36
Rating Scale
A grading continuum is provided for respondents to express the frequency of a par-
ticular health event or attack. For example, how many times did you express blue
status during the last week? Once Twice Thrice More than 3
Checklist
Items presented in a PROM using a checklist are usually binary or dichotomous
outcome items. Respondents are asked to check in a box the occurrence of certain
events or symptoms. There is no response grading or continuum in this case and the
item is analyzed as a dichotomous item. Example: Please place a check (√) in the
box in front of the symptoms you expressed more during the last month. Insomnia
Dyspnea Body aches Fatigue
Developing and Validating a PROMS Instrument
Some Important Definitions [ 52 ]
PRO Concept—It is the event intended to be measured by the tool. It can be called
as the specific measurable goal of the instrument; e.g., symptom or group of
symptoms.
PRO Domain—A sub-concept represented by a score of an instrument that mea-
sures a larger concept comprised of multiple domains; e.g., depression sometimes
referred as scale.
PRO Item—An individual question, statement, or task (and its standardized
response options) that should be answered by the patient and it addresses a particu-
lar concept; e.g., Are you feeling depressed?
Conceptual Framework—The conceptual framework explicitly defines the con-
cepts measured by the instrument in a diagram that presents a description of the
relationships between items, domain (sub-concepts), and concepts measured and
the scores produced by a PROMs instrument (Fig. 2.4).
End Point—The measurement that will be statistically compared among treat-
ment groups to assess the effect of treatment or the intervention, and that corre-
sponds again with the intervention’s objectives, design, and data analysis.
End-Point Model—A diagram of the hierarchy of relationships among all end
points, both PRO and non-PRO, that corresponds to the clinical trial’s objectives,
design, and data analysis plan (Fig. 2.5).
Conceptual Equivalence—It is the equivalence in relevance and meaning of the
concepts being measured in different languages and/or cultures [ 53 ].
M. El Gaafary