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Published in: Current Anesthesiology Reports 4/2019

01-12-2019 | Research Methods and Statistical Analyses (Y Le Manach, Section Editor)

Outcomes in Pain Clinical Research: What Really Matters for Patients?

Authors: James S. Khan, Rutvij Shah, Ian Gilron

Published in: Current Anesthesiology Reports | Issue 4/2019

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Abstract

Purpose of Review

The measurement and assessment of pain outcomes is critical to the design, analysis, and interpretation of a pain clinical trial. Results from clinical research impact a number of stakeholders, but it can be argued that patients are the most affected. The purpose of this review is to summarize the most important pain outcomes to patients and discuss methodological considerations in collecting these data in a clinical trial.

Recent Findings

We found that there are a number of outcomes that are important to patients. The outcomes that consistently appear in the literature include reductions in pain intensity, changes in medications, and improvements in physical functioning, sleep, and emotional well-being.

Summary

Further work is needed to identify what patients truly consider important, minimally important changes, and how best to measure and report these outcomes in pain clinical research.
Literature
1.
go back to reference Merskey H. The definition of pain. Eur J Psychiatry. 1991;6:153–9. Merskey H. The definition of pain. Eur J Psychiatry. 1991;6:153–9.
2.
go back to reference Cohen M, Quintner J, van Rysewyk S. Reconsidering the International Association for the Study of Pain definition of pain. Pain reports. 2018;3. Cohen M, Quintner J, van Rysewyk S. Reconsidering the International Association for the Study of Pain definition of pain. Pain reports. 2018;3.
3.
go back to reference Treede R. The International Association for the Study of Pain definition of pain: as valid in 2018 as in 1979, but in need of regularly updated footnotes. Pain Reports. 2018;3. Treede R. The International Association for the Study of Pain definition of pain: as valid in 2018 as in 1979, but in need of regularly updated footnotes. Pain Reports. 2018;3.
4.
go back to reference Dueñas M, Ojeda B, Salazar A, Mico JA, Failde I. A review of chronic pain impact on patients, their social environment and the health care system. J Pain Res. 2016;9:457–67.PubMedPubMedCentral Dueñas M, Ojeda B, Salazar A, Mico JA, Failde I. A review of chronic pain impact on patients, their social environment and the health care system. J Pain Res. 2016;9:457–67.PubMedPubMedCentral
5.
go back to reference Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10:287–333.PubMed Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10:287–333.PubMed
6.
7.
go back to reference Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews? – a survey of the Co-ordinating Editors of Cochrane review groups. Trials. 2013;14:21.PubMedPubMedCentral Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews? – a survey of the Co-ordinating Editors of Cochrane review groups. Trials. 2013;14:21.PubMedPubMedCentral
8.
go back to reference Prinsen CAC, et al. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials. 2014;15:247.PubMedPubMedCentral Prinsen CAC, et al. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials. 2014;15:247.PubMedPubMedCentral
10.
go back to reference •• Dworkin RH, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19 IMMPACT recommendations for core outcome measures in chronic pain clinical trials. PubMed •• Dworkin RH, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19 IMMPACT recommendations for core outcome measures in chronic pain clinical trials. PubMed
11.
go back to reference • Dworkin RH, et al. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain, 2009. 146:238–44 IMMPACT recommendations on how to interpret group differences in chronic pain clinical trials. • Dworkin RH, et al. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain, 2009. 146:238–44 IMMPACT recommendations on how to interpret group differences in chronic pain clinical trials.
12.
go back to reference Turk DC, et al. Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations. Pain. 2006;125:208–15.PubMed Turk DC, et al. Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations. Pain. 2006;125:208–15.PubMed
13.
go back to reference Kaiser U, Kopkow C, Deckert S, Sabatowski R, Schmitt J. Validation and application of a core set of patient-relevant outcome domains to assess the effectiveness of multimodal pain therapy (VAPAIN): a study protocol. BMJ Open. 2015;5:e008146.PubMedPubMedCentral Kaiser U, Kopkow C, Deckert S, Sabatowski R, Schmitt J. Validation and application of a core set of patient-relevant outcome domains to assess the effectiveness of multimodal pain therapy (VAPAIN): a study protocol. BMJ Open. 2015;5:e008146.PubMedPubMedCentral
14.
go back to reference Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63:1179–94.PubMedPubMedCentral Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63:1179–94.PubMedPubMedCentral
15.
go back to reference Savigny P, Watson P, Underwood M, Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009;338(b1805). Savigny P, Watson P, Underwood M, Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009;338(b1805).
