Distribution-based thresholds for clinically important differences in patient-reported outcomes for adults with congenital heart disease

Q: What is the clinical evidence from this study?

Study design: Cross-Sectional. Population: Congenital heart disease (n=8415). Intervention: Patient-reported outcomes (PROs) assessment. Primary outcome: Minimal, moderate, and large clinically important differences for core PROs (PCS, MCS, EQ-VAS, PHQ-8, GAD-7, LAS).

Philip Moons; Liesbet Van Bulck; Adrienne H. Kovacs; Eva Goossens; Laila Ladak; Leye Mohamed; Alexander Van De Bruaene; Ming Chern Leong; Anna Kaneva-Nencheva; Fernando José do Amaral; John Jairo Araujo; Navaneetha Sasikumar; Harald Gabriel; Dejuma Yadeta Goshu; Chun‐Wei Lu; Junko Enomoto; Maria Emília Areias; Diamantis Kosmidis; Louise Coats; Anne-Marie Valente-Feliciano; Ju Ryoung Moon; Magalie Ladouceur; Corina Thomet; Jamie L. Jackson; Camilla Sandberg; Edward Callus; Yuli Y. Kim; Birgitte Lykkeberg; Luis Alday; Charlène Bredy; Arwa Saidi; Fernando Baraona Reyes; Samuel Menahem; Michèle de Hosson; Joanna Hlebowicz; Christina Christersson; Ali N. Zaidi; Bengt Johansson; Brith Andresen; Jean-Claude Ambassa; Zacharias Mandalenakis; Andrew Constantine; Pascal Amédro; Joost P van Melle; Shelby Kutty; Lucia Ortiz; Fatma Demir; Paul Khairy; Jonathan Windram; Judith Bouchardy; Maryanne Caruana; Susan M. Fernandes; Vaikom S. Mahadevan; Lidija McGrath; Julius Chacha Mwita; Koen Luyckx; Navaneetha Sasikumar; J Enomoto; Yoshiko Mizuno; Ming Chern Leong; Izzatun Nafsi Binto Sabran; Laila Ladak; Babar Hasan; Ayat Siddiqui; Ju Ryoung Moon; June Huh; Hsiao‐Ling Yang; Jou-Kou Wang; Chun-Wei Lu; Fatma Demir; Tuğba Öden; Endale Tefera; Julius Mwita; Jean-Claude Ambassa; Charles Mvondo; Marcel Fanka; Dejuma Yadeta; Mulualem Alemayehu; Mohamed Leye; Khadija Gueye; H. Gabriel; Matthias Svhneider; Selina Seeliger; Werner Budts; Alexander Van De Bruaene; P Moons; Eva Goossens; Liesbet Van Bulck; Jessica Rassart; Koen Luyckx; Michele De Hosson; Julie De Backer; Anna Kaneva; M Marková; Birgitte Lykkeberg; Miriam Biyai; Magalie Ladouceur; Anissa Boubrit; Jean-Benoît Thambo; Amandine Ruissel

doi:10.1093/eurjcn/zvag110

July 8, 2026European Journal of Cardiovascular NursingOpen Access

Distribution-based thresholds for clinically important differences in patient-reported outcomes for adults with congenital heart disease

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Key result

Minimal clinically important differences in adult congenital heart disease average ~4 points for general health.

n=8,415

Key Points

To establish distribution-based thresholds for minimal, moderate, and large clinically important differences across core patient-reported outcomes in adults with congenital heart disease.
Analyzed data from the international, multicenter APPROACH-IS II study cohort.
Assessed health status, psychological distress, and quality of life using PCS, MCS, EQ-VAS, PHQ-8, GAD-7, and the Linear Analog Scale.
Applied statistical distribution-based methods to derive group-level difference thresholds.
Enrolled participants had a median age of 32 years and 53.9% were women, with baseline PRO scores of PCS 75.2 ± 21.3, MCS 69.2 ± 18.7, EQ-VAS 73.3 ± 17.8, PHQ-8 5.28 ± 4.71, GAD-7 4.88 ± 4.82, and LAS 72.5 ± 20.0.
Minimal clinically important differences were approximately 4 points for PCS, MCS, self-rated health, and quality of life, and about 1 point for PHQ-8 and GAD-7.
Moderate and large differences corresponded to approximately two-fold and four-fold increases of minimal thresholds, respectively.

Study Design

Type

Cross-Sectional (n=8,415)

Multicenter

Yes

Structured PICO

P

Population

8,415 adults (median age 32 years, 53.9% female) with congenital heart disease from 32 countries who completed patient-reported outcome measures.

O

Outcome

Distribution-based thresholds for minimal, moderate, and large clinically important differences for core patient-reported outcomes (PCS, MCS, EQ-VAS, PHQ-8, GAD-7, LAS)patient reported

Limitations

Distribution-based methods rely on statistical parameters rather than external patient-reported anchors or judgments.
Does not capture the subjective or contextual meaning of differences or changes for individual patients.
Thresholds are sample dependent and may not transfer directly to narrower clinical subgroups or single-centre settings.
Distribution-based methods rely on statistical parameters rather than external patient-reported anchors, failing to capture subjective or contextual meaning for individual patients.
Thresholds are sample dependent, derived from a large, heterogeneous international cohort.
Thresholds may not transfer directly to narrower clinical subgroups or single-centre settings with different variability.
Thresholds may be influenced by non-normal distributions or cross-country response patterns.

Implication

This study establishes distribution-based thresholds for clinically important differences in core patient-reported outcomes for adults with congenital heart disease, providing a pragmatic tool to interpret the magnitude of group-level differences in research.

Abstract

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Discussion

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Cite This Study

Moons et al. (2026) conducted a cross-sectional in Congenital heart disease (n=8,415). Patient-reported outcomes (PROs) assessment was evaluated on Minimal, moderate, and large clinically important differences for core PROs (PCS, MCS, EQ-VAS, PHQ-8, GAD-7, LAS). Distribution-based minimal clinically important differences in adults with congenital heart disease were approximately 4 points for physical and mental health summaries and 1 point for depression and anxiety.

synapsesocial.com/papers/6a9943d9ea739e5cccf5b712 https://doi.org/10.1093/eurjcn/zvag110

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Distribution-based thresholds for clinically important differences in patient-reported outcomes for adults with congenital heart disease

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Distribution-based thresholds for clinically important differences in patient-reported outcomes for adults with congenital heart disease

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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