This pilot study for a new method of conducting post-marketing surveillance uses two drugs, Levsin and Bentyl, as the drugs of interest. These drugs are standard drug therapy for irritable bowel syndrome (IBS). Patients over the age of 18 who fill a prescription for Levsin or Bentyl through one of the Eckerd Pharmacy chain stores will be eligible to participate. Patients will be contacted by the Eckerd Intervention Center, which is staffed by pharmacists and pharmacy technicians to assist with a variety of programs that Eckerd undertakes. For this study, they will use materials prepared by SEC study personnel to approach eligible subjects and invite them to participate.
Because this is a pilot study of a new method, we will be evaluating various approaches to determine the most effective methods of recruiting study subjects. Potential subjects will be randomly assigned to receive either a) an initial phone call explaining the study or b) a mail packet describing the study and including the consent form and initial questionnaire. Half of each of these two groups will be offered a $5 payment.
The study group will consist of those who return the questionnaire. The initial questionnaire will focus on gastrointestinal symptoms, as well as basic demographic information.
Subjects who return the signed consent and initial questionnaire will receive a follow-up questionnaire one month later. The questionnaire will inquire about current gastrointestinal symptoms and history of other drug treatments. In addition, subjects who report having been hospitalized will be asked to sign a medical record release form to allow us to review details of the hospitalization. In the pilot phase, there will be no further follow-up of these subjects.
A particular strength of this approach relates to validity: the Eckerd database will allow us to assess the representativeness of the enrolled population with regard to selected characteristics, such as age, sex, zip code of residence, and payment method (i.e. insurance or self-pay).