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Article: Process evaluation and its application in clinical research of acupuncture: preliminary considerations.

Chen, Huan / Gang, Weijuan / Ouyang, Menglu / Hu, Xiaoyi / Tian, Ziyu / Xiu, Wencui / Ming, Tianyu / Hu, Xiangyu / Jing, Xianghong

Zhongguo zhen jiu = Chinese acupuncture & moxibustion

2024 Volume 44, Issue 3, Page(s) 327–332

Abstract: As an important supplementary approach to randomized controlled trial, process evaluation(PE) aims to evaluate implementation of complex intervention and contextual factors associated with variation in outcomes, in order to explain the observed results ... ...

Title translation	过程评价及其在针刺临床研究中应用的思考与建议.
Abstract	As an important supplementary approach to randomized controlled trial, process evaluation(PE) aims to evaluate implementation of complex intervention and contextual factors associated with variation in outcomes, in order to explain the observed results in a comprehensive manner. However, PE has not been well applied in the clinical research of acupuncture. Based on existing literature, this paper summarized the main methodological frameworks of PE, as well as the status-quo of its application in acupuncture research. Meanwhile, it explored the research perspectives and implementation factors that were potentially relevant to PE in parallel with acupuncture trials. In addition, the paper put forward preliminary considerations on key contents corresponding to each step during the development of PE for acupuncture trials, in order to provide useful reference and innovative pathway for future studies that strive for comprehensive evaluation of acupuncture's effect.
MeSH term(s)	Acupuncture ; Acupuncture Therapy/methods ; Humans ; Randomized Controlled Trials as Topic
Language	Chinese
Publishing date	2024-03-20
Publishing country	China
Document type	Randomized Controlled Trial ; Journal Article
ISSN	0255-2930
ISSN	0255-2930
DOI	10.13703/j.0255-2930.20231128-k0006
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Article ; Online: Anticoagulants for acute ischaemic stroke: a Cochrane review.

Wang, Xia / Ouyang, Menglu / Yang, Jie / Song, Lili / Yang, Min / Anderson, Craig S

Emergencias : revista de la Sociedad Espanola de Medicina de Emergencias

2023 Volume 35, Issue 6, Page(s) 463–464

Title translation	Anticoagulantes en el ictus isquémico agudo: una revisión Cochrane.
MeSH term(s)	Humans ; Anticoagulants/therapeutic use ; Brain Ischemia/complications ; Brain Ischemia/drug therapy ; Ischemic Stroke ; Stroke/drug therapy ; Stroke/prevention & control
Chemical Substances	Anticoagulants
Language	English
Publishing date	2023-12-20
Publishing country	Spain
Document type	Journal Article ; Review
ZDB-ID	2127173-2
ISSN	2386-5857 ; 2386-5857
ISSN (online)	2386-5857
ISSN	2386-5857
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Article ; Online: Prognostic Value of Serum Cardiac Troponin in Acute Ischemic Stroke: An Updated Systematic Review and Meta-Analysis.

Zhang, Yao / Ouyang, Menglu / Qiu, Jianting / Cao, Xiaopan / Xu, Bing / Sui, Yi

Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association

2022 Volume 31, Issue 6, Page(s) 106444

Abstract: Background and purpose: Cardiac troponin (cTn) is a specific biomarker of cardiac injury and elevation of cTn is related to increased mortality. However, prognostic value of cTn in patients with acute ischemic stroke (AIS) still remains to be elucidated. ...

