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BACKGROUND/OBJECTIVES: The Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial is a unique pragmatic, multi-centre, patient and assessor masked, randomised controlled trial. We evaluate the clinical characteristics and pathology of this large trial cohort of patients with open globe injuries undergoing vitreoretinal surgery, including the associations between patient characteristics and their baseline vision. SUBJECTS/METHODS: We (i) summarise demographics, injury history and ocular history of the 280 participants recruited into the ASCOT trial using descriptive statistics; (ii) analyse the national and seasonal variation across England and Scotland in these participant characteristics; and (iii) explore the associations between participant demographic, trauma history, ocular history and presenting baseline visual acuity (measured using the Early Treatment Diabetic Retinopathy Study, ETDRS) using multivariable regression analyses. RESULTS: The majority of participants with open globe penetrating injuries were of white ethnicity (233, 84%), male (246, 88%), with a median age of 43 years (IQR 30-55 years). There was considerable variability in presenting visual acuity with 75% unable to read any letters on the ETDRS chart, whilst the median ETDRS letter score was 58 (IQR 24-80) for those who could read ≥1 letter. The most common causes of injury were workplace related (31%) or interpersonal violence (24%). Previous eye surgery, visual axis corneal scar, lens status, hyphaemia and vitreous haemorrhaging were found to be associated with presenting vision as measured by the ETDRS chart. CONCLUSION: The ASCOT trial provides valuable insights into the spectrum of pathology of patients with open globe eye injuries undergoing vitreoretinal surgery. The identified causes of injury and clinical presentation of the cases will help in training and resource planning to deal with these often challenging surgical cases. TRIAL REGISTRATION: EudraCT No. 014-002193-37. HTA Project 12/35/64.
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Lesões da Córnea , Ferimentos Oculares Penetrantes , Humanos , Masculino , Adulto , Pessoa de Meia-Idade , Acuidade Visual , Visão Ocular , Lesões da Córnea/cirurgia , Procedimentos Cirúrgicos Oftalmológicos , Hemorragia Vítrea/cirurgia , Estudos Retrospectivos , Ferimentos Oculares Penetrantes/complicações , PrognósticoRESUMO
BACKGROUND: The effect of 3 commonly recommended combinations of anti-hypertensive agents-amlodipine plus hydrochlorothiazide (calcium channel blocker [CCB]+thiazide), amlodipine plus perindopril (CCB+ACE [angiotensin-converting enzyme]-inhibitor), and perindopril plus hydrochlorothiazide (ACE-inhibitor+thiazide) on blood pressure variability (V) are unknown. METHODS: We calculated the blood pressure variability (BPV) in 405 patients (130, 146, and 129 randomized to ACE-inhibitor+thiazide, CCB+thiazide, and CCB+ACE-inhibitor, respectively) who underwent ambulatory blood pressure monitoring after 6 months of treatment in the Comparisons of Three Combinations Therapies in Lowering Blood Pressure in Black Africans trial (CREOLE) of Black African patients. BPV was calculated using the SD of 30-minute interval values for 24-hour ambulatory BPs and for confirmation using the coefficient of variation. Linear mixed model regression was used to calculate mean differences in BPV between treatment arms. Within-clinic BPV was also calculated from the mean SD and coefficient of variation of 3 readings at clinic visits. RESULTS: Baseline distributions of age, sex, and blood pressure parameters were similar across treatment groups. Participants were predominately male (62.2%) with mean age 50.4 years. Those taking CCB+thiazide had significantly reduced ambulatory systolic and diastolic BPV compared with those taking ACE-inhibitor+thiazide. The CCB+thiazide and CCB+ACE-inhibitor groups showed similar BPV. Similar patterns of BPV were apparent among groups using within-clinic blood pressures and when assessed by coefficient of variation. CONCLUSIONS: Compared with CCB-containing combinations, ACE-inhibitor plus thiazide was associated with higher levels, generally significant, of ambulatory and within-clinic systolic and diastolic BPV. These results supplement the differential ambulatory blood pressure-lowering effects of these therapies in the CREOLE trial.
