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The First International Consortium for Health Outcomes Measurement (ICHOM) Standard Dataset for Reporting Outcomes in
Emmanuel Lansac1, Kevin M Veen2, Andria Joseph3
1Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris, France.
Insights
A new standard set of outcomes for heart valve disease (HVD) was developed, shifting focus from procedures to patient-centered care. This aims to standardize global HVD outcome measurement and improve patient management.
Area of Science:
- Cardiology
- Thoracic Surgery
- Health Outcomes Research
Background:
- Heart valve disease (HVD) management varies globally, with outcome measurement often procedure-focused rather than patient-focused.
- Existing outcome metrics for HVD lack standardization, hindering comparative analysis and patient-centered care improvements.
Purpose of the Study:
- To develop a patient-related standard set of outcomes and case mix for heart valve disease (HVD).
- To establish a framework for monitoring the patient journey from HVD diagnosis through treatment.
Main Methods:
- A multisociety working group, including patient representatives, was formed.
- Candidate outcomes and case mix variables were identified via systematic reviews and benchmark analyses.
- A modified Delphi process was used to finalize the standard set of outcomes and case mix definitions.
Main Results:
- The standard set includes patients with aortic, mitral, or tricuspid valve disease, or aortic root/ascending aorta dilation.
- Five outcome domains were defined: vital status, patient-reported outcomes, disease progression, cardiac function/durability, and treatment complications.
- Sixteen outcome measures, including two patient-reported outcomes, and comprehensive case-mix variables were selected.
Conclusions:
- A collaborative effort yielded a standardized set of measures for HVD, prioritizing patient-centered outcomes.
- Implementation will enable global standardization of HVD outcome measurement and facilitate healthcare system comparisons.
- This initiative is expected to improve clinical practice guidelines and enhance patient care for HVD globally.
Objective:
Globally significant variation in treatment and course of heart valve disease (HVD) exists, and outcome measurement is procedure focused instead of patient focused. This article describes the development of a patient-related (International Consortium for Health Outcomes Measurement) standard set of outcomes and case mix to be measured in patients with HVD.
Methods:
A multisociety working group was formed that included patient representatives and representatives from scientific cardiology and cardiothoracic surgery societies that publish current guidelines for HVD. The standard set was developed to monitor the patient's journey from diagnosis to treatment with either a surgical or transcatheter procedure. Candidate clinical and patient-reported outcome measures (PROMs) and case mix were identified through benchmark analyses and systematic reviews. Using an online modified Delphi process, the working group voted on final outcomes/case mix and corresponding definition.
Results:
Patients with aortic/mitral/tricuspid valve disease or root/ascending aorta >40 mm were included in the standard set. Patients entered the dataset when the diagnosis of HVD was established, allowing outcome measurement in the preprocedural, periprocedural, and postprocedural phases of patients' lives. The working group defined 5 outcome domains: vital status, patient-reported outcomes, progression of disease, cardiac function and durability, and complications of treatment. Subsequently, 16 outcome measures, including 2 patient-reported outcomes, were selected to be tracked in patients with HVD. Case-mix variables included demographic factors, demographic variables, echocardiographic variables, heart catheterization variables, and specific details on aortic/mitral/tricuspid valves and their specific interventions.
Conclusions:
Through a unique collaborative effort between patients and cardiology and cardiothoracic surgery societies, a standard set of measures for HVD was developed. This dataset focuses on outcome measurement regardless of treatment, moving from procedure- to patient-centered outcomes. Implementation of this dataset will facilitate global standardization of outcome measurement, allow meaningful comparison between health care systems and evaluation of clinical practice guidelines, and eventually improve patient care for those experiencing HVD worldwide.
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