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Abstract Introduction People with severe mental illness (SMI) face a higher risk of premature mortality due to physical morbidity compared to the general population. Establishing regular contact with a general practitioner (GP) can mitigate this risk, yet barriers to healthcare access persist. Population initiatives to overcome these barriers require efficient identification of those persons in need. Objective To develop a predictive model to identify persons with SMI not attending a GP regularly. Method For individuals with psychotic disorder, bipolar disorder, or severe depression between 2011 and 2016 (n = 48,804), GP contacts from 2016 to 2018 were retrieved. Two logistic regression models using demographic and clinical data from Danish national registers predicted severe mental illness without GP contact. Model 1 retained significant main effect variables, while Model 2 included significant bivariate interactions. Goodness-of-fit and discriminating ability were evaluated using Hosmer-Lemeshow (HL) test and area under the receiver operating characteristic curve (AUC), respectively, via cross-validation. Results The simple model retained 11 main effects, while the expanded model included 13 main effects and 10 bivariate interactions after backward elimination. HL tests were non-significant for both models (p = 0.50 for the simple model and p = 0.68 for the extended model). Their respective AUC values were 0.789 and 0.790. Conclusion Leveraging Danish national register data, we developed two predictive models to identify SMI individuals without GP contact. The extended model had slightly better model performance than the simple model. Our study may help to identify persons with SMI not engaging with primary care which could enhance health and treatment outcomes in this group.

ABSTRACTBackground: Prior studies comparing the mental healthcare utilisation (MHU) of Danish formerly deployed military personnel (FDP) with the general population have not included data on psychotherapy through the Defence or talking therapy with the general practitioner. This study included these and several other data sources in a comprehensive comparison of MHU between Danish FDP and civilians.Methods: First-time deployed military personnel (N = 10,971) who had returned from a mission to Kosovo, Afghanistan, Iraq or Lebanon between January 2005 and July 2017 were included. A sex and birth-year-matched civilian reference group was randomly drawn from the entire Danish non-deployed population (N = 253,714). Furthermore, a sub-cohort, including male FDP and civilians deemed eligible for military service, was defined. These cohorts were followed up in military medical records and registers covering the primary and secondary civilian health sectors from 2005 to 2018, and the rates of MHU were compared.Results: Approximately half of the initial help-seeking for FDP took place through the Defence (49.4%), and the remainder through the civilian healthcare system. When help-seeking through the Defence was not included, MHU was significantly lower among FDP in the main cohort during the first two years (IRR = 0.84, 95% CI: [0.77, 0.92]) compared to civilians. When help-seeking through the Defence was included, MHU was significantly higher among FDP compared to civilians both in the first two years of follow-up (IRR = 2.01, 95% CI: [1.89, 2.13]) and thereafter (IRR = 1.18, 95% CI: [1.13, 1.23]). In the sub-cohort, these differences were even more pronounced both in the first two years of follow-up and thereafter.Conclusions: MHU was higher among Danish FDP compared to civilians only when data from the Defence was included. The inclusion of data on both civilian and military healthcare services is necessary to evaluate the full impact of deployment on MHU among Danish FDP.

Abstract Background Rotator cuff (RC) tendinopathy is the most reported shoulder disorder in the general population with highest prevalence in overhead athletes and adult working-age population. A growing body of evidence support exercise therapy as an effective intervention, but to date there are no prospective randomized controlled trials addressing pain as an intervention variable. Methods A single-site, prospective, pragmatic, assessor-blinded randomized controlled superiority trial. Eighty-four patients aged 18–55 years with chronic (symptom duration over 3 months) RC tendinopathy are randomized 1:1 to receive shoulder exercise during which pain is either allowed or avoided. The intervention period lasts 26 weeks. During that period, participants in both groups are offered 8 individual on-site sessions with an assigned sports physiotherapist. Participants perform home exercises and are provided with a pain and exercise logbook and asked to report completed home-based exercise sessions and reasons for not completing sessions (pain or other reasons). Patients are also asked to report load and the number of sets and repetitions per sets for each exercise session. The logbooks are collected continuously throughout the intervention period. The primary and secondary outcomes are obtained at baseline, 6 weeks, 26 weeks, and 1 year after baseline. The primary outcome is patient-reported pain and disability using the Shoulder PAin and Disability Index (SPADI). Secondary outcomes are patient-reported pain and disability using Disability Arm Shoulder and Hand short-form (Quick DASH), and shoulder pain using Numeric Pain Rating Scale. Objective outcomes are shoulder range of motion, isometric shoulder muscle strength, pain sensitivity, working ability, and structural changes in the supraspinatus tendon and muscle using ultrasound. Discussion The results of this study will contribute knowledge about the treatment strategies for patients with RC tendinopathy and help physiotherapists in clinical decision-making. This is the first randomized controlled trial comparing the effects of allowing pain versus avoiding pain during shoulder exercises in patients with chronic RC tendinopathy. If tolerating pain during and after exercise proves to be effective, it will potentially expand our understanding of “exercising into pain” for this patient group, as there is currently no consensus. Trial registration ClinicalTrials.gov NCT05124769. Registered on August 11, 2021.

Abstract Background Evaluation of psychosocial consequences of lung cancer screening with LDCT in high-risk populations has generally been performed using generic psychometric instruments. Such generic instruments have low coverage and low power to detect screening impacts. This study aims to validate an established lung cancer screening-specific questionnaire, Consequences Of Screening Lung Cancer (COS-LC), in Australian-English and describe early results from the baseline LDCT round of the International Lung Screen Trial (ILST). Methods The Danish-version COS-LC was translated to Australian-English using the double panel method and field tested in Australian-ILST participants to examine content validity. A random sample of 200 participants were used to assess construct validity using Rasch item response theory models. Reliability was assessed using classical test theory. The COS-LC was administered to ILST participants at prespecified timepoints including at enrolment, dependent of screening results. Results Minor linguistic alterations were made after initial translation of COS-LC to English. The COS-LC demonstrated good content validity and adequate construct validity using psychometric analysis. The four core scales fit the Rasch model, with only minor issues in five non-core scales which resolved with modification. 1129 Australian-ILST participants were included in the analysis, with minimal psychosocial impact observed shortly after baseline LDCT results. Conclusion COS-LC is the first lung cancer screening-specific questionnaire to be validated in Australia and has demonstrated excellent psychometric properties. Early results did not demonstrate significant psychosocial impacts of screening. Longer-term follow-up is awaited and will be particularly pertinent given the announcement of an Australian National Lung Cancer Screening Program. Trial registration NCT02871856.

