ISAC

RESPONSABLE DEL GRUP
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Francisco Martín Luján
fmartin.tgn.ics@gencat.cat
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Publicacions

Delivering an innovative multi-infection and female genital mutilation screening to high-risk migrant populations (ISMiHealth): study protocol of a cluster randomised controlled trial with embedded process evaluation

A. CRUZ, A. CUXART-GRAELL, A. GONCALVES, J. VAZQUEZ-VILLEGAS, S. VALLEJO-GODOY, J. SALAS-CORONAS, N. PIQUERAS, S. MARTINEZ-TORRES, E. ARTIGUES-BARBERA, Y. RANDO-MATOS, A. MARGALEJO, J. VIZCAINO, P. REQUENA, A. MARTINEZ-PEREZ, E. FERRER, L. MENDEZ-BOO, E. COMA, M. LUZON-GARCIA, E. SEQUEIRA-AYMAR, A. CASELLAS, M. VAZQUEZ, C. JACQUES-AVINO, L. MEDINA-PERUCHA, E. SICURI, S. EVANGELIDOU, C. AGUILAR MARTIN and A. REQUENA-MENDEZ
2024 Nov 4; . doi:10.1136/bmjopen-2023-078337; PMID:39496367

  • Ans: 04/11/2024
  • FI: 2.4

Introduction ISMiHealth is a clinical decision support system, integrated as a software tool in the electronic health record system of primary care, that aims to improve the screening performance on infectious diseases and female genital mutilation (FGM) in migrants. The aim of this study is to assess the health impact of the tool and to perform a process evaluation of its feasibility and acceptability when implemented in primary care in Catalonia (Spain).Methods and analysis This study is a cluster randomised control trial where 35 primary care centres in Catalonia, Spain will be allocated into one of the two groups: intervention and control. The health professionals in the intervention centres will receive prompts, through the ISMiHealth software, with screening recommendations for infectious diseases and FGM targeting the migrant population based on an individualised risk assessment. Health professionals of the control centres will follow the current routine practice. A difference in differences analysis of the diagnostic rates for all aggregated infections and each individual condition between the intervention and control centres will be performed. Mixed-effects logistic regression models will be carried out to identify associations between the screening coverage and predictor factors. In addition, a process evaluation will be carried out using mixed methodology.Methods and analysis This study is a cluster randomised control trial where 35 primary care centres in Catalonia, Spain will be allocated into one of the two groups: intervention and control. The health professionals in the intervention centres will receive prompts, through the ISMiHealth software, with screening recommendations for infectious diseases and FGM targeting the migrant population based on an individualised risk assessment. Health professionals of the control centres will follow the current routine practice. A difference in differences analysis of the diagnostic rates for all aggregated infections and each individual condition between the intervention and control centres will be performed. Mixed-effects logistic regression models will be carried out to identify associations between the screening coverage and predictor factors. In addition, a process evaluation will be carried out using mixed methodology.Ethics and dissemination The study protocol has been approved by the institutional review boards at Hospital Cl & iacute;nic (16 June 2022, HCB/2022/0363), Clinical Research Ethics Committee of the Primary Care Research Institute IDIAPJGol (22 June 2022, 22/113-P) and the Almer & iacute;a Research Ethics Committee (27 July 2022, EMC/apg). The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards. Findings will be disseminated in peer-reviewed journals and communications to congresses.Ethics and dissemination The study protocol has been approved by the institutional review boards at Hospital Cl & iacute;nic (16 June 2022, HCB/2022/0363), Clinical Research Ethics Committee of the Primary Care Research Institute IDIAPJGol (22 June 2022, 22/113-P) and the Almer & iacute;a Research Ethics Committee (27 July 2022, EMC/apg). The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards.
Findings will be disseminated in peer-reviewed journals and communications to congresses.Trial registration number NCT05868005.

Results of the implementation of the DP-TRANSFERS project in Catalonia: a translational method to improve diabetes screening and prevention in primary care.

