Study Design

Study Design_JKang_10262015.docx

Recruitment and Debriefing of Human Subjects for Field Test of Vehicle Occupant Protection Technologies

Study Design

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Attachment 1. Sample size comparison between original and revised experimental design



  1. Within-Subject Design (Original study design, described in 60-day Federal Register Notice)


Table 1 Original Study Design

 

Part-time users (n=16)

Non-seat belt users (n=16)

 

Young driver (n=8)

Middle-aged driver (n=8)

Young driver (n=8)

Middle-aged driver (n=8)

 

Male(n=4)

Female (n=4)

Male(n=4)

Female (n=4)

Male(n=4)

Female (n=4)

Male(n=4)

Female (n=4)

Baseline (A/B)

4

4

4

4

4

4

4

4

Treatment A

4

4

4

4

4

4

4

4

Treatment B

4

4

4

4

4

4

4

4





Research questions

Sample size for comparison

Comparison between Baseline A and Treatment A

n=16

Comparison between Baseline B and Treatment B

n=16

Comparison between part-time user and non-seatbelt user

n=16

Comparison between A and B

n=32

Comparison between young and middle-aged

n=16

The interaction effect of System (A/B) *age

n=16

The interaction effect of System (A/B) *belt user group

n=16

The interaction effect of System (A/B) *gender

n=16

The interaction effect of System (A/B) *age*belt user group

n=8

The interaction effect of System (A/B) *age*gender

n=8










  1. Between-Subject Design (Revised study design, subject to funding availability)



Table 2 Revised Study Design

Test Condition

Part-time users (n=24)

Non-seat belt users (n=24)

Young driver (n=12)

Middle-aged driver (n=12)

Young driver (n=12)

Middle-aged driver (n=12)

Male(n=6)

Female (n=6)

Male(n=6)

Female (n=6)

Male(n=6)

Female (n=6)

Male(n=6)

Female (n=6)

Baseline A

3

3

3

3

3

3

3

3

Treatment A

3

3

3

3

3

3

3

3

Baseline B

3

3

3

3

3

3

3

3

Treatment B

3

3

3

3

3

3

3

3



Research questions

Sample size for comparison

Comparison between Baseline A and Treatment A

n=24

Comparison between Baseline B and Treatment B

n=24

Comparison between part-time user and non-seatbelt user

n=24

Comparison between A and B

n=24

Comparison between young and middle-aged

n=24

The interaction effect of System (A/B) *age

n=12

The interaction effect of System (A/B) *belt user group

n=12

The interaction effect of System (A/B) *gender

n=12

The interaction effect of System (A/B) *age*belt user group

n=6

The interaction effect of System (A/B) *age*gender

n=6



Table 3 Additional Cost to Implement Revised Study Design

ID

Description

Cost Estimate

1

Cost increase in labor charges due to increased subject sample size and engineering support (i.e., increased labor in vehicle installation, data maintenance & download, server maintenance, subject recruitment and data analysis)

$84,330.24

2

Cost increase in research supplies (i.e.; vehicle insurance cost, gas and instrumentation)

$21,934.00

3

Subject fees ($90/subject * (16 more subjects+8more drop outs)

$2,680.00

4

OEM Costs (i.e., extended vehicle rental period

$12,886.80

5

Indirect costs on research supplies and subject fees

$13,594.34

TOTAL

$135,425.38



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