Abstract Background Concussion may lead to persisting post-concussive symptoms affecting work ability and employment. This study examined the transitions between labour market states an individual can experience after the acute phase of concussion. The aim was to describe the incidence of favourable and adverse transitions between different labour market states (e.g., employment, sick leave) in relation to socioeconomic and health characteristics in individuals with concussion relative to matched controls. Methods This Danish nationwide register-based cohort study extracted 18–60-year-old individuals between 2003–2007 with concussion from the Danish National Patient Register (ICD-10 S06.0). Controls were matched on age, sex, and municipality. Patients and controls were followed for 5 years starting three months after injury. Exclusion criteria were neurological injuries and unavailability to the labour market in the inclusion period (2003–2007) and 5-years before injury (1998–2002). Labour market states were defined from transfer income data in the Danish Register for Evaluation of Marginalization. Incidence rates of transitions between these labour market states were analysed in multistate models. Transitions were bundled in favourable and adverse transitions between labour market states and the difference in incidence rates between individuals with concussion relative to matched controls were assessed with hazard ratios from Cox regression models. Results Persons with concussion (n = 15.580) had a lower incidence of favourable transitions (HR 0.88, CI 0.86–0.90) and a higher incidence of adverse transitions (HR 1.30, CI 1.27–1.35), relative to matched controls (n = 16.377). The effect of concussion differed depending on health and socioeconomic characteristics. Notably, individuals between 30–39 years (HR 0.83, CI 0.79–0.87), individuals with high-income (200.000–300.000 DKK) (HR 0.83, CI 0.80–0.87), and wage earners with management experience (HR 0.60, CI 0.44–0.81) had a markedly lower incidence of favourable transitions compared to controls. Additionally, individuals with high income also had a higher incidence of adverse transitions (HR 1.46, CI 1.34–1.58) compared to controls. Conclusions Concussion was associated with enhanced risk of adverse transitions between labour market states and lower occurrence of favourable transitions, indicating work disability, potentially due to persistent post-concussive symptoms. Some age groups, individuals with high income, and employees with management experience may be more affected.

Abstract Background Multimorbidity is a burden for the individual and to the healthcare sector worldwide, leading to a rising number of intervention studies towards this patient group. To measure a possible effect of such interventions, an adequate patient-reported outcome measure (PROM) is essential. The aim of this study was to assess the draft MultiMorbidity Questionnaire (MMQ), a PROM measuring needs-based quality of life and self-perceived inequity in patients with multimorbidity, for its psychometric properties and to adjust it accordingly to create a content- and construct valid measure. Methods The draft MMQ was sent to 1198 eligible respondents with multimorbidity. Modern test theory and classical test theory were used to analyse data. Dimensionality of the suggested domains and invariance of the items were assessed through item analysis, examining the fit to a psychometric model. Results The psychometric analyses were based on responses from 390 patients with multimorbidity. In the MMQ1, measuring needs-based QoL, evidence of six unidimensional scales was confirmed: physical ability (6 items), worries (6 items), limitations in everyday life (10 items), my social life (6 items), self-image (6 items), and personal finances (3 items). The psychometric analyses of the MMQ2 outlined four unidimensional scales measuring the feeling of Self-perceived inequity in patients with multimorbidity: experiences of being stigmatised (4–5 items), Experiences of insufficient understanding of the burden of disease (3 items), Experiences of not being seen and heard (4 items), Experience of powerlessness (5 items). These scales are relevant for patients’ with multimorbidity encounters with (1) their general pratitioner, (2) staff at their general practitioner’s surgery, (3) healthcare professionals, (4) staff at the local authorities and (5) friends, family, and others. Conclusion The MMQ, a QoL measure for patients living with multimorbidity has been validated: the MMQ1 is a condition-specific PROM with adequate psychometric properties designed to measure needs-based QoL. The MMQ2 measuring Self-perceived inequity, has also been found to possess adequate measurement properties; however due to the risk of type 2 error a revalidation of MMQ2 is suggested.

Abstract Background Signposting to web-based interventions is becoming increasingly popular in primary care. Most resources are focused on individuals with clinical problems, but less is known about the uptake of general practice (GP) signposted web-based interventions. GPs in Denmark are responsible for scheduled preventive care during pregnancy and the child’s first five years. In the “Family Well-being in General Practice” trial the web-based intervention “Resilientchild.dk” is introduced at these consultations. Resilientchild.dk is designed to improve the capacity of parents to understand the mental state of themselves, their partners, and their children. In this study we assess the uptake and use of this web-based intervention. Objective To describe participant and practice characteristics associated with the use of a web-based psychoeducational intervention. Eligible participants were pregnant women presenting at their first antenatal assessment, usually around 6–10 gestational weeks. Methods The study was nested in a cluster randomised trial of resilientchild.dk. We conducted a relative importance analysis, which allows for determination of the variables most strongly associated with website use. To assess the direction and magnitude of the influences of the identified variables, we applied multinomial generalized linear mixed modelling. A practice random effect allows us to account for clustering of women within practices. Results Parity and the absence of a nurse or midwife in the practice were important factors driving a decrease in the likelihood of using resilientchild.dk. Being a student or living outside the capital city were important factors driving an increase in the likelihood of using resilientchild.dk. Conclusion The data offer unique opportunities to assess the utilisation of a web-based mental health-promotion intervention following advice from a clinician. This study draws conclusions about which patients are likely to access similar resources and which practice characteristics encourage their use. Trial registration Registered in clinicaltrials.gov, Trial number: NCT04129359 Date of registration: 16/10/2019 ( https://clinicaltrials.gov/ct2/show/NCT04129359 ).

Abstract Objective To evaluate the feasibility and fidelity of implementing and assessing the SOFIA coordinated care program aimed at lowering mortality and increasing quality of life in patients with severe mental illness by improving somatic health care in general practice. Design A cluster-randomised, non-blinded controlled pilot trial. Setting General Practice in Denmark. Intervention The SOFIA coordinated care program comprised extended structured consultations carried out by the GP, group-based training of GPs and staff, and a handbook with information on signposting patients to relevant municipal, health, and social initiatives. Patients Persons aged 18 years or older with a diagnosis of psychotic, bipolar, or severe depressive disorder. Main outcome measures We collected quantitative data on the delivery, recruitment and retention rates of practices and patients, and response rates of questionnaires MMQ and EQ-5D-5 L. Results From November 2020 to March 2021, nine practices were enrolled and assigned in a 2:1 ratio to the intervention group (n = 6) or control group (n = 3). Intervention group practices included 64 patients and Control practices included 23. The extended consultations were delivered with a high level of fidelity in the general practices; however, thresholds for collecting outcome measures, and recruitment of practices and patients were not reached. Conclusion Our findings suggest that delivering the coordinated care program in a fully powered trial in primary care is likely feasible. However, the recruitment methodology requires improvement to ensure sufficient recruitment and minimize selective inclusion. Trial registration The date of pilot trial protocol registration was 05/11/2020, and the registration number is NCT04618250.

