Updates & Features
Living with pain: How can the patient experience inform your research?
Can integrating the patient perspective into your research improve outcomes?
PainSolve Editorial Team
The burden of pain
Chronic pain imposes a significant burden across multiple aspects of the lives of sufferers and their families. In addition to the obvious physical consequences, chronic pain is known to have psychosocial, emotional and economic consequences (Figure 1).1–3 Hadi et al. (2018) found that, compared with both the general population and those with other long-term conditions, the quality of life (QoL) of those with chronic pain is significantly lower across all domains, including general health, mental health and physical functioning.2 In addition, it interferes with work, family and social lives, sleep and mood.2
“Living with CRPS and other chronic pain diseases has affected my life in every single way possible.”
“…how do you torture a human being? You inflict physical pain and deprive them of sleep. Welcome to the world of high-impact chronic pain. That's what we're dealing with 24/7 and we don't really have hope of it ever going away.”
Figure 1. Biopsychosocial consequences of chronic pain1
Fundamentally, those with chronic pain are unable to function adequately in society – and this is made even harder by having a ‘hidden’ condition that goes unrecognised and is too often misunderstood.
The quest for pain relief
On average, it takes 2.2 years to receive a diagnosis of chronic pain, with 26% of patients waiting 1–5 years and 11% waiting even longer.4 However, diagnosis is just the first step – the journey to pain relief is continuous, multimodal and completely individual. Each year, individuals with chronic pain make an average of seven visits to healthcare professionals (HCPs), and yet a substantial proportion (38%) still report that their pain is not adequately managed.4
“It was about 3 years before I got a proper diagnosis and I saw 42 doctors.”
Figure 2 provides an illustration of the journey patients must go on to receive a diagnosis and the quest for effective management. This particular journey is for those with vulvodynia but the story plays out similarly for those with other chronic pain conditions.
The management of chronic pain presents a major challenge to HCPs. Individuals experience pain in very different ways, which is why there is no ‘one-size-fits-all’ approach to management and why it is a challenge to develop a ‘gold standard’ measure of treatment efficacy. However, despite the limitations of current treatments, it is important to the patient experience that HCPs acknowledge pain and understand pain conditions and their impact. It is also important that HCPs are familiar with the pain lexicon; patients use many different words to describe their pain (e.g. stabbing, burning, sharp, relentless, blinding, electrical) and these adjectives often provide more useful information than asking patients to rate their pain on a numerical scale.
“…some of the hardest moments for me…was not feeling heard or validated by the medical profession. I constantly was seeking that out. I just wanted a doctor to say, even if they didn't have an answer…, ‘I hear you’… And I didn't get that”
These insights are important not only for HCPs, but also for researchers who can harness them to better inform the development of effective treatment strategies and assessments.
Involving patients in pain research – working together to make a difference
Patient insight is necessary in pain medicine. With myriad effects on a person’s life, pain is a symptom that cannot be measured objectively and only patients can tell us about it. However, current assessments and patient-reported outcome measures are not adequate to accurately assess the true impact of pain or the effects of management on QoL.5 Moreover, they are not adequate to support new drug approvals based on the standards imposed by regulators.5,6
Translating patient insights into clinical evaluation endpoints aims to ensure future QoL measures are bettered tailored to real-life patients and their needs.
“Our true passion is working with industry. We partner with industry to advance therapies to patients. I'm hoping more patients get involved in research... We talk about patient-centric care today; patients’ voices should be heard not just in legislation, but also in research and development.”
“Patient reported outcome measures are central to clinical trials because we're trying to measure the patient's experience, and the patient… is the only one who knows their experience. Therefore, we have to give them an instrument that allows them to convey in a precise way the nature and magnitude of their experience.”
Grünenthal has been working closely with more than 40 patient advocacy groups (PAGs) across multiple pain disorders in Europe and the US, investing time in listening to patients and understanding the burden of their disease and what they would consider clinically meaningful outcomes. Table 1 summarises the work Grünenthal has done in this area.
Table 1. Grünenthal’s work with chronic pain PAGs
|Meetings with PAGs||To understand PAGs’ priorities and obtain insights that can be translated into QoL endpoints and evaluated in clinical trial programmes
To discuss the most common words used to describe pain, and how relevant they are to patients’ own symptoms
|Grünenthal has used these insights when considering how to measure the effectiveness of a given treatment|
|Patient interviews and surveys||To understand the patient journey from symptoms to diagnosis and management
To understand the different symptoms of a chronic pain condition and identify different patient subtypes
|Grünenthal has used these insights to help understand the most suitable QoL endpoints and patient characteristics|
|Pain scale project||To understand patient satisfaction with current pain assessment tools and identify the gaps in questions currently asked by HCPs||Refining pain scale measures to reflect patient preferences will ensure pain measures used in research and clinical assessment are more accurate and useful, leading to better medications that address patient unmet needs|
|Protocol focus groups||People with a chronic pain condition were asked for feedback on Grünenthal’s clinical trial protocol to:
||Feedback has led to appropriate modifications to Grünenthal clinical trial design, including incentivising recruitment, adaptation of intervention and change of outcome measure|
|‘Pain language awareness’ campaign||To improve how patients, HCPs and researchers communicate about pain with the objective of improving care||Improving the level of detail in which patients can describe their pain experience provides a more exact way for researchers to understand how medications impact individual pain symptoms|
|Development of patient journey infographics||To better understand the patient journey from diagnosis through to treatment||Patient journey infographics have been utilised both internally and externally to educate people on the patient perspective and unique challenges they face|
|Development of patient-reported outcome (PRO) instrument||To overcome the limitations of current PRO instruments that present pain as a single overall concept, which may not fully capture the pain sensations of chronic low back pain specifically||Grünenthal developed the Patient Assessment for Low Back Pain–Symptoms (PAL-S), a PRO assessment tool designed to specifically reflect the pain sensations experienced by patients with chronic low back pain7|
This work has yielded a wealth of patient insights that have helped us better understand the patient perspective and pain subtypes, inspired new endpoint creation and informed the adaptation of Grünenthal’s clinical trial design to ensure it is aligned with what can appropriately be expected from patients.
Patient involvement in the design of studies can inform the development of new assessments and management strategies, with the potential for a greater impact on everyday life for those with chronic pain. To learn more about how to engage patients in your own research, register to learn about forthcoming webinars and surveys that will provide more information on how to approach and work with PAGs.
“All clinical trial work in Grünenthal in an ideal future should include the active involvement of patients and patient leaders. Only through such unbiased insights will the evaluation of new compounds against pain be better tailored to patients’ needs.”
“To researchers, I would want them to know that I thank them from the bottom of my heart. They might never meet me and yet, the work that they're doing could change my future and it could change millions of others.”
- Dueñas M, et al. J Pain Res 2016;9:457–67
- Hadi MA, et al. J Patient Exp 2018. doi: 10.1177/2374373518786013
- Fine PG. Pain Medicine 2011;12:996–1004
- Pain Proposal. A European Consensus Report. September 2010. Available at: https://www.dgss.org/fileadmin/pdf/Pain_Proposal_European_Consensus_Report.pdf
- Kuss M. Applied Clinical Trials 2013;22. Available at: http://www.appliedclinicaltrialsonline.com/patient-reported-outcomes-analgesia-clinical-trials-chronic-pain
- Ramasamy A, et al. Pain Medicine 2017;18:1098–110
- Martin ML, et al. Pain 2018;159:1045–55