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Hipertensão , Perindopril , Humanos , Masculino , Pessoa de Meia-Idade , Perindopril/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/farmacologia , Pressão Sanguínea , Monitorização Ambulatorial da Pressão Arterial , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/complicações , Quimioterapia Combinada , Anlodipino/uso terapêutico , Anlodipino/farmacologia , Hidroclorotiazida/uso terapêutico , Hidroclorotiazida/farmacologia , Bloqueadores dos Canais de Cálcio/uso terapêutico , Bloqueadores dos Canais de Cálcio/farmacologia , Combinação de Medicamentos , Tiazidas/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/farmacologiaRESUMO
OBJECTIVES: Frequentist trials in Rare disease/small population trials often require unfeasibly large sample size to detect minimum clinically important differences. A targeted review was performed investigating what design and analysis methods these trials use when facing restricted recruitment. STUDY DESIGN AND SETTING: Targeted Review searching EMBASE and MEDLINE for Phase II-IV RCTs reporting 'rare' disease or 'small population' within title or abstract, since 2009. RESULTS: A total of 6,128 articles were screened with 64 trials eligible (four Bayesian, 60 frequentist trials). Frequentists trials had planned power ranging 72-90% (median: 80%) but reported recruiting a mean of 6.6% below the planned sample size (n = 38) [median 0%, IQR (-5%, 5%)], most used standard type I error (52 used 5% and one used 1%), and the average standardized effect was high (0.7) with 50% missing their assumed level. Of the four Bayesian trials, three used informed priors, two and one trials performed sensitivity analysis for the impact of priors on design and analysis respectively. Historical data, expert consensus, or both were used to construct informative priors. Bayesian trials required 30-2400% less participants than using frequentist frameworks. CONCLUSION: Bayesian trials required lower sample size through use of informative priors. Most frequentists didn't achieve their target sample size. Bayesian methods offer promising solutions for such trials but are underutilized.
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Doenças Raras , Projetos de Pesquisa , Teorema de Bayes , Humanos , Doenças Raras/terapia , Tamanho da AmostraRESUMO
May Measurement Month is a global campaign aimed at raising public awareness of hypertension and to improve the management of hypertension-the main risk factor for cardiovascular diseases in the population. Screening was carried out at 400 sites on a national scale. More than 500 volunteers, including physicians (80%) and students of medical universities (20%) participated in the screening. To familiarize them with the research tools and standard blood pressure (BP) measurement method, they were trained by the members of the Georgian Society of Hypertension and the National Center for Disease Control and Public Health's staff. Medical societies, health-care professionals, public health workers, social mass media, and other stakeholders were actively involved in the recruitment process. A total of 13 267 (38.5% males and 61.5% females) individuals were screened. The mean age of participants was 54.7 years (SD 15.9). All participants were Caucasian. After imputation of missing BP readings, 8510 (64.1%) were found to have hypertension, out of whom 7269 (85.4%) were aware of their condition, 7232 (85.0%) were on medication, and 1278 (15.0%) were not taking any medication. Of those taking antihypertensive medication, 34.8% had their BP controlled (<140/90 mmHg). May Measurement Month detected a high proportion of participants with hypertension, with results indicating low rates of control in Georgia.
