ORCID Profile
0000-0001-7917-6858
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George Institute for Global Health
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Publisher: BMJ
Date: 09-2022
DOI: 10.1136/BMJOPEN-2021-057597
Abstract: The aim of this review is to map out the use of process evaluation (PE) in complex interventions that address non-communicable diseases (NCDs) and neglected tropical diseases (NTDs) to identify gaps in the design and conduct, as well as strengths, limitations and implications, of this type of research in low- and middle-income countries (LMICs). Scoping review of PE studies of complex interventions implemented in LMICs. Six databases were searched focused on studies published since 2008. Embase, PubMed, EbscoHost, Web of Science (WOS), Virtual Health Library (VHL) Regional Portal and Global Index Medicus: Regional Indexes AIM (AFRO), LILACS (AMRO/PAHO), IMEMR (EMRO), IMSEAR (SEARO), WPRIM (WPRO) Global Index Regional Indexes, MEDLINE, SciELO. Studies conducted in LMICs on PEs of randomised controlled trials (RCTs) and non-RCTs published between January 2008 and January 2020. Other criteria were studies of interventions for people at risk or having physical and mental NCDs, and/or NTDs, and/or their healthcare providers and/or others related to achieve better health for these two disease groups. Studies were excluded if they were not reported in English or Spanish or Portuguese or French, not peer-reviewed articles, not empirical research and not human research. Data extracted to be evaluated were: available evidence in the utilisation of PE in the areas of NCDs and NTDs, including frameworks and theories used methods applied to conduct PEs and in a subs le, the barriers and facilitators to implement complex interventions identified through the PE. Variables were extracted and categorised. The information was synthesised through quantitative analysis by reporting frequencies and percentages. Qualitative analysis was also performed to understand facilitators and barriers presented in these studies. The implications for PEs, and how the information from the PE was used by researchers or other stakeholders were also assessed in this approach. 303 studies were identified, 79% were for NCDs, 12% used the label ‘PE’, 27% described a theory or framework for the PE, and 42% used mixed methods to analyse their findings. Acceptability, barriers and facilitators to implement the interventions, experiences and perceptions, and feasibility were the outcomes most frequently evaluated as part of the PEs. Barriers and facilitators themes identified were contextual factors, health system factors, human resources, attitudes and policy factors. PEs in NCDs and NTDs are used in LMICs with a wide variety of methods. This review identified many PEs that were not labelled by the authors as such, as well as a limited application of PE-related theories and frameworks, and heterogeneous reporting of this type of study.
Publisher: Frontiers Media SA
Date: 15-06-2022
Abstract: The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3) is an ongoing, international, multicenter, stepped-wedge cluster, prospective, randomized, open, blinded endpoint assessed trial evaluating the effectiveness of a quality improvement “care bundle” for the management of patients with acute spontaneous intracerebral hemorrhage (ICH) in low- and middle-income countries (LMICs). An embedded process evaluation aims to explore the uptake and implementation of the intervention, and understand the context and stakeholder perspectives, for interpreting the trial outcomes. The design was informed by Normalization Process Theory and the UK Medical Research Council process evaluation guidance. Mixed methods are used to evaluate the implementation outcomes of fidelity, reach, dose, acceptability, appropriateness, adoption, sustainability, and relevant contextual factors and mechanisms affecting delivery of the care bundle. Semi-structured interviews and non-participant observations are conducted with the primary implementers (physicians and nurses) and patients/carers to explore how the care bundle was integrated into routine care. Focus group discussions are conducted with investigators and project operational staff to understand challenges and possible solutions in the organization of the trial. Data from observational records, surveys, routine monitoring data, field notes and case report forms, inform contextual factors, and adoption of the intervention. Purposive s ling of sites according to pre-specified criteria is used to achieve s le representativeness. Implementation outcomes, and relevant barriers and facilitators to integrating the care bundle into routine practice, will be reported after completion of the process evaluation. The embedded process evaluation will aid understanding of the causal mechanisms between care bundle elements and clinical outcomes within complex health systems across erse LMIC settings. The INTERACT3 study is registered at ClinicalTrials.gov (NCT03209258).
