Development of an international standard set of outcome measures for patients with venous thromboembolism: an International Consortium for Health Outcomes Measurement consensus recommendation

Adam M Gwozdz¹, Cindy M M de Jong², Luz Sousa Fialho³, Theerawich Likitabhorn⁴, Frieda Sossi³, Paula Blancarte Jaber³, Anette Arbjerg Højen⁵, Juan I Arcelus⁶, William R Auger⁷, Cihan Ay⁸, Stefano Barco⁹, Marcelo B Gazzana¹⁰, Julie Bayley¹¹, Laurent Bertoletti¹², Arina Ten Cate-Hoek¹³, Alexander T Cohen¹⁴, Jean M Connors¹⁵, Jean-Philippe Galanaud¹⁶, Nicos Labropoulos¹⁷, Nicole Langlois¹⁸, Mark H Meissner¹⁹, Simon Noble²⁰, Esther J Nossent²¹, Paula Ponce de León Lovatón²², Helia Robert-Ebadi²³, Rachel P Rosovsky²⁴, Noa Smolenaars²⁵, Mark Toshner²⁶, Cécile Tromeur²⁷, Kang-Ling Wang²⁸, Eli Westerlund²⁹, Kerstin de Wit³⁰, Stephen A Black³¹, Frederikus A Klok³²

Affiliations

¹ Academic Department of Vascular Surgery, Section of Vascular Risk and Surgery, School of Cardiovascular Medicine and Science, Guy's and Saint Thomas' Hospital, King's College London, London, UK; Academic Section of Vascular Surgery, Department of Surgery and Cancer and Department of Vascular Surgery, Imperial College Healthcare NHS Trust, Imperial College London, London, UK.
² Department of Medicine: Thrombosis and Haemostasis, Leiden University Medical Center, Leiden University, Leiden, Netherlands.
³ International Consortium for Health Outcomes Measurement, London, UK.
⁴ International Consortium for Health Outcomes Measurement, Boston, MA, USA.
⁵ Aalborg Thrombosis Research Unit, Department of Cardiology, Aalborg University Hospital, Aalborg University, Aalborg, Denmark.
⁶ Department of Surgery, University of Granada Medical School, University of Granada, Granada, Spain.
⁷ Department of Pulmonary Medicine, University of California, San Diego, CA, USA.
⁸ Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.
⁹ Department of Angiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland; Centre for Thrombosis and Haemostasis, Johannes Gutenberg University Mainz, Mainz, Germany.
¹⁰ Department of Pulmonology and Thoracic Surgery, Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul, Brazil; National Association of Private Hospitals, Porto Alegre, Rio Grande do Sul, Brazil.
¹¹ Lincoln Impact Literacy Institute, University of Lincoln, Lincoln, UK.
¹² Department of Vascular and Therapeutic Medicine, University Hospital of Saint-Étienne, University of Saint-Étienne, Saint-Étienne, France; CIC-1408, INSERM, University Hospital of Saint-Étienne, University of Saint-Étienne, Saint-Étienne, France; French Clinical Research Infrastructure Network [F-CRIN] INNOvenous thromboembolism, University Hospital of Saint-Étienne, University of Saint-Étienne, Saint-Étienne, France; UMR1059, INSERM, Université Jean-Monnet, Saint-Étienne, France.
¹³ Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht University, Maastricht, Netherlands.
¹⁴ Department of Haematological Medicine, Guy's and Saint Thomas' Hospital, King's College London, London, UK.
¹⁵ Hematology Division, Brigham and Women's Hospital, Harvard Medical School, Harvard University, Boston, MA, USA.
¹⁶ Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.
¹⁷ Division of Vascular Surgery, Department of Surgery, Stony Brook Hospital, Stony Brook, NY, USA.
¹⁸ Department of Medicine, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹⁹ Department of Surgery, University of Washington, Seattle, WA, USA.
²⁰ Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, UK.
²¹ Department of Pulmonary Medicine, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
²² Clínica San Felipe, Jesús María, Peru.
²³ Division of Angiology and Haemostasis, Geneva University Hospitals, University of Geneva, Geneva, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland.
²⁴ Division of Hematology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Harvard University, Boston, MA, USA.
²⁵ Department of Industrial Design, University of Technology Eindhoven, Eindhoven, Netherlands.
²⁶ Heart Lung Research Institute, Department of Medicine, University of Cambridge, Cambridge, UK.
²⁷ French Clinical Research Infrastructure Network [F-CRIN] INNOvenous thromboembolism, University Hospital of Saint-Étienne, University of Saint-Étienne, Saint-Étienne, France; Department of Internal Medicine and Pneumology, University Hospital of Brest, Brest, France; Group d'etude de la thrombose de Bretagne Occidentale, Université de Bretagne Occidentale, Brest, France.
²⁸ General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan.
²⁹ Department of Clinical Sciences, Karolinska Institutet; Danderyd Hospital, Danderyd, Sweden.
³⁰ Department of Emergency Medicine, Queen's University, Kingston, ON, Canada; Departments of Medicine and Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
³¹ Academic Department of Vascular Surgery, Section of Vascular Risk and Surgery, School of Cardiovascular Medicine and Science, Guy's and Saint Thomas' Hospital, King's College London, London, UK.
³² Department of Medicine: Thrombosis and Haemostasis, Leiden University Medical Center, Leiden University, Leiden, Netherlands. Electronic address: f.a.klok@lumc.nl.

