A systematic review of health-related quality of life assessment tools for children with congenital heart disease

doi:10.3761/j.issn.0254-1769.2026.20.015

Abstract

Abstract:

Objective To comprehensively evaluate the methodological quality and psychometric properties of health-related quality of life assessment tools for children with congenital heart disease，and to provide evidence-based references for clinical practitioners in selecting appropriate instruments. Methods A systematic search was conducted in PubMed，Web of Science，Cochrane Library，Embase，Chinese National Knowledge Infrastructure，Wanfang Data，SinoMed，and VIP databases for studies on health-related quality of life assessment tools for children with congenital heart disease，covering the period from the inception of each database to December 17，2025. Totally 2 researchers independently performed literature screening and data extraction. We assessed the included tools for methodological soundness and psychometric characteristics based on the COSMIN framework，from which we then derived the final recommendations. Results Our final analysis incorporated 15 articles and 9 evaluation instruments. Among them，the Congenital Quality of Life，Preschool Pediatric Cardiac Quality of Life Inventory，and Pediatric Quality of Life Inventory Version 3.0 Cardiac Module received a grade A recommendation，whereas the other 6 instruments were assigned a grade B designation. Conclusion A variety of tools exist for assessing health-related quality of life in children with congenital heart disease，yet the reporting of their psychometric properties remains incomplete. Future research should further verify the unassessed measurement properties and refine the Chinese localized versions，so as to enhance the scientific validity and clinical applicability of these instruments in clinical practice.

Key words: Congenital Heart Disease, Assessment Tools, Health-Related Quality of Life, Evidence-Based Nursing, Systematic Review

摘要：

目的对先天性心脏病患儿健康相关生活质量评估工具的测量学性能及其研究方法学质量进行系统评价，以期为临床实践中选择恰当的测评工具提供证据支持。方法检索中国生物医学文献数据库、维普数据库、万方数据库、中国知网及Cochrane Library、PubMed、Web of Science、Embase中有关先天性心脏病患儿健康相关生活质量评估工具的研究，检索时限为建库至2025年12月17日。文献筛选与资料提取由2名研究者独立进行，采用基于共识的健康测量工具遴选标准评估工具的方法学质量和测量学质量，进而形成推荐意见。结果最终纳入文献15篇，包括9个评估工具。其中，先天性生活质量量表、学龄前儿童心脏生活质量量表、儿科生活质量量表3.0心脏病模块为A级推荐；其余6个工具为B级推荐。结论评估先天性心脏病患儿健康相关生活质量的工具种类多样，但各工具的测量学属性报告仍欠完整。未来应进一步验证各工具未明确的测量属性，完善中文版本，以提升临床应用的科学性与适用性。

关键词: 先天性心脏病, 评估工具, 健康相关生活质量, 循证护理学, 系统评价

XU Qi, ZHANG Xiaotong, LI Yuxin, LI Minmin. A systematic review of health-related quality of life assessment tools for children with congenital heart disease[J]. Chinese Journal of Nursing, 2026, 61(20): 2840-2846.

徐奇, 张晓彤, 李雨欣, 李敏敏. 先天性心脏病患儿健康相关生活质量评估工具的系统评价[J]. 中华护理杂志, 2026, 61(20): 2840-2846.

