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CHIPS试验(妊娠期高血压控制研究)中女性的观点及产后随访

Women's views and postpartum follow-up in the CHIPS Trial (Control of Hypertension in Pregnancy Study).

作者信息

Vidler Marianne, Magee Laura A, von Dadelszen Peter, Rey Evelyne, Ross Susan, Asztalos Elizabeth, Murphy Kellie E, Menzies Jennifer, Sanchez Johanna, Singer Joel, Gafni Amiram, Gruslin Andrée, Helewa Michael, Hutton Eileen, Lee Shoo K, Lee Terry, Logan Alexander G, Ganzevoort Wessel, Welch Ross, Thornton Jim G, Moutquin Jean-Marie

机构信息

Obstetrics and Gynaecology, University of British Columbia, Canada.

Medicine, University of British Columbia, Canada.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:105-113. doi: 10.1016/j.ejogrb.2016.07.509. Epub 2016 Sep 10.

Abstract

OBJECTIVE

To compare women's views about blood pressure (BP) control in CHIPS (Control of Hypertension In Pregnancy Study) (NCT01192412).

DESIGN

Quantitative and qualitative analysis of questionnaire responses.

SETTING

International randomised trial (94 sites, 15 countries).

POPULATION/SAMPLE: 911 (92.9%) women randomised to 'tight' (target diastolic blood pressure, 85mmHg) or 'less tight' (target diastolic blood pressure, 100mmHg) who completed questionnaires.

METHODS

A questionnaire was administered at ∼6-12 weeks postpartum regarding post-discharge morbidity and views about trial participation. Questionnaires were administered by the site co-ordinator, and contact was made by phone, home or clinic visit; rarely, data was collected from medical records. Quantitative analyses were Chi-square or Fisher's exact test for categorical variables, mixed effects multinomial logistic regression to adjust for confounders, and p<0.001 for statistical significance. NVivo software was used for thematic analysis of women's views.

MAIN OUTCOME MEASURES

Satisfaction, measured as willingness to have the same treatment in another pregnancy or recommend that treatment to a friend.

RESULTS

Among the 533 women in 'tight' (N=265) vs. 'less tight' (N=268) control who provided comments for qualitative analysis, women in 'tight' (vs. 'less tight') control made fewer positive comments about the amount of medication taken (5 vs. 28 women, respectively) and intensity of BP monitoring (7 vs. 17, respectively). However, this did not translate into less willingness to either have the same treatment in another pregnancy (434, 95.8% vs. 423, 92.4%, respectively; p=0.14) or recommend that treatment to a friend (435, 96.0% and 428, 93.4%, respectively; p=0.17). Importantly, although satisfaction remained high among women with an adverse outcome, those in 'tight' control who suffered an adverse outcome (vs. those who did not) were not consistently less satisfied, whereas this was not the case among women in 'less tight' control among whom satisfaction was consistently lower for the CHIPS primary outcome (p<0.001), severe hypertension (p≤0.01), and pre-eclampsia (p<0.001).

CONCLUSIONS

Women in 'tight' (vs. 'less tight') control were equally satisfied with their care, and more so in the face of adverse perinatal or maternal outcomes.

摘要

目的

比较CHIPS(妊娠期高血压控制研究,NCT01192412)中女性对血压控制的看法。

设计

对问卷回复进行定量和定性分析。

背景

国际随机试验(94个地点,15个国家)。

研究对象/样本:911名(92.9%)被随机分配到“严格”(目标舒张压85mmHg)或“较宽松”(目标舒张压100mmHg)组并完成问卷的女性。

方法

在产后约6 - 12周发放一份关于出院后发病率及对试验参与看法的问卷。问卷由研究点协调员发放,通过电话、家访或门诊访视进行联系;极少数情况下,从医疗记录中收集数据。对分类变量进行卡方检验或费舍尔精确检验进行定量分析,采用混合效应多项逻辑回归调整混杂因素,统计学显著性设定为p<0.001。使用NVivo软件对女性的看法进行主题分析。

主要观察指标

满意度,以再次怀孕时愿意接受相同治疗或向朋友推荐该治疗的意愿来衡量。

结果

在为定性分析提供评论的533名“严格”组(N = 265)与“较宽松”组(N = 268)对照的女性中,“严格”组女性对服药量(分别为5名和28名女性)和血压监测强度(分别为7名和17名)的积极评价较少。然而,这并未转化为再次怀孕时接受相同治疗的意愿降低(分别为434名,95.8%与423名,92.4%;p = 0.14)或向朋友推荐该治疗的意愿降低(分别为435名,96.0%和428名,93.4%;p = 0.17)。重要的是,尽管不良结局女性的满意度仍然较高,但“严格”组中出现不良结局的女性(与未出现不良结局的女性相比)并非一直满意度较低,而“较宽松”组女性在CHIPS主要结局(p<0.001)、重度高血压(p≤0.01)和子痫前期(p<0.001)方面的满意度一直较低。

结论

“严格”组(与“较宽松”组相比)女性对其治疗同样满意,在面对不良围产期或孕产妇结局时更是如此。

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