5 tips on how to select a prom for your study presentation notes
5 Tips on How to Select a Patient Reported Outcome Measure for your Study Presentation Notes Keith Meadows DHP Research & Consultancy LtdIn this brief audio presentation, we provide five key tips to help you select theright PROM for your study so as to maximise the possibility of finding a potentialtreatment benefit where one exists.
Tip 1: Always have a hypothesisA PROM should be selected on the basis of a clear rationale as to why it is beingused and formulating a hypothesis will help you to get clear in your mind what itis you want to measure and why.A hypothesis is a prediction as to what you think will happen and will be linked tothe objectives of the study, patient population, disease and any interventionunder evaluation.The point is that formulating a hypothesis helps you define just what it is youwant to measure, from which you can then identify what would be the mostappropriate patient outcome measure to choose.
Tip 2: Ensure the content of the PROM is relevantPROMs measure a wide range of health concepts including, health status,health-related quality of life, QoL, well-being, treatment satisfaction, symptomsand functioning.Often however, PROMs are chosen on the basis of their popularity or becausetheir name seems to be appropriate to what is going to be measured and withlittle attention being paid to the content of the individual items within themeasure. 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 widerange of patient groups and the general population and as such can be used forcomparison across different conditions as well as with healthy populations.Due however, to the generic nature of their content, they will most likelyinclude items that are not particularly relevant to many patient groups.Also generic measures are more likely to exclude content that is of particularrelevance to a specific disease group.In contrast, disease-specific or condition-specific measures have beendeveloped to capture those elements of health and QoL of relevance to aspecific patient group.Examination of the measure’s content by looking at the individual items andresponse options will also give a good idea as to how relevant the measure isbut, most importantly the measure’s content should be based on an explicittheoretical or conceptual framework.From this you should be able to identify which items are linked to the particularhealth concepts that are purported to be measured.
Tip 3: Ensure the selected measure is acceptable to your patient groupIn addition to establishing the relevance of the measure’s content, it’s importantthat the selected PROM does not pose a significant burden on the participantwhen completing it, resulting in the possibility of a lowered response rate.Length is of course important, the longer the measure the more likelyparticipants will fail to complete it, however, there is evidence that participantswill answer a long questionnaire if the content is perceived as being relevant tothem.Synonymous with length is the time taken to complete the measure. Measuresneed to be completed in the shortest time and expecting participants to takehalf an hour or more to complete it is unreasonable and can result in lower itemresponse 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 useof technical jargon. Layout should not be cramped with a clear differentiationbetween instructions, question items and response categories.
Tip 4: Ensure the measure has been developed with scientific rigourWhen selecting a PROM, it’s essential that there is evidence that itsdevelopment has been carried out using appropriate methodologies and meetsrecognised scientific criteria in terms of reliability and validity.the PROM should be reliable in so much that it produce the same results onrepeated occasions when administered to the same participants, assuming therehas been no change in the measured concept?We should also look for the ability of the PROM to discriminate betweenpatients, for example, with varying levels of health, depression and anxiety etc.When using a PROM to evaluate for example, a clinical intervention, animportant requirement is its ability to detect change as a result. For examplethe PROM is able to demonstrate changes in score for groups of patients whosehealth is known to have changed as a consequence of some form ofintervention.
Tip 5: Make sure you can interpret your PROM data correctlyThe interpretation of PROMS data - in terms of what does a score tell us, poses anumber of difficulties. For example, the concepts that PROMs are purported toassess, can mean different things to different people at different times andcontexts. Also understanding the meaning of what a change or difference in ascore means clinically can be problematic.You need to consider whether you have the expertise and confidence inundertaking the data analysis and interpreting just what the score might mean. Ifnot, you might find it more beneficial to collaborate with someone who does.
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