PRJ2250: Survey of patient and prescriber understanding of risks associated with TROBALT

Trial description: The European Risk Management Plan (RMP) describes the measures taken by GlaxoSmithKline (GSK), the maker of retigabine, to communicate the identified risks associated with retigabine. As part of this RMP, GSK will conduct a survey of physicians’ understanding of specific risks associated with retigabine, as described in the Prescribing Information (PI) and communicated to health care professionals. The goal of the survey is to assess prescriber awareness of label changes for retigabine and evaluate the effectiveness of the communication of recognised risks related to use of retigabine in 11 European markets and Hong Kong. The results of this survey will be used to inform GSK as to whether any additional measures are needed to help ensure appropriate use of the product. The objective of this study is to assess prescribers’ awareness of recent label changes, including the appropriate patient population related to retigabine as evaluated by a survey instrument.This is a cross sectional survey of a targeted sample of 1000 physicians who have prescribed an anti-epileptic drug (AED) at least once in the last 6 months, and who were sent a Dear Healthcare Professional (DHCP) letter in June 2013, and who practice in one of the following 12 countries (Austria, Belgium, Bulgaria, France, Hong Kong, Italy, Norway, Poland, Slovakia, Spain, Switzerland and the United Kingdom). The study will consist of two parts, (1) Comprehension Testing (sample in UK only) to determine if the survey instrument is clear and questions are understood, and (2) the online Physician Survey.The Comprehension Testing will be conducted among a group of 16 physicians in the UK to evaluate the draft survey instrument and study procedures prior to rolling out the Physician Survey in12 countries. A full description of the Comprehension Testing has been detailed in a separate qualitative research plan including a description of the research methodology and the physician sample to be recruited. The findings from the Comprehension Testing will serve as the basis for whether or not any modifications need to be made to the survey instrument.The Physician Survey will be conducted in two phases: Screening Phase and Assessment Phase.The Screening Phase of the survey will include up to 1000 potential prescribers of retigabine (i.e. those who have prescribed any AED within the past 6 months) in order to reach a target sample of 200 prescribers and 200 non-prescribers assuming a recruitment failure of 60%.The respondents will be asked several questions to obtain information on their medical specialty, country in which they practice, AED prescribing history, and whether they have prescribed retigabine. Respondents, who have prescribed retigabine, and a sample of those who have not prescribed retigabine, will be asked to take part in the Assessment Phase of the survey.The purpose of the Assessment Phase of the survey is to evaluate respondents’ understanding of the risks associated with retigabine. There will be approximately 200 prescribing physicians who have prescribed retigabine included in the study across the following countries: Austria, Belgium, Bulgaria, France, Hong Kong, Italy, Norway, Poland, Slovakia, Spain, Switzerland and the United Kingdom. Additionally, there will be up to 200 prescribing physicians who have never or not recently prescribed retigabine selected from all countries.The outcome of the survey is the proportion of physicians providing correct responses to a series of questions concerning specific risks associated with retigabine. Additional analyses will compare the level of understanding between physicians who have prescribed retigabine and those who have never or not recently prescribed the product.