Sponsored: Real-world evidence in pain - Page 10

is designed to be complementary to that obtained from an RCT , in practice RWE can serve to corroborate findings from controlled trials . For example , in a retrospective analysis exploring the use of an analgesic plaster containing lidocaine 5 % for neuropathic pain , Katz et al 14 showed that both efficacy and resource utilisation in daily clinical practice data were comparable to the information derived from RCTs . Similarly , using data from the Clinical Practice Research Datalink ( CPRD ), a longitudinal , anonymised research database in the UK , Morgan et al 15 investigated the comparability of the adverse event rates seen in a real-world setting to those observed in RCTs for patients prescribed the prolonged-release opiate , tapentadol versus either slow release morphine or oxycodone , which served as controls . In a sample of 1246 patients , the analysis revealed how gastrointestinal adverse effects were significantly reduced compared with both control opiates , which reflected the observations in RCTs . Furthermore , both resource utilisation and costs were lower for tapentadol than controls . In an exploratory post hoc analysis of a US claims database , Morlion et al 16 examined the fracture incidence for tapentadol and oxycodone among patients with either post-operative pain , back pain and osteoarthritis . While the analysis was limited because of the inclusion of patients with different characteristics and treatment patterns , it did show that the fracture rate was lower for tapentadol compared with oxycodone ( 1.51 vs 3.01 ). Finally , in a prospective observational study of 341 patients using sufentanil sublingual tablets for patientcontrolled management of post-operative pain , the drug reduced resting pain intensity , with 87 % of patients reporting the pain control to be either “ good ” or “ excellent ”, which was comparable to the findings from controlled trials . 17 The above mentioned examples in the field of pain suggest that treatment effect found in well-designed RWD studies can be consistent with the findings of RCTs , as shown for other clinical fields . 18 When there is lack of agreement between results of RCTs and observational studies , confounding factors like difference in disease state , pre-treatments and others , not study design per se , should be considered when exploring reasons for this apparent inconsistency . 19
RWE and pain management Pain and , in particular , chronic pain , is extremely common , with one European survey of over 46,000 people finding that 19 % reported experiencing pain for longer than six months . 20 As the majority of the RCTs controlled phases are less than 12 weeks in duration , such studies are clearly unable to fully capture the real-world effectiveness of a drug treatment for chronic pain . Chronic pain can be both nociceptive , arising from actual damage to non-neural tissue , and neuropathic , when it has an effect on the somatosensory nervous system , 21 although in practice , long-term chronic pain , for example , low back pain , is characterised by the presence of both nociceptive and neuropathic elements . 22 Chronic pain places an enormous burden upon sufferers , leading to several distinct comorbidities including depression , panic / anxiety disorder and sleep disturbance . 17 Taken together , these different factors negatively impact on an individual ’ s perception of their general health and can interfere with daily activities and affect relationships with family and friends . 23
While an RCT demonstrates the efficacy of a drug and will routinely assess changes in pain scores , though useful , have limited capability in capturing some aspects that really matter to patients , for instance , the personal impact of pain on the number of physician visits due to this pain or the economic situation well-being , physical functioning etc . Nevertheless , pain scores can be of value if used to correlate with the resultant disability induced by pain . For instance , in an observational study of patients with chronic and recurrent low back pain , McGorry et al 24 used daily pain scores and , in doing so , were able to demonstrate how the episodic nature of the pain led to significant disability that affected individuals ’ ability to function at work and in their personal lives . Online self-completed patient datasets can also be interrogated to determine how both the severity and frequency of pain impacts on quality of life and healthcare resource utilisation . As an example , the National Health and Wellness Survey ( NHWS ) is an internet-based cross-sectional study of the healthcare attitudes , behaviours and characteristics of the adult population from several European countries and the US . Using data from this survey , Langley et al 25 sought to calculate the impact of pain and its frequency on health-related quality of life and healthcare resource utilisation , among individuals who reported experiencing pain ( excluding acute pain ) in the last month . In a sample of 11,891 patients , 59.2 % and 22.8 % reported experiencing moderate and severe pain , respectively , with 43.6 % stating that they had daily pain . In regression analysis , pain and its frequency were significantly associated with a deficit in healthrelated quality of life and increased healthcare resource utilisation . More importantly , the analysis revealed how pain and its corresponding frequency , had the most significant impact and was much higher than for other factors such as age and comorbidities . In further work using the NHWS , the same group estimated the association between the burden and frequency of chronic pain and its effect on work and absenteeism using the workplace productivity and activity impairment scale ( WPAI ). 26 The scale provides a measure of the amount of time work has been missed and impaired because of a health problem and the study showed how the presence of severe pain was associated with a 20-point reduction in the probability of being in full-time work . The analysis also indicated how the effect of pain on labour force participation and absenteeism was far greater than for other health status markers ( for example , comorbidities and body mass index ).
In a separate analysis , Liedgens et al 27 examined the specific impact of neuropathic pain on work and productivity in a sample of patients from several European countries . Data were drawn from the Adelphi Neuropathic Pain Disease Specific programme , which is a real-world survey of clinical practice in Germany , France , Italy , Spain and the UK . Physicians provided data on patients presenting with neuropathic pain including time of current sick leave , and the number of workers who had to retire because of their pain . In addition , patients completed outcome questionnaires covering work productivity and quality of life impairment . The final analysis was based on records available for 3956 patients and revealed a significant economic and socioeconomic burden associated with neuropathic pain . Nevertheless , a more relevant finding from the study was how focusing solely on healthcare resource use greatly underestimated the true burden of neuropathic pain , particularly when including the cost of time off work and the caregiver burden , and the authors concluded how neuropathic
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