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To bolster the awareness of high blood pressure (BP) and to monitor the trend of hypertension control rate. Similar to May Measurement Month (MMM) 2017 and 2018 campaigns, we conducted the MMM 2019 campaign in 643 community pharmacies across Taiwan, and recruited adults aged 20 years or over in May and June of 2019. After filling in an anonymous questionnaire regarding medical history and lifestyle habits and having 10-min sitting rest, pharmacists took triplicate upper-arm BP readings on participants using an automated oscillometric sphygmomanometer. The means of the second and third BP readings were used as the screening BP estimates. Hypertension was defined if one of the followings was met: use of antihypertensive medications, systolic BP ≥140 mmHg, or diastolic BP ≥90 mmHg. Controlled BP was defined as BP of <140/90 mmHg. Of the 24 851 participants enrolled (mean age, 55.8 ± 15.2 years), 12 427 (50.0%) were women. Among 12 351 (49.7%) participants with hypertension, 10 463 (84.7%) were aware of their high BP, and 10 142 (82.1%) received antihypertensive medications. While 59.2% of all hypertensive participants had controlled BP, the BP control rate was 72.0% in treated hypertensive participants. MMM campaigns offer a feasible way to monitor the trends in both awareness and control of hypertension. This nationwide annual BP screening campaign, from 2017 to 2019, demonstrated continued improvement in hypertension control in Taiwan.
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Raised blood pressure (BP) is the biggest risk factor that contributes to the global burden of disease and mortality. May Measurement Month (MMM) is a global initiative aimed to improved awareness of BP and has been a temporary solution to the lack of screening programmes. An opportunistic cross-sectional survey of volunteers aged ≥18 was carried out in May 2019. Blood pressure measurement, the definition of hypertension, and statistical analysis followed the standard MMM protocol. In total, 7112 individuals were screened (mean age 41.3 years; 50.4% female; 99.5% black) in 6 of the 18 Angolan provinces. In total, 99.6% of screenees provided three BP readings with an average BP of the 2nd and 3rd readings of 126/81 mmHg. After imputation, 2745 (38.6%) had hypertension of whom 1389 (59.8%) were aware of their diagnosis and 50.6% were on antihypertensive medication. Of those 1389 treated participants, 41.2% were controlled (<140/90 mmHg) and of all hypertensive individuals, 20.8% were controlled. Also, 1356 individuals had untreated hypertension and 817 were inadequately treated. Angolan MMM19 follows on from the MMM17 (n = 17481) and MMM18 (n = 14433) studies, which were the largest BP screening campaigns undertaken in Angola. The 2019 results showed a high percentage of hypertensive individuals and almost 2200 adults had either untreated or inadequately treated hypertension, demonstrating that there is work to do but also that the Angolan MMM is being effective at raising awareness at least among these individuals.
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The Argentinean Society of Hypertension, in agreement with the May Measurement Month (MMM) initiative of the International Society of Hypertension, implemented for the third consecutive year a hypertension screening campaign. A volunteer cross-sectional survey was carried out in public spaces and health centres during the month of May 2019 across 33 cities in Argentina. Hypertension was defined as systolic blood pressure (BP) ≥140 mmHg and/or diastolic BP ≥90 mmHg based on the mean of the second and third BP measurements, or in those on treatment for high BP. A total of 94 523 individuals (53.9 ± 17.8 years old, 55 231women and 39 292 men), were evaluated. The age and sex standardized mean BP was 124.7/77.2 mmHg. Among participants, 34.7% were overweight (25-29.9 m/kg2) and 28.7% had obesity (≥30 m/kg2). Individuals identified as being overweight had BP 3/2 mmHg higher and individuals with obesity 6/4 mmHg higher than those with normal weight. The prevalence of hypertension was 52.5%. Although 81.1% were aware and 77.7% were on antihypertensive treatment, only 46.0% of all individuals with hypertension had their BP controlled. Moreover, 19.8% of those not on any antihypertensive medication were found with raised BP. The low level of control of hypertension generates the critical need for the development of community-based prevention strategies reinforcing strategies to increase the awareness and control of hypertension.
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Hypertension awareness and control is poor in low- and middle-income countries. Thus, implementing strategies to increase hypertension detection is needed. Colombia participated as one of the 92 countries involved in the third campaign of the May Measurement Month in 2019. Blood pressure (BP) was measured in 48 324 volunteers from 13 departments in Colombia. In total, 27.9% individuals were identified with hypertension. Of those with hypertension, 63.7% were aware of their condition, 60.0% were on antihypertensive medication, and 38.4% had controlled BP. These results showed low levels of awareness, treatment, and control of hypertension in this sample of subjects volunteered to participate, suggest the urgent necessity of implementing programmes to improve the diagnosis and management of hypertension in Colombia.