Objective: Ductal carcinoma in situ (DCIS) is a risk factor for invasive breast cancer (IBC). The prognosis of DCIS is considerably better than for IBC, yet women do not distinguish between the threat. We aimed to compare the psychosocial consequences of screen-detected DCIS and IBC, and to examine this comparison over time. Methods: We surveyed a Danish mammography-screening cohort from 2004 to 2018. We assessed outcomes at six-time points: baseline, 1, 6, 18, 36 months, and 14 years after the screening. We measured psychosocial consequences with the Consequences Of Screening – Breast Cancer (COS-BC): a condition-specific questionnaire that is psychometrically validated and encompasses 14 psychosocial dimensions. We used weighted linear models with generalized estimating equations to compare responses between groups. We used a 1% level of significance. Results: 170 out of 1309 women were diagnosed with breast cancer (13.0%). 23 were diagnosed with DCIS (13.5%) and 147 with IBC (86.5%). From baseline to six months after diagnosis, there were no significant differences between women with DCIS and IBC. However, mean scores indicated that IBC generally was more affected than DCIS. After six months, we observed that women with DCIS and IBC might be affected differently in the long term; mean scores and mean differences showed that IBC were more affected on some scales, while DCIS were on others. Conclusion: Overall, the DCIS and IBC experienced similar levels of psychosocial consequences. Women might benefit from renaming DCIS to exclude cancer nomenclature.

Introduction Patients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.Methods and analysis In this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.Ethics and dissemination The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.Trial registration number NCT05676541.

Background: Severe mental illness (SMI) is associated with increased cardiovascular risk. Dyslipidaemia is a potentially modifiable risk factor, which may be inadequately managed in patients with SMI. Objectives: To assess management of dyslipidaemia in patients with SMI versus healthy controls (HCs) in 2005 and 2015. Design and methods: Using Danish registers, we identified adult patients with SMI in the Greater Copenhagen Area (schizophrenia spectrum disorders or bipolar disorder) with ⩾1 general practitioner contact in the year before 2005 and 2015, respectively, and HCs without SMI matched on age and gender (1:5). Outcomes were lipid-profile measurements, presence of dyslipidaemia and redemption of lipid-lowering pharmacotherapy. Differences in outcomes between patients with SMI and controls were measured with multivariable logistic regression. Results: We identified 7217 patients with SMI in 2005 and 9939 in 2015. After 10 years, patients went from having lower odds of lipid measurements to having higher odds of lipid measurements compared with HCs [odds ratio (OR) 2005 0.70 (99% confidence interval (CI) 0.63–0.78) versus OR 2015 1.34 (99% CI 1.24–1.44); p 2005 versus 2015

Abstract Background People with multimorbidity, defined as the co-existence of two or more chronic conditions in an individual, often suffer from pain and functional limitations caused by musculoskeletal disorders and the chronic conditions. In chiropractic practice, two thirds of patients are treated for low back pain (LBP). It is unknown to what extent LBP is accompanied with chronic conditions in chiropractic practice. The objective was to determine the prevalence of multimorbidity among patients with LBP in chiropractric practice and to investigate if multimorbidity affects pain intensity, self-rated health, physical and mental health. Finally, to explore if individuals with multimorbidity have a different recovery for the LBP. Methods Patients presenting with a new episode of LBP were recruited from 10 chiropractic clinics in 2016–2018. Patient-reported data concerning socio-demographics, self-rated health, pain intensity, history of LBP, mental health and chronic conditions were collected at baseline. The prevalence of multimorbidity was determined. To evaluate differences in recovery from the LBP, we estimated changes in the Roland Morris Disability Questionnaire (RMDQ) score and use of pain medication at baseline, 2 weeks, 3 months and 12 months. The analyses were adjusted using regression models. Results 2083 patients were included at baseline and 71%, 68% and 64% responded to follow-up questionnaires at 2 weeks, 3 and 12 months. 1024 (49%) participants reported to have at least one chronic condition and 421 (20%) had multimorbidity (≥ 2 chronic conditions). The presence of multimorbidity was associated with increased odds of poor self-rated health (OR 2.13), physical fitness (OR 1.79), poor muscular strength (OR 1.52), poor endurance (OR 1.51), and poor balance (OR 1.33). Patients with high LBP intensity combined with multimorbidity showed a poorer recovery than patients without chronic diseases (mean difference in RMDQ score 3.53 at 12 months follow-up). More patients with multimorbidity used pain medication for LBP at 12 months follow-up compared to those without chronic disease (OR 2.36). Conclusions Chiropractors should be aware that patients with LBP may suffer from multimorbidity with poor general health. Patients with multimorbidity also have poorer recovery from LBP than people without chronic disease and clinical follow-up may be indicated.

Abstract Background Social, emotional and behavioural problems in early childhood are associated with increased risk for a wide range of poor outcomes associated with substantial cost and impact on society as a whole. Some of these problems are rooted in the early mother-infant relationship and might be prevented. In Denmark, primary health care has a central role in preventive care during pregnancy and the first years of the child’s life and general practice provides opportunities to promote a healthy mother-infant relationship in early parenthood. Objective In the context of standardised antenatal and child development assessments focused on psychosocial wellbeing, we examine the impact of a complex intervention designed to improve maternal mentalisation skills, involving training of general practice clinicians and signposting towards a web-based resource. Joint main outcomes are child socio-emotional and language development at age 30 months measured by parentally reported questionnaires (Communicative Development Inventory and Strengths and Difficulties Questionnaire). Methods The study is a cluster-randomised controlled trial based in general practices in the Capital Region and the Zealand Region of Denmark. Seventy practices were included. Practices were randomised by a computer algorithm in a ratio of 1:1 to intervention or control groups. Each practice was asked to recruit up to 30 women consecutively at their first scheduled antenatal assessment. Clinicians in both groups received one day of training in preventive antenatal and child development consultations with added focus on parental psychosocial well-being, social support, and parent–child interaction. These preventive consultations delivered in both trial arms require enhanced data recording about psychosocial factors. In intervention clinics, clinicians were asked to signpost a web page at three scheduled antenatal consultations and at four scheduled consultations when the child is 5 weeks, 5 months, 1 and 2 years. Discussion We hypothesise that the intervention will increase mothers’ ability to be sensitive to their child’s mental state to an extent that improves the child’s language and mental state at 30 months of age measured by parent-reported questionnaires. Trial registration ClinicalTrials.gov NCT04129359. Registered on Oct 16 2019.

