PROs

Question 1

significance of PROs

Answer 1

measures QOL instead of just disease markers

Question 2

reasons PRO labeling may not be approved

Answer 2

study design
validity of PRO measures
no statistical/clinical difference
excessive missing data

Question 3

QoL vs HRQoL

Answer 3

QoL: all dimensions that affect people’s well-being, satisfaction, and happiness: including housing, income, occupation

HRQoL: aspects of life contributed to illness & its consequences of therapy: including functional status, physiologic status, perceptions of well being and general life satisfaction

Question 4

direct vs indirect measures of health

Answer 4

direct: vision, hearing, pain, mobility
indirect: self-care, usual activities, interpersonal relations, social functioning, participation

Question 5

different ways to scale survey responses

Answer 5

categorical judgment
continuous judgment

Question 6

what is categorical judgment

Answer 6

results in a nominal scale of measurement (yes/no?)

Question 7

what is continuous judgment

Answer 7

direct estimation method; visual analogue scale or likert scale (agree-disagree continuum)

Question 8

what is pretesting

Answer 8

use about 20 patients, analysis of results to assure understanding

Question 9

reliability vs validity

Answer 9

reliability: the extent to which the measure yields the same number or score

validity: the degree which the measure reflects what it is supposed to measure rather than something else

Question 10

types of reliability

Answer 10

inter-rater
intra-rater
internal consistency

Question 11

what is inter-rater reliability

Answer 11

agreement between different observers, refers to a comparison of scores assigned to the same target by two or more raters

Question 12

what is intra-rater reliability

Answer 12

when you administer the same instrument to the same patient at a different point in time

Question 13

what is internal consistency?

Answer 13

more than one item addressing same dimension/domain

measured by cronbach’s alpha (correlation among items)

Question 14

types of validity

Answer 14

content validity
criterion-related validity
construct validity

Question 15

what is content validity

Answer 15

judges whether the instrument samples all the relevant or important content or domains

Question 16

what is criterion-related validity

Answer 16

does the measure correlate highly with the gold standard

Question 17

what is construct validity

Answer 17

do the measures correlate with measures of other variables in hypothesized ways?

Question 18

what does construct validity depend on

Answer 18

convergence (correlation) between different measures and discriminality (differences) between measures

Question 19

ways to administer survey

Answer 19

face to face interview
telephone questionnaire
mailed questionnaire
computer assisted
online

Question 20

generic vs specific health-related instruments

Answer 20

generic: designed to assess QoL for different diseases

specific: designed to assess a specific disease, patient population, function, or condition (ex asthma, children)

Question 21

length/complexity in general vs specific instruments

Answer 21

general is longer and more complex
thus has lower responsiveness

Question 22

transformation of QoL score formula

Answer 22

transformed scale= [(actual raw score-lowest possible score)/possible raw score range] x 100