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1. Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial

Author

McGree, J.M., Hockham, C., Kotwal, S., Wilcox, A., Bassi, A., Pollock, C., Burrell, L.M., Snelling, T., Jha, V., Jardine, M., Jones, M., and for the CLARITY Trial Steering Committee

Subjects
Coronavirus, Angiotensin Receptor Antagonists, Data Interpretation, Statistical, Sample Size, Respiratory Tract Diseases, COVID-19, Medicine (miscellaneous), Humans, Pharmacology (medical), Bayes Theorem, COVID-19 Drug Treatment
Abstract

The CLARITY trial (Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease) is a two-arm, multi-centre, randomised controlled trial being run in India and Australia that investigates the effectiveness of angiotensin receptor blockers in addition to standard care compared to placebo (in Indian sites) with standard care in reducing the duration and severity of lung failure in patients with COVID-19. The trial was designed as a Bayesian adaptive sample size trial with regular planned analyses where pre-specified decision rules will be assessed to determine whether the trial should be stopped due to sufficient evidence of treatment effectiveness or futility. Here, we describe the statistical analysis plan for the trial and define the pre-specified decision rules, including those that could lead to the trial being halted. The primary outcome is clinical status on a 7-point ordinal scale adapted from the WHO Clinical Progression scale assessed at day 14. The primary analysis will follow the intention-to-treat principle. A Bayesian adaptive trial design was selected because there is considerable uncertainty about the extent of potential benefit of this treatment.Trial registrationClinicalTrials.gov NCT04394117. Registered on 19 May 2020Clinical Trial Registry of India CTRI/2020/07/026831Version and revisionsVersion 1.0. No revisions.

Published
2021

5. May Measurement Month 2017: an analysis of blood pressure screening results from Australia - South-East Asia and Australasia

Author

Carnagarin, R., Fonseca, R., Brockman, D., Hering, D., Matthews, V.B., Mihailidou, A., Reid, Christopher, Lee, R., Lambert, G.W., Burrell, L.M., Sharman, J.E., Xia, X., Poulter, N.R., Beaney, T., Islam, S.M., Carrington, M., Schlaich, M.P., Carnagarin, R., Fonseca, R., Brockman, D., Hering, D., Matthews, V.B., Mihailidou, A., Reid, Christopher, Lee, R., Lambert, G.W., Burrell, L.M., Sharman, J.E., Xia, X., Poulter, N.R., Beaney, T., Islam, S.M., Carrington, M., and Schlaich, M.P.

Abstract

Increased blood pressure (BP) is the single biggest contributing risk factor to the global disease burden. May Measurement Month (MMM) is a global initiative of the International Society of Hypertension aimed at raising awareness of high BP. In Australia, hypertension affects around six million adults and continues to remain the greatest attributable cause of cardiovascular mortality and morbidity (48.3%), stroke deaths (28%), and kidney disease (14%). An opportunistic cross-sectional survey was carried out during May 2017 predominantly in capital cities across Australia which included adult volunteers. Blood pressure measurement, the definition of hypertension and statistical analysis followed the standard MMM protocol. Additional information obtained included anthropometric data and responses to questionnaires on demographic, lifestyle, and environmental factors. Data were collected from 3817 individuals. After multiple imputation, of the 3758 individuals for whom a mean of the second and third BP reading was available, 1188 (31.2%) had hypertension. Of 3213 individuals not receiving antihypertensive treatment, 591 (18.4%) were hypertensive, and 239 (40.1%) of the 596 individuals receiving treatment had uncontrolled BP. Adjusted BP was higher in association with antihypertensive medication, cerebrovascular disease, smoking, and alcohol consumption. Blood pressure was higher when measured on the right arm and on Tuesdays. MMM17 was one of the largest BP screening campaigns undertaken in Australia using standardized BP measurements. In line with previous surveys, around one-third of screened adults had hypertension and approximately 40% of treated individuals remained uncontrolled. These results suggest that opportunistic screening can identify significant numbers with raised BP.

Published
2019

8. Passive ventricular constraint amends the course of heart failure: a study in an ovine model of dilated cardiomyopathy.