Objectives Childhood cataract is a chronic condition that may interfere with the child’s learning capacities. We aimed to investigate whether childhood cataract influences academic development by comparing school performance in reading and mathematics in children with cataract to a matched control group.Design Nationwide registry-based cohort study.Settings Two surgical centres that perform all treatments for childhood cataract in Denmark.Participants Children born between 2000 and 2009 diagnosed with cataract before 10 years of age (n=275) and an age-matched and sex-matched control group (n=2473).Main outcome measures School performance was assessed as test scores in national tests performed at regular intervals from grade 2 to grade 8 in reading and mathematics. Analyses were corrected for birth origin, child somatic and mental disorder and parental socioeconomic status and mental disorders.Results Of 275 children, 85 (30.9%) were operated for bilateral cataract, 79 (28.7%) unilateral cataract and 111 (40,4%) were not operated. We found that children with cataract have lower participation rate in the tests (62.5%) compared with the control cohort (77.2%) (p value=0.0001). After adjusting the pooled analyses for birth origin, somatic and mental disease in the child and parental socioeconomic status and mental disorders, we found that the children with cataract scored significantly lower in mathematics compared with those without cataract (mean difference=−4.78, 95% CI: −8.18 to −1.38, p value=0.006), whereas no difference was found regarding scores in reading (p=0.576). The lower score in mathematics was driven by children who had been operated for bilateral cataract (p-value=0.004).Conclusion Children with cataract without somatic or neurodevelopmental comorbidities or psychosocial adversities seem to do well in school, whereas children operated for bilateral cataract have higher frequencies of difficulties in mathematical tasks.

Abstract Background Total hip arthroplasty is considered an efficacious procedure for relieving pain and disability, but despite that objectively measured physical activity level remains unchanged compared to pre-surgery and is still considerably lower than that of a healthy age- and sex-matched population 6–12 months post-surgery. Since there is a graded relationship between physical activity level and functional performance, increasing physical activity may enhance the outcome of the procedure. This study aims to investigate whether promotion and support of physical activity initiated 3 months after total hip arthroplasty complementary to usual rehabilitation care can increase objective measured physical activity 6 months post-surgery. Methods The trial is designed as a pragmatic, parallel group, two-arm, assessor-blinded, superiority, randomized (1:1), controlled trial with post intervention follow-up 6 and 12 months after total hip arthroplasty. Home-dwelling, independent, and self-reliant patients with hip osteoarthritis are provisionally enrolled prior to surgery and re-screened about 2–3 months post-surgery to confirm eligibility. Baseline assessment is conducted 3 months post-surgery. Subsequently, patients (n=200) are randomized to either a 3-month, multimodal physical activity promotion/education intervention or control (no further attention). The intervention consists of face-to-face and telephone counselling, patient education material, pedometer, and step-counting journal. The primary outcome is objectively measured physical activity, specifically the proportion of patients that complete on average ≥8000 steps per day 6 months post-surgery. Secondary outcomes include core outcomes (i.e., physical function, pain, and patient global assessment) and health-related quality of life. Furthermore, we will explore the effect of the intervention on self-efficacy and outcome expectations (i.e., tertiary outcomes). Discussion By investigating the effectiveness of a pedometer-driven, face-to-face, and telephone-assisted counselling, behavior change intervention in complementary to usual rehabilitation, we hope to deliver applicable and generalizable knowledge to support physical activity after total hip arthroplasty and potentially enhance the outcome of the procedure. Trial registration www.clinicaltrials.gov NCT04471532 . Registered on July 15, 2020.

Objective To compare the long-term psychosocial consequences of mammography screening among women with breast cancer, normal results and false-positive results.Design A matched cohort study with follow-up of 12–14 years.Setting Denmark from 2004 to 2019.Participants 1170 women who participated in the Danish mammography screening programme in 2004–2005.Intervention Mammography screening for women aged 50–69 years.Outcome measures We assessed the psychosocial consequences with the Consequences Of Screening–Breast Cancer, a condition-specific questionnaire that is psychometrically validated and encompasses 14 psychosocial dimensions.Results Across all 14 psychosocial outcomes, women with false-positive results averagely reported higher psychosocial consequences compared with women with normal findings. Mean differences were statistically insignificant except for the existential values scale: 0.61 (95% CI (0.15 to 1.06), p=0.009). Additionally, women with false-positive results and women diagnosed with breast cancer were affected in a dose–response manner, where women diagnosed with breast cancer were more affected than women with false-positive results.Conclusion Our study suggests that a false-positive mammogram is associated with increased psychosocial consequences 12–14 years after the screening. This study adds to the harms of mammography screening. The findings should be used to inform decision-making among the invited women and political and governmental decisions about mammography screening programmes.

Introduction While lower respiratory tract infections are the main cause of death for children under 5 globally, only a small proportion of children with respiratory tract infections need antibiotics. Overuse of antibiotics globally is leading to increasing rates of antibiotic resistance. In Kyrgyzstan, healthcare workers regularly prescribe antibiotics when clinical uncertainty is present to err on the side of caution. Targeting antibiotic use with biomarkers of inflammation such as C reactive protein (CRP) testing at the point-of-care test (POCT) has been shown to reduce antibiotic use in general, but only few studies have been done in children and no studies exist from Central Asia. This study aims to assess whether the use of a CRP POCT can safely decrease prescription of antibiotics for children with acute respiratory symptoms in primary level healthcare centres in Kyrgyzstan.Methods and analysis Multicentre, open-label, individually randomised, controlled clinical trial with 14 days follow-up (follow-up by phone on days 3, 7 and 14) in rural lowland Chui and highland Naryn regions of Kyrgyzstan. The population are children aged 6 months to 12 years attending the primary level healthcare centres during normal business hours with acute respiratory symptoms. CRP POCT equipment will be supplied to healthcare centres, along with a short training session in CRP use, including the interpretation of results to support the clinical evaluation of the child with acute respiratory infection. The primary outcomes are the proportion of patients prescribed an antibiotic within 14 days of index consultation (superiority analysis) and days to recovery (non-inferiority analysis). Secondary outcomes are antibiotics prescribed at index consultation, reconsultations, hospital admission and vital status within 14 days. Analysis of the first primary outcome, antibiotic use, will be intention to treat using a logistic regression model. Analysis of the second primary outcome, days to recovery, will be per protocol using a linear regression model and a non-inferiority margin of 1 day.Ethics and dissemination The study was approved on 18 June 2021 by the Ethics Committee (ref: no. 1) of the National Centre of Maternity and Childhood Care, Bishkek, Kyrgyzstan. The results of the study regardless of the conclusion will be presented at international conferences and published in peer-reviewed scientific medical journals along with policy briefs and technical reports.Trial registration number NCT05195866.

