Appraisal of congenital heart disease guidelines and consensus

Abstract

Objective:

This is a systematic review of methodological and reporting quality of CHD guidelines and consensus statements.To systematically appraise the methodological and reporting quality of global congenital heart disease (CHD) guidelines and consensus statements, identifying key areas for improvement with implications for international guideline development.

Methods:

We searched Chinese and English databases up to November 2025. Four appraisers independently evaluated documents using AGREE II and RIGHT tools. Inter-rater reliability was assessed via ICC; subgroup analyses examined document type, methodology, developer number, and region. The systematic review protocol was registered with PROSPERO (CRD420261415315).

Results:

Among 33 included documents (17 CPGs, 16 ECSs), AGREE II scores varied substantially, highest in “Scope and Purpose” (58.42%) and lowest in “Applicability” (32.35%). RIGHT assessment showed sufficient basic reporting but critical gaps in evidence summaries, benefit-harm analyses, and update plans. Guidelines, evidence-based documents, and those with ≥50 developers scored higher. International guidelines outperformed Chinese ones in all quality domains (ICCs > 0.75).

Conclusion:

Current CHD guidance documents are purposeful but deficient in rigor, applicability, and transparency. Chinese guidelines lag behind international standards. Future development must adopt evidence-based methods, emphasize applicability, mandate patient and family engagement and improve reporting to effectively translate evidence into practice.

Systematic Review Registration:

https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD420261415315, PROSPERO CRD420261415315.

Highlights

• First systematic appraisal of methodological and reporting quality for congenital heart disease guidelines and expert consensus globally.

• Identified critical deficiencies in applicability, development rigor, and stakeholder involvement despite clear scope and purpose.

• Chinese guidelines significantly lag behind international standards in methodological and reporting quality.

• Evidence-based guidelines with ≥50 developers scored higher, underscoring the value of structured methodology and broad collaboration.

• Provides actionable recommendations for improving future Chinese guideline development using AGREE II and RIGHT frameworks.

1 Introduction

Congenital heart disease (CHD) represents one of the most prevalent birth defects globally, exerting a substantial impact on infant survival rates and long-term clinical outcomes (1). Over recent decades, advancements in diagnostic modalities and therapeutic interventions have markedly enhanced the detection rate and treatment efficacy for CHD (2). However, the inherent complexity of the disease spectrum and the diversity of available management strategies impose increasingly sophisticated demands on clinical decision-making.

In response to these challenges, numerous clinical practice guidelines and expert consensus statements (hereafter collectively referred to as guidance documents) addressing various aspects of CHD care—including screening, diagnosis, treatment, and long-term management—have been promulgated by professional societies and academic organizations worldwide. These documents aim to standardize clinical approaches, reduce practice variation, and ultimately improve patient prognosis (3). Nonetheless, significant heterogeneity exists among these publications concerning their developmental methodology, evidentiary foundations, and reporting standards, resulting in variable quality that may undermine their scientific credibility and practical utility (4).

Quality deficiencies in clinical guidance documents are not new. In 2000, Grilli et al. found that 88% of 431 specialty society guidelines lacked literature search strategies and only 5% met three basic quality criteria—an “unsatisfactory” finding (5). Subsequent studies confirm persistence: Kovacevic et al. reported a median AGREE II score of 36% for 74 Croatian national guidelines, with applicability as low as 15%; Jhawar et al. found that >50% of recommendations across 11 of 14 specialties were supported by the lowest evidence level (C); and Nagavci et al. showed that 66% of 98 scientific societies rely on expert opinion—mostly to fill evidence gaps—without standardized definitions (6–8). Thus, despite decades of methodological progress, guideline quality remains a persistent global challenge, particularly for the complex and rapidly evolving field of CHD.

