16 12 11_-_sdm_project[1] [modo de compatibilidade]

Universidade do Estado do Rio de Janeiro
Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos

SHARED DECISION MAKING
- The case of biosimilars -

Mirhelen Mendes de Abreu, M.D., Ph. D.
mirhelen@ufscar.br


Agenda

• SDM approach to discuss biosimilar and biologic agents
- ClaBio Project: SDM branch

mirhelen@ufscar.br 2


Brief literature review

Key words First <1995 1996 – 2001 – 2006 – 2011
citation 2000 2005 2010
SDM (1474) 1968 61 97 380 760 176

Biosimilars 2004 - - 5 88 75
(168)

Source: Pubmed/ Medline in December 13th, 2011



Shared decision making
approach to discuss biosimilars
- ClapBio Project -


Rationale


Rationale

1. Implementing shared decision making will require
techniques that will enable the decision makers to
communicate effectively about:

– Defining the decision
– Creating the working knowledge base
– Value-based tradeoffs
– Reaching a decision



• A model of decision making

Adapted from Haynes et al BMJ 2002; 324: 1350


Research scope and aims



Research questions

1. What is stakeholders’ perspective on SDM approach to guide
decisions in healthcare?

2. Is SDM a feasible approach to guide discussions on
biosimilars from society’s perspective?



Research questions

3. What barriers are experienced by providers seeking to
implement explicit priority setting? How can these barriers
be addressed?

4. What barriers are experienced by patients/populations
seeking to implement explicit priority setting? How can
these barriers be addressed?


Aims

1. To explore stakeholders’ perspective on SDM approach to
guide decisions in healthcare

2. To develop, test and validate a Biosimilar x Biological Agents
Decision Aid for Latin America to guide discussions on
biosimilars and biological agents (taking into account each
country’s culture and values)



Stages

Stage 1 – International survey

• SDM approach and reception in Latin America

• Investigate society’s posture to issues regarding biosimilars
and biological agents and acceptance

Stage 2 – Development, testing and validation of a Biosimilar x
Biological Agents Decision Aid for Latin America




The international survey will be designed to provide a
picture of SDM acceptability in some Latin American
countries, taking biosimilars and biological agents into
account.




• Electronic format

• Pilot study

– To qualify language, format and type of questions in
different countries. It aims to refine feedback

– To provide elements to guide sample calculation and
statistical analysis



Stage 2 – Biosimilar x Biological Agents Decision Aid for Latin
America - Development, testing and validation

• A basic component framework for the decision aid

– Evidence

– Stakeholder involvement

– Decision process



EVIDENCE

• Incorporate the best level of evidence available for each
alternative

• Expose the evidence in an appropriate language for each
stakeholder, considering the SAME content
– Stakeholder Panel
• Language adequacy regarding stakeholders’ culture and
literacy



EVIDENCE

• Provide a brief overview including the concept of biological
agents, biotechnology and biosimilar agents in a legal
language

– Evidences regarding risk and benefits of each option,
without naming them.

– “Option 1” AND “Option 2” to avoid bias



EVIDENCE – A BASIC DECISION AID MODEL



STAKEHOLDERS INVOLVEMENT

• Explore the level of involvement of each stakeholder group
in decision-making processes

• Introduce changes in stakeholders participation in
decision-making process
Processes to enhance public and patient involvement in
priority setting
Public consultation processes
Processes to enhance clinical engagement


STAKEHOLDERS INVOLVEMENT – INCLUDE DIFFERENT
PERSPECTIVE



DECISION PROCESS

To offer a model of decision to guide discussion and to
present options on micro level decision

To explore the level of comprehension about the points
under discussion (self-test evaluation)

Decision-tree framework



DECISION PROCESS – INCLUDE DIFFERENT SCENARIOS



The research team will provide documents including

Ethical frameworks used

Policy documentation

Presentations and workshop notes

Meeting agendas



Future directions

Expected Results

• This study seeks to be an investigative platform to future
studies that aim:
To map potential barriers and challenges to the full development
of SDM to guide decisions on biosimilars discussion;

To provide a substratum for the development of decisions
/regulatory strategies;



• Future directions
– Next step

To apply the Biosimilar x Biological Agents
Decision Aid for Latin America – another project.


Schedule
Write the project in detail 1m

Forms preparation 1m

1m
Submission to Institutionals Review Board
Interviewers screening and training 2m

Contact with persons in charge of the 1m
sites to be included in the study

Patients enrollment 6m

Follow-up 12
m
Data input and information validation 2m

Data analysis 2m

Results discussion 2m

Preparation of the report/manuscript for 1m
publication

Total, months 27


Ongoing projects on
Shared Decision Making



Ongoing projects

Rheumatology Interprofessional Research and Care Team –
Research Project: improving communication to enhance the
clinical encounter



First step. Understanding the stakeholders’ point of view

Project 1. Quality of care: reference and counter reference from
family physicians and rheumatologists' perspectives in São
Carlos – SP, Brazil

Project 2. Communication in multiprofessional teamwork and
shared decision making: the case of Family Health Units in
São Carlos – SP, Brazil

Sponsored by FAPESP


First step. Understanding the stakeholders’ point of view

Project 3. Shared decision making at the Family Physician Unit:
the patient’s perspective

Project 4. Shared decision making in secondary care:
rheumatologic patient’s perspective

Sponsored by FAPESP


THANK YOU!


16 12 11_-_sdm_project[1] [modo de compatibilidade]

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16 12 11_-_sdm_project[1] [modo de compatibilidade]