Author

Power, J.M, Raman, J, Dornom, A, Farish, S.J, Burrell, L.M, Tonkin, A.M, Buxton, B, and Alferness, C.A

Abstract

Objective: Dilated cardiomyopathy (DCM) is associated with a progressive deterioration in cardiac function. We hypothesised that some of the deleterious effects of DCM could be reduced by mechanically limiting the degree of cardiac dilatation. Methods: A Transonic 20A cardiac output (CO) flow-probe was implanted in the pulmonary artery of 12 adult (52±4 kg) sheep. Early heart failure was created by rapid right ventricular (RV) pacing for 21 days at a rate which resulted in an initial 10% decrease in CO (to a maximum of 190 bpm). A custom polyester jacket (Acorn Cardiovascular, St Paul, MN) was then placed, via a partial lower sternotomy, on the ventricular epicardium of all sheep. Animals were randomised either to jacket retention (wrap) or removal (sham). Pacing was recommenced at a higher rate (that initiated a further 10% decrease in CO) for 28 days. Haemodynamic and echocardiographic parameters were determined at baseline, implant and at termination. Results: At termination, the left ventricular fractional shortening was significantly higher (p=0.03), the degree of mitral valve regurgitation lower (scaled 0–3) (p=0.03) and the left ventricular long axis area smaller (p=0.02) in the wrap animals compared with sham. Conclusions: In this model of heart failure, ventricular constraint with a polyester jacket diminished the deterioration in cardiac function associated with progressive dilated cardiomyopathy. These results suggest that maintainance of a more normal cardiac size and shape may be beneficial in patients with dilated cardiomyopathy. [ABSTRACT FROM PUBLISHER]

Published
1999
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9. Negative regulators may mediate some of the inhibitory effects of HIV‐1 infected stromal cell layers on erythropoiesis and myelopoiesis in human bone marrow long term cultures

Author

Schwartz, G.N., Kessler, S.W., Szabo, J.M., Burrell, L.M., and Francisš, M.L.

Abstract

This report presents results concerning the potential role of negative regulators in hematopoietic suppression observed in human immunodeficiency virus (HIV)‐infected long‐term cultures (LTC) of human bone marrow cells. Confluent stromal cell layers established from human bone marrow cells were exposed to HIV‐1ADA, a monocytotropic strain of HIV‐1. A progressive increase in the concentration of HIV‐1 p24 antigen in cultures exposed to HIV‐1ADAdemonstrated that there was a productive infection. Cells from both noninfected and HIV‐infected stromal cell layers produced factors that stimulated the proliferation of colony‐forming units for granulocytes and macrophages (CFU‐GM) from noninfected CD34+cells. In contrast, when noninfected CD34+cells were directly cocultured on intact stromal cell layers fewer CFU‐GM and burst‐forming units for erythroid cells (BFU‐E) were detected in HIV‐infected LTC than in noninfected LTC. One week after the addition of CD34+cells, the number of CFU‐GM in HTV‐infected LTC in six of nine experiments was reduced compared to noninfected control LTC. In those six experiments, the number of CFU‐GM was only 53 ± 5% (SEM) of the number in noninfected LTC. The number of BFU‐E in HIV‐1‐infected LTC was only 46 ± 5% of the number in noninfected LTC (n= 5). There were fewer BFU‐E in HIV‐1‐infected LTC, whether or not there was a reduced number of CFU‐GM. Neutralizing antibody to tumor necrosis factor α (TNF‐α) had no effect on the number of BFU‐E in HIV‐infected LTC. The number of BFU‐E, however, was 2.1 ± 0.2‐fold greater (n= 3) in HIV‐infected LTC incubated with neutralizing antibody to interferon‐α. In HIV‐infected LTC with decreased numbers of CFU‐GM, the number of CFU‐GM was approximately 2‐fold greater after incubation of HIV‐infected LTC with anti–interleukin‐4 (IL‐4). The effect of anti–TNF‐α was variable, and anti–transforming growth factor‐β had no effect on the number of CFU‐GM in HIV‐infected LTC. After 2 weeks, the number of CFU‐GM in HIV‐infected LTC incubated with anti–IL‐4 and anti–TNF‐α was 2‐ to 4‐fold greater than in untreated HIV‐infected LTC. Antibody treatment did not promote an increase in the number of CFU‐GM in noninfected LTC or in LTC in which CFU‐GM numbers were not reduced after HIV infection. These results demonstrate that some cells in the stromal cell layers of LTC were targets for HTV‐1ADA, and that HIV‐infected stromal cell layers suppressed or delayed the production of both CFU‐GM and BFU‐E. These results also suggest that hematopoietic suppression in HIV‐infected LTC may be mediated by growth‐inhibitory cytokines that are different for erythropoiesis and myelopoiesis. J. Leukoc. Biol.57: 948–955; 1995.