16.
go back to reference Tugwell PS, Maxwell LJ, Beaton DE, Busse JW, Christensen R, Conaghan PG, et al. Dialogue on developing consensus on measurement and presentation of patient-important outcomes, using pain outcomes as an exemplar, in systematic reviews: a preconference meeting at OMERACT 12. J Rheumatol. 2015;42:1931–3.PubMed Tugwell PS, Maxwell LJ, Beaton DE, Busse JW, Christensen R, Conaghan PG, et al. Dialogue on developing consensus on measurement and presentation of patient-important outcomes, using pain outcomes as an exemplar, in systematic reviews: a preconference meeting at OMERACT 12. J Rheumatol. 2015;42:1931–3.PubMed
17.
go back to reference Phillips K, Taylor A, Mease PJ, Simon LS, Conaghan PG, Choy EH, et al. Harmonizing pain outcome measures: results of the Pre-OMERACT Meeting on partnerships for consensus on patient-important pain outcome domains between the Cochrane Musculoskeletal Group and OMERACT. J Rheumatol. 2015;42:1943–6.PubMed Phillips K, Taylor A, Mease PJ, Simon LS, Conaghan PG, Choy EH, et al. Harmonizing pain outcome measures: results of the Pre-OMERACT Meeting on partnerships for consensus on patient-important pain outcome domains between the Cochrane Musculoskeletal Group and OMERACT. J Rheumatol. 2015;42:1943–6.PubMed
18.
go back to reference Jones JE, Jones LL, Keeley TJH, Calvert MJ, Mathers J. A review of patient and carer participation and the use of qualitative research in the development of core outcome sets. PLoS One. 2017;12:e0172937.PubMedPubMedCentral Jones JE, Jones LL, Keeley TJH, Calvert MJ, Mathers J. A review of patient and carer participation and the use of qualitative research in the development of core outcome sets. PLoS One. 2017;12:e0172937.PubMedPubMedCentral
19.
go back to reference Forsythe LP, Ellis LE, Edmundson L, Sabharwal R, Rein A, Konopka K, et al. Patient and stakeholder engagement in the PCORI pilot projects: description and lessons learned. J Gen Intern Med. 2016;31:13–21.PubMed Forsythe LP, Ellis LE, Edmundson L, Sabharwal R, Rein A, Konopka K, et al. Patient and stakeholder engagement in the PCORI pilot projects: description and lessons learned. J Gen Intern Med. 2016;31:13–21.PubMed
20.
go back to reference Poulin P, et al. Researching what matters to improve chronic pain care in Canada: a priority-setting partnership process to support patient-oriented research. Can J Pain. 2018;2:191–204.PubMedPubMedCentral Poulin P, et al. Researching what matters to improve chronic pain care in Canada: a priority-setting partnership process to support patient-oriented research. Can J Pain. 2018;2:191–204.PubMedPubMedCentral
21.
go back to reference •• Turk DC, et al. Identifying important outcome domains for chronic pain clinical trials: An IMMPACT survey of people with pain. Pain. 2008;137:276–85 A large online survey of chronic pain patients reporting on most important patient outcomes in pain clinical trials. PubMed •• Turk DC, et al. Identifying important outcome domains for chronic pain clinical trials: An IMMPACT survey of people with pain. Pain. 2008;137:276–85 A large online survey of chronic pain patients reporting on most important patient outcomes in pain clinical trials. PubMed
22.
go back to reference Bromley Milton M, et al. Is pain intensity really that important to assess in chronic pain patients? A study based on the Swedish Quality Registry for Pain Rehabilitation (SQRP). PLoS One. 2013;8. Bromley Milton M, et al. Is pain intensity really that important to assess in chronic pain patients? A study based on the Swedish Quality Registry for Pain Rehabilitation (SQRP). PLoS One. 2013;8.
23.
go back to reference Maxwell LJ, Wells GA, Simon LS, Conaghan PG, Grosskleg S, Scrivens K, et al. Current state of reporting pain outcomes in Cochrane reviews of chronic musculoskeletal pain conditions and considerations for an OMERACT research agenda. J Rheumatol. 2015;42:1934–42.PubMedPubMedCentral Maxwell LJ, Wells GA, Simon LS, Conaghan PG, Grosskleg S, Scrivens K, et al. Current state of reporting pain outcomes in Cochrane reviews of chronic musculoskeletal pain conditions and considerations for an OMERACT research agenda. J Rheumatol. 2015;42:1934–42.PubMedPubMedCentral
24.
go back to reference Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale. SF Arthritis Care Res (Hoboken). 2011;63(Suppl 1):S240–52. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale. SF Arthritis Care Res (Hoboken). 2011;63(Suppl 1):S240–52.