Figures/Tables 2

References 34

[1]	张茜, 刘亚飞, 李梦然, 等. 先天性心脏病患儿围生期护理管理专家共识[J]. 中华护理杂志, 2025, 60(5):552-557.
	Zhang Q, Liu YF, Li MR, et al. Expert consensus on perinatal nursing management for children with congenital heart disease[J]. Chin J Nurs, 2025, 60(5):552-557.
[2]	Mandalenakis Z, Giang KW, Eriksson P, et al. Survival in child-ren with congenital heart disease:have we reached a peak at 97%?[J]. J Am Heart Assoc, 2020, 9(22):e017704. DOI URL
[3]	兰岚, 张婷. 先天性心脏病患者从青少年到成人过渡期护理的研究进展[J]. 中国护理管理, 2024, 24(4):626-630.
	Lan L, Zhang T. Research progress on transitional nursing for patients with congenital heart disease from adolescents to adults[J]. Chin Nurs Manag, 2024, 24(4):626-630.
[4]	Amodeo G, Ragni B, Calcagni G, et al. Health-related quality of life in Italian children and adolescents with congenital heart diseases[J]. BMC Cardiovasc Disord, 2022, 22(1):173. DOI
[5]	Werner H, Latal B, Valsangiacomo Buechel E, et al. Health-re-lated quality of life after open-heart surgery[J]. J Pediatr, 2014, 164(2):254-258. DOI URL
[6]	Brudy L, Meyer M, Oberhoffer R, et al. Move more-be happier? Physical activity and health-related quality of life in children with congenital heart disease[J]. Am Heart J, 2021, 241:68-73. DOI URL
[7]	O’Connor AM, Wray J, Tomlinson RS, et al. Impact of surgical complexity on health-related quality of life in congenital heart disease surgical survivors[J]. J Am Heart Assoc, 2016, 5(7):e001234. DOI URL
[8]	Prinsen CAC, Mokkink LB, Bouter LM, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures[J]. Qual Life Res, 2018, 27(5):1147-1157. DOI PMID
[9]	Mokkink LB, de Vet HCW, Prinsen CAC, et al. COSMIN risk of bias checklist for systematic reviews of patient-reported outcome measures[J]. Qual Life Res, 2018, 27(5):1171-1179. DOI PMID
[10]	Terwee CB, Prinsen CAC, Chiarotto A, et al. COSMIN methodo-logy for evaluating the content validity of patient-reported outcome measures:a Delphi study[J]. Qual Life Res, 2018, 27(5):1159-1170. DOI PMID
[11]	Alhazzani W, Guyatt G. An overview of the GRADE approach and a peek at the future[J]. Med J Aust, 2018, 209(7):291-292. PMID
[12]	Amedro P, Huguet H, Macioce V, et al. Psychometric valida-tion of the French self and proxy versions of the PedsQL^TM 4.0 generic health-related quality of life questionnaire for 8-12 year-old children[J]. Health Qual Life Outcomes, 2021, 19(1):75. DOI
[13]	Gandhi M, Chen CK, Zhang DZ, et al. PedsQL Generic Core Scales was more discriminative while EQ-5D-Y-5L was more responsive in a longitudinal study of multiethnic Asian children and adolescents with heart disease[J]. J Clin Epide-miol, 2025, 188:111982.
[14]	Berkes A, Varni JW, Pataki I, et al. Measuring health-related quality of life in Hungarian children attending a cardiology clinic with the Pediatric Quality of Life Inventory^TM[J]. Eur J Pediatr, 2010, 169(3):333-347. DOI PMID
[15]	Huang YC, Chen YC, Gau BS, et al. Psychometric evaluation of the traditional Chinese version of PedsQL^TM 3.0 cardiac module scale in adolescents with congenital heart disease:reliability,validity,measurement invariance,and adolescent-parent agreement[J]. Health Qual Life Outcomes, 2023, 21(1):39. DOI
[16]	Sand P, Kljajić M, Sunnegårdh J. The reliability of the Pedia-tric Quality of Life Inventory 3.0 Cardiac Module^TM for Swe-dish children with congenital heart defects[J]. Nord Psychol, 2013, 65(3):210-223.
[17]	郑蕾, 傅丽娟. 《心脏疾病儿童生活质量量表》(中文版)的信度和效度评价[J]. 解放军护理杂志, 2010, 27(16):1220-1222.
	Zheng L, Fu LJ. Evaluation on reliability and validity of Chinese version of Pediatric Quality of Life Inventory Cardiac Module[J]. Nurs J Chin PLA, 2010, 27(16):1220-1222.
[18]	Uzark K, Jones K, Burwinkle TM, et al. The Pediatric Quality of Life Inventory in children with heart disease[J]. Prog Pe-diatr Cardiol, 2003, 18(2):141-149.
