Evaluating the quality of subgroup analyses in randomized controlled trials of therapist-delivered interventions for nonspecific low back pain: A systematic review

Spine

Volumn 39, Issue 7, 2014, Pages 618-629

  Mistry, Dipesh ^a   Patel, Shilpa ^a   Hee, Siew Wan ^a   Stallard, Nigel ^a   Underwood, Martin ^a  

^a UNIVERSITY OF WARWICK   (United Kingdom)

Author keywords

Back pain; Effect modifi cation; Heterogeneity of treatment effect; Interaction; Low back pain; Randomized controlled trial; Subgroup analysis

Indexed keywords

AUSTRALIA; AUSTRALIA AND NEW ZEALAND; CLINICAL ASSESSMENT; DENMARK; EVALUATION STUDY; FINLAND; GERMANY; HUMAN; LOW BACK PAIN; NETHERLANDS; NONSPECIFIC LOW BACK PAIN; PHYSIOTHERAPIST; PRIORITY JOURNAL; QUALITY CONTROL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH PRIORITY; REVIEW; SWEDEN; SYSTEMATIC REVIEW; UNITED KINGDOM; UNITED STATES; EVIDENCE BASED MEDICINE; LITERATURE; STATISTICS; TREATMENT OUTCOME;

EVIDENCE-BASED MEDICINE; HUMANS; LITERATURE; LOW BACK PAIN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STATISTICS AS TOPIC; TREATMENT OUTCOME;

EID: 84897570998     PISSN: 03622436     EISSN: 15281159     Source Type: Journal    
DOI: 10.1097/BRS.0000000000000231     Document Type: Review

References (61)