Andersen et al. evaluate lymphocyte dynamics in chronic lymphocytic leukemia (CLL) patients prior to diagnosis. The authors develop a model to predict risk of requiring CLL treatment or death based on pre-diagnostic lymphocyte growth rates.

Abstract Background Findings about the relationship between individuals’ social relations and general practitioner (GP) contact are ambiguous as to whether weak social relations are associated with an increased or decreased consultation pattern. Furthermore, social relations may affect GP contact differently for men compared to women, between socioeconomic groups and according to perceived need. The overall aim of the study is to examine the association between functional aspects of social relations, perceived emotional and instrumental social support, the tendency to consult a GP and the frequency of GP contact. Methods The study comprised 6911 individuals aged 49–61 at baseline from the Copenhagen Aging and Midlife Biobank (CAMB). We conducted a two-part regression to explore the association between perceived emotional and instrumental social support and GP contact (tendency and frequency), controlling for age, sex, occupational social class, cohabitation status and number of morbidities. Results Results show no overall effect of the perceived social support aspects of social relations on GP contact independent of health-related needs. Conclusions Our results do not support that perceived social support, reflecting functional aspects of social relations, are associated with general practitioner contact among middle-aged people. Trial registration The study has been registered and approved by the Danish Data Protection Agency and the local ethical committee (approval No.H-A-2008-126 and No. 2013-41-1814).Keywords: social relations, perceived social support, healthcare utilisation, general practitioner, middle-aged

Abstract Background Pregnancy and early motherhood are sensitive times where epidemic disease outbreaks can affect mental health negatively. Countries and health care systems handled the pandemic and lockdowns differently and knowledge about how the COVID-19 pandemic affected the mental well-being of pregnant women and new mothers is limited and points in different directions. Aim To investigate symptoms of anxiety and depression in a population of pregnant women and new mothers in various stages of infection pressure and lockdown during the first 15 months of the COVID-19 pandemic in Denmark. Methods The study population was nested an inception cohort of women recruited in their first trimester of pregnancy. Data about mental health of the woman were obtained in relation to pregnancy and child development (first trimester, 8 weeks postpartum and 5 months postpartum), and data were analysed cross-sectionally according to calendar time (periods defined by infection rate and lock-down during the COVID-19 pandemic). Results No differences in reported levels of depressive symptoms between the six examined time periods of the pandemic were observed. Specifically, symptoms remained unchanged after the first lock-down. No major changes in anxiety symptoms were observed in relation to increased infection pressure or lockdowns, but a small increase was observed during the second lockdown in women 8 weeks postpartum. Conclusion No clear change in mood among pregnant women was seen between during the stages of COVID-19 pandemic in Denmark.

Abstract Introduction The Cancer Patient Pathway for Non-specific Symptoms and Signs of Cancer (NSSC-CPP) has been implemented in Denmark with regional and intra-regional differences. In some places, the initial diagnostic work-up (often including a CT scan) is performed by general practitioners (GPs) and in others by hospitals. Variations may influence the use of Organ Specific Cancer Patient Pathways (OS-CPPs) and prognostic outcomes for the patients. Therefore, the aims were: 1) To analyse how a CT scan referred from GP or hospital is followed by OS-CPPs and NSSC-CPPs at the national and regional level, and 2) To analyse, nationally and regionally, the diagnostic outcomes of persons referred to CT scan by either GP or hospital six months after and mortality one year after CT scan. Methods A nationwide population-based study including individuals with a first CT scan in 2013-2016, either referred from GP or hospital. Results Overall, individuals with a CT scan referred from GPs were more likely to start a NSSC-CPP or an OS-CPP than individuals with a CT scan referred by hospitals. Across the five Regions in Denmark, CT scans referred by GPs were associated with reduced odds of total mortality in all regions; (North, OR=0.78 [0.73 0.83], Central, OR=0.92 [0.87 0.96], South, OR=0.85 [0.81 0.89], Capital, OR=0.96 [0.91 1.00] and Zealand, OR=0.85 [0.79 0.90]) and increased odds of cancer-specific mortality in four regions, ORs ranging from 1.15-1.51 with no difference in Region North (1.00 [0.91 1.10]). Conclusion No obvious association between more CT scans and CPPs and reduced diagnoses and mortality was observed. The different diagnostic models might not explain the prognostic outcomes, but the different use of CT scans in, and between Regions play a large role in the differences in incidence and mortality.

IntroductionPhysical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening programs have found more frequent and severe physical harm from screening procedures, e.g., bleeding and perforation, than reported in previous trials. Therefore, the objectives of the study were to systematically review the evidence on the risk of bleeding and perforation in Colorectal Cancer Screening.DesignSystematic review with descriptive statistics and random-effects meta-analyses.MethodsWe systematically searched five databases for studies investigating physical harms related to Colorectal Cancer Screening. We assessed the internal and the external validity using the ROBINS-I tool and the GRADE approach. Harm estimates was calculated using mixed Poisson regression models in random-effect meta-analyses.ResultsWe included 89 studies. Reporting and measurement of harms was inadequate in most studies. In effect, the risk of bias was critical in 97.3% and serious in 98.3% of studies. All GRADE ratings were very low. Based on severe findings with not-critical risk of bias and 30 days follow-up, the risk of bleedings per 100,000 people screened were 8 [2;24] for sigmoidoscopy, 229 [129;408] for colonoscopy following fecal immunochemical test, 68 [39;118] for once-only colonoscopy, and 698 [443;1045] for colonoscopy following any screening tests. The risk of perforations was 88 [56;138] for colonoscopy following fecal immunochemical test and 53 [25;112] for once-only colonoscopy. There were no findings within the subcategory severe perforation with long-term follow-up for colonoscopy following any screening tests and sigmoidoscopy.DiscussionHarm estimates varied widely across studies, reporting and measurement of harms was mostly inadequate, and the risk of bias and GRADE ratings were very poor, collectively leading to underestimation of harm. In effect, we consider our estimates of perforation and bleeding as conservative, highlighting the need for better reporting and measurement in future studies.Trial registrationPROSPERO registration number: CRD42017058844.

