A minimal common outcome measure set for COVID-19 clinical research

The Lancet Infectious Diseases

Volumn 20, Issue 8, 2020, Pages e192-e197

  Marshall, John C ^a   Murthy, Srinivas ^a   Diaz, Janet ^a   Adhikari, Neil ^a   Angus, Derek C ^a   Arabi, Yaseen M ^a   Baillie, Kenneth ^a   Bauer, Michael ^a   Berry, Scott ^a   Blackwood, Bronagh ^a   Bonten, Marc ^a   Bozza, Fernando ^a   Brunkhorst, Frank ^a   Cheng, Allen ^a   Clarke, Mike ^a   Dat, Vu Quoc ^a   de Jong, Menno ^a   Denholm, Justin ^a   Derde, Lennie ^a   Dunning, Jake ^a   Feng, Xiaobin ^a   Fletcher, Tom ^a   Foster, Nadine ^a   Fowler, Rob ^a   Gobat, Nina ^a   Gomersall, Charles ^a   Gordon, Anthony ^a   Glueck, Thomas ^a   Harhay, Michael ^a   Hodgson, Carol ^a   Horby, Peter ^a   Kim, YaeJean ^a   Kojan, Richard ^a   Kumar, Bharath ^a   Laffey, John ^a   Malvey, Denis ^a   Martin Loeches, Ignacio ^a   McArthur, Colin ^a   McAuley, Danny ^a   McBride, Stephen ^a   McGuinness, Shay ^a   Merson, Laura ^a   Morpeth, Susan ^a   Needham, Dale ^a   Netea, Mihai ^a   Oh, Myoung Don ^a   Phyu, Sabai ^a   Piva, Simone ^a   Qiu, Ruijin ^a   Salisu Kabara, Halima ^a   Shi, Lei ^a   Shimizu, Naoki ^a   Sinclair, Jorge ^a   Tong, Steven ^a   Turgeon, Alexis ^a   Uyeki, Tim ^a   van de Veerdonk, Frank ^a   Webb, Steve ^a   Williamson, Paula ^a   Wolf, Timo ^a   Zhang, Junhua ^a   more..

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL OUTCOME; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CORONAVIRUS DISEASE 2019; DISEASE ASSESSMENT; DISEASE EXACERBATION; HEALTH CARE SYSTEM; HOSPITAL DISCHARGE; HUMAN; MORTALITY RATE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUESTIONNAIRE; REAL TIME POLYMERASE CHAIN REACTION; REVIEW; SURVIVAL RATE; VIRUS LOAD; WHO CLINICAL PROGRESSION SCALE; WORLD HEALTH ORGANIZATION; BETACORONAVIRUS; CORONAVIRUS INFECTION; ISOLATION AND PURIFICATION; PANDEMIC; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VIRUS PNEUMONIA;

BETACORONAVIRUS; CLINICAL TRIALS AS TOPIC; CORONAVIRUS INFECTIONS; HUMANS; OUTCOME ASSESSMENT, HEALTH CARE; PANDEMICS; PATIENT OUTCOME ASSESSMENT; PNEUMONIA, VIRAL; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VIRAL LOAD;

EID: 85086916476     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(20)30483-7     Document Type: Review

References (30)

