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Feasibility of a randomized controlled trial to assess treatment of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection in Saudi Arabia: a survey of physicians.
BMC Anesthesiol. 2016 07 12; 16(1):36.BA

Abstract

BACKGROUND

The Middle East Respiratory Syndrome coronavirus (MERS-CoV) is an emerging respiratory pathogen with a high mortality rate and no specific treatments available to date. The purpose of this study was to determine the feasibility of conducting a randomized controlled trial (RCT) of convalescent plasma therapy for MERS-CoV-infected patients by using MERS-CoV-specific convalescent plasma obtained from previously recovered patients.

METHODS

A survey was adapted from validated questionnaire originally aimed to measure network capacities and capabilities within the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC). The questionnaire was modified for this study to include 26 items that were divided into three main domains of interest: (1) the ability to care for critically ill MERS-CoV patients; (2) laboratory capacity to diagnose MERS-CoV and blood bank ability to prepare convalescent plasma; and (3), research capacity to conduct randomized controlled trials. The questionnaire was emailed to physicians.

RESULTS

Of 582 physicians who were invited to the survey, 327 responded (56.2 %). The professional focus of the majority of respondents was critical care (106/249 (43 %)), pediatrics (59/249, (24 %)) or internal medicine (52/249 (21 %)) but none was blood banking. Nearly all respondents (251/263 (95 %)) reported to have access to ICU facilities within their institutions. Most respondents (219/270 (81 %)) reported that intensivists were the most physician group responsible for treatment decisions about critically ill SARI patients. While 125/165 respondents (76 %) reported that they conduct research in ICUs, and 80/161 (49.7 %) had been involved in the conduct of RCTs, including using a placebo comparison (60/161 (37 %)), only 49/226 (21 %) of respondents regularly participated in research networks.

CONCLUSIONS

Our survey indicated that in the Kingdom of Saudi Arabia (KSA), ICUs are the most likely clinical locations for conducting a clinical trial of convalescent plasma therapy for MERS-CoV, and that most ICUs have experience with such research designs.

Authors+Show Affiliations

Intensive Care Department, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, PO Box 22490, Riyadh, 11426, Saudi Arabia. arabi@ngha.med.sa.Intensive Care Department, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, PO Box 22490, Riyadh, 11426, Saudi Arabia.University of Oxford Centre for Tropical Medicine (CCVTM), Churchill Hospital Old Road, Headington, Oxford, OX3 7LE, UK. International Severe Acute Respiratory & emerging Infection Consortium (ISARIC), Old Road Campus, Headington, OX3 7FZ, UK.Infection Control Department, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.Emergency & Critical Care Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.AlFaisal University, Riyadh, Saudi Arabia.Critical Care & Pulmonary Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah, Saudi Arabia.University of Oxford Centre for Tropical Medicine (CCVTM), Churchill Hospital Old Road, Headington, Oxford, OX3 7LE, UK. International Severe Acute Respiratory & emerging Infection Consortium (ISARIC), Old Road Campus, Headington, OX3 7FZ, UK.Pandemic and Epidemic Diseases Department, World Health Organization, Geneva, Switzerland.Department of Medicine and Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada. Department of Medicine and Interdepartmental Division of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27405596

Citation

Arabi, Yaseen M., et al. "Feasibility of a Randomized Controlled Trial to Assess Treatment of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Infection in Saudi Arabia: a Survey of Physicians." BMC Anesthesiology, vol. 16, no. 1, 2016, p. 36.
Arabi YM, Al-Enezi F, Longuere KS, et al. Feasibility of a randomized controlled trial to assess treatment of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection in Saudi Arabia: a survey of physicians. BMC Anesthesiol. 2016;16(1):36.
Arabi, Y. M., Al-Enezi, F., Longuere, K. S., Balkhy, H. H., Al-Sultan, M., Al-Omari, A., Al-Hameed, F. M., Carson, G., Shindo, N., & Fowler, R. (2016). Feasibility of a randomized controlled trial to assess treatment of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection in Saudi Arabia: a survey of physicians. BMC Anesthesiology, 16(1), 36. https://doi.org/10.1186/s12871-016-0198-x
Arabi YM, et al. Feasibility of a Randomized Controlled Trial to Assess Treatment of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Infection in Saudi Arabia: a Survey of Physicians. BMC Anesthesiol. 2016 07 12;16(1):36. PubMed PMID: 27405596.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Feasibility of a randomized controlled trial to assess treatment of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection in Saudi Arabia: a survey of physicians. AU - Arabi,Yaseen M, AU - Al-Enezi,Farhan, AU - Longuere,Kajsa-Stina, AU - Balkhy,Hanan H, AU - Al-Sultan,Mohamed, AU - Al-Omari,Awad, AU - Al-Hameed,Fahad M, AU - Carson,Gail, AU - Shindo,Nahoko, AU - Fowler,Robert, Y1 - 2016/07/12/ PY - 2015/07/15/received PY - 2016/05/28/accepted PY - 2016/7/14/entrez PY - 2016/7/14/pubmed PY - 2017/10/7/medline KW - Convalescent plasma KW - Middle East respiratory syndrome coronavirus (MERS-CoV) KW - Randomized controlled trial SP - 36 EP - 36 JF - BMC anesthesiology JO - BMC Anesthesiol VL - 16 IS - 1 N2 - BACKGROUND: The Middle East Respiratory Syndrome coronavirus (MERS-CoV) is an emerging respiratory pathogen with a high mortality rate and no specific treatments available to date. The purpose of this study was to determine the feasibility of conducting a randomized controlled trial (RCT) of convalescent plasma therapy for MERS-CoV-infected patients by using MERS-CoV-specific convalescent plasma obtained from previously recovered patients. METHODS: A survey was adapted from validated questionnaire originally aimed to measure network capacities and capabilities within the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC). The questionnaire was modified for this study to include 26 items that were divided into three main domains of interest: (1) the ability to care for critically ill MERS-CoV patients; (2) laboratory capacity to diagnose MERS-CoV and blood bank ability to prepare convalescent plasma; and (3), research capacity to conduct randomized controlled trials. The questionnaire was emailed to physicians. RESULTS: Of 582 physicians who were invited to the survey, 327 responded (56.2 %). The professional focus of the majority of respondents was critical care (106/249 (43 %)), pediatrics (59/249, (24 %)) or internal medicine (52/249 (21 %)) but none was blood banking. Nearly all respondents (251/263 (95 %)) reported to have access to ICU facilities within their institutions. Most respondents (219/270 (81 %)) reported that intensivists were the most physician group responsible for treatment decisions about critically ill SARI patients. While 125/165 respondents (76 %) reported that they conduct research in ICUs, and 80/161 (49.7 %) had been involved in the conduct of RCTs, including using a placebo comparison (60/161 (37 %)), only 49/226 (21 %) of respondents regularly participated in research networks. CONCLUSIONS: Our survey indicated that in the Kingdom of Saudi Arabia (KSA), ICUs are the most likely clinical locations for conducting a clinical trial of convalescent plasma therapy for MERS-CoV, and that most ICUs have experience with such research designs. SN - 1471-2253 UR - https://www.unboundmedicine.com/medline/citation/27405596/Feasibility_of_a_randomized_controlled_trial_to_assess_treatment_of_Middle_East_Respiratory_Syndrome_Coronavirus__MERS_CoV__infection_in_Saudi_Arabia:_a_survey_of_physicians_ L2 - https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-016-0198-x DB - PRIME DP - Unbound Medicine ER -