25.
go back to reference • Gilron I, Jensen MP. Clinical trial methodology of pain treatment studies: selection and measurement of self-report primary outcomes for efficacy. Reg Anesth Pain Med. 2011;36:374–81 A good review on patient-reported pain clinical outcomes. PubMed • Gilron I, Jensen MP. Clinical trial methodology of pain treatment studies: selection and measurement of self-report primary outcomes for efficacy. Reg Anesth Pain Med. 2011;36:374–81 A good review on patient-reported pain clinical outcomes. PubMed
26.
go back to reference Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity : a comparison of six methods. Pain. 1986;27:117–26.PubMed Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity : a comparison of six methods. Pain. 1986;27:117–26.PubMed
27.
go back to reference Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77:371–83.PubMed Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77:371–83.PubMed
28.
go back to reference Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94:149–58.PubMed Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94:149–58.PubMed
29.
go back to reference Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004;8:283–91.PubMed Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004;8:283–91.PubMed
30.
go back to reference Goldsmith ES, Taylor BC, Greer N, Murdoch M, MacDonald R, McKenzie L, et al. Focused evidence review: psychometric properties of patient-reported outcome measures for chronic musculoskeletal pain. J Gen Intern Med. 2018;33:61–70.PubMedPubMedCentral Goldsmith ES, Taylor BC, Greer N, Murdoch M, MacDonald R, McKenzie L, et al. Focused evidence review: psychometric properties of patient-reported outcome measures for chronic musculoskeletal pain. J Gen Intern Med. 2018;33:61–70.PubMedPubMedCentral
31.
go back to reference Hays RD, Cella D, Revicki D, Hays RD, Sloan J. Recommended methods for determining responsiveness and minimal important differences for patient-reported outcomes PROMIS View project CAHPS (AHRQ); PCAR (NCI), CAM, PROMIS oral health view project recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Artic J Clin Epidemiol. 2008. Hays RD, Cella D, Revicki D, Hays RD, Sloan J. Recommended methods for determining responsiveness and minimal important differences for patient-reported outcomes PROMIS View project CAHPS (AHRQ); PCAR (NCI), CAM, PROMIS oral health view project recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Artic J Clin Epidemiol. 2008.
33.
go back to reference Tashjian RZ, Hung M, Keener JD, Bowen RC, McAllister J, Chen W, et al. Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty. J Shoulder Elb Surg. 2017;26:144–8. Tashjian RZ, Hung M, Keener JD, Bowen RC, McAllister J, Chen W, et al. Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty. J Shoulder Elb Surg. 2017;26:144–8.
34.
go back to reference Danoff JR, Goel R, Sutton R, Maltenfort MG, Austin MS. How much pain is significant? Defining the minimal clinically important difference for the visual analog scale for pain after total joint arthroplasty. J Arthroplast. 2018;33:S71–S75.e2. Danoff JR, Goel R, Sutton R, Maltenfort MG, Austin MS. How much pain is significant? Defining the minimal clinically important difference for the visual analog scale for pain after total joint arthroplasty. J Arthroplast. 2018;33:S71–S75.e2.
35.
go back to reference de Vet HCW, et al. Minimally important change values of a measurement instrument depend more on baseline values than on the type of intervention. J Clin Epidemiol. 2015;68:518–24.PubMed de Vet HCW, et al. Minimally important change values of a measurement instrument depend more on baseline values than on the type of intervention. J Clin Epidemiol. 2015;68:518–24.PubMed
36.
go back to reference Thorne FM, Morley S. Prospective judgments of acceptable outcomes for pain, interference and activity: Patient-determined outcome criteria. Pain. 2009;144:262–9.PubMed Thorne FM, Morley S. Prospective judgments of acceptable outcomes for pain, interference and activity: Patient-determined outcome criteria. Pain. 2009;144:262–9.PubMed
37.
go back to reference Peter M. Drossaers–Bakker, K., Taal, E. & van de Laar, M. Patient-perceived satisfactory improvement (PPSI): interpreting meaningful change in pain from the patient’s perspective. Pain. 2006;121:1–24. Peter M. Drossaers–Bakker, K., Taal, E. & van de Laar, M. Patient-perceived satisfactory improvement (PPSI): interpreting meaningful change in pain from the patient’s perspective. Pain. 2006;121:1–24.