Publisher: Elsevier BV
Date: 06-2023
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-09-2021
Publisher: BMJ
Date: 28-09-2020
Abstract: The COVID-19 pandemic and physical distancing guidelines have compelled stroke practices worldwide to reshape their delivery of care significantly. We aimed to illustrate how the stroke services were interrupted during the pandemic in China. A 61-item questionnaire designed on Wenjuanxing Form was completed by doctors or nurses who were involved in treating patients with stroke from 1 February to 31 March 2020. A total of 415 respondents completed the online survey after informed consent was obtained. Of the respondents, 37.8%, 35.2% and 27.0% were from mild, moderate and severe epidemic areas, respectively. Overall, the proportion of severe impact (reduction %) on the admission of transient ischaemic stroke, acute ischaemic stroke (AIS) and intracerebral haemorrhage (ICH) was 45.0%, 32.0% and 27.5%, respectively. Those numbers were 36.9%, 27.9% and 22.3% 36.5%, 22.1% and 22.6% and 66.4%, 47.5% and 41.1% in mild, moderate and severe epidemic areas, respectively (all p .0001). For AIS, thrombolysis was moderate (20%–50% reduction) or severely impacted ( %), as reported by 54.4% of the respondents, while thrombectomy was 39.3%. These were 44.4%, 26.3% 44.2%, 39.4% and 78.2%, 56.5%, in mild, moderate and severe epidemic areas, respectively (all p .0001). For patients with acute ICH, 39.8% reported the impact was severe or moderate for those eligible for surgery who had surgery. Those numbers were 27.4%, 39.0% and 58.1% in mild, moderate and severe epidemic areas, respectively. For staff resources, about 20% (overall) to 55% (severe epidemic) of the respondents reported moderate or severe impact on the on-duty doctors and nurses. We found a significant reduction of admission for all types of patients with stroke during the pandemic. Patients were less likely to receive appropriate care, for ex le, thrombolysis/thrombectomy, after being admitted to the hospital. Stroke service in severe COVID-19 epidemic areas, for ex le, Wuhan, was much more severely impacted compared with other regions in China.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2022
Publisher: Frontiers Media SA
Date: 02-05-2022
DOI: 10.3389/FPUBH.2022.887065
Abstract: To demonstrate the trends of hypercholesterolemia change in Shenzhen, China from 1997 to 2018. Participants were residents aged 18 to 69 years in Shenzhen, China, and were recruited using multi-stage cluster s ling. All participants were surveyed about their socio-demographics, lifestyle, occupation, mental health, and social support. Physical measurements and blood s les for subsequent measurements were collected according to a standardized protocol. A total of 26,621 in iduals participated in the three surveys with 8,266 in 1997, 8,599 in 2009, and 9,756 in 2018. In both women and men, there was a significant downward linear trend in age-adjusted mean high-density lipoprotein-cholesterol (HDL-C) from 1997 to 2018 (women: 0.17 ± 0.06, p = 0.008 vs. men: 0.21 ± 0.04, p & 0.001). In contrast, the age-adjusted total triglycerides and total cholesterol in both sexes have demonstrated an increasing trend in the past two decades. However, no significant changes in age-adjusted low-density lipoprotein-cholesterol (LDL-C) in both men and women between 2009 and 2018 were found (women: 0.00 ± 0.02, p = 0.85 vs. men 0.02 ± 0.03, p = 0.34). The age-adjusted prevalence of hypercholesterolemia observed a rapid rise from 1997 to 2009 and appeared to be stabilized in 2018, which was similar to the trend of the prevalence of high total triglycerides in women. Changes in trends were varied by different types of lipids traits. Over the observed decades, there was a clear increasing trend of prevalence of low HDL-C (& .04 mmol/L) in both sexes (women: 8.8% in 1997 and doubled to reach 17.5% in 2018 vs. men was 22.1% in 1997 and increased to 39.1% in 2018), particularly among younger age groups. Hence, a bespoke public health strategy aligned with the characteristics of lipids epidemic considered by sex and age groups needs to be developed and implemented.
