{"title":"关于“钠-葡萄糖共转运蛋白-2抑制剂能否改善心力衰竭患者的睡眠质量、焦虑和生活质量?”的方法学和统计学关注?","authors":"Rajeev Gupta, Shekhar Vohra, Anshul Yadav, Neelesh Gupta, Rohit Mody","doi":"10.1002/clc.70203","DOIUrl":null,"url":null,"abstract":"<p>The recent article by Erbay et al. reporting improved sleep quality, anxiety, and quality of life in heart failure patients receiving SGLT2 inhibitors [<span>1</span>] addresses a clinically important but underexplored area. However, several methodological limitations merit attention before these findings are generalized.</p><p>First, there was a significant baseline imbalance in Pittsburgh Sleep Quality Index (PSQI) scores between groups (5.0 vs. 6.0, <i>p</i> = 0.036). This difference, favoring the SGLT2 inhibitor group at baseline, may partially explain the magnitude of improvement observed. While within-group analyses were performed, regression models should have included baseline PSQI as a covariate to mitigate this confounding [<span>2</span>].</p><p>Second, the multivariate logistic regression did not adjust for several potential confounders that could influence patient-reported outcomes, including changes in diuretic dosing, concurrent initiation of other guideline-directed medical therapies, and intercurrent hospitalizations. These variables are known to impact congestion, sleep, and mood in heart failure [<span>3, 4</span>].</p><p>Third, the subgroup analyses by ejection fraction status are based on small sample sizes, limiting statistical power and precision. Without reporting interaction <i>p</i>-values, the assertion of consistent benefit across EF strata is premature [<span>5</span>].</p><p>Fourth, multiple SF-36 domains and other secondary outcomes were tested without correction for multiplicity. In this setting, the risk of false-positive findings is high, particularly in small observational cohorts [<span>6</span>].</p><p>Lastly, the study's observational, single-center design precludes definitive causal inference, yet several statements in the discussion imply a treatment effect. This language should be tempered to reflect association rather than causation [<span>7</span>].</p><p>Given the increasing integration of SGLT2 inhibitors into heart failure care, it is critical that conclusions about novel patient-reported benefits be supported by rigorous methodology. Randomized controlled trials incorporating objective sleep measures (e.g., polysomnography) and adequate adjustment for confounding are needed to validate these intriguing findings.</p><p>Use of AI for paraphrasing and in analyzing the statistical model used in the study.</p><p>The authors declare no conflicts of interest.</p>","PeriodicalId":10201,"journal":{"name":"Clinical Cardiology","volume":"48 9","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/clc.70203","citationCount":"0","resultStr":"{\"title\":\"Methodological and Statistical Concerns Regarding “Can Sodium-Glucose Co-Transporter-2 Inhibitors Improve Sleep Quality, Anxiety, and Quality of Life in Patients With Heart Failure?”\",\"authors\":\"Rajeev Gupta, Shekhar Vohra, Anshul Yadav, Neelesh Gupta, Rohit Mody\",\"doi\":\"10.1002/clc.70203\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>The recent article by Erbay et al. reporting improved sleep quality, anxiety, and quality of life in heart failure patients receiving SGLT2 inhibitors [<span>1</span>] addresses a clinically important but underexplored area. However, several methodological limitations merit attention before these findings are generalized.</p><p>First, there was a significant baseline imbalance in Pittsburgh Sleep Quality Index (PSQI) scores between groups (5.0 vs. 6.0, <i>p</i> = 0.036). This difference, favoring the SGLT2 inhibitor group at baseline, may partially explain the magnitude of improvement observed. While within-group analyses were performed, regression models should have included baseline PSQI as a covariate to mitigate this confounding [<span>2</span>].</p><p>Second, the multivariate logistic regression did not adjust for several potential confounders that could influence patient-reported outcomes, including changes in diuretic dosing, concurrent initiation of other guideline-directed medical therapies, and intercurrent hospitalizations. These variables are known to impact congestion, sleep, and mood in heart failure [<span>3, 4</span>].</p><p>Third, the subgroup analyses by ejection fraction status are based on small sample sizes, limiting statistical power and precision. Without reporting interaction <i>p</i>-values, the assertion of consistent benefit across EF strata is premature [<span>5</span>].</p><p>Fourth, multiple SF-36 domains and other secondary outcomes were tested without correction for multiplicity. In this setting, the risk of false-positive findings is high, particularly in small observational cohorts [<span>6</span>].