Objectives Patient and stakeholder engagements in research have increasingly gained attention in healthcare and healthcare-related research. A common and rigorous approach to establish research priorities based on input from people and stakeholders is the James Lind Alliance Priority Setting Partnership (JLA-PSP). The aim of this study was to establish research priorities for chronic musculoskeletal (MSK) pain by engaging with people living with chronic MSK pain, relatives to people living with chronic MSK pain, healthcare professionals (HCP), and researchers working with chronic MSK pain. Methods This JLA-PSP included a nation-wide survey in Denmark, an interim prioritisation, and an online consensus building workshop. The information gained from this was the basis for developing the final list of specific research priorities within chronic MSK pain. Results In the initial survey, 1010 respondents (91% people living with chronic MSK pain/relatives, 9% HCPs/researchers) submitted 3121 potential questions. These were summarised into 19 main themes and 36 sub-themes. In the interim prioritisation exercise, 51% people living with pain/relatives and 49% HCPs/researchers reduced the list to 33 research questions prior to the final priority setting workshop. 23 participants attended the online workshop (12 people/relatives, 10 HCPs, and 1 researcher) who reached consensus for the most important research priorities after two rounds of discussion of each question. Conclusions This study identified several specific research questions generated by people living with chronic MSK pain, relatives, HCPs, and researchers. The stakeholders proposed prioritization of the healthcare system’s ability to support patients, focus on developing coherent pathways between sectors and education for both patients and HCP. These research questions can form the basis for future studies, funders, and be used to align research with end-users’ priorities.
Aim The benefits of cardiac rehabilitation (CR) after acute coronary syndrome (ACS) are well established. However, the relative benefit of CR in those with comorbidities, including diabetes, is not well understood. This systematic review and meta-analysis examined the benefit of CR on exercise capacity and secondary outcomes in ACS patients with a co-diagnosis of diabetes compared to those without. Methods Five databases were searched in May 2021 for randomised controlled trials (RCTs) and observational studies reporting CR outcomes in ACS patients with and without diabetes. The primary outcome of this study was exercise capacity expressed as metabolic equivalents (METs) at the end of CR and ≥ 12-month follow-up. Secondary outcomes included health-related quality of life, cardiovascular- and diabetes-related outcomes, lifestyle-related outcomes, psychological wellbeing, and return to work. If relevant/possible, studies were pooled using random-effects meta-analysis. Results A total of 28 studies were included, of which 20 reported exercise capacity and 18 reported secondary outcomes. Overall, the studies were judged to have a high risk of bias. Meta-analysis of exercise capacity was undertaken based on 18 studies (no RCTs) including 15,288 patients, of whom 3369 had diabetes. This analysis showed a statistically significant smaller difference in the change in METs in ACS patients with diabetes (standardised mean difference (SMD) from baseline to end of CR: − 0.15 (95% CI: − 0.24 to − 0.06); SMD at the ≥ 12-month follow-up: − 0.16 (95% CI: − 0.23 to − 0.10, four studies)). Conclusion The benefit of CR on exercise capacity in ACS patients was lower in those with diabetes than in those without diabetes. Given the small magnitude of this difference and the substantial heterogeneity in the results of the study caused by diverse study designs and methodologies, further research is needed to confirm our findings. Future work should seek to eliminate bias in observational studies and evaluate CR based on comprehensive outcomes.
Background: In the continuous work to reduce the use of coercion in psychiatric care, attention in Denmark has especially been directed towards mechanical restraint. While the use of mechanical restraint is currently decreasing, an increase in other types of coercion is observed (e.g. medication and hour-long episodes of physical holding). Physical holding has, in this cultural context, been considered less intrusive to a patient's autonomy than the use of mechanical restraint. However, no study has yet compared the experiences of the patients on these two types of coercion in the same population. The objective of this study was to explore patients' perspectives on physical holding and mechanical restraint, respectively. Methods: Audio-recorded, semi-structured interviews following an interview guide were conducted with patients sharing their experiences with both types of coercion. The interviews were transcribed verbatim. The analytical approach was based on the principles of thematic content analysis. Results: Nine informants were interviewed between September 2020 and April 2021. Four main themes were identified: experiences with physical holding, experiences with mechanical restraint, the effects of coercion on patients and their relation to mental health care, and improved mental health care. Conclusion: It is inconclusive which type of restraint the patients preferred. This challenges the present hierarchy of coercive measures. To avoid coercion in the first place more communication and time with the patient are needed.