Publisher: S. Karger AG
Date: 2021
DOI: 10.1159/000512608
Abstract: b i Background: /i /b Patients with premorbid functional impairment are generally excluded from acute stroke trials. We aimed to determine the impact of including such patients in the Head Positioning in acute Stroke Trial (HeadPoST) and early additional impairment on outcomes. b i Methods: /i /b Post hoc analyses of HeadPoST, an international, cluster-randomized crossover trial of lying-flat versus sitting-up head positioning in acute stroke. Associations of early additional impairment, defined as change in modified Rankin scale (mRS) scores from premorbid levels (estimated at baseline) to Day 7 (“early ΔmRS”), and poor outcome (mRS score 3–6) at Day 90 were determined with generalized linear mixed model. Heterogeneity of the trial treatment effect was tested according to premorbid mRS scores 0–1 versus 2–5. b i Results: /i /b Of 8,285 patients (38.9% female, mean age 68 ± 13 years) with complete data, there were 1,984 (23.9%) with premorbid functional impairment (mRS 2–5). A significant linear association was evident for early ∆mRS and poor outcome (per 1-point increase in ΔmRS, adjusted odds ratio 1.20, 95% confidence interval 1.14–1.27 i /i & #x3c 0.0001). Patients with greater premorbid functional impairment were less likely to develop additional impairment, but their risk of poor 90-day outcome significantly increased with increasing (worse) premorbid mRS scores (linear trend i /i & #x3c 0.0001). There was no heterogeneity of the trial treatment effect by level of premorbid function. b i Conclusions: /i /b Early poststroke functional impairment that exceeded premorbid levels was associated with worse 90-day outcome, and this association increased with greater premorbid functional impairment. Yet, including premorbid impaired patients in the HeadPoST did not materially affect the subsequent treatment effect. b i Clinical Trial Registration: /i /b HeadPoST is registered at www.ClinicalTrials.gov (NCT02162017).
Publisher: Frontiers Media SA
Date: 18-01-2023
DOI: 10.3389/FGWH.2022.1032592
Abstract: Studies of sex differences in the use and outcomes of endovascular treatment (EVT) for acute ischemic stroke report inconsistent results 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. 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). 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. www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=226100 , identifier: CRD42021226100.
Publisher: Instituto Nacional de Salud Publica
Date: 13-06-2022
DOI: 10.21149/12853
Abstract: Complex interventions are needed to effectively tackle non-communicable diseases. However, complex interventions can contain a mix of effective and ineffective actions. Process evaluation (PE) in public health research is of great value as it could clarify the mechanisms and contextual factors associated with variation in the outcomes, better identify effective components, and inform adaptation of the intervention. The aim of this paper is to demonstrate the value of PE through five case studies that span the research cycle. The interventions include using digital health, salt reduction strategies, use of fixed dose combinations, and task shifting. Insights of the methods used, and the implications of the PE findings to the project, were discussed. PE of complex interventions can refute or confirm the hypothesized mechanisms of action, thereby enabling intervention refinement, and identifying implementation strategies that can address local contextual needs, so as to improve service delivery and public health outcomes.
Publisher: SAGE Publications
Date: 19-02-2021
Abstract: An indwelling urinary catheter (IUC) is often inserted to manage bladder dysfunction, but its impact on prognosis is uncertain. We aimed to determine the association of IUC use on clinical outcomes after acute stroke in the international, multi-center, cluster crossover, Head Positioning in Acute Stroke Trial (HeadPoST). Data were analyzed on HeadPoST participants (n = 11,093) randomly allocated to the lying-flat or sitting-up head position. Binomial, logistic regression, hierarchical mixed models were used to determine associations of early insertion of IUC within seven days post-randomization and outcomes of death or disability (defined as “poor outcome,” scores 3–6 on the modified Rankin scale) and any urinary tract infection at 90 days with adjustment of baseline and post-randomization management covariates. Overall, 1167 (12%) patients had an IUC, but the frequency and duration of use varied widely across patients in different regions. IUC use was more frequent in older patients, and those with vascular comorbidity, greater initial neurological impairment (on the National Institutes of Health Stroke Scale), and intracerebral hemorrhage as the underlying stroke type. IUC use was independently associated with poor outcome (adjusted odds ratio (aOR): 1.40, 95% confidence interval (CI): 1.13–1.74), but not with urinary tract infection after adjustment for antibiotic treatment and stroke severity at hospital separation (aOR: 1.13, 95% CI: 0.59–2.18). The number exposed to IUC for poor outcome was 13. IUC use is associated with a poor outcome after acute stroke. Further studies are required to inform appropriate use of IUC.