It has been argued that persons with severe mental illness (SMI) receive poorer treatment for somatic comorbidities. This study assesses the treatment rates of glucose-lowering and cardiovascular medications among persons with incident type 2 diabetes (T2D) and SMI compared to persons with T2D without SMI. We identified persons ≥30 years old with incident diabetes (HbA1c ≥ 48 mmol/mol and/or glucose ≥ 11.0 mmol/L) from 2001 through 2015 in the Copenhagen Primary Care Laboratory (CopLab) Database. The SMI group included persons with psychotic, affective, or personality disorders within five years preceding the T2D diagnosis. Using a Poisson regression model, we calculated the adjusted rate ratios (aRR) for the redemption of various glucose-lowering and cardiovascular medications up to ten years after T2D diagnosis. We identified 1,316 persons with T2D and SMI and 41,538 persons with T2D but no SMI. Despite similar glycemic control at diagnosis, persons with SMI redeemed a glucose-lowering medication more often than persons without SMI in the period 0.5-2 years after the T2D diagnosis; for example, the aRR was 1.05 (95% CI 1.00-1.11) in the period 1.5-2 years after the T2D diagnosis. This difference was mainly driven by metformin. In contrast, persons with SMI were less often treated with cardiovascular medications during the first 3 years after T2D diagnosis, e.g., in the period 1.5-2 years after T2D diagnosis, the aRR was 0.96 (95% CI 0.92-0.99). For people with SMI in addition to T2D, metformin is more likely to be used in the initial years after T2D diagnosis, while our results suggest potential room for improvement regarding the use of cardiovascular medications.

Abstract 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.

Objective This study aimed to describe prescription of antibiotics to the elderly population in general practice in Denmark from 2010–2017. Design This is a national register-based observational study. Setting General practice, Denmark Main outcome measure The main outcome measure was prescriptions/1,000 inhabitants/day (PrID) in relation to year, age and sex, indication, and antibiotic agent. Subjects In this study, we included inhabitants of Denmark, ≥65 years of age between 01st July 2010–30th June 2017. Results 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. Conclusion 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 Points 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.

Objective In Sweden, an abdominal aortic aneurysm (AAA) screening programme was gradually implemented from 2009 to reduce the incidence of rupture and thereby mortality. AAA screening introduces a variety of unintended, but generally unavoidable, harms, e.g. stress and worry. Such psychosocial consequences have previously only been investigated with generic measures. Therefore, the aim of this study was to describe and compare the psychosocial consequences in men with a screening detected AAA to men with a normal screening result after they participated in the Swedish national AAA-screening programme using a validated psychometric instrument. Material and methods This study was a cross-sectional survey. Data were originally collected to validate the COS-AAA and has previously been published in details. The Consequences of Screening in Abdominal Aortic Aneurysm (COS-AAA) questionnaire was sent to 250 men with a screening detected AAA and 500 with a normal screening result who were randomly selected from a Swedish population-based screening register. Results In total, 158 (63%) men with a screening detected AAA and 275 (55%) men with a normal screening result completed the COS-AAA. We found that men with a screening detected AAA reported negative psychosocial consequences to a greater extent in 10 of 13 COS-AAA Part 1 scales, all statistically significant except three (behaviour, sleep and negative experiences from examination). For COS-AAA Part 2, there was a statistically significant difference between groups in four of five scales. Conclusions Men diagnosed with a screening detected AAA, reported more negative psychosocial consequences compared to men with a normal result. Screening for abdominal aorta aneurism (AAA) introduces intended benefits and unintended harms. Adequate measures are necessary to determine the balance between them.Key points: This study applied a condition-specific questionnaire with high content validity and adequate psychometric properties to measure psychosocial consequences in men participating in AAA screening. We found that men with a screening detected AAA reported more negative psychosocial consequences than men with a normal aorta size. The risk of negative psychosocial consequences is important to include in the decision making on whether to participate in screening or not.

Introduction Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma.Methods and analysis TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial.Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen (>21%) that ensures an SpO2 of 94%. The liberal group receives 12–15 L O2/min or FiO2=0.6–1.0.The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome).With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group.Ethics and dissemination TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website (www.traumox2.org) is available for updates and study results will be published in an international peer-reviewed scientific journal.Trial registration numbers EudraCT 2021-000556-19; NCT05146700.

Background: The patient-centered consultation model comprises four elements: exploring health, illness and disease experiences, understanding the whole person, finding common ground, and enhancing the patient-doctor relationship. This method is taught at the course in general practice at Copenhagen University. The aim of the study was to develop a simple tool consisting of a questionnaire about the patient-centered elements and a test video consultation. The outcome is the change in the students’ ability to identify these elements. Used as a pre-course and post-course test it can inform the teachers which elements of the patient-centered consultation need intensifying in the teaching. Methods: The students from a course in general practice volunteered to participate in all steps of the development. They took part in individual interviews to select items from an already existing questionnaire (DanSCORE). The preliminary questionnaire was tested for face and content validity, pilot-tested and tested for test-retest reliability. All video consultations were transcribed and assessed for patient-centered elements through a conversation analysis. The videos showed medical students seeing real patients. Results: The preliminary version of the questionnaire (called DanOBS) had 23 items. In the subsequent interviews, items were reduced to 17, each with three response options. After a pilot test, the questionnaire was further reduced to 13 items, all strictly relevant to the model and with two response options. The final questionnaire had acceptable test-retest reliability. The number of test consultation videos underwent a reduction from six videos to one. Conclusions: The DanOBS combined with a test video consultation, used as a pre-and post-course test demonstrates for teachers which elements in the patient-centered consultation need to be intensified in the teaching.

