Review Article
Volume 9 Issue 5 - 2022
Challenges for the Generation of Real-World Evidence in Heart Failure in Europe
Vera Vesela*, Shashidhar Rao and Rachel Studer
Novartis Pharma AG, Basel, Switzerland
*Corresponding Author: Vera Vesela, Novartis Pharma AG, Basel, Switzerland.
Received: June 26, 2022; Published: June 28, 2022




Abstract

Heart failure (HF) constitutes a substantial health burden in Europe and, indeed, globally, warranting improvements in disease management strategies. Real-world evidence (RWE) research is a useful tool that can guide treatment intervention and preventative strategies if based on large, comprehensive data sources, covering a wide variety of patient demographics and clinical characteristics. However, some inherent challenges associated with HF that influence the generation of RWE in Europe are those relating to diagnosis and disease management. Despite the availability of evidence-based guidelines for HF treatment, heterogeneity in the HF population and disease course can contribute to variation in the management of HF in routine clinical practice globally, making interpretation of real-world data difficult. In this review, we summarise and discuss these challenges in the context of ways in which they affect the generation of RWE in HF. Addressing these matters could see greatly increased usability of RWE in HF, which could translate into improvement in treatment interventions and best practice of patient care.

Keywords: Real-World Evidence; Heart Failure; Europe; Disease Management; Registry

