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1.
BMJ Open Qual ; 13(2)2024 May 20.
Article in English | MEDLINE | ID: mdl-38769027

ABSTRACT

BACKGROUND: The Philippines has a shortage and uneven distribution of healthcare workers (HCWs). Job satisfaction is an important element to HCW retention and attracting new HCWs into the health system. OBJECTIVE: This study measured HCWs' intent to stay and HCWs' satisfaction after implementation of multiple interventions intended to strengthen the primary care system, and determine factors significantly associated with HCWs' intent to stay. METHODOLOGY: This is a serial cross-sectional study in urban, rural and remote primary care sites in the Philippines. All physicians, nurses, midwives, dentists, community health workers and support staff were invited to participate. Baseline HCWs' intent to stay and satisfaction were obtained using a self-administered questionnaire prior to implementation of interventions. The same survey was again conducted in the years 2021 and 2022, corresponding to 5 and 6 years after initial implementation for the urban site, and 2 and 3 years for the rural and remote sites. We used multiple logistic regression to determine factors associated with intent to stay. RESULTS: There were 430 survey respondents (89.4% response rate) for year 2021, and 417 survey respondents (97.4% response rate) for year 2022. The urban and rural sites had significant increase in several HCW satisfaction domains, while the remote site had significant decrease in several HCW satisfaction domains. There was no significant difference in the intent to stay in the three sites. Factors that decreased intent to stay included length of employment, job involvement and employment as a nurse, while factors that increased intent to stay included job satisfaction, enjoyment and working in the urban site. CONCLUSION: HCW satisfaction improved in the urban site and rural site, while HCW satisfaction declined in the remote site. Intention to stay of primary care HCWs did not significantly change.


Subject(s)
Health Personnel , Job Satisfaction , Primary Health Care , Humans , Philippines , Cross-Sectional Studies , Primary Health Care/statistics & numerical data , Primary Health Care/standards , Female , Male , Surveys and Questionnaires , Adult , Health Personnel/statistics & numerical data , Health Personnel/psychology , Middle Aged , Follow-Up Studies , Intention , Personnel Turnover/statistics & numerical data
2.
BMJ Open Qual ; 13(2)2024 Apr 18.
Article in English | MEDLINE | ID: mdl-38637020

ABSTRACT

OBJECTIVES: A thorough understanding of user needs and behavioural intent-to-use underpins the development of a responsive health information system. This study aimed to examine health workers' intent-to-use an electronic health record (EHR) system in an urban, rural and remote setting in the Philippines. METHODS: Following the Unified Theory of Acceptance and Use of Technology framework, user acceptance and the factors influencing intent-to-use the EHR were examined through a self-administered questionnaire. A total of 128 EHR users, comprising physicians, nurses, midwives, barangay health workers and administrative staff, were surveyed. Median scores for each domain were compared across the sites using the Kruskal-Wallis test. Ridge regression analysis was used to identify factors associated with behavioural intent-to-use. RESULTS: Over 94% of users across all sites reported their intent-to-use the EHR in the near future. Of the seven predictor variables examined, only self-efficacy was found to be significantly associated with behavioural intent-to-use. Intent-to-use the EHR increased by 31% (p=0.007) for each unit increase in self-efficacy score among participants. DISCUSSION: Acceptance was high across the three sites, with self-efficacy being a predictor of intent-to-use the technology. This suggests that users are more likely to adopt an EHR if they believe they have the capacity to successfully navigate the technology and perform their designated tasks with it. CONCLUSION: Co-producing interventions with primary care providers is crucial in sustaining EHR systems. Rather than developing a technology based on the surveillance needs of policymakers, an EHR developed from the grassroots was shown to be well-received by end-users.


Subject(s)
Electronic Health Records , Physicians , Humans , Attitude of Health Personnel , Philippines , Health Personnel
3.
eClinicalMedicine ; 70: 102515, abr.2024. tab
Article in English | CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1537467

ABSTRACT

BACKGROUND Smoking is a major risk factor for the global burden of stroke. We have previously reported a global population attributable risk (PAR) of stroke of 12.4% associated with current smoking. In this study we aimed to explore the association of current tobacco use with different types of tobacco exposure and environmental tobacco smoke (ETS) exposure on the risk of stroke and stroke subtypes, and by regions and country income levels. METHODS The INTERSTROKE study is a case­control study of acute first stroke and was undertaken with 13,462 stroke cases and 13,488 controls recruited between January 11, 2007 and August 8, 2015 in 32 countries worldwide. Association of risk of tobacco use and ETS exposure were analysed with overall stroke, ischemic and intracerebral hemorrhage (ICH), and with TOAST etiological stroke subtypes (large vessel, small vessel, cardioembolism, and undetermined). FINDINGS Current smoking was associated with an increased risk of all stroke (odds ratio [OR] 1.64, 95% CI 1.46­1.84), and had a stronger association with ischemic stroke (OR 1.85, 95% CI 1.61­2.11) than ICH (OR 1.19 95% CI 1.00­1.41). The OR and PAR of stroke among current smokers varied significantly between regions and income levels with high income countries (HIC) having the highest odds (OR 3.02 95% CI 2.24­4.10) and PAR (18.6%, 15.1­22.8%). Among etiological subtypes of ischemic stroke, the strongest association of current smoking was seen for large vessel stroke (OR 2.16, 95% CI 1.63­2.87) and undetermined cause (OR 1.97, 95% CI 1.55­2.50). Both filtered (OR 1.73, 95% CI 1.50­1.99) and non-filtered (OR 2.59, 95% CI 1.79­3.77) cigarettes were associated with stroke risk. ETS exposure increased the risk of stroke in a dose-dependent manner, exposure for more than 10 h per week increased risk for all stroke (OR 1.95, 95% CI 1.69­2.27), ischemic stroke (OR 1.89, 95% CI 1.59­2.24) and ICH (OR 2.00, 95% CI 1.60­2.50). INTERPRETATION There are significant variations in the magnitude of risk and PAR of stroke according to the types of tobacco used, active and ETS exposure, and countries with different income levels. Specific strategies to discourage tobacco use by any form and to build a smoke free environment should be implemented to ease the global burden of stroke. FUNDING The Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Canadian Stroke Network, Swedish Research Council, Swedish Heart and Lung Foundation, The Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland, and through unrestricted grants from several pharmaceutical companies with major contributions from Astra Zeneca, Boehringer Ingelheim (Canada), Pfizer (Canada), MERCK, Sharp and Dohme, Swedish Heart and Lung Foundation, UK Chest, and UK Heart and Stroke.