Well-constructed, methodologically rigorous guidelines serve as invaluable tools for clinicians, providing evidence-based frameworks that facilitate standardized care, optimize therapeutic decision-making, enhance treatment outcomes, and improve patients' quality of life. Conversely, recommendations derived from less stringent methodologies or inadequately reported processes may engender clinical inconsistencies, potentially lead to suboptimal care pathways, inefficient allocation of healthcare resources, and adverse impacts on patient outcomes (9). Therefore, ensuring methodological robustness, scientific integrity, and transparent reporting is paramount in the development and dissemination of CHD-related guidance documents.

The WHO Handbook for Guideline Development (2nd edition, 2014) represents the international gold standard. It mandates systematic evidence synthesis, GRADE methodology, rigorous conflict-of-interest management, multidisciplinary stakeholder engagement, and explicit implementation planning. The Guidelines Review Committee (GRC) ensures adherence to these standards, and studies show GRC-approved guidelines score significantly higher in the “rigour of development” domain. Therefore, this study uses the WHO Handbook as the normative benchmark to assess current CHD guideline quality (9).

The Appraisal of Guidelines for Research and Evaluation (AGREE) instrument, particularly its refined version AGREE II, has emerged as the international standard for the systematic assessment of guideline methodological quality (10). Concurrently, the Reporting Items for practice Guidelines in HealThcare (RIGHT) checklist provides a comprehensive framework for evaluating the transparency and completeness of guideline reporting (11). This study employs both the AGREE II instrument and RIGHT checklist to conduct a systematic evaluation of the methodological and reporting quality of published CHD-related clinical guidelines and consensus statements. The primary objectives are to identify prevailing strengths and weaknesses in current guidance documents, and to furnish evidence-based recommendations for the future development and revision of high-quality, clinically applicable CHD guidelines in China.

2 Materials and methods

2.1 Inclusion and exclusion criteria

2.2 Search strategy

A comprehensive systematic search was conducted across Chinese and English databases and specialized guideline platforms to identify all relevant CHD clinical practice guidelines and consensus statements.The complete search strategies for each database are provided in the PROSPERO protocol (CRD420261415315) and are also available as Supplementary File S1. The following resources were searched from their inception to November 2025:

English Databases: PubMed, Embase, Web of Science

Chinese Databases: China Biology Medicine disc (CBM), WanFang Data, China National Knowledge Infrastructure (CNKI)

Guideline Platforms: Guidelines International Network (GIN), National Institute for Health and Care Excellence (NICE) website, American Heart Association (AHA) and American College of Cardiology (ACC) official websites, and the Yimaitong Guideline Channel.

Search terms combined Medical Subject Headings (MeSH) and free-text keywords. The following are representative examples:

Chinese Search Terms: 先天性心脏病, 先天性心脏缺陷, 心脏畸形, 指南, 共识, 实践指南, 专家共识, 推荐意见, 管理规范

English Search Terms: “Congenital Heart Disease,” “Congenital Heart Defect,” “Heart Defect, Congenital,” “guideline,” “consensus,” “practice guideline,” “expert consensus,” “recommendation,” “statement”.

2.3 Methodological reference standard

The WHO Handbook (2nd edition) served as our methodological standard. Its 10-chapter framework spans planning, PICO questions, systematic reviews, GRADE, balanced recommendations, COI management, GRC peer review, dissemination, and transparency (9). We used AGREE II and RIGHT to assess all documents against these WHO-endorsed criteria, which cover evidence synthesis, stakeholder engagement, applicability, and reporting.

2.4 Study selection and data extraction

Two researchers independently screened titles, abstracts, and subsequently full texts according to the predefined criteria. Discrepancies were resolved through discussion or consultation with a third researcher. For missing information, efforts were made to contact the corresponding authors. GRADE methodology, mandated by the WHO Handbook, served as the reference standard for assessing evidence quality and recommendation strength in included documents; consistent GRADE adoption indicates adherence to WHO standards (9).

2.5 Quality assessment

Four trained researchers with doctoral-level expertise independently evaluated the included documents using the AGREE II instrument and RIGHT checklist. AGREE II comprises 23 items across six domains. Each item is scored on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Domain scores were calculated as standardized percentages: (Obtained Score − Minimum Possible Score)/(Maximum Possible Score − Minimum Possible Score) × 100%.

