A PATIENT-CENTRIC OUTCOMES RESEARCH STUDY WITH A BRANDED PROTON-PUMP INHIBITOR IN A COMMUNITY PHARMACY SETTING- FEASIBILITY AND IMPLEMENTATION OF A REAL-WORLD OBSERVATIONAL OUTCOMES RESEARCH STUDY

Author(s)

Chaponis RJ1, Bayliss M2, Livote E2, Lopes V2, Hospattankar A1
1GlaxoSmithKline, Parsippany, NJ, USA, 2Optum, Lincoln, RI, USA

OBJECTIVES: There is limited experience in recruiting consumers for real world outcomes research in a community-based retail pharmacy setting, particularly those self-selecting over-the-counter (OTC) medications at the point of sale.  A pilot study was conducted  to evaluate the feasibility of conducting observational outcomes research in a cohort of consumers self-treating frequent heartburn (heartburn ≥2 days/week) with a branded version of OTC lansoprazole (15mg) over a 14 day period. METHODS: This was a non-interventional, open-label, single-arm, 14-day prospective study in the retail pharmacy setting.  To facilitate recruitment, potential participants were directed to the pharmacist through a proprietary cash register receipt program after self-selecting and purchasing branded lansoprazole 15mg to treat frequent heartburn. Enrolled subjects were ≥18 years who: provided written informed consent and were willing to complete 2 online assessments. The study excluded those with contraindications to branded lansoprazole 15mg per the OTC label; or participating in any ongoing clinical trial. At Baseline and Day 14, subjects completed a web-based survey on the Smart Measurement® System, assessing HRQoL (4-item heartburn-specific scale) and overall satisfaction with branded lansoprazole 15mg. Data analyses involved descriptive statistics of baseline and change data. RESULTS: Of 580 receipts generated at 17 retail US pharmacies, 10 participants were enrolled (1.7%). 80% of those (n=8) completed the baseline survey and 75% of baseline respondents (n=6) completed the follow-up survey.  Despite the small sample size, all completed study participants reported satisfaction with branded OTC lansoprazole, and improved HRQoL parameters (normal social activities, sleep, and food habits) after treatment. CONCLUSIONS: Though limited conclusions on product use can be drawn because of the sample limitations, this pilot study demonstrated the ability to execute an observational study in a retail pharmacy setting and collect patient data online.  Understanding barriers to recruitment from this study may further improve real-world recruitment methods for future research.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PRM184

Topic

Study Approaches

Disease

Gastrointestinal Disorders

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