Sponsored: Real-world evidence in pain - Page 11

pain results in a huge economic burden on society . Given the large number of patients reporting moderate or severe chronic pain , it is important to try and address whether this represents a failure to manage chronic pain effectively and how to improve such management . Some insight as to how well chronic pain is managed comes from a retrospective analysis of 738 patients who reported having moderate or severe back pain in the last three months . 28 More than half ( 56.1 %) reported having had their back pain diagnosed at least six years earlier with 70.5 % of those experiencing severe pain on a daily basis . However , given the longevity of symptoms , what was more revealing from the analysis was that 69 % of those with severe pain stated that there had been no change to their treatment . In their conclusion , the authors noted that whether this finding reflects a failure of pain management is a moot point but entirely possible , given that such a large proportion continue to experience severe pain .
Patient-reported outcomes A final yet highly relevant consideration is for RWE to include information on an individual ’ s health status obtained directly from the patient . These patient-reported outcome ( PRO ) data are important for several reasons : they provide information on the long-term tolerability and safety of a treatment and capture how a patient feels and functions during routine clinical care . PRO data are particularly important for long-term conditions such as chronic pain given its subjective interpretation . Nonetheless , a fundamental consideration for any patient-related outcomes is whether these are meaningful to the patient . In other words , although a reduction in pain scores clearly shows that a treatment has an effect , does this align with the expected goals desired by the patient ? Unfortunately , the evidence to date reveals that there is frequently a dissonance between what is perceived as meaningful by clinicians and patients . In a study of patients receiving physiotherapy for lower back pain , Pires et al 29 found that meaningful changes in disability and pain intensity failed to identify patients who perceived a global benefit from treatment . While pain relief was important , the data also highlighted that a successful outcome for patients also included gaining control of their condition , reducing medication intake , improving sleep quality and a sense of well-being and normality . Similar conclusions were drawn by Gardner et al 30 in a study of patients also receiving physiotherapy in which goals centred on physical activity and psychosocial functioning were perceived as relevant and not necessarily aligned with standard clinical outcome measures .
Conclusion The limitations and extensive costs of RCTs have led to an increasing recognition of the importance of RWE as a rich source of evidence that can be used to help inform clinical decision-making . RWE provides valuable information additional and complimentary to that captured in RCTs . RWE should be thought as complementary , not substitutive , evidence to RCTs . Future RWE studies in chronic pain should continue to collect information from existing sources such as patient registries , electronic health records , self-reported survey databases and administrative claims databases . The quality of the data and finding the right database are crucial prerequisites to produce reliable RWE . In addition , it is necessary to refine these information sources to incorporate outcomes that go beyond simple measures such as pain scores and attempt to capture data that include valid indicators of global improvement as perceived by the patients themselves , such as the effect on health-related quality of life and changes in physical and psycho-social functioning . Providing answers to these questions using adequate transparent RWE methodologies , nonetheless taking advantage of the significant advancements in data analysis capabilities , allow for a better understanding of the patient symptom burden and disease progression and will ultimately help to answer the questions posed by clinicians and their patients in routine daily practice .
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