Pain relief that matters to patients: Systematic review of empirical studies assessing the minimum clinically important difference in acute pain

BMC Medicine

Volumn 15, Issue 1, 2017, Pages

  Olsen, Mette Frahm ^a   Bjerre, Eik ^a   Hansen, Maria Damkjær ^b   Hilden, Jørgen ^c   Landler, Nino Emanuel ^d   Tendal, Britta ^a   Hróbjartsson, Asbjørn ^e  

^a Rigshospitalet   (Denmark)

^b FREDERIKSBERG HOSPITAL   (Denmark)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

^d GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^e UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

Author keywords

Minimum clinically important difference; Pain; Systematic review

Indexed keywords

ANALGESIA; COCHRANE LIBRARY; CONSENSUS DEVELOPMENT; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; EMBASE; EMPIRICISM; HUMAN; MEDLINE; META ANALYSIS; PATIENT CODING; PROSPECTIVE STUDY; REFERENCE VALUE; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY; STUDY DESIGN; SYMPTOM; SYSTEMATIC REVIEW; VISUAL ANALOG SCALE; ACUTE PAIN; ADOLESCENT; ADULT; AGED; DISABILITY; MIDDLE AGED; PROCEDURES; YOUNG ADULT;

ACUTE PAIN; ADOLESCENT; ADULT; AGED; DISABILITY EVALUATION; HUMANS; MIDDLE AGED; PAIN MANAGEMENT; YOUNG ADULT;

EID: 85013192533     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/s12916-016-0775-3     Document Type: Article

References (78)

