Evaluation of statistical methods in observational studies on heart failure treatment devices: a cross-sectional survey_Chinese Journal of Evidence-Based Medicine

Authors：

LIAO Mingyu ^1,2,3 , WU Mengyao ^1,2,3 , ZHAO Peng ^1,2,3 , GUO Jin ^1,2,3,4 , ZHENG Mengyuan ^1,2,3 , LIU Chunrong ^1,2,3 , JIA Yulong ^1,2,3 , REN Yan ^1,2,3 , HUANG Wei ⁵ ,  TAN Jing ^1,2,3 ,  SUN Xin ^1,2,3,4 ,  XIONG Yiquan ^1,2,3

1. Clinical Epidemiology and Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. NHC Key Laboratory of Clinical Epidemiology and Evidence-based Medicine, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
3. IDEAL China Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
4. West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu 610041, P. R. China;
5. West China Center of Excellence for Pancreatitis, Institute of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding?author：

TAN Jing, Email: tanjing84@outlook.com; SUN Xin, Email: sunxin@wchscu.cn; XIONG Yiquan, Email: xiongyq@scu.edu.cn

Keywords：

Heart failure; Medical devices; Observational studies; Statistical methods

DOI：

10.7507/1672-2531.202511160

Video：

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Objective To systematically investigate the implementation and reporting quality of statistical analysis methods in observational studies for the clinical evaluation of heart failure treatment and management devices, and to provide references for the standardized design and reporting of statistical analyses in future studies within this field. Methods A comprehensive search was conducted in the PubMed database for observational studies published between October 2014 and September 2024 that aimed to evaluate the effectiveness and/or safety of heart failure treatment devices with a control group. Two researchers independently screened the literature and extracted data. The basic characteristics of the included studies and the implementation and reporting features of their statistical analysis methods were analyzed. Results A total of 65 studies were included, comprising 63 (96.92%) cohort studies and 2 (3.08%) case-control studies. Among these, only 39 (60.00%) studies performed multivariable analyses. The median number of confounders included was 9 (IQR 5 to 16), and only 22 (56.41%) studies reported specific methods for identifying confounders. None of the studies considered procedure-related confounders such as operator experience or institutional procedure volume. The most frequently used multivariable method was Cox regression (20, 51.28%), followed by propensity score methods (13, 33.33%). Only 15 (23.08%) studies conducted subgroup analyses and 11 (16.92%) performed sensitivity analyses. Compared with studies published in non-Q1 journals according to the journal citation reports (JCR), studies published in Q1 journals had larger sample sizes and higher proportions of using multivariable analysis. Conclusion Observational studies on the clinical evaluation of heart failure treatment devices exhibit notable deficiencies in the implementation of statistical analysis methods, including inadequate identification and control of confounding factors and low proportions of subgroup and sensitivity analyses. Addressing these methodological limitations in future research will be essential for generating robust, high-quality evidence to inform clinical decision-making.

Citation： LIAO Mingyu, WU Mengyao, ZHAO Peng, GUO Jin, ZHENG Mengyuan, LIU Chunrong, JIA Yulong, REN Yan, HUANG Wei, TAN Jing, SUN Xin, XIONG Yiquan. Evaluation of statistical methods in observational studies on heart failure treatment devices: a cross-sectional survey. Chinese Journal of Evidence-Based Medicine, 2026, 26(4): 453-460. doi: 10.7507/1672-2531.202511160 Copy

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1. Khan MS, Shahid I, Bennis A, et al. Global epidemiology of heart failure. Nat Rev Cardiol, 2024, 21(10): 717-734.
2. Kang K, Wang Q, Li Y, et al. Global and Chinese perspectives on the growing burden of heart failure: trends, gender, and age-related differences (1990-2021) based on GBD 2021 data. BMC Cardiovasc Disord, 2025, 25(1): 510.
3. Dunlay SM, Roger VL, Killian JM, et al. Advanced heart failure epidemiology and outcomes: a population-based study. JACC Heart Fail, 2021, 9(10): 722-732.
4. 國家心血管病中心, 國家心血管病專家委員會心力衰竭專業委員會, 中國醫師協會心力衰竭專業委員會, 等. 國家心力衰竭指南2023(精簡版). 中國循環雜志, 2023, 38(12): 1207-1238.
5. Mcdonagh TA, Metra M, Adamo M, et al. 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J, 2021, 42(36): 3599-3726.
6. 明堅, 魏艷, 何運臻, 等. 醫療器械和診斷產品的衛生技術評估路在何方—基于國際經驗的啟示. 中國醫療保險, 2021, (6): 69-74.
7. Kostis JB, Dobrzynski JM. Limitations of randomized clinical trials. Am J Cardiol, 2020, 129: 109-115.
8. 黃亞芳, 閻小妍, 李雪迎, 等. 真實世界證據在醫療器械臨床研究中的應用. 中國循證醫學雜志, 2017, 17(12): 1373-1377.
9. Samuel M, Batomen B, Rouette J, et al. Evaluation of propensity score used in cardiovascular research: a cross-sectional survey and guidance document. BMJ Open, 2020, 10(8): e036961.
10. Velders BJJ, Boltje JWT, Vriesendorp MD, et al. Confounding adjustment in observational studies on cardiothoracic interventions: a systematic review of methodological practice. Eur J Cardiothorac Surg, 2023, 64(4): ezad271.
11. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Circulation, 2022, 145(18): e895-e1032.
12. Estep JD, Salah HM, Kapadia SR, et al. HFSA scientific statement: update on device based therapies in heart failure. J Card Fail, 2024, 30(11): 1472-1488.
13. 賴宇星, 蘇津自. 心力衰竭器械治療的研究進展. 心血管病學進展, 2023, 44(8): 718-723,727.
14. Zhu H, Qin C, Du A, et al. Comparisons of long-term clinical outcomes with left bundle branch pacing, left ventricular septal pacing, and biventricular pacing for cardiac resynchronization therapy. Heart Rhythm, 2024, 21(8): 1342-1353.
15. Trenson S, Voros G, Martens P, et al. Long-term outcome after upgrade to cardiac resynchronization therapy: a propensity score-matched analysis. Eur J Heart Fail, 2024, 26(2): 511-520.
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Chinese Journal of Evidence-Based Medicine

Evaluation of statistical methods in observational studies on heart failure treatment devices: a cross-sectional survey

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