5 tips on how to select a prom for your study presentation notes
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Presentation nTRANSCRIPT
In this brief audio presentation, we provide five key tips to help you select the
right PROM for your study so as to maximise the possibility of finding a potential
treatment benefit where one exists.
5 Tips on How to Select a Patient Reported Outcome Measure for your Study
Presentation Notes
Keith Meadows
DHP Research & Consultancy Ltd
A PROM should be selected on the basis of a clear rationale as to why it is being
used and formulating a hypothesis will help you to get clear in your mind what it
is you want to measure and why.
A hypothesis is a prediction as to what you think will happen and will be linked to
the objectives of the study, patient population, disease and any intervention
under evaluation.
The point is that formulating a hypothesis helps you define just what it is you
want to measure, from which you can then identify what would be the most
appropriate patient outcome measure to choose.
Tip 1: Always have a hypothesis
PROMs measure a wide range of health concepts including, health status,
health-related quality of life, QoL, well-being, treatment satisfaction, symptoms and functioning.
Often however, PROMs are chosen on the basis of their popularity or because
their name seems to be appropriate to what is going to be measured and with
little attention being paid to the content of the individual items within the measure. Both these approaches should be avoided.
PROMs can be generally categorised as generic and disease or condition-specific, with each having their own strengths and weaknesses.
The generic PROM measures health concepts that are of relevance to a wide
range of patient groups and the general population and as such can be used for
comparison across different conditions as well as with healthy populations.
Due however, to the generic nature of their content, they will most likely include items that are not particularly relevant to many patient groups.
Also generic measures are more likely to exclude content that is of particular relevance to a specific disease group.
In contrast, disease-specific or condition-specific measures have been
developed to capture those elements of health and QoL of relevance to a
specific patient group.
Examination of the measure’s content by looking at the individual items and
response options will also give a good idea as to how relevant the measure is
but, most importantly the measure’s content should be based on an explicit
theoretical or conceptual framework.
From this you should be able to identify which items are linked to the particular
health concepts that are purported to be measured.
Tip 2: Ensure the content of the PROM is relevant
In addition to establishing the relevance of the measure’s content, it’s important
that the selected PROM does not pose a significant burden on the participant when completing it, resulting in the possibility of a lowered response rate.
Length is of course important, the longer the measure the more likely
participants will fail to complete it, however, there is evidence that participants
will answer a long questionnaire if the content is perceived as being relevant to them.
Synonymous with length is the time taken to complete the measure. Measures
need to be completed in the shortest time and expecting participants to take
half an hour or more to complete it is unreasonable and can result in lower item response and return rates.
Design of the PROM can also have a significant impact on acceptability.
Instruction need to be simple and clear as does the language, avoiding the use
of technical jargon. Layout should not be cramped with a clear differentiation
between instructions, question items and response categories.
Tip 3: Ensure the selected measure is acceptable
to your patient group
When selecting a PROM, it’s essential that there is evidence that its
development has been carried out using appropriate methodologies and meets recognised scientific criteria in terms of reliability and validity.
the PROM should be reliable in so much that it produce the same results on
repeated occasions when administered to the same participants, assuming there
has been no change in the measured concept?
We should also look for the ability of the PROM to discriminate between
patients, for example, with varying levels of health, depression and anxiety etc.
When using a PROM to evaluate for example, a clinical intervention, an
important requirement is its ability to detect change as a result. For example
the PROM is able to demonstrate changes in score for groups of patients whose
health is known to have changed as a consequence of some form of intervention.
Tip 4: Ensure the measure has been developed
with scientific rigour
The interpretation of PROMS data - in terms of what does a score tell us, poses a
number of difficulties. For example, the concepts that PROMs are purported to
assess, can mean different things to different people at different times and
contexts. Also understanding the meaning of what a change or difference in a
score means clinically can be problematic.
You need to consider whether you have the expertise and confidence in
undertaking the data analysis and interpreting just what the score might mean. If not, you might find it more beneficial to collaborate with someone who does.
Tip 5: Make sure you can interpret your PROM
data correctly
