in 2009-212.5 TIY in 2018. The average increase in TIY per unit increase in socioeconomic municipality score changed from 20.05 [7.69-31.06] in 2009 to -4.58 [-16.02-5.60] in 2018, representing a decreasing association between socioeconomic municipality score and use of antibiotic in the respective municipalities.CONCLUSION: The trend in antibiotic prescription to children aged 0-6 years old decreased substantially in all the investigated municipalities in the 10-year study period. Local differences in prescription rates declined towards a more uniform prescription pattern across municipalities and association with socioeconomic status of the municipalities was reduced.

BACKGROUND: Urinary tract infection (UTI) is a common condition in general practice, and urine culture can help reduce inappropriate antibiotic prescriptions. In case of delay of the result, antibiotic treatment can be guided by one or more point-of-care (POC) tests. In Denmark, POC microscopy and POC urine culture are widely used for this purpose.OBJECTIVES: To investigate if availability of POC microscopy or POC culture in general practice was associated with a more appropriate treatment decision in patients with suspected UTI while waiting for the result from the microbiological laboratory.METHODS: This prospective observational study was conducted in 2016 in general practice in the Copenhagen area, Denmark. Data on all patients presenting in general practice with symptoms of UTI were registered anonymously and a urine sample was sent for culture at the microbiological laboratory. The association between the availability of POC tests and the appropriateness of antibiotic prescribing was assessed with multivariable logistic regression.RESULTS: Seventy-six general practices included 1545 patients (83% female); 71% received appropriate treatment in practices with POC culture available and 65% in practices without POC culture available (p = 0.042). Having a microscope available was not associated with more appropriate treatment (70% vs. 69%, p = 0.54).CONCLUSION: Availability of POC culture marginally increased appropriate treatment while waiting for the result from the microbiological laboratory. Practices should adopt a strategy where they either perform culture within the practice or send urine for culture at the microbiological laboratory.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02698332.

PURPOSE: To examine the incidence of mental disorders in children with cataract compared with children without cataract. DESIGN: Nationwide cohort study based on entries in comprehensive national databases. METHODS: The incidence of mental disorders in children born between 2000 and 2017 diagnosed with cataract before 10 years of age (n = 485) was compared with sex- and age-matched controls (n = 4358). Analyses were corrected to somatic disease in the child and parental socioeconomic status and psychiatric morbidity. The study was conducted as 2 university hospitals in Denmark managing children 6 years of age our younger with cataract. RESULTS: The incidence of mental disorders was nearly doubled in children with cataract compared with controls (odds ratio [OR], 1.83; 95% CI, 1.28–3.63). The risk of anxiety disorders was quadrupled (OR, 4.10; 95% CI, 1.90–8.84) and the risk of developmental delay was doubled (OR, 2.66; 95% CI, 1.45–4.90). The risk of mental disorders was significantly higher in children diagnosed with cataract in the first 3 years of life compared with controls (OR, 2.36; 95% CI, 1.53–3.64), whereas those diagnosed with cataract later in childhood did not have an increased risk (OR, 1.24; 95% CI, 0.66–2.30). CONCLUSIONS: The risk of mental disorders, in particular anxiety and neurodevelopmental delay, is markedly increased in children with cataract and even more so in those diagnosed within the first 3 years of life. Psychiatric screening instruments may be integrated in the management of these children.

Objective: The aim of the present study was to examine selection in a general practice-based pregnancy cohort. Design: Survey linked to administrative register data. Setting and subjects: In spring 2015, GPs were recruited from two Danish regions. They were asked to invite all pregnant women in their practice who had their first prenatal care visit before 15 August 2016 to participate in the survey. Outcome measures: The characteristics of GPs and the pregnant women were compared at each step in the recruitment process–the GP’s invitation, their agreement to participate, actual GP participation, and the women’s participation–with an uncertainty coefficient to quantify the step where the largest selection occurs. Results: Significant differences were found between participating and non-participating practices with regards to practice characteristics such as the number of patients registered with the practice, the age and sex of doctors, and the type of practice. Despite these differences, the characteristics of the eligible patients differed little between participating and non-participating practices. In participating practices significant differences were, however, observed between recruited and non-recruited patients. Conclusion: The skewed selection of patients was mainly caused by a high number of non-participants within practices that actively took part in the study. We recommend that a focus on the sampling within participating practices be the most important factor in representative sampling of patient populations in general practice.Key points Selection among general practitioners (GPs) is often unavoidable in practice-based studies, and we found significant differences between participating and non-participating practices. These include practice characteristics such as the number of GPs, the number of patients registered with the GP practice, as well as the sex and age of the GPs. •Despite this, only small differences in the characteristics of the eligible patients were observed between participating and non-participating practices. •In participating practices, however, significant differences were observed between recruited and non-recruited patients. •Comprehensive sampling within participating practices may be the best way to generate representative samples of patients.

To evaluate the surgical success after trabeculotomy for primary congenital glaucoma (PCG) in Denmark in the last 40 years.Retrospective review of medical files on children who all underwent trabeculotomy as the first surgical intervention between January 1rst, 1977 and December 31, 2016. Information on diagnosis and surgical procedures were extracted. Primary outcome was surgical success was defined as intraocular pressure (IOP) 21 mmHg without medications one year after surgery. Secondary outcome was the number of reoperations needed.Out of 118 children with PCG, 96 children (144 eyes) had an ab externo trabeculotomy as primary IOP lowering procedure opening Schlemm's channel 4 clock hours into the anterior chamber. Complete surgical success at one year was achieved in 73% (106 of 144 eyes). On the long term, IOP could be controlled by one surgical procedure in 2/3 of children, eight eyes required5 surgical procedures to control IOP. In 12.1% of children the second glaucoma procedure was performed5 years after the initial trabeculotomy. There was a tendency towards greater risk of needing a second procedure in patients 3 months of age at primary trabeculotomy (hazard ratio, HR, 2.01, 95% CI 0.96-4.22) and in boys (HR 2.02, 95% CI 0.97-4.18) and a lower risk of requiring a third surgery if the second surgery was trabeculectomy with MMC.Dedicated follow-up of patients with PCG is essential as the disease may continue to progress even after years of quiescence and some children need multiple surgeries to control IOP. Additional glaucoma procedures are required in 1/3 of children and boys and younger patients seem to be at greater risk.

Background Cardiac surgery is associated with a risk of complications, including post-operative cognitive dysfunction (POCD). In the randomized Perfusion Pressure Cerebral Infarcts (PPCI) trial, we allocated cardiac surgery patients to either a low-target mean arterial pressure (40-50 mm Hg) or a high-target pressure (70-80 mm Hg). The study found no difference in the volume of new ischemic cerebral lesions nor POCD, but 30-day mortality tended to be higher in the high-target group. In the present study we did a long-term 3-year follow-up to assess survival and level of cognitive functioning. The primary hypothesis was that patients allocated to a high-target blood pressure had a higher long-term mortality at 3-year follow-up. Methods We determined long-term mortality of patients included in the PPCI trial at 3-year follow-up using national registries and we assessed POCD using a cognitive test battery. Subjective level of functioning was assessed with questionnaires. POCD and subjective functioning at follow-up were evaluated in logistic regression models. Results Among the 197 patients who participated in the original study, there was no significant difference in mortality over a median of 3.4 years according to blood pressure target during cardiopulmonary bypass (hazards ratio 1.23 [high vs low] 95% confidence interval: 0.50-3.02, P = .65). POCD was found in 18.9% and 14.0% in the high-target and low-target groups, respectively adjusted odds ratio 1.01 (CI 95% 0.33-3.12). No differences were found for subjective functioning between groups. Conclusions No difference in mortality nor in the level of cognitive functioning was found according to blood pressure target during cardiac surgery long-term at 3-year follow-up.

