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Determinants of adherence and consequences of the transition from adolescence to adulthood among young people with severe haemophilia (TRANSHEMO): study protocol for a multicentric French national observational cross-sectional study
  1. Noémie Resseguier1,
  2. Natacha Rosso-Delsemme2,3,
  3. Any Beltran Anzola1,
  4. Karine Baumstarck1,4,
  5. Vanessa Milien3,4,
  6. Laurent Ardillon5,
  7. Sophie Bayart6,
  8. Claire Berger7,
  9. Marie-Anne Bertrand8,
  10. Christine Biron-Andreani9,
  11. Annie Borel-Derlon10,
  12. Sabine Castet11,
  13. Pierre Chamouni12,
  14. Ségolène Claeyssens Donadel13,
  15. Emmanuelle De Raucourt14,
  16. Dominique Desprez15,
  17. Céline Falaise3,
  18. Birgit Frotscher16,
  19. Valérie Gay17,
  20. Jenny Goudemand18,
  21. Yves Gruel5,
  22. Benoît Guillet6,
  23. Annie Harroche19,
  24. Abel Hassoun20,
  25. Yoann Huguenin11,
  26. Thierry Lambert21,
  27. Aurélien Lebreton22,
  28. Anne Lienhart23,
  29. Michèle Martin16,
  30. Sandrine Meunier23,
  31. Fabrice Monpoux24,
  32. Guillaume Mourey8,
  33. Claude Negrier23,
  34. Philippe Nguyen25,
  35. Placide Nyombe26,
  36. Caroline Oudot27,
  37. Brigitte Pan-Petesch28,
  38. Benoît Polack29,
  39. Anne Rafowicz14,21,
  40. Antoine Rauch18,
  41. Delphine Rivaud26,
  42. Pascale Schneider12,
  43. Alexandra Spiegel15,
  44. Cecile Stoven26,
  45. Brigitte Tardy7,
  46. Marc Trossaërt30,
  47. Jean-Baptiste Valentin5,
  48. Stéphane Vanderbecken26,
  49. Fabienne Volot31,
  50. Annelise Voyer-Ebrard32,
  51. Bénédicte Wibaut18,
  52. Tanguy Leroy1,33,
  53. Thomas Sannie34,
  54. Hervé Chambost3,4,
  55. Pascal Auquier1,4
  1. 1 CERESS, Aix Marseille University, Marseille, France
  2. 2 LPCPP, Aix Marseille Unviersity, Aix-en-Provence, France
  3. 3 Department of Paediatric Haematology, Children Hospital La Timone, , APHM, Marseille, France
  4. 4 FranceCoag Network, Marseille, France
  5. 5 Haemophilia Treatment Centre, University Hospital of Tours, Tours, France
  6. 6 Haemophilia Treatment Centre, University Hospital of Rennes, Rennes, France
  7. 7 Haemophilia Treatment Centre, University Hospital of Saint-Etienne, Saint-Etienne, France
  8. 8 Haemophilia Treatment Centre, University Hospital of Besançon, Besançon, France
  9. 9 Haemophilia Treatment Centre, University Hospital of Montpellier, Montpellier, France
  10. 10 Haemophilia Treatment Centre, University Hospital of Caen, Caen, France
  11. 11 Haemophilia Treatment Centre, University Hospital of Bordeaux, Bordeaux, France
  12. 12 Haemophilia Treatment Centre, University Hospital of Rouen, Rouen, France
  13. 13 Haemophilia Treatment Centre, University Hospital of Toulouse, Toulouse, France
  14. 14 Haemophilia Treatment Centre, Hospital of Versailles, Versailles, France
  15. 15 Haemophilia Treatment Centre, University Regional Hospital of Strasbourg, Strasbourg, France
  16. 16 Haemophilia Treatment Centre, University Hospital of Nancy, Nancy, France
  17. 17 Haemophilia Treatment Centre, Hospital of Chambery, Chambery, France
  18. 18 Haemophilia Treatment Centre, University Regional Hospital of Lille, Lille, France
  19. 19 Haemophilia Treatment Centre, Hospital Necker, Assistance Publique—Hopitaux de Paris, Paris, France
  20. 20 Haemophilia Treatment Centre, Hospital of Simone Veil d’Eaubonne, Montmorency, France
  21. 21 Haemophilia Treatment Centre, Hospital Bicêtre, Assistance Publique—Hopitaux de Paris, Paris, France
  22. 22 Haemophilia Treatment Centre, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France
  23. 23 Haemophilia Treatment Centre, Hospital Edouard Herriot, University Hospital of Lyon, Lyon, France
  24. 24 Haemophilia Treatment Centre, University Hospital of Nice, Nice, France
  25. 25 Haemophilia Treatment Centre, University Hospital of Reims, Reims, France
  26. 26 Haemophilia Treatment Centre, University Hospital of Reunion, Reunion Island, France
  27. 27 Haemophilia Treatment Centre, University Hospital of Limoges, Limoges, France
  28. 28 Haemophilia Treatment Centre, University Hospital of Brest, Brest, France
  29. 29 Haemophilia Treatment Centre, University Hospital of Grenoble, Grenoble, France
  30. 30 Haemophilia Treatment Centre, University Hospital of Nantes, Nantes, France
  31. 31 Haemophilia Treatment Centre, University Hospital of Dijon, Dijon, France
  32. 32 Haemophilia Treatment Centre, University Hospital of Amiens, Amiens, France
  33. 33 Social Psychology Research Group (GRePS EA 4163), Lumière Lyon 2 University, Lyon, France
  34. 34 French Patients' Association for People with Haemophilia (AFH), Paris, France
  1. Correspondence to Dr Noémie Resseguier; noemie.resseguier{at}univ-amu.fr