A questionnaire-based screening tool for male athletes at risk of low energy availability (LEA) could facilitate both research and clinical practice. The present options rely on proxies for LEA such screening tools for disordered eating, exercise dependence, or those validated in female athlete populations. in which the female-specific sections are excluded. To overcome these limitations and support progress in understanding LEA in males, centres in Australia, Norway, Denmark, and Sweden collaborated to develop a screening tool (LEAM-Q) based on clinical investigations of elite and sub-elite male athletes from multiple countries and ethnicities, and a variety of endurance and weight-sensitive sports. A bank of questions was developed from previously validated questionnaires and expert opinion on various clinical markers of LEA in athletic or eating disorder populations, dizziness, thermoregulation, gastrointestinal symptoms, injury, illness, wellbeing, recovery, sleep and sex drive. The validation process covered reliability, content validity, a multivariate analysis of associations between variable responses and clinical markers, and Receiver Operating Characteristics (ROC) curve analysis of variables, with the inclusion threshold being set at 60% sensitivity. Comparison of the scores of the retained questionnaire variables between subjects classified as cases or controls based on clinical markers of LEA revealed an internal consistency and reliability of 0.71. Scores for sleep and thermoregulation were not associated with any clinical marker and were excluded from any further analysis. Of the remaining variables, dizziness, illness, fatigue, and sex drive had sufficient sensitivity to be retained in the questionnaire, but only low sex drive was able to distinguish between LEA cases and controls and was associated with perturbations in key clinical markers and questionnaire responses. In summary, in this large and international cohort, low sex drive was the most effective self-reported symptom in identifying male athletes requiring further clinical assessment for LEA.
Background High-dose influenza vaccines provide better protection against influenza infection than standard-dose in persons aged 65 years and above; however, in most countries, high-dose vaccines are not widely implemented. Assessing the relative effectiveness of high-dose compared to standard-dose vaccines on hospitalizations and mortality would enable more robust public health and cost-effectiveness estimates. This study aims to investigate the feasibility of conducting a pragmatic randomized clinical trial in Denmark comparing high-dose to standard-dose vaccines utilizing existing vaccination infrastructure and the Danish nationwide health registries for data collection. Methods The DANFLU-1 trial (NCT05048589) is a pragmatic, open-label, active-controlled randomized trial randomizing Danish citizens aged 65–79 years to either high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine. The study utilizes the infrastructure of a private vaccination provider (Danske Lægers Vaccinations Service) for recruitment, inclusion, randomization, and vaccination. All collection of baseline and follow-up data including safety monitoring is performed centrally by the Department of Cardiology at Herlev and Gentofte Hospital, Copenhagen, Denmark using the Danish nationwide health registries. The study aims to include 40,000 participants during the 2021/2022 influenza season. The primary endpoints address feasibility and include the number of participants enrolled, randomization balance, and representativeness compared to the Danish general population. Relative vaccine effectiveness will also be assessed, however, this feasibility study is not powered for clinical outcomes and may be affected by the COVID-19 pandemic. Discussion The DANFLU-1 study is investigating the feasibility of conducting a large-scale pragmatic clinical trial in Denmark utilizing existing infrastructure and the Danish nationwide registries. This will provide valuable insight, especially for potential future fully powered vaccine trials, but also for trials wishing to investigate other interventions. Trial registration Clinicaltrials.gov: NCT05048589, registered September 17, 2021.