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Hypertension is an important public health concern of high prevalence among adults. It is associated with an increased mortality rate. The prevalence of hypertension in Lebanon has increased during the last decades, affecting around one-third of the Lebanese population. Since diagnosis and treatment of hypertension is associated with a better prognosis, annual screening and raising awareness about this 'silent killer' disease is of extreme value. We conducted a cross-sectional survey in various Lebanese cities in 2019. We recruited adults (≥18 years old) from different sites, through an opportunistic sampling method. For each participant, three blood pressure (BP) readings were recorded and the average of the last two was analysed. In addition, data on lifestyle factors and comorbidities were collected. Participants were considered hypertensive if they had at least one of the following: systolic or diastolic BP ≥140 and/or ≥90 mmHg, respectively, or taking antihypertensive medication. Blood pressure was measured in 7019 participants. The mean age was 46.0 (SD 16.6) years. In total, 2572 participants (36.6%) had hypertension among whom only 64.1% were aware of their disease and 62.3% were on treatment. Blood pressure was controlled in 62.6% of participants taking antihypertensive medications. This study is the largest on hypertension prevalence in Lebanon. The results demonstrated that around one-third of the hypertensive population were not aware of their disease, and that a high percentage was not being treated. These results suggest the need for rapid interventions aimed at raising awareness regarding hypertension in the Lebanese population.
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The Cabo Verdean population is aging and, consequently, non-communicable diseases, namely cardiovascular diseases, are increasing, with hypertension being an important risk factor. Following Cabo Verde's engagement with the May Measurement Month (MMM) campaign, in 2019, it was possible to improve the screening capacity, at the same time that a major social mobilization campaign was carried out to improve the population's knowledge about raised blood pressure (BP) and its consequences. With activities on nine islands, telemedicine was used to train researchers and volunteers. The MMM app was used to collect participant data. Individuals aged ≥18 years were recruited through opportunistic sampling. Each participant completed a questionnaire on demographic, lifestyle and environmental factors and had three BP measurements and weight and height measurements. Hypertension was defined as a systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg (mean of the second and third readings), or when using antihypertensive medication. When respondents did not provide three BP readings, multiple imputation using chained equations was used to calculate the mean of the second and third readings. A total of 17 627 individuals [mean age of 42.7 (SD 16.2); 63.8% women] were screened. After multiple imputation, 5990 (34.0%) had hypertension, of which 68.4% knew the diagnosis previously and 51.3% used antihypertensive drugs. The reported use of antihypertensive medication and a previous diagnosis of hypertension were strong predictors of higher levels of systolic and diastolic BP. Corrective actions were taken with an updated national protocol for hypertension treatment in primary health care. The II Non-Communicable Diseases Survey corroborated MMM national data that we see as an ideal initiative to reach the public, raising awareness about this important cardiovascular risk factor and providing political decision instruments.