4.
EClinicalMedicine ; 70: 102515, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38516107

ABSTRACT

Background: Smoking is a major risk factor for the global burden of stroke. We have previously reported a global population attributable risk (PAR) of stroke of 12.4% associated with current smoking. In this study we aimed to explore the association of current tobacco use with different types of tobacco exposure and environmental tobacco smoke (ETS) exposure on the risk of stroke and stroke subtypes, and by regions and country income levels. Methods: The INTERSTROKE study is a case-control study of acute first stroke and was undertaken with 13,462 stroke cases and 13,488 controls recruited between January 11, 2007 and August 8, 2015 in 32 countries worldwide. Association of risk of tobacco use and ETS exposure were analysed with overall stroke, ischemic and intracerebral hemorrhage (ICH), and with TOAST etiological stroke subtypes (large vessel, small vessel, cardioembolism, and undetermined). Findings: Current smoking was associated with an increased risk of all stroke (odds ratio [OR] 1.64, 95% CI 1.46-1.84), and had a stronger association with ischemic stroke (OR 1.85, 95% CI 1.61-2.11) than ICH (OR 1.19 95% CI 1.00-1.41). The OR and PAR of stroke among current smokers varied significantly between regions and income levels with high income countries (HIC) having the highest odds (OR 3.02 95% CI 2.24-4.10) and PAR (18.6%, 15.1-22.8%). Among etiological subtypes of ischemic stroke, the strongest association of current smoking was seen for large vessel stroke (OR 2.16, 95% CI 1.63-2.87) and undetermined cause (OR 1.97, 95% CI 1.55-2.50). Both filtered (OR 1.73, 95% CI 1.50-1.99) and non-filtered (OR 2.59, 95% CI 1.79-3.77) cigarettes were associated with stroke risk. ETS exposure increased the risk of stroke in a dose-dependent manner, exposure for more than 10 h per week increased risk for all stroke (OR 1.95, 95% CI 1.69-2.27), ischemic stroke (OR 1.89, 95% CI 1.59-2.24) and ICH (OR 2.00, 95% CI 1.60-2.50). Interpretation: There are significant variations in the magnitude of risk and PAR of stroke according to the types of tobacco used, active and ETS exposure, and countries with different income levels. Specific strategies to discourage tobacco use by any form and to build a smoke free environment should be implemented to ease the global burden of stroke. Funding: The Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Canadian Stroke Network, Swedish Research Council, Swedish Heart and Lung Foundation, The Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland, and through unrestricted grants from several pharmaceutical companies with major contributions from Astra Zeneca, Boehringer Ingelheim (Canada), Pfizer (Canada), MERCK, Sharp and Dohme, Swedish Heart and Lung Foundation, UK Chest, and UK Heart and Stroke.

5.
BMJ Open Qual ; 13(1)2024 Mar 05.
Article in English | MEDLINE | ID: mdl-38448041

ABSTRACT

OBJECTIVES: This study measured changes in patient satisfaction levels before and after the introduction of primary care system strengthening interventions in urban, rural, and remote sites in the Philippines. METHODS: A previously validated 16-item questionnaire was distributed to 200 patients per site before implementation of interventions and to a different set of 200 patients 1 year after implementation. We compared the percentage change in highly satisfied patients per site before and after implementing interventions using a two-proportion Z-test. RESULTS: The urban site had a significant increase in patient satisfaction in 13 survey items, which corresponded to the domains of healthcare availability, service efficiency, technical competency and health communication. The rural site had a significant increase in six survey items, which corresponded to the domains of service efficiency, environment, location, health communication and handling. The remote site had a decrease in patient satisfaction in 10 survey items, with a significant increase in only 4 items under the domains of healthcare availability and handling. CONCLUSION: Our findings support the 'inverse equity hypothesis', where well-resourced urban communities quickly adopt complex health interventions while rural and remote settings experience delays in effectively meeting patient needs and system demands. Extended intervention periods and targeted strategies may be necessary to impact patient satisfaction in underserved areas considerably.


