Development and Testing of Interventions in Occupational Therapy: Toward a New Generation of Research in Occupational Therapy

Abstract

Development, refinement, and testing of occupational therapy interventions require a systematic approach. The authors explain the four phases for clinical trials used in pharmaceutical research and apply them to the development and testing of occupational therapy interventions. The challenges faced by occupational therapy researchers in designing clinical trials include difficulties in specifying the intervention, blinding subjects, therapists, and evaluators, and identifying objective but client-centered measures of primary outcomes. Examples are provided of researchers who have developed and tested occupational therapy interventions in phases.

References

American Occupational Therapy Association. (2005). Occupational therapy code of ethics (revised ethics document). American Journal of Occupational Therapy, 59, 639–642.

Bandura

(1997). Self-efficacy: The exercise of control. New York: W. H. Freeman.

Boutron

Moher

Altman

D. G.

Schulz

K. F.

Ravaud

(2008). Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: Explanation and elaboration. Annals of Internal Medicine, 148, 295–309.

Christiansen

C. H.

Townsend

E. A.

(2004). Introduction to occupation: The art and science of living. Upper Saddle River, NJ: Prentice Hall.

Clark

Azen

S. P.

Zemke

Jackson

Carlson

Mandel

. (1997). Occupational therapy for independent-living older adults: A randomized controlled trial. JAMA, 278, 1321–1326.

Clark

Carlson

Zemke

Frank

Patterson

Ennevor

B. L.

. (1996). Life domains and adaptive strategies of a group of low-income, well older adults. American Journal of Occupational Therapy, 50, 99–108.

Creswell

J. W.

(2009). Research design: Qualitative, quantitative, and mixed methods approaches (3rd ed.). Thousand Oaks, CA: SAGE Publications.

Dillman

D. A.

Dillman

D. A.

(2000). Mail and Internet surveys: The tailored design method (2nd ed.). New York: J. Wiley.

Edlund

Gronseth

Franklin

(2004). American Academy of Neurology Clinical Practice Guideline Process Manual 180. St. Paul, MN: American Academy of Neurology.

10.

Food and Drug Administration DHHS. (December 17, 1997). International Conference on Harmonisation: Guidance on General Consideration for Clinical Trials, Federal Register (vol. 62, pp. 6613–6619). Washington, DC: U. S. Government Printing Office, Office of the Federal Register.

11.

Goodheart

C. D.

Kazdin

A. E.

Sternberg

R. J.

(2006). Evidence-based psychotherapy: Where practice and research meet (1st ed.). Washington, DC: American Psychological Association.

12.

Goverover

Johnston

M. V.

Toglia

Deluca

(2007). Treatment to improve self-awareness in persons with acquired brain injury. Brain Injury, 21, 913–923.

13.

Guyatt

G. H.

Oxman

A. D.

Vist

G. E.

Kunz

Falck-Ytter

Alonso-Coello

. (2008). GRADE: An emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 336, 924–926.

14.

Higgins

J. P. T.

Green

S. E.

(2008). Cochrane Handbook for Systematic Reviews of Interventions, Version 5.0 (updated February 2008). Retrieved October 12, 2008, from www.cochrane-handbook.org.

15.

Horn

S. D.

Gassaway

(2007). Practice-based evidence study design for comparative effectiveness research. Medical Care, 45(10 Suppl. 2), S50–S57.

16.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2005). ICH Guidelines, Safety Guidelines. Retrieved October 12, 2008, from http://www.ich.org/cache/compo/276-254-1.html.

17.

ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice. (2001). Journal of Postgraduate Medicine, 47, 199–203.

18.

Johnston

M. V.

Ottenbacher

K. J.

Reichardt

C. S.

(1995). Strong quasi-experimental designs for research on the effectiveness of rehabilitation. American Journal of Physical Medicine and Rehabilitation, 74, 383–392.

19.

Johnston

M. V.

Sherer

Whyte

(2006). Applying evidence standards to rehabilitation research: An overview. American Journal of Physical Medicine and Rehabilitation, 85, 292–309.

20.

Johnston

M. V.

Stineman

Velozo

C. A.

Fuhrer

(1997). Outcomes research in medical rehabilitation: Foundations from the past and directions for the future. In Furher

(Ed.), Assessing medical rehabilitation practices: The promise of Outcomes research (pp. 1–41). Baltimore: Paul H. Brookes.

21.

Kane

R. L.

(2006). Understanding health care outcomes research (2nd ed.). Sudbury, MA: Jones and Bartlett.

22.

Kielhofner

(2006). Research in occupational therapy: Methods of inquiry for enhancing practice. Philadelphia: F. A. Davis.

23.

Kielhofner

(2008). Model of human occupation: Theory and application (4th ed.). Baltimore: Lippincott, Williams & Wilkins.

24.

Liberman

R. P.

Wallace

C. J.

Blackwell

Kopelowicz

Vaccaro

J. V.

Mintz

(1998). Skills training versus psychosocial occupational therapy for persons with persistent schizophrenia. American Journal of Psychiatry, 155, 1087–1091.

25.

Lipsey

M. W.

(1993). Theory as method: Small theories of treatment. New Directions for Program Evaluation, 57(Spring), 5–38.

26.

Lorig

Holman

(1993). Arthritis self-management studies: A twelve-year review. Health Education Quarterly, 20, 17–28.

27.

H. I.

Trombly

C. A.

Robinson-Podolski

(1999). The effect of context on skill acquisition and transfer. American Journal of Occupational Therapy, 53, 138–144.