1. Sinatra RS, Jahr JS, Reynolds L, Groudine SB, Royal MA, Breitmeyer JB, et al. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012;12:357-65.
2. Stockler M, Vardy J, Pillai A, Warr D. Acetaminophen (paracetamol) improves pain and well-being in people with advanced cancer already receiving a strong opioid regimen: a randomized, double-blind, placebo-controlled cross-over trial. J Clin Oncol. 2004;22:3389-94.
3. Dalton JD, Schweinle JE. Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains. Ann Emerg Med. 2006;48:615-23.
4. Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, et al. Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain: a randomized clinical trial. JAMA. 2015;314:1572-80.
5. Jones P, Dalziel SR, Lamdin R, Miles-Chan JL, Frampton C. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2015;7:CD007789.
6. Farahmand S, Shiralizadeh S, Talebian M-T, Bagheri-Hariri S, Arbab M, Basirghafouri H, et al. Nebulized fentanyl vs intravenous morphine for ED patients with acute limb pain: a randomized clinical trial. Am J Emerg Med. 2014;32:1011-5.
7. Chau JKM, Seikaly HR, Harris JR, Villa-Roel C, Brick C, Rowe BH. Corticosteroids in peritonsillar abscess treatment: a blinded placebo-controlled clinical trial. Laryngoscope. 2014;124:97-103.
8. Santamato A, Solfrizzi V, Panza F, Tondi G, Frisardi V, Leggin BG, et al. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of people with subacromial impingement syndrome: a randomized clinical trial. Phys Ther. 2009;89:643-52.
9. Luedtke K, Rushton A, Wright C, Geiss B, Juergens TP, May A. Transcranial direct current stimulation for the reduction of clinical and experimentally induced pain: a systematic review and meta-analysis. Clin J Pain. 2012;28:452-61.
10. Biran V, Gourrier E, Cimerman P, Walter-Nicolet E, Mitanchez D, Carbajal R. Analgesic effects of EMLA cream and oral sucrose during venipuncture in preterm infants. Pediatrics. 2011;128:e63-70.
11. Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009;338:a3115.
12. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407-15.
13. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56:395-407.
14. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9:105-21.
15. Glassman SD, Copay AG, Berven SH, Polly DW, Subach BR, Carreon LY. Defining substantial clinical benefit following lumbar spine arthrodesis. J Bone Joint Surg Am. 2008;90:1839-47.
16. Ostelo RWJG, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. 2008;33:90-4.
17. Auleley G-R, Benbouazza K, Spoorenberg A, Collantes E, Hajjaj-Hassouni N, van der Heijde D, et al. Evaluation of the smallest detectable difference in outcome or process variables in ankylosing spondylitis. Arthritis Rheum. 2002;47:582-7.
18. Chansirinukor W, Maher CG, Latimer J, Hush J. Comparison of the functional rating index and the 18-item Roland-Morris Disability Questionnaire: responsiveness and reliability. Spine. 2005;30:141-5.
19. Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013;346:f167.
20. Stauffer ME, Taylor SD, Watson DJ, Peloso PM, Morrison A. Definition of nonresponse to analgesic treatment of arthritic pain: an analytical literature review of the smallest detectable difference, the minimal detectable change, and the minimal clinically important difference on the pain visual analog scale. Int J Inflamm. 2011;2011:231926.
21. Lopez BL, Flenders P, Davis-Moon L, Corbin T, Ballas SK. Clinically significant differences in the visual analog pain scale in acute vasoocclusive sickle cell crisis. Hemoglobin. 2007;31:427-32.
22. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR, Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77:371-83.
23. Deyo RA, Centor RM. Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance. J Chronic Dis. 1986;39:897-906.
24. Lambert PC, Sutton AJ, Abrams KR, Jones DR. A comparison of summary patient-level covariates in meta-regression with individual patient data meta-analysis. J Clin Epidemiol. 2002;55:86-94.
25. Aicher B, Peil H, Peil B, Diener H-C. Responsiveness of efficacy endpoints in clinical trials with over the counter analgesics for headache. Cephalalgia Int J Headache. 2012;32:953-62.
26. Bailey B, Daoust R, Doyon-Trottier E, Dauphin-Pierre S, Gravel J. Validation and properties of the verbal numeric scale in children with acute pain. Pain. 2010;149:216-21.
27. Bernstein SL, Bijur PE, Gallagher EJ. Relationship between intensity and relief in patients with acute severe pain. Am J Emerg Med. 2006;24:162-6.
28. Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003;10:390-2.
29. Bijur PE, Chang AK, Esses D, Gallagher EJ. Identifying the minimum clinically significant difference in acute pain in the elderly. Ann Emerg Med. 2010;56:517-21. e1.
30. Bijur PE, Chang AK, Esses D, Gallagher EJ. Problems with measurement of the minimum clinically significant difference in acute pain in elders. Acad Emerg Med. 2011;18:135-9.
31. Bird SB, Dickson EW. Clinically significant changes in pain along the visual analog scale. Ann Emerg Med. 2001;38:639-43.
32. Bulloch B, Tenenbein M. Assessment of clinically significant changes in acute pain in children. Acad Emerg Med. 2002;9:199-202.
33. Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003;105:151-7.
34. Chow E, Ling A, Davis L, Panzarella T, Danjoux C. Pain flare following external beam radiotherapy and meaningful change in pain scores in the treatment of bone metastases. Radiother Oncol. 2005;75:64-9.
35. Degerli V, Karcioglu O, Larkin GL, Karaduman S, Korkmaz T, Tunc MA. The minimum clinically significant difference in acute nontraumatic thoracoabdominal pain in adult emergency department patients in Turkey. J Emerg Med. 2012;19(3):171-6.
36. Farrar JT, Polomano RC, Berlin JA, Strom BL. A comparison of change in the 0-10 numeric rating scale to a pain relief scale and global medication performance scale in a short-term clinical trial of breakthrough pain intensity. Anesthesiology. 2010;112:1464-72.
37. Fosnocht DE, Chapman CR, Swanson ER, Donaldson GW. Correlation of change in visual analog scale with pain relief in the ED. Am J Emerg Med. 2005;23:55-9.
38. Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001;38:633-8.
39. Gallagher EJ, Bijur PE, Latimer C, Silver W. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med. 2002;20:287-90.
40. Grilo RM, Treves R, Preux PM, Vergne-Salle P, Bertin P. Clinically relevant VAS pain score change in patients with acute rheumatic conditions. Jt Bone Spine Rev Rhum. 2007;74:358-61.