Publisher: Elsevier BV
Date: 06-2022
DOI: 10.1016/J.JSTROKECEREBROVASDIS.2022.106444
Abstract: 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. 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. 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). 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. CRD42020160912.
Publisher: S. Karger AG
Date: 31-08-2023
DOI: 10.1159/000525869
Abstract: b i Introduction: /i /b The Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) showed that a low-dose alteplase was safe but not clearly non-inferior to standard-dose alteplase in acute ischemic stroke (AIS). Given the significant cost of this medicine, we undertook a cost-effectiveness analysis to determine the probability that low-dose is cost-effective relative to standard-dose alteplase in China. b i Methods: /i /b For ENCHANTED participants in China with available health cost data, cost-effectiveness and cost-utility analyses were undertaken in which death or disability (modified Rankin scale scores 2–6) at 90 days and quality-adjusted life-years (QALYs) were used as outcome measures, respectively. There was adherence to standard guidelines for health economic evaluations alongside non-inferiority trials and according to a health-care payer’s perspective. The equivalence margin for cost and effectiveness was set at USD 691 and −0.025 QALYs, respectively, for the base-case analysis. Probabilistic sensitivity analyses were used to evaluate the probability of low-dose alteplase being non-inferior. b i Results: /i /b While the mean cost of alteplase was lower in the low-dose group (USD 1,569 vs. USD 2,154 in the standard-dose group), the total cost was USD 56 (95% confidence interval [CI]: −1,000–1,113) higher compared to the standard-dose group due to higher hospitalization costs in the low-dose group. There were 462 (95% CI: 415–509) and 410 (95% CI: 363–457) patients with death or disability per 1,000 patients in the low-dose and standard-dose groups, respectively. The low-dose group had marginally lower (0.008, 95% CI: −0.016–0.001) QALYs compared to their standard-dose counterparts. The low-dose group was found to have an 88% probability of being non-inferior based on cost-effectiveness versus the standard-dose group. b i Conclusions: /i /b This health economic evaluation alongside the ENCHANTED indicates that the use of low-dose alteplase does not save overall healthcare costs nor lead to a gain in QALYs in the management of Chinese patients with AIS compared to the use of standard dose. There is little justification on economic grounds to shift from standard-of-care thrombolysis in AIS.
Publisher: Wiley
Date: 22-10-2021
Publisher: S. Karger AG
Date: 2021
DOI: 10.1159/000516487
Abstract: b i Background and Purpose: /i /b As outcomes for acute ischemic stroke (AIS) vary according to clinical profile and management approaches, we aimed to determine disparities in clinical outcomes between Asian and non-Asian participants of the international, Enhanced Control of Hypertension and Thrombolysis Stroke study (ENCHANTED). b i Methods: /i /b ENCHANTED was a multicenter, prospective, partial-factorial, randomized, open trial of low-dose (0.6 mg/kg) versus standard-dose (0.9 mg/kg) alteplase, and intensive (target systolic blood pressure [SBP] 130–140 mm Hg) or guideline-recommended (& #x3c mm Hg) BP management, in thrombolysis-eligible AIS patients. Logistic regression models were used to examine the associations with outcomes of death or disability (modified Rankin scale [mRS] scores 2–6), major disability (mRS 3–5), death, and intracranial hemorrhage (ICH), with adjustment prognostic factors, alteplase dose, and mean SBP over 1–24 h. b i Results: /i /b Among 4,551 thrombolyzed AIS patients (mean age 66.7 years, 37.8% female), there were 65.4% Asians who were younger, fewer female, and with less atrial fibrillation, hypercholesterolemia, premorbid symptoms, and concomitant antihypertensive, antithrombotic and statin treatment, and more prior stroke, compared to non-Asians. Frequencies of hypertension, coronary artery disease, and diabetes mellitus were comparable between groups. Asian patients were less likely to be admitted to an acute stroke unit and receive early mobilization by a therapist or rehabilitation but more likely to receive intensive care. There were no significant differences between Asians and non-Asians in functional outcome (defined by mRS scores 2–6 or 3–5 adjusted odds ratio [OR] 1.00, 95% confidence interval [CI] 0.85–1.19 [ i /i = 0.958] and OR 0.95, 95% CI 0.80–1.13 [ i /i = 0.572], respectively), or death (OR 1.25, 95% CI 0.95–1.65 i /i = 0.116), despite Asians having greater odds of ICH (OR 1.51, 95% CI 1.23–1.86 i /i = 0.0001) and neurological deterioration within 24 h (OR 1.58, 95% CI 1.18–2.12 i /i = 0.002). b i Conclusions: /i /b Within the context of an international clinical trial of thrombolyzed AIS patients, demography, risk factors, management, and odds of early neurological deterioration and ICH, all differ between Asian and non-Asian participants. However, patterns of functional recovery are similar between these major regional groups.