Subject(s)
Patient Satisfaction , Patient-Centered Care , Humans , Philippines , Health Facilities
6.
BMJ Open Qual ; 13(1)2024 02 29.
Article in English | MEDLINE | ID: mdl-38423587

ABSTRACT

INTRODUCTION: Strengthening primary care helps address health inequities that continue to persist in the Philippines. The Philippine Primary Care Studies pilot-tested interventions to improve the primary care system. One intervention was the provision of a free subscription to an electronic decision support application called UpToDate (UTD) for primary care providers (PCPs), including doctors, nurses, midwives and community health workers (CHWs). This study aimed to (1) assess the feasibility of using UTD as information source for PCPs in urban, rural and remote settings, (2) determine the acceptability of UTD as an information source for PCPs and (3) examine the impact of UTD access on PCP clinical decision-making. METHODS: Four focus group discussions (FGDs) and two key informant interviews (KII) were conducted to gather insights from 30 PCPs. Thematic analysis through coding in NVivo V.12 was done using the technology acceptance model (TAM) as a guiding framework. RESULTS: All PCPs had positive feedback regarding UTD use because of its comprehensiveness, accessibility, mobility and general design. The participants relayed UTD's benefit for point-of-contact use, capacity-building and continuing professional development. PCPs across the three sites, including CHWs with no formal medical education, were able to provide evidence-based medical advice to patients through UTD. However, external factors in these settings impeded the full integration of UTD in the PCPs' workflow, including poor internet access, unstable sources of electricity, lack of compatible mobile devices and the need for translation to the local language. CONCLUSION: UTD was a feasible and acceptable clinical decision support tool for the PCPs. Factors affecting the feasibility of using UTD include technological and environmental factors (ie, internet access and the lack of translation to the local language), as well as the organisational structure of the primary care facility which determines the roles of the PCPs. Despite the difference in roles and responsibilities of the PCPs, UTD positively impacted decision-making and patient education for all PCPs through its use as a point-of-contact tool and a tool for capacity-building.


Subject(s)
Decision Support Systems, Clinical , Humans , Feasibility Studies , Philippines , Clinical Decision-Making , Primary Health Care
7.
Front Immunol ; 14: 1190093, 2023.
Article in English | MEDLINE | ID: mdl-37457735

ABSTRACT

Introduction: Information on the magnitude and durability of humoral immunity against COVID-19 among specific populations can guide policies on vaccination, return from isolation and physical distancing measures. The study determined the durability of SARS-CoV-2 antibodies after an initial infection among Filipinos in Metro Manila, Philippines, and the extent of protection SARS-CoV-2 antibodies confer against reinfection. Methods: We conducted a cohort study to monitor the antibody levels of patients diagnosed with COVID-19. Receptor-binding domain (RBD)-specific antibodies were measured at Days 21, 90, 180, 270 and 360. Antibody levels were reported as geometric mean titers (GMT) with geometric standard deviation (GSD). Differences in GMT were tested using Friedman test and Kruskal Wallis test, with Bonferroni multiple comparisons procedure. Adjusted hazard ratios on the development of probable reinfection were estimated using Cox proportional models. Results: There were 307 study participants included in the study, with 13 dropouts. Study participants received SARS-CoV-2 vaccines at varying times, with 278 participants (90.5%) fully vaccinated by the end of study. The GMT of the study cohort increased over time, from 19.7 U/mL (GSD 11) at Day 21; to 284.5 U/mL (GSD 9.6) at Day 90; 1,061 U/mL (GSD 5.3) at Day 180; 2,003 U/mL (GSD 6.7) at Day 270; and 8,403 U/mL (GSD 3.1) at Day 360. The increase was statistically significant from Day 21 to Day 90 (p<0.0001), Day 90 to Day 180 (p=0.0005), and Day 270 to Day 360 (p<0.0001). Participants with more severe initial infection demonstrated significantly higher antibody levels compared to those with milder infection at Day 21. Sixty-four patients had probable COVID-19 reinfection (incidence of 20.8%, 95% CI 16.4, 25.8%). The GMT of these 64 patients was 411.8 U/mL (GSD 6.9) prior to the occurrence of the probable reinfection. Majority (87.5%) were fully vaccinated. Antibody titers significantly affected the risk of developing reinfection, with adjusted hazard ratio of 0.994, 95% CI 0.992-0.996, p<0.001. Conclusion: Antibody levels against SARS-CoV-2 increased over a one-year follow-up. Higher antibody levels were observed among those with more severe initial infection and those vaccinated. Higher antibody levels are associated with a lower risk of probable reinfection.


Subject(s)
COVID-19 , Humans , SARS-CoV-2 , COVID-19 Vaccines , Philippines/epidemiology , Cohort Studies , Reinfection , Antibodies, Viral
8.
JAMA ; 329(19): 1650-1661, 2023 05 16.
Article in English | MEDLINE | ID: mdl-37191704

