Clinical Outcomes — An Observational Study on Patients With NTM Pulmonary Disease
Citation(s)
Adjemian J, Olivier KN, Seitz AE, Holland SM, Prevots DR Prevalence of nontuberculous mycobacterial lung disease in U.S. Medicare beneficiaries. Am J Respir Crit Care Med. 2012 Apr 15;185(8):881-6. doi: 10.1164/rccm.201111-2016OC. Epub 2012 Feb 3.
Ding LW, Lai CC, Lee LN, Hsueh PR Disease caused by non-tuberculous mycobacteria in a university hospital in Taiwan, 1997-2003. Epidemiol Infect. 2006 Oct;134(5):1060-7. Epub 2006 Feb 22.
Falkinham JO 3rd Environmental sources of nontuberculous mycobacteria. Clin Chest Med. 2015 Mar;36(1):35-41. doi: 10.1016/j.ccm.2014.10.003. Epub 2014 Nov 6. Review.
Gupta RS, Lo B, Son J Phylogenomics and Comparative Genomic Studies Robustly Support Division of the Genus Mycobacterium into an Emended Genus Mycobacterium and Four Novel Genera. Front Microbiol. 2018 Feb 13;9:67. doi: 10.3389/fmicb.2018.00067. eCollection 2018. Erratum in: Front Microbiol. 2019 Apr 09;10:714.
Henkle E, Winthrop KL Nontuberculous mycobacteria infections in immunosuppressed hosts. Clin Chest Med. 2015 Mar;36(1):91-9. doi: 10.1016/j.ccm.2014.11.002. Epub 2014 Dec 23. Review.
Hwang JA, Kim S, Jo KW, Shim TS Natural history of Mycobacterium avium complex lung disease in untreated patients with stable course. Eur Respir J. 2017 Mar 8;49(3). pii: 1600537. doi: 10.1183/13993003.00537-2016. Print 2017 Mar.
Johnson MM, Odell JA Nontuberculous mycobacterial pulmonary infections. J Thorac Dis. 2014 Mar;6(3):210-20. doi: 10.3978/j.issn.2072-1439.2013.12.24. Review.
Kim HO, Lee K, Choi HK, Ha S, Lee SM, Seo GH Incidence, comorbidities, and treatment patterns of nontuberculous mycobacterial infection in South Korea. Medicine (Baltimore). 2019 Nov;98(45):e17869. doi: 10.1097/MD.0000000000017869.
Park J, Cho J, Lee CH, Han SK, Yim JJ Progression and Treatment Outcomes of Lung Disease Caused by Mycobacterium abscessus and Mycobacterium massiliense. Clin Infect Dis. 2017 Feb 1;64(3):301-308. doi: 10.1093/cid/ciw723. Epub 2016 Nov 10. Erratum in: Clin Infect Dis. 2017 May 15;64(10):1469.
Stout JE, Koh WJ, Yew WW Update on pulmonary disease due to non-tuberculous mycobacteria. Int J Infect Dis. 2016 Apr;45:123-34. doi: 10.1016/j.ijid.2016.03.006. Epub 2016 Mar 11. Review.
Thomson R, Donnan E, Konstantinos A Notification of Nontuberculous Mycobacteria: An Australian Perspective. Ann Am Thorac Soc. 2017 Mar;14(3):318-323. doi: 10.1513/AnnalsATS.201612-994OI.
Zweijpfenning SMH, Ingen JV, Hoefsloot W Geographic Distribution of Nontuberculous Mycobacteria Isolated from Clinical Specimens: A Systematic Review. Semin Respir Crit Care Med. 2018 Jun;39(3):336-342. doi: 10.1055/s-0038-1660864. Epub 2018 Aug 2.
A Prospective Observational Study of Parameters Related to the Clinical Outcomes of NTM Pulmonary Disease in Prince of Wales Hospital
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.