Abstract	Background and purpose: Cardiac troponin (cTn) is a specific biomarker of cardiac injury and elevation of cTn is related to increased mortality. However, prognostic value of cTn in patients with acute ischemic stroke (AIS) still remains to be elucidated. The aim of this review is to explore the strength of association between elevated cTn and mortality after AIS onset. Methods: PubMed, EMBASE, and Cochrane Library were searched from inception to July 12, 2021 without language restriction. All studies reporting the association between cTn on admission and mortality in AIS patients have been included in this review. Meta-analysis was performed for overall and pre-specified subgroup risk ratios (RR) were obtained using a random effect model. Study quality was assessed for each included study. Results: There were 20 studies included in this meta-analysis with 9779 AIS patients met the inclusion criteria. There was significant association between elevated cTn and mortality in patients with AIS (RR 3.87; 95% CI 3.24-4.63). The association was consistent across the pre-specified subgroup analyses by type of troponin (cTnT or cTnI), assay of troponin (conventional or high-sensitivity), region (Asian or Non-Asian), definite exclusion of ACS/AMI patients or not (yes or not mentioned), adjusted AF, HF and impaired renal function or not (yes or no). Conclusions: AIS patients with elevated cTn at baseline has an increased risk of mortality. Early and routine evaluation of cTn may contribute to timely detection of comorbid cardiac injury and prevent unfavorable outcomes in patients with AIS. Prospero registration number: CRD42020160912.
MeSH term(s)	Biomarkers ; Humans ; Ischemic Stroke ; Prognosis ; Troponin I ; Troponin T
Chemical Substances	Biomarkers ; Troponin I ; Troponin T
Language	English
Publishing date	2022-03-24
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	1131675-5
ISSN	1532-8511 ; 1052-3057
ISSN (online)	1532-8511
ISSN	1052-3057
DOI	10.1016/j.jstrokecerebrovasdis.2022.106444
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Article ; Online: Sex differences in the utilization and outcomes of endovascular treatment after acute ischemic stroke: A systematic review and meta-analysis.

Ouyang, Menglu / Shajahan, Sultana / Liu, Xiaoying / Sun, Lingli / Carcel, Cheryl / Harris, Katie / Anderson, Craig S / Woodward, Mark / Wang, Xia

Frontiers in global women's health

2023 Volume 3, Page(s) 1032592

Abstract: Background: Studies of sex differences in the use and outcomes of endovascular treatment (EVT) for acute ischemic stroke report inconsistent results.: Methods: We systematically searched PubMed and Embase databases for studies examining sex-specific ... ...

Abstract	Background: Studies of sex differences in the use and outcomes of endovascular treatment (EVT) for acute ischemic stroke report inconsistent results. Methods: We systematically searched PubMed and Embase databases for studies examining sex-specific utilization of EVT for acute ischemic stroke published before 31 December 2021. Estimates were compared by study type: randomized clinical trials (RCTs) and non-RCTs (hospital-based, registry-based or administrative data). Random effects odds ratios (ORs) were generated to quantify sex differences in EVT use. To estimate sex differences in functional outcome on the modified Rankin scale after EVT, the female:male ratio of ORs and 95% confidence intervals (CIs) were obtained from ordinal or binary analysis. Results: 6,396 studies were identified through database searching, of which 594 qualified for a full review. A total of 51 studies (36 non-RCT and 15 RCTs) reporting on sex-specific utilization of EVT were included, and of those 10 estimated the sex differences of EVT on functional outcomes. EVT use was similar in women and men both in non-RCTs (OR: 1.03, 95% CI: 0.96-1.11) and RCTs (1.02, 95% CI: 0.89-1.16), with consistent results across years of publication and regions of study, except that in Europe EVT treatment was higher in women than men (1.15, 95% CI: 1.13-1.16). No sex differences were found in the functional outcome by either ordinal and binary analyses (ORs 0.95, 95% CI: 0.68-1.32] and 0.90, 95% CI: 0.65-1.25, respectively). Conclusions: No sex differences in EVT utilization or on functional outcomes were evident after acute ischemic stroke from large-vessel occlusion. Further research may be required to examine sex differences in long-term outcomes, social domains, and quality of life. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=226100, identifier: CRD42021226100.
Language	English
Publishing date	2023-01-18
Publishing country	Switzerland
Document type	Journal Article ; Review
ISSN	2673-5059
ISSN (online)	2673-5059
DOI	10.3389/fgwh.2022.1032592
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Article ; Online: Anticoagulants for acute ischaemic stroke.