ABSTRACT

Importance: Most epidemiological studies of heart failure (HF) have been conducted in high-income countries with limited comparable data from middle- or low-income countries. Objective: To examine differences in HF etiology, treatment, and outcomes between groups of countries at different levels of economic development. Design, Setting, and Participants: Multinational HF registry of 23 341 participants in 40 high-income, upper-middle-income, lower-middle-income, and low-income countries, followed up for a median period of 2.0 years. Main Outcomes and Measures: HF cause, HF medication use, hospitalization, and death. Results: Mean (SD) age of participants was 63.1 (14.9) years, and 9119 (39.1%) were female. The most common cause of HF was ischemic heart disease (38.1%) followed by hypertension (20.2%). The proportion of participants with HF with reduced ejection fraction taking the combination of a ß-blocker, renin-angiotensin system inhibitor, and mineralocorticoid receptor antagonist was highest in upper-middle-income (61.9%) and high-income countries (51.1%), and it was lowest in low-income (45.7%) and lower-middle-income countries (39.5%) (P < .001). The age- and sex- standardized mortality rate per 100 person-years was lowest in high-income countries (7.8 [95% CI, 7.5-8.2]), 9.3 (95% CI, 8.8-9.9) in upper-middle-income countries, 15.7 (95% CI, 15.0-16.4) in lower-middle-income countries, and it was highest in low-income countries (19.1 [95% CI, 17.6-20.7]). Hospitalization rates were more frequent than death rates in high-income countries (ratio = 3.8) and in upper-middle-income countries (ratio = 2.4), similar in lower-middle-income countries (ratio = 1.1), and less frequent in low-income countries (ratio = 0.6). The 30-day case-fatality rate after first hospital admission was lowest in high-income countries (6.7%), followed by upper-middle-income countries (9.7%), then lower-middle-income countries (21.1%), and highest in low-income countries (31.6%). The proportional risk of death within 30 days of a first hospital admission was 3- to 5-fold higher in lower-middle-income countries and low-income countries compared with high-income countries after adjusting for patient characteristics and use of long-term HF therapies. Conclusions and Relevance: This study of HF patients from 40 different countries and derived from 4 different economic levels demonstrated differences in HF etiologies, management, and outcomes. These data may be useful in planning approaches to improve HF prevention and treatment globally.


Subject(s)
Developed Countries , Developing Countries , Global Health , Heart Failure , Female , Humans , Male , Middle Aged , Causality , Heart Failure/epidemiology , Heart Failure/etiology , Heart Failure/mortality , Heart Failure/therapy , Hospitalization/economics , Hospitalization/statistics & numerical data , Hypertension/complications , Hypertension/epidemiology , Income , Stroke Volume , Global Health/statistics & numerical data , Registries/statistics & numerical data , Developed Countries/economics , Developed Countries/statistics & numerical data , Developing Countries/economics , Developing Countries/statistics & numerical data , Aged
10.
Lancet Respir Med ; 10(12): 1160-1168, 2022 12.
Article in English | MEDLINE | ID: mdl-36228639

ABSTRACT

BACKGROUND: The large number of patients worldwide infected with the SARS-CoV-2 virus has overwhelmed health-care systems globally. The Anti-Coronavirus Therapies (ACT) outpatient trial aimed to evaluate anti-inflammatory therapy with colchicine and antithrombotic therapy with aspirin for prevention of disease progression in community patients with COVID-19. METHODS: The ACT outpatient, open-label, 2 × 2 factorial, randomised, controlled trial, was done at 48 clinical sites in 11 countries. Patients in the community aged 30 years and older with symptomatic, laboratory confirmed COVID-19 who were within 7 days of diagnosis and at high risk of disease progression were randomly assigned (1:1) to receive colchicine 0·6 mg twice daily for 3 days and then 0·6 mg once daily for 25 days versus usual care, and in a second (1:1) randomisation to receive aspirin 100 mg once daily for 28 days versus usual care. Investigators and patients were not masked to treatment allocation. The primary outcome was assessed at 45 days in the intention-to-treat population; for the colchicine randomisation it was hospitalisation or death, and for the aspirin randomisation it was major thrombosis, hospitalisation, or death. The ACT outpatient trial is registered at ClinicalTrials.gov, NCT04324463 and is ongoing. FINDINGS: Between Aug 27, 2020, and Feb 10, 2022, 3917 patients were randomly assigned to colchicine or control and to aspirin or control; after excluding 36 patients due to administrative reasons 3881 individuals were included in the analysis (n=1939 colchicine vs n=1942 control; n=1945 aspirin vs 1936 control). Follow-up was more than 99% complete. Overall event rates were 5 (0·1%) of 3881 for major thrombosis, 123 (3·2%) of 3881 for hospitalisation, and 23 (0·6%) of 3881 for death; 66 (3·4%) of 1939 patients allocated to colchicine and 65 (3·3%) of 1942 patients allocated to control experienced hospitalisation or death (hazard ratio [HR] 1·02, 95% CI 0·72-1·43, p=0·93); and 59 (3·0%) of 1945 of patients allocated to aspirin and 73 (3·8%) of 1936 patients allocated to control experienced major thrombosis, hospitalisation, or death (HR 0·80, 95% CI 0·57-1·13, p=0·21). Results for the primary outcome were consistent in all prespecified subgroups, including according to baseline vaccination status, timing of randomisation in relation to onset of symptoms (post-hoc analysis), and timing of enrolment according to the phase of the pandemic (post-hoc analysis). There were more serious adverse events with colchicine than with control (34 patients [1·8%] of 1939 vs 27 [1·4%] of 1942) but none in either group that led to discontinuation of study interventions. There was no increase in serious adverse events with aspirin versus control (31 [1·6%] vs 31 [1·6%]) and none that led to discontinuation of study interventions. INTERPRETATION: The results provide no support for the use of colchicine or aspirin to prevent disease progression or death in outpatients with COVID-19. FUNDING: Canadian Institutes for Health Research, Bayer, Population Health Research Institute, Hamilton Health Sciences Research Institute, and Thistledown Foundation. TRANSLATIONS: For the Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section.