BACKGROUND: Discrepancies exist in Danish guidelines for the treatment of bacterial community-acquired pneumonia (CAP). This study aimed to investigate how general practitioners (GPs) treat adults with CAP and explore associations between GP characteristics and treatment duration.METHODS: In autumn 2020, GPs in the North Denmark Region were asked to complete an electronic questionnaire on antibiotic prescribing for CAP. Information about GP gender, age, experience and type of practice was obtained. Multivariable logistic regression was used to analyse the association between GP characteristics and treatment duration.RESULTS: A total of 298 GPs were invited to participate of whom 108 completed the survey. Penicillin V was used as first line treatment for CAP by all participants. Treatment duration varied from 5 (54.6%) to 10 days (8.3%). A 5-day course of penicillin was less likely to be prescribed by male GPs (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.13-0.94) and more likely to be prescribed by GPs with 5-9 years of experience in general practice (OR 5.03, 95% CI 1.09-23.21) compared to those with 10-19 years of experience.CONCLUSION: Variation in antibiotic treatment of CAP emphasises the importance of generating solid evidence about the optimal duration regarding both effectiveness and safety.

Background: Few studies have investigated the importance of the time interval between contact to the emergency medical service and neurosurgical admission in patients with spontaneous subarachnoid haemorrhage. We hypothesised that longer time to treatment would be associated with an increased risk of death or early retirement.Methods: This was a retrospective observational study with 4 years follow-up. Those who reached a neurosurgical department in fewer than 4 h were compared with those who reached it in more than 4 h. Individual level data were merged from the Danish National Patient Register, medical records, the Copenhagen Emergency Medical Dispatch Centre, the Civil Registration System, and the Ministry of Employment and Statistics Denmark. Patients were ≥18 years and had a verified diagnosis of spontaneous subarachnoid haemorrhage. The primary outcome was death or early retirement after 4 years.Results: Two hundred sixty-two patients admitted within a three-and-a-half-year time period were identified. Data were available in 124 patients, and 61 of them were in their working age. Four-year all-cause mortality was 25.8%. No significant association was found between time to neurosurgical admission and risk of death or early retirement (OR = 0.35, 95% confidence interval [CI]: 0.10–1.23, p = 0.10).Conclusion: We did not find an association between the time from emergency telephone call to neurosurgical admission and the risk of death or early retirement.

Background: The use of telephone in delivering cancer care increases, but not in cancer workup. Current protocols for breaking bad news assume a single in-person meeting. Cancer workup involves multiple opportunities for patient information. We investigated the psychosocial consequences in gradually informed patients of receiving lung cancer workup results by telephone versus in-person. Methods: A randomised, controlled, open-label, assessor-blinded, single-centre trial including patients referred for invasive workup for suspected malignancy (clinical trials no. NCT04315207). Patients were informed on probable cancer at referral, after imaging, and on the day of invasive workup (Baseline visit). Primary endpoint: change (Δ) from baseline to follow-up (4 weeks after receiving workup results) in scores of a validated, sensitive, condition-specific questionnaire (COS-LC) assessing consequences on anxiety, behaviour, dejection and sleep. Results: Of 492 eligible patients, we randomised 255 patients (mean age: 68 years; female: 38%; malignancy diagnosed: 68%) to the telephone (n = 129) or in-person (n = 126) group. Groups were comparable at baseline and follow-up, and no between-groups difference in ΔCOS-LC was observed in the intention-to-treat population, or in subgroups diagnosed with or without malignancy. Conclusion: Breaking final result of cancer workup by telephone is not associated with adverse psychosocial consequences compared to in-person conversation in well-informed patients.

Purpose: The aim was to investigate and compare the prevalence of symptoms of depression throughout pregnancy and postpartum among women who at the first pregnancy consultation had (1) record of mental disease, (2) self-reported psychological difficulties but no record of mental disease, or (3) no mental vulnerability. Materials and methods: Prospective cohort study. An electronic questionnaire containing the Major Depression Inventory (MDI) was e-mailed to 1494 pregnant women after the first, second and third prenatal care consultation and eight weeks postpartum. High depression score was considered present with MDI scores of 21 or more. Information on sociodemographic, somatic comorbidities and previous psychiatric disorders was collected. We used logistic regression to estimate odds ratios with 95% confidence intervals. Results: The overall prevalence of symptoms of depression (MDI ≥ 21) dropped throughout pregnancy. At the first prenatal care consultation the prevalence was 15.3%, 10.7% in the second trimester, 9.3% in the third trimester and 5.6% postpartum. Logistic regression showed increased risk of symptoms of depression throughout pregnancy and postpartum for both women with mental disease and psychological difficulties. For each outcome, the increase in odds for the psychological difficulties group was about one third of the increase in odds for the mental illness group. Conclusions: Self-reported psychological difficulties may indicate higher odds of depressive symptoms. The healthcare staff meeting the pregnant women in early pregnancy have a good opportunity to identify this subgroup of vulnerable women by means of the Pregnancy Health Records and additional questions exploring women’s experiences with previous psychological difficulties.

Aim Diabetic foot ulcer (DFU) is a major complication of both Type 1 Diabetes (T1D) and Type 2 Diabetes (T2D); however research into risk factors for DFU does not separate between these two types. The purpose of the present investigation was to identify risk factors for development of first time DFU (FTDFU) over a period of 15 years in patients with T1D and T2D separately. Methods This retrospective cohort study included 25,220 feet from 5588 patients with T1D and 7113 patients with T2D treated in the period 2001–2015. Data on baseline characteristics and comorbidities were collected from electronic patient records. Influences of various risk factors for the development of FTDFU were assessed by hazard ratios (HR) from Cox proportional hazard regression models on time from enrolment to FTDFU diagnosis or end-of-follow-up. Results In T1D independent risk factors were male sex, age >60 years, high HbA1c, long diabetes duration, history of cardiovascular disease, macro-albuminuria, decreased visual acuity, advanced diabetic retinopathy, decreased/absent vibration sense, presence of patient reported symptoms of neuropathy, and absence of foot pulses. In T2D the independent risk factors were the same except age >60 years, a history of cardiovascular disease, and long diabetes duration. Conclusions This study documents that much of the standard clinical information obtained as part of the routine follow-up are also independent risk factors for development of FTDFU. This may be used to create a basis for in which patient and when prevention should be started.

Clinical signs of lower urinary tract disease in dogs are characteristic but non-specific for infection. It has been hypothesized that age, sex and neuter status influences the prevalence of urinary tract infection (UTI), but the predictive value of the combined clinical presentation has not been explored in dogs. The aim of the study was to assess clinical predictors (sex/neuter status, age, dysuria/stranguria, pollakiuria, macroscopic hematuria, malodorous urine and history of recurrent UTI) for bacterial cystitis, and to develop a clinical decision rule. Data was retrieved from medical records (retrospective cases) or from standardized recording sheets (prospective cases). Bacterial cystitis was defined as significant bacteriuria on quantitative bacterial culture in dogs with compatible clinical signs of urinary tract disease. Dogs of any breed, sex and age were included. A total of 1727 microbiology records were screened and 424 samples were included in the analysis. Bacterial cystitis was confirmed in 46% of the cases. Four variables predicted bacterial cystitis: sex/neuter status, age, pollakiuria and hematuria. A score was designated to each variable and a clinical rule was constructed. This rule attained an AUC of 0.75 and had sensitivity of 83% and specificity of 55% at its optimal cut-off (score ≥2.0). A score cut-off of ≥3.0 had a positive predictive value of 70%. Several factors predicted bacterial cystitis, but the clinical rule had only modest predictive value. Other variables or point-of-care test results should be included in future research to optimize overall precision.

Background Brain injury and cognitive dysfunction are serious complications after cardiac surgery. In the perfusion pressure cerebral infarcts (PPCI) trial, we allocated cardiac surgery patients to a mean arterial pressure of either 70-80 mm Hg (high-target) or 40-50 mm Hg (low-target) during cardiopulmonary bypass. In this secondary analysis, we aimed to assess potential differences in domain-specific patterns of cognitive deterioration between allocation groups and to investigate any associations of postoperative cognitive dysfunction (POCD) with diffusion-weighted magnetic resonance imaging (DWI)-detected brain lesions. Methods Of the 197 patients randomized in the PPCI trial, 89 in the low-target group and 80 in the high-target group had complete DWI datasets, and 92 and 80 patients had complete data for an evaluation of cognitive function at discharge respectively. Cognitive function was assessed prior to surgery, at discharge and at 3 months. DWI was obtained at baseline and on postoperative days 3 to 6. Results We found no statistically significant differences between the two groups when comparing the proportion of patients with a domain-specific deterioration over the pre-defined critical level in seven individual test variables at discharge. Significant deterioration was most common in tests thought to assess cognitive flexibility and interference susceptibility and least common in the memory test. POCD at discharge was more frequent in patients with DWI-positive brain lesions (OR adjusted for age and group allocation: 2.24 [95% CI 1.48-3.00], P = 0.036). Conclusions Domain-specific patterns of POCD were comparable between groups. A significant association was seen between DWI-positive brain lesions and POCD.