Wang, Xia / Ouyang, Menglu / Yang, Jie / Song, Lili / Yang, Min / Anderson, Craig S

The Cochrane database of systematic reviews

2021 Volume 10, Page(s) CD000024

Abstract: Background: Stroke is the third leading cause of early death worldwide. Most ischaemic strokes are caused by a blood clot blocking an artery in the brain. Patient outcomes might be improved if they are offered anticoagulants that reduce their risk of ... ...

Abstract	Background: Stroke is the third leading cause of early death worldwide. Most ischaemic strokes are caused by a blood clot blocking an artery in the brain. Patient outcomes might be improved if they are offered anticoagulants that reduce their risk of developing new blood clots and do not increase the risk of bleeding. This is an update of a Cochrane Review first published in 1995, with updates in 2004, 2008, and 2015. Objectives: To assess the effectiveness and safety of early anticoagulation (within the first 14 days of onset) for people with acute presumed or confirmed ischaemic stroke. Our hypotheses were that, compared with a policy of avoiding their use, early anticoagulation would be associated with: • reduced risk of death or dependence in activities of daily living a few months after stroke onset; • reduced risk of early recurrent ischaemic stroke; • increased risk of symptomatic intracranial and extracranial haemorrhage; and • reduced risk of deep vein thrombosis and pulmonary embolism. Search methods: We searched the Cochrane Stroke Group Trials Register (August 2021); the Cochrane Database of Systematic Reviews (CDSR); the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 7), in the Cochrane Library (searched 5 August 2021); MEDLINE (2014 to 5 August 2021); and Embase (2014 to 5 August 2021). In addition, we searched ongoing trials registries and reference lists of relevant papers. For previous versions of this review, we searched the register of the Antithrombotic Trialists' (ATT) Collaboration, consulted MedStrategy (1995), and contacted relevant drug companies. Selection criteria: Randomised trials comparing early anticoagulant therapy (started within two weeks of stroke onset) with control in people with acute presumed or confirmed ischaemic stroke. Data collection and analysis: Two review authors independently selected trials for inclusion, assessed trial quality, and extracted data. We assessed the overall certainty of the evidence for each outcome using RoB1 and GRADE methods. Main results: We included 28 trials involving 24,025 participants. Quality of the trials varied considerably. We considered some studies to be at unclear or high risk of selection, performance, detection, attrition, or reporting bias. Anticoagulants tested were standard unfractionated heparin, low-molecular-weight heparins, heparinoids, oral anticoagulants, and thrombin inhibitors. Over 90% of the evidence is related to effects of anticoagulant therapy initiated within the first 48 hours of onset. No evidence suggests that early anticoagulation reduced the odds of death or dependence at the end of follow-up (odds ratio (OR) 0.98, 95% confidence interval (CI) 0.92 to 1.03; 12 RCTs, 22,428 participants; high-certainty evidence). Similarly, we found no evidence suggesting that anticoagulant therapy started within the first 14 days of stroke onset reduced the odds of death from all causes (OR 0.99, 95% CI 0.90 to 1.09; 22 RCTs, 22,602 participants; low-certainty evidence) during the treatment period. Although early anticoagulant therapy was associated with fewer recurrent ischaemic strokes (OR 0.75, 95% CI 0.65 to 0.88; 12 RCTs, 21,665 participants; moderate-certainty evidence), it was also associated with an increase in symptomatic intracranial haemorrhage (OR 2.47; 95% CI 1.90 to 3.21; 20 RCTs, 23,221 participants; moderate-certainty evidence). Similarly, early anticoagulation reduced the frequency of symptomatic pulmonary emboli (OR 0.60, 95% CI 0.44 to 0.81; 14 RCTs, 22,544 participants; high-certainty evidence), but this benefit was offset by an increase in extracranial haemorrhage (OR 2.99, 95% CI 2.24 to 3.99; 18 RCTs, 22,255 participants; moderate-certainty evidence). Authors' conclusions: Since the last version of this review, four new relevant studies have been published, and conclusions remain consistent. People who have early anticoagulant therapy after acute ischaemic stroke do not demonstrate any net short- or long-term benefit. Treatment with anticoagulants reduced recurrent stroke, deep vein thrombosis, and pulmonary embolism but increased bleeding risk. Data do not support the routine use of any of the currently available anticoagulants for acute ischaemic stroke.
MeSH term(s)	Activities of Daily Living ; Anticoagulants/adverse effects ; Brain Ischemia/drug therapy ; Heparin/adverse effects ; Humans ; Ischemic Stroke ; Stroke/drug therapy ; Stroke/prevention & control ; Systematic Reviews as Topic
Chemical Substances	Anticoagulants ; Heparin (9005-49-6)
Language	English
Publishing date	2021-10-22
Publishing country	England
Document type	Journal Article ; Review ; Systematic Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD000024.pub5
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Article ; Online: Sensitivity and specificity of 5 min cognitive screening tests in patients with acute coronary syndrome.