38.
go back to reference Casarett D, Karlawish J, Sankar P, Hirschman K, Asch DA. Designing pain research from the patient’s perspective: what trial end points are important to patients with chronic pain? Pain Med. 2001;2:309–16.PubMed Casarett D, Karlawish J, Sankar P, Hirschman K, Asch DA. Designing pain research from the patient’s perspective: what trial end points are important to patients with chronic pain? Pain Med. 2001;2:309–16.PubMed
39.
go back to reference McCracken LM, Hoskins J, Eccleston C. Concerns about medication and medication use in chronic pain. J Pain. 2006;7:726–34.PubMed McCracken LM, Hoskins J, Eccleston C. Concerns about medication and medication use in chronic pain. J Pain. 2006;7:726–34.PubMed
40.
go back to reference Timmerman L, Stronks DL, Groeneweg JG, Huygen FJ. Prevalence and determinants of medication non-adherence in chronic pain patients: a systematic review. Acta Anaesthesiol Scand. 2016;60:416–31.PubMed Timmerman L, Stronks DL, Groeneweg JG, Huygen FJ. Prevalence and determinants of medication non-adherence in chronic pain patients: a systematic review. Acta Anaesthesiol Scand. 2016;60:416–31.PubMed
41.
go back to reference Silverman DG, O’Connor TZ, Brull SJ. Integrated assessment of pain scores and rescue morphine use during studies of analgesic efficacy. Anesth Analg. 1993;77:168–70.PubMed Silverman DG, O’Connor TZ, Brull SJ. Integrated assessment of pain scores and rescue morphine use during studies of analgesic efficacy. Anesth Analg. 1993;77:168–70.PubMed
42.
go back to reference Dai F, et al. Integration of pain score and morphine consumption in analgesic clinical studies. J Pain. 2013;14:767–777.e8.PubMed Dai F, et al. Integration of pain score and morphine consumption in analgesic clinical studies. J Pain. 2013;14:767–777.e8.PubMed
43.
go back to reference Edwards TC, Lavallee DC, Bauer Z, Comstock BA, Jarvik JG, Patrick DL, et al. Problem areas identified as important to older adults with lumbar spinal stenosis. Spine J. 2015;15:1636–44.PubMed Edwards TC, Lavallee DC, Bauer Z, Comstock BA, Jarvik JG, Patrick DL, et al. Problem areas identified as important to older adults with lumbar spinal stenosis. Spine J. 2015;15:1636–44.PubMed
44.
go back to reference Wiklund I, Holmstrom S, Stoker M, Wyrwich KW, Devine M. Are treatment benefits in neuropathic pain reflected in the self assessment of treatment questionnaire? Health Qual Life Outcomes. 2013;11:8.PubMedPubMedCentral Wiklund I, Holmstrom S, Stoker M, Wyrwich KW, Devine M. Are treatment benefits in neuropathic pain reflected in the self assessment of treatment questionnaire? Health Qual Life Outcomes. 2013;11:8.PubMedPubMedCentral
45.
go back to reference Gardner T, Refshauge K, McAuley J, Goodall S, Hübscher M, Smith L. 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;98:1035–8.PubMed Gardner T, Refshauge K, McAuley J, Goodall S, Hübscher M, Smith L. 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;98:1035–8.PubMed
46.
go back to reference Bagraith KS, Hayes J, Strong J. Mapping patient goals to the international classification of functioning, disability and health (ICF): examining the content validity of the low back pain core sets. J Rehabil Med. 2013;45:481–7.PubMed Bagraith KS, Hayes J, Strong J. Mapping patient goals to the international classification of functioning, disability and health (ICF): examining the content validity of the low back pain core sets. J Rehabil Med. 2013;45:481–7.PubMed
47.
go back to reference Wall PD. On the relation of injury to pain the John J. Bonica Lecture. Pain. 1979;6:253–64.PubMed Wall PD. On the relation of injury to pain the John J. Bonica Lecture. Pain. 1979;6:253–64.PubMed
48.
go back to reference Wertli MM, Rasmussen-Barr E, Weiser S, Bachmann LM, Brunner F. The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review. Spine J. 2014;14:816–836.e4.PubMed Wertli MM, Rasmussen-Barr E, Weiser S, Bachmann LM, Brunner F. The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review. Spine J. 2014;14:816–836.e4.PubMed
49.
go back to reference Rainville J, Smeets RJ, Bendix T, Tveito TH, Poiraudeau S, Indahl AJ. Fear-avoidance beliefs and pain avoidance in low back pain—translating research into clinical practice. Spine J. 2011;11:895–903.PubMed Rainville J, Smeets RJ, Bendix T, Tveito TH, Poiraudeau S, Indahl AJ. Fear-avoidance beliefs and pain avoidance in low back pain—translating research into clinical practice. Spine J. 2011;11:895–903.PubMed
50.
go back to reference Hodges PW, Smeets RJ. Interaction between pain, movement, and physical activity: short-term benefits, long-term consequences, and targets for treatment. Clin J Pain. 2015;31:97–107.PubMed Hodges PW, Smeets RJ. Interaction between pain, movement, and physical activity: short-term benefits, long-term consequences, and targets for treatment. Clin J Pain. 2015;31:97–107.PubMed
51.
