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1. Use cases of registry‐based randomized controlled trials—A review of the registries' contributions and constraints.

Author

Kubesch, Nadine, Gaitonde, Sneha, Petriti, Uarda, Bakker, Elisabeth, Basu, Swati, Birks, Laura Ellen, Aubrun, Elodie, de Vries, Sieta T., and Schneider, Rahel

Subjects
*MEDICAL equipment, *PATIENT selection, *MEDICAL care, *DATA quality, *DESCRIPTIVE statistics, *MEDICAL registries
Abstract

Registry‐based randomized controlled trials (RRCTs) can combine the advantages of registries with those of randomization. This review aimed to expand the current knowledge on RRCT utilization and implementation by providing a comprehensive overview of RRCT use cases. A targeted literature search was conducted through July 2023 to identify articles on RRCTs. Information regarding the RRCT characteristics, their utilization, and the registries' contributions and the constraints faced was extracted. Descriptive statistics were used. We identified 102 RRCTs in 110 publications. RRCTs were mostly performed for the assessment of medical devices or surgical/clinical procedures (n = 45), followed by drugs (n = 30). More than half of the RRCTs were conducted in the Nordic countries (n = 58) and the most used registry types were health service registries/administrative health data (n = 63), followed by disease registries (n = 46). Approximately half of the RRCTs (n = 53) utilized additional data sources aside from registry data. The contribution of a registry to the RRCT was mostly for data collection and study follow‐up (n = 90–92), followed by patient recruitment (n = 56–61), and randomization (n = 28–38), with varying levels of transparency in reporting. We collated author‐reported constraints related to the used registries into four overarching themes, that is, data availability and completeness, data quality, representativeness, and registry infrastructure and accessibility. This review shows that RRCTs are already used in different domains and geographic regions. Guidelines on structured and transparent reporting of RRCT methods and the optimal use are, however, needed to inform decision‐making by health authorities and to reach their full potential. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Improving health through policies that promote active travel: A review of evidence to support integrated health impact assessment

Author

de Nazelle, Audrey, Nieuwenhuijsen, Mark J., Antó, Josep M., Brauer, Michael, Briggs, David, Braun-Fahrlander, Charlotte, Cavill, Nick, Cooper, Ashley R., Desqueyroux, Hélène, Fruin, Scott, Hoek, Gerard, Panis, Luc Int, Janssen, Nicole, Jerrett, Michael, Joffe, Michael, Andersen, Zorana Jovanovic, van Kempen, Elise, Kingham, Simon, Kubesch, Nadine, Leyden, Kevin M., Marshall, Julian D., Matamala, Jaume, Mellios, Giorgos, Mendez, Michelle, Nassif, Hala, Ogilvie, David, Peiró, Rosana, Pérez, Katherine, Rabl, Ari, Ragettli, Martina, Rodríguez, Daniel, Rojas, David, Ruiz, Pablo, Sallis, James F., Terwoert, Jeroen, Toussaint, Jean-François, Tuomisto, Jouni, Zuurbier, Moniek, and Lebret, Erik

Published
2011
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10. Effects of Leisure-Time and Transport-Related Physical Activities on the Risk of Incident and Recurrent Myocardial Infarction and Interaction With Traffic-Related Air Pollution:A Cohort Study

Author

Kubesch, Nadine J., Therming Jørgensen, Jeanette, Hoffmann, Barbara, Loft, Steffen, Nieuwenhuijsen, Mark J, Raaschou-Nielsen, Ole, Pedersen, Marie, Hertel, Ole, Overvad, Kim, Tjønneland, Anne, Prescot, Eva, Andersen, Zorana J, Kubesch, Nadine J., Therming Jørgensen, Jeanette, Hoffmann, Barbara, Loft, Steffen, Nieuwenhuijsen, Mark J, Raaschou-Nielsen, Ole, Pedersen, Marie, Hertel, Ole, Overvad, Kim, Tjønneland, Anne, Prescot, Eva, and Andersen, Zorana J