Abstract

Introduction Severe haemophilia is a rare disease characterised by spontaneous bleeding from early childhood, which may lead to various complications, especially in joints. It is nowadays possible to avoid these complications thanks to substitutive therapies for which the issue of adherence is major. The transition from adolescence to adulthood in young people with severe haemophilia is a critical period as it is associated with a high risk of lack of adherence to healthcare, which might have serious consequences on daily activities and on quality of life.

Methods and analysis We present the protocol for a cross-sectional, observational, multicentric study to assess the differences between adolescents and young adults with severe haemophilia in France through the transition process, especially on adherence to healthcare. This study is based on a mixed methods design, with two complementary and consecutive phases, comparing data from a group of adolescents (aged 14–17 years) with those from a group of young adults (aged 20–29 years). The quantitative phase focuses on the determinants (medical, organisational, sociodemographic and social and psychosocial and behavioural factors) of adherence to healthcare (considered as a marker of the success of transition). The qualitative phase explores participants’ views in more depth to explain and refine the results from the quantitative phase. Eligible patients are contacted by the various Haemophilia Treatment Centres participating in the French national registry FranceCoag.

Ethics and dissemination The study was approved by the French Ethics Committee and by the French National Agency for Medicines and Health Products Safety (number: 2016-A01034-47). Study findings will be disseminated to the scientific and medical community in peer-reviewed journals and presented at scientific meetings. Results will be popularised to be communicated via the French association for people with haemophilia to participants and to the general public.

Trial registration number NCT02866526; Pre-results.

  • adherence
  • haemophilia
  • transition
  • adolescents
  • young adults

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors NR, ABA, KB, TL, HC, PA contributed to the design of this study and wrote this article. The investigators (LA, SB, CB, M-AB, CB-A, AB-D, SC, PC, SCD, EDR, DD, CF, BF, VG, JG, YG, BG, AH, AH, YH, TL, AL, AL, MM, SM, FM, GM, CN, PN, PN, CO, BP-P, BP, AR, AR, DR, PS, AS, CS, BT, MT, J-BV, SV, FV, AV-E, BW) of the French Haemophilia Treatment Centres contribute to enroll participants, they revised the manuscript and approved the final version. Members of steering committee (NR-D, VM, TS) contributed to the design of this study, they revised the manuscript and approved the final version.

  • Funding The project was funded by a grant from the French Ministry of Social Affairs and Health (Ministère des Affaires sociales et de la Santé, grant number: PREPS-15-0597) and was supported by the ’Filière MHEMO' organisation.

  • Disclaimer The funders were neither involved in study design nor in data collection.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval The study was approved by the French Ethics Committee (Comité de Protection des Personnes Sud Méditerranée V) on 8 November 2016 and by the French National Agency for Medicines and Health Products Safety on 22 September 2016 (reference number ID RCB: 2016-A01034-47). Data collection, recording and analysis process was approved by the French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés, authorisation number 918045).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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