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Hypertension is the biggest contributing risk factor to cerebrovascular disease and is associated with increased risk of coronary artery disease. The May Measurement Month (MMM) campaign is a global initiative aimed at raising awareness of hypertension and acting as a temporary solution to the lack of screening programs worldwide. An opportunistic cross-sectional survey of participants aged ≥18 was carried out during May 2019 in Korea. Over 10â000 participants were recruited in the MMM campaign in Korea, with a slogan of 'A simple measure to save lives-#checkyourpressure'. A total of 9975 participants with valid clinical and blood pressure (BP) data were used for analysis. All participants were Korean in ethnicity, mean age was 57.2 (SD ± 21.2) years, 57.7% were females, and the mean body mass index was 23.4 kg/m2 (SD ± 3.3). In total, 37.7% of the participants reported a previous diagnosis of hypertension, and 91.3% of those diagnosed were on antihypertensive medications. For other comorbidities, 11.6% reported having diabetes mellitus, 2.0% had previous stroke, and 1.0% had previous myocardial infarction. Mean BP was 130.0/81.0 mmHg in the overall population. After multiple imputation, 47.6% of participants were classified as hypertensive (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg or on treatment for raised BP). Among all hypertensive participants, the awareness rate, the treatment rate, and the control rate (systolic BP <140 mmHg and diastolic BP <90 mmHg) were 76.2%, 74.0%, and 50.5%, respectively. Of those on antihypertensive medication, the control rate was 68.2%. While awareness and treatment rates were relatively high in the MMM19 campaign, the BP control rate of the total hypertensive population was still only â¼50%, which demands more emphasis on strict BP control.
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Elevated blood pressure (BP) is a growing burden worldwide, leading to over 10 million deaths each year. May Measurement Month (MMM) is a global initiative to raise awareness of high BP and act as a temporary solution to the lack of screening programmes worldwide. We aimed to screen for hypertension and cardiovascular risk factors in people aged ≥18 years in the community, thereby defining the proportion of subjects with elevated BP and assess the awareness and the effectiveness of its treatment. An opportunistic cross-sectional survey of volunteers aged ≥18 years was carried out in May 2019. Blood pressure measurement, the definition of hypertension and statistical analysis followed the standard MMM protocol. From May 2019 to June 2019, through 10 cities/provinces in Vietnam, 25 887 individuals with mean age 48.7 (SD ±17.7) years were screened. After multiple imputations, 8758 (33.8%) had hypertension. Of individuals not receiving antihypertensive medication, 3025 (15.0%) were hypertensive. Of individuals receiving antihypertensive medication, 2800 (48.8%) had uncontrolled BP. Raised BP [systolic BP (SBP) ≥140 mmHg and/or diastolic BP (DBP) ≥90 mmHg] was also associated with additional risk factors including smoking, alcohol intake, previous hypertension in pregnancy, and obesity. May Measurement Month 2019 was the most extensive BP screening campaign ever undertaken in Vietnam. Undiagnosed and uncontrolled hypertension in Vietnam remains a substantial health problem. Local campaigns applying standardized methods such as MMM 2019 will be beneficial to screen for the significant number of individuals with raised BP and increase the awareness of hypertension.
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In Zambia, hypertension accounts for the highest proportion of deaths due to cardiovascular diseases causing 3.3% of all deaths, killing an average of 670 people per year. May Measurement Month (MMM) is an annual global screening campaign aiming to improve awareness of blood pressure (BP) at the individual and population level. Adults (≥18 years) recruited through opportunistic sampling were screened at multiple sites within Lusaka during May and June 2019. Ideally, three BP readings were measured for each participant, and data on lifestyle factors and comorbidities were collected. Data were analysed centrally by the MMM project team and multiple imputations were performed where necessary. Of the total of 9232 enrolled, 8.7% of them had never had their BP measured, 2.5% had diabetes mellitus, 1.9% had had a myocardial infarction, 1.5% had had a stroke, 10.6% were current smokers, and 10.0% consumed alcohol once or more per week. Blood pressure fell from a mean of 128.6/82.9 mmHg for the 1st reading to a mean of 123.2/80.0 mmHg for the 3rd reading. The lowest proportion of participants with hypertension was identified by the 3rd reading alone (30.0%). Of all the participants, 30.7% had hypertension, though only 42.6% of them were aware of their diagnosis. Seven hundred and eighty-three (27.6%) were on antihypertensive medication though only 35.0% of them had controlled BP (systolic BP <140 mmHg and diastolic BP <90 mmHg). Compared with MMM17 data, there is deterioration of the monitored parameters calling for urgent and accelerated public health policy and clinical practice interventions. We think that the MMM campaign should continue annually to raise awareness of this treatable condition.