El Ansari W, Elhag W Weight Regain and Insufficient Weight Loss After Bariatric Surgery: Definitions, Prevalence, Mechanisms, Predictors, Prevention and Management Strategies, and Knowledge Gaps-a Scoping Review. Obes Surg. 2021 Apr;31(4):1755-1766. doi: 10.1007/s11695-020-05160-5. Epub 2021 Feb 8.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Jirapinyo P, de Moura DTH, Thompson CC Endoscopic submucosal dissection with suturing for the treatment of weight regain after gastric bypass: outcomes and comparison with traditional transoral outlet reduction (with video). Gastrointest Endosc. 2020 Jun;91(6):1282-1288. doi: 10.1016/j.gie.2020.01.036. Epub 2020 Jan 31.
Jirapinyo P, Kumar N, AlSamman MA, Thompson CC Five-year outcomes of transoral outlet reduction for the treatment of weight regain after Roux-en-Y gastric bypass. Gastrointest Endosc. 2020 May;91(5):1067-1073. doi: 10.1016/j.gie.2019.11.044. Epub 2019 Dec 7.
Schulman AR, Kumar N, Thompson CC Transoral outlet reduction: a comparison of purse-string with interrupted stitch technique. Gastrointest Endosc. 2018 May;87(5):1222-1228. doi: 10.1016/j.gie.2017.10.034. Epub 2017 Nov 3.
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.
