Objective: The aim of this prospective study of large sample of pregnant women with asthma was to... more Objective: The aim of this prospective study of large sample of pregnant women with asthma was to investigate incidence and severity of exacerbations of asthma during pregnancy. Methods: Since 2007 all pregnant women referred to give birth at Hvidovre Hospital has been offered participation in the Management of Asthma during Pregnancy (MAP) study. Women were included if they met the following criteria: 1) a diagnosis of asthma and 2) first visit to the pulmonary outpatient clinic within the first 18 weeks of pregnancy. After the initial visit, patients were scheduled for follow-up visits every four weeks throughout pregnancy. Exacerbations were classified as mild (i.e. step-up in inhaled therapy) or severe (requiring rescue oral corticosteroid and/or hospital admission) together with worsening of symptoms. Results: The cohort comprised 1.283 pregnancies in 1.208 women; mean age 31 years (range 17 to 44) and 63% on inhaled corticosteroids. A total of 468 exacerbations (273 and 195, respectively, mild and severe) were observed in 430 pregnancies (34% of pregnancies), and 67 hospital admissions for asthma in 63 pregnancies (4.9% of the cohort). In pregnancies with a least one exacerbation (n=430), 205 (48%) had an exacerbation in 1. trimester (i.e. before enrolment into the management program). Conclusion: The majority of acute exacerbations in the present large cohort of pregnant women with asthma were observed in the first trimester of pregnancy, indicating that enrolment in an asthma management program with regular follow-up visits improve asthma control, and by that reduces incidence of exacerbations.
BACKGROUND Wide-ranging patient recruitment not restricted to the location of the investigator wi... more BACKGROUND Wide-ranging patient recruitment not restricted to the location of the investigator will provide a better representation of the patient population in clinical studies. OBJECTIVE To assess the feasibility of a broad online recruitment strategy in an 8-week observational study of 500 study participants with psoriasis and healthy controls from locations remote from the investigator, and to assess the cost associated with each participant. METHODS An online team in Denmark recruited patients with psoriasis and healthy controls using Google and Facebook advertisements and posts to Facebook groups. All individuals were screened online, and patients diagnosed with psoriasis were included. Questionnaires regarding itch and sleep were completed by both groups at inclusion, week four, and week eight. RESULTS During a two-week recruitment period, 12,887 unique advertisement views were registered, and 839 participants were enrolled, of which 507 completed the study (220 with psoriasi...
Background Research has linked homelessness with increased risk of skin conditions. However, repr... more Background Research has linked homelessness with increased risk of skin conditions. However, representative studies of diagnosis-specific information on skin conditions in people experiencing homelessness are lacking. Objectives To examine the association between homelessness and diagnosed skin conditions, prescribed medication, and type of consultation. Methods This cohort study included data from the Danish nationwide health, social, and administrative registers from January 1, 1999, to December 31, 2018. All people with Danish origin living in Denmark and aged at least 15 years at some point during the study period were included. Homelessness, measured by homeless shelter contacts, was the exposure. The outcome was any diagnosis of a skin disorder and specific skin disorders recorded in the Danish National Patient Register. Information on diagnostic consultation type (i.e., dermatologic, non-dermatologic, and emergency room) and dermatological prescriptions was studied. We estima...
Hintergrund: Die Kosten für die Entwicklung eines neuen Medikaments liegen bei etwa 2,6 Milliarde... more Hintergrund: Die Kosten für die Entwicklung eines neuen Medikaments liegen bei etwa 2,6 Milliarden US-Dollar, und mehr als zwei Drittel der Gesamtkosten sind mit der klinischen Testphase verbunden. Hauptursache für Verzögerungen bei klinischen Studien ist die Patientenrekrutierung, und derartige Verzögerungen können für Pharmaunternehmen Umsatzeinbußen von bis zu 8 Millionen US-Dollar pro Tag zur Folge haben. Darüber hinaus ist es schwierig, Probanden in klinischen Studien zu halten, und bis zu 40 % brechen ihre Teilnahme ab. Zur Überwindung dieser Herausforderungen setzen Pharmaunternehmen und Forschungseinrichtungen (z. B. Universitäten) zunehmend ein neu aufkommendes Konzept ein: virtuelle klinische Studien (VCTs), die auf einem Remote (Fern)-Ansatz basieren. Zusammenfassung: Virtuelle klinische Studien (VCTs) (ohne Prüfzentrum) sind eine vergleichsweise neue Methode zur Durchführung klinischer Studien, die die technologischen Möglichkeiten (Apps, Monitoring-Geräte usw.) sowie In...
