HPE Chronic pain – part two - Page 6

or reaching for a shelf. The questionnaire consists of 36 points (36 points indicating 100% ability to perform all 12 tasks in daily life; 0 points indicating 0% ability to perform all 12 tasks in daily life and therefore maximal impairment). A score of 80–100% (29–36 points) is considered to indicate normal functionality, 60–79% (22–28 points) moderate functionality, and <60% (<21 points) is considered as relevant impairment of functionality. 28 Pain Assessment for Lower Back-Symptoms (PAL-S) and Impacts (PAL-I) These questionnaires were developed recently to incorporate patient perspective of benefit of a treatment in cLBP trials. 29 The PAL-I and PAL-S were developed in accordance with US FDA guidance for PROMs to be used for label claims of patientreported improvements in symptoms and impact of medications to treat cLBP. The PAL-S is a recent PRO assessment tool designed to specifically reflect the pain sensations experienced by patients with cLBP. The qualitative evidence collected during this study supports the assessment of both the neuropathic- and nonneuropathic sensations in these patients. The variations of severity and disturbances observed among the specific concepts of pain underscore their importance in evaluating how patients feel and function and are therefore relevant and important in the assessment of potential treatment benefit. The instrument had a crosscultural patient input. The PAL-S reflects the specific symptoms of pain associated with cLBP and is not a generic measure. 30 The PAL-I provides a single total impact score on a scale of 0 to 3, with higher scores indicating greater impact due to cLBP. Patients score each of the nine items with response options of: Not at all limited (score 0); Limited a little (score 1); Limited a lot (score 2); Did not do because of my LBP (score 3); or patients can opt-out of an item (Did not do for TABLE 1 Low back pain concepts PAL-I 31 1 Limited your walking 2 Limited your sitting 3 Limited your standing 4 Limited your lifting 5 Limited your sleep 6 Limited your social activities (going out and seeing friends) 7 Limited travelling (daily driving and taking trips) 8 Affected your climbing up or down stairs (at home or at other locations) 9 Limited your turning, twisting, or bending other reasons) (Table 1). The mean score for all scored items (excluding opt-out items) represents the single total impact score. PAL-I and PAL-S are designed for use in clinical trials to treat cLBP. Although not specifically developed for use in clinical practice, both of these might be useful in assessing patients’ status associated with their cLBP and to provide helpful information to clinicians considering the next steps of care. 31 PAL-I demonstrated content validity, that is, the items in the instruments are relevant and representative of the cLBP experience based on input from patients with cLBP. PAL-I demonstrated one-week test–retest reliability, convergent validity with relevant components of existing instruments, and appropriate item-level performance, scale structure and scoring. The psychometric measurement properties have been validated and prove useful in assessing impairment in a clinical setting, by providing the opportunity to tailor individual patient therapy and improve patient– physician communication and patient outcomes. 31 Conclusions Functionality must be the main consideration when evaluating the efficacy of cLBP treatments. There is no validated or perfect instrument for measuring functionality, but clinicians can use any of a range of questionnaires mentioned previously in daily clinical practice. Fulfilment of individualised functional goals of treatment can be considered as the main outcome to assess functionality, including factors such as the ability to sleep and accomplishing day-to-day activities (including work) as surrogate dimensions. It is evident that more outcome measures are needed and there might be discrepancies between different pain measurement tools and different populations; nevertheless, measuring functionality is fundamental in cLBP and might be more objective and goal-oriented than assessment of pure pain intensity. References 1 Manchikanti L et al. Epidemiology of low back pain in adults. Neuromodulation 2014;17 Suppl 2:3–10. 