Background People with advanced cancer need to balance their resources and energy in order to experience enjoyment and quality of life in the time they have left. A resource-oriented intervention is developed targeting these aspects. The present protocol presents a feasibility study of this resource-oriented intervention in people with advanced cancer. Methods A feasibility study with a repeated-measurement design without a control group will be conducted at the research clinic of REHPA, the Danish Knowledge Center for Rehabilitation and Palliative Care. Data will be gathered at baseline, during and after a 5-day residential stay, after 6 weeks, during a 2-day follow-up stay and after 12 weeks. In total, 20–25 home-living adults (≥ 18 years) with advanced cancer reporting needs in everyday life will be recruited. The intervention consists of workshops and engagement in physical and creative everyday activities provided by a multidisciplinary team. Outcome measures are quality of life, physical function and fatigue, which will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core-30. Balance in everyday activities will be assessed using the Occupational Balance Questionnaire. Feasibility data will also be collected regarding (1) fidelity, (2) adherence, (3) dose and (4) reach and mechanisms of impact. For exploration of mechanism of impact, participant observations and focus group interviews will be used. Discussion This study presents a new approach in rehabilitation and palliative care aimed at supporting people with advanced cancer; instead of identification of problems, the present resource-oriented palliative rehabilitation intervention will target people’s resources, enhancing balance in everyday activities and underpinning enjoyment and quality of life. The results from the feasibility study can inform ways in which to support the everyday life of people with advanced cancer and thus have potential to improve their quality of life. The long-term perspectives are to evaluate the intervention in terms of effect, process and cost-effectiveness. This will provide evidence to adjust the content of rehabilitation and palliative care for this group of people. Trial registration NCT04772690 Name of the registry: Balance, Activity and Quality of Life (BAL) Date of registry: February 26, 2021
Aims: We estimated and compared health-related quality of life for individuals with normal glucose tolerance, prediabetes and diabetes. Methods: Participants in the ADDITION-PRO study, Denmark, who attended a health assessment between 2009 and 2011, and who completed the 3-level EuroQoL 5-dimensions (EQ-5D-3L) questionnaire were included. For the present study, they were classified as normal glucose tolerance, prediabetes and diabetes (screen-detected and known) using the 2019 American Diabetes Association criteria. Prediabetes was defined as impaired fasting glucose, impaired glucose tolerance or HbA1c between 5.7 - 6.4% (39-47 mmol/mol). EQ-5D-3L data were converted into utility scores using Danish and UK values, where '1' equals full health and '0' equals death. Regression models estimated the association between utility and the different glucose health states. Results: The mean EQ-5D-3L score in the sample population was 0.86±0.17 (median 0.85, interquartile range 0.76 to 1) using UK values. Almost half of the sample (48%) reported full health with an EQ-5D score of '1'. Individuals with known diabetes reported the lowest EQ-5D-3L utility scores (0.81±0.20), followed by individuals with screen-detected diabetes (0.85±0.19), prediabetes (0.86±0.17) and normal glucose tolerance (0.90±0.15). The differences were statistically significant for normal glucose and known diabetes relative to prediabetes, after adjusting for sex, age, smoking, BMI and physical activity. These findings also held using Danish values albeit the differences were of smaller magnitude. Conclusions: Having prediabetes and diabetes was significantly associated with lower health-related quality of life relative to normal glucose tolerance. Our estimates will be useful to inform the value of interventions to prevent diabetes or prediabetes.
Background Little is known about the impact of pregnancy on long‐term cardiovascular health in individuals with congenital heart disease (CHD). We aimed to determine if giving birth in patients with CHD is associated with higher risk of long‐term cardiovascular morbidity. Methods and Results We studied a cohort of 1262 individuals with CHD giving birth (live or still) from 1993 to 2015 using Danish nationwide registers. We randomly sampled a comparison cohort matched on age of women with CHD who had not given birth at the time. We balanced the 2 cohorts on baseline demographic (eg, education) and clinical variables (eg, CHD severity) using inverse probability of treatment weighting. Individuals were followed for critical (eg, heart failure), other cardiovascular morbidity (eg, arrhythmia), and cardiac surgery/interventions after pregnancy. Individuals were followed for median 6.0 years (interquartile range 3.2–9.2). Among individuals giving birth the incidence rate per 1000 person‐years was 1.6, 10.0, and 6.0 for critical and other cardiovascular morbidity and cardiac surgery, respectively. There was no overall difference in risk of neither critical and other cardiovascular morbidity nor cardiac surgery among individuals who gave birth and individuals who did not; adjusted hazard ratios (aHR) were 0.74 (95% CI, 0.37–1.48), 0.88 (95% CI, 0.65–1.19), and 0.78 (95% C,I 0.54–1.12), respectively. However, individuals with obstetric complications had a higher long‐term risk of other cardiovascular morbidity (aHR, 1.85; 95% CI, 1.07–3.20). Conclusions Giving birth seemed not to be associated with a higher risk of long‐term cardiovascular morbidity among women with CHD. However, individuals having obstetric complications had a higher risk of other cardiovascular morbidity in the long term.