Background: Increasing costs and complexity in clinical trials requires recruitment of more narro... more Background: Increasing costs and complexity in clinical trials requires recruitment of more narrowly defined patient populations. However, recruitment for clinical trials remains a considerable challenge. Aim: Our overall aim was to quantify recruitment performance in industry-sponsored phase III clinical trials conducted globally during 2008-2019 with primary aim to examine development of overall clinical trial measures (number of trials completed, number of participants enrolled, trial duration in months) and key recruitment metrics (recruitment rate, number of sites, number of patients enrolled per site). Methods: The publicly available AACT database containing data on all trials registered at ClinicalTrials.gov since 2008 was used. The analysis was completed during three time periods from 2008-2019 of 4 years each. Results and conclusion: Recruitment duration for industry-sponsored phase III clinical trials have increased significantly during the last 12 years from an average re...
Journal of the European Academy of Dermatology and Venereology : JEADV, Jan 14, 2018
Obesity has been associated with atopic dermatitis (AD); however, the results have been conflicti... more Obesity has been associated with atopic dermatitis (AD); however, the results have been conflicting. Our aim was to provide an update on current knowledge from observational studies addressing the possible association between obesity and AD. Systematic literature review was performed by identifying studies addressing a possible link between AD and overweight/obesity from PubMed, EMBASE and the Cochrane Library in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. The quality of the included studies was assessed using the Newcastle-Ottawa Scale. A total of 45 studies (comprising more than 90 000 individuals with AD) fulfilled the criteria and were included in the present review. The available studies revealed inconsistencies, but the majority indicated that obesity is associated with AD. Studies addressing obesity in infancy or early childhood (age < 2 years) and AD reported a positive association. From childhood into adulth...
Background Asthma is a serious global health issue and the most prevalent chronic disorder among ... more Background Asthma is a serious global health issue and the most prevalent chronic disorder among Danish pregnant women. Exacerbations of asthma during pregnancy have been associated with increased risk of adverse pregnancy and perinatal outcomes, and by that making asthma a potential serious medical condition during pregnancy. Monitoring of asthma every four to six weeks is recommended during pregnancy, although evidence is lacking that following this recommendation will improve pregnancy outcome and, not least, be beneficial for all pregnant women with asthma. Aim The overall aim of the present thesis was to gain more knowledge of the interaction between asthma and pregnancy. The specific research questions were to identify pregnancies with low risk of an exacerbation during pregnancy, to identify risk factors for an exacerbation during pregnancy, and to compare the adverse pregnancy and perinatal outcomes in women without asthma and women with asthma monitored closely as recommend...
INTRODUCTION Infants with bronchopulmonary dysplasia (BPD) are at high risk of developing cardiov... more INTRODUCTION Infants with bronchopulmonary dysplasia (BPD) are at high risk of developing cardiovascular sequelae in the form of pulmonary hypertension (PH) which significantly increases morbidity and mortality. The aim of this study was to evaluate the incidence of BPD, to identify characteristics associated with BPD and to identify characteristics associated with PH in infants with BPD. MATERIAL AND METHODS A retrospective study was performed. Data were obtained from a regional neonatal database and by reviewing medical records of infants admitted during the 2002-2010 period. A total of 400 infants with a birth weight (BW) < 1,500 g were identified. Eight were excluded and 74 infants met the criteria for BPD. A total of 17 infants with BPD had PH. RESULTS We found that the incidence of BPD at the Neonatal Department at Hvidovre Hospital between January 2002 and December 2010 was 18%. Infants with BPD differed significantly from infants without BPD with regard to the following c...
Decentralised clinical trials are a modification of traditional clinical trials, which make studi... more Decentralised clinical trials are a modification of traditional clinical trials, which make studies cost-effective, time-saving and easier for participants. The use of digital solutions and health technologies in part or the entire trial process from patient recruitment, participant information, obtaining informed consent, clinical site visits, trial procedures, sampling, medication administration and safety monitoring enables for more effective conduct of the trial. Collecting data from multiple digital platforms allows for better and continuous monitoring of trial participants. In this review, we summarise those points.
