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Quality of life improves in vasovagal syncope patients after clinical trial enrollment regardless of fainting in follow-up
Autonomic Neuroscience ( IF 2.7 ) Pub Date : 2019-07-01 , DOI: 10.1016/j.autneu.2019.04.001
Jessica Ng 1 , Robert S Sheldon 1 , Connor Maxey 1 , Debbie Ritchie 1 , Vidya Raj 2 , Derek V Exner 1 , Satish R Raj 1
Affiliation  

BACKGROUND Frequent syncope is linked to poorer health-related quality of life (HRQoL). Recurrent syncope has been observed to reduce in all groups after seeing a syncope expert and enrolling in a clinical trial. It is unknown if HRQoL improves with this reduction in syncope recurrence. OBJECTIVES We examined the change in HRQoL over time in vasovagal syncope (VVS) patients seen by a syncope expert and enrolled in a trial. We also explored whether change differed with treatment or the frequency of fainting during follow up. METHODS The Short Form Health Survey (SF36) was completed at baseline (BL), 6 m, and 12 m post-enrollment by VVS patients in the 1st and 2nd Prevention of Syncope Trials, which were multi-centered, randomized, placebo-controlled trials of metoprolol (POST) and fludrocortisone (POST2). Differences in HRQoL at BL, 6 m, and 12 m were analyzed and compared by faints in follow-up and randomization group. RESULTS Complete study data were available for 143 VVS patients (40 ± 17 years, 62% F). Over 12 months, patients reported improvement in all SF36 dimensions except for bodily pain. Post hoc analyses indicated that differences first occurred between BL and 6 m for all but general health. Fainting in follow-up or drug randomization group did not diminish the improvements. The baseline syncope burden was not different whether patients' HRQoL improved or not. CONCLUSION HRQoL of VVS patients improves over time after enrolling in a clinical trial, even with recurrent faints or randomization to placebo. Improvements may result from alternative factors, such as interaction with experts or patient adjustment.

中文翻译:

无论在随访中是否昏厥,入组临床试验后血管迷走性晕厥患者的生活质量均有所改善

背景 频繁晕厥与较差的健康相关生活质量 (HRQoL) 相关。在就诊晕厥专家并参加临床试验后,观察到所有组的复发性晕厥均有所减少。不知道 HRQoL 是否会随着晕厥复发的减少而改善。目标 我们检查了晕厥专家所见并参加试验的血管迷走性晕厥 (VVS) 患者 HRQoL 随时间的变化。我们还探讨了治疗或随访期间昏厥频率的变化是否有所不同。方法 在第一和第二次预防晕厥试验中,VVS 患者在基线 (BL)、入组后 6 m 和 12 m 时完成了简短健康调查 (SF36),这些试验是多中心、随机、安慰剂对照的美托洛尔 (POST) 和氟氢可的松 (POST2) 的试验。HRQoL 在 BL、6 m、随访组和随机组分别对12 m和12 m进行晕厥分析比较。结果 143 名 VVS 患者(40 ± 17 岁,62% F)可获得完整的研究数据。超过 12 个月,患者报告除身体疼痛外的所有 SF36 维度都有所改善。事后分析表明,除一般健康外,BL 和 6 m 之间首先出现差异。在随访或药物随机分组中昏厥并没有减少改善。无论患者的 HRQoL 是否改善,基线晕厥负担没有差异。结论 VVS 患者的 HRQoL 在参加临床试验后随着时间的推移而改善,即使是反复昏厥或随机分配到安慰剂。改进可能来自其他因素,例如与专家的互动或患者的调整。
更新日期:2019-07-01
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