PURPOSE: To assess the association between exposure to physical workload throughout working life and risk of mobility limitations in midlife in a population-based Danish cohort.METHODS: The study was cross-sectional with a retrospective exposure assessment, and data were from a questionnaire used in the Copenhagen Aging and Biobank. Cumulative physical workload was estimated by combining information about the participants' employments and data from a job exposure matrix. Daily amount of lifting was standardised in ton-years (lifting 1000 kg/day/year) and grouped in 5 exposure groups (no/minor (1-2 ton-years)/low (3-10 ton-years)/moderate (11-20 ton-years)/high exposure (> 20 ton-years)). The outcome was self-reports of mobility limitations (running 100 m, walking 400 m, and climbing stairs to the 2nd floor) in midlife. The association between exposure and outcome was analysed using logistic regression models.RESULTS: We included 4996 men and 2247 women, mean age 56 years. 21% of men and 10% of women were in the highest exposure-group (> 20 ton-years). Higher cumulative exposure was associated with higher odds for mobility limitations. Exposure to more than 20 ton-years compared to no exposure increased the odds for limitations in walking, age-adjusted odds ratio (OR) 3.2 (95% CI: 2.4-4.3) for men, 2.3 (1.4-3.8) for women. Corresponding results for running: 2.5 (2.2-3.0) for men, 1.6 (1.2-2.2) for women, and for limitations in climbing stairs: 4.2 (3.3-5.2) for men, 1.7 (1.2-2.4) for women. Results were attenuated when confounders were added.CONCLUSIONS: Exposure to physical workload throughout working life is associated with higher odds for mobility limitations in midlife.

Purpose: First, to investigate associations between mobility limitations and use of general practitioners and hospitalizations of acute care sensitive conditions, respectively. Second, to investigate whether these associations vary by socio-demographic factors. Methods: The study included 3574 females and males aged 75 or 80 years from the Danish Intervention Study on Preventive Home Visits. Fixed-effects logistic and poisson regression models were applied to study the relationship between mobility limitations (measured two-four times) and general practitioner consultations and hospitalizations with acute care sensitive conditions each subsequent year, respectively. Results: Each additional mobility limitation was associated with 15% higher odds of general practitioner home consultation (Odds ratio 1.15, 95% CI 1.07;1.23) and 4% increased incidence rate of general practitioner consultations among those with ≥ 1 consultation (Incidence rate ratio 1.04, 95% CI 1.03;1.04). There were no associations between mobility limitations and whether older adults had at least one general practitioner consultation nor acute care sensitive condition hospitalization. Test of interactions (p < 0.03) showed that more mobility limitations were associated with greater incidence rate of general practitioner consultations among males compared to females, married compared to unmarried, and older adults with high compared to low financial assets. Conclusions: Older adults with more mobility limitations had more often a general practitioner home consultation. Mobility limitations were not associated with whether older adults had at least one general practitioner consultation, but increased mobility limitations were associated with higher contact rate among those who had ≥ 1 consultation, especially among males and older adults who were married or had high financial assets.

Fatigue in multiple sclerosis (MS) is a debilitating symptom and experienced by most patients. In recent studies investigating this phenomenon, the majority of patients had a relapsing-remitting disease course.Patients with progressive MS participating in one of three treatment trials during a period from 2010 to 2014 were included. Fatigue was assessed with the Fatigue Scale for Motor and Cognitive Functions (FSMC) and patients were further examined with a cognitive test battery, including Symbol Digit Modalities Test (SDMT), and 3 T MRI with subsequent quantitative analyses of 13 cortical regions of interest, deep grey matter and lesion volume.Twenty-two patients were enrolled. The thickness of the pre-central gyrus correlated significantly with motor fatigue. We found only a non-significant trend towards a correlation between cognitive fatigue and the thickness of the pre-central gyrus, the parietal inferior supra-marginal gyrus and the opercular part of the inferior frontal gyrus. 36% of participants had impaired processing speed and 9% had normal function on all tests. The scores on the FSMC-cognitive scale were related to performance on SDMT.In this exploratory study of patients with progressive MS, fatigue was related to processing speed. Motor fatigue was also related to the cortical thickness of the primary motor cortex and there was a trend towards a relationship between cognitive fatigue and the thickness of cortical areas involved in attentional processes. Additional studies are needed to further elucidate the relationship between regional cortical atrophy, cognitive functioning and the perception of fatigue.FSMC: Motor and Cognitive Functions; MS: Multiple Sclerosis; SDMT: Symbol Digit Modalities Test; MRI: Magnetic Resonance Imaging; RRMS: Relapsing-Remitting Disease Course; EDSS: Kurtzke Expanded Disability Status Scale; FLAIR: Fluid Attenuated Inversion Recovery; NAWM: Normal-Appearing White Matter; CGM: Cortical Grey Matter; CTh: Cortical Thickness; ROIs: Regions of Interest; Raven: Raven Progressive Matrices; TM A: Trail Making A; TM B: Trail Making B; Rey: Rey Complex Figure; Similarities: WAIS III Similarities; Stroop: Stroop Colour Naming Test; BDI: Becks Depression Inventory II.

ObjectivesTo investigate the psychosocial consequences of receiving a false-positive (no abnormalities) result or being diagnosed with polyps compared with receiving a negative result in a colorectal cancer (CRC) screening programme.Design and settingThis was a longitudinal study nested in the roll-out of the Danish CRC screening programme that targets all individuals aged 50–74 years.ParticipantsIn the inclusion period (April–September 2017), all positive screenees (n=1854) were consecutively enrolled and matched 2:1:1 on sex, age (±2 years), municipality and screening date with negative screenees (n=933) and individuals not yet invited to screening (n=933).Questionnaires were sent by mail to all eligible participants in Region Zealand, Denmark, after the screening result, 2 months and 12 months after the final result.Positive screenees who did not receive the follow-up procedure were excluded.Main outcome measuresThe primary outcomes were psychosocial consequences. Outcomes were measured with the CRC screening-specific questionnaire Consequences of screening in CRC with 11 outcomes after the screening result and with 21 outcomes at the two later assessments.ResultsAfter receiving the screening result, individuals with no abnormalities, low-risk and medium-risk and high-risk polyps scored significantly worse on 8 of 11 outcomes compared with the negative screenee group. At the 12-month follow-up, the differences were still significant in 8 of 21 outcomes (no abnormalities), 4 of 21 outcomes (low-risk polyps) and 10 of 21 outcomes (medium-risk and high-risk polyps). The negative screenee group and the group not yet invited to screening differed psychosocially on 5 of 11 outcomes after the screening result, but on none of the 21 outcomes at the 2 months and 12 months follow-up.ConclusionsThe study showed that there are both short-term and long-term psychosocial consequences associated with receiving a no abnormalities result or being diagnosed with polyps. The consequences were worst for individuals diagnosed with medium-risk and high-risk polyps.

Objective Teriflunomide is a once-daily, oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (MS). We studied clinical outcomes in a real-world setting involving a population-based large cohort of unselected patients enrolled in The Danish Multiple Sclerosis Registry (DMSR) who started teriflunomide treatment between 2013–2019. Methods This was a complete nationwide population-based cohort study with prospectively enrolled unselected cases. Demographic and disease-specific patient parameters related to treatment history, efficacy outcomes, and discontinuation and switching rates among other clinical variables were assessed at baseline and during follow-up visits. Results A total of 3239 patients (65.4% female) started treatment with teriflunomide during the study period, 56% of whom were treatment-naïve. Compared to previously treated patients, treatment-naïve patients were older on average at disease onset, had a shorter disease duration, a lower Expanded Disability Status Scale score at teriflunomide treatment start and more frequently experienced a relapse in the 12 months prior to teriflunomide initiation. In the 3001 patients initiating teriflunomide treatment at least 12 months before the cut-off date, 72.7% were still on treatment one year after treatment start. Discontinuations in the first year were due mainly to adverse events (15.6%). Over the full follow-up period, 47.5% of patients discontinued teriflunomide treatment. Sixty-three percent of the patients treated with teriflunomide for 5 years were relapse-free, while significantly more treatment-naïve versus previously treated patients experienced a relapse during the follow-up (p Conclusions Solid efficacy and treatment persistence data consistent with other real-world studies were obtained over the treatment period. Treatment outcomes in this real-world scenario of the population-based cohort support previous findings that teriflunomide is an effective and generally well-tolerated DMT for relapsing MS patients with mild to moderate disease activity.