Subject(s)
COVID-19 , Thrombosis , Humans , Aspirin/therapeutic use , SARS-CoV-2 , Colchicine/therapeutic use , Treatment Outcome , Canada , Disease Progression
11.
BMC Complement Med Ther ; 22(1): 252, 2022 Sep 30.
Article in English | MEDLINE | ID: mdl-36180884

ABSTRACT

BACKGROUND: Traditional, complementary and alternative medicine (TCAM) is used to treat a broad range of conditions. In low- and middle-income countries (LMICs), TCAM use is particularly common among those with low socio-economic status. To better understand the patterns and impact of TCAM use on the management of non-communicable diseases in these populations, this study examines the prevalence and characteristics of TCAM use for hypertension, its determinants, and its association with hypertension management outcomes and wellbeing among low-income adults in two Southeast Asian countries at different levels of economic and health system development, Malaysia and the Philippines. METHODS: We analysed cross-sectional data from 946 randomly selected adults diagnosed with hypertension from low-income rural and urban communities in Malaysia (n = 495) and the Philippines (n = 451). We compared the prevalence, characteristics and household expenditure on TCAM use between countries and used multi-level, mixed-effects regression to estimate associations between TCAM use and its determinants, and five hypertension management outcomes and wellbeing. RESULTS: The prevalence of TCAM use to manage hypertension was higher in the Philippines than in Malaysia (18.8% vs 8.8%, p < 0.001). Biologically-based modalities, e.g. herbal remedies, were the most common type of TCAM used in both countries, mainly as a complement, rather than an alternative to conventional treatment. Households allocated around 10% of health spending to TCAM in both countries. Belief that TCAM is effective for hypertension was a positive predictor of TCAM use, while belief in conventional medicine was a negative predictor. TCAM use was not strongly associated with current use of medications for hypertension, self-reported medication adherence, blood pressure level and control, or wellbeing in either country. CONCLUSIONS: A small, but significant, proportion of individuals living in low-income communities in Malaysia and the Philippines use TCAM to manage their hypertension, despite a general lack of evidence on efficacy and safety of commonly used TCAM modalities. Recognising that their patients may be using TCAM to manage hypertension will enable health care providers to deliver safer, more patient-centred care.


Subject(s)
Complementary Therapies , Hypertension , Adult , Cross-Sectional Studies , Humans , Hypertension/epidemiology , Hypertension/therapy , Malaysia/epidemiology , Philippines/epidemiology , Prevalence
12.
J Stroke ; 24(2): 224-235, 2022 May.
Article in English | MEDLINE | ID: mdl-35677977

ABSTRACT

BACKGROUND AND PURPOSE: The association of dyslipidemia with stroke has been inconsistent, which may be due to differing associations within etiological stroke subtypes. We sought to determine the association of lipoproteins and apolipoproteins within stroke subtypes. METHODS: Standardized incident case-control STROKE study in 32 countries. Cases were patients with acute hospitalized first stroke, and matched by age, sex and site to controls. Concentrations of total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein A1 (apoA1), and apoB were measured. Non-HDL-C was calculated. We estimated multivariable odds ratio (OR) and population attributable risk percentage (PAR%). Outcome measures were all stroke, ischemic stroke (and subtypes), and intracerebral hemorrhage (ICH). RESULTS: Our analysis included 11,898 matched case-control pairs; 77.3% with ischemic stroke and 22.7% with ICH. Increasing apoB (OR, 1.10; 95% confidence interval [CI], 1.06 to 1.14 per standard deviation [SD]) and LDL-C (OR, 1.06; 95% CI, 1.02 to 1.10 per SD) were associated with an increase in risk of ischemic stroke, but a reduced risk of ICH. Increased apoB was significantly associated with large vessel stroke (PAR 13.4%; 95% CI, 5.6 to 28.4) and stroke of undetermined cause. Higher HDL-C (OR, 0.75; 95% CI, 0.72 to 0.78 per SD) and apoA1 (OR, 0.63; 95% CI, 0.61 to 0.66 per SD) were associated with ischemic stroke (and subtypes). While increasing HDL-C was associated with an increased risk of ICH (OR, 1.20; 95% CI, 1.14 to 1.27 per SD), apoA1 was associated with a reduced risk (OR, 0.80; 95% CI, 0.75 to 0.85 per SD). ApoB/A1 (OR, 1.38; 95% CI, 1.32 to 1.44 per SD) had a stronger magnitude of association than the ratio of LDL-C/HDL-C (OR, 1.26; 95% CI, 1.21 to 1.31 per SD) with ischemic stroke (P<0.0001). CONCLUSIONS: The pattern and magnitude of association of lipoproteins and apolipoproteins with stroke varies by etiological stroke subtype. While the directions of association for LDL, HDL, and apoB were opposing for ischemic stroke and ICH, apoA1 was associated with a reduction in both ischemic stroke and ICH. The ratio of apoB/A1 was the best lipid predictor of ischemic stroke risk.