Cabré JJ, Barrio F, Vizcaíno J, Martínez A, Mur T, Sagarra R and Dalmau S
2024 Nov 1; . doi:10.1016/j.rceng.2024.08.003; PMID:39216807

  • Ans: 01/11/2024
  • FI: 2.3

INTRODUCTION: DP-TRANSFERS is a translational lifestyle intervention project, which follows a previous protocol described in the DE-PLAN-CAT study. OBJECTIVE: Analyze the feasibility of reproducing the intensive intervention and estimating the effect of translation in real conditions of clinical practice in primary care. METHODOLOGY: Implementation of the face-to-face group intervention adjusted to 2 years. After screening, the intervention consisted of a basic module and a continuity module. Stratifying by clusters (health centers), a representative sample (centers, professionals and participants) was evaluated (FINDRISC > 11 and/or prediabetes) from 2016 to 2020. The effect of the intervention on the incidence of diabetes was analyzed. RESULTS: The intervention, feasible in 95 of 123 centers, involved 343 of 647 professionals. Of 2381 subjects screened, 1713 participated in the basic module, with 1186 participants completing the first year and 776 completing the second. 121 participants (7.06%) were diagnosed with diabetes: 77 (4.49%) during the first year; 44 (2.57%) during the second. The bivariate analysis showed that those subjects in whom diabetes affected differed in: previous glycemic status, A1c, HDL-cholesterol, FINDRISC score and adherence to the Mediterranean diet, and in the differences between the beginning and end of the study of: body weight, BMI and abdominal circumference. CONCLUSIONS: The intensive intervention substantially reduced (23.6%) the incidence of diabetes compared to that previously estimated in standardized intervention. The following acted as protective factors: a better glycemic status, lower baseline risk, elevated HDL-cholesterol, or achieving a reduction in weight or abdominal circumference during the study.

Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European Healthcare Data Sources: Methods and Results of the Second Study Feasibility Assessment

F. AHMADIZAR, J. FORTUNY, A. ROYO, E. PLANA, R. WEINRIB, R. ESTEBAN, K. BORIC, N. YEFIMENKO, M. HAUGH, J. CARRERAS, A. URCHUEGUÍA-FORNES, E. CORRECHER, J. VAN DEN BERG, T. LYSEN, F. VILLALOBOS, C. BISSACCO, E. NEWBERN, C. WILLAME, N. PRAET and M. STURKENBOOM
2024 Nov 1;

  • Ans: 01/11/2024
  • FI: 2.4
Assessing the Impact of Data Diversity on Background Incidence Rates of Adverse Events of Special Interest: The Component Strategy from the COVID-19 Vaccine Monitoring Project

G. ROBERTO, D. MESSINA, C. DURÁN, J. RIERA-ARNAU, P. GARCIA, M. MARTÍN-PÉREZ, O. PAOLETTI, C. BISSACCO, F. VILLALOBOS, J. CARRERAS, A. MIRA, P. SOUVEREIN, F. RIEFOLO, O. KLUNGEL, M. STURKENBOOM and R. GINI
2024 Nov 1;

  • Ans: 01/11/2024
  • FI: 2.4
A Comparison of Self-Controlled Study Designs in an Analysis of COVID-19 Vaccines and Myocarditis Using Five European Databases

A. SCHULTZE, I. MARTIN, D. MESSINA, S. BOTS, S. BELITSER, J. CARRERAS, E. CORRECHER-MARTINEZ, A. URCHUEGUÍA-FORNES, M. MARTÍN-PÉREZ, P. GARCIA, F. VILLALOBOS, M. PALLEJÀ-MILLÁN, C. BISSACCO, E. SEGUNDO, P. SOUVEREIN, F. RIEFOLO, C. DURÁN, R. GINI, M. STURKENBOOM, O. KLUNGEL and I. DOUGLAS
2024 Nov 1;

  • Ans: 01/11/2024
  • FI: 2.4

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