Published
1995
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10. May Measurement Month 2018: a pragmatic global screening campaign to raise awareness of blood pressure by the International Society of Hypertension

Author

Beaney, Thomas, Burrell, Louise M, Castillo, Rafael R, Charchar, Fadi J, Cro, Suzie, Damasceno, Albertino, Kruger, Ruan, Nilsson, Peter M, Prabhakaran, Dorairaj, Ramirez, Agustin J, Schlaich, Markus P, Schutte, Aletta E, Tomaszewski, Maciej, Touyz, Rhian, Wang, Ji-Guang, Weber, Michael A, Poulter, Neil R, Burazeri, Genc, Qirjako, Gentiana, Roshi, Enver, Cunashi, Rudina, Fernandes, Mario J C C, Victória Pereira, Savarino S, Neto, Marisa F M P, Oliveira, Pombalino N M, Feijão, Ana C G, Cerniello, Yamila, Marin, Marcos J, Garcia Vasquez, Fortunato, Espeche, Walter G, Stisman, Diego, Fuentes, Inés A, Zilberman, Juith M, Rodriguez, Pablo, Babinyan, Kamsar Yu, Engibaryan, Anna H, Avagyan, Avag M, Minasyan, Arsen A, Gevorkyan, Ani T, Carnagarin, Revathy, Carrington, Melinda J, Sharman, James E, Lee, Rebecca, Perl, Sabine, Niederl, Ella, Malik, Fazila-Tun-Nesa, Choudhury, Sohel R, Al Mamun, Mohammad A, Ishraquzzaman, Mir, Anthony, Fiona, Connell, Kenneth, De Backer, Tine L M, Krzesinski, Jea, Houenassi, Martin D, Houehanou, Corine Y, Sokolovic, Sekib, Bahtijarevic, Rankica, Tiro, Mary B, Mosepele, Mosepele, Masupe, Tiny K, Barroso, Weimar S, Gomes, Marco A M, Feitosa, Audes D M, Brandão, Andrea A, Miranda, Roberto D, Azevedo, Vanda M A A, Dias, Luis M, Garcia, Glenda D N, Martins, Idiana P P, Dzudie, Anastase, Kingue, Samuel, Djomou, Florent A N, Njume, Epie, Khan, Nadia, Lanas, Fernando T, Garcia, Maria S, Paccot, Melanie F, Torres, Pamela I, Li, Yan, Liu, Min, Xu, Liying, Li, Li, Chen, Xin, Deng, Junping, Zhao, Wenwu, Fu, Lingjuan, Zhou, Yi, Lopez-Jaramillo, Patricio, Otero, Johanna, Camacho, Paul A, Accini, Jose L, Sanchez, Gregorio, Arcos, Edgar, M’Buyamba-Kabangu, Jean-René, Katamba, Fortunat K, Ngoyi, Georges N, Buila, Nathan M, Bayauli, Pascal M, Ellenga Mbolla, Bertrand F, Bakekolo, Paterne R, Kouala Landa, Christian M, Kimbally Kaky, Gisele S, Kramoh, Euloge K, Ngoran, Yves N K, Olsen, Michael H, Valdez Valoy, Laura, Santillan, Marcos, Angel Rafael, Gonzalez Medina, Peñaherrera, Carlos E, Villalba, Jose, Ramirez, Maria I, Arteaga, Fabricio, Delgado, Patricia, Beistline, Holly, Cappuccio, Francesco P, Keitley, James, Tay, Tricia, Goshu, Dejuma Y, Kassie, Desalew M, Gebru, Sintayehu A, Pathak, Atul, Denolle, Thierry, Tsinamdzgvrishvili, Bezhan, Trapaidze, Dali, Sturua, Lela, Abesadze, Tamar, Grdzelidze, Nino, Grabfelder, Mark, Krämer, Bernhard K, Schmeider, Roland E, Twumasi-Ankrah, Betty, Tannor, Elliot K, Lincoln, Mary D, Deku, Enoch M, Wyss Quintana, Fernando S, Kenerson, John, Jean Baptiste, Emmanuela D, Saintilmond, Wideline W, Barrientos, Ana L, Peiger, Briggitte, Lagos, Ashley R, Forgas, Marcelo A, Lee, Vivian W Y, Tomlinson, Brian W Y, Járai, Zoltán, Páll, Dénes, More, Arun, Maheshwari, Anuj, Verma, Narsingh, Sharma, Meenakshi, Mukherjee, Tapan K, Patil, Mansi, Pulikkottil Jose, Arun, Takalkar, Anant, Turana, Yuda, Widyantoro, Bambang, Danny, Siska