Contributions
Abstract: P1207
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: There is a growing need for patient and public involvement (PPI) to influence the way that research is prioritized, commissioned, designed, executed, interpreted and disseminated. Randomised controlled trials (RCTs) are particularly likely to benefit from PPI. Little is known about how or when researchers incorporate PPI in their RCTs and the impact of this involvement. Sharing models of effective PPI in RCTs will help maximize potential and evaluate impact.
Objective/Aims: Describe the use of PPI within the development of an application, early design and site setting of an international clinical trial comparing treatment approaches in multiple sclerosis (MS).
Methods: DELIVER-MS is an international clinical trial funded by the Patient Centered Outcomes Research Institute (PCORI) aiming to recruit 800 people with MS (pwMS). The research theme was prioritized by PCORI on the basis of patient-engagement, in line with research priorities identified by the MS Society-James Lind Alliance Priority Setting Partnership. PPI involvement followed a structured approach, aiming to minimize bias and achieve equivalence in the design, implementation and interpretation of the study:
- PPI contributors as members of the research team and inputting across all stages of the study
- Study design was influenced by PPI within the outline and full application stage including five heterogeneous focus groups (n= 35) in the US and UK
- Ongoing involvement of PPI contributors on the study advisory board
- In preparation for trial recruitment, 2 further focus groups (n=20) were conducted to produce contextually sensitive trial information materials. Data was analysed within and across groups using thematic framework analysis.
Results: 25 key recommendations for study design and management were identified with relevance to the contextual circumstances of potential participants across international sites, how and when to approach participants, the format and content of information materials, perceived barriers and facilitators to randomization and retention in the study and ongoing management of this cross-cultural study.
Conclusions: PPI can start at various stages of RCTs and influence many research aspects. It is important, however, to evaluate the impact PPI has on research outcomes and to share experience of effective models. Here we provide a real life example of how PPI has been employed effectively in the planning of an international clinical trial.
Disclosure: AM: Funding from MS Society, Medical Research Council (UK), NIHR
DMM: Consulting fees from Hoffman-Roche, Ltd
SMP: Funding from Guthy Jackson Charitable Foundation
BZC: Personal fees for consulting and speaking from Genentech and Sanofi-Genzyme.
CB: No disclosures
NL: No disclosures
EG: No disclosures
DO: Funding from PCORI, NIH, NMSS, Race to Erase, Genentech, Genzyme. Consulting from Biogen Idec, Genentech, Genzyme, Merck
NE: funding and support from PCORI, MS society, Biogen, Novartis, Roche,Teva
ET: Funding and support from PCORI, Merck, Biogen and Novartis
Abstract: P1207
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: There is a growing need for patient and public involvement (PPI) to influence the way that research is prioritized, commissioned, designed, executed, interpreted and disseminated. Randomised controlled trials (RCTs) are particularly likely to benefit from PPI. Little is known about how or when researchers incorporate PPI in their RCTs and the impact of this involvement. Sharing models of effective PPI in RCTs will help maximize potential and evaluate impact.
Objective/Aims: Describe the use of PPI within the development of an application, early design and site setting of an international clinical trial comparing treatment approaches in multiple sclerosis (MS).
Methods: DELIVER-MS is an international clinical trial funded by the Patient Centered Outcomes Research Institute (PCORI) aiming to recruit 800 people with MS (pwMS). The research theme was prioritized by PCORI on the basis of patient-engagement, in line with research priorities identified by the MS Society-James Lind Alliance Priority Setting Partnership. PPI involvement followed a structured approach, aiming to minimize bias and achieve equivalence in the design, implementation and interpretation of the study:
- PPI contributors as members of the research team and inputting across all stages of the study
- Study design was influenced by PPI within the outline and full application stage including five heterogeneous focus groups (n= 35) in the US and UK
- Ongoing involvement of PPI contributors on the study advisory board
- In preparation for trial recruitment, 2 further focus groups (n=20) were conducted to produce contextually sensitive trial information materials. Data was analysed within and across groups using thematic framework analysis.
Results: 25 key recommendations for study design and management were identified with relevance to the contextual circumstances of potential participants across international sites, how and when to approach participants, the format and content of information materials, perceived barriers and facilitators to randomization and retention in the study and ongoing management of this cross-cultural study.
Conclusions: PPI can start at various stages of RCTs and influence many research aspects. It is important, however, to evaluate the impact PPI has on research outcomes and to share experience of effective models. Here we provide a real life example of how PPI has been employed effectively in the planning of an international clinical trial.
Disclosure: AM: Funding from MS Society, Medical Research Council (UK), NIHR
DMM: Consulting fees from Hoffman-Roche, Ltd
SMP: Funding from Guthy Jackson Charitable Foundation
BZC: Personal fees for consulting and speaking from Genentech and Sanofi-Genzyme.
CB: No disclosures
NL: No disclosures
EG: No disclosures
DO: Funding from PCORI, NIH, NMSS, Race to Erase, Genentech, Genzyme. Consulting from Biogen Idec, Genentech, Genzyme, Merck
NE: funding and support from PCORI, MS society, Biogen, Novartis, Roche,Teva
ET: Funding and support from PCORI, Merck, Biogen and Novartis