Collaborating with Outcomes Research

Analyses that Inform marketing strategy

Publications that support

brand positioning

Market Research and Outcomes Research drive their functional priorities through the use of data

Market Research Outcomes Research

Data

Market Research and Outcomes Research use data from common sources

Clinical Trials

Transactional Databases

Quantitative Surveys

Qualitative Research

Market Research Outcomes Research

X

XX

XX

X

Despite the overlap in data sources, Market Research and Outcomes Research…

n Oftentimes don't know one another

n Are typically unaware of each others research priorities

n Rarely plan collaborative research

What are the benefits of conducting integrated primary research?

n By partnering with Outcomes Research for surveys, Market Research can:

• Improve the quality of information collected

• Increase the likelihood that research is fully integrated with marketing strategy

• Share cost of study across both groups

How Outcomes Research Uses Survey Data Collected

by Market Research

Outcomes research analyzes the end result (outcomes) of health care practices / interventions

Biological Variables

Ex. weight

Symptoms

Ex. nausea

Function

Ex. Ability to walk or climb stairs

Health Perceptions

Ex. Feeling better

Health Related

QoL

Ex.Physical Health

1 Wilson I, Cleary PD. Linking clinical variables with health-related quality of life: A conceptual model of patient outcomes. JAMA. 1995 273(1):59-65.

Categories of Outcomes Measures

Outcomes Research creates publications with data to serve multiple purposes

n Establish the epidemiology of conditions

n Measure the burden of illness• Define need and benefit of drug intervention• Defend reimbursements and payment

n Results are communicated in poster / podium presentations at symposia / congresses or in publications in peer-reviewed journals

How to Leverage A Market Research Survey for Outcomes Research

Considerations when using survey data for Outcomes: Use Validated Scales

n Validated scales are proven to measure the intended concept(s) (validity) and items within the scale are internally consistent (reliability)

n When multiple scales are available, consider: length, cost (public use vs. licensing), history of use in publications

Example: WPAI (public use) measures Work Productivity and Impairment

2.0

1.2

1.5

58.9%

BMI <25 (B)(25.8 MM)

2.2

1.3

1.6

56.2%

Total Adult Population (A)

(67.7 MM)

1.4ABHealth affected work productivity (scale 0-10)

2.8ABHealth affected daily activities (scale 0-10)

2.1ABMean work hours missed due to health (past 7 days)

53.3%

BMI 30 and over (C)

(15.5 MM)WPAI Scale

Currently Employed

German Adult Work and Productivity And Activity Impairment - 2005

Considerations when using survey data for Outcomes: Seek IRB Approval

n An Institutional Review Board reviews and monitors research involving human subjects to assure their ethical treatment

n IRBs place special attention on:• Insuring fully informed and voluntary participation• Assessing risks to subjects vs. benefits to all• Maximize safety and confidentiality of participants

n IRB approval should be done before fielding. Exemptions are possible for use of available data

Considerations when using survey data for Outcomes: Involve opinion leaders in design

n Publications / presentations have more impact when the lead author is a key opinion leader

n Best practice is to involve opinion leaders throughout the research process.• Development of hypotheses• Input into sampling and survey design • Act as principle investigator for IRB approval• Knowledge of study prior to invitation as lead author

Considerations when using survey data for Outcomes: Plan ahead

n Choose generally accepted guidelines to develop survey questions

n Consider study limitations ahead of time and determine how best to address them

Case Study: The Bipolar Disorder

Market Expansion Study

Marketing Challenge Objectives

A single marketing challenge drives different objectives for Outcomes and Market Research