1. 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: 8-20
2. Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain 2000; 84: 95-103
3. Vos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: A systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2163-96
4. Savigny P KS, Watson P, Underwood M, et al. Low Back Pain: Early Management of Persistent Non-Specific Low Back Pain. London: National Collaborating Centre for Primary Care and Royal College of General Practitioners; 2009
5. Tilbrook HE, Cox H, Hewitt CE, et al. Yoga for chronic low back pain. Ann Intern Med 2011; 155: 569-78
6. Team UBT. United Kingdom Back Pain Exercise and Manipulation (UK BEAM) randomised trial: Effectiveness of physical treatments for back pain in primary care. BMJ 2004; 329: 1377
7. Lamb SE, Lall R, Hansen Z, et al. A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial. Health Technol Assess 2010; 14: 1-253, iii-iv
8. Little P, Lewith G, Webley F, et al. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain [reprint in: Br J Sports Med 2008;42:965-8]. BMJ 2008; 337: A884
9. Kraemer HC, Stice E, Kazdin A, et al. How do risk factors work together? Mediators, moderators, and independent, overlapping, and proxy risk factors. Am J Psychiatry 2001; 158: 848-56
10. Kent P, Keating J, Leboeuf-Yde C. Research methods for subgrouping low back pain. BMC Med Res Methodol 2010; 10: 62
11. Borkan JM, Koes B, Reis S, et al. A report from the second international forum for primary care research on low back pain. Reexamining priorities. Spine (Phila Pa 1976) 1998; 23: 1992-6
12. Pincus T, Miles C, Froud R, et al. Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials: A consensus study. BMC Med Res Methodol 2011; 11: 14
13. Rothwell PM. Subgroup analysis in randomised controlled trials: Importance, indications, and interpretation. Lancet 2005; 365 : 176-86
14. Lagakos SW. The challenge of subgroup analyses-reporting without distorting. N Engl J Med 2006; 354: 1667-9
15. Sheets C, Machado LA, Hancock M, et al. Can we predict response to the McKenzie method in patients with acute low back paiñ A secondary analysis of a randomized controlled trial. Eur Spine J 2012; 21: 1250-6
16. Smeets RJEM, Maher CG, Nicholas MK, et al. Do psychological characteristics predict response to exercise and advice for subacute low back paiñ Arthritis Rheum 2009; 61: 1202-9
17. Underwood M, Mistry D, Lall R, et al. Predicting response to a cognitive-behavioral approach to treating low back pain: Secondary analysis of the BeST data set. Arthritis Care Res 2011; 63 : 1271-9
18. Witt CM, Jena S, Selim D, et al. Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain. Am J Epidemiol 2006; 164: 487-96
19. Gudavalli MR, Cambron JA, McGregor M, et al. A randomized clinical trial and subgroup analysis to compare fl exion-distraction with active exercise for chronic low back pain. Eur Spine J 2006; 15: 1070-82
20. Hansen FR, Bendix T, Skov P, et al. Intensive, dynamic back-muscle exercises, conventional physiotherapy, or placebo-control treatment of low-back pain. A randomized, observer-blind trial. Spine (Phila Pa 1976) 1993; 18: 98-108
21. Hay EM, Mullis R, Lewis M, et al. Comparison of physical treatments versus a brief pain-management programme for back pain in primary care: A randomised clinical trial in physiotherapy practice. Lancet 2005; 365: 2024-30
22. Johnson RE, Jones GT, Wiles NJ, et al. Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: A randomized controlled trial. Spine (Phila Pa 1976) 2007; 32: 1578-85
23. Bishop MD, Bialosky JE, Cleland JA. Patient expectations of benefi t from common interventions for low back pain and effects on outcome: Secondary analysis of a clinical trial of manual therapy interventions. J Man Manip Ther 2011; 19: 20-5
24. Beurskens AJ, de Vet HC, Koke AJ, et al. Efficacy of traction for non-specifi c low back pain: A randomised clinical trial. Lancet 1995; 346: 1596-600
25. Cherkin DC, Deyo RA, Battie M, et al. A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain. N Engl J Med 1998; 339: 1021-9
26. Hsieh LL-C, Kuo C-H, Yen M-F, et al. A randomized controlled clinical trial for low back pain treated by acupressure and physical therapy. Prev Med 2004; 39: 168-76
27. Roche G, Ponthieux A, Parot-Shinkel E, et al. Comparison of a functional restoration program with active individual physical therapy for patients with chronic low back pain: A randomized controlled trial. Arch Phys Med Rehabil 2007; 88 : 1229-35
28. Underwood MR, Morton V, Farrin A, et al. Do baseline characteristics predict response to treatment for low back paiñ Secondary analysis of the UK BEAM dataset [ISRCTN32683578]. Rheumatology (Oxford) 2007; 46: 1297-302
29. Seferlis T, Nemeth G, Carlsson AM, et al. Conservative treatment in patients sick-listed for acute low-back pain: A prospective randomised study with 12 months' follow-up. Eur Spine J 1998; 7 : 461-70
30. Bendix AF, Bendix T, Haestrup C. Can it be predicted which patients with chronic low back pain should be offered tertiary rehabilitation in a functional restoration program? A search for demographic, socioeconomic, and physical predictors. Spine (Phila Pa 1976) 1998; 23: 1775-83; discussion 83-4
31. Mellin G, Hurri H, Harkapaa K, et al. A controlled study on the outcome of inpatient and outpatient treatment of low back pain, part II: Effects on physical measurements three months after treatment. Scand J Rehabil Med 1989; 21: 91-5