Tendon injury is a considerable problem affecting both physically active and sedentary people. The aim of this study was to examine the relationship between markers for metabolic disorders (hyperglycemia, hypercholesterolemia, and metabolic syndrome) and the risk of developing tendon injuries requiring referral to a hospital. The Copenhagen City Heart Study is a prospective study of diabetic and non-diabetic individuals from the Danish general population with different physical activity levels. The cohort was followed for 3 years via national registers with respect to tendon injuries. Data from 5856 individuals (median age 62 years) were included. The overall incidence of tendon injury in both upper and lower extremities that required an out-patient or in-house visit to a hospital was ~5.7/1000 person years. Individuals with elevated HbA1c (glycated hemoglobin) even in the prediabetic range (HbA1c>5.7%) had a ~3 times higher risk of tendon injury in the lower extremities only, as compared to individuals with normal HbA1C levels. Hypercholesterolemia (total cholesterol>5 mmol/L) increased risk of tendon injury in the upper extremities by ~1.5 times, and individuals with metabolic syndrome had ~2.5 times higher risk of tendon injury in both upper and lower extremities. In conclusion, these data demonstrate for the first time in a large cohort with different physical activity levels that the indicators for metabolic syndrome are a powerful systemic determinant of tendon injury, and two of its components, hyperglycemia and hypercholesterolemia, each independently make tendons susceptible for damage and injury.

ObjectivePatients with multimorbidity may carry a large symptom burden. Symptoms are often what drive patients to seek healthcare and they also assist doctors with diagnosis. We examined whether symptom burden is additive in people with multimorbidity compared with people with a single morbidity.DesignThis is a longitudinal cohort study drawing on questionnaire and Danish national registry data. Multimorbidity was defined as having diagnoses from at least two out of ten morbidity groups. Associations between morbidity groups and symptom burden were estimated with multivariable models.ParticipantsIn 2012, 47 452 participants from the Danish Symptom Cohort answered a questionnaire about symptoms (36 symptoms in total), including whether symptoms were affecting their daily activities (impairment score) and their worries about present symptoms (worry score) (the highest score among the 36 symptoms on a 0–4 scale).Main outcome measureThe primary outcome was symptom burden.ResultsParticipants without morbidity reported 4.77 symptoms (out of 36 possible). Participants with one, two or three morbidities reported more symptoms than patients without morbidity (0.95 (CI 0.86 to 1.03), 1.87 (CI 1.73 to 2.01) and 2.89 (CI 2.66 to 3.12), respectively). Furthermore, they reported a higher impairment score (0.36 (0.32 to 0.39), 0.65 (0.60 to 0.70) and 1.06 (0.98 to 1.14)) and a higher worry score (0.34 (0.31 to 0.37), 0.62 (0.57 to 0.66) and 1.02 (0.94 to 1.10)) than participants without morbidity. In 45 possible combinations of multimorbidity (participants with two morbidities), interaction effects were additive in 37, 41 and 36 combinations for the number of symptoms, impairment score and worry score, respectively.ConclusionParticipants without morbidity reported a substantial number of symptoms. Having a single morbidity or multimorbidity resulted in approximately one extra symptom for each extra morbidity. In most combinations of multimorbidity, symptom burden was additive.

Background Little is known about factors associated with a clinically relevant reduction in menopausal symptoms through a brief acupuncture approach for women with moderate-to-severe menopausal symptoms. Methods Post hoc analysis of a randomized controlled trial where participants were allocated to early versus late standardized acupuncture. Both the early group and the late group are included in this study. The late group got an identical intervention parallel staged by 6 weeks. By means of the relative importance, the effect was evaluated for both early versus late women with a 6-week follow-up. We included four symptom subscales from the validated MenoScores Questionnaire: hot flushes, day and night sweats, general sweating, menopausal-specific sleeping problems, as well as an overall score, which is the sum of the four outcomes in the analysis. Results 67 women with moderate to severe menopausal symptoms were included of whom 52 (77.6%) experienced a clinically relevant reduction in any of the four surveyed symptom subscales or overall score. 48 (71.6%) women experienced a clinically relevant reduction in any of the vasomotor symptom subscales: hot flushes, day and night sweats, general sweating. Women with vocational education were most likely to experience improvement compared to women with higher education. Beyond education, other factors of some importance for a clinically relevant reduction were no alcohol consumption, two or more births and urinary incontinence. Conclusions Level of education was the most consistent factor associated with improvement. Beyond education, other factors of some importance were no alcohol consumption, two or more births and urinary incontinence. Trial registration This study was registered in ClinicalTrials.gov at April 21, 2016. The registration number is NCT02746497.

We aimed to investigate the Non-specific Symptoms and Signs of Cancer-Cancer Patient Pathway (NSSC-CPP) in order to describe organisational and clinical practice similarities and differences in the diagnostic work-up of suspected cancer in Denmark. A questionnaire on the organisation and practice pertaining to the NSSC-CPP was completed by all 21 diagnostic units in the five healthcare regions in Denmark. The questionnaire responses revealed regional and intraregional differences in the organisation and clinical practice of the NSSC-CPP. CT scan was the most often used imaging in the NSSC-CPP but there was no consensus whether the CT scan should be ordered and evaluated by general practitioners (GPs) or by the diagnostic units. Two regions were consistent but had different modalities regarding referrals from GPs. Three regions had intra-regional differences. The units reported on different types and frequency of forum for patient plan discussion and how to end a NSSC-CPP. The NSSC-CPP is implemented with great regional and intra-regional differences in Denmark. GPs face different requirements when referring to the NSSC-CPP, which indicates that the division of role and responsibility between GPs and the diagnostic units is not well defined.KEY POINTSIn Denmark, the cancer patient pathway for non-specific symptoms and signs of cancer (NSSC-CPP) has been implemented with variations, but little is known about these different modalities. This study showed that both at a regional and an intra-regional level:•General practitioners meet different implementation of national guidelines in the diagnostic units when referring to the NSSCP-CPP•The suitable patient group for the NSSC-CPP is not well defined•Quality criteria are needed to monitor, evaluate and improve the diagnostic work-up for patients with non-specific symptoms and signs of cancer In Denmark, the cancer patient pathway for non-specific symptoms and signs of cancer (NSSC-CPP) has been implemented with variations, but little is known about these different modalities. This study showed that both at a regional and an intra-regional level: •General practitioners meet different implementation of national guidelines in the diagnostic units when referring to the NSSCP-CPP •The suitable patient group for the NSSC-CPP is not well defined •Quality criteria are needed to monitor, evaluate and improve the diagnostic work-up for patients with non-specific symptoms and signs of cancer

BackgroundPsychosocial consequences of colorectal cancer (CRC) screening can arise anywhere in the screening cascade. Previous studies have investigated the consequences of participating in CRC screening; however, we have not identified any studies investigating the psychosocial consequences of receiving the invitation. Therefore, the objective of this study was to investigate psychosocial consequences of invitation to CRC screening.MethodsThe study was a longitudinal study performed in Region Zealand, Denmark. Participants included in this study were a random sample of 1000 CRC screening invitees and 1000 control persons, not invited to screening, matched in a 1:1 design on sex, age and municipality. We assessed psychosocial consequences before and after invitation in both study groups concurrently. The primary outcomes were psychosocial consequences measured with the condition-specific questionnaire Consequences of Screening in ColoRectal Cancer.ResultsPreinvitation response rates were 575 (57.5%) and 610 (61.0%) for the invitation group and control group, respectively. Postinvitation response rates were 442 (44.2%) for the invitation group and 561 (56.1%) for the control group.No differences in mean change in scale score were seen except for the scale ‘Change in body perception’. The invitation group had a 0.39 lower change (99% CI (−0.78 to −0.004), p=0.009) in mean score than the control group in the direction of a less negative body perception after invitation.ConclusionsThis study did not identify an association between invitation to CRC screening and negative psychosocial consequences.