Gallagher, Robyn / Ouyang, Meng-Lu / Tofler, Geoffrey / Bauman, Adrian / Zhao, Emma / Weddell, Joseph / Naismith, Sharon L

European journal of cardiovascular nursing

2022 Volume 22, Issue 2, Page(s) 166–174

Abstract: Aims: This study aimed to determine the sensitivity and specificity of the National Institute of Neurological Disorders and Stroke (NINDS) and the Canadian Stroke Network (CSN) brief (5 min) screen composed of three items of the Montreal Cognitive ... ...

Abstract	Aims: This study aimed to determine the sensitivity and specificity of the National Institute of Neurological Disorders and Stroke (NINDS) and the Canadian Stroke Network (CSN) brief (5 min) screen composed of three items of the Montreal Cognitive Assessment (MoCA), in acute coronary syndrome (ACS) patients during hospital admission, relative to the full MoCA and potential alternative combinations of other items. Methods and results: Participants were consecutively recruited during ACS admission and administered the MoCA before discharge. The three NINDS-CSN screen items were extracted, collated and compared to the full MoCA. Receiver operator characteristic (ROC) curves were created to determine the sensitivity, specificity, and appropriate cut-off scores of the screens. The mean age of the sample (n = 81) was 63.49 [standard deviation (SD) 10.85] years and 49.4% screened positive for cognitive impairment. The NINDS-CSN mean score was 9.22 (SD 2.09 of the potential range 0-12). Area under the ROC (AUC) indicated high accuracy levels for screening for cognitive impairment (AUC = 0.89, P < 0.01, 95% confidence interval 0.82, 0.96) with none of the alternative combination screens performing better on both sensitivity and specificity. A cut-off score of ≤10 on the NINDS-CSN protocol provided 83% sensitivity and 80% specificity for classifying cognitive impairment. Conclusion: The NINDS-CSN protocol presents an accurate, feasible screen for cognitive impairment in patients following ACS for use at the bedside and potentially also for telephone screens. Diagnostic accuracy should be confirmed using a neurocognitive battery.
MeSH term(s)	Humans ; Child ; Cognition Disorders ; Acute Coronary Syndrome ; Canada ; Sensitivity and Specificity ; Cognitive Dysfunction ; Stroke/psychology ; Neuropsychological Tests ; Cognition ; ROC Curve
Language	English
Publishing date	2022-06-16
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2151245-0
ISSN	1873-1953 ; 1474-5151
ISSN (online)	1873-1953
ISSN	1474-5151
DOI	10.1093/eurjcn/zvac026
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Article ; Online: Statistical Analysis Plan for the INTEnsive Care Bundle with Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial: A Stepped-Wedge Cluster Randomized Controlled Trial.