go back to reference Hazes JM, Taylor P, Strand V, Purcaru O, Coteur G, Mease P. Physical function improvements and relief from fatigue and pain are associated with increased productivity at work and at home in rheumatoid arthritis patients treated with certolizumab pegol. Rheumatology. 2010;49:1900–10.PubMedPubMedCentral Hazes JM, Taylor P, Strand V, Purcaru O, Coteur G, Mease P. Physical function improvements and relief from fatigue and pain are associated with increased productivity at work and at home in rheumatoid arthritis patients treated with certolizumab pegol. Rheumatology. 2010;49:1900–10.PubMedPubMedCentral
52.
go back to reference Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015;29:1155–67.PubMed Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015;29:1155–67.PubMed
53.
go back to reference Hoffman MD, Hoffman DR. Does aerobic exercise improve pain perception and mood? A review of the evidence related to healthy and chronic pain subjects. Curr Pain Headache Rep. 2007;11:93–7.PubMed Hoffman MD, Hoffman DR. Does aerobic exercise improve pain perception and mood? A review of the evidence related to healthy and chronic pain subjects. Curr Pain Headache Rep. 2007;11:93–7.PubMed
54.
go back to reference Taylor AM, Phillips K, Patel KV, Turk DC, Dworkin RH, Beaton D, et al. Assessment of physical function and participation in chronic pain clinical trials. Pain. 2016;157:1836–50.PubMedPubMedCentral Taylor AM, Phillips K, Patel KV, Turk DC, Dworkin RH, Beaton D, et al. Assessment of physical function and participation in chronic pain clinical trials. Pain. 2016;157:1836–50.PubMedPubMedCentral
55.
go back to reference Patel KV, Allen R, Burke L, Farrar JT, Gewandter JS, Gilron I, et al. Evaluation of composite responder outcomes of pain intensity and physical function in neuropathic pain clinical trials. Pain. 2018;159:2245–54.PubMedPubMedCentral Patel KV, Allen R, Burke L, Farrar JT, Gewandter JS, Gilron I, et al. Evaluation of composite responder outcomes of pain intensity and physical function in neuropathic pain clinical trials. Pain. 2018;159:2245–54.PubMedPubMedCentral
57.
go back to reference Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–40.PubMed Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–40.PubMed
58.
go back to reference Martin Bennett R, Bennett R. The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses S-154. Clin Exp Rheumatol. 2005;23. Martin Bennett R, Bennett R. The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses S-154. Clin Exp Rheumatol. 2005;23.
59.
go back to reference Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983;8:141–4. Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983;8:141–4.
60.
go back to reference Fairbank JC, Couper J, Davies JB, O’brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271–3.PubMed Fairbank JC, Couper J, Davies JB, O’brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271–3.PubMed
61.
go back to reference Ware J, Sherbourne C. The MOS 36-item short-form health survey (SF-36). Med Care. 1992;30:473–83.PubMed Ware J, Sherbourne C. The MOS 36-item short-form health survey (SF-36). Med Care. 1992;30:473–83.PubMed
62.
go back to reference Kim SH, Seo DY. Effects of a therapeutic climbing program on muscle activation and SF-36 scores of patients with lower back pain. J Phys Ther Sci. 2015;27(3):743–6.PubMedPubMedCentral Kim SH, Seo DY. Effects of a therapeutic climbing program on muscle activation and SF-36 scores of patients with lower back pain. J Phys Ther Sci. 2015;27(3):743–6.PubMedPubMedCentral
63.
go back to reference Powell P, Bentall RP, Nye FJ, Edwards RH. Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syndrome. BMJ. 2001;322:387–90.PubMedPubMedCentral Powell P, Bentall RP, Nye FJ, Edwards RH. Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syndrome. BMJ. 2001;322:387–90.PubMedPubMedCentral
64.
go back to reference Papou A, Hussain S, McWilliams D, Zhang W, Doherty M. Responsiveness of SF-36 Health Survey and Patient Generated Index in people with chronic knee pain commenced on oral analgesia: analysis of data from a randomised controlled clinical trial. Qual Life Res. 2017;26(3):761–6.PubMed Papou A, Hussain S, McWilliams D, Zhang W, Doherty M. Responsiveness of SF-36 Health Survey and Patient Generated Index in people with chronic knee pain commenced on oral analgesia: analysis of data from a randomised controlled clinical trial. Qual Life Res. 2017;26(3):761–6.PubMed
65.