Urinary tract infection (UTI) is a common cause for prescription of antibiotics among women in general practice. Diagnosis is often established by inquiry into clinical history and symptoms, and these may be experienced differently depending on menopause status of the woman. The aim of this study was to assess differences in severity and bothersomeness of UTI symptoms between pre- and postmenopausal women. We used a convenience sample of 313 women with suspected UTIs and typical symptoms recruited in general practice. Each woman completed the Holm and Cordoba UTI score (HCUTI), measuring the severity and bothersomeness of the dimensions: dysuria, frequency, lower back, and general symptoms. The exposure was menopausal status. Differences in the various HCUTI dimensions between the menopause groups were investigated in linear regression models, adjusting for potential confounders. Premenopausal women had a significantly higher severity score for the item “feeling unwell” than postmenopausal women (mean difference −0.59, 95% CI −0.88 to −0.31). They also had a significantly higher bothersomeness score for the items “pain on urination” (mean difference −0.54, 95% CI −0.83 to −0.25), “feeling unwell” (mean difference −0.62, 95% CI −0.92 to −0.32), and for the dimension “dysuria” (mean difference −0.38, 95% CI −0.61 to −0.15) than postmenopausal women. This study found differences in some aspects of symptom severity and bothersomeness between pre- and postmenopausal women presenting in general practice with suspected UTIs. Menopausal status should be taken into account when using symptoms to diagnose and evaluate response to UTI treatment in both clinical practice and research.

Abstract Background Harms of colorectal cancer (CRC) screening include psychosocial consequences. We have not identified studies using a participant-relevant questionnaire with adequate measurement properties to investigate these harms. However, Brodersen et al. have previously developed a core questionnaire consequences of screening (COS) for use in screening for life-threatening diseases. Therefore, the objectives were: (1) To investigate content validity of COS in a CRC screening setting and in case of gaps in content coverage (2) generate new items and themes and (3) test the possibly extended version of COS for dimensionality and differential item functioning (DIF) using Rasch Models. Methods We performed two-part-focus-groups with CRC screenees. Screenees were recruited by strategic sampling. In the first part 16 screenees with false-positive results (n = 7) and low-risk polyps (n = 9) were interviewed about their CRC screening experiences and in the second part COS was examined for content validity. When new information was developed in the focus groups, new items covering this topic were generated. Subsequently, new items were, together with COS, tested in the subsequent interviews. A random subsample (n = 410) from a longitudinal questionnaire study, not yet published, was used to form the data for this paper. We analysed multidimensionality and uniform DIF with Andersen’s conditional likelihood ratio test. We assessed individual item fit to the model. We also analysed Local Dependence (LD) and DIF by partial gamma coefficients using Rasch Models. Results COS was found relevant in a CRC screening setting. However, new information was discovered in the focus groups, covered by 18 new CRC screening-specific items. The Rasch analyses only revealed minor problems in the COS-scales. The 18 new items were distributed on four new CRC screening-specific dimensions and one single item. Conclusion An extended version of COS specifically for use in a CRC screening setting has been developed. The extended part encompasses four new scales and one new single item. The original COS with the CRC-screening specific extension is called consequences of screening in colorectal cancer (COS-CRC). COS-CRC possessed reliability, unidimensionality and invariant measurement.

Abstract 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.

Abstract 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 .

Objective 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. Material and methods 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. Results 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. Conclusion 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 POINTS 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

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.

Background: The patient-centered consultation model comprises four elements: exploring health, illness and disease experiences, understanding the whole person, finding common ground, and enhancing the patient-doctor relationship. This method is taught at the course in general practice at Copenhagen University. The aim of the study was to develop a simple tool consisting of a questionnaire about the patient-centered elements and a test video consultation. The outcome is the change in the students’ ability to identify these elements. Used as a pre-course and post-course test it can inform the teachers which elements of the patient-centered consultation need intensifying in the teaching. Methods: The students from a course in general practice volunteered to participate in all steps of the development. They took part in individual interviews to select items from an already existing questionnaire (DanSCORE). The preliminary questionnaire was tested for face and content validity, pilot-tested and tested for test-retest reliability. All video consultations were transcribed and assessed for patient-centered elements through a conversation analysis. The videos showed medical students seeing real patients. Results: The preliminary version of the questionnaire (called DanOBS) had 23 items. In the subsequent interviews, items were reduced to 17, each with three response options. After a pilot test, the questionnaire was further reduced to 13 items, all strictly relevant to the model and with two response options. The final questionnaire had acceptable test-retest reliability. The number of test consultation videos underwent a reduction from six videos to one. Conclusions: The DanOBS combined with a test video consultation, used as a pre-and post-course test demonstrates for teachers which elements in the patient-centered consultation need to be intensified in the teaching.

Abstract 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.

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.

Abstract 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.

The assessment and formulation of the risk of violence and other unwanted behaviors at forensic psychiatric facilities have been attempted for decades. Structured professional judgment tools, such as the Short-Term Assessment of Risk and Treatability (START), are among the recent attempts to overcome the challenge of accomplishing these goals. This study examined the effect of implementing START in clinical practice for the most serious adverse events among the target group of severely mentally ill forensic psychiatric inpatients. Results were based on the use of mechanical restraints as an outcome. This study is a pragmatic, stepped-wedge, cluster-randomized controlled trial and was conducted over 5 years. It included eight forensic psychiatric units. Fifty out of 156 patients who had a basic aggression score of more than 0 were included in the study. We found that the rate of mechanical restraint use within the START period were 82% [relative risk (RR) = 0.18], lower than those outside of the START period. Patients evaluated within the START period were also found to have a 36% (RR = 0.64) lower risk of having higher Brøset Violence Checklist scores than patients evaluated outside the START period. Previous studies on START have primarily focused on validation, the predictive capability of the assessment, and implementation. We were only able to identify one study that aimed to identify the benefits and outcomes of START in a forensic setting. This study showed a significant reduction in the chance for inpatients in a forensic psychiatric facility to become mechanically restrained during periods where the START was used as risk assessment.

In the original publication [...]

Rational antibiotic treatment of urinary tract infections (UTI) is important. To improve the quality of antibiotic treatment of UTI, it is essential to obtain insight into diagnostic approaches and prescribing patterns in general practice. The aim of this study was to investigate the quality of diagnostics and treatment of UTI in general practice by means of quality indicators (QIs). QIs provide a quantitative measure of quality and are defined by a numerator (the number of patients receiving a specific investigation or treatment) and a denominator (the number of patients included in the quality assessment). For adult patients with suspected UTI, practices registered the following: age, sex, risk factors, symptoms and signs, examinations, diagnosis and treatment. The levels of the QIs were compared with their corresponding standards. Half of the patients diagnosed with lower UTI or pyelonephritis fulfilled the diagnostic criteria for UTI: characteristic UTI symptoms and clear signs of bacteriuria, respectively. Urinalysis was performed for nearly all patients, including patients without characteristic symptoms of UTI. One-fourth of the patients with suspected lower UTI were treated with antibiotics despite no urinalysis and nearly half received antibiotics despite an inconclusive dipstick test. Pivmecillam was the preferred antibiotic. The findings of this study indicate that there is room for improvement in the management of UTI in Danish general practice.