13.
Eur J Prev Cardiol ; 29(14): 1817-1826, 2022 10 20.
Article in English | MEDLINE | ID: mdl-35512128

ABSTRACT

AIMS: Elevated body mass index (BMI) is an important cause of cardiovascular disease (CVD). The population-level impact of pharmacologic strategies to mitigate the risk of CVD conferred by the metabolic consequences of an elevated BMI is not well described. METHODS AND RESULTS: We conducted an analysis of 145 986 participants (mean age 50 years, 58% women) from 21 high-, middle-, and low-income countries in the Prospective Urban and Rural Epidemiology study who had no history of cancer, ischaemic heart disease, heart failure, or stroke. We evaluated whether the hazards of CVD (myocardial infarction, stroke, heart failure, or cardiovascular death) differed among those taking a cardiovascular medication (n = 29 174; including blood pressure-lowering, blood glucose-lowering, cholesterol-lowering, or anti-thrombotic medications) vs. those not taking a cardiovascular medication (n = 116 812) during 10.2 years of follow-up. Cox proportional hazard models with the community as a shared frailty were constructed by adjusting age, sex, education, geographic region, physical activity, tobacco, and alcohol use. We observed 7928 (5.4%) CVD events and 9863 (6.8%) deaths. Cardiovascular medication use was associated with different hazards of CVD (interaction P < 0.0001) and death (interaction P = 0.0020) as compared with no cardiovascular medication use. Among those not taking a cardiovascular medication, as compared with those with BMI 20 to <25 kg/m2, the hazard ratio (HR) [95% confidence interval (95% CI)] for CVD were, respectively, 1.14 (1.06-1.23); 1.45 (1.30-1.61); and 1.53 (1.28-1.82) among those with BMI 25 to <30 kg/m2; 30 to <35 kg/m2; and ≥35 kg/m2. However, among those taking a cardiovascular medication, the HR (95% CI) for CVD were, respectively, 0.79 (0.72-0.87); 0.90 (0.79-1.01); and 1.14 (0.98-1.33). Among those not taking a cardiovascular medication, the respective HR (95% CI) for death were 0.93 (0.87-1.00); 1.03 (0.93-1.15); and 1.44 (1.24-1.67) among those with BMI 25 to <30 kg/m2; 30 to <35 kg/m2; and ≥35 kg/m2. However, among those taking a cardiovascular medication, the respective HR (95% CI) for death were 0.77 (0.69-0.84); 0.88 (0.78-0.99); and 1.12 (0.96-1.30). Blood pressure-lowering medications accounted for the largest population attributable benefit of cardiovascular medications. CONCLUSION: To the extent that CVD risk among those with an elevated BMI is related to hypertension, diabetes, and an elevated thrombotic milieu, targeting these pathways pharmacologically may represent an important complementary means of reducing the CVD burden caused by an elevated BMI.


Subject(s)
Cardiovascular Diseases , Heart Failure , Stroke , Adult , Female , Humans , Middle Aged , Male , Blood Pressure/physiology , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/drug therapy , Cardiovascular Diseases/epidemiology , Blood Glucose , Body Mass Index , Prospective Studies , Risk Factors , Proportional Hazards Models , Cholesterol , Heart Failure/complications
14.
Eur Heart J Cardiovasc Pharmacother ; 8(8): 786-795, 2022 12 02.
Article in English | MEDLINE | ID: mdl-35383832

ABSTRACT

AIMS: To describe outcomes of patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial who were treated with the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily during long-term open-label extension (LTOLE). METHODS AND RESULTS: Of the 27 395 patients enrolled in COMPASS, 12 964 (mean age at baseline 67.2 years) from 455 sites in 32 countries were enrolled in LTOLE and treated with the combination of rivaroxaban and aspirin for a median of 374 additional days (range 1-1191 days). During LTOLE, the incident events per 100 patient years were as follows: for the primary outcome [cardiovascular death, stroke, or myocardial infarction (MI)] 2.35 [95% confidence interval (CI) 2.11-2.61], mortality 1.87 (1.65-2.10), stroke 0.62 (0.50-0.76), and MI 1.02 (0.86-1.19), with CIs that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major and minor bleeding were 1.01 (0.86-1.19) and 2.49 (2.24-2.75), compared with 1.67 (1.48-1.87) and 5.11 (95% CI 4.77-5.47), respectively, during the randomized treatment phase with the combination. CONCLUSION: In patients with chronic CAD and/or PAD, extended combination treatment for a median of 1 year and a maximum of 3 years was associated with incidence rates for efficacy and bleeding that were similar to or lower than those seen during the randomized treatment phase, without any new safety signals.


Subject(s)
Myocardial Infarction , Peripheral Arterial Disease , Stroke , Humans , Infant , Aspirin , Drug Therapy, Combination , Myocardial Infarction/epidemiology , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/drug therapy , Peripheral Arterial Disease/epidemiology , Rivaroxaban , Stroke/epidemiology
15.
CJC Open ; 4(6): 568-576, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35252829

ABSTRACT

Background: Effective treatments for COVID-19 are urgently needed, but conducting randomized trials during the pandemic has been challenging. Methods: The Anti-Coronavirus Therapy (ACT) trials are parallel factorial international trials that aimed to enroll 3500 outpatients and 2500 inpatients with symptomatic COVID-19. The outpatient trial is evaluating colchicine vs usual care, and aspirin vs usual care. The primary outcome for the colchicine randomization is hospitalization or death, and for the aspirin randomization, it is major thrombosis, hospitalization, or death. The inpatient trial is evaluating colchicine vs usual care, and the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily vs usual care. The primary outcome for the colchicine randomization is need for high-flow oxygen, need for mechanical ventilation, or death, and for the rivaroxaban plus aspirin randomization, it is major thrombotic events, need for high-flow oxygen, need for mechanical ventilation, or death. Results: At the completion of enrollment on February 10, 2022, the outpatient trial had enrolled 3917 patients, and the inpatient trial had enrolled 2611 patients. Challenges encountered included lack of preliminary data about the interventions under evaluation, uncertainties related to the expected event rates, delays in regulatory and ethics approvals, and in obtaining study interventions, as well as the changing pattern of the COVID-19 pandemic. Conclusions: The ACT trials will determine the efficacy of anti-inflammatory therapy with colchicine, and antithrombotic therapy with aspirin given alone or in combination with rivaroxaban, across the spectrum of mild, moderate, and severe COVID-19. Lessons learned from the conduct of these trials will inform planning of future trials.