go back to reference Hollingworth W, Deyo RA, Sullivan SD, Emerson SS, Gray DT, Jarvik JG. The practicality and validity of directly elicited and SF-36 derived health state preferences in patients with low back pain. Health Econ. 2002;11(1):71–85.PubMed Hollingworth W, Deyo RA, Sullivan SD, Emerson SS, Gray DT, Jarvik JG. The practicality and validity of directly elicited and SF-36 derived health state preferences in patients with low back pain. Health Econ. 2002;11(1):71–85.PubMed
66.
go back to reference Fredheim OMS, Borchgrevink PC, Saltnes T, Kaasa S. Validation and comparison of the health-related quality-of-life instruments EORTC QLQ-C30 and SF-36 in assessment of patients with chronic nonmalignant pain. J Pain Symptom Manag. 2007;34(6):657–65. Fredheim OMS, Borchgrevink PC, Saltnes T, Kaasa S. Validation and comparison of the health-related quality-of-life instruments EORTC QLQ-C30 and SF-36 in assessment of patients with chronic nonmalignant pain. J Pain Symptom Manag. 2007;34(6):657–65.
67.
go back to reference Bombardier C, Hayden J, Beaton DE. Minimal clinically important difference. Low back pain: outcome measures J Rheumatol. 2001;28:431–8.PubMed Bombardier C, Hayden J, Beaton DE. Minimal clinically important difference. Low back pain: outcome measures J Rheumatol. 2001;28:431–8.PubMed
68.
go back to reference Hägg O, Fritzell P, Nordwall A. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003;12(1):12–20.PubMed Hägg O, Fritzell P, Nordwall A. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003;12(1):12–20.PubMed
69.
go back to reference Escobar A, Quintana JM, Bilbao A, Arostegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthr Cartil. 2007;15(3):273–80. Escobar A, Quintana JM, Bilbao A, Arostegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthr Cartil. 2007;15(3):273–80.
70.
go back to reference Finan PH, Goodin BR, Smith MT. The association of sleep and pain: an update and a path forward. J Pain. 2013;14:1539–52.PubMedPubMedCentral Finan PH, Goodin BR, Smith MT. The association of sleep and pain: an update and a path forward. J Pain. 2013;14:1539–52.PubMedPubMedCentral
71.
go back to reference Aili K, et al. Sleep problems and fatigue as predictors for the onset of chronic widespread pain over a 5- and 18-year perspective. BMC Musculoskelet Disord. 2018;19:390.PubMedPubMedCentral Aili K, et al. Sleep problems and fatigue as predictors for the onset of chronic widespread pain over a 5- and 18-year perspective. BMC Musculoskelet Disord. 2018;19:390.PubMedPubMedCentral
72.
go back to reference Afolalu EF, Ramlee F, Tang NK. Effects of sleep changes on pain-related health outcomes in the general population: a systematic review of longitudinal studies with exploratory meta-analysis. Sleep Med Rev. 2018;39:82–97.PubMedPubMedCentral Afolalu EF, Ramlee F, Tang NK. Effects of sleep changes on pain-related health outcomes in the general population: a systematic review of longitudinal studies with exploratory meta-analysis. Sleep Med Rev. 2018;39:82–97.PubMedPubMedCentral
73.
go back to reference Naughton F, Ashworth P, Skevington SM. Does sleep quality predict pain-related disability in chronic pain patients? The mediating roles of depression and pain severity. Pain. 2007;127:243–52.PubMed Naughton F, Ashworth P, Skevington SM. Does sleep quality predict pain-related disability in chronic pain patients? The mediating roles of depression and pain severity. Pain. 2007;127:243–52.PubMed
74.
go back to reference Smith MT, Wegener ST. Measures of sleep: the Insomnia Severity Index, Medical Outcomes Study (MOS) Sleep Scale, Pittsburgh Sleep Diary (PSD), and Pittsburgh Sleep Quality Index (PSQI). Arthritis Rheum. 2004;49:S184–96. Smith MT, Wegener ST. Measures of sleep: the Insomnia Severity Index, Medical Outcomes Study (MOS) Sleep Scale, Pittsburgh Sleep Diary (PSD), and Pittsburgh Sleep Quality Index (PSQI). Arthritis Rheum. 2004;49:S184–96.