ObjectivesThe aim of this study was to investigate the impact of age on the diagnostic properties of typical symptoms of urinary tract infection (UTI) in women presenting in general practice with symptoms suggestive of UTI with significant bacteriuria as the reference standard.DesignDiagnostic accuracy study.SettingGeneral practice, Copenhagen, Denmark.ParticipantsAdult 15 years or older. Women presenting in general practice with symptoms suggestive of UTI where urine was collected for investigation.Primary and secondary outcome measuresAccuracy of four symptoms of UTI (dysuria, frequency, urge and abdominal pain) in six different age groups.Results90 practices included 1178 adult women. The prevalence of bacteriuria varied between 30% in women aged 30–44 years and 67% in women aged 75–89 years. The likelihood ratios for dysuria varied between age groups with the best performance in women aged 15–29 (positive likelihood ratio (pLR): 1.62 (1.30–1.94), negative likelihood ratio (nLR): 0.36 (0.19–0.54)) and women aged 30–44 (pLR: 1.74 (1.30–2.17), nLR: 0.48 (0.27–0.68)). CIs included or approximated one for the remaining symptoms in most age groups. When symptoms were combined to calculate post-test probabilities, the combined effect of the varying prevalence of bacteriuria and the varying diagnostic values resulted in a large variation of the post-test probabilities between age groups.ConclusionsThe diagnostic value of symptoms of UTI as well as the prevalence of bacteriuria in women presenting to general practice with suspected UTI vary between age groups with considerable clinical implications. Diagnostic studies should take demographics such as age into consideration.Trial registration numberClinicalTrials.gov: NCT02698332.

OBJECTIVE: The incidence of hypothyroidism is not expected to differ by socioeconomic factors. However, the decision to test and initiate treatment may differ. We aimed to examine whether educational level influences the probability of thyroid stimulation hormone (TSH)-measurement and initiation of levothyroxine treatment.DESIGN: Citizens in the greater Copenhagen Area during 2001-2015 were included. Individual-level data on educational level, diagnoses, GP-contact, TSH-measurement and medication were derived from administrative and healthcare registers. The relative risks (RR) between educational levels of annual TSH-measurement and treatment initiation following a TSH-measurement were analysed in Poisson regression models with generalized estimation equations.RESULTS: A TSH-measurement was performed in 19% of 9,390,052 person years. The probability of TSH-measurement was higher with short (RR 1.16 [95% CI 1.15-1.16]) and medium (RR 1.11 [95% CI 1.06-1.12]) compared with long education. Treatment was initiated after 0.8% of 2,049,888 TSH-measurements. For TSH < 5 mIU/L, RR for treatment initiation ranged between 0.47 (95%CI 0.39-0.57) and 0.78 (95%CI 0.67-0.91) for short and medium compared with long education. For TSH 5-10 mIU/L, there was no statistically significant difference. For TSH > 10 mIU/L, RR was 1.07 (95% CI 1.02-1.12) for short and 1.08 (95% CI 1.03-1.13) for medium compared with long education.CONCLUSION: The probability of TSH-measurement was higher with shorter education, and the probability of treatment initiation with TSH > 10 mIU/L was marginally higher with short-medium education compared with long education. However, the probability of treatment initiation with TSH < 5 mIU/L, that is treatment incongruous with guidelines, was substantially higher in persons with long education.

Background Participation in lung cancer CT-screening can be associated with a need for follow-up procedures. The screening and waiting for test results introduce the risk of experiencing psychosocial consequences. Therefore, the aims of this study were: 1) To investigate if the psychosocial consequences changed from before an annual screening round to before a three-month follow-up CT-scan in participants with a positive screening result. 2) To investigate potential differences in psychosocial consequences between false positives (FP) and true positives (TP). FP were defined as those where cancer was not confirmed in the follow-up CT-scan and TP where it was. Materials and Methods : This longitudinal study was based on data from the Danish Lung Cancer Screening Trial (DLCST). The Consequences of Screening – Lung cancer (COS-LC) questionnaire was used to measure psychosocial consequences among 130 participants who all received an abnormal CT-screening result at their annual screening round. Eligible participants completed the COS-LC before their annual CT-screening and before the three-month follow-up. Results We found a statistically significant increase in negative psychosocial consequences between the annual lung cancer CT-screening and the three-month follow-up CT-scan in four of nine psychosocial scales; Sense of dejection, Self-blame, Focus on airway symptoms and Harm of smoking. Furthermore, an increase, however not statistically significant, was identified in all remaining scales, except for the scale Stigmatisation which was slightly decreased. We found no evidence of an association between psychosocial consequences and diagnostic groups, FP and TP. Conclusions: An increase in negative psychosocial consequences was observed between the annual lung cancer CT-screening and the three-month follow-up CT-scan. Since we found no statistically significant difference between the diagnostic groups, the increase in negative psychosocial consequences is interpreted as a nocebo effect of living three months in uncertainty not knowing if one’s positive CT-screening result was true or false.

BackgroundOur objective was to investigate whether the effect of a brief and standardised acupuncture approach persists after the end of the acupuncture treatment (post-treatment effect) and whether the anticipation of future acupuncture treatment affects menopausal symptoms (pre-treatment effect).MethodThis study is a post hoc analysis of data from a randomised controlled trial where women with moderate to severe menopausal symptoms were offered weekly acupuncture treatment over five consecutive weeks and randomised (1:1) to an early intervention group that received treatment immediately and a late intervention group with a 6-week delay. The acupuncture style was Western medical, administered at CV3, CV4 and bilateral LR8, SP6 and SP9. Acupuncturists were general practitioners. The effect was evaluated repeatedly during and after the interventions using scales from the validated MenoScores Questionnaire (MSQ) for hot flushes (HF), day and night sweats (DNS), general sweating (GS) and menopausal-specific sleeping problems (MSSP) with a 26-week follow-up period (corresponding to 21 or 15 weeks post-treatment for the early and late intervention groups, respectively). Multivariable linear mixed models were used to analyse the extent and duration of effects.ResultsSeventy participants were included in the study. Four participants dropped out. Furthermore, one participant was excluded from the short- and long-term follow-up analyses after the insertion of a hormonal intrauterine device, and nine participants were excluded from the long-term follow-up analysis due to the initiation of co-interventions. For each of the four outcomes, the effect was sustained up to 21 weeks post-treatment with an effect size that was only slightly diminished. A small, but significant, pre-treatment effect was observed in the HF scale scores. The same trend, although not significant, was observed in the DNS and MSSP scale scores. No serious harms were reported.ConclusionThis study demonstrated that the overall effect of a brief and standardised acupuncture treatment on menopause-relevant outcomes was sustained up to 21 weeks post-treatment and that there was a small pre-treatment effect.

Background Several factors may play a role in the ability of patients with Alzheimer’s disease to perform activities of daily living (ADL). The aim of this study was to examine the impact of different aspects of physical performance and cognitive functions on ADL in patients suffering from mild-to-moderate Alzheimer’s disease. Methods We conducted secondary analyses on cross-sectional baseline data from the randomized controlled multicentre study “Preserving quality of life, physical health and functional ability in Alzheimer’s Disease: The effect of physical exercise” (ADEX). In total, 185 AD patients (76 women and 109 men), with a mean age on 70,4 years, were included. Data from physical performance tests (Astrand cycle test, Timed up & Go (TUG), Sit to Stand test (STS)) and cognitive tests (Mini Mental Status Examination (MMSE), Symbol Digit Modalities Test (SDMT), Stroop Color and Word test (Stroop)) were used. Their associations with ADL, measured on the ADCS-ADL scale was assessed in multivariable regression analyses. Results SDMT and MMSE had significant, moderate correlations with total ADL (SDMT: r = 0.33, MMSE: r = 0.42) and instrumental ADL (SDMT: r = 0.31, MMSE: r = 0.42), but not with basic ADL. Adjusting for age and sex, the associations between SDMT and MMSE to total ADL and instrumental ADL persisted. No significant associations were found between Astrand, TUG, STS or Stroop and total ADL, basic ADL or instrumental ADL. Conclusion Total ADL and instrumental ADL are associated with cognitive functions, including executive function. No significant association between examined physical performance parameters and ADL functions was observed, and consequently does not support an impact of physical function on ADL functions in patients with mild-to-moderate Alzheimer’s disease and relatively well-preserved physical function. Strategies aimed to improve cognition may be better suited to improve ADL function in patients with mild-to-moderate Alzheimer’s disease. Trial registration NCT01681602. Registered 10 September 2012, retrospectively registered.