Publisher: Springer Science and Business Media LLC
Date: 25-05-2021
DOI: 10.1186/S12888-021-03203-4
Abstract: To examine the relationship between the main caregiver during the “doing-the-month” (a traditional Chinese practice which a mother is confined at home for 1 month after giving birth) and the risk of postpartum depression (PPD) in postnatal women. Participants were postnatal women stayed in hospital and women who attended the hospital for postpartum examination, at 14–60 days after delivery from November 1, 2013 to December 30, 2013. Postpartum depression status was assessed using the Edinburgh Postnatal Depression Scale. Univariate and multivariable logistic regressions were used to identify the associations between the main caregiver during “doing-the-month” and the risk of PPD in postnatal women. One thousand three hundred twenty-five postnatal women with a mean (SD) age of 28 (4.58) years were included in the analyses. The median score (IQR) of PPD was 6.0 (2, 10) and the prevalence of PPD was 27%. Of these postnatal women, 44.5% were cared by their mother-in-law in the first month after delivery, 36.3% cared by own mother, 11.1% by “yuesao” or “maternity matron” and 8.1% by other relatives. No association was found between the main caregivers and the risk of PPD after multiple adjustments. Although no association between the main caregivers and the risk of PPD during doing-the-month was identified, considering the increasing prevalence of PPD in Chinese women, and the contradictions between traditional culture and latest scientific evidence for some of the doing-the-month practices, public health interventions aim to increase the awareness of PPD among caregivers and family members are warranted.
Publisher: SAGE Publications
Date: 16-11-2023
DOI: 10.1177/17474930221135983
Abstract: The epidemiology of stroke is evolving in China as the population undergoes demographic, lifestyle, and economic transitions. An updated review is pertinent to providing feedback on current, and in planning future, prevention and management strategies. To identify high-quality epidemiological studies for quantifying the prevalence, incidence, mortality, and case fatality for stroke in China. A search was undertaken across a range of bibliographic databases on 30 November 2021 without time limitation. Assessments were made of the risk of bias of the included studies. The outcomes were synthesized using a random-effects model. Subgroup analysis and meta-regression models were used to define the source of heterogeneity. Of 9407 identified records, 26 population-based studies were included. Due to significant heterogeneity across the studies, the original range for crude rates of indices was wide. The pooled annual prevalence was 1329.5/100,000 (95% confidence interval (CI) 713.6–2131.9, p 0.001), incidence 442.1/100,000 (327.6–573.8, p 0.001), mortality 154.1/100,000 (52.6–308.8, I 2 = 100%, p 0.001), and case fatality 35.8% (26.1% to 46.1%, I 2 = 97%, p 0.001). The prevalence and incidence of stroke have increased, but stroke-related case fatality has declined in China over recent decades. There are significant regional and rural-urban differences in incidence rates. Despite improved public health policies and healthcare delivery, the burden of stroke remains high in China. Further coordinated efforts are required in prevention and community care to offset the likelihood of further expansion in the absolute number of stroke cases in this large population.