1. Gates, B, Innovation for pandemics. N Engl J Med 378 (2018), 2057–2060.
2. Marston, HD, Paules, CI, Fauci, AS, The critical role of biomedical research in pandemic preparedness. JAMA 318 (2017), 1757–1758.
3. Keusch, GT, McAdam, KPWJ, Clinical trials during epidemics. Lancet 389 (2017), 2455–2457.
4. Williamson, PR, Altman, DG, Blazeby, JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials, 13, 2012, 132.
5. Clarke, M, Williamson, PR, Core outcome sets and systematic reviews. Syst Rev, 5, 2016, 11.
6. WHO. International Clinical Trials Registry Platform (ICTRP). https://www.who.int/ictrp/search/en. (Accessed 25 April 2020)
7. Guan, WJ, Ni, ZY, Hu, Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 382 (2020), 1708–1720.
8. Wang, D, Hu, B, Hu, C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA 323 (2020), 1061–1069.
9. Huang, C, Wang, Y, Li, X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 395 (2020), 497–506.
10. Grasselli, G, Zangrillo, A, Zanella, A, et al. Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy region, Italy. JAMA 323 (2020), 1574–1581.
11. Goyal, P, Choi, JJ, Pinheiro, LC, et al. Clinical characteristics of Covid-19 in New York City. N Engl J Med, 2020 published online April 17. DOI:10.1056/NEJMc2010419.
12. International Severe Acute Respiratory and Emerging Infections Consortium. COVID-19 report: 08 April 2020. https://media.tghn.org/medialibrary/2020/04/ISARIC_Data_Platform_COVID-19_Report_8APR20.pdf. (Accessed 22 April 2020)
13. Baud, D, Qi, X, Nielsen-Saines, K, Musso, D, Pomar, L, Favre, G, Real estimates of mortality following COVID-19 infection. Lancet Infect Dis, 2020 published online March 12. https://doi.org/10.1016/S1473-3099(20)30195-X.
14. Wu, JT, Leung, K, Bushman, M, et al. Estimating clinical severity of COVID-19 from the transmission dynamics in Wuhan, China. Nat Med 26 (2020), 506–510.
15. Ji, Y, Ma, Z, Peppelenbosch, MP, Pan, Q, Potential association between COVID-19 mortality and health-care resource availability. Lancet Glob Health, 8, 2020, e480.
16. Jernigan, DB, Update: public health response to the coronavirus disease 2019 outbreak—United States, February 24, 2020. MMWR Morb Mortal Wkly Rep 69 (2020), 216–219.
17. Johns Hopkins University and Medicine. Coronavirus resource center: mortality analyses. https://coronavirus.jhu.edu/data/mortality, 2020. (Accessed 24 April 2020)
18. Llitjos, JF, Leclerc, M, Chochois, C, et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients. J Thromb Haemost, 2020 published online April 22. DOI:10.1111/jth.14869.
19. Xie, X, Zhong, Z, Zhao, W, Zheng, C, Wang, F, Liu, J, Chest CT for typical 2019-nCoV pneumonia: relationship to negative RT-PCR testing. Radiology, 2020 published online Feb 12. DOI:10.1148/radiol.2020200343.
20. Xu, Y, Liu, H, Hu, K, Wang, M, Clinical management of lung cancer patients during the outbreak of 2019 novel coronavirus disease (COVID-19). Zhongguo Fei Ai Za Zhi 23 (2020), 136–141.
21. Beigel, JH, Aga, E, Elie-Turenne, M-C, et al. Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial. Lancet Respir Med 7 (2019), 941–950.
22. Cao, B, Wang, Y, Wen, D, et al. A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19. N Engl J Med 382 (2020), 1787–1799.
23. Knapp, TR, Treating ordinal scales as interval scales: an attempt to resolve the controversy. Nurs Res 39 (1990), 121–123.
24. Norman, G, Likert scales, levels of measurement and the “laws” of statistics. Adv Health Sci Educ Theory Pract 15 (2010), 625–632.
25. Hobart, JC, Cano, SJ, Zajicek, JP, Thompson, AJ, Rating scales as outcome measures for clinical trials in neurology: problems, solutions, and recommendations. Lancet Neurol 6 (2007), 1094–1105.
26. Kirkham, JJ, Boers, M, Tugwell, P, Clarke, M, Williamson, PR, Outcome measures in rheumatoid arthritis randomised trials over the last 50 years. Trials, 14, 2013, 324.
27. Leon, AC, Olfson, M, Portera, L, Farber, L, Sheehan, DV, Assessing psychiatric impairment in primary care with the Sheehan Disability Scale. Int J Psychiatry Med 27 (1997), 93–105.
28. Liu, HI, Tsai, JR, Chung, WH, Bock, CH, Chiang, KS, Effects of quantitative ordinal scale design on the accuracy of estimates of mean disease severity. Agronomy, 9, 2019, 565.
29. WHO. Global COVID-19: clinical platform: novel coronavius (COVID-19): rapid version. https://www.who.int/publications-detail/global-covid-19-clinical-platform-novel-coronavius-(-covid-19)-rapid-version, April 16, 2020. (Accessed 22 April 2020)
30. WHO. “Solidarity” clinical trial for COVID-19 treatments. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments, 2020. (Accessed 24 April 2020)