Purpose To investigate which patient-related outcomes are dependent on the experience of the cataract surgeon. Methods The study was designed as a prospective observational study. Novice ( 1000 surgeries performed) cataract surgeons from the Department of Ophthalmology, Rigshospitalet - Glostrup and Nordsjaellands Hospital - Hillerod were included in the study. Patients operated by the included surgeons were examined preoperatively, 1 day, 3 days, and 3 weeks after standard, noncomplicated cataract surgery. Primary outcomes were change in central corneal thickness and endothelial cell loss. Secondary outcomes were best-corrected visual acuity, intraocular pressure, aqueous flare, central macular thickness, and surgical complications. Results Surgery performed by novice surgeons resulted in significantly lower visual acuity (mean -3.6 letters (Early Treatment Diabetic Retinopathy Study (ETDRS)); 95% CI: -7.3; -0.4, p = 0.03) and greater corneal thickness (mean 26.7 µm; 95% CI: 6.8; 46.6, p = 0.01) on the first day postoperative than surgery performed by experienced surgeons. Conclusion The experience of the cataract surgeon affected visual acuity and central corneal thickness in the immediate postoperative period. In the future, these patient-related outcomes may be used to assess the technical proficiency of surgical trainees and investigate the effect of different training programs.

Objectives Patients with dementia have an increased 30‐day mortality after hip fracture. We investigated clinical management including time to surgery, out‐of‐hours admission and surgery, surgery on weekends, surgery volume per ward, and anesthesia technique for this excess mortality risk. Method This register‐ and population‐based study comprised 12,309 older adults (age 70+) admitted to hospital for a first‐time hip fracture in 2013–2014, of whom 11,318 underwent hip fracture surgery. Cox proportional hazards regression models were applied for the analysis. Results The overall postoperative 30‐day mortality was 11.4%. Patients with dementia had a 1.5 times increased mortality risk than those without (HR = 1.50 [95% CI 1.31–1.72]). We observed no time‐to‐surgery difference by patient dementia status; additionally, the excess mortality risk in patients with dementia could not be explained by the clinical management factors we examined. Conclusions Increased mortality in patients with dementia could not be explained by the measured preoperative clinical management. Suboptimal handling of postoperative complication and rehabilitation are to be investigated for their role in the witnessed increased mortality for patients with dementia., In this register‐ and population‐based cohort study of 12,309 older adults (age 70+) with hospital admission for a first‐time hip fracture in 2013–2014, we found an increased 30‐day postoperative mortality in patients with dementia. However, this excess mortality was not explained by the clinical factors examined (out‐of‐hours admission, surgery on weekends, anesthesia technique, and surgery volume per ward). Additionally, we found no difference in time to surgery by the patient's dementia status.

Purpose The purpose of this study was to investigate seasonal variation in cases of biopsy-proven GCA in eastern Denmark in a 29-year period. Methods Pathology records of all temporal artery biopsies in eastern Denmark between 1990 and 2018 were reviewed. For each patient, data were collected which included age, sex, date of birth and biopsy result. Seasonality was evaluated using logistic regression and Poisson regression analysis. Lastly, an explorative pilot study was conducted to investigate a possible association between three weather parameters (average temperature, amount of rain and hours of sunshine) and the biopsy outcome. Results One thousand three hundred twenty-three biopsies were included of which 336 fulfilled objective criteria for GCA diagnosis. Mean age at diagnosis was 75.6 years (range 52-94 years). Among the biopsy-proven cases of GCA, there were 223 women (66.3%, mean age 76.2 years) and 113 men (33.7%, mean age 74.4 years) giving a female to male ratio of 1.97:1. The peak occurrence of GCA was in the 70-79 years age group. Statistical analysis of seasonal variation showed an increased risk of a positive biopsy during summer compared to autumn (p = 0.037). No association between the three weather parameters and the biopsy outcome was found. Conclusion In this study of biopsy-proven GCA in a large Danish patient cohort, the occurrence of GCA showed seasonal variation with higher occurrence in the summer months when compared to autumn. Future studies pooling all cases of GCA worldwide are needed to determine seasonality in the occurrence of GCA.

Background Mechanical ventilation of trauma patients is common, and many will require a higher than normal fraction of inspired oxygen (FiO2) to avoid hypoxaemia. The primary objective of this study was to assess the association between FiO2 and all-cause, one-year mortality in intubated trauma patients. Methods Adult trauma patients intubated in the initial phase post-trauma between 2015 and 2017 were retrospectively identified. Information on FiO2 during the first 24 hours of hospitalisation and mortality was registered. For each patient the number of hours of the first 24 hours exposed to an FiO2 ≥ 80%, ≥ 60%, and ≥ 40%, respectively, were determined and categorised into exposure durations. The associations of these FiO2 exposures with mortality were evaluated using Cox regression adjusting for age, sex, body mass index (BMI), Injury Severity Score (ISS), prehospital Glasgow Coma Scale (GCS) score, and presence of thoracic injuries. Results We included 218 intubated trauma patients. The median prehospital GCS score was 6 and the median ISS was 25. One-year mortality was significantly increased when patients had received an FiO2 above 80% for 3-4 hours compared to Conclusion A fraction of inspired oxygen above 60% for more than 2 hours during the first 24 hours of admission was associated with increased mortality in intubated trauma patients in a duration-dependent manner. However, given the limitations of this retrospective study, the findings need to be confirmed in a larger, randomized set-up.

Summary Background When suspecting a urinary tract infection (UTI), the nursing home staff contacts a physician with clinical information on behalf of the resident; hence, poor understanding of UTI or a lack of clinical communicative skills can cause overtreatment with antibiotics. We investigated whether a tailored intervention that improves knowledge about UTI and communication skills in nursing home staff influences antibiotic prescriptions for UTI. Methods This open-label, parallel-group, cluster randomised controlled trial was done at 22 participating nursing homes in Denmark. Patients were eligible if they were nursing home residents aged 65 years or older, had the nursing home listed as their permanent address, and resided in a living space designated for those with dementia or somatic health-care needs. We included nursing homes that were not participating in other UTI projects and those in which staff were present at all hours. Using computer-generated random numbers and stratification by municipality, a statistician randomised the nursing homes (1:1) to receive either interactive educational sessions and use of a dialogue tool or to continue standard practice. The statistical analysis was blinded. Staff attended 75 min sessions over 8 weeks to learn how to distinguish between UTIs and asymptomatic bacteriuria, evaluate non-specific symptoms, and use the dialogue tool. The primary outcome was the number of antibiotic prescriptions for acute UTI per resident per days at risk, defined as the number of days the resident had been present at the nursing home during the trial period. The trial is registered at ClinicalTrials.gov , NCT03715062 . Findings Between June 1, 2017, and June 1, 2018, 22 of 68 invited nursing homes were recruited. Of 22 randomised nursing homes (n=1625 residents), 11 received the intervention (770 [92·2%] of 835 allocated residents) and 11 were in the control group (705 [89·2%] of 790 allocated residents). The standardised number of nursing home staff was 572 in the intervention group and 535 in the control group. All nursing homes completed the trial. 65 residents were excluded from data collection in the intervention group and 85 were excluded in the control group. 1470 residents (intervention n=765; control n=705) were analysed for the primary endpoint. The number of antibiotic prescriptions for UTI per resident was 134 per 84 035 days at risk in the intervention group and 228 per 77817 days at risk in the control group. The rate ratio (RR) of receiving an antibiotic for UTI was 0·51 (95% CI 0·37–0·71) in the unadjusted model and 0·42 (0·31–0·57) in the adjusted model. Of 140 diary entries of suspected UTIs, no deaths were reported. 421 (28·5%) of 1475 residents were admitted to hospital. The risk of all-cause hospitalisation increased in the intervention group (adjusted model RR 1·28, 95% CI 0·95–1·74), whereas all-cause mortality was lower in the intervention group (0·91, 0·62–1·33). Interpretation The intervention effectively reduced antibiotic prescriptions and inappropriate treatments for UTI without substantially influencing all-cause hospitalisations and mortality. Funding Danish Ministry of Health and the Velux Foundation.