</p><p>Lastly, the study's observational, single-center design precludes definitive causal inference, yet several statements in the discussion imply a treatment effect. This language should be tempered to reflect association rather than causation [<span>7</span>].</p><p>Given the increasing integration of SGLT2 inhibitors into heart failure care, it is critical that conclusions about novel patient-reported benefits be supported by rigorous methodology. Randomized controlled trials incorporating objective sleep measures (e.g., polysomnography) and adequate adjustment for confounding are needed to validate these intriguing findings.</p><p>Use of AI for paraphrasing and in analyzing the statistical model used in the study.</p><p>The authors declare no conflicts of interest.</p>\",\"PeriodicalId\":10201,\"journal\":{\"name\":\"Clinical Cardiology\",\"volume\":\"48 9\",\"pages\":\"\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/clc.70203\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Cardiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/clc.70203\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Cardiology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/clc.70203","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
Erbay等人最近发表的一篇文章报道,接受SGLT2抑制剂[1]治疗的心力衰竭患者的睡眠质量、焦虑和生活质量得到改善,这是一个临床重要但尚未得到充分探索的领域。然而,在推广这些发现之前,有几个方法上的局限性值得注意。首先,匹兹堡睡眠质量指数(PSQI)评分在两组之间存在显著的基线不平衡(5.0 vs. 6.0, p = 0.036)。这种差异,在基线时有利于SGLT2抑制剂组,可能部分解释了观察到的改善幅度。在进行组内分析时,回归模型应包括基线PSQI作为协变量,以减轻这种混淆。其次,多变量logistic回归没有调整可能影响患者报告结果的几个潜在混杂因素,包括利尿剂剂量的变化,同时开始其他指南指导的药物治疗,以及同时住院治疗。已知这些变量会影响心力衰竭患者的充血、睡眠和情绪[3,4]。第三,通过射血分数状态进行的亚组分析基于小样本量,限制了统计能力和精度。如果不报告相互作用的p值,断言EF地层的一致效益是不成熟的。第四,对多个SF-36结构域和其他次要结果进行检验,但未对多重性进行校正。在这种情况下,假阳性结果的风险很高,特别是在小型观察队列中。最后,该研究的观察性、单中心设计排除了明确的因果推理,但讨论中的几个陈述暗示了治疗效果。这种措辞应该有所缓和,以反映关联,而不是因果关系。鉴于SGLT2抑制剂越来越多地整合到心力衰竭治疗中,关于新的患者报告益处的结论得到严格方法的支持是至关重要的。为了验证这些有趣的发现,需要随机对照试验,包括客观睡眠测量(例如,多导睡眠图)和对混杂因素的适当调整。使用人工智能来解释和分析研究中使用的统计模型。作者声明无利益冲突。
Methodological and Statistical Concerns Regarding “Can Sodium-Glucose Co-Transporter-2 Inhibitors Improve Sleep Quality, Anxiety, and Quality of Life in Patients With Heart Failure?”
The recent article by Erbay et al. reporting improved sleep quality, anxiety, and quality of life in heart failure patients receiving SGLT2 inhibitors [1] addresses a clinically important but underexplored area. However, several methodological limitations merit attention before these findings are generalized.
First, there was a significant baseline imbalance in Pittsburgh Sleep Quality Index (PSQI) scores between groups (5.0 vs. 6.0, p = 0.036). This difference, favoring the SGLT2 inhibitor group at baseline, may partially explain the magnitude of improvement observed. While within-group analyses were performed, regression models should have included baseline PSQI as a covariate to mitigate this confounding [2].
Second, the multivariate logistic regression did not adjust for several potential confounders that could influence patient-reported outcomes, including changes in diuretic dosing, concurrent initiation of other guideline-directed medical therapies, and intercurrent hospitalizations. These variables are known to impact congestion, sleep, and mood in heart failure [3, 4].
Third, the subgroup analyses by ejection fraction status are based on small sample sizes, limiting statistical power and precision. Without reporting interaction p-values, the assertion of consistent benefit across EF strata is premature [5].
Fourth, multiple SF-36 domains and other secondary outcomes were tested without correction for multiplicity. In this setting, the risk of false-positive findings is high, particularly in small observational cohorts [6].
Lastly, the study's observational, single-center design precludes definitive causal inference, yet several statements in the discussion imply a treatment effect. This language should be tempered to reflect association rather than causation [7].
Given the increasing integration of SGLT2 inhibitors into heart failure care, it is critical that conclusions about novel patient-reported benefits be supported by rigorous methodology. Randomized controlled trials incorporating objective sleep measures (e.g., polysomnography) and adequate adjustment for confounding are needed to validate these intriguing findings.
Use of AI for paraphrasing and in analyzing the statistical model used in the study.
期刊介绍:
Clinical Cardiology provides a fully Gold Open Access forum for the publication of original clinical research, as well as brief reviews of diagnostic and therapeutic issues in cardiovascular medicine and cardiovascular surgery.
The journal includes Clinical Investigations, Reviews, free standing editorials and commentaries, and bonus online-only content.
The journal also publishes supplements, Expert Panel Discussions, sponsored clinical Reviews, Trial Designs, and Quality and Outcomes.