Abstract

BACKGROUND: Physical activity enhances the uptake of air pollutants, possibly reducing its beneficial effects. We examined the effects of leisure-time and transport-related physical activities on the risk of myocardial infarction (MI), and whether potential benefits on MI are reduced by exposure to traffic-related air pollution.METHODS AND RESULTS: A group of 57 053 participants (50-65 years of age) from the Danish Diet, Cancer, and Health cohort reported physical activity at baseline (1993-1997) and were linked to registry data on hospital contacts and out-of-hospital deaths caused by MI, until December 2015. Nitrogen dioxide levels were estimated at participants' baseline residences. We used Cox regressions to associate participation in sports, cycling, walking, and gardening with incident and recurrent MI, and tested for interaction by nitrogen dioxide. Of 50 635 participants without MI at baseline, 2936 developed incident MI, and of 1233 participants with MI before baseline, 324 had recurring MI during follow-up. Mean nitrogen dioxide concentration was 18.7 μg/m3 at baseline (1993-1997). We found inverse statistically significant associations between participation in sports (hazard ratio; 95% confidence interval: 0.85; 0.79-0.92), cycling (0.91; 0.84-0.98), gardening (0.87; 0.80-0.95), and incident MI, while the association with walking was statistically nonsignificant (0.95; 0.83-1.08). Recurrent MI was statistically nonsignificantly inversely associated with cycling (0.80; 0.63-1.02), walking (0.82, 0.57-1.16), and gardening (0.91; 0.71-1.18), and positively with sports (1.06; 0.83-1.35). There was no effect modification of the associations between physical activity and MI by nitrogen dioxide.CONCLUSIONS: Benefits of physical activity on both the incidence and the recurrence of MI are not reduced by exposure to high levels of air pollution.

Published
2018

11. Estimated effects of air pollution and space-time-activity on cardiopulmonary outcomes in healthy adults:A repeated measures study

Author

Cole-Hunter, Tom, de Nazelle, Audrey, Donaire-Gonzalez, David, Kubesch, Nadine, Carrasco-Turigas, Gloria, Matt, Florian, Foraster, Maria, Martinez, Tania, Ambros, Albert, Cirach, Marta, Martinez, David, Belmonte, Jordina, Nieuwenhuijsen, Mark, Cole-Hunter, Tom, de Nazelle, Audrey, Donaire-Gonzalez, David, Kubesch, Nadine, Carrasco-Turigas, Gloria, Matt, Florian, Foraster, Maria, Martinez, Tania, Ambros, Albert, Cirach, Marta, Martinez, David, Belmonte, Jordina, and Nieuwenhuijsen, Mark

Published
2018

13. Effects of Leisure‐Time and Transport‐Related Physical Activities on the Risk of Incident and Recurrent Myocardial Infarction and Interaction With Traffic‐Related Air Pollution: A Cohort Study

Author

Kubesch, Nadine J., primary, Therming Jørgensen, Jeanette, additional, Hoffmann, Barbara, additional, Loft, Steffen, additional, Nieuwenhuijsen, Mark J., additional, Raaschou‐Nielsen, Ole, additional, Pedersen, Marie, additional, Hertel, Ole, additional, Overvad, Kim, additional, Tjønneland, Anne, additional, Prescot, Eva, additional, and Andersen, Zorana J., additional

Published
2018
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18. Health effects of traffic-related air pollution and physical activity: A real-world exposure experimental study

Author

Kubesch, Nadine Janet, Nieuwenhuijsen, Mark J., and Universitat Pompeu Fabra. Departament de Ciències Experimentals i de la Salut

Subjects
Inflammation, Inflamación, Actividad física, Air pollution, Blood pressure, Physical Activity, Función pulmonar, Contaminación del aire, Presión sanguínea, Lung function
Abstract

Exposure to traffic-related air pollution (TRAP) has been associated with adverse health outcomes. Physical activity (PA) in polluted air may increase pollutant uptake and hence affect health. The main aim of this thesis is to determine the short-term health effects of TRAP in healthy participants and any possible modifying effect of PA. A crossover real-world exposure study was conducted which compared in 28 healthy participants lung, systemic, and blood pressure responses to four different exposure scenarios: two hours of exposure in a high and low TRAP environment, each at rest and in combination with intermittent moderate PA, that comprised alternating 15-minute rest and cycling intervals. The data was analysed by using mixed effect models for repeated measures. High levels of TRAP induced airway and systemic inflammatory responses, as well as increased blood pressure. Physical activity improved lung function and attenuated the blood pressure increase. Physical activity in high levels of TRAP also induced lung and systemic inflammation, and decreased the circulating levels of the brain-derived neurotrophic factor (BDNF). The short-term exposure to TRAP is associated with adverse health effects. Physical activity has beneficial effects on health, even when performed in high levels of TRAP. The clinical meaning of the decreases in BDNF as a response to the intermitted physical activity in the experimental setting and the more habitual physical activity in daily life remains unclear. This study also suggests that the health effects of traffic-related air pollution and physical activity are predominantly independent in high levels of TRAP. L'exposició a la contaminació de l'aire relacionada amb el tràfic (CART) s'ha associate amb resultats adversos per a la salut. L'activitat física (AF) realitzada en ambients amb aire contaminat pot augmentar l'absorció de contaminants i amb això produir efectes en la salut. L'objectiu principal d'aquesta tesi va ser determinar els efectes en la salut de l’exposició a la CART a curt termini en participants sans així com qualsevol possible efecte modificador de l’AF. S’ha realitzat un estudi en disseny del creuament amb exposició del “món real” comparant en 28 participants sans les respostes pulmonars, sistèmics i de la pressió arterial en quatre escenaris diferents d'exposició: 2 hores d’exposició en un entorn d'alta i baixa CART, cadascun en repòs i en combinació amb AF moderada i intermitent, que consta de quatre intervals de 15 minuts de descans i ciclisme. Les dades es van analitzar utilitzant models d'efectes mixtes per a mesures repetides. Els nivells alts de CART van induïr una resposta inflamatòria sistèmica i de la via aèria, i un augment de la pressió arterial. L’AF va millorar la funció pulmonar i va atenuar l’augment de la pressió arterial. L’AF en alts nivells de CART també va induïr una inflamació pulmonar i sistèmica y una disminució dels nivells circulants del factor neurotròfic derivat del cervell (FNDC)1. L'exposició a curt termini a CART s'associa amb efectes adversos per a la salut. L’AF té efectes beneficiosos sobre la salut, encara quan es realitza en alts nivells de CART. El significat clínic de les disminucions en el FNDC com a resposta a l’AF intermitent en l'entorn experimental i l’AF més habitual de la vida quotidiana segueix essent poc clara. Aquest estudi també suggereix que els efectes sobre la salut de la CART i l’AF són predominantment independents dels nivells alts de CART. 1 també conegut com “BDNF”, de l'anglès “Brain-derived Neurotrophic Factor”.