Purpose: To investigate the socio-economic status of families affected by childhood cataract and to assess how the socio-economic status is affected by cataract diagnosis. Materials and methods: Children born between 2000 and 2017, seen between the age 0 and 10 years in the same period at Rigshospitalet or Aarhus University Hospital for cataract (N = 485), were included and compared to a matched children group without cataract (N = 4358). Socio-economic status was evaluated by the parents’ income, employment, education, marital status and family structure. Results: Parents of children with cataract were more likely to have a low yearly income (OR = 1.60, 95% CI (1.12–2.27)), be out of work (OR = 1.74, 95% CI (1.34–2.26)) and have basic education as the highest attained education (OR = 1.64, 95% CI (1.27–2.13)) prior to diagnosis. This social gradient was not affected by the diagnosis. In addition, a higher number of children with cataract lived in multi-family residencies (13.8% versus 8% in group of children without cataract) and they had a greater number of siblings (6.2% had ≥4 siblings versus 2.1% in group of children without cataract). Conclusion: Families affected by childhood cataract have a lower socio-economic status and educational background even before cataract is diagnosed but the diagnosis does not aggravate the differences between these families and the background population. The lower socio-economic status and parental educational background should be taken into consideration in the management of these families.

Background Development of the maternal antenatal attachment (MAA) constitutes an important aspect of the transition into motherhood. Early identification of women at risk of developing a poor MAA provides possibilities for preventive interventions targeting maternal mental health and the emerging mother-infant relationship. In this study, we investigate the relative importance of an extensive set of psychosocial, pregnancy-related, and physiological factors measured in the first trimester of pregnancy for MAA measured in third trimester. Methods A prospective study was conducted among pregnant women in Danish general practice (GP). Data were obtained in the first and the third trimester from pregnancy health records and electronic questionnaires associated with routine GP antenatal care visits. The Maternal Antenatal Attachment Scale (MAAS) was used to assess maternal antenatal attachment. The relative importance of potential determinants of maternal antenatal attachment was assessed by the relative contribution of each factor to the fit (R2) calculated from multivariable regression models. Results The sample consisted of 1328 women. Low antenatal attachment (Total MAAS ≤ 75) was observed for 513 (38.6%) women. Perceived social support (having someone to talk to and having access to practical help when needed) emerged as the most important determinant. Furthermore, scores on the MAAS decreased with worse self-rated health, poor physical fitness, depression, increasing age, having given birth previously, and higher education. Conclusion Pregnant women reporting lack of social support and general low physical and mental well-being early in pregnancy may be at risk for developing a poor MAA. An approach targeting both psychosocial and physiological well-being may positively influence expectant mothers’ successful adaptation to motherhood.

In low-dose computed tomography (LDCT) screening for lung cancer, all three main conditions for overdiagnosis in cancer screening are present: 1) a reservoir of slowly or nongrowing lung cancer exists; 2) LDCT is a high-resolution imaging technology with the potential to identify this reservoir; and 3) eligible screening participants have a high risk of dying from causes other than lung cancer. The degree of overdiagnosis in cancer screening is most validly estimated in high-quality randomised controlled trials (RCTs), with enough follow-up time after the end of screening to avoid lead-time bias and without contamination of the control group. Nine RCTs investigating LDCT screening were identified. Two RCTs were excluded because lung cancer incidence after the end of screening was not published. Two other RCTs using active comparators were also excluded. Therefore, five RCTs were included: two trials were at low risk of bias, two of some concern and one at high risk of bias. In a meta-analysis of the two low risk of bias RCTs including 8156 healthy current or former smokers, 49% of the screen-detected cancers were overdiagnosed. There is uncertainty about this substantial degree of overdiagnosis due to unexplained heterogeneity and low precision of the summed estimate across the two trials. Key points Nine randomised controlled trials (RCTs) on low-dose computed tomography screening were identified; five were included for meta-analysis but only two of those were at low risk of bias. In a meta-analysis of recent low risk of bias RCTs including 8156 healthy current or former smokers from developed countries, we found that 49% of the screen-detected cancers may be overdiagnosed. There is uncertainty about the degree of overdiagnosis in lung cancer screening due to unexplained heterogeneity and low precision of the point estimate. If only high-quality RCTs are included in the meta-analysis, the degree of overdiagnosis is substantial. Educational aims To appreciate that low-dose computed tomography screening for lung cancer meets all three main conditions for overdiagnosis in cancer screening: a reservoir of indolent cancers exists in the population; the screening test is able to “tap” this reservoir by detecting biologically indolent cancers as well as biologically important cancers; and the population being screened is characterised by a relatively high competing risk of death from other causes To learn about biases that might affect the estimates of overdiagnosis in randomised controlled trials in cancer screening, In low-dose computed tomography (LDCT) screening for lung cancer, all three main reasons for overdiagnosis are present. Half of people detected as having lung cancer via their participation in LDCT screening are overdiagnosed. http://bit.ly/32tLZk4

Background Sleep problems in late pregnancy are common, but sleep in early pregnancy is less well described. The aim of this study was to describe the occurrence and severity of sleep complaints in early pregnancy. We asked the women about worries due to sleep problems. Furthermore, we investigated the associations between sleep complaints and pregnancy-related symptoms. This association was studied taking into account physical and mental health, sociodemographic characteristics, and reproductive history of the women. Methods Cross-sectional study in Danish general practice based on an electronic questionnaire completed by pregnant women and a Pregnancy Health Record filled in by the general practitioner (GP). The questionnaire measured three sleep complaints and 11 common physical pregnancy-related symptoms. The sleep complaints were measured as mild, moderate or severe, and it was recorded how much they worried the women. The associations between the physical pregnancy-related symptoms and sleep complaints were assessed by odds ratios from multivariable logistic regression models. Results The questionnaire was completed by 1338 out of 1508 eligible women before the end of gestation week 16. The gestational age ranged from 5 to 16 weeks (median 11 weeks) among the included women. On average, more than one third of the women reported to have at least one of the three sleep complaints in the questionnaire. Problems “taking a long time to fall asleep” was reported by 312 women (23%), “waking up too early” was reported by 629 (47%), and 183 (14%) had been “lying awake most of the night”. One sleep complaint was reported by 38%, two by 16, and 4% had all three symptoms. The majority were not at all or only mildly worried because of their sleep disturbances, but moderate or severe worries were found among 46% of those“ taking a long time to fall asleep” and among 40% of those “lying awake most of the night”. “Moderate or severe complaints” were reported by 277 (21%) women “Moderate or severe complaints” were associated with pregnancy-related physical symptoms, such as back pain, pelvic girdle pain and pelvic cavity pain, but only the association with pelvic cavity pain stayed significant after adjustment for depression. Conclusion This study showed that sleep complaints in early pregnancy are common, and sleep complaints showed association with physical as well as mental symptoms. It may be important for pregnant patients that clinicians address depression, and mood in relation to sleep problems during pregnancy.

ObjectivesWe investigated if psychosocial status, sociodemographics and smoking status affected non-attendance in the control group in the randomised Danish Lung Cancer Screening Trial (DLCST).Design and settingThis study was an observational study nested in the DLCST. Due to large non-attendance in the control group in the second screening round we made an additional effort to collect questionnaire data from non-attenders in this group in the third screening round. We used a condition-specific questionnaire to assess psychosocial status. We analysed the differences in psychosocial status in the third and preceding rounds between non-attenders and attenders in the control group in multivariable linear regression models adjusted for sociodemographics and smoking status reported at baseline. Differences in sociodemographics and smoking status were analysed with χ2tests (categorical variables) and t-tests (continuous variables).Primary outcome measurePrimary outcome was psychosocial status.ParticipantsAll control persons participating in the third screening round in the DLCST were included.ResultsNon-attenders in the third round had significantly worse psychosocial status than attenders in the scales: ‘behaviour’ 0.77 (99% CI 0.18 to 1.36), ‘self-blame’ 0.59 (99% CI 0.14 to 1.04), ‘focus on airway symptoms’ 0.22 (99% CI 0.08 to 0.36), ‘stigmatisation’ 0.51 (99% CI 0.16 to 0.86), ‘introvert’ 0.56 (99% CI 0.23 to 0.89) and ‘harms of smoking’ 0.35 (99% CI 0.11 to 0.59). Moreover, non-attenders had worse scores than attendees in the preceding screening rounds. Non-attenders also reported worse sociodemographics at baseline.ConclusionsNon-attenders had a significantly worse psychosocial status and worse sociodemographics compared with attenders. The results of our study contribute with evidence of non-response and attrition driven by psychosocial status, which in turn may be influenced by the screening intervention itself. This can be used to adjust cancer screening trial results for bias due to differential non-attendance.Trial registration numberClinicaltrials.gov Protocol Registration System (NCT00496977).