Publisher: Springer Science and Business Media LLC
Date: 12-2021
DOI: 10.1186/S13063-021-05881-7
Abstract: Early intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH. INTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH ( 6 h of onset) recruited from 110 hospitals (average of 19 consecutive patients per phase) in low- and middle-income countries. After a control phase, each hospital implements the intervention (intensive BP lowering, target systolic 140 mmHg glucose control, target 6.1–7.8 mmol/L and 7.8–10.0 mmol/L in those without and with diabetes mellitus, respectively anti-pyrexia treatment to target body temperature ≤ 37.5 °C and reversal of anticoagulation, target international normalized ratio 1.5 within 1 h). Information will be obtained on demographic and baseline clinical characteristics, in-hospital management, and 7-day outcomes. Central trained blinded assessors will conduct telephone interviews to assess physical function and health-related quality of life at 6 months. The primary outcome is the modified Rankin scale (mRS) at 6 months analyzed using ordinal logistic regression. The s le size of 8360 subjects provides 90% power ( α = 0.05) to detect a 5.6% absolute improvement (shift) in the primary outcome of the intervention versus control standard care, with various assumptions. As the largest clinical trial in acute ICH, INTERACT3 is on schedule to provide an assessment of the effectiveness of a widely applicable goal-directed care bundle for a serious condition in which a clearly proven treatment has yet to be established. ClinicalTrials.gov NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017
Publisher: S. Karger AG
Date: 2020
DOI: 10.1159/000511394
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2021
DOI: 10.1161/STROKEAHA.120.030435
Abstract: We determined associations of physiological abnormalities (systolic blood pressure, glucose, and body temperature) and warfarin use with outcomes in spontaneous intracerebral hemorrhage. Post hoc analyses of INTERACT2 (Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial) comparing systolic blood pressure control ( versus mm Hg) in 2839 hypertensive patients with intracerebral hemorrhage (onset hours). Multivariable logistic regression defined associations of baseline scores assigned as 0 to 6 per 10 mm Hg systolic blood pressure increase (range, 150–220 mm Hg) and 0 or 1 for serum glucose (≤6.5 versus .5 mmol/L), body temperature (≤37.5 °C versus .5 °C), and warfarin use (no versus yes) and death or major disability (modified Rankin Scale scores 3–6 at 90 days). Baseline score distribution was 0 (7.7%), 1 (15.6%), 2 (19.0%), 3 (19.1%), 4 (15.2%), 5 (11.6%), 6 (8.9%), and 7 (2.9%). After adjustment for baseline neurological severity and potential confounders, significant linear associations were evident for increasing (per point) score and death or major disability (odds ratio, 1.12 [95% CI, 1.07–1.17]), death (odds ratio, 1.15 [95% CI, 1.07–1.23]), and major disability (odds ratio, 1.10 [95% CI, 1.05–1.15]). Combination of abnormal physiological parameters and warfarin use is associated with poor outcomes in intracerebral hemorrhage. Effects of their early control is under investigation in INTERACT3 (Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial). URL: www.clinicaltrials.gov . Unique identifier: NCT00716079.
Publisher: SAGE Publications
Date: 21-06-2020
Abstract: Dysphagia is associated with aspiration pneumonia after stroke. Data are limited on the influences of dysphagia screen and assessment in clinical practice. To determine associations between a “brief” screen and “detailed” assessment of dysphagia on clinical outcomes in acute stroke patients. A prospective cohort study analyzed retrospectively using data from a multicenter, cluster cross-over, randomized controlled trial (Head Positioning in Acute Stroke Trial [HeadPoST]) from 114 hospitals in nine countries. HeadPoST included 11,093 acute stroke patients randomized to lying-flat or sitting-up head positioning. Herein, we report predefined secondary analyses of the association of dysphagia screening and assessment and clinical outcomes of pneumonia and death or disability (modified Rankin scale 3–6) at 90 days. Overall, 8784 (79.2%) and 3917 (35.3%) patients were screened and assessed for dysphagia, respectively, but the frequency and timing for each varied widely across regions. Neither use of a screen nor an assessment for dysphagia was associated with the outcomes, but their results were compared to “screen-pass” patients, those who failed had higher risks of pneumonia (adjusted odds ratio [aOR] = 3.00, 95% confidence interval [CI] = 2.18–4.10) and death or disability (aOR = 1.66, 95% CI = 1.41–1.95). Similar results were evidence for the results of an assessment for dysphagia. Subsequent feeding restrictions were related to higher risk of pneumonia in patients failed dysphagia screen or assessment (aOR = 4.06, 95% CI = 1.72–9.54). Failing a dysphagia screen is associated with increased risks of pneumonia and poor clinical outcome after acute stroke. Further studies concentrate on determining the effective subsequent feeding actions are needed to improve patient outcomes.