Background Influenza infection may increase the risk of stroke and acute myocardial infarction (AMI). Whether influenza vaccination may reduce mortality in patients with hypertension is currently unknown. Methods and Results We performed a nationwide cohort study including all patients with hypertension in Denmark during 9 consecutive influenza seasons in the period 2007 to 2016 who were prescribed at least 2 different classes of antihypertensive medication (renin‐angiotensin system inhibitors, diuretics, calcium antagonists, or beta‐blockers). We excluded patients who were aged <18 years, >100 years, had ischemic heart disease, heart failure, chronic obstructive lung disease, cancer, or cerebrovascular disease. The exposure to influenza vaccination was assessed before each influenza season. The end points were defined as death from all‐causes, from cardiovascular causes, or from stroke or AMI. For each influenza season, patients were followed from December 1 until April 1 the next year. We included a total of 608 452 patients. The median follow‐up was 5 seasons (interquartile range, 2–8 seasons) resulting in a total follow‐up time of 975 902 person‐years. Vaccine coverage ranged from 26% to 36% during the study seasons. During follow‐up 21 571 patients died of all‐causes (3.5%), 12 270 patients died of cardiovascular causes (2.0%), and 3846 patients died of AMI/stroke (0.6%). After adjusting for confounders, vaccination was significantly associated with reduced risks of all‐cause death (HR, 0.82; P <0.001), cardiovascular death (HR, 0.84; P <0.001), and death from AMI/stroke (HR, 0.90; P =0.017). Conclusions Influenza vaccination was significantly associated with reduced risks of death from all‐causes, cardiovascular causes, and AMI/stroke in patients with hypertension. Influenza vaccination might improve outcome in hypertension.
Objective: The purpose of this study was to examine overall and site-specific cancer risk among individuals diagnosed with migraine compared with the general population. Background: Current evidence regarding migraine and risk of cancer is sparse and inconclusive. Methods: We conducted a nationwide population-based cohort study with data collected routinely and prospectively from Danish population-based registries from 1995 to 2017. We computed the age- and sex-standardized incidence ratio (SIR) as the ratio of observed to expected cancers among patients diagnosed with migraine in the study population overall, and by encounter type of first diagnosis (inpatient, outpatient specialty clinic, and emergency department). Site-specific cancers were grouped according to etiology. Results: We identified 72,826 patients with a first-time hospital migraine diagnosis. There were 3090 observed overall cancer cases among individuals diagnosed with migraine as compared with 3108 expected cases (SIR 0.99, 95% confidence interval [CI]: 0.96-1.03). The cumulative incidence of all cancers combined from 1995 to 2017 among those with a first-time migraine diagnosis was 9.47% (95% CI: 9.08-9.87). The SIRs for most cancers were consistent with absence of an association: 1.00 (95% CI: 0.94-1.06) for hormone-related cancers, 0.96 (95% CI: 0.88-1.03) for smoking-related cancers, 1.10 (95% CI: 0.98-1.24) for hematologic cancers, and 0.95 (95% CI: 0.85-1.06) for immune-related cancers. Exceptions were SIRs for gastrointestinal cancers (0.78, 95% CI: 0.70-0.87) and for cancers of neurological origin (1.57, 95% CI: 1.40-1.76). Conclusions: For most cancer groups, our results did not support an association with migraine. The exceptions were an increased risk for cancers of neurological origin and a decreased risk for gastrointestinal cancers. These findings may reflect a true difference in risk among individuals with migraine, or more plausibly they reflect other forces, such as differences in medication use, detection bias and reverse causation, or shared risk factors.