The RIGHT checklist includes 22 items across seven domains. Each item is rated as “reported” (1 point), “partially reported” (0.5 points), or “not reported” (0 points). Total scores were calculated accordingly.

2.6 Statistical analysis

Descriptive analyses were performed using Excel. SPSS 26.0 was employed for statistical testing. The intraclass correlation coefficient (ICC) was calculated to assess inter-rater reliability for AGREE II scores. ICC values were interpreted as follows: <0.40 = poor reliability; 0.40–0.75 = moderate reliability; >0.75 = excellent reliability. Between-group comparisons were analyzed using non-parametric tests (Mann–Whitney U test). A two-tailed P-value <0.05 was considered statistically significant.

2.7 Protocol registration

This systematic review was registered with PROSPERO (International Prospective Register of Systematic Reviews; registration number: CRD420261415315). The registered protocol detailed the research question, search strategy, inclusion and exclusion criteria, data extraction procedures, quality appraisal methods (AGREE II and RIGHT), and planned subgroup analyses.

3 Results

3.1 Study selection

The initial search yielded 5, 326 citations. After deduplication and sequential screening of titles/abstracts and full texts, 33 documents (clinical guidelines and consensus statements) met the inclusion criteria (1–4, 11–39). No full-text articles were excluded; all records that did not meet the inclusion criteria were excluded during title/abstract screening. The study selection process is summarized in Figure 1.

Figure 1

Figure 2

3.2 Characteristics of included articles

Among the 33 included documents, 17 (51.51%) were clinical guidelines and 16 (48.48%) were consensus statements. 17 documents (51.51%) involved ≥50 developers, while 16 (48.48%) involved <50. 18 documents (54.54%) were developed using evidence-based methods, whereas 15 (45.45%) relied primarily on expert opinion or narrative review. 20 documents (60.60%) originated from China, and 13 (39.39%) were international (predominantly European/American). 31 documents (93.93%) were issued by professional societies/associations, and two (6.06%) were published by individual authors. The detailed characteristics are presented in Table 1.

3.3 Methodological quality assessment (AGREE II)

The ICC values for all documents exceeded 0.75, indicating excellent inter-rater agreement (Table 2).

3.3.1 Overall AGREE II results

3.3.2 Subgroup analysis (AGREE II)

3.4 Reporting quality assessment (RIGHT)

3.4.1 Overall RIGHT results

Reporting quality was highest for basic information items (Items 1a, 2, 4: 100% reported) and lowest for evidence summary tables (Item 14b: 93.93% not reported), analysis of benefits/harms (Item 8b: 81.81% not reported), and update procedures (Item 20: 69.69% not reported). Table 5 summarizes reporting rates.

3.4.2 Subgroup analysis (RIGHT)

4 Discussion

This comprehensive evaluation of 33 CHD-related clinical guidelines and consensus statements using AGREE II and RIGHT instruments reveals significant quality variations, with pronounced deficiencies in core methodological and reporting domains. While “Scope and Purpose” was relatively well-addressed, critical weaknesses were identified in “Rigour of Development,” “Applicability,” and “Stakeholder Involvement”—findings consistent with quality appraisals in other medical fields (40). However, the CHD domain presents unique challenges due to disease heterogeneity, rapid technological evolution, and the need for lifelong patient management, which may exacerbate these methodological shortcomings.

Applying WHO Handbook standards reveals that while Scope and Purpose (58.42%) approximates international acceptability, Rigour of Development (41.12%) falls far below WHO requirements. This gap is concerning: Burda et al. found that WHO GRC-approved guidelines scored significantly higher in rigour of development, suggesting that better adherence to the Handbook and GRC oversight could improve quality (9).

