Advertisement

The Patient - Patient-Centered Outcomes Research

, Volume 6, Issue 4, pp 291–305 | Cite as

Development of a Questionnaire to Assess the Impact of Chronic Low Back Pain for Use in Regulated Clinical Trials

  • Jonathan StokesEmail author
  • Christopher J. Evans
  • Farrah Pompilus
  • Alan L. Shields
  • Kent H. Summers
Original Research Article

Abstract

Background

Chronic low back pain (CLBP) is the most common chronic pain condition and is associated with clinical, economic, social, and public health impacts. The effect of CLBP on patients’ health-related quality of life (HRQoL) is significant. The symptoms and impacts most often associated with CLBP include pain and disability; patients most affected are often crippled by the condition. CLBP also affects patients’ mental, physical, and psychosocial well-being. A variety of self-report measures have been developed for the assessment of CLBP, such as the Roland Morris Disability Questionnaire (RMDQ); however, existing measures may not meet current regulatory expectation for the development, documentation, and use of patient-reported outcomes (PRO) questionnaires (U.S. Department of Health and Human Services, Food and Drug Administration, 2009).

Objectives

This report describes the qualitative development of the Chronic Low Back Pain Impact Questionnaire (CLBP-IQ), created for use in clinical trials.

Methods

A total of 22 CLBP patients recruited by clinicians participated in concept elicitation interviews to identify target measurement concepts. An instrument development team generated the instructions, items, and response options guided by patient input. Cognitive debriefing interviews were conducted with 21 patients recruited by the same clinicians who recruited for concept elicitation interviews. During cognitive interviews, a draft instrument composed of 28 items was presented to individuals with CLBP to evaluate its readability and comprehensiveness. All research activities were conducted in the US.

Results

During concept elicitation interviews, participants reported a variety of physical, emotional, and social impacts associated with CLBP. Participants also reported CLBP impacts on sleep, energy, daily activities, work, household activities, leisure activities, cognition, self-care, and sex life. Impacts deemed simple, important, and relevant to CLBP patients became targets of measurement for the CLBP-IQ. During cognitive debriefing, seventeen items were interpreted as intended by at least 90 % of participants, and no items were interpreted incorrectly by more than five patients (24 %). Additionally, seventeen items were experienced by at least 90 % of participants, and no single item was experienced by less than 67 % of participants (n = 14).

Conclusions

The CLBP-IQ was developed in accordance with current US Food and Drug Administration guidance on instrument development. Results from both concept elicitation and cognitive debriefing interviews support the content validity of the CLBP-IQ in patients with CLBP. Future development should proceed with psychometric evaluation.

Keywords

Oswestry Disability Index Cognitive Interview Roland Morris Disability Questionnaire Concept Elicitation Cognitive Debriefing Interview 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

The authors would like to acknowledge Andrea Zeytoonjian, Megan Daggett, Roger Lamoureux, and Gina Kevane for their assistance in the conduct of the research reported herein.

Disclosures

Funding source Endo Pharmaceuticals sponsored the research activities presented here for the development of the Chronic Low Back Pain Impact Questionnaire. A. L. S. is the designated guarantor of the content contained in this manuscript.

Author contributions All authors contributed equally to this work. All authors discussed the results and their implications and commented on the manuscript at all stages.

Conflicts of interest Authors J. S., C. E., F. P., and A. L. S. are or were employees of Adelphi Values (formerly Mapi Values), which received compensation from Endo Pharmaceuticals for the conduct of the research activities reported here as well as the composition of the present manuscript. Author K. H. S. is an employee of Endo Pharmaceuticals.

