Contributions
Abstract: P1305
Type: Poster
Abstract Category: Therapy - symptomatic - Quality of life
Objectives: A disease and its treatment may impact patients" lives in different ways that are only known by the patients. This study sought to identify daily life activities important to patients with early stage relapsing remitting multiple sclerosis (RRMS) that are impacted by the disease. Findings will also inform patient-reported outcomes instrument use and development.
Methods: Semi-structured interviews were conducted with RRMS patients scoring 0 or 1 (none to mild disability) on the Patient Determined Disease Steps. Interviews were audio-recorded, transcribed and analysed using an inductive and iterative line-by-line coding technique using ATLAS.TI software. A saturation analysis was conducted in order to confirm the appropriate sample size. Concepts derived from the patient interviews were inductively categorized into conceptual domains and sub-domains. Codes reflecting Impacts of early RRMS were further reviewed and inductively selected for inclusion in a conceptual framework focusing on daily life activities that were identified as relevant and important by early RRMS patients.
Results: A sample of 88 early RRMS patients were interviewed (mean age = 40 years; 74% female), 97% of whom were diagnosed within the previous two years. A rich pool of 446 unique concept codes was generated. These codes were separated into symptoms, bodily function, and impacts. A saturation analysis yielded only 3% (n=12) of the total concept codes emerging in the final eight interviews, suggesting that saturation was reached. The final conceptual framework of daily life activities comprises five sub-domains: Self-care (e.g. dressing and bathing); Domestic life (e.g. shopping, driving, and cleaning); Social and recreational (e.g. attending social events and hobbies); Sports and exercise (e.g. running), and Work and school (e.g. work attendance and productivity).
Conclusions: In order to fully understand the impact of early stage RRMS symptoms, it is vital to collect information about the extent, type and kind of issues important to this patient population. In this study, we have provided a comprehensive conceptual framework of relevant daily life activities important to early stage RRMS patients. This framework can be used as a foundation for future patient-reported outcomes instrument development and selection to quantify and capture the impact of new treatments in a clinically meaningful and individualized way.
Disclosure: The study was funded by Biogen.
Shih-Yin Chen, Jennifer Petrillo, Carmen Castrillo-Viguera, and Diego Cadavid are employees of and stockholders in Biogen.
Farrah Pompilus, Sophie Cleanthous, Stefan Cano, and Patrick Marquis are employees of Modus Outcomes, which received payment from Biogen to conduct this research.
Sara Strzok is a sub-contractor of Modus Outcomes, which received payment from Biogen Pharmaceuticals to conduct this research.
Stan Cohan receives research support from Biogen, Novartis, Mallincrodt, Sanofi-Genzyme, Genentech and Opexa, is a paid consultant and/or serves on advisory boards for Biogen, Sanofi-Genzyme, Novartis and have received speaking honoraria, travel expenses and meals/lodging from Biogen, Novartis, Sanofi-Genzyme, Acorda, and Genentech.
Myla Goldman has received personal consultancy funds from Genzyme and Serepta, institutional consultancy and/or research funds from Acorda, Biogen Idec, and Novartis Pharmaceuticals, and grant supported by the NIH (K23NS062898).
Kiren Kresa-Reahl Speaker"s Bureau Honoraria: Biogen, Novartis, TEVA, EMDSerono, Mallinckrodt, Genzyme. Consultant services: Biogen, Genentech, EMDSerono. Research Support: Biogen, Novartis, Mallinckrodt, Genzyme, Genentech
Abstract: P1305
Type: Poster
Abstract Category: Therapy - symptomatic - Quality of life
Objectives: A disease and its treatment may impact patients" lives in different ways that are only known by the patients. This study sought to identify daily life activities important to patients with early stage relapsing remitting multiple sclerosis (RRMS) that are impacted by the disease. Findings will also inform patient-reported outcomes instrument use and development.
Methods: Semi-structured interviews were conducted with RRMS patients scoring 0 or 1 (none to mild disability) on the Patient Determined Disease Steps. Interviews were audio-recorded, transcribed and analysed using an inductive and iterative line-by-line coding technique using ATLAS.TI software. A saturation analysis was conducted in order to confirm the appropriate sample size. Concepts derived from the patient interviews were inductively categorized into conceptual domains and sub-domains. Codes reflecting Impacts of early RRMS were further reviewed and inductively selected for inclusion in a conceptual framework focusing on daily life activities that were identified as relevant and important by early RRMS patients.
Results: A sample of 88 early RRMS patients were interviewed (mean age = 40 years; 74% female), 97% of whom were diagnosed within the previous two years. A rich pool of 446 unique concept codes was generated. These codes were separated into symptoms, bodily function, and impacts. A saturation analysis yielded only 3% (n=12) of the total concept codes emerging in the final eight interviews, suggesting that saturation was reached. The final conceptual framework of daily life activities comprises five sub-domains: Self-care (e.g. dressing and bathing); Domestic life (e.g. shopping, driving, and cleaning); Social and recreational (e.g. attending social events and hobbies); Sports and exercise (e.g. running), and Work and school (e.g. work attendance and productivity).
Conclusions: In order to fully understand the impact of early stage RRMS symptoms, it is vital to collect information about the extent, type and kind of issues important to this patient population. In this study, we have provided a comprehensive conceptual framework of relevant daily life activities important to early stage RRMS patients. This framework can be used as a foundation for future patient-reported outcomes instrument development and selection to quantify and capture the impact of new treatments in a clinically meaningful and individualized way.
Disclosure: The study was funded by Biogen.
Shih-Yin Chen, Jennifer Petrillo, Carmen Castrillo-Viguera, and Diego Cadavid are employees of and stockholders in Biogen.
Farrah Pompilus, Sophie Cleanthous, Stefan Cano, and Patrick Marquis are employees of Modus Outcomes, which received payment from Biogen to conduct this research.
Sara Strzok is a sub-contractor of Modus Outcomes, which received payment from Biogen Pharmaceuticals to conduct this research.
Stan Cohan receives research support from Biogen, Novartis, Mallincrodt, Sanofi-Genzyme, Genentech and Opexa, is a paid consultant and/or serves on advisory boards for Biogen, Sanofi-Genzyme, Novartis and have received speaking honoraria, travel expenses and meals/lodging from Biogen, Novartis, Sanofi-Genzyme, Acorda, and Genentech.
Myla Goldman has received personal consultancy funds from Genzyme and Serepta, institutional consultancy and/or research funds from Acorda, Biogen Idec, and Novartis Pharmaceuticals, and grant supported by the NIH (K23NS062898).
Kiren Kresa-Reahl Speaker"s Bureau Honoraria: Biogen, Novartis, TEVA, EMDSerono, Mallinckrodt, Genzyme. Consultant services: Biogen, Genentech, EMDSerono. Research Support: Biogen, Novartis, Mallinckrodt, Genzyme, Genentech