The subgroup analyses provide actionable insights. The superior performance of guidelines over consensus statements underscores the importance of formal guideline development frameworks. The marked advantage of evidence-based methodologies highlights the necessity of systematic evidence synthesis rather than reliance on expert opinion alone. The positive association between developer numbers and quality suggests that multidisciplinary collaboration enhances comprehensiveness. Most notably, the substantial gap between international and Chinese documents indicates systematic deficiencies in China's guideline development ecosystem.

Our findings align with a recent systematic review by Gomes et al., who assessed the rigour of development of ESC and ACC/AHA guidelines from 2013 to 2024 using the AGREE II third domain (41). They reported a mean score of 29 out of 56, indicating substantial methodological deficiencies, and noted that ACC/AHA guidelines scored significantly higher than ESC guidelines (36 vs. 24). In our study, among the 13 international guidelines (which include ESC and ACC/AHA documents), we observed a comparable pattern: the AGREE II third domain scores for ACC/AHA guidelines were consistently higher than those for ESC guidelines. Moreover, our study extends these findings in several important ways. First, we evaluated all six AGREE II domains, revealing that “Applicability” and “Rigour of development” were the poorest-performing domains globally. Second, we included expert consensus statements and demonstrated that their methodological quality is substantially lower than that of formal guidelines. Third, we assessed reporting quality using the RIGHT checklist, identifying critical gaps in evidence summaries, benefit-harm analyses, and update procedures. Fourth, we included Chinese guidelines and found a significant quality gap compared with international standards, highlighting an urgent need for capacity building in China. Together, our study and that of Gomes et al. underscore that even the most influential cardiovascular guidelines have substantial room for improvement in methodological rigour and transparency, and that this issue is even more pronounced in China and in consensus-type documents.Due to the limited number of ACC/AHA guidelines in our sample (n = 2, out of 13 international guidelines) and the scattered publication years, we did not generate a separate figure for the year-by-year trend. Instead, we present the comparison in text, noting that our observed pattern (ACC/AHA > ESC) is fully consistent with Gomes et al.Importantly, our subgroup analysis only compared Chinese guidelines with European/North American ones. However, guidelines from other emerging economies—such as India's first national CHD guidelines (2019–2020)—remain unexplored (42). Future research should systematically appraise such regions, as their experiences in balancing evidence with resource constraints may offer more relevant lessons for China than those derived solely from high-resource settings. Three major areas require urgent attention. (1) Strengthenthe methodological rigour, particularly regarding transparent evidence selection criteria, critical appraisal of evidence limitations, and explicit linkage between recommendations and their evidentiary foundations (43). (2) Enhance the practical applicability; guidelines should proactively address implementation barriers, resource implications, and provide tools for clinical integration (44). (3) Improve the reporting transparency, especially concerning evidence summary tables, benefit-harm analyses, and update procedures.

This study also has several limitations. Firstly, only Chinese and English language documents were included, potentially excluding relevant guidelines in other languages. Secondly, while AGREE II and RIGHT are validated tools, certain domain assessments may involve subjective interpretation despite our measures to ensure consistency. Thirdly, the search was limited to November 2025 and was not updated during the revision process. Given the short time interval and the stable nature of methodological quality appraisal, the inclusion of newly published guidelines is unlikely to alter the overall conclusions. Nevertheless, future updates of this review may be warranted as the field evolves. Finally, we focused on methodological and reporting quality rather than clinical content validity, which represents a different but important aspect of guideline evaluation.

5 Conclusion

This systematic appraisal demonstrates that current CHD clinical guidelines and consensus statements exhibit significant quality deficiencies, particularly in methodological rigour, practical applicability, and reporting transparency. While international guidelines generally meet higher standards, Chinese documents show substantial room for improvement. The transition toward high-quality, evidence-based CHD guidelines requires systematic adoption of international development standards, strengthened implementation frameworks, transparent reporting, and ongoing update mechanisms. These improvements are crucial for ensuring that clinical recommendations are scientifically valid, practically feasible, and capable of improving patient care and outcomes in CHD management.

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