75.
go back to reference Smith MT, Perlis ML, Smith MS, Giles DE, Carmody TP. Sleep quality and presleep arousal in chronic pain. J Behav Med. 2000;23(1):1–13.PubMed Smith MT, Perlis ML, Smith MS, Giles DE, Carmody TP. Sleep quality and presleep arousal in chronic pain. J Behav Med. 2000;23(1):1–13.PubMed
76.
go back to reference Currie SR, Wilson KG, Curran D. Clinical significance and predictors of treatment response to cognitive-behavior therapy for insomnia secondary to chronic pain. J Behav Med. 2002;25(2):135–53.PubMed Currie SR, Wilson KG, Curran D. Clinical significance and predictors of treatment response to cognitive-behavior therapy for insomnia secondary to chronic pain. J Behav Med. 2002;25(2):135–53.PubMed
77.
go back to reference Menefee LA, Frank ED, Doghramji K, Picarello K, Park JJ, Jalali S, et al. Self-reported sleep quality and quality of life for individuals with chronic pain conditions. Clin J Pain. 2000;16(4):290–7.PubMed Menefee LA, Frank ED, Doghramji K, Picarello K, Park JJ, Jalali S, et al. Self-reported sleep quality and quality of life for individuals with chronic pain conditions. Clin J Pain. 2000;16(4):290–7.PubMed
78.
go back to reference Aǧargün MY, Tekeoǧlu I, Güneş A, Adak B, Kara H, Ercan M. Sleep quality and pain threshold in patients with fibromyalgia. Compr Psychiatry. 1999;40(3):226–8.PubMed Aǧargün MY, Tekeoǧlu I, Güneş A, Adak B, Kara H, Ercan M. Sleep quality and pain threshold in patients with fibromyalgia. Compr Psychiatry. 1999;40(3):226–8.PubMed
79.
go back to reference Yatani H, Studts J, Cordova M, Carlson CR, Okeson JP. Comparison of sleep quality and clinical and psychologic characteristics in patients with temporomandibular disorders. J Orofac Pain. 2002;16(3). Yatani H, Studts J, Cordova M, Carlson CR, Okeson JP. Comparison of sleep quality and clinical and psychologic characteristics in patients with temporomandibular disorders. J Orofac Pain. 2002;16(3).
80.
go back to reference Weiss AR, Johnson NL, Berger NA, Redline S. Validity of activity-based devices to estimate sleep. J Clin Sleep Med. 2010;6. Weiss AR, Johnson NL, Berger NA, Redline S. Validity of activity-based devices to estimate sleep. J Clin Sleep Med. 2010;6.
81.
go back to reference Wilson KG, Watson ST, Currie SR. Daily diary and ambulatory activity monitoring of sleep in patients with insomnia associated with chronic musculoskeletal pain. Pain. 1998;75:75–84.PubMed Wilson KG, Watson ST, Currie SR. Daily diary and ambulatory activity monitoring of sleep in patients with insomnia associated with chronic musculoskeletal pain. Pain. 1998;75:75–84.PubMed
82.
go back to reference Wells G, Li T, Maxwell L, MacLean R, Tugwell P. Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. J Rheumatol. 2007;34(2):280–9.PubMed Wells G, Li T, Maxwell L, MacLean R, Tugwell P. Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. J Rheumatol. 2007;34(2):280–9.PubMed
83.
go back to reference Burns J. Arousal of negative emotions and symptom-specific reactivity in chronic low back pain patients. Emotion. 2006;6:309.PubMed Burns J. Arousal of negative emotions and symptom-specific reactivity in chronic low back pain patients. Emotion. 2006;6:309.PubMed
84.
go back to reference Wiech K, Tracey I. The influence of negative emotions on pain: behavioral effects and neural mechanisms. Neuroimage. 2009;47(3):987–94.PubMed Wiech K, Tracey I. The influence of negative emotions on pain: behavioral effects and neural mechanisms. Neuroimage. 2009;47(3):987–94.PubMed
85.
go back to reference Tan G, Jensen MP, Thornby J, Sloan PA. Negative emotions, pain, and functioning. Psychol Serv. 2008;5(1):26. Tan G, Jensen MP, Thornby J, Sloan PA. Negative emotions, pain, and functioning. Psychol Serv. 2008;5(1):26.
86.
go back to reference Deshpande MA, Holden RR, Gilron I. The impact of therapy on quality of life and mood in neuropathic pain: what is the effect of pain reduction? Anesth Analg. 2006;102:1473–9.PubMed Deshpande MA, Holden RR, Gilron I. The impact of therapy on quality of life and mood in neuropathic pain: what is the effect of pain reduction? Anesth Analg. 2006;102:1473–9.PubMed
87.
go back to reference Frondini C, Lanfranchi G, Minardi M, Cucinotta D. Affective, behavior and cognitive disorders in the elderly with chronic musculoskelatal pain: the impact on an aging population. Arch Gerontol Geriatr. 2007;44:167–71.PubMed Frondini C, Lanfranchi G, Minardi M, Cucinotta D. Affective, behavior and cognitive disorders in the elderly with chronic musculoskelatal pain: the impact on an aging population. Arch Gerontol Geriatr. 2007;44:167–71.PubMed
88.
go back to reference Birket-Smith M. Somatization and chronic pain. Acta Anaesthesiol Scand. 2001:1114–20. Birket-Smith M. Somatization and chronic pain. Acta Anaesthesiol Scand. 2001:1114–20.