Publisher: SAGE Publications
Date: 02-03-2022
DOI: 10.1177/23969873221078136
Abstract: Low blood pressure (BP) in acute ischaemic stroke (AIS) is associated with poor functional outcome, death, or severe disability. Increasing BP might benefit patients with post-stroke hypotension including those with potentially salvageable ischaemic penumbra. This updated systematic review considers the present evidence regarding the use of vasopressors in AIS. We searched the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE and trial databases using a structured search strategy. We examined reference lists of relevant publications for additional studies examining BP elevation in AIS. We included 27 studies involving 1886 patients. Nine studies assessed increasing BP during acute reperfusion therapy (intravenous thrombolysis, mechanical thrombectomy, intra-arterial thrombolysis or combined). Eighteen studies tested BP elevation alone. Phenylephrine was the most commonly used agent to increase BP (n = 16 studies), followed by norepinephrine (n = 6), epinephrine (n = 3) and dopamine (n = 2). Because of small patient numbers and study heterogeneity, a meta-analysis was not possible. Overall, BP elevation was feasible in patients with fluctuating or worsening neurological symptoms, large vessel occlusion with labile BP, sustained post-stroke hypotension and ineligible for intravenous thrombolysis or after acute reperfusion therapy. The effects on functional outcomes were largely unknown and close monitoring is advised if such intervention is undertaken. Although theoretical arguments support increasing BP to improve cerebral blood flow and sustain the ischaemic penumbra in selected AIS patients, the data are limited and results largely inconclusive. Large, randomised controlled trials are needed to identify the optimal BP target, agent, duration of treatment and effects on clinical outcomes.
Publisher: Public Library of Science (PLoS)
Date: 15-07-2019
Publisher: Publicidad Permanyer, SLU
Date: 29-09-2023
Publisher: S. Karger AG
Date: 05-09-2023
DOI: 10.1159/000526384
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 & #x3c 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 s le 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.
Publisher: BMJ
Date: 25-06-2020
Abstract: Although the Head Positioning in acute Stroke Trial (HeadPoST) showed no effect of the flat head position (FP vs sitting up head position (SUP)) on functional outcome, we hypothesised that it could still offer benefits if commenced early in those with acute ischaemic stroke (AIS) of at least moderate severity. Subgroup analysis of HeadPoST in participants with National Institutes of Health Stroke Scale (NIHSS) scores ≥7, ≥10 and ≥14, randomised to FP or SUP .5 hours of AIS onset on functional outcomes defined by a shift in scores on the modified Rankin scale (mRS) and death/disability (mRS scores 3–6), and any cardiovascular serious adverse event. Logistic regression analyses were undertaken adjusted for study design and baseline risk factors. There was no significant differential treatment effect in patient subgroups defined by increasing baseline NIHSS scores: adjusted OR and 95% CI for ordinal shift and binary (3–6) mRS scores: for NIHSS ≥7 (n=867) 0.92 (0.67 to 1.25) and 0.74 (0.52 to 1.04) NIHSS ≥ 10 (n=606) 0.80 (0.58 to 1.10) and 0.77 (0.49 to 1.19) NIHSS ≥14 (n=378) 0.82 (0.54 to 1.24) and 1.22 (0.69 to 2.14). Early FP had no significant effect in patients with moderate–severe AIS. NCT02162017 .
Publisher: Elsevier BV
Date: 03-2023
Publisher: Springer Science and Business Media LLC
Date: 12-2021
DOI: 10.1186/S13063-021-05860-Y
Abstract: Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4). A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The s le size was estimated to provide 90% power ( α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression. INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke. ClinicalTrials.gov NCT03790800. Registered on 2 January 2019 Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.