Objective: The aim of this prospective study of large sample of pregnant women with asthma was to... more Objective: The aim of this prospective study of large sample of pregnant women with asthma was to investigate incidence and severity of exacerbations of asthma during pregnancy. Methods: Since 2007 all pregnant women referred to give birth at Hvidovre Hospital has been offered participation in the Management of Asthma during Pregnancy (MAP) study. Women were included if they met the following criteria: 1) a diagnosis of asthma and 2) first visit to the pulmonary outpatient clinic within the first 18 weeks of pregnancy. After the initial visit, patients were scheduled for follow-up visits every four weeks throughout pregnancy. Exacerbations were classified as mild (i.e. step-up in inhaled therapy) or severe (requiring rescue oral corticosteroid and/or hospital admission) together with worsening of symptoms. Results: The cohort comprised 1.283 pregnancies in 1.208 women; mean age 31 years (range 17 to 44) and 63% on inhaled corticosteroids. A total of 468 exacerbations (273 and 195, respectively, mild and severe) were observed in 430 pregnancies (34% of pregnancies), and 67 hospital admissions for asthma in 63 pregnancies (4.9% of the cohort). In pregnancies with a least one exacerbation (n=430), 205 (48%) had an exacerbation in 1. trimester (i.e. before enrolment into the management program). Conclusion: The majority of acute exacerbations in the present large cohort of pregnant women with asthma were observed in the first trimester of pregnancy, indicating that enrolment in an asthma management program with regular follow-up visits improve asthma control, and by that reduces incidence of exacerbations.
BACKGROUND Wide-ranging patient recruitment not restricted to the location of the investigator wi... more BACKGROUND Wide-ranging patient recruitment not restricted to the location of the investigator will provide a better representation of the patient population in clinical studies. OBJECTIVE To assess the feasibility of a broad online recruitment strategy in an 8-week observational study of 500 study participants with psoriasis and healthy controls from locations remote from the investigator, and to assess the cost associated with each participant. METHODS An online team in Denmark recruited patients with psoriasis and healthy controls using Google and Facebook advertisements and posts to Facebook groups. All individuals were screened online, and patients diagnosed with psoriasis were included. Questionnaires regarding itch and sleep were completed by both groups at inclusion, week four, and week eight. RESULTS During a two-week recruitment period, 12,887 unique advertisement views were registered, and 839 participants were enrolled, of which 507 completed the study (220 with psoriasi...
Background Research has linked homelessness with increased risk of skin conditions. However, repr... more Background Research has linked homelessness with increased risk of skin conditions. However, representative studies of diagnosis-specific information on skin conditions in people experiencing homelessness are lacking. Objectives To examine the association between homelessness and diagnosed skin conditions, prescribed medication, and type of consultation. Methods This cohort study included data from the Danish nationwide health, social, and administrative registers from January 1, 1999, to December 31, 2018. All people with Danish origin living in Denmark and aged at least 15 years at some point during the study period were included. Homelessness, measured by homeless shelter contacts, was the exposure. The outcome was any diagnosis of a skin disorder and specific skin disorders recorded in the Danish National Patient Register. Information on diagnostic consultation type (i.e., dermatologic, non-dermatologic, and emergency room) and dermatological prescriptions was studied. We estima...
Hintergrund: Die Kosten für die Entwicklung eines neuen Medikaments liegen bei etwa 2,6 Milliarde... more Hintergrund: Die Kosten für die Entwicklung eines neuen Medikaments liegen bei etwa 2,6 Milliarden US-Dollar, und mehr als zwei Drittel der Gesamtkosten sind mit der klinischen Testphase verbunden. Hauptursache für Verzögerungen bei klinischen Studien ist die Patientenrekrutierung, und derartige Verzögerungen können für Pharmaunternehmen Umsatzeinbußen von bis zu 8 Millionen US-Dollar pro Tag zur Folge haben. Darüber hinaus ist es schwierig, Probanden in klinischen Studien zu halten, und bis zu 40 % brechen ihre Teilnahme ab. Zur Überwindung dieser Herausforderungen setzen Pharmaunternehmen und Forschungseinrichtungen (z. B. Universitäten) zunehmend ein neu aufkommendes Konzept ein: virtuelle klinische Studien (VCTs), die auf einem Remote (Fern)-Ansatz basieren. Zusammenfassung: Virtuelle klinische Studien (VCTs) (ohne Prüfzentrum) sind eine vergleichsweise neue Methode zur Durchführung klinischer Studien, die die technologischen Möglichkeiten (Apps, Monitoring-Geräte usw.) sowie In...