89.
go back to reference McWilliams LA, Cox BJ, Enns MW. Mood and anxiety disorders associated with chronic pain: an examination in a nationally representative sample. Pain. 2003;106:127–33.PubMed McWilliams LA, Cox BJ, Enns MW. Mood and anxiety disorders associated with chronic pain: an examination in a nationally representative sample. Pain. 2003;106:127–33.PubMed
90.
go back to reference Karp J, et al. Pain predicts longer time to remission during treatment of recurrent depression. J Clin Psychiatry. 2005;66:591–7.PubMed Karp J, et al. Pain predicts longer time to remission during treatment of recurrent depression. J Clin Psychiatry. 2005;66:591–7.PubMed
91.
go back to reference Ratcliffe GE, Enns MW, Belik S, Sareen J. Chronic pain conditions and suicidal ideation and suicide attempts : an epidemiologic perspective. Clin J Pain. 2008;24. Ratcliffe GE, Enns MW, Belik S, Sareen J. Chronic pain conditions and suicidal ideation and suicide attempts : an epidemiologic perspective. Clin J Pain. 2008;24.
92.
go back to reference Turk DC, Fillingim RB, Ohrbach R, Patel KV. Assessment of psychosocial and functional impact of chronic pain. J Pain. 2016;17:T21–49.PubMed Turk DC, Fillingim RB, Ohrbach R, Patel KV. Assessment of psychosocial and functional impact of chronic pain. J Pain. 2016;17:T21–49.PubMed
93.
go back to reference de Williams AC, Richardson PH. What does the BDI measure in chronic pain? Pain. 1993;55:259–66. de Williams AC, Richardson PH. What does the BDI measure in chronic pain? Pain. 1993;55:259–66.
94.
go back to reference Harris CA, D’Eon JL. Psychometric properties of the Beck Depression Inventory-Second Edition (BDI-II) in individuals with chronic pain. PAIN. 2008;137:609–22.PubMed Harris CA, D’Eon JL. Psychometric properties of the Beck Depression Inventory-Second Edition (BDI-II) in individuals with chronic pain. PAIN. 2008;137:609–22.PubMed
95.
go back to reference Okifuji A, Turk DC, Curran SL. Anger in chronic pain: investigations of anger targets and intensity. J Psychosom Res. 1999;47(1):1–12.PubMed Okifuji A, Turk DC, Curran SL. Anger in chronic pain: investigations of anger targets and intensity. J Psychosom Res. 1999;47(1):1–12.PubMed
96.
go back to reference Kroenke K, Outcalt S, Krebs E, Bair MJ, Wu J, Chumbler N, et al. Association between anxiety, health-related quality of life and functional impairment in primary care patients with chronic pain. Gen Hosp Psychiatry. 2013;35(4):359–65.PubMed Kroenke K, Outcalt S, Krebs E, Bair MJ, Wu J, Chumbler N, et al. Association between anxiety, health-related quality of life and functional impairment in primary care patients with chronic pain. Gen Hosp Psychiatry. 2013;35(4):359–65.PubMed
97.
go back to reference McCracken LM, Zayfert C, Gross RT. The pain anxiety symptoms scale: development and validation of a scale to measure fear of pain. Pain. 1992;50:67–73.PubMed McCracken LM, Zayfert C, Gross RT. The pain anxiety symptoms scale: development and validation of a scale to measure fear of pain. Pain. 1992;50:67–73.PubMed
98.
go back to reference Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992;31:301–6.PubMed Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992;31:301–6.PubMed
99.
go back to reference Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988;56(6):893–7.PubMed Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988;56(6):893–7.PubMed
100.
go back to reference Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70.PubMed Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70.PubMed
101.
go back to reference Shacham S. A shortened version of the profile of mood states. J Pers Assess. 1983;47:305–6.PubMed Shacham S. A shortened version of the profile of mood states. J Pers Assess. 1983;47:305–6.PubMed
102.
go back to reference Guy W. ECDEU assessment manual for psychopharmacology (DHEW Publication No. ADM 76-338). Washington, D.C.: Government Printing Office; 1976. Guy W. ECDEU assessment manual for psychopharmacology (DHEW Publication No. ADM 76-338). Washington, D.C.: Government Printing Office; 1976.
Metadata
Title
Outcomes in Pain Clinical Research: What Really Matters for Patients?
Authors
James S. Khan
Rutvij Shah
Ian Gilron
Publication date
01-12-2019
Publisher
Springer US
Published in
Current Anesthesiology Reports / Issue 4/2019
Electronic ISSN: 2167-6275
DOI
https://doi.org/10.1007/s40140-019-00361-w

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