Developing a prediction model to identify people with severe mental illness without regular contact to their GP - a study based on data from the Danish national registers.

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.

Deaths and cardiopulmonary events following colorectal cancer screening-A systematic review with meta-analyses.

BACKGROUND: Colorectal cancer screening programmes (CRCSPs) are implemented worldwide despite recent evidence indicating more physical harm occurring during CRCSPs than previously thought. Therefore, we aimed to review the evidence on physical harms associated with endoscopic diagnostic procedures during CRCSPs and, when possible, to quantify the risk of the most serious types of physical harm during CRCSPs, i.e. deaths and cardiopulmonary events (CPEs). METHODS: Systematic review with descriptive statistics and random-effects meta-analyses of studies investigating physical harms following CRCSPs. We conducted a systematic search in the literature and assessed the risk of bias and the certainty of the evidence. RESULTS: We included 134 studies for review, reporting findings from 151 unique populations when accounting for multiple screening interventions per study. Physical harm can be categorized into 17 types of harm. The evidence was very heterogeneous with inadequate measurement and reporting of harms. The risk of bias was serious or critical in 95% of assessments of deaths and CPEs, and the certainty of the evidence was very low in all analyses. The risk of death was assessed for 57 populations with large variation across studies. Meta-analyses indicated that 3 to 23 deaths occur during CRCSPs per 100,000 people screened. Cardiopulmonary events were assessed for 55 populations. Despite our efforts to subcategorize CPEs into 17 distinct subtypes, 41% of CPE assessments were too poorly measured or reported to allow quantification. We found a tendency towards lower estimates of deaths and CPEs in studies with a critical risk of bias. DISCUSSION: Deaths and CPEs during CRCSPs are rare, yet they do occur during CRCSPs. We believe that our findings are conservative due to the heterogeneity and low quality of the evidence. A standardized system for the measurement and reporting of the harms of screening is warranted. TRIAL REGISTRATION: PROSPERO Registration number CRD42017058844.

To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial).

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.

Effectiveness of an adaptive, multifaceted intervention to enhance care for patients with complex multimorbidity in general practice: protocol for a pragmatic cluster randomised controlled trial (the MM600 trial).

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.

The Feasibility of C-Reactive Protein Point-of-Care Testing to Reduce Overuse of Antibiotics in Children with Acute Respiratory Tract Infections in Rural Kyrgyzstan: A Pilot Study.

Background: In Kyrgyzstan, the morbidity prevalence of and morbidity from acute respiratory tract infections (ARTI) in children is high. Local healthcare workers (HCW) often prescribe antibiotics that are not indicative due to a mix of professional and societal factors. It is suggested to precede with a decision on antibiotics by a point-of-care test (POCT) on the appropriateness of the treatment, eg, a measurement of C-reactive protein (CRP). CRP-guided antibiotic stewardship in children with ARTI has not previously been studied in Central Asia. Purpose: This pilot study was conducted to examine the feasibility of the methods and procedures to be used in the upcoming randomised controlled COORDINATE clinical trial (NCT05195866) and in daily clinical practice in primary care. Patients and methods: HCWs from three selected rural healthcare facilities were trained in the CRP POCT and in interpretation of results. Children aged 6 months to 12 years attending the primary healthcare facilities with respiratory symptoms were randomly assigned to CRP-guided management or standard care, guided by clinical findings only. Children were followed up for 14 days by scheduled telephone calls to caregivers. Results: Eighty-one children participated in this pilot study. The CRP POCT and the trial procedures were acceptable to the target group as well as to the HCWs. Children from both groups recovered equally well, with an observed significant lower use of antibiotics in the CRP group. HCWs generally adhered to the CRP guidelines, and only once was an antibiotic prescribed despite low CRP results. No safety concerns were observed. Four parents provided wrong phone numbers impeding follow-up. We will collect all mobile phone numbers in the household for the main trial. Conclusion: The pilot provided satisfactory results, suggesting that the COORDINATE trial of CRP POCT is effective, feasible with minor adjustments and without apparent safety concerns for the participants.

Mental healthcare utilisation among Danish formerly deployed military personnel and their civilian counterparts: a cohort study.

Background: 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.

This study compared mental healthcare utilisation among Danish deployed military personnel and civilians.Most personnel sought help first through the Defence.When all data sources were included, mental healthcare utilisation was significantly higher among military personnel.

Validation of the psychosocial consequences of screening in lung cancer questionnaire in the international lung screen trial Australian cohort.

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.

The development of type 2 diabetes management in people with severe mental illness in the Capital Region of Denmark from 2001 to 2015.