Aims Despite landmark heart failure (HF) with reduced ejection fraction (HFrEF) trials showing effect of Mineralocorticoid Receptor Antagonists (MRA) on the risk of death and HF hospitalization, it has been suggested that MRAs are underutilized or frequently withdrawn. This study sought to identify temporal trends in the initiation of MRAs and the subsequent risk of withdrawal and adherence of MRAs in HF patients treated with a renin-angiotensin system inhibitor and a beta-blocker in Denmark from 2003–2017. Methods and results From nationwide registries, we identified patients receiving a diagnosis of HF. Use of MRA was identified by at least one prescription within six months after the diagnosis. The absolute risk of withdrawal with treatment was assessed with cumulative incidence, accounting for the competing risk of death. To estimate adherence, we calculated the proportion of days covered (PDC). We included 51 512 patients with incident HF. During the study period 20 779 (40.3%) patients initiated MRA therapy. The incidence of withdrawal of MRA was 49.2% throughout the study period. 48.0% of the HF patients were adherent with the treatment. Among patients withdrawing treatment with MRA, the cumulative incidence of reinitiating was 36.6%. Conclusions In a nationwide cohort of patients with HF, approximately half of the patients received MRA as third-line therapy within the first six months after diagnosis and approximately half of these withdrew MRA within 5 years. These findings warrant an increasing focus on retention to MRA treatment in a real-life setting. This article is protected by copyright. All rights reserved.
Aim To investigate reasons for the declining prevalence of cerebral palsy (CP) in children born at term in Denmark by evaluating obstetric and neonatal factors associated with CP, and their changes over time. Method In this cohort study, we included 987 495 children (504 600 [51.1%] males and 482 895 [48.9%] females) born after 37 completed gestational weeks during birth years 1997 to 2013. Risk ratios of CP for each factor were calculated with log-binominal regression analyses. Significant factors were evaluated concerning their development in prevalence over time. Results In the antenatal period, there were significant associations with an increased risk of CP and high maternal body mass index (BMI), smoking during pregnancy, nulliparity, male sex, gestational age, and low birthweight. In the study period, fewer females smoked during pregnancy and fewer children were born post-term, dropping from 22.6% to 11.4% and 9.4% to 2.5% respectively. Conversely, the proportion of females with high BMI increased. Most significant risk factors were found in the neonatal period, with an increase in children with diagnosed birth defects and children admitted to neonatal care. Interpretation Reasons for the declining prevalence of CP appear to be multifactorial and likely include the decline in maternal smoking and children born post-term along with centralization and advances in neonatal treatment.
The benchmark dose (BMD) methodology has become the recommended approach to derive reference values for risk assessment for several authorities. However, in practice, the BMD approach is not standard use in the risk assessment for pesticides where the no observed adverse effect level (NOAEL), lowest observed adverse effect level (LOAEL), and the ED50 or EDx prevail. The regression-based BMD and BMDL (Benchmark dose lower confidence limit) have several advantages, such as utilizing more information of the generated data and being less dependent on the tested dose levels. However, the BMD approach requires some degree of expert knowledge, i.e., for defining an appropriate risk level for estimating the BMD and using more sophisticated statistical methods for calculating the BMD and the BMDL. The BMD approach is one way to move away from p-value-based binary decision-making towards putting the weight on effect sizes. We review the advantages and disadvantages of focusing the risk assessment of pesticides on the BMD approach. Further, we discuss potential applications in efficacy trials for pest management purposes. This article is protected by copyright. All rights reserved.