[19]	González-Gil T, Mendoza-Soto A, Alonso-Lloret F, et al. The Spanish version of the Health-related Quality of Life Questionnaire for Children and Adolescents with Heart Disease(PedsQL^TM)[J]. Rev Esp CardiolRev Esp Cardiol(Eng), 2012, 65(3):249-257.
[20]	Grimaldi CT, Bevilacqua F, Vallone R, et al. Validity and reliability of the Italian version of the Cardiac Quality of Life Questionnaire for Pediatric Patients with Heart Disease(PedsQLTM)[J]. BMC Cardiovasc Disord, 2021, 21(1):398. DOI
[21]	Macran S, Birks Y, Parsons J, et al. The development of a new measure of quality of life for children with congenital cardiac disease[J]. Cardiol Young, 2006, 16(2):165-172. PMID
[22]	Helm PC, Bauer UMM, Ewert P, et al. Development and vali-dation of the CHDSI questionnaire:a new tool for measuring disease-specific quality of life in children and adolescents with congenital heart defects[J]. Medicina, 2025, 61(7):1311. DOI URL
[23]	Niemitz M, Seitz DCM, Oebels M, et al. The development and validation of a health-related quality of life questionnaire for pre-school children with a chronic heart disease[J]. Qual Life Res, 2013, 22(10):2877-2888. DOI PMID
[24]	Marino BS, Tomlinson RS, Wernovsky G, et al. Validation of the Pediatric Cardiac Quality of Life Inventory[J]. Pediatrics, 2010, 126(3):498-508. DOI PMID
[25]	Marino BS, Shera D, Wernovsky G, et al. The development of the Pediatric Cardiac Quality of Life Inventory:a quality of life measure for children and adolescents with heart disease[J]. Qual Life Res, 2008, 17(4):613-626. DOI URL
[26]	Marino BS, Drotar D, Cassedy A, et al. External validity of the Pediatric Cardiac Quality of Life Inventory[J]. Qual Life Res, 2011, 20(2):205-214. DOI PMID
[27]	Mokkink LB, Elsman EBM, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures ver-sion 2.0[J]. Qual Life Res, 2024, 33(11):2929-2939. DOI
[28]	彭健, 沈蓝君, 陈祎婷, 等. COSMIN-RoB清单简介及测量工具内部结构研究的偏倚风险清单解读[J]. 中国循证医学杂志, 2020, 20(10):1234-1240.
	Peng J, Shen LJ, Chen YT, et al. An overview of the COSMIN-RoB checklist and the interpretation of it in evaluating the risk of bias of studies on internal structure[J]. Chin J Evid Based Med, 2020, 20(10):1234-1240.
[29]	刘素香, 边莉, 张叶群, 等. 基于COSMIN指南对糖尿病患者健康素养评估工具的系统评价[J]. 中华护理杂志, 2023, 58(21):2670-2677. DOI
	Liu SX, Bian L, Zhang YQ, et al. A systematic review of health literacy assessment tools for diabetic patients based on COSMIN guidelines[J]. Chin J Nurs, 2023, 58(21):2670-2677. DOI
[30]	陈祎婷, 沈蓝君, 彭健, 等. 改良版定量系统评价证据分级方法对患者报告结局测量工具的评价[J]. 解放军护理杂志, 2020, 37(10):57-60.
	Chen YT, Shen LJ, Peng J, et al. Modified GRADE evaluation of COSMIN method for patient reported outcome measures[J]. Nurs J Chin PLA, 2020, 37(10):57-60.
[31]	Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN study reached international consensus on taxonomy,terminology,and definitions of measurement properties for health-related patient-reported outcomes[J]. J Clin Epidemiol, 2010, 63(7):737-745. DOI URL
[32]	Terwee CB, Prinsen CAC, Ricci Garotti MG, et al. The quality of systematic reviews of health-related outcome measurement instruments[J]. Qual Life Res, 2016, 25(4):767-779. DOI PMID
[33]	陆诗燕, 刘羡, 江笑笑, 等. 肝癌患者特异性自我报告结局评估工具测量学属性的系统评价[J]. 中华护理杂志, 2024, 59(22):2734-2741. DOI
	Lu SY, Liu X, Jiang XX, et al. Systematic review of measure-ment properties of liver cancer patient specific self-reported outcome assessment tools[J]. Chin J Nurs, 2024, 59(22):2734-2741.
[34]	余晓燕, 袁长蓉, 王浩, 等. 患者报告结局测量工具在先天性心脏病儿童中应用的范围综述[J]. 护理学报, 2025, 32(12):55-61.
	Yu XY, Yuan CR, Wang H, et al. A scoping review of the application of patient-reported outcome measurement tools in children with congenital heart disease[J]. J Nurs(China), 2025, 32(12):55-61.