PMID: 36055334
DOI: 10.1016/S2352-3026(22)00215-0

Review

Development of an international standard set of outcome measures for patients with venous thromboembolism: an International Consortium for Health Outcomes Measurement consensus recommendation

Adam M Gwozdz et al. Lancet Haematol. 2022 Sep.

. 2022 Sep;9(9):e698-e706.

doi: 10.1016/S2352-3026(22)00215-0.

Authors

Affiliations

¹ Academic Department of Vascular Surgery, Section of Vascular Risk and Surgery, School of Cardiovascular Medicine and Science, Guy's and Saint Thomas' Hospital, King's College London, London, UK; Academic Section of Vascular Surgery, Department of Surgery and Cancer and Department of Vascular Surgery, Imperial College Healthcare NHS Trust, Imperial College London, London, UK.
² Department of Medicine: Thrombosis and Haemostasis, Leiden University Medical Center, Leiden University, Leiden, Netherlands.
³ International Consortium for Health Outcomes Measurement, London, UK.
⁴ International Consortium for Health Outcomes Measurement, Boston, MA, USA.
⁵ Aalborg Thrombosis Research Unit, Department of Cardiology, Aalborg University Hospital, Aalborg University, Aalborg, Denmark.
⁶ Department of Surgery, University of Granada Medical School, University of Granada, Granada, Spain.
⁷ Department of Pulmonary Medicine, University of California, San Diego, CA, USA.
⁸ Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.
⁹ Department of Angiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland; Centre for Thrombosis and Haemostasis, Johannes Gutenberg University Mainz, Mainz, Germany.
¹⁰ Department of Pulmonology and Thoracic Surgery, Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul, Brazil; National Association of Private Hospitals, Porto Alegre, Rio Grande do Sul, Brazil.
¹¹ Lincoln Impact Literacy Institute, University of Lincoln, Lincoln, UK.
¹² Department of Vascular and Therapeutic Medicine, University Hospital of Saint-Étienne, University of Saint-Étienne, Saint-Étienne, France; CIC-1408, INSERM, University Hospital of Saint-Étienne, University of Saint-Étienne, Saint-Étienne, France; French Clinical Research Infrastructure Network [F-CRIN] INNOvenous thromboembolism, University Hospital of Saint-Étienne, University of Saint-Étienne, Saint-Étienne, France; UMR1059, INSERM, Université Jean-Monnet, Saint-Étienne, France.
¹³ Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht University, Maastricht, Netherlands.
¹⁴ Department of Haematological Medicine, Guy's and Saint Thomas' Hospital, King's College London, London, UK.
¹⁵ Hematology Division, Brigham and Women's Hospital, Harvard Medical School, Harvard University, Boston, MA, USA.
¹⁶ Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.
¹⁷ Division of Vascular Surgery, Department of Surgery, Stony Brook Hospital, Stony Brook, NY, USA.
¹⁸ Department of Medicine, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹⁹ Department of Surgery, University of Washington, Seattle, WA, USA.
²⁰ Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, UK.
²¹ Department of Pulmonary Medicine, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
²² Clínica San Felipe, Jesús María, Peru.
²³ Division of Angiology and Haemostasis, Geneva University Hospitals, University of Geneva, Geneva, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland.
²⁴ Division of Hematology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Harvard University, Boston, MA, USA.
²⁵ Department of Industrial Design, University of Technology Eindhoven, Eindhoven, Netherlands.
²⁶ Heart Lung Research Institute, Department of Medicine, University of Cambridge, Cambridge, UK.
²⁷ French Clinical Research Infrastructure Network [F-CRIN] INNOvenous thromboembolism, University Hospital of Saint-Étienne, University of Saint-Étienne, Saint-Étienne, France; Department of Internal Medicine and Pneumology, University Hospital of Brest, Brest, France; Group d'etude de la thrombose de Bretagne Occidentale, Université de Bretagne Occidentale, Brest, France.
²⁸ General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan.
²⁹ Department of Clinical Sciences, Karolinska Institutet; Danderyd Hospital, Danderyd, Sweden.
³⁰ Department of Emergency Medicine, Queen's University, Kingston, ON, Canada; Departments of Medicine and Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
³¹ Academic Department of Vascular Surgery, Section of Vascular Risk and Surgery, School of Cardiovascular Medicine and Science, Guy's and Saint Thomas' Hospital, King's College London, London, UK.
³² Department of Medicine: Thrombosis and Haemostasis, Leiden University Medical Center, Leiden University, Leiden, Netherlands. Electronic address: f.a.klok@lumc.nl.