S, Djono, Suhar, Handari, Saskia D, Tambunan, Marihot, Tiksnadi, Badai B, Hermiawaty, Eka, Tavassoli, Elham, Zolfaghari, Mahsa, Dolan, Eamon, O'Brien, Eoin, Borghi, Claudio, Ferri, Claudio, Torlasco, Camilla, Parati, Gianfranco, Nwokocha, Chukwuemeka R, Nwokocha, Magdalene I, Ogola, Elijah N, Gitura, Bernard M, Barasa, Anders L, Barasa, Felix A, Wairagu, Anne W, Nalwa, Wafula Z, Najem, Robert N, Abu Alfa, Ali K, Fageh, Hatem A, Msalam, Omar M, Derbi, Hawa A, Bettamar, Kzaki A, Zakauskiene, Urte, Vickiene, Alvita, Calmes, Jessica, Alkerwi, Ala'a, Gantenbein, Manon, Ndhlovu, Henry L L, Masiye, Jones K, Chirwa, Maureen L, Nyirenda, Nancy M, Dhlamini, Tiyezge D, Chia, Yook C, Ching, Siew M, Devaraj, Navin K, Ouane, Nouhoum, Fane, Tidiani, Kowlessur, Sudhir, Ori, Bhooshun, Heecharan, Jaysing, Alcocer, Luis, Chavez, Adolfo, Ruiz, Griselda, Espinosa, Cutberto, Gomez-Alvarez, Enrique, Neupane, Dinesh, Bhattarai, Harikrishna, Ranabhat, Kamal, Adhikari, Tara B, Koirala, Sweta, Toure, Ibrahim A, Soumana, Kabirou H, Wahab, Kolawole W, Omotoso, Ayodele B, Sani, Mahmoud U, Okubadejo, Njideka U, Nadar, Sunil K, Al-Riyami, Hassan A, Ishaq, Mohammad, Memon, Feroz, Sidique, Sualat, Choudhry, Hafeez A, Khan, Rasheed A, Ayala, Myrian, Maidana, Angel J O, Bogado, Graciela GG, Ona, Deborah I, Atilano, Alberto, Granada, Carmela, Bartolome, Regina, Manese, Loudes, Mina, Arnold, Dumlao, Maria C, Villaruel, Mariyln C, Gomez, lynn, Jóźwiak, Jacek, Małyszko, Jolanta, Banach, Maciej, Mastej, Mirosław, de Carvalho Rodrigues, Manuel M, Martins, Luis L, Paval, Alexandra, Dorobantu, Maria, Konradi, Alexandra O, Chazova, Irina E, Rotar, Oxana, Spoares, Miryan C, Viegas, Deolsanik, Almustafa, Bader A, Alshurafa, Saleh A, Brady, Adrian, Bovet, Pascal, Viswanathan, Bharathi, Oladapo, Olulola O, Russell, James W, Brguljan-Hitij, Jana, Bozic, Nina, Knez, Judita, Dolenc, Primoz, Hassan, Mohammed M, Woodiwiss, Angela J, Myburgh, Caitlynd, Vally, Muhammed, Ruilope, Luis M, Molinero, Ana, Rodilla, Enrique, Gijón-Conde, Teresa, Beheiry, Hind M, Ali, I A, Osman, Asma A A, fahal, Naiema A W, Osman, Hana A, Altahir, Fatima, Persson, Margaretha, Wuerzner, Gregoire, Burkard, Thilo, Wang, Tzung-Dau, Lin, Hung-Ju, Pan, Heng-Yu, Chen, Wen-Jone, Lin, Eric, Mondo, Charles K, Ingabire, Prossie M, Khomazyuk, Tatyana TA, Krotova, Viktoriia V-Yu, Negresku, Elena, Evstigneeva, Olena, Bazargani, Nooshin NB, Agrawal, Amrish, Bin Belaila, Buthaina A, Suhail, Aisha M, Muhammed, Khalifa O, Shuri, Hassan H, Wainford, Richard D, Levy, Philip D, Boggia, José JG, Garré, Laura L, Hernandez-Hernandez, Rafael, Octavio-Seijas, Jose A, Lopez-Rivera, Jesus A, Morr, Igor, Duin, Amanda, Huynh, Minh V, Cao, Sinh T, Nguyen, Viet L, To, Muoi, Phan, Hung N, Cockroft, John, McDonnell, Barry, Goma, Fastone M, Syatalimi, Charity, Chifamba, Jephat, Gwini, Rudo, Tiburcio, Osiris Valdez, Xia, Xin, 20035632 - Kruger, Ruan, 10922180 - Schutte, Aletta Elisabeth, Beaney T., Burrell L.M., Castillo R.R., Charchar F.J., Cro S., Damasceno A., Kruger R., Nilsson P.M., Prabhakaran D., Ramirez A.J., Schlaich M.P., Schutte A.E., Tomaszewski M., Touyz R., Wang J.-G., Weber M.A., Poulter N.R., and Borghi C