Aims/hypothesis Data on type 1 diabetes incidence and prevalence are limited, particularly for adults. This study aims to estimate global numbers of incident and prevalent cases of type 1 diabetes in 2017 for all age groups, by country and areas defined by income and region. Methods Incidence rates of type 1 diabetes in children (available from 94 countries) from the IDF Atlas were used and extrapolated to countries without data. Age-specific incidence rates in adults (only known across full age range for fewer than ten countries) were obtained by applying scaling ratios for each adult age group relative to the incidence rate in children. Age-specific incidence rates were applied to population estimates to obtain incident case numbers. Duration of diabetes was estimated from available data and adjusted using differences in childhood mortality rate between countries from United Nations demographic data. Prevalent case numbers were derived by modelling the relationship between prevalence, incidence and disease duration. Sensitivity analyses were performed to quantify the impact of alternative assumptions and model inputs. Results Global numbers of incident and prevalent cases of type 1 diabetes were estimated to be 234,710 and 9,004,610, respectively, in 2017. High-income countries, with 17% of the global population, accounted for 49% of global incident cases and 52% of prevalent cases. Asia, which has the largest proportion of the world’s population (60%), had the largest number of incident (32%) and prevalent (31%) cases of type 1 diabetes. Globally, 6%, 35%, 43% and 16% of prevalent cases were in the age groups 0–14, 15–39, 40–64 and 65+ years, respectively. Based on sensitivity analyses, the estimates could deviate by ±15%. Conclusions/interpretation Globally, type 1 diabetes represents about 2% of the estimated total cases of diabetes, ranging from less than 1% in certain Pacific countries to more than 15% in Northern European populations in 2017. This study provides information for the development of healthcare and policy approaches to manage type 1 diabetes. The estimates need further validation due to limitations and assumptions related to data availability and estimation methods. Graphical abstract
Background: Little is known about variations in the provision of chronic care services in primary care. Aim: To describe the frequency of chronic care services provided by GPs and analyse the extent of non-random variation in service provision. Design and setting: Nationwide cohort study in Denmark in 2016. Method: Information on chronic care services was obtained from national health registers, including annual chronic care consultations, chronic care procedures, outreach home visits, and talk therapy. The associations between provided services, patient morbidity, and socioeconomic factors were estimated. Service variations were analysed, and excess variation related to practice-specific factors was estimated while accounting for random variation. Results: Chronic care provision was associated with increasing patient age, increasing number of long-term conditions, and indicators of low socioeconomic status. Variation across practices ranged from 1.4 to 128 times more than expected after adjusting for differences in patient population and random variation. Variation related to practice-specific factors was present for all investigated chronic care services. Older patients with lower socioeconomic status and multimorbidity were clustered in practices with low propensity to provide certain chronic care services. Conclusion: Chronic care was provided to patients typically in need of healthcare, i.e. the old, those with multimorbidity, and those with low socioeconomic status, but service provision varied more than expected across practices. GPs provided slightly fewer chronic care services than expected in practices where many patients with multimorbidity and low socioeconomic status were clustered, suggesting inverse care law mechanisms.
The aim was to examine whether motor development problems in infancy predicted mental disorders later in childhood, taking a wide array of potential confounder variables into consideration. This longitudinal study included an unselected study population of 33,238 newborn children from the Copenhagen area in Denmark. Data on the predictor variable motor development problems at age 8-10 months was obtained from the community health nurses’ systematic evaluation of the child’s motor development problems during a home visit stored in the Child Health Database. Data on outcome, diagnosed mental disorders before age 8 years, was obtained from the Danish National Patient Register. The study included potential confounders obtained from the Child Health Database, the National Birth Register, and the Civil Registration System. The prevalence of motor development problems at age 8-10 months was 19.3% and the incidence of any diagnosed mental disorder from age 11 months to the 8 th birthday was 4.0%. Motor development problems were associated with an overall increased risk of being diagnosed with a mental disorder before the 8 th birthday, adjusted odds ratio (AOR) 1.47 (1.29-1.67), in particular diagnosed neuro-developmental disorders, AOR 1.77 (1.52-2.06), such as autism-spectrum disorders, AOR 1.63 (1.31-2.03), hyperactivity/ attention deficit disorders, AOR 1.29 (1.03-1.61) and disorders of intellectual disability, AOR 3.28 (2.39-4.49). Conclusion : Motor development problems as early at age 9-10 months are predictive of neurodevelopmental disorders at age 1-8 years. The findings call for clinical attention and more research in the preventive potentials in the community child health care.