Billot, Laurent / Song, Lili / Hu, Xin / Ma, Lu / Ouyang, Menglu / Chen, Xiaoying / You, Chao / Anderson, Craig S

Cerebrovascular diseases (Basel, Switzerland)

2022 Volume 52, Issue 3, Page(s) 251–254

Abstract: The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) is an international, multicenter, stepped-wedge (4 phases/3 steps) cluster randomized trial involving 110 hospitals in mainly low- and middle- ... ...

Abstract	The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) is an international, multicenter, stepped-wedge (4 phases/3 steps) cluster randomized trial involving 110 hospitals in mainly low- and middle-income countries during 2017-2022. The aim is to determine the effectiveness of a goal-directed care bundle of intensive blood pressure (BP) lowering, glycemic control, antipyrexia, and anticoagulation reversal treatment versus usual standard of care, in patients with acute intracerebral hemorrhage (ICH). After a "usual care" period, hospitals were randomly allocated to implementing care-bundle protocols for control targets (systolic BP <140 mm Hg; glucose 6.1-7.8/7.8-10.0 mmol/L according to diabetes mellitus status; temperature ≤37.5°C; normalization of anticoagulation). A sample size of 8,360 patients (mean 19 per phase per site) provides 90% power (α = 0.05) for a 5.6% absolute improvement in the primary outcome of scores on the modified Rankin scale at 6 months, analyzed by ordinal logistic regression. A detailed statistical analysis plan (SAP) was developed to prespecify the method of analysis for all outcomes and key variables collected in the trial. The primary analysis will use ordinal logistic regression adjusted for the stepped-wedge design. The SAP also includes planned sensitivity analyses, including covariate adjustments, missing data imputations, and subgroup analysis. This SAP allows transparent, verifiable, and prespecified analyses in consideration of the challenges in conducting the study during the COVID pandemic. It also avoids analysis bias arising from prior knowledge of the findings in determining the benefits and harms of a care bundle in acute ICH.
MeSH term(s)	Humans ; Blood Pressure ; Patient Care Bundles ; Treatment Outcome ; COVID-19 ; Cerebral Hemorrhage/therapy ; Cerebral Hemorrhage/drug therapy ; Critical Care ; Antihypertensive Agents/adverse effects
Chemical Substances	Antihypertensive Agents
Language	English
Publishing date	2022-09-05
Publishing country	Switzerland
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1069462-6
ISSN	1421-9786 ; 1015-9770
ISSN (online)	1421-9786
ISSN	1015-9770
DOI	10.1159/000526384
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Zs.A 3181: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Intrauterine contraceptive device training and outcomes for healthcare providers in developed countries: A systematic review.

Ouyang, Menglu / Peng, Ke / Botfield, Jessica R / McGeechan, Kevin

PloS one

2019 Volume 14, Issue 7, Page(s) e0219746

Abstract: Intrauterine contraceptive devices (IUCD) are a safe and cost-effective contraceptive method for medically eligible women. Despite this, the utilisation rate for IUCDs is relatively low in many high-income countries, including Australia. Provision of ... ...