Bipolar is frequently

misdiagnosed as unipolardepression

Issue

Improved diagnoses will increase use

of bipolar therapies

Opportunity

Market Research

Size opportunity

and understand drivers

Outcomes Research

Publish impact and help clinicians diagnose

A patient survey was conducted in 2003 and 2005

n Sample of 1,500+ patients per wave recruited from the National Health and Wellness Survey database. Respondents met following criteria:• Diagnosed depression with a depressive episode in the past year• Not diagnosed with bipolar disorder, manic depression, or

schizophrenia

n Bipolar patients were identified based on their self report of symptoms of a manic episode• American Psychiatric Association's (APA) Diagnostic and

Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)

Syndicated, online survey of twenty minutes covering:

n Diagnosis / Treatmentn DSM-IV identification criteria n Comorbiditiesn The Psychological General Well-Being Scalen Interaction with physiciann Sources of Informationn Demographics

Market Research Objective: Size the Opportunity

The Misdiagnosed

n 14% of depression patients, or 4.75 million US adults exhibit symptoms of bipolar disorder.

14%

86%

Misdiagnosed(4.75 MIL)

Unipolar Depression(27.11 MIL)

Incidence in Past Year

Market Research Objective: Understand Drivers (example)

Misdiagnosed4.75 M(n=219)

Did Not Discuss Symptoms with Dr.

1.44 M(n=62)30%

DiscussedSymptoms with Dr.

3.31 M(n=157)

70%

Mania Untreated*2.77 M(n=132)

84%

Mania Treated*0.54 M(n=25)16%

*Mania treatments include mood stabilizers and antipsychotics. Those whose manic symptoms are untreated may still be using antidepressants or anxiolytics.

Dr. RecommendedTreatment*

1.26 M(n=61)45%

Dr. Did NotRecommendTreatment*

1.51 M(n=71)55%

Market Research Objective: Determine How to Reach Patients

6%10%Support group

27%32%Psychiatrist

24%28%Psychologist

52%54%Primary care physician

4%8%Pharmacist

7%11%Nurse

24%28%Mental health specialist

20%20%Library or medical publications

51%59%Internet

19%16%Media

8%7%Did not use any sources

Misdiagnosed

4%

7%

16%

36%

Yes

3%Pharmaceutical company ads

5%Mental health association

7%Health insurance

30%Family or friends

No

Sources of Information About Symptoms and Progression of Mental

Health Conditions

Statistically higher at 95% confidence

Outcomes Objective: Publish Impact on Patients

Rajagopalan K, Bolge SC. Quality of life: misdiagnosed bipolar vs. depression and bipolar disorder [Poster]. 4th European Stanley Conference on Bipolar Disorder, Aarhus, Denmark, September 2004.

Data presented in both a Poster (left) and Manuscript

0% 10% 20% 30% 40% 50% 60% 70%

Social anxiety disorder (p<0.001)

Post-traumatic stress disorder (p<0.001)

Phobias (p=0.001)

Panic disorder (p<0.001)

Obsessive compulsive disorder (p<0.001)

Migraine (p=0.019)

Insomnia (p<0.001)

Generalized anxiety disorder (p<0.001)

Anxiety (p<0.001)

UnipolarDepression

Misdiagnosed

Outcomes Objective: Help Clinicians Identify Patients

Nanry K, Bolge S, Bourne E, Thompson T, Leadbetter R. Misdiagnosed bipolar disorder. Patient characteristics and symptomatology [Poster]. The 2006 US Psychiatric and Mental Health Congress, New Orleans, LA, November 2006.

Comorbid conditionsData presented in both a Poster and Manuscript (pending publication)

Conclusions

Integrating Outcomes and Market Research requires some trade-offs

Use Validated Scalesn Money (if licensed)n Survey length

Seek IRB Approval

Involve Opinion Leaders

Plan Ahead

Research Consideration Trade Off

n Timeline (~2 weeks)n Money (<US$5K)

n Timelinen Money (honoraria)

n Timeline

There is a significant opportunity to extend the utility of current and future market research

n By partnering with Outcomes Research for surveys, Market Research can:

• Improve the quality of information collected

• Increase the likelihood that research is fully integrated with marketing strategy

• Share cost of study across both groups