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.

We investigated whether prior use of antibiotics affects the risk of mecillinam/trimethoprim/nitrofurantoin/multi-resistant Escherichia coli urinary tract infection (UTI) among elderly patients in general practice. Data on urine culture came from urine samples performed in general practice and sent to hospitals in the Capital Region of Denmark, and prescription data came from a nationwide prescription database. The study population consisted of patients with UTI episodes (n = 41,027) caused by E. coli that received a concurrent antibiotic prescription against UTI from 2012 to 2017. We used a case-control design. Cases were UTI episodes caused by mecillinam, trimethoprim, nitrofurantoin or multi-resistant E. coli and controls were UTI episodes caused by E. coli not displaying the respective resistance pattern. We analyzed whether exposure to antibiotics in a period of 8–90 days prior to the UTI episode affected the risk of antibiotic resistant uropathogenic E coli. The analyses were adjusted for age, sex, hospital admission and nursing home status. The odds of resistance to all of the four antibiotics increased significantly after exposure to antibiotics within 90 days prior to the UTI episode. In general, mecillinam showed the lowest increase in the odds for selection of resistance. The results indicate that mecillinam is a favorable antibiotic choice in terms of selection of resistance.

Abstract Background Survival from many cancer types is steadily increasing, and as a result, a growing number of cancer patients will live with other chronic diseases, of which diabetes is one of the most prevalent. This study aims to describe the impact of cancer on health outcomes in patients with type 2 diabetes and to compare the effectiveness of a multifactorial intervention in diabetes patients with and without cancer. Methods The randomized controlled trial Diabetes Care in General Practice (DCGP) included 1381 patients newly diagnosed with type 2 diabetes. Patients were randomized to either six years of structured personal diabetes care or routine care. In a post hoc analysis, we followed patients for 19 years in Danish national registries for the occurrence of diabetes-related outcomes. We used Cox regression models to estimate hazard ratios for outcomes. Results At diagnosis 48 patients had cancer, and 243 patients were diagnosed with cancer during follow up. Patients with diabetes and cancer had excess all-cause mortality (HR 3.33; 95%CI 2.72–4.06), as well as an increased incidence of myocardial infarction (HR 1.76; 95%CI 1.29–2.39) and any diabetes-related outcome (HR 1.36; 95%CI 1.07–1.71). The intervention reduced the risk of both these endpoints in patients without cancer. Furthermore, there was no statistically significant difference in the effectiveness of the intervention among patients with and without cancer. Conclusions Diabetes patients with cancer had an increased risk of myocardial infarction and any diabetes-related outcome. The observed positive effect of structured personal diabetes care on clinical outcomes did not differ between patients with and without cancer. Attention to and prevention of diabetes complications in patients with both type 2 diabetes and cancer is warranted. Trial registration ClinicalTrials.gov NCT01074762 (February 24, 2010).

Objective Patients 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.Design This 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.Participants In 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 measure The primary outcome was symptom burden.Results Participants 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.Conclusion Participants 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.

A recent COSMIN review found that the Victorian Institute of Sports Assessment-Achilles tendinopathy questionnaire (VISA-A) has flawed construct validity. The objective of the current study was to assess specifically the process of how VISA-A was constructed and validated, and whether the Danish version of VISA-A is a valid patient-reported outcome measure (PROM) for measuring the perceived impact of Achilles tendinopathy. The original item generation strategy for content validity and the process for confirming the scaling properties (construct validity) were examined. In addition, construct validity was evaluated directly using several psychometric methods (Rasch analysis, confirmatory factor analysis (CFA), and multivariable linear regression) in a cohort of 318 persons with Achilles tendinopathy with symptom duration groups ranging from less than 3 months to more than 1 year of chronicity, and a group of 120 healthy persons. We found that the item generation and item reduction in the original construction of VISA-A was based on literature review and clinician consensus with little or no patient involvement. We determined that 1) VISA-A consists of ambiguous conceptual item themes and thus lacks content validity, 2) there was no thorough investigation of the psychometric properties of the original version of VISA-A, which thus lacks construct validity, and 3) rigorous direct assessment of the psychometric properties of the Danish VISA-A revealed inadequate psychometric properties. In agreement with the COSMIN study, we conclude that when used as a single score, VISA-A is not an adequate scale for measuring self-reported impact of Achilles tendinopathy.

Balancing the benefits and harms of mammography screening is difficult and involves a value judgement. Screening is both a medical and a social intervention, therefore public opinion could be considered when deciding if mammography screening programmes should be implemented and continued. Opinion polls have revealed high levels of public enthusiasm for cancer screening, however, the public tends to overestimate the benefits and underestimate the harms. In the search for better public decision on mammography screening, this study investigated the quality of public opinion arising from a Deliberative Poll. In a Deliberative Poll a representative group of people is brought together to deliberate with each other and with experts based on specific information. Before, during and after the process, the participants’ opinions are assessed. In our Deliberative Poll a representative sample of the Danish population aged between 18 and 70 participated. They studied an online video and took part in five hours of intense online deliberation. We used survey data at four timepoints during the study, from recruitment to one month after the poll, to estimate the quality of decisions by the following outcomes: 1) Knowledge; 2) Ability to form opinions; 3) Opinion stability, and 4) Opinion consistency. The proportion of participants with a high level of knowledge increased from 1% at recruitment to 56% after receiving video information. More people formed an opinion regarding the effectiveness of the screening programme (12%), the economy of the programme (27%), and the ethical dilemmas of screening (10%) due to the process of information and deliberation. For 11 out of 14 opinion items, the within-item correlations between the first two inquiry time points were smaller than the correlations between later timepoints. This indicates increased opinion stability. The correlations between three pairs of opinion items deemed theoretically related a priori all increased, indicating increased opinion consistency. Overall, the combined process of online information and deliberation increased opinion quality about mammography screening by increasing knowledge and the ability to form stable and consistent opinions.