Publisher: Elsevier BV
Date: 08-2021
DOI: 10.1016/J.CLINEURO.2021.106796
Abstract: Uncertainty exists over the prognostic significance of low arterial oxygen saturation (SaO Post-hoc analyzes of HeadPoST, a pragmatic cluster-crossover randomized trial of lying flat versus sitting up head positioning in 11,093 patients (age ≥18 years) with acute stroke at 114 hospitals in 9 countries during 2015-2016. Associations of the lowest recorded SaO There was an inverse J-shaped association between SaO Any change in SaO HeadPoST is registered at ClinicalTrials.gov (NCT02162017).
Publisher: Oxford University Press (OUP)
Date: 17-06-2022
Abstract: 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. 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 s le (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. 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.
Publisher: S. Karger AG
Date: 20-12-2022
DOI: 10.1159/000520669
Abstract: b i Background: /i /b The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral Haemorrhage Trial is an ongoing international, multicentre, stepped wedge, cluster-randomized trial to determine the effectiveness of a goal-directed care bundle (early intensive blood pressure [BP] lowering, glycaemic control, treatment of pyrexia, and reversal of anticoagulation), as compared to standard of care, on patient-centred outcomes after acute intracerebral haemorrhage (ICH). An embedded process evaluation aims to identify factors related to the uptake and implementation of the intervention. Herein, we present the process evaluation results for hospital sites in China. b i Methods/Design: /i /b A mixed methods approach, including surveys, focused group discussions and interviews with clinicians, routine monitoring, and recruitment logs were used to collect data across purposively s led hospitals. Medical Research Council guidance and normalization process theory were used as theoretical frameworks for design, data analysis, and synthesis. b i Results: /i /b Twenty quantitative surveys were completed with clinicians, and 26 interviews and 2 focus group discussions were conducted during 2019–2020. The care bundle was generally delivered as planned and acceptable by doctors and nurses, but difficulties were reported in achieving the protocol-defined target levels of BP and glycaemic control. Resistance to implementing the care bundle occurred for patients perceived to be at high risk of adverse effects. Common organizational contextual factors that impeded implementation included delayed processes and limited medication supply, while established background care procedures, expertise, and capacity influenced its integration into routine practice. Areas to facilitate implementation included optimizing workflow within available resources, having a dedicated team, and recognizing the potential benefits of the intervention. b i Conclusions: /i /b Varied established care protocols across sites, different levels of background expertise, and lack of staff capacity impeded the integration of goal-directed care bundle into routine practice for ICH patients in China. Ready identification, and efforts to address, these barriers could facilitate uptake of future guideline-recommended interventions for the management of patients with ICH.
Publisher: Wiley
Date: 06-09-2022
DOI: 10.1002/BRB3.2752
Abstract: We aimed to investigate the prescription of antithrombotic drugs (including anticoagulants and antiplatelets) and medication adherence after stroke. We performed a systematic literature search across MEDLINE and Embase, from January 1, 2015, to February 17, 2022, to identify studies reporting antithrombotic medications (anticoagulants and antiplatelets) post stroke. Two people independently identified reports to include, extracted data, and assessed the quality of included studies according to the Newcastle–Ottawa scale. Where possible, data were pooled using random‐effects meta‐analysis. We included 453,625 stroke patients from 46 studies. The pooled proportion of prescribed antiplatelets and anticoagulants among patients with atrial fibrillation (AF) was 62% (95% CI: 57%–68%), and 68% (95% CI: 58%–79%), respectively. The pooled proportion of patients who were treated according to the recommendation of guidelines of antithrombotic medications from four studies was 67% (95% CI: 41%–93%). It was reported that 11% (95% CI: 2%–19%) of patients did not receive antithrombotic medications. Good adherence to antiplatelet, anticoagulant, and antithrombotic medications was 78% (95% CI: 67%–89%), 71% (95% CI: 57%–84%), and 73% (95% CI: 59%–86%), respectively. In conclusion, we found that less than 70% of patients were prescribed and treated according to the recommended guidelines of antithrombotic medications, and good adherence to antithrombotic medications is only 73%. Prescription rate and good adherence to antithrombotic medications still need to be improved among stroke survivors.
Publisher: Elsevier BV
Date: 07-2023
Publisher: Elsevier BV
Date: 12-2020
No related grants have been discovered for Menglu Ouyang.