Contexte: Il est urgent de mettre au point des traitements efficaces contre la COVID-19, mais il n'est pas facile de réaliser des essais à répartition aléatoire dans un contexte pandémique. Méthodologie: Les essais internationaux factoriels ACT (Anti-Coronavirus Therapy) avaient un objectif d'inscription de 3 500 patients externes et de 2 500 patients hospitalisés présentant une COVID-19 symptomatique. L'essai mené auprès de patients externes visait à évaluer la colchicine par rapport aux soins habituels, et l'aspirine par rapport aux soins habituels. Le paramètre d'évaluation principal au terme de la répartition aléatoire des patients était l'hospitalisation ou le décès dans le groupe traité par la colchicine, et la thrombose majeure, l'hospitalisation ou le décès dans le groupe traité par l'aspirine. L'essai mené auprès de patients hospitalisés visant à évaluer la colchicine par rapport aux soins habituels, et un traitement associant le rivaroxaban à 2,5 mg deux fois par jour et l'aspirine à 100 mg une fois par jour par rapport aux soins habituels. Le paramètre d'évaluation principal au terme de la répartition aléatoire des patients était le recours à l'oxygénothérapie à haut débit ou à la ventilation mécanique ou le décès dans le groupe traité par la colchicine, et la survenue de manifestations thrombotiques majeures, le recours à l'oxygénothérapie à haut débit ou à la ventilation mécanique ou le décès dans le groupe traité par l'association rivaroxaban-aspirine. Résultats: À la fin de la période d'inscription, le 10 février 2022, 3 917 patients externes et 2 611 patients hospitalisés formaient la population des essais. Certains aspects se sont révélés problématiques, notamment le manque de données préliminaires sur les interventions à évaluer, les incertitudes liées aux taux d'événements prévus, les retards touchant les approbations réglementaires et éthiques et les interventions de recherche, de même que l'évolution de la pandémie de COVID-19. Conclusions: Les essais ACT détermineront l'efficacité du traitement anti-inflammatoire par la colchicine et du traitement antithrombotique par l'aspirine, administrée seule ou en association avec le rivaroxaban, contre la COVID-19 légère, modérée ou sévère. Les leçons tirées de ces essais orienteront la planification d'essais ultérieurs.

16.
Lancet Glob Health ; 10(2): e216-e226, 2022 02.
Article in English | MEDLINE | ID: mdl-35063112

ABSTRACT

BACKGROUND: Separate studies suggest that the risks from smoking might vary between high-income (HICs), middle-income (MICs), and low-income (LICs) countries, but this has not yet been systematically examined within a single study using standardised approaches. We examined the variations in risks from smoking across different country income groups and some of their potential reasons. METHODS: We analysed data from 134 909 participants from 21 countries followed up for a median of 11·3 years in the Prospective Urban Rural Epidemiology (PURE) cohort study; 9711 participants with myocardial infarction and 11 362 controls from 52 countries in the INTERHEART case-control study; and 11 580 participants with stroke and 11 331 controls from 32 countries in the INTERSTROKE case-control study. In PURE, all-cause mortality, major cardiovascular disease, cancers, respiratory diseases, and their composite were the primary outcomes for this analysis. Biochemical verification of urinary total nicotine equivalent was done in a substudy of 1000 participants in PURE. FINDINGS: In PURE, the adjusted hazard ratio (HR) for the composite outcome in current smokers (vs never smokers) was higher in HICs (HR 1·87, 95% CI 1·65-2·12) than in MICs (1·41, 1·34-1·49) and LICs (1·35, 1·25-1·46; interaction p<0·0001). Similar patterns were observed for each component of the composite outcome in PURE, myocardial infarction in INTERHEART, and stroke in INTERSTROKE. The median levels of tar, nicotine, and carbon monoxide displayed on the cigarette packs from PURE HICs were higher than those on the packs from MICs. In PURE, the proportion of never smokers reporting high second-hand smoke exposure (≥1 times/day) was 6·3% in HICs, 23·2% in MICs, and 14·0% in LICs. The adjusted geometric mean total nicotine equivalent was higher among current smokers in HICs (47·2 µM) than in MICs (31·1 µM) and LICs (25·2 µM; ANCOVA p<0·0001). By contrast, it was higher among never smokers in LICs (18·8 µM) and MICs (11·3 µM) than in HICs (5·0 µM; ANCOVA p=0·0001). INTERPRETATION: The variations in risks from smoking between country income groups are probably related to the higher exposure of tobacco-derived toxicants among smokers in HICs and higher rates of high second-hand smoke exposure among never smokers in MICs and LICs. FUNDING: Full funding sources are listed at the end of the paper (see Acknowledgments).