Abstract	Intrauterine contraceptive devices (IUCD) are a safe and cost-effective contraceptive method for medically eligible women. Despite this, the utilisation rate for IUCDs is relatively low in many high-income countries, including Australia. Provision of education and training regarding IUCDs to healthcare providers, including nurses and midwives, is one approach to overcome some of the barriers that may prevent wider uptake of IUCDs. This study aims to explore the types and impact of IUCD insertion training for healthcare providers. A systematic review was undertaken in January 2017 to determine the effectiveness of IUCD training for healthcare providers in relation to provision of IUCDs to women. The databases MEDLINE, EMBASE, CINAHL, COCHRANE and SCOPUS were searched to identify studies from high-income countries relating to IUCD training for healthcare providers and relevant outcomes. A total of 30 studies were included in the review. IUCD training for healthcare providers contributed to increased knowledge and improved positive attitudes towards IUCDs, high rates of successful insertions, low complication rates, and increased provision of IUCDs. Successful insertions and low complication rates were similar across different healthcare provider types. No notable differences between provider types in terms of knowledge increase or insertion outcomes were observed. Different training programs for healthcare providers were found to be effective in improving knowledge and successful provision of IUCDs. Increasing the number of healthcare providers skilled in IUCD insertions in high-income countries, including nurses and midwives, will enhance access to this method of contraception and allow women greater contraceptive choice.
MeSH term(s)	Attitude of Health Personnel ; Clinical Competence ; Contraception/adverse effects ; Contraception/methods ; Contraception/statistics & numerical data ; Developed Countries ; Education, Medical, Continuing/methods ; Education, Nursing, Continuing/methods ; Female ; Gynecology/education ; Health Educators/education ; Health Knowledge, Attitudes, Practice ; Health Personnel/education ; Humans ; Internship and Residency ; Intrauterine Devices/adverse effects
Language	English
Publishing date	2019-07-15
Publishing country	United States
Document type	Journal Article ; Systematic Review
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0219746
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Article ; Online: Trends of mean systolic and diastolic blood pressure among adults in Shenzhen, China, 1997-2018: findings from three rounds of the population-based survey.

Peng, Ke / Cai, Weicong / Liu, Xiaoying / Liu, Yishu / Ouyang, Menglu / Gong, Jessica / Wang, Zhihui / Wang, Yunfeng / Hao, Jing / Wang, Wei / Zhao, Honglei / Lin, Kaihao / Han, Guiyuan / Shi, Yu / Xie, Yinghao / Xie, Yuxin / Lei, Lin / Si, Lei

BMJ open

2024 Volume 14, Issue 2, Page(s) e074575

Abstract: Objective: To quantify the trends in systolic and diastolic blood pressure (BP) among adults in Shenzhen from 1997 to 2018.: Design: Cross-sectional study.: Settings: The data were collected from all districts in Shenzhen, China in the years of ... ...

Abstract	Objective: To quantify the trends in systolic and diastolic blood pressure (BP) among adults in Shenzhen from 1997 to 2018. Design: Cross-sectional study. Settings: The data were collected from all districts in Shenzhen, China in the years of 1997, 2009 and 2018 by multistage cluster sampling procedure. Participants: Participants were residents aged 18-69 years in Shenzhen, China. A total of 26 621 people were included: 8266 people in 1997, 8599 people in 2009 and 9756 people in 2018. Primary and secondary outcome measures: All participants were surveyed about their sociodemographic and lifestyle information. BP was measured by trained physicians using a mercury sphygmomanometer. Hypertension was defined as systolic BP of at least 140 mm Hg and diastolic BP of at least 90 mm Hg, self-reported use of antihypertensive medications or both. Hypertension control was defined as systolic BP values of less than 140 mm Hg and diastolic BP values of less than 90 mm Hg. Result: Age-adjusted mean systolic BP increased from 117±16 mm Hg to 123±15 mm Hg (p<0.001) in males, and from 113±18 mm Hg to 115±16 mm Hg (p<0.001) in females from 1997 to 2018. Diastolic BP among males increased from 75 mm Hg (SD=11) to 79 mm Hg (SD=11) and increased from 71 mm Hg (SD=10) to 73 mm Hg (SD=10) among females between 1997 and 2018 (p<0.001). Rate of hypertension rose rapidly from 17.71% (95% CI: 16.60% to 18.90%) in 2009 to 24.01% (95% CI: 22.84% to 25.22%) in 2018 among males (p<0.001), whereas the prevalence among females remained stable at around 13.5% (p=0.98). Both awareness and treatment rates of hypertension among males and females showed a decreased trend between 2009 and 2018, while no significant changes were observed for control rates. Conclusions: The mean systolic BP and diastolic BP among adults in Shenzhen increased from 1997 to 2018, and no improvements in hypertension awareness, treatment and control rates were found.
MeSH term(s)	Adult ; Male ; Female ; Humans ; Blood Pressure ; Cross-Sectional Studies ; Hypertension/drug therapy ; Antihypertensive Agents/therapeutic use ; Antihypertensive Agents/pharmacology ; China/epidemiology
Chemical Substances	Antihypertensive Agents
Language	English
Publishing date	2024-02-10
Publishing country	England
Document type	Journal Article
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2023-074575
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Article ; Online: Intensive blood pressure lowering and renal function in ischemic stroke patients: secondary analysis of ENCHANTED trial.