28.

Maher

C. G.

Sherrington

Herbert

R. D.

Moseley

A. M.

Elkins

(2003). Reliability of the PEDro Scale for Rating Quality of Randomized Controlled Trials. Physical Therapy, 83, 713–721.

29.

Marks

Allegrante

J. P.

Lorig

(2005). A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: Implications for health education practice (part II). Health Promotion Practice, 6(2), 148–156.

30.

Mathiowetz

Matuska

K. M.

Murphy

M. E.

(2001). Efficacy of an energy conservation course for persons with multiple sclerosis. Archives of Physical Medicine and Rehabilitation, 82, 449–456.

31.

Mathiowetz

V. G.

Finlayson

M. L.

Matuska

K. M.

Chen

H. Y.

Luo

(2005). Randomized controlled trial of an energy conservation course for persons with multiple sclerosis. Multiple Sclerosis, 11, 592–601.

32.

Mathiowetz

V. G.

Matuska

K. M.

Finlayson

M. L.

Luo

Chen

H. Y.

(2007). One-year follow-up to a randomized controlled trial of an energy conservation course for persons with multiple sclerosis. International Journal of Rehabilitation Research, 30, 305–313.

33.

Miller

L. J.

Coll

J. R.

Schoen

S. A.

(2007). Fidelity in sensory integration intervention research. American Journal of Occupational Therapy, 61, 228–238.

34.

Multiple Sclerosis Council for Clinical Practice Guidelines. (1998). Fatigue and multiple sclerosis: Evidence-based management strategies for fatigue in multiple sclerosis. Washington, DC: Paralyzed Veterans of America.

35.

Nathan

D. G.

Schechter

A. N.

(2006). NIH support for basic and clinical research: Biomedical researcher angst in 2006. JAMA, 295, 2656–2658.

36.

National Cancer Institute. (2006). Clinical trials: Questions and answers. Retrieved October 12, 2008, from http://www.cancer.gov/cancertopics/factsheet/information/clinical-trials.

37.

National Institutes of Health. (2008). Estimates of funding for various diseases, conditions, research areas. Retrieved November 8, 2008, 2008, from http://www.nih.gov/news/fundingresearchareas.htm.

38.

Nelson

D. L.

(2006). Group comparison studies: Quantitative research designs. In Kielhofner

(Ed.), Research in occupational therapy: Methods of inquiry for enhancing practice (pp. 65–90). Philadelphia: F. A. Davis.

39.

Nelson

D. L.

Mathiowetz

(2004). Randomized controlled trials to investigate occupational therapy research questions. American Journal of Occupational Therapy, 58, 24–34.

40.

Newman

Steed

Mulligan

(2004). Self-management interventions for chronic illness. Lancet, 364, 1523–1537.

41.

Ottenbacher

K. J.

Hinderer

S. R.

(2001). Evidence-based practice: Methods to evaluate individual patient improvement. American Journal of Physical Medicine and Rehabilitation, 80, 786–796.

42.

Parham

L. D.

Cohn

E. S.

Spitzer

Koomer

J. A.

Miller

L. J.

Burke

J. P.

. (2007). Fidelity in sensory integration intervention research. American Journal of Occupational Therapy, 61, 216–227.

43.

Portney

L. G.

Watkins

M. P.

(2008). Foundations of clinical research: Applications to practice (3rd ed.). Upper Saddle River, NJ: Pearson/Prentice Hall.

44.

Santacroce

S. J.

MacCarelli

L. M.

Grey

(2004). Intervention fidelity. Nursing Research, 53, 63–66.

45.

Schneider

Carney

Kilpatrick

Schmidt

W. H.

Shavelson

R. J.

(2007). Estimating causal effects using experimental and observational designs (Report from the Governing Board of the American Educational Research Association Grants Program). Washington, DC: American Educational Research Association.

46.

Taylor

R. R.

(2004). Quality of life and symptom severity for individuals with chronic fatigue syndrome: Findings from a randomized clinical trial. American Journal of Occupational Therapy, 58, 35–43.

47.

Taylor

R. R.

Jason

L. A.

, (2002). Group intervention involving a client with chronic fatigue syndrome: A clinical case study. Clinical Case Studies, I, 183–210.

48.

Vanage

S. M.

Gilbertson

K. K.

Mathiowetz

(2003). Effects of an energy conservation course on fatigue impact for persons with progressive multiple sclerosis. American Journal Occupational Therapy, 57, 315–323.

49.

West

King

Carey

T. S.

Lohr

K. N.

Sutton

S. F.

Lux

(2002). Systems to rate the strength of scientific evidence. Evidence report/technology assessment: Number 47 (No. AHRQ Publication No. 02-E015). Rockville, MD: Agency for Healthcare Research and Quality.

50.

West

S. G.

Duan

Pequegnat

Gaist

Des Jarlais

D. C.

Holtgrave

. (2008). Alternatives to the randomized controlled trial. American Journal of Public Health, 98, 1359–1366.

51.

Whyte

(2008). A grand unified theory of rehabilitation (we wish!). The 57th John Stanley Coulter Memorial Lecture. Archives of Physical Medicine and Rehabilitation, 89, 203–209.

52.

Whyte

Hart

(2003). It's more than a black box; it's a Russian doll: Defining rehabilitation treatments. American Journal of Physical Medicine and Rehabilitation, 82, 639–652.

53.

Zhan

Ottenbacher

K. J.

(2001). Single subject research designs for disability research. Disability and Rehabilitation, 23(1), 1–8.