Subject(s)
Developed Countries/statistics & numerical data , Developing Countries/statistics & numerical data , Myocardial Infarction/epidemiology , Stroke/epidemiology , Tobacco Smoking/epidemiology , Adult , Aged , Carbon Monoxide/analysis , Cardiovascular Diseases/epidemiology , Female , Humans , Male , Middle Aged , Myocardial Infarction/mortality , Neoplasms/epidemiology , Nicotine/analysis , Prospective Studies , Respiratory Tract Diseases/epidemiology , Stroke/mortality , Tobacco Smoking/adverse effects
17.
Eur Heart J Qual Care Clin Outcomes ; 8(8): 899-908, 2022 11 17.
Article in English | MEDLINE | ID: mdl-34962984

ABSTRACT

AIMS: The International Polycap Study 3 (TIPS-3) trial demonstrated that a polypill containing cholesterol- and multiple blood-pressure-lowering drugs reduces cardiovascular events by 20% compared with placebo in people without cardiovascular disease. The polypill plus aspirin led to a 31% relative risk reduction in cardiovascular disease events compared with double placebo. We report regional variations in costs and affordability of a polypill based on the TIPS-3 trial. METHODS AND RESULTS: Countries were categorized using World Bank economic groups: lower-middle-income, upper-middle-income, and high-income countries. Country-specific costs were obtained for hospitalization events, procedures, and non-study medications (2019 US dollars). Polypill price was based on the cheapest equivalent substitute (CES) for each component. For the polypill vs. placebo, the difference in cost over the 4.6 years of the trial was $291 [95% confidence interval (CI): $243-339] per participant in lower-middle-income countries, $1068 (95% CI: $992-1144) in upper-middle-income countries, and $48 (95% CI: -$271 to $367) in high-income countries. Results were similar for the polypill plus aspirin vs. a double placebo. In both cases, the polypill was affordable in all groups using monthly household capacity to pay or a threshold of 4% of the gross national income per capita. CONCLUSION: The use of a polypill (CES) in TIPS-3 increases costs in lower-middle-income countries and upper-middle-income countries but is affordable in countries at various economic levels and is cost neutral (dominant) in high-income countries.


Subject(s)
Cardiovascular Diseases , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Humans , Aspirin , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/drug therapy , Drug Combinations , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Platelet Aggregation Inhibitors , Primary Prevention/methods
18.
Contemp Clin Trials ; 107: 106466, 2021 08.
Article in English | MEDLINE | ID: mdl-34098039

ABSTRACT

BACKGROUND/AIMS: To examine how measuring adherence at 3 weeks by self-report and pill counts compares to measurements at 7 weeks in a pre-randomization run-in period. METHODS: Study within a trial of an international parallel group randomized controlled trial (RCT) that compares spironolactone to placebo. Adults receiving dialysis enter an 8-week active run-in period with spironolactone. Adherence was assessed by both self-report and pill counts in a subgroup of participants at both 3 weeks and 7 weeks. RESULTS: 332 participants entered the run-in period of which 166 had complete data. By self-report, 146/166 (94.0%) and 153/166 (92.2%) had at least 80% adherence at 3 and 7 weeks respectively (kappa = 0.27 (95% C.I. 0.16 to 0.38). By pill counts, the mean (SD) adherence was 96.5% (16.1%) and 92.4% (18.2%) at 3 and 7 weeks respectively (r = 0.32) with a mean (SD) difference of 3.1% (17.8%) and a 95% limit of agreement from -31.7% to +37.9%. The proportion of adherent participants by self-report and pill counts at 3 weeks agreed in 87.4% of participants (McNemar's p-value 0.58, kappa 0.11, p = 0.02) and at 7 weeks agreed in 92.2% (McNemar's p-value 0.82, kappa 0.47, p < 0.001). CONCLUSIONS: Three and seven-week run-in periods and both self-reported and pill count assessments performed similarly. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03020303.


Subject(s)
Medication Adherence , Renal Dialysis , Adult , Humans , Random Allocation , Self Report
20.
Neuroepidemiology ; 55(3): 206-215, 2021.
Article in English | MEDLINE | ID: mdl-33951632

ABSTRACT

BACKGROUND: Previous studies reported an association of renal impairment with stroke, but there are uncertainties underpinning this association. AIMS: We explored if the association is explained by shared risk factors or is independent and whether there are regional or stroke subtype variations. METHODS: INTERSTROKE is a case-control study and the largest international study of risk factors for first acute stroke, completed in 27 countries. We included individuals with available serum creatinine values and calculated estimated glomerular filtration rate (eGFR). Renal impairment was defined as eGFR <60 mL/min/1.73 m2. Multivariable conditional logistic regression was used to determine the association of renal function with stroke. RESULTS: Of 21,127 participants, 41.0% were female, the mean age was 62.3 ± 13.4 years, and the mean eGFR was 79.9 ± 23.5 mL/min/1.73 m2. The prevalence of renal impairment was higher in cases (22.9% vs. 17.7%, p < 0.001) and differed by region (p < 0.001). After adjustment, lower eGFR was associated with increased odds of stroke. Renal impairment was associated with increased odds of all stroke (OR 1.35; 95% CI: 1.24-1.47), with higher odds for intracerebral hemorrhage (OR 1.60; 95% CI: 1.35-1.89) than ischemic stroke (OR 1.29; 95% CI: 1.17-1.42) (pinteraction 0.12). The largest magnitudes of association were seen in younger participants and those living in Africa, South Asia, or South America (pinteraction < 0.001 for all stroke). Renal impairment was also associated with poorer clinical outcome (RRR 2.97; 95% CI: 2.50-3.54 for death within 1 month). CONCLUSION: Renal impairment is an important risk factor for stroke, particularly in younger patients, and is associated with more severe stroke and worse outcomes.


Subject(s)
Stroke , Aged , Case-Control Studies , Cerebral Hemorrhage , Female , Glomerular Filtration Rate , Humans , Middle Aged , Risk Factors , Stroke/epidemiology
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