Supplementary material

40271_2013_26_MOESM1_ESM.doc (140 kb)
Supplementary material 1 (DOC 140 kb)
40271_2013_26_MOESM2_ESM.doc (252 kb)
Supplementary material 2 (DOC 251 kb)

References

  1. 1.
    U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; 2009.Google Scholar
  2. 2.
    Andersson G. The epidemiology of spinal disorders. In: Frymoyer J, editor. The adult spine: principles and practice. New York: Raven Press; 1997. p. 93–141.Google Scholar
  3. 3.
    Deyo RA, Tsui-Wu YJ. Descriptive epidemiology of low-back pain and its related medical care in the United States. Spine (Phila Pa 1976). 1987;12(3):264–8.CrossRefGoogle Scholar
  4. 4.
    Manchikanti L, Singh V, Datta S, Cohen SP, Hirsch JA. Comprehensive review of epidemiology, scope, and impact of spinal pain. Pain Physician. 2009;12(4):E35–70.PubMedGoogle Scholar
  5. 5.
    Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, et al. The rising prevalence of chronic low back pain. Arch Intern Med. 2009;169(3):251–8.PubMedCrossRefGoogle Scholar
  6. 6.
    Palmer KT, Walsh K, Bendall H, Cooper C, Coggon D. Back pain in Britain: comparison of two prevalence surveys at an interval of 10 years. BMJ. 2000;320(7249):1577–8.PubMedCrossRefGoogle Scholar
  7. 7.
    Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999;354(9178):581–5.PubMedCrossRefGoogle Scholar
  8. 8.
    Cherkin DC, Deyo RA, Street JH, Barlow W. Predicting poor outcomes for back pain seen in primary care using patients’ own criteria. Spine. 1996;21(24):2900–7.PubMedCrossRefGoogle Scholar
  9. 9.
    Epping-Jordan JE, Wahlgren DR, Williams RA, Pruitt SD, Slater MA, Patterson TL, et al. Transition to chronic pain in men with low back pain: predictive relationships among pain intensity, disability, and depressive symptoms. Health Psychol. 1998;17(5):421–7.PubMedCrossRefGoogle Scholar
  10. 10.
    Nunez M, Sanchez A, Nunez E, Casals T, Alegre C, Munoz-Gomez J. Patients’ perceptions of health related quality of life in rheumatoid arthritis and chronic low back pain. Qual Life Res. 2006;15(1):93–102.PubMedCrossRefGoogle Scholar
  11. 11.
    Koes BW, van Tulder MW. Diagnosis and treatment of low back pain. Br Med J. 2006;332(7560):1430–4.CrossRefGoogle Scholar
  12. 12.
    Boden SD, Zdeblick TA, Sandhu HS, Heim SE. The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: a preliminary report. Spine (Phila Pa 1976). 2000;25(3):376–81.CrossRefGoogle Scholar
  13. 13.
    Rives PA, Douglass AB. Evaluation and treatment of low back pain in family practice. J Am Board Fam Pract. 2004;17(Suppl):S23–31.PubMedCrossRefGoogle Scholar
  14. 14.
    Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1—eliciting concepts for a new PRO instrument. Value Health. 2011;14(8):967–77.PubMedCrossRefGoogle Scholar
  15. 15.
    Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 2-assessing respondent understanding. Value Health. 2011;14(8):978–88.PubMedCrossRefGoogle Scholar
  16. 16.
  17. 17.
    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(2):141–4.CrossRefGoogle Scholar
  18. 18.
    Stratford PW, Binkley JM. Measurement properties of the RM-18. A modified version of the Roland-Morris Disability Scale. Spine (Phila Pa 1976). 1997;22(20):2416–21.CrossRefGoogle Scholar
  19. 19.
    Fairbank JC, Couper J, Davies JB, O’Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271–3.PubMedGoogle Scholar
  20. 20.
    Williams NH, Wilkinson C, Russell IT. Extending the Aberdeen Back Pain Scale to include the whole spine: a set of outcome measures for the neck, upper and lower back. Pain. 2001;94(3):261–74.PubMedCrossRefGoogle Scholar
  21. 21.
