5 tips for_selecting_prom
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A guide to selecting the appropriate patient reported outcome (PRO) measure for a study

A guide to selecting the appropriate patient reported outcome (PRO) measure for a study

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  • 1. How to Select a Patient Reported Outcome MeasureDr Keith Meadows, DHP Research & Consultancy LtdCopyright DHP Research & Consultancy Ltd 2011 All rights reserved
  • 2. Tip 1: Always have a hypothesisA PROM should be selected on the basis of a clear rationale as to why it is being used and formulatinga 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 thestudy, 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, fromwhich you can then identify what would be the most appropriate patient outcome measure to choose.
  • 3. Tip 2: Ensure the content of the PROM is relevantPROMs measure a wide range of health concepts In contrast, disease-specific or condition-specificincluding, health status, health-related quality measures have been developed to capture thoseof life, QoL, well-being, treatment satisfaction, elements of health and QoL of relevance to asymptoms and functioning. specific patient group.PROMs can be generally categorised as generic Examination of the measure’s content by lookingand disease or condition-specific, with each at the individual items and response optionshaving their own strengths and weaknesses. will also give a good idea as to how relevant the measure is but, most importantly the measure’sThe generic PROM measures health concepts that content should be based on an explicit theoreticalare of relevance to a wide range of patient groups or conceptual framework.and the general population and as such can beused for comparison across different conditions as From this you should be able to identify whichwell as with healthy populations. items are linked to the particular health concepts that are purported to be measured.Due however, to the generic nature of their content,they will most likely include items that are notparticularly relevant to many patient groups.Generic measures are also more likely to excludecontent that is of particular relevanceto a specific disease group.
  • 4. Tip 3: Ensure the selected measure is acceptable to your patient groupIn addition to establishing the relevance of the measure’s content, it’s important that the selectedPROM does not pose a significant burden on the participant when completing it, resulting in thepossibility of a lowered response rate.Length is of course important, the longer the measure the more likely participants will fail to completeit, however, there is evidence that participants will answer a long questionnaire if the content isperceived as being relevant to them.Synonymous with length is the time taken to complete the measure. Measures need to be completedin the shortest time and expecting participants to take half an hour or more to complete it isunreasonable 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 simpleand clear as does the language, avoiding the use of technical jargon. Layout should not be cramped.
  • 5. Tip 4: Ensure the measure has been developed with scientific rigourWhen selecting a PROM, it’s essential that there is evidence that its development has been carriedout using appropriate methodologies and meets recognised scientific criteria in terms of reliabilityand validity.The PROM should be reliable in so much that it produce the same results on repeated occasions whenadministered 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, withvarying levels of health, depression and anxiety etc.When using a PROM to evaluate for example, a clinical intervention, an important requirement is itsability to detect change as a result. For example the PROM is able to demonstrate changes in scorefor groups of patients whose health is known to have changed as a consequence of some formof intervention.
  • 6. 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 a number of difficulties.For example, the concepts that PROMs are purported to assess, can mean different things to differentpeople at different times and contexts. Also understanding the meaning of what a change or differencein a score means clinically can be problematic.You need to consider whether you have the expertise and confidence in undertaking the data analysis andinterpreting just what the score might mean. If not, you might find it more beneficial to collaborate withsomeone who does.
  • 7. DHP Research & Consultancy Ltd113 Lower Camden Chislehurst Kent BR7 5JDTel: +44 (0)20 8467 3739Email: kmeadows@dhpresearch.comwww.dhpresearch.com