BACKGROUND: Type 2 diabetes (T2D) treatment has changed markedly within the last decades. We aimed to explore whether people with severe mental illness (SMI) have followed the same changes in T2D treatment as those without SMI, as multiple studies suggest that people with SMI receive suboptimal care for somatic disorders. METHODS: In this registry-based annual cohort study, we explored the T2D treatment from 2001 to 2015 provided in general practices of the Greater Copenhagen area. We stratified the T2D cohorts by their pre-existing SMI status. T2D was defined based on elevated glycated hemoglobin (≥48 mmol/mol) or glucose (≥11 mmol/L) using data from the Copenhagen Primary Care Laboratory Database. Individuals with schizophrenia spectrum disorders (ICD-10 F20-29) or affective disorders (bipolar disorder or unipolar depression, ICD-10 F30-33) were identified based on hospital-acquired diagnoses made within 5 years before January 1 each year for people with prevalent T2D or 5 years before meeting our T2D definition for incident patients. For comparison, we defined a non-SMI group, including people who did not have a hospital-acquired diagnosis of schizophrenia spectrum disorders, affective disorders, or personality disorders. For each calendar year, we assembled cohorts of people with T2D with or without SMI. We used Poisson regression to calculate the rates per 100 person-years of having at least one biochemical test (glycated hemoglobin, low-density lipoprotein cholesterol, estimated glomerular filtration rate, and urine albumin-creatinine ratio), having poor control of these biochemical results, taking glucose-lowering or cardiovascular medications, or experiencing a clinical outcome, including all-cause mortality and cardiovascular mortality. Three outcomes (cardiovascular events, cardiovascular mortality, and all-cause mortality) were additionally examined and adjusted for age and sex in a post hoc analysis. RESULTS: From 2001 to 2015, 66,914 individuals were identified as having T2D. In 2015, 1.5% of the study population had schizophrenia spectrum disorder and 1.4% had an affective disorder. The number of people who used biochemical tests or had poor biochemical risk factor control was essentially unrelated to SMI status. One exception was that fewer LDL cholesterol tests were done on people with affective disorders and schizophrenia spectrum disorders at the beginning of the study period compared to people in the non-SMI group. This difference gradually diminished and was almost nonexistent by 2011. There was also a slightly slower rise in UACR test rates in the SMI groups compared to other people with T2D during the period. Throughout the study period, all groups changed their use of medications in similar ways: more metformin, less sulfonylurea, more lipid-lowering drugs, and more ACEi/ARBs. However, people with schizophrenia disorder consistently used fewer cardiovascular medications. Cardiovascular events were more common in the affective disorder group compared to the non-SMI group from 2009 to 2015 (rate ratio 2015 : 1.36 [95% CI 1.18-1.57]). After adjustment for age and sex, all-cause mortality was significantly higher among people with a schizophrenia spectrum disorder each year from 2003 to 2015 compared to the non-SMI group (rate ratio 2015 : 1.99 [95% CI 1.26-3.12]). CONCLUSION: Persons with schizophrenia or affective disorders demonstrated the same treatment changes for T2D as those without SMI in general practice. The lower use of most types of cardiovascular medications among people with schizophrenia disorders indicates potential undertreatment of hypertension and dyslipidemia and remains throughout the study period. Cardiovascular events were most common among people with affective disorders, but this was not reflected in a higher proportion using cardiovascular preventive medications. This knowledge should be considered in the management of this vulnerable patient group.

Ophthalmic symptoms, clinical signs and diagnostic delay in infants diagnosed with brain tumours in Denmark between 2007 and 2017.

PURPOSE: To investigate ophthalmic onset manifestations and the impact of diagnostic delay on the prognosis in infants (<1 year) diagnosed with a brain tumour. METHODS: A retrospective population-based nationwide study of infants diagnosed with a brain tumour between 2007 and 2017 in Denmark. Data was retrieved from the Danish Childhood Cancer Registry, the National Danish Health registries, and medical files. Primary outcome measures included symptoms, clinical findings, time to diagnosis and survival. RESULTS: Thirty-seven infants were diagnosed with a brain tumour in Denmark between 2007 and 2017. In total, 19/37 infants (51%, 95% CI: 34-68) had ophthalmic manifestations at any time prior to or at diagnosis; and in 6/37 (16%, 95% CI: 6-32) ophthalmic manifestations were the initial symptom. The most common ophthalmic manifestations were strabismus (n = 7), sunset eyes (n = 6), nystagmus (n = 4), reduced pupillary light reflex (n = 4), and/or decreased vision (n = 4). The median number of symptoms per infant at the time of diagnosis was three (range 0-9). The median diagnostic delay was 26 days (range 0-283, IQR: 6;90). 5-year survival rate was 75% (95% CI: 61-90) and all children with diagnostic delay > 100 days (n = 9, 24%) were still alive at the end of follow-up (median 6.3 years, range 2.2-10.2). CONCLUSION: We provide an overview of symptoms and clinical signs in a nation-wide series of infants with CNS tumours and demonstrate that ophthalmic manifestations are frequently observed in infants prior to diagnosis, but, often in combination with other clinical signs. The diagnostic delay was substantial for a large part of the infants, but this was not associated with increased mortality.

Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sjögren's syndrome: A randomized clinical trial.

PURPOSE: This double-blinded randomized clinical trial aimed to evaluate the efficacy of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) for the treatment of dry eye disease (DED) secondary to Sjögren's syndrome (SS). METHODS: Fifty-four participants with severe DED secondary to SS were included and allocated to either ASCs (n = 20), vehicle (n = 20), or a non-randomized observation group (n = 14). The intervention groups received a single injection of either ASCs or an active comparator (vehicle, Cryostor® CS10) into the LG in one eye, while the observation group received lubricating eye drops only. The primary outcome measure was changes in Ocular Surface Disease Index (OSDI) score and secondary outcome measures were non-invasive tear break-up time, tear meniscus height, Schirmer's test, and Oxford score within a 12-month follow-up. RESULTS: A significant reduction in OSDI score was observed in the ASCs and vehicle groups compared to the observation group. In addition, the ASCs group demonstrated a significant increase in non-invasive tear break-up time compared to the vehicle group at the 4-week follow-up and to the observation group at the 12-month follow-up. A significant improvement in ocular surface staining, tear osmolarity, and Schirmer test score from baseline was also observed in the ASCs group; however, these changes were not significant compared to the other groups. CONCLUSION: Improvement of subjective and objective signs and symptoms of DED was observed in both intervention groups following injection into the LG compared to the observation group. Future studies should investigate the mode-of-action of both injection treatments.

Long-term functional and structural outcomes in patients with primary congenital glaucoma-A Danish nationwide study.

PURPOSE: Evaluation of long-term functional and structural outcomes in patients with primary congenital glaucoma (PCG) based on visual acuity (VA), visual field (VF) using standard automated perimetry, and peripapillary retinal nerve fibre layer thickness (pRNFL). METHODS: We retrospectively reviewed medical records of all patients diagnosed with PCG in Denmark from 1977 to 2016. Severe vision loss was defined as VA <6/60 and/or VF >20 decibels (dB). Prognostic factors were evaluated in a correlation matrix. RESULTS: The median age of the 94 patients (153 PCG eyes) was 12 years (IQR 9-16). In PCG eyes 62% had VA ≥6/18 but 22% had <6/60. VA in the better seeing eye was ≥6/18 in 90% and <6/60 in 5%. VF was measured in 59 PCG eyes and the median mean defect was 5.1 dB (IQR 2.1-9.6) with 52% better than 6 dB and 9% worse than 20 dB. Generalized pRNFL was reduced below the age-expected 1st percentile in 29% of the 58 PCG eyes where pRNFL was measured. Poor VA, poor VF and reduced pRNFL were all correlated (p = 0.0001). More surgeries (p < 0.0001) and longer diagnostic delay (p = 0.004) were associated with poorer vision and to a lesser degree with poor VF pRNFL. CONCLUSION: In Denmark, most patients with bilateral PCG retain VA ≥6/18 in the better seeing eye. Poor VA was associated with poor VF. Longer diagnostic delay and more surgeries were associated with a poorer prognosis.

Relationship between cumulative exposure to occupational lifting throughout working life and risk of ischemic heart disease in men and women. The Copenhagen Aging and Midlife Biobank.

Ischemic heart disease (IHD) causes mortality and morbidity. High levels of occupational physical activity (OPA) increases IHD risk, and occupational lifting (OL) is suggested as a detrimental OPA exposure. This study investigated the association between accumulated OL throughout working life, and risk for IHD, and potential sex and hypertension differences. Data from Copenhagen Ageing and Midlife Biobank linked to register-based information on incident IHD during 9 years follow-up in the Danish National Patient Registry were included. The outcome was the odds of IHD from baseline (2009-2011) to end of follow-up (2018), among participants without IHD at baseline. Accumulated OL was assessed by linking occupational codes to a Job Exposure Matrix, creating a measure in ton-years (lifting 1,000 kg/day/year). Multivariable logistic regression tested associations between level of accumulated OL and IHD, among the 6,606 included individuals (68% men). During follow-up, 7.3% men and 3.6% women were hospitalized with IHD. Among all participants, the odds for IHD were 47% (OR 1.47, 95% CI 1.05-2.06) higher among those with ≥5 to <10 ton-years, 39% (OR 1.39, 95% CI 1.06-1.83) higher among those with ≥10 to <30 ton-years, and 62% (OR 1.62, 95% CI 1.18-2.22) higher among those with ≥30 ton-years, compared to no accumulated OL. However, these increased odds were in the same direction in the fully-adjusted model but statistically insignificant, ≥5 to <10 ton-years OR 1.28, 95% CI 0.88-1.88; ≥10 to <30 ton-years OR 1.20, 95% CI 0.85-1.69; and ≥30 ton-years OR 1.22, 95% CI 0.81-1.84. No statistically significant interactions, nor any associations, between OL and sex, or hypertension were seen.