41. Grotle M, Brox JI, Vøllestad NK. Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain. Spine. 2004;29:E492-501.
42. Holdgate A, Asha S, Craig J, Thompson J. Comparison of a verbal numeric rating scale with the visual analogue scale for the measurement of acute pain. Emerg Med (Fremantle). 2003;15:441-6.
43. Jensen MP, Chen C, Brugger AM. Postsurgical pain outcome assessment. Pain. 2002;99:101-9.
44. Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998;5:1086-90.
45. Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med. 2001;18:205-7.
46. Kelly AM. Setting the benchmark for research in the management of acute pain in emergency departments. Emerg Med. 2001;13:57-60.
47. Kendrick DB, Strout TD. The minimum clinically significant difference in patient-assigned numeric scores for pain. Am J Emerg Med. 2005;23:828-32.
48. Mark M, Au T, Choi Y, Wong T. The minimum clinically significant difference in visual analogue scale pain score in a local emergency setting. Hong Kong J Emerg Med. 2009;16:233-6.
49. Martin WJ, Ashton-James C, Skorpil N, Heymans M, Forouzanfar T. What constitutes a clinically important pain reduction in patients after third molar surgery? Pain Res Manag. 2013;18:319-22.
50. McConahay T, Bryson M, Bulloch B. Clinically significant changes in acute pain in a pediatric ED using the Color Analog Scale. Am J Emerg Med. 2007;25:739-42.
51. Mohan H, Ryan J, Whelan B, Wakai A. The end of the line? The Visual Analogue Scale and Verbal Numerical Rating Scale as pain assessment tools in the emergency department. Emerg Med J. 2010;27:372-5.
52. Myrvik MP, Brandow AM, Drendel AL, Yan K, Hoffmann RG, Panepinto JA. Clinically meaningful measurement of pain in children with sickle cell disease. Pediatr Blood Cancer. 2013;60:1689-95.
53. Powell CV, Kelly AM, Williams A. Determining the minimum clinically significant difference in visual analog pain score for children. Ann Emerg Med. 2001;37:28-31.
54. Sloman R, Wruble AW, Rosen G, Rom M. Determination of clinically meaningful levels of pain reduction in patients experiencing acute postoperative pain. Pain Manag Nurs. 2006;7:153-8.
55. Stahmer SA, Shofer FS, Marino A, Shepherd S, Abbuhl S. Do quantitative changes in pain intensity correlate with pain relief and satisfaction? Acad Emerg Med. 1998;5:851-7.
56. Todd KH, Funk JP. The minimum clinically important difference in physician-assigned visual analog pain scores. Acad Emerg Med. 1996;3:142-6.
57. Tsze DS, Hirschfeld G, von Baeyer CL, Bulloch B, Dayan PS. Clinically significant differences in acute pain measured on self-report pain scales in children. Acad Emerg Med. 2015;22:415-22.
58. Tubach F, Dougados M, Falissard B, Baron G, Logeart I, Ravaud P. Feeling good rather than feeling better matters more to patients. Arthritis Rheum. 2006;55:526-30.
59. Voepel-Lewis T, Burke CN, Jeffreys N, Malviya S, Tait AR. Do 0-10 numeric rating scores translate into clinically meaningful pain measures for children? Anesth Analg. 2011;112:415-21.
60. Guyatt GH, Townsend M, Keller JL, Singer J. Should study subjects see their previous responses: data from a randomized control trial. J Clin Epidemiol. 1989;42:913-20.
61. Doganay Erdogan B, Leung YY, Pohl C, Tennant A, Conaghan PG. Minimal clinically important difference as applied in rheumatology: an OMERACT Rasch Working Group systematic review and critique. J Rheumatol. 2016;43:194-202.
62. Wyrwich KW, Metz SM, Kroenke K, Tierney WM, Babu AN, Wolinsky FD. Triangulating patient and clinician perspectives on clinically important differences in health-related quality of life among patients with heart disease. Health Serv Res. 2007;42(6 Pt 1):2257-74. discussion 2294-323.
63. Terwee CB, Roorda LD, Dekker J, Bierma-Zeinstra SM, Peat G, Jordan KP, et al. Mind the MIC: large variation among populations and methods. J Clin Epidemiol. 2010;63:524-34.
64. Gatchel RJ, Mayer TG. Testing minimal clinically important difference: consensus or conundrum? Spine J. 2010;10:321-7.
65. Glassman SD, Carreon L, Dimar JR. Outcome of lumbar arthrodesis in patients sixty-five years of age or older. Surgical technique. J Bone Joint Surg Am. 2010;92 Suppl 1 Pt 1:77-84.
66. Hageman WJ, Arrindell WA. Establishing clinically significant change: increment of precision and the distinction between individual and group level of analysis. Behav Res Ther. 1999;37:1169-93.
67. Beaton DE, Bombardier C, Katz JN, Wright JG, Wells G, Boers M, et al. Looking for important change/differences in studies of responsiveness. OMERACT MCID Working Group. Outcome Measures in Rheumatology. Minimal Clinically Important Difference. J Rheumatol. 2001;28:400-5.
68. Copay AG, Subach BR, Glassman SD, Polly Jr DW, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007;7:541-6.
69. Rouquette A, Blanchin M, Sébille V, Guillemin F, Côté SM, Falissard B, et al. The minimal clinically important difference determined using item response theory models: an attempt to solve the issue of the association with baseline score. J Clin Epidemiol. 2014;67(4):433-40.
70. Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61:102-9.
71. Mercadante S, Adile C, Torta R, Varetto A, Fulfaro F, Giarratano A, et al. Meaningful cut-off pain intensity for breakthrough pain changes in advanced cancer patients. Curr Med Res Opin. 2013;29:93-7.
72. Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis. 2005;64:34-7.
73. Moore RA, Straube S, Aldington D. Pain measures and cut-offs - "no worse than mild pain" as a simple, universal outcome. Anaesthesia. 2013;68:400-12.
74. Ferreira ML, Herbert RD, Ferreira PH, Latimer J, Ostelo RW, Grotle M, et al. The smallest worthwhile effect of nonsteroidal anti-inflammatory drugs and physiotherapy for chronic low back pain: a benefit-harm trade-off study. J Clin Epidemiol. 2013;66:1397-404.
75. Ferreira ML, Ferreira PH, Herbert RD, Latimer J. People with low back pain typically need to feel "much better" to consider intervention worthwhile: an observational study. Aust J Physiother. 2009;55:123-7.
76. Barrett B. Sufficiently important difference: concepts, caveats, and challenges. Med Decis Mak. 2013;33:869-74.
77. Carragee EJ. The rise and fall of the "minimum clinically important difference". Spine J. 2010;10:283-4.
78. Ruyssen-Witrand A, Tubach F, Ravaud P. Systematic review reveals heterogeneity in definition of a clinically relevant difference in pain. J Clin Epidemiol. 2011;64:463-70.