Background: Increasing costs and complexity in clinical trials requires recruitment of more narro... more Background: Increasing costs and complexity in clinical trials requires recruitment of more narrowly defined patient populations. However, recruitment for clinical trials remains a considerable challenge. Aim: Our overall aim was to quantify recruitment performance in industry-sponsored phase III clinical trials conducted globally during 2008-2019 with primary aim to examine development of overall clinical trial measures (number of trials completed, number of participants enrolled, trial duration in months) and key recruitment metrics (recruitment rate, number of sites, number of patients enrolled per site). Methods: The publicly available AACT database containing data on all trials registered at ClinicalTrials.gov since 2008 was used. The analysis was completed during three time periods from 2008-2019 of 4 years each. Results and conclusion: Recruitment duration for industry-sponsored phase III clinical trials have increased significantly during the last 12 years from an average re...
Journal of the European Academy of Dermatology and Venereology : JEADV, Jan 14, 2018
Obesity has been associated with atopic dermatitis (AD); however, the results have been conflicti... more Obesity has been associated with atopic dermatitis (AD); however, the results have been conflicting. Our aim was to provide an update on current knowledge from observational studies addressing the possible association between obesity and AD. Systematic literature review was performed by identifying studies addressing a possible link between AD and overweight/obesity from PubMed, EMBASE and the Cochrane Library in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. The quality of the included studies was assessed using the Newcastle-Ottawa Scale. A total of 45 studies (comprising more than 90 000 individuals with AD) fulfilled the criteria and were included in the present review. The available studies revealed inconsistencies, but the majority indicated that obesity is associated with AD. Studies addressing obesity in infancy or early childhood (age < 2 years) and AD reported a positive association. From childhood into adulth...
Background Asthma is a serious global health issue and the most prevalent chronic disorder among ... more Background Asthma is a serious global health issue and the most prevalent chronic disorder among Danish pregnant women. Exacerbations of asthma during pregnancy have been associated with increased risk of adverse pregnancy and perinatal outcomes, and by that making asthma a potential serious medical condition during pregnancy. Monitoring of asthma every four to six weeks is recommended during pregnancy, although evidence is lacking that following this recommendation will improve pregnancy outcome and, not least, be beneficial for all pregnant women with asthma. Aim The overall aim of the present thesis was to gain more knowledge of the interaction between asthma and pregnancy. The specific research questions were to identify pregnancies with low risk of an exacerbation during pregnancy, to identify risk factors for an exacerbation during pregnancy, and to compare the adverse pregnancy and perinatal outcomes in women without asthma and women with asthma monitored closely as recommend...
INTRODUCTION Infants with bronchopulmonary dysplasia (BPD) are at high risk of developing cardiov... more INTRODUCTION Infants with bronchopulmonary dysplasia (BPD) are at high risk of developing cardiovascular sequelae in the form of pulmonary hypertension (PH) which significantly increases morbidity and mortality. The aim of this study was to evaluate the incidence of BPD, to identify characteristics associated with BPD and to identify characteristics associated with PH in infants with BPD. MATERIAL AND METHODS A retrospective study was performed. Data were obtained from a regional neonatal database and by reviewing medical records of infants admitted during the 2002-2010 period. A total of 400 infants with a birth weight (BW) < 1,500 g were identified. Eight were excluded and 74 infants met the criteria for BPD. A total of 17 infants with BPD had PH. RESULTS We found that the incidence of BPD at the Neonatal Department at Hvidovre Hospital between January 2002 and December 2010 was 18%. Infants with BPD differed significantly from infants without BPD with regard to the following c...
Decentralised clinical trials are a modification of traditional clinical trials, which make studi... more Decentralised clinical trials are a modification of traditional clinical trials, which make studies cost-effective, time-saving and easier for participants. The use of digital solutions and health technologies in part or the entire trial process from patient recruitment, participant information, obtaining informed consent, clinical site visits, trial procedures, sampling, medication administration and safety monitoring enables for more effective conduct of the trial. Collecting data from multiple digital platforms allows for better and continuous monitoring of trial participants. In this review, we summarise those points.
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