32. Carr JL, Klaber Moffett JA, Howarth E, et al. A randomized trial comparing a group exercise programme for back pain patients with individual physiotherapy in a severely deprived area. Disabil Rehabil 2005; 27: 929-37
33. Jellema P, van der Windt DAWM, van der Horst HE, et al. Why is a treatment aimed at psychosocial factors not effective in patients with (sub)acute low back paiñ Pain 2005; 118: 350-9
34. Klaber Moffett JA, Carr JM, Howarth EM. High fear-Avoiders of physical activity benefi t from an exercise program for patients with back pain. Spine (Phila Pa 1976) 2004; 29: 1167-72
35. van der Roer N, van Tulder M, Barendse J, et al. Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: A randomised controlled trial. Eur Spine J 2008; 17: 1193-200
36. Vollenbroek-Hutten MMR, Hermens HJ, Wever D, et al. Differences in outcome of a multidisciplinary treatment between subgroups of chronic low back pain patients defi ned using two multiaxial assessment instruments: The multidimensional pain inventory and lumbar dynamometry. Clin Rehabil 2004; 18: 566-79
37. Yusuf S, Wittes J, Probstfield J, et al. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266: 93-8
38. Becker A, Leonhardt C, Kochen MM, et al. Effects of two guideline implementation strategies on patient outcomes in primary care: A cluster randomized controlled trial. Spine (Phila Pa 1976) 2008; 33: 473-80
39. Juni P, Battaglia M, Nuesch E, et al. A randomised controlled trial of spinal manipulative therapy in acute low back pain. Ann Rheum Dis 2009; 68: 1420-7
40. Smeets RJEM, Vlaeyen JWS, Hidding A, et al. Active rehabilitation for chronic low back pain: Cognitive-behavioral, physical, or both? First direct post-Treatment results from a randomized controlled trial [ISRCTN22714229]. BMC Musculoskelet Disord 2006; 7: 5
41. Thomas KJ, MacPherson H, Thorpe L, et al. Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specifi c low back pain. BMJ 2006; 333: 623
42. Ferreira ML, Ferreira PH, Latimer J, et al. Relationship between spinal stiffness and outcome in patients with chronic low back pain. Man Ther 2009; 14: 61-7
43. Sherman KJ, Cherkin DC, Ichikawa L, et al. Characteristics of patients with chronic back pain who benefi t from acupuncture. BMC Musculoskelet Disord 2009; 10: 114
44. van der Hulst M, Vollenbroek-Hutten MMR, Groothuis-Oudshoorn KGM, et al. Multidisciplinary rehabilitation treatment of patients with chronic low back pain: A prognostic model for its outcome. Clin J Pain 2008; 24: 421-30
45. Cecchi F, Negrini S, Pasquini G, et al. Predictors of functional outcome in patients with chronic low back pain undergoing back school, individual physiotherapy or spinal manipulation. Eur J Phys Rehabil Med 2012; 48: 371-8
46. Cherkin DC, Eisenberg D, Sherman KJ, et al. Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med 2001; 161: 1081-8
47. Cherkin DC, Sherman KJ, Avins AL, et al. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med 2009; 169: 858-66
48. Kalauokalani D, Cherkin DC, Sherman KJ, et al. Lessons from a trial of acupuncture and massage for low back pain: Patient expectations and treatment effects. Spine (Phila Pa 1976) 2001; 26 : 1418-24
49. Karjalainen K, Malmivaara A, Mutanen P, et al. Mini-intervention for subacute low back pain: Two-year follow-up and modifi ers of effectiveness. Spine (Phila Pa 1976) 2004; 29: 1069-76
50. Kole-Snijders AM, Vlaeyen JW, Goossens ME, et al. Chronic lowback pain: What does cognitive coping skills training add to operant behavioral treatment? Results of a randomized clinical trial. J Consult Clin Psychol 1999; 67: 931-44
51. Myers SS, Phillips RS, Davis RB, et al. Patient expectations as predictors of outcome in patients with acute low back pain. J Gen Intern Med 2008; 23: 148-53
52. Smeets RJEM, Vlaeyen JWS, Hidding A, et al. Chronic low back pain: Physical training, graded activity with problem solving training, or both? The one-year post-Treatment results of a randomized controlled trial [reprint in: Ned Tijdschr Geneeskd 2009;153:543. Pain 2008; 134: 263-76
53. Lachenbruch PA. A note on sample size computation for testing interactions. Stat Med 1988; 7: 467-9
54. Lamb SE, Hansen Z, Lall R, et al. Group cognitive behavioural treatment for low-back pain in primary care: A randomised controlled trial and cost-effectiveness analysis. Lancet 2010; 375: 916-23
55. Brookes ST, Whitley E, Peters TJ, et al. Subgroup analyses in randomised controlled trials: Quantifying the risks of false-positives and false-negatives. Health Technol Assess 2001; 5: 1-56
56. Pincus T, Santos R, Breen A, et al. A review and proposal for a core set of factors for prospective cohorts in low back pain: A consensus statement. Arthritis Care Res 2008; 59: 14-24
57. Su X, Tsai C-L, Wang H, et al. Subgroup analysis via recursive partitioning. SSRN eLibrary 2009; 10: 141-58
58. Dusseldorp E, Meulman JJ. The regression trunk approach to discover treatment covariate interaction. Psychometrika 2004; 69 : 355-74
59. Lipkovich I, Dmitrienko A, Denne J, et al. Subgroup identifi cation based on differential effect search-A recursive partitioning method for establishing response to treatment in patient subpopulations. Stat Med 2011; 30: 2601-21
60. Wang R, Lagakos SW, Ware JH, et al. Statistics in medicine-reporting of subgroup analyses in clinical trials. N Engl J Med 2007; 357: 2189-94
61. Glazov G. The infl uence of baseline characteristics on response to a laser acupuncture intervention: An exploratory analysis. Acupunct Med 2010; 28: 6-11.