Background The prevalence of depression and the exposure to antidepressants are high among women of reproductive age and during pregnancy. Duloxetine is a selective serotonin-norepinephrine reuptake inhibitor (SNRI) approved in the United States and Europe in 2004 for the treatment of depression. Fetal safety of duloxetine is not well established. The present study evaluates the association of exposure to duloxetine during pregnancy and the risk of major and minor congenital malformations and the risk of stillbirths. Methods and findings A population-based observational study was conducted based on data from registers in Sweden and Denmark. All registered births and stillbirths in the medical birth registers between 2004 and 2016 were included. Malformation diagnoses were identified up to 1 year after birth. Logistic regression analyses were used. Potential confounding was addressed through multiple regression, propensity score (PS) matching, and sensitivity analyses. Confounder variables included sociodemographic information (income, education, age, year of birth, and country), comorbidity and comedication, previous psychiatric contacts, and birth-related information (smoking during pregnancy and previous spontaneous abortions and stillbirths). Duloxetine-exposed women were compared with 4 comparators: (1) duloxetine-nonexposed women; (2) selective serotonin reuptake inhibitor (SSRI)-exposed women; (3) venlafaxine-exposed women; and (4) women exposed to duloxetine prior to, but not during, pregnancy. Exposure was defined as redemption of a prescription during the first trimester and throughout pregnancy for the analyses of malformations and stillbirths, respectively. Outcomes were major and minor malformations and stillbirths gathered from the national patient registers. The cohorts consisted of more than 2 million births with 1,512 duloxetine-exposed pregnancies. No increased risk for major malformations, minor malformations, or stillbirth was found across comparison groups in adjusted and PS-matched analyses. Duloxetine-exposed versus duloxetine-nonexposed PS-matched analyses showed odds ratio (OR) 0.98 (95% confidence interval [CI] 0.74 to 1.30, p = 0.909) for major malformations, OR 1.09 (95% CI 0.82 to 1.45, p = 0.570) for minor malformation, and 1.18 (95% CI 0.43 to 3.19, p = 0.749) for stillbirths. For the individual malformation subtypes, some findings were statistically significant but were associated with large statistical uncertainty due to the extremely small number of events. The main limitations for the study were that the indication for duloxetine and a direct measurement of depression severity were not available to include as covariates. Conclusions Based on this observational register-based nationwide study with data from Sweden and Denmark, no increased risk of major or minor congenital malformations or stillbirth was associated with exposure to duloxetine during pregnancy.
Introduction: Good quality of cardiopulmonary resuscitation (CPR) provided by bystanders is important for the outcome in out-of-hospital cardiac arrest (OHCA). A live video stream from the bystander’s smartphone to the medical dispatcher might improve the quality of chest compressions performed during CPR. Methods: At the Copenhagen Emergency Medical Services in Denmark, the medical dispatcher can add a live video to the emergency call. In case of OHCA, the medical dispatcher guides bystanders in dispatcher-assisted CPR (DA-CPR). After initiating chest compressions, the medical dispatcher can add live video streaming. A cohort study was conducted with an evaluation of performed chest compressions from the video footage before and after the dispatcher used the video to instruct CPR (video-instructed DA-CPR). Correct chest compressions were defined according to European Resuscitation Council Guidelines. Results: CPR was provided with a live video stream in 52 OHCA calls, in which 90 bystanders performed chest compressions. Thirty OHCA occurred at a public location, and more than four bystanders were present in 32 (62%) cases. In 26 cases, chest compressions were performed by more than one bystander. Eight (9%) bystanders performed correct chest compressions before video-instructed DA-CPR. For the bystanders first initiating insufficient CPR improvements were observed for: hand placement 58% (n=17/29), compressions rate 73% (n=17/21), and compressions depth 62% (n=19/31) following video-instructed DA-CPR. For the second bystander providing CPR (n=26) improvements were still observed for: hand placement 57% (n=4/7), compressions rate 73% (N=8/11), and compressions depth 53% (n=11/21) following video-instructed DA-CPR. For the third and fourth bystander (n=10), providing CPR improvements were seen for: hand placement 100% (n=2/2), compressions rate 50 % (n=2/4), and compressions depth 60% (n=3/5). Eighteen bystanders had a chest compressions performance measurement that could not be observed. Conclusions: A live video from the bystander`s smartphone to the medical dispatcher could improve the quality of chest compressions in CPR, and guidance seems important not just for the first bystander but for all bystanders performing CPR.
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