Published
2015

19. Impact of traffic-related air pollution on acute changes in cardiac autonomic modulation during rest and physical activity: a cross-over study

Author

Cole-Hunter, Tom, primary, Weichenthal, Scott, additional, Kubesch, Nadine, additional, Foraster, Maria, additional, Carrasco-Turigas, Glòria, additional, Bouso, Laura, additional, Martínez, David, additional, Westerdahl, Dane, additional, de Nazelle, Audrey, additional, and Nieuwenhuijsen, Mark, additional

Published
2015
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22. Improving health through policies that promote active travel:a review of evidence to support integrated health impact assessment

Author

de Nazelle, Audrey, Nieuwenhuijsen, Mark J, Antó, Josep M, Brauer, Michael, Briggs, David, Braun-Fahrlander, Charlotte, Cavill, Nick, Cooper, Ashley R, Desqueyroux, Hélène, Fruin, Scott, Hoek, Gerard, Panis, Luc Int, Janssen, Nicole, Jerrett, Michael, Joffe, Michael, Andersen, Zorana Jovanovic, van Kempen, Elise, Kingham, Simon, Kubesch, Nadine, Leyden, Kevin M, Marshall, Julian D, Matamala, Jaume, Mellios, Giorgos, Mendez, Michelle, Nassif, Hala, Ogilvie, David, Peiró, Rosana, Pérez, Katherine, Rabl, Ari, Ragettli, Martina, Rodríguez, Daniel, Rojas, David, Ruiz, Pablo, Sallis, James F, Terwoert, Jeroen, Toussaint, Jean-François, Tuomisto, Jouni, Zuurbier, Moniek, Lebret, Erik, de Nazelle, Audrey, Nieuwenhuijsen, Mark J, Antó, Josep M, Brauer, Michael, Briggs, David, Braun-Fahrlander, Charlotte, Cavill, Nick, Cooper, Ashley R, Desqueyroux, Hélène, Fruin, Scott, Hoek, Gerard, Panis, Luc Int, Janssen, Nicole, Jerrett, Michael, Joffe, Michael, Andersen, Zorana Jovanovic, van Kempen, Elise, Kingham, Simon, Kubesch, Nadine, Leyden, Kevin M, Marshall, Julian D, Matamala, Jaume, Mellios, Giorgos, Mendez, Michelle, Nassif, Hala, Ogilvie, David, Peiró, Rosana, Pérez, Katherine, Rabl, Ari, Ragettli, Martina, Rodríguez, Daniel, Rojas, David, Ruiz, Pablo, Sallis, James F, Terwoert, Jeroen, Toussaint, Jean-François, Tuomisto, Jouni, Zuurbier, Moniek, and Lebret, Erik

Abstract

Substantial policy changes to control obesity, limit chronic disease, and reduce air pollution emissions, including greenhouse gasses, have been recommended. Transportation and planning policies that promote active travel by walking and cycling can contribute to these goals, potentially yielding further co-benefits. Little is known, however, about the interconnections among effects of policies considered, including potential unintended consequences.

Published
2011

27. E-048

Author

Kubesch, Nadine, primary, de Nazelle, Audrey, additional, Bouso, Laura, additional, Carrasco, Gloria, additional, and Nieuwenhuijsen, Mark, additional

Published
2012
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