References

  1. Metra M and Teerlink JR. "Heart failure". The Lancet10106 (2017): 1981-1995.
  2. McDonagh TA., et al. "2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure". European Heart Journal36 (2021): 3599-3726.
  3. Ponikowski P., et al. "Heart failure: preventing disease and death worldwide". ESC Heart Failure1 (2014): 4-25.
  4. Bozkurt B., et al. "Universal definition and classification of heart failure: A report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure: Endorsed by Canadian Heart Failure Society, Heart Failure Association of India, the Cardiac Society of Australia and New Zealand, and the Chinese Heart Failure Association". European Journal of Heart Failure3 (2021): 352-380.
  5. Triposkiadis F., et al. "The continuous heart failure spectrum: moving beyond an ejection fraction classification". European Heart Journal26 (2019): 2155-2163.
  6. Pocock SJ., et al. "Predicting survival in heart failure: a risk score based on 39 372 patients from 30 studies". European Heart Journal19 (2013): 1404-1413.
  7. Sara JD., et al. "Asymptomatic left ventricle systolic dysfunction”. European Cardiology Review 15 (2020): e13.
  8. Camm AJ and Fox KAA. "Strengths and weaknesses of 'real-world' studies involving non-vitamin K antagonist oral anticoagulants". Open Heart1 (2018): e000788.
  9. Maissenhaelter BE., et al. "Real-world evidence research based on big data: Motivation-challenges-success factors". Die Onkologiesupple 2 (2018): 91-98.
  10. Use of Real-World Evidence to Support Regulatory Decision-making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2017).
  11. Khosla S., et al. "Real world evidence (RWE) - a disruptive innovation or the quiet evolution of medical evidence generation? F1000 Research 7 (2018): 111.
  12. Bolislis WR., et al. "Use of Real-world Data for New Drug Applications and Line Extensions". Clinical Therapeutics5 (2020): 926-938.
  13. Hachamovitch R., et al. "Imaging Registries and Single-Center Series". Cardiovascular Imaging 10.3 (2017): 276-285.
  14. Lund LH., et al. "Association between enrolment in a heart failure quality registry and subsequent mortality-a nationwide cohort study". European Journal of Heart Failure9 (2017): 1107-1116.
  15. Savarese G., et al. "The Swedish Heart Failure Registry: a living, ongoing quality assurance and research in heart failure". Upsala Journal of Medical Sciences1 (2019): 65-69.
  16. Arcopinto M., et al. "The Tosca Registry: An Ongoing, Observational, Multicenter Registry for Chronic Heart Failure". Translational Medicine 14 (2016): 21-27.
  17. gov. Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction (SPIRRIT) (2016).
  18. Lauer MS and D'Agostino RB Sr. "The randomized registry trial – the next disruptive technology in clinical research?" The New England Journal of Medicine. 369.17 (2013): 1579-1581.
  19. Savarese G., et al. "The Swedish Heart Failure Registry: a living, ongoing quality assurance and research in heart failure". Upsala Journal of Medical Sciences1 (2019): 65-69.
  20. Wierda E., et al. "Privacy of patient data in quality-of-care registries in cardiology and cardiothoracic surgery: the impact of the new general data protection regulation EU-law". European Heart Journal- Quality of Care and Clinical Outcomes4 (2018): 239-245.
  21. Ko DT., et al. "Readmission and Mortality After Hospitalization for Myocardial Infarction and Heart Failure". Journal of the American College of Cardiology7 (2020): 736-746.
  22. Abouelmehdi K., et al. "Big healthcare data: preserving security and privacy". Journal of Big Data 5 (2018): 1.
  23. Cainzos-Achirica M., et al. "Challenges of evaluating chronic heart failure and acute heart failure events in research studies using large health care databases". American Heart Journal 202 (2018): 76-83.
  24. Hobbs FD., et al. "The diagnosis of heart failure in European primary care: The IMPROVEMENT Programme survey of perception and practice". European Journal of Heart Failure5 (2005): 768-779.
  25. Hayhoe B., et al. "Adherence to guidelines in management of symptoms suggestive of heart failure in primary care". Heart9 (2019): 678-685.
  26. Oktay AA and Shah SJ. "Diagnosis and management of heart failure with preserved ejection fraction: 10 key lessons". Current Cardiology Reviews1 (2015): 42-52.
  27. Kalogirou F., et al. "Heart failure disease management: a systematic review of effectiveness in heart failure with preserved ejection fraction". ESC Heart Failure1 (2020): 195-213.
  28. McCormick N., et al. "Validity of heart failure diagnoses in administrative databases: a systematic review and meta-analysis". PLoS One8 (2014): e104519.
  29. Mard S and Nielsen FE. "Positive predictive value and impact of misdiagnosis of a heart failure diagnosis in administrative registers among patients admitted to a University Hospital cardiac care unit". Clinical Epidemiology 2 (2010): 235-239.
  30. Verdú-Rotellar JM., et al. "Validation of heart failure diagnosis registered in primary care records in two primary care centres in Barcelona (Spain) and factors related. A cross-sectional study". The European Journal of General Practice1 (2017): 107-113.
  31. Raphael C., et al. "Limitations of the New York Heart Association functional classification system and self-reported walking distances in chronic heart failure". Heart4 (2007): 476-482.
  32. Bottle A., et al. "Real-world presentation with heart failure in primary care: do patients selected to follow diagnostic and management guidelines have better outcomes?" Open Heart 5 (2018): e000935.
  33. Huusko J., et al. "Heart failure in Finland: clinical characteristics, mortality, and healthcare resource use". ESC Heart Failure4 (2019): 603-612.
  34. Uijl A., et al. "Risk factors for incident heart failure in age- and sex-specific strata: a population-based cohort using linked electronic health records". European Journal of Heart Failure10 (2019): 1197-1206.
  35. Kapoor John R., et al. "Precipitating Clinical Factors, Heart Failure Characterization, and Outcomes in Patients Hospitalized With Heart Failure With Reduced, Borderline, and Preserved Ejection Fraction". JACC: Heart Failure6 (2016): 464-472.
  36. Mangla A., et al. "Comparison of Predictors of Heart Failure–Related Hospitalization or Death in Patients With Versus Without Preserved Left Ventricular Ejection Fraction". The American Journal of Cardiology12 (2013): 1907-1912.
  37. JARDIANCE SmPC (2022).
  38. JARDIANCE Prescribing Information (2022).
  39. ENTRESTO Prescribing Information (2021).
  40. Giezeman M., et al. "Adherence to guidelines in patients with chronic heart failure in primary health care". Scandinavian Journal of Primary Health Care4 (2017): 336-343.
  41. Joseph J., et al. "Guideline-directed medical therapy in heart failure patients: impact of focused care provided by a heart failure clinic in comparison to general cardiology out-patient department”. The Egyptian Heart Journal1 (2020): 1-8.
  42. Mentz RJ., et al. "International differences in clinical characteristics, management, and outcomes in acute heart failure patients: better short-term outcomes in patients enrolled in Eastern Europe and Russia in the PROTECT trial". European Journal of Heart Failure6 (2014): 614-624.
  43. Tromp J., et al. "Heart failure around the world". European Journal of Heart Failure10 (2019): 1187-1196.
  44. Moertl D., et al. "Disease management programs in chronic heart failure : Position statement of the Heart Failure Working Group and the Working Group of the Cardiological Assistance and Care Personnel of the Austrian Society of Cardiology". Wiener Klinische Wochenschrift 129 (2017): 869-878.
  45. Taylor CJ. "Diagnosing heart failure: challenges in primary care”. Heart9 (2019): 663-664.
  46. Agvall B., et al. "The benefits of using a heart failure management programme in Swedish primary healthcare". European Journal of Heart Failure2 (2012): 228-236.
  47. Maggioni AP., et al. "Are hospitalized or ambulatory patients with heart failure treated in accordance with European Society of Cardiology guidelines? Evidence from 12,440 patients of the ESC Heart Failure Long-Term Registry". European Journal of Heart Failure10 (2013): 1173-1184.
  48. Andrew NE., et al. "Addressing the challenges of cross-jurisdictional data linkage between a national clinical quality registry and government-held health data". Australian and New Zealand Journal of Public Health5 (2016): 436-442.
  49. Seferović PM., et al. "Heart Failure Association of the European Society of Cardiology Quality of Care Centres Programme: design and accreditation document". European Journal of Heart Failure5 (2020): 763-774.
  50. Ferrari R. "EUR Observational Research Programme". European Heart Journal9 (2010): 1023-1031.
  51. Wallentin L., et al. "EuroHeart: European Unified Registries On Heart Care Evaluation and Randomized Trials: An ESC project to develop a new IT registry system which will encompass multiple features of cardiovascular medicine". European Heart Journal33 (2019): 2745-2749.
  52. EHDEN Project Factsheet IMI Innovative Medicines Initiativen.
  53. BigData@Heart. BigData@Heart (2017).
  54. Karanatsios B., et al. "Defining key design elements of registry-based randomised controlled trials: a scoping review". Trials 21 (2020): 552.
  55. Li G., et al. "Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research?" Journal of Clinical Epidemiology 80 (2016): 16-24.
  56. Burns DJP., et al. "International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients". Heart Failure 8 (2020): 212-222.
  57. Tripoliti EE., et al. "Heart Failure: Diagnosis, Severity Estimation and Prediction of Adverse Events Through Machine Learning Techniques". Computational and Structural Biotechnology Journal 15 (2016): 26-47.
  58. Ski CF., et al. "Putting AI at the centre of heart failure care". ESC Heart Failure5 (2020): 3257-3258.
  59. Mahesri M., et al. "External validation of a claims-based model to predict left ventricular ejection fraction class in patients with heart failure". PLoS One6 (2021): e0252903.
  60. Wilkinson MD., et al. "The FAIR Guiding Principles for scientific data management and stewardship". Scientific Data 3 (2016): 160018.
Citation: Vera Vesela., et al. “Challenges for the Generation of Real-World Evidence in Heart Failure in Europe”. EC Cardiology 9.5 (2022): 03-12.

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