Chen, Chen / Ren, Xinwen / Zhao, Yang / Ouyang, Menglu / Li Mbiostat, Qiang / Wang, Xia / Li, Yunke / You, Shoujiang / Wang, Yanan / Robinson, Thompson G / Lindley, Richard / Arima, Hisatomi / Chalmers, John / Li, Gang / Chen, Xiaoying / Anderson, Craig S / Song, Lili

Cerebrovascular diseases (Basel, Switzerland)

2024

Abstract: Background: Renal failure is a major safety concern of intensive systolic blood pressure (SBP) lowering. We aimed to determine the effect of this treatment on early change in renal function in participants of the international Enhanced Control of ... ...

Abstract	Background: Renal failure is a major safety concern of intensive systolic blood pressure (SBP) lowering. We aimed to determine the effect of this treatment on early change in renal function in participants of the international Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED). Methods: Post-hoc analysis of the ENCHANTED BP-arm in which thrombolyzed patients with acute ischemic stroke (AIS) were randomized to intensive (target 130-140 mm Hg within 1 h) or guideline-recommended (target <180 mm Hg) management within 6 h of symptom onset. Primary outcome is early change in renal function, defined by a difference in estimated glomerular filtration rate (∆eGFR = 24 h - baseline eGFR), analyzed using linear regression with adjustment for clinical variables. Key SBP parameters were attained (mean), variability (standard deviation [SD]) and magnitude of reduction within 24 h. Results: Of 2151 participants (mean age 66.9 years; 38% female) included with available baseline eGFR, there were significant differences in attained 144.3±10.2 vs 149.8±12.0 [5.5 mm Hg]; P<0.0001), variation (15.1±5.4 vs 14.0±5.6 mm Hg; P<0.0001) and magnitude of reduction (44.6±16.2 vs 38.7±17.6 mm Hg; P<0.0001) in SBP within 24 hours. 1718 (79.9%) participants with complete follow-up eGFR were included in the primary analysis, and there was no significant difference in ∆eGFR (adjusted mean difference -1.10, 95% confidence interval [CI] -3.14 to -0.94; P=0.29) between the intensive and guideline groups, respectively. The neutral effect on ∆eGFR was consistent in patients with different baseline eGFR stages and in sensitivity analysis after multiple imputation for missing follow-up eGFR. SBP variability was significantly associated with decreasing ∆eGFR (per 5 mm Hg increase by category: adjusted mean difference -1.35, 95%CI -2.43 to -0.28; P for trend=0.01). Conclusions: Intensive SBP lowering with a target of 130-140 mm Hg had no impact on early renal function in thrombolyzed AIS patients. Wide SBP variability was associated with a larger decline in eGFR. Clinical trial registration: ENCHANTED is registered at ClinicalTrials.gov (NCT01422616).
Language	English
Publishing date	2024-01-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	1069462-6
ISSN	1421-9786 ; 1015-9770
ISSN (online)	1421-9786
ISSN	1015-9770
DOI	10.1159/000536275
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In stock of ZB MED Cologne/Königswinter

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Full text online

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In stock of ZB MED Cologne/Königswinter

Order via subito