Outcomes Research

Message Planning & Evaluation

Strategic Consulting

• Patient Reported Outcome (PRO) regulatory planning for labeling and promotion
• Participation on thought leader advisory boards
• Development of patient outcomes strategy and research programs
• Identification of product value messages
• Testing of PRO messages

Scientific Consultation

• Development of new PRO and clinical instruments
• Design of patient outcomes studies and clinical trials
• Development and guidance regarding different methodological approaches to PRO assessment
• Interpretation of PRO and clinical endpoints
• PRO instrument selection
• Critique scientific quality of publications, unpublished documents, research instruments or analytical methods
• Development of new methods to evaluate treatment outcomes

Background Briefing & Position Papers

• Systematic reviews (to Cochrane standards)
• Review and interpretation of theoretical developments
• Discussion of novel areas of scientific development
• Review and critique of patient-reported outcomes measures
• Review and critique of health outcome methods
• Develop position papers and manuscripts addressing standards of evidence for labeling and promotional claims
• Communicate new outcomes research methodologies

Building Product Positioning

Clinical study design

• Development of PRO measurement strategies
• Observation intervals and data collection methods
• Procedures for minimizing missing PRO data
• Development and implementation of statistical analysis plans
• Preparation of reports and manuscripts

Instrument Development and Evaluation

• Development of new PRO and clinical measures
• Adaptation of existing instruments to new populations or diseases
• Psychometric assessment of new or existing PRO and clinical measures

Health Preference Assessment

• Utility estimation (through standard gamble, time trade-off, visual analog scale and multi-attribute utility measures)
• Determination of patient preferences through discrete choice experiments, conjoint analysis and willingness to pay
• Development of preference assessment methods

Integrated Translation Services and Cultural Adaptation

• Full-scale linguistic and cultural translations

Communicating Product Value

Message Communication

• Development of PRO message communication plans
• Author scientific abstracts and posters
• Preparation and delivery of conference presentations
• Preparation and peer review of scientific manuscripts for publication
• Development of PRO promotional claims strategies
• Define appropriate methods to communicate outcomes research findings to scientists, clinicians, decision-makers and consumers

Training and Education

• Training seminars and workshops on outcomes research methods, health and economic consequences of disease, and integrating outcomes studies with product development