Labour market attachment dynamics in patients with concussion: a Danish nationwide register-based cohort study.

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.

Management of dyslipidaemia in individuals with severe mental illness: a population-based study in the Greater Copenhagen Area.

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 OR2015 1.34 (99% CI 1.24-1.44); p2005versus2015 < 0.01]. Patients had higher odds of dyslipidaemia during both years [OR2005 1.43 (99% CI 1.10-1.85) and OR2015 1.23 (99% CI 1.08-1.41)]. Patients went from having lower odds of receiving lipid-lowering pharmacotherapy to having higher odds of receiving lipid-lowering pharmacotherapy [OR2005 0.77 (99% CI 0.66-0.89) versus OR2015 1.37 (99% CI 1.24-1.51); p2005versus2015 < 0.01]. However, among persons at high cardiovascular risk, patients had lower odds of receiving lipid-lowering pharmacotherapy during both years, including subsets with previous acute coronary syndrome [OR2005 0.30 (99% CI 0.15-0.59) and OR2015 0.44 (99% CI 0.24-0.83)] and ischaemic stroke or transient ischaemic attack (TIA) [OR2005 0.43 (99% CI 0.26-0.69) and OR 2015 0.61 (99% CI 0.41-0.89)]. Conclusion: These results imply an increased general awareness of managing dyslipidaemia among patients with SMI in the primary prophylaxis of cardiovascular disease. However, secondary prevention with lipid-lowering drugs in patients with SMI at high cardiovascular risk may be lacking.

The risk of bleeding and perforation from sigmoidoscopy or colonoscopy in colorectal cancer screening: A systematic review and meta-analyses.

INTRODUCTION: Physical 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. DESIGN: Systematic review with descriptive statistics and random-effects meta-analyses. METHODS: We 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. RESULTS: We 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. DISCUSSION: Harm 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 REGISTRATION: PROSPERO registration number: CRD42017058844.

Factors in early pregnancy predicting pregnancy-related pain in the second and third trimester.

INTRODUCTION: Pain during pregnancy affects women's well-being, causes worry and is a risk factor for the child and the mother during labor. The aim was to investigate the relative importance of an extensive set of pregnancy-related physiological symptoms and psychosocial factors assessed in the first trimester compared with the occurrence of pregnancy-related pain symptoms later in the pregnancy. MATERIAL AND METHODS: Included were all women who booked an appointment for a first prenatal visit in one of 125 randomly selected general practitioner practices in Eastern Denmark from April 2015 to August 2016. These women answered an electronic questionnaire containing questions on the occurrence of five pregnancy-related pain symptoms: back pain, leg cramps, pelvic cavity pain, pelvic girdle pain and uterine contractions. The questionnaire also included sociodemographic questions and questions on chronic diseases, physical symptoms, mental health symptoms, lifestyle and reproductive background. The questionnaire was repeated in each trimester. The relative importance of this set of factors from the first trimester on the five pregnancy-related pain symptoms compared with the second and third trimesters was assessed in a dominance analysis. RESULTS: A total of 1491 women were included. The most important factor for pregnancy-related pain in the second trimester and third trimester is the presence of the corresponding pain in the first trimester. Parity was associated with pelvic cavity pain and uterine contractions in the following pregnancies. For back pain and pelvic cavity pain, the odds increased as the women's estimated low self-assessed fitness decreased and had low WHO-5 wellbeing scores. CONCLUSIONS: When including physical risk factors, sociodemographic factors, psychological factors and clinical risk factors, women's experiences of pregnancy-related pain in the first trimester are the most important predictors for pain later in pregnancy. Beyond the expected positive effects of pregnancy-related pain, notably self-assessed fitness, age and parity were predictive for pain later in pregnancy.

Measuring needs-based quality of life and self-perceived health inequity in patients with multimorbidity: investigating psychometric measurement properties of the MultiMorbidity Questionnaire (MMQ) using primarily Rasch models.

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.

The SOFIA pilot study: assessing feasibility and fidelity of coordinated care to reduce excess mortality and increase quality of life in patients with severe mental illness in a general practice setting; a cluster-randomised pilot trial.

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.

Uptake of signposting to web-based resources: pregnant women's use of a preventive web-based intervention.

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 ).

School performances in children with cataract: results from a population-based cohort study.

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.