2 Fatoye F, Gebrye T, Odeyemi I. Real-world incidence and prevalence of low back pain using routinely collected data. Rheumatol Int 2019;39(4):619–26. 3 Gedin F et al. Effectiveness, costs and cost-effectiveness of chiropractic care and physiotherapy compared with information and advice in the treatment of non-specific chronic low back pain: study protocol for a randomised controlled trial. Trials 2017;18(1):613. 4 Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J 2008;8(1):8–20. 5 Hartvigsen J et al. What low back pain is and why we need to pay attention. Lancet 2018;391(10137):2356–67. 6 Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 2015;386(9995): 743–800. 7 Global Burden of Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2018;392(10159):1789–858. 8 Clark S, Horton R. Low back pain: a major global challenge. Lancet 2018;391(10137):2302. 9 Mutubuki EN et al. The longitudinal relationships between pain severity and disability versus healthrelated quality of life and costs among chronic low back pain patients. Qual Life Res 2020;29(1):275–87. 10 Mehra M et al. The burden of chronic low back pain with and without a neuropathic component: a healthcare resource use and cost analysis. J Med Econ 2012;15(2):245–52. 11 Gierthmühlen J et al. Sensory symptoms in low back pain – how do they matter? Curr Med Res Opin 2018;34(4):657–67. 12 Gardner T et al. Patient led goal setting in chronic low back pain-What goals are important to the patient and are they aligned to what we measure? Patient Educ Couns 2015;98(8):1035–8. 13 Schug SA et al. Working Group of the Australian and New Zealand College of Anaesthetists and Faculty of Pain. Acute Pain Management: Scientific Evidence (4th edition), ANZCA & FPM, Melbourne; 2015. 14 Taylor AM et al. Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/ OMERACT recommendations. Pain 2016;157(9):1836–50. 15 US Food and Drug Administration. Guidance for Industry: patient-reported outcome measures: use in medical product development to support labelling claims.2009. 16 World Health Organization. ICD-11. International Classification of Diseases 11th revision. https://icd.who.int/en. 17 Treede RD et al. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD- 11). Pain 2019;160(1):19–27. 18 Nugraha B et al. The IASP classification of chronic pain for ICD-11: functioning properties of chronic pain. Pain 2019;160(1):88–94. 19 Croft P, Sharma S, Foster NE. Primary care for low back pain: we don’t know the half of it. Pain 2020;161(4):663–5. 20 Chiarotto A et al. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain 2018;159(3):481–95. 21 Ware Jr JE, Sherbourne CD. The MOS 36-item shortform health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30(6):473–83. 22 Ibrahim AA et al. The Hausa 12-item short-form health survey (SF-12): Translation, cross-cultural adaptation and validation in mixed urban and rural Nigerian populations with chronic low back pain. PLoS One 2020;15(5):e0232223. 23 Walsh TL et al. Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36. Spine (Phila Pa 1976) 2003;28(6):607–15. 24 Ware Jr JE, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34(3):220–33. 25 Gandek B et al. Crossvalidation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. J Clin Epidemiol 1998;51(11):1171–8. 26 Herndon CM, Zoberi KS, Gardner BJ. Common questions about chronic low back pain. Am Fam Physician 2015;91(10): 708–14. 27 Roland MO, Morris RW. A study of the natural history of back pain. Part 1: Development of a reliable and sensitive measure of disability in low back pain. Spine 1983;8:141–4. 28 Magnussen L, Strand LI, Lygren H. Reliability and validity of the back performance scale: observing activity limitation in patients with back pain. Spine (Phila Pa 1976) 2004;29(8):903–7. 29 Bushnell DM et al. Pain assessment for chronic lower back pain: performance of the PAL-S and PAL-I patientreported measures for symptoms and impacts. Curr Med Res Opin 2020:1–11. 30 Martin ML et al. Mixedmethods development of a new patient-reported outcome instrument for chronic low back pain: part 1 – the Patient Assessment for Low Back Pain – Symptoms (PAL-S). Pain 2018;159(6):1045–55. 31 Bushnell DM et al. Mixedmethods development of a new patient-reported outcome instrument for chronic low back pain: part 2 – The Patient Assessment for Low Back Pain-Impacts (PAL-I). Pain 2018;159(10):2066–75. 6 | 2020 | hospitalpharmacyeurope.com