Subjects
Male, Cardiac & Cardiovascular Systems, Cross-sectional study, Blood Pressure, 030204 cardiovascular system & hematology, Global Burden of Disease, 0302 clinical medicine, Surveys and Questionnaires, MMM Investigators, Mass Screening, 030212 general & internal medicine, 1102 Cardiorespiratory Medicine and Haematology, Antihypertensive medication, RISK, Global, Awareness, Middle Aged, PREVALENCE, Hypertension, Blood pressure, Screening, Raised blood pressure, Female, Cardiology and Cardiovascular Medicine, BURDEN, Life Sciences & Biomedicine, Control, Adult, medicine.medical_specialty, Fast Track Clinical Research, Opportunistic Sampling, 03 medical and health sciences, Internal medicine, medicine, SYSTEMATIC ANALYSIS, MANAGEMENT, Humans, Mass screening, Disease burden, Antihypertensive Agents, Science & Technology, business.industry, Case-control study, Blood Pressure Determination, Treatment, Editor's Choice, RAMADAN, Cross-Sectional Studies, Cardiovascular System & Hematology, Case-Control Studies, Cardiovascular System & Cardiology, business, Hypertension, Blood pressure, Screening, Global, Treatment, Control
Abstract

Aims Raised blood pressure (BP) is the biggest contributor to mortality and disease burden worldwide and fewer than half of those with hypertension are aware of it. May Measurement Month (MMM) is a global campaign set up in 2017, to raise awareness of high BP and as a pragmatic solution to a lack of formal screening worldwide. The 2018 campaign was expanded, aiming to include more participants and countries. Methods and results Eighty-nine countries participated in MMM 2018. Volunteers (≥18 years) were recruited through opportunistic sampling at a variety of screening sites. Each participant had three BP measurements and completed a questionnaire on demographic, lifestyle, and environmental factors. Hypertension was defined as a systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, or taking antihypertensive medication. In total, 74.9% of screenees provided three BP readings. Multiple imputation using chained equations was used to impute missing readings. 1 504 963 individuals (mean age 45.3 years; 52.4% female) were screened. After multiple imputation, 502 079 (33.4%) individuals had hypertension, of whom 59.5% were aware of their diagnosis and 55.3% were taking antihypertensive medication. Of those on medication, 60.0% were controlled and of all hypertensives, 33.2% were controlled. We detected 224 285 individuals with untreated hypertension and 111 214 individuals with inadequately treated (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg) hypertension. Conclusion May Measurement Month expanded significantly compared with 2017, including more participants in more countries. The campaign identified over 335 000 adults with untreated or inadequately treated hypertension. In the absence of systematic screening programmes, MMM was effective at raising awareness at least among these individuals at risk.

Published
2019
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