Chronic Rhinosinusitis — Determinants of Surgical Outcomes in Chronic Sinusitis
Citation(s)
Chester AC, Sindwani R, Smith TL, Bhattacharyya N Fatigue improvement following endoscopic sinus surgery: a systematic review and meta-analysis. Laryngoscope. 2008 Apr;118(4):730-9. doi: 10.1097/MLG.0b013e318161e57b. Review.
Litvack JR, Griest S, James KE, Smith TL Endoscopic and quality-of-life outcomes after revision endoscopic sinus surgery. Laryngoscope. 2007 Dec;117(12):2233-8.
Poetker DM, Litvack JR, Mace JC, Smith TL Recurrent acute rhinosinusitis: presentation and outcomes of sinus surgery. Am J Rhinol. 2008 May-Jun;22(3):329-33. doi: 10.2500/ajr.2008.22.3177.
Poetker DM, Mendolia-Loffredo S, Smith TL Outcomes of endoscopic sinus surgery for chronic rhinosinusitis associated with sinonasal polyposis. Am J Rhinol. 2007 Jan-Feb;21(1):84-8.
Reh DD, Mace J, Robinson JL, Smith TL Impact of age on presentation of chronic rhinosinusitis and outcomes of endoscopic sinus surgery. Am J Rhinol. 2007 Mar-Apr;21(2):207-13.
Sautter NB, Mace J, Chester AC, Smith TL The effects of endoscopic sinus surgery on level of fatigue in patients with chronic rhinosinusitis. Am J Rhinol. 2008 Jul-Aug;22(4):420-6. doi: 10.2500/ajr.2008.22.3196.
Soler ZM, Mace J, Smith TL Fibromyalgia and chronic rhinosinusitis: outcomes after endoscopic sinus surgery. Am J Rhinol. 2008 Jul-Aug;22(4):427-32. doi: 10.2500/ajr.2008.22.3198.
Soler ZM, Mace J, Smith TL Symptom-based presentation of chronic rhinosinusitis and symptom-specific outcomes after endoscopic sinus surgery. Am J Rhinol. 2008 May-Jun;22(3):297-301. doi: 10.2500/ajr.2008.22.3172.
Stewart MG, Smith TL Objective versus subjective outcomes assessment in rhinology. Am J Rhinol. 2005 Sep-Oct;19(5):529-35.
Determinants of Surgical Outcomes in Chronic Sinusitis
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.