Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: Defining content and format

BMC Complementary and Alternative Medicine

Volumn 11, Issue , 2011, Pages

  Ritenbaugh, Cheryl ^a,b   Nichter, Mimi ^b   Nichter, Mark A ^b   Kelly, Kimberly L ^a,b   Sims, Colette M ^a   Bell, Iris R ^a   Castañeda, Heide M ^c   Elder, Charles R ^d   Koithan, Mary S ^b   Sutherland, Elizabeth G ^e   Verhoef, Marja J ^f   Warber, Sarah L ^g   Coons, Stephen J ^h  

^a UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF ARIZONA   (United States)

^c UNIVERSITY OF SOUTH FLORIDA   (United States)

^d CENTER FOR HEALTH RESEARCH   (United States)

^e National College of Natural Medicine   (United States)

^f UNIVERSITY OF CALGARY   (Canada)

^g UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^h Patient Reported Outcome Consortium   (United States)

Author keywords

Complementary and alternative medicine (CAM); Non specific outcomes; Patient centered care; Patient reported outcomes (PROs); Questionnaire development; Retrospective pre test; Well being

Indexed keywords

ACUPUNCTURE; ADDICTION; ADULT; AGED; ALTERNATIVE MEDICINE; ANXIETY; ARTICLE; CHINESE MEDICINE; CHIROPRACTIC; COGNITION; DIETITIAN; FEMALE; GRIEF; HEALTH EDUCATION; HEPATITIS C; HERBAL MEDICINE; HOMEOPATHY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INJURY; INTEGRATIVE MEDICINE; INTERVIEW; LANGUAGE; MAGNETOTHERAPY; MALE; MASSAGE; MEDITATION; MIDWIFERY EDUCATION; NEOPLASM; OUTCOME ASSESSMENT; PAIN; PSYCHOMETRY; QUESTIONNAIRE; READING; REIKI; STRESS; SUPPORT GROUP; TAI CHI; VISUAL ANALOG SCALE; YOGA; EMOTION; EVALUATION; METHODOLOGY; MIDDLE AGED; PATIENT; PSYCHOLOGICAL ASPECT; RETROSPECTIVE STUDY; UTILIZATION REVIEW;

ADULT; AGED; AGED, 80 AND OVER; COGNITION; COMPLEMENTARY THERAPIES; EMOTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PATIENTS; QUESTIONNAIRES; RESEARCH DESIGN; RETROSPECTIVE STUDIES;

EID: 84855175475     PISSN: None     EISSN: 14726882     Source Type: Journal    
DOI: 10.1186/1472-6882-11-135     Document Type: Article

References (59)

1. Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use among adults: United States, 2002. Advance data 2004, (343):1-19.
2. Wang C, Kalish R, Yinh J, McAlindon T, Schmid CH, Lee Y, Rones R, Goldenberg DL. A randomized trial of tai chi for fibromyalgia. New England Journal of Medicine 2010, 363(8):743-754. 10.1056/NEJMoa0912611, 3023168, 20818876.
3. CAM Basics What is Complementary and Alternative Medicine. CAM Basics., http://nccam.nih.gov/health/whatiscam/
4. Gould A, MacPherson H. Patient Perspectives on Outcomes After Treatment with Acupuncture. The Journal of Alternative & Complementary Medicine 2001, 7(3):261-268. 10.1089/107555301300328133, 22210098.
5. Oberbaum M, Singer SR, Vithoulkas G. The colour of the homeopathic improvement: the multidimensional nature of the response to homeopathic therapy. Homeopathy: the Journal of the Faculty of Homeopathy 2005, 94(3):196-199.
6. Ritenbaugh C, Verhoef M, Fleishman S, Boon H, Leis A. Whole systems research: a discipline for studying complementary and alternative medicine. Alternative Therapies in Health and Medicine 2003, 9(4):32-36.
7. Schulman D. The Unexpected Outcomes of Acupuncture: Case Reports in Support of Refocusing Research Designs. The Journal of Alternative & Complementary Medicine 2004, 10(5