Sleep Must be Assessed in Pain Research and Pain Management

It will lead to wrong conclusions and less sensitivity both in research and in individual pain management, if we fail to assess the parameters pain patients find most important for their Quality of Life (QoL). Pain patients tells us, that sleep problems is one of the most influential factors of their QoL, and (chronic) pain and insomnia has been shown to have a reciprocal negative impact on each other. Nevertheless sleep was not included as an outcome parameter in close to two third of all published pain research studies looking at QoL.

Causes of sleep deprivation is elected as one of TEDMED’s Great Challenges. This week I will present these findings at a poster at the “14th World Congress on Pain” held by IASP (the International Society for the Study of Pain) in Milan.

The proportions of this problem are enormous, research has found that at least 50% of patients with persistent pain problems report significant sleep disturbance, some studies even find that number to be 70-80% telling us that more than approximately 50 million persons in EU and also more than 50 million persons in USA are affected of the combined problems with pain and sleep.

Looking at published papers, that included QoL as an outcome, from five international high ranking pain journals (PAIN, European Journal of Pain, Clinical Journal of Pain , Pain Medicine, The Journal of Pain and Pain Practice) from 2009 and 2010, I found, that 64% of papers referring clinical trials AND including QoL as an outcome measurement did not include sleep as a parameter either as part of QoL or as an outcome alone. For epidemiological studies sleep was not included as part of QoL or an outcome alone in 54% of published papers. Furthermore was sleep only included as part of QoL-assessment in 20% of the clinical trials and in 38% of the epidemiological studies.

These studies are what we base our recommendations and our decisions  upon. By selecting outcome parameters important for the persons this is concerning, the pain patients, we will both be able to find more relevant conclusions and we will get a higher sensitivity for respond to treatment. In an IMMPACT study close to 1000 patients have told us, that sleep problems are one of the most important factors for pain patients QoL. The most used QoL assessment tool were MOS-SF-36 followed by EQ-5D(EuroQoL), neither of these include sleep related questions. The group behind Medical Outcome Study (MOS) has documented a direct association between assessment using a single indicator of sleep problems and HRQoL, and in addition a monotonic relationship between severity of sleep problems and decreases in work productivity and increases in healthcare utilization. But in the development of SF-36 sleep problems was omitted together with other domains, based on a selection process by choosing health concepts most frequently represented in other surveys and not involving patients directly. SF-36 was developed as a health measurement tool.

The process of designing the new tool is today recommended involving a panel of experts, including clinicians, statisticians, and patients. An instrument must not only demonstrate the expected methodological properties and performance but also a positive contribution to care. The necessity of implementation of direct patient-reporting methods has been highlighted by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This was what we did, when we developed the DoloTest, and how sleep became included.

You can find the poster here.

Please Leave a Reply below

Kim Kristiansen, M.D. (2012). Sleep Must be Assessed in Pain Research and Pain Management Picture of Pain blog