    Greenough CG, Fraser RD. Assessment of outcome in patients with low-back pain. Spine (Phila Pa 1976). 1992;17(1):36–41.CrossRefGoogle Scholar
  22. 22.
    Lawlis GF, Cuencas R, Selby D, McCoy CE. The development of the Dallas Pain Questionnaire. An assessment of the impact of spinal pain on behavior. Spine (Phila Pa 1976). 1989;14(5):511–6.CrossRefGoogle Scholar
  23. 23.
    Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82.CrossRefGoogle Scholar
  24. 24.
    Charmaz K. Grounded theory. In: Smith JA, Harre R, Van Langenhove L, editors. Rethinking methods in psychology. London: Sage; 1995. p. 27–49.CrossRefGoogle Scholar
  25. 25.
    Glaser BG, Strauss A. The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine Transaction; 1967.Google Scholar
  26. 26.
    User’s Manual for Atlas.ti 5.0 Berlin: Atlas.ti [computer program]. Version 5.0. Berlin; 2004.Google Scholar
  27. 27.
    Strauss A, Corbin J. Basics of qualitative research: techniques and procedures for developing grounded theory. London: Sage; 1998.Google Scholar
  28. 28.
    Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995;273(1):59–65.PubMedCrossRefGoogle Scholar
  29. 29.
    Miles MB, Huberman AM. Qualitative data analysis. London: Sage Publications; 1994.Google Scholar
  30. 30.
    Bowen GA. Grounded theory and sensitizing concepts. Int J Qual Methods. 2006;5(3):Article 2.Google Scholar
  31. 31.
    Clark L, Watson D. Constructing validity: basic issues in objective scale development. Psychol Assess. 1995;7:309–19.CrossRefGoogle Scholar
  32. 32.
    DeVellis R. Scale development: theories and applications. Newbury Park: Sage Publication Inc; 1994.Google Scholar
  33. 33.
    Dillman D. Mail and internet surveys: the tailored design method. New York: Wiley; 2000.Google Scholar
  34. 34.
    Stone MH. Substantive scale construction. J Appl Meas. 2003;4(3):282–97.PubMedGoogle Scholar
  35. 35.
    Presser S, Rothgeb JM, Couper MP, Lessler JT, Martin E, Martin J, et al. Methods for testing and evaluating survey questionnaires. Hoboken: Wiley; 2004.CrossRefGoogle Scholar
  36. 36.
    Stull DE, Leidy NK, Parasuraman B, Chassany O. Optimal recall periods for patient-reported outcomes: challenges and potential solutions. Curr Med Res Opin. 2009;25(4):929–42.PubMedCrossRefGoogle Scholar
  37. 37.
    Davidson M, Keating JL. A comparison of five low back disability questionnaires: reliability and responsiveness. Phys Ther. 2002;82(1):8–24.PubMedGoogle Scholar
  38. 38.
    Kopec JA. Measuring functional outcomes in persons with back pain: a review of back-specific questionnaires. Spine (Phila Pa 1976). 2000;25(24):3110–4.CrossRefGoogle Scholar
  39. 39.
    Hammersly M. The dilemma of qualitative method: Herbert Blumer and the Chicago tradition. London: Routledge; 1990.Google Scholar
  40. 40.
    Lincoln YS, Guba EG. Designing a naturalistic inquiry. Naturalistic inquiry. London: Sage Publications; 1985. p. 221–49.Google Scholar
  41. 41.
    Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1–2):9–19.PubMedCrossRefGoogle Scholar
  42. 42.
    Herr KA, Spratt K, Mobily PR, Richardson G. Pain intensity assessment in older adults: use of experimental pain to compare psychometric properties and usability of selected pain scales with younger adults. Clin J Pain. 2004;20(4):207–19.PubMedCrossRefGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2013

Authors and Affiliations

  • Jonathan Stokes
    • 1
    • 3
    Email author
  • Christopher J. Evans
    • 2
  • Farrah Pompilus
    • 1
  • Alan L. Shields
    • 1
  • Kent H. Summers
    • 3
  1. 1.Adelphi ValuesBostonUSA
  2. 2.Mapi ValuesBostonUSA
  3. 3.Endo Health SolutionsMalvernUSA

Personalised recommendations