Contributions
Abstract: P767
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Patient understanding of the complex risk-benefit profiles of disease-modifying drugs (DMD's) facilitates effective decision making and adherence. An evidence-based protocol was designed for presenting DMD risks and benefits: Benefit and Risk Information for Medication in Multiple Sclerosis (BRIMMS).
Goal: To evaluate effect of the BRIMMS protocol on MS patients' understanding and confidence in treatment decisions, compared to standard presentation of treatment information in the UK.
Methods: 24 relapsing-remitting MS patients (mean age: 42.56, 21 females) were recruited in a single-blind 4-condition 4-period randomised crossover trial, and were given faux drug information. All patients experienced four conditions, randomly ordered: BRIMMS protocol (spoken (S), spoken and written (SW)), and standard presentation (S, SW).
Understanding and decisional confidence (DCS) was recorded after each condition. Fatigue (FSS), depression and anxiety (HADS), numerical reasoning (VESPAR), pre-morbid IQ (WTAR) and cognitive abilities (BICAMS), were also assessed.
Results: Treatment understanding was significantly affected by conditions (linear mixed-effects model, F(3,57)=995.31, p< .001). Pairwise comparisons revealed greater understanding for BRIMMS-S, compared to standard-S (t(23)=31.25, p< .001) and standard-SW (t(23)=46.71, p< .001). Understanding was also greater for BRIMMS-SW, compared to standard-S (t(23)=41.73, p< .001) and standard-SW (t(23)=46.86, p< .001). BRIMMS-SW produced the best understanding overall.
Confidence in treatment decisions was also significantly affected by conditions (F(3,57)=70.44, p< .001). Pairwise comparisons revealed greater decisional confidence for BRIMMS-S, compared to standard-S (t(23)=-10.86, p< .001) and standard-SW (t(23)=-8.21, p< .001). Decisional confidence was also greater for BRIMMS-SW, compared to standard-S (t(23)=-11.80, p< .001) and standard-SW (t(23)=-8.61,
p< .001). BRIMMS-S and BRIMMS-SW did not differ significantly for decisional confidence.
Cognitive factors, pre-morbid IQ, anxiety and fatigue were not related to understanding in the BRIMMS protocol, but were negative influences for standard presentation. Conversely, depression did influence understanding on the BRIMMS protocol (r=.539, p< .01), but not for standard presentation.
Conclusions: BRIMMS protocol offers an effective, evidence-based format for presenting MS medication information and was not significantly influenced by cognition.
Disclosure:
GR has nothing to disclose.
ES has acted as an advisor or received financial support for research and for educational purposes, and hospitality, from Merck-Serono, Biogen, TEVA, Bayer-Schering and Novartis; and through his NHS trust has also received financial support for projects/service developments from some of these companies. He has been an investigator in commercial trials sponsored by Biogen Idec, Novartis, TEVA, Receptos, Roche, GW Pharma and GSK.
DL has participated on advisory boards/received consultancy/received research grants or is in the speaker Bureau for: Bayer, Novartis, Teva, Excemed, Roche, Merck and Biogen.
This study was supported by an investigator initiated research grant from Biogen. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of this abstract.
Abstract: P767
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Patient understanding of the complex risk-benefit profiles of disease-modifying drugs (DMD's) facilitates effective decision making and adherence. An evidence-based protocol was designed for presenting DMD risks and benefits: Benefit and Risk Information for Medication in Multiple Sclerosis (BRIMMS).
Goal: To evaluate effect of the BRIMMS protocol on MS patients' understanding and confidence in treatment decisions, compared to standard presentation of treatment information in the UK.
Methods: 24 relapsing-remitting MS patients (mean age: 42.56, 21 females) were recruited in a single-blind 4-condition 4-period randomised crossover trial, and were given faux drug information. All patients experienced four conditions, randomly ordered: BRIMMS protocol (spoken (S), spoken and written (SW)), and standard presentation (S, SW).
Understanding and decisional confidence (DCS) was recorded after each condition. Fatigue (FSS), depression and anxiety (HADS), numerical reasoning (VESPAR), pre-morbid IQ (WTAR) and cognitive abilities (BICAMS), were also assessed.
Results: Treatment understanding was significantly affected by conditions (linear mixed-effects model, F(3,57)=995.31, p< .001). Pairwise comparisons revealed greater understanding for BRIMMS-S, compared to standard-S (t(23)=31.25, p< .001) and standard-SW (t(23)=46.71, p< .001). Understanding was also greater for BRIMMS-SW, compared to standard-S (t(23)=41.73, p< .001) and standard-SW (t(23)=46.86, p< .001). BRIMMS-SW produced the best understanding overall.
Confidence in treatment decisions was also significantly affected by conditions (F(3,57)=70.44, p< .001). Pairwise comparisons revealed greater decisional confidence for BRIMMS-S, compared to standard-S (t(23)=-10.86, p< .001) and standard-SW (t(23)=-8.21, p< .001). Decisional confidence was also greater for BRIMMS-SW, compared to standard-S (t(23)=-11.80, p< .001) and standard-SW (t(23)=-8.61,
p< .001). BRIMMS-S and BRIMMS-SW did not differ significantly for decisional confidence.
Cognitive factors, pre-morbid IQ, anxiety and fatigue were not related to understanding in the BRIMMS protocol, but were negative influences for standard presentation. Conversely, depression did influence understanding on the BRIMMS protocol (r=.539, p< .01), but not for standard presentation.
Conclusions: BRIMMS protocol offers an effective, evidence-based format for presenting MS medication information and was not significantly influenced by cognition.
Disclosure:
GR has nothing to disclose.
ES has acted as an advisor or received financial support for research and for educational purposes, and hospitality, from Merck-Serono, Biogen, TEVA, Bayer-Schering and Novartis; and through his NHS trust has also received financial support for projects/service developments from some of these companies. He has been an investigator in commercial trials sponsored by Biogen Idec, Novartis, TEVA, Receptos, Roche, GW Pharma and GSK.
DL has participated on advisory boards/received consultancy/received research grants or is in the speaker Bureau for: Bayer, Novartis, Teva, Excemed, Roche, Merck and Biogen.
This study was supported by an investigator initiated research grant from Biogen. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of this abstract.