This survey, which consisted of a 25-min, face-to-face, structured, questionnaire-interview, was designed to assess patient perceptions and preferences for the Benepali autoinjector compared to the Enbrel MYCLIC autoinjector. The survey was conducted between December 2015 and April 2016 in France, Germany, Italy, Spain, and the UK. The survey, including the pilot survey, was conducted by Kantar Health, an independent global market research and consulting firm, based in Munich, Germany. Kantar Health performed the survey in accordance with market research guidelines, data protection laws, and data privacy legislation, ensuring the implementation of an effective quality assurance system. Kantar Health operates in compliance with ISO 20252:2012, the International Standard for Market, Opinion and Social Research and, as a member of numerous market research associations, including Arbeitskreis Deutscher Markt und Sozialforschungsinstitute e.V. (ADM), the European Pharmaceutical Marketing Research Association (EphMRA), the Council for American Survey Research Organizations (CASRO), and the European Society for Opinion and Market Research (ESOMAR), strictly adheres to the latest industry codes of conduct and guidelines in market research.
Patient recruitment was outsourced by Kantar Health to another agency, Schmiedl Marktforschung GmbH, who enrolled patients from a number of sources, including patient panels and patient-support groups, as well as recommendations from nurses and physicians. To be eligible to participate in the survey, patients had to have been diagnosed with moderate or severe RA by a physician and had to be using the Enbrel MYCLIC autoinjector for at least 1 month at the time of recruitment into the survey. There were no specific exclusion criteria for this survey. Patients provided written consent before participating in the survey and were compensated for their time with an honorarium.
The survey was developed in a two-stage process, with the guidance on the interview questions and process taken from a recent survey in patients with relapsing–remitting multiple sclerosis, which investigated patients’ perceptions of the importance of different general attributes of autoinjectors . Initially, an English structured quantitative master questionnaire was created, which was then tested and validated in pilot interviews (n = 4) to ensure appropriate content, flow, and clarity of the survey. During these pilot interviews, respondents were asked to provide those autoinjector attributes that they considered to be the most important for inclusion in the main quantitative survey. These interviews were also used to determine whether respondents fully understood the instructions provided with the questionnaire. The final version of the English questionnaire was then translated into four languages (German, Italian, French, and Spanish). All interviews were conducted in the relevant local language and were performed by experienced interviewers working on behalf of the recruitment agency (Schmiedl Marktforschung GmbH). Interviewer training was conducted by Kantar Health via video conference prior to commencement of the survey, with scheduled weekly feedback calls to check on the progress of the interviews and to ensure that they were being performed correctly.
During a 25-min face-to-face interview, each patient was asked a series of questions in sequence by the interviewer and all responses were documented. In addition, patients were shown an instructional video and device-handling leaflet for the Benepali autoinjector, received a live demonstration on the Benepali training autoinjector, and were given access to both the Benepali and Enbrel MYCLIC training autoinjectors.
The questionnaire was broadly divided into four sections. In the first section (Q1), patients were asked to rate the importance of ten attributes, when using an autoinjector device in general for self-injection of their RA treatment, on a seven-point scale (1 = not important at all; 7 = extremely important). The following attributes were assessed: (1) size of the autoinjector, (2) attractive design of the autoinjector, (3) easy to grip the autoinjector, (4) easy to operate the self-injection with the autoinjector, (5) audible feedback after treatment has been successfully injected, (6) visual feedback after treatment has been successfully injected, (7) concealing the injection needle in the injector body, (8) intuitive/self-explaining usage, (9) button-free autoinjector, and (10) weight of the autoinjector. In the second section of the questionnaire (Q2–Q11), patients were asked for their preference of autoinjector (Benepali, Enbrel MYCLIC, or both the same) based on nine of the ten attributes assessed in section 1 (button-free device was excluded from this section as this attribute related only to the Benepali autoinjector). In the third section of the questionnaire (Q12–Q13), patients were asked which autoinjector they would prefer to use for self-injection of their RA treatment (Benepali, Enbrel MYCLIC, or no preference), taking into consideration the information that they had received from the instructional video and device-handling leaflet, their own previous experience of handling the Enbrel MYCLIC autoinjector and their first experience of handling the Benepali autoinjector. Patients were then asked to select the top three attributes that drove their preference for one autoinjector over the other, based on the attributes assessed in section 1 of the questionnaire. The final section of the questionnaire included questions on patient demographics, including country of origin, gender, and age (see supplementary material for full details on the questionnaire).
The analysis population included all patients who completed the survey. During the face-to-face interviews, patient responses were recorded by the interviewer and data input from all interviews was collected by the recruitment agency (Schmiedl Marktforschung GmbH). All analyses were performed by Kantar Health. Based on the results of previous quantitative primary market research surveys, a minimum of 30 respondents per country is a validated and robust sample size and an eligible base for significant testing . Statistical significance was estimated using Student’s t test (Microsoft Excel, Ver. 2013, Microsoft Corp. Redmond, WA, USA).