PMID: 36055334
DOI: 10.1016/S2352-3026(22)00215-0

Abstract

The International Consortium for Health Outcomes Measurement assembled an international working group of venous thromboembolism experts and patient representatives to develop a standardised minimum set of outcomes and outcome measurements for integration into clinical practice and potentially research to support clinical decision making and benchmarking of quality of care. 15 core outcomes important to patients and health-care professionals were selected and categorised into four domains: patient-reported outcomes, long term consequences of the disease, disease-specific complications, and treatment-related complications. The outcomes and outcome measures were designed to apply to all patients with venous thromboembolism aged 16 years or older. A measurement tool package was selected for inclusion in the core standard set, with a minimum number of items to be measured at predefined timepoints, which capture all core outcomes. Additional measures can be introduced to the user by a cascade opt-in system that allows for further assessment if required. This set of outcomes and measurement tools will facilitate the implementation of the use of patient-centred outcomes in daily practice.

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Conflict of interest statement

Declaration of interests AAH reports research grants from The Danish Heart Foundation and The Novo Nordisk Foundation, consulting fees from Bayer and The Bristol-Myers Squibb-Pfizer Alliance, speaker bureaus from Bayer, The Bristol-Myers Squibb-Pfizer Alliance, and Merck Sharp & Dohme, and role as vice chair of special interest group venous thromboembolism of Danish Nurses’ Council. JIA reports honoraria from Sanofi and Rovi for educational activities, and research funding from Sanofi and Bayer AG. WRA reports payment or honoraria from Bayer Pharmaceuticals, support for attending meeting from Bayer Pharmaceuticals, and participation as Clinical Advisor for Janssen. CA received personal fees for lectures and participation in advisory boards from Bayer, Bristol Myers Squibb, Daiichi-Sankyo, Pfizer, and Sanofi. SB reports unrestricted scientific grants from Bayer, INARI, Boston Scientific, Medtronic, Bard, SANOFI, and Concept Medical; consulting fees from INARI, Bayer, Boston Scientific, and Concept Medical; and travel financial support for attending meetings from Bayer and Daiichi Sankyo. LB reports personal fees and non-financial support from Aspen, personal fees and non-financial support from Bayer, Bristol Myers Squibb-Pfizer, Leo Pharma, and Johnson and Johnson; grants, personal fees and non-financial support from Merck Sharp & Dohme, outside the submitted work. ATC reports grants from Alexion Pharmaceuticals, Bayer Pharma AG, and Bristol Myers Squibb-Pfizer, consulting fees from Alexion Pharmaceuticals, Bayer Pharma AG, and Bristol Myers Squibb-Pfizer, and payments from Alexion Pharmaceuticals, Bayer Pharma AG, and Bristol Myers Squibb-Pfizer, all fees paid to his company. HR-E reports speaker's honoraria from Bayer and Daichi-Sankyo, and support for attending meetings and travel from Bayer. RPR reports consulting fees from Bristol Myers Squibb, Janssen, Inari, Penumbra, Abbott, and research grants paid to her institution from Bristol Myers Squibb and Janssen, all outside the scope of this paper. CT reports honoraria from Riche Bayer, Astra Zeneca, Actelion, and Janssen. K-LW reports honoraria from Bayer, Boehringer Ingelheim, Daiichi-Sankyo, and Pfizer for Continuing Medical Education lectures. SAB reports consulting fees from Boston Scientific, Gore, Becton Dickinson, Cook, Phillips, Vesper, Veryan, Vetex, and Medtronic; honoraria from Boston Scientific, Gore, Becton Dickinson, Cook, Philips, Vesper, Veryan, Vetex, and Medtronic; research grants from Boston Scientific and Medtronic that are paid to his institution; is on the advisory board for Philips, Medtronic, Gore, and Boston Scientific. FAK reports research grants from Bayer, Bristol-Myers Squibb, Boehringer-Ingelheim, Merck Sharp & Dohme, Leo Pharma, Daiichi-Sankyo, Actelion, The Netherlands Organisation for Health Research and Development, The Dutch Thrombosis Association, The Dutch Heart Foundation, and the Horizon Europe Program, all outside the submitted work and paid to his institution. All other authors declare no competing interests.

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Development of an international standard set of outcome measures for patients with venous thromboembolism: an International Consortium for Health Outcomes Measurement consensus recommendation

Affiliations

Development of an international standard set of outcome measures for patients with venous thromboembolism: an International Consortium for Health Outcomes Measurement consensus recommendation

Authors

Affiliations

Abstract

Conflict of interest statement

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LinkOut - more resources

Full Text Sources

Medical