IntroductionA study based on the Danish Randomised Controlled Lung Cancer Screening Trial (DLCST) calculated the healthcare costs of lung cancer screening by comparing costs in an intervention group with a control group. Participants in both groups, however, experienced significantly increased negative psychosocial consequences after randomisation. Substantial participation bias has also been documented: The DLCST participants reported fewer negative psychosocial aspects and experienced better living conditions compared with the random sample.ObjectiveTo comprehensively analyse the costs of lung cancer CT screening and to determine whether invitations to mass screening alter the utilisation of the healthcare system resulting in indirect costs. Healthcare utilisation and costs are analysed in the primary care sector (general practitioner psychologists, physiotherapists, other specialists, drugs) and the secondary care sector (emergency room contacts, outpatient visits, hospitalisation days, surgical procedures and non-surgical procedures).DesignTo account for bias in the original trial, the costs and utilisation of healthcare by participants in DLCST were compared with a new reference group, selected in the period from randomisation (2004–2006) until 2014.SettingFour Danish national registers.ParticipantsDLCST included 4104 current or former heavy smokers, randomly assigned to the CT group or the control group. The new reference group comprised a random sample of 535 current or former heavy smokers in the general Danish population who were never invited to participate in a cancer screening test.Main outcome measuresTotal healthcare costs including costs and utilisation of healthcare in both the primary and the secondary care sector.ResultsCompared with the reference group, the participants in both the CT group (offered annual CT screening, lung function test and smoking counselling) and the control group (offered annual lung function test and smoking counselling) had significantly increased total healthcare costs, calculated at 60% and 48% respectively. The increase in costs was caused by increased use of healthcare in both the primary and the secondary sectors.ConclusionCT screening leads to 60% increased total healthcare costs. Such increase would raise the expected annual healthcare cost per participant from EUR 2348 to EUR 3756. Cost analysis that only includes costs directly related to the CT scan and follow-up procedures most likely underestimates total costs. Our data show that the increased costs are not limited to the secondary sector.Trial registration numberNCT00496977.

Neutropenia (NP), that is, an absolute blood neutrophil count (ANC)1.5 g/L, accompanies various diseases. However, the clinical significance of NP, detected in routine complete blood cell counts (CBC) in primary care, is poorly characterized. Here, from a primary care resource with ANCs from370 000 individuals, we identified and followed neutropenic subjects for the next 4 years for novel ICD-10 based diagnoses of viral infections and hematological malignancies (ie, previously identified major outcomes in NP individuals) in Danish nationwide health registers. Risk estimates were assessed for children/adolescents (1-18 years) and adults (19-90 years) in relation to NP severity, and for isolated NP, bi- or pancytopenias. We found that NP was observed in 4.9% of children and in 1.9% of adults. The lower the ANC, the likelier was a diagnosis of viral infections or hematological malignancies established during the ensuing 4 years. Among neutropenic children, unspecified viral infections predominated, followed by mononucleosis (with other cytopenias in only 7% and 25% of the cases, respectively). All NP children with acute leukemia presented with bi- or pancytopenia from start of follow-up. In NP adults, hepatitis, followed by HIV, were the most common infections, and acute myelogenous leukemia (AML) and myelodysplastic syndromes (MDSs) the predominating hematological malignancies. Adult NP patients, subsequently diagnosed with hepatitis, HIV or AML, MDS, were bi- or pancytopenic in 42%, 47%, 90% and 91% of cases, respectively. Thus, presence of NP in even one CBC may be the first sign of a latent viral or hematological disorder requiring careful follow-up.

Parkinson&rsquo, s disease (PD) is a neurodegenerative disease and a multidisciplinary approach to rehabilitation has been suggested as the best clinical practice. However, very few studies have investigated the long-term effects of a multidisciplinary rehabilitation approach, particularly regarding whether this can slow the progression of PD. The purpose was to investigate the short- and long-term effect of a 2-week multidisciplinary rehabilitation regimen on the PD-related decline in health-related quality of life (HRQOL), mobility, and muscle function. Individuals with PD (IPD) participated in a 2-week inpatient multidisciplinary rehabilitation regimen that focused on improving HRQOL, mobility, and muscle function. Data from the primary outcome: HRQOL (Parkinson&rsquo, s Disease Questionnaire 39, PDQ-39), secondary outcomes: handgrip strength, Timed-up and Go (TUG), Hospital Anxiety and Depression Scale (HADS), and Falls Efficacy Scale-International (FES-I) were compared at pre-visitation, before and after the 2-week regimen, and again at 4 and 10 months follow-up. In total, 224 patients with PD were included. There were short-term improvements in all outcomes. PDQ-39 was maintained at the same level as pre-visitation after 10 months follow-up. A 2-week multidisciplinary rehabilitation regimen improved short-term mobility, muscle function, and HRQOL in individuals with Parkinson&rsquo, s disease. HRQOL was maintained after 10 months demonstrating long-term effects.

Under-diagnosis of asthma in ‘under-fives’ may be alleviated by improved inquiry into disease history. We assessed a questionnaire-based screening tool for asthma among 614 ‘under-fives’ with severe respiratory illness in Uganda. The questionnaire responses were compared to post hoc consensus diagnoses by three pediatricians who were guided by study definitions that were based on medical history, physical examination findings, laboratory and radiological tests, and response to bronchodilators. Children with asthma or bronchiolitis were categorized as “asthma syndrome”. Using this approach, 253 (41.2%) had asthma syndrome. History of and present breathing difficulties and present cough and wheezing was the best performing combination of four questionnaire items [sensitivity 80.8% (95% CI 77.6–84.0); specificity 84.7% (95% CI 81.8–87.6)]. The screening tool for asthma syndrome in ‘under-fives’ may provide a simple, cheap and quick method of identifying children with possible asthma. The validity and reliability of this tool in primary care settings should be tested.

Aim: To examine diagnostic and prognostic potential of quantitative electroencephalography (qEEG) analyzed by the statistical pattern recognition (SPR) method in patients with cognitive impairment. We compared the differential diagnostic ability of SPR to visual EEG analysis. Correlation between SPR findings and cerebrospinal fluid (CSF) Alzheimer disease (AD) biomarkers were evaluated. Methods: It is a multicenter cohort study involving 129 patients, (mild cognitive impairment [MCI], AD, and healthy controls). Standardized EEG was performed at baseline. Patients were continuously clinically evaluated. Results: Receiver Operating Characteristic curves showed a low discriminative ability of SPR and no ability to predict clinical progression in patients with MCI. Moderate correlation between SPR analysis and CSF AD biomarkers was found. Conclusion: The diagnostic and prognostic abilities of qEEG were low. The SPR method was superior to the visual EEG analysis. The qEEG method correlates well to CSF AD biomarkers, suggesting association with pathology in AD.

Background: Mammography screening may cause psychosocial harm for women experiencing a false-positive screening result. Previous studies suggest long-term consequences. The aim of the present study was to assess psychosocial consequences of false-positive findings on screening mammography within a six month follow-up. Methods: A prospective matched cohort survey study using the questionnaire ‘Consequences of Screening for Breast Cancer’ (COS-BC), which was translated from Danish to Norwegian. Psychometric analyses investigated the measurement properties of the Norwegian version. Two screening clinics in Norway distributed the survey to 299 women with an abnormal mammogram and 541 women with a normal screen. Women received the questionnaire when receiving the screening result, and one and six months after screening. Results: At six months, statistically significant differences appeared in two scales: existential values and breast examination. At six-month follow-up, women with false-positive results showed no statistically significant differences from women diagnosed with breast cancer in three outcomes: sense of dejection, anxiety, and keeping my mind off things. Conclusion: Our results indicate that the psychosocial consequences from having false-positive screening mammography results diminish after six months. The results support previous research describing breast-specific outcomes. However, our results indicate that Norwegian women are less frightened than other Scandinavian mammography screening participants. © 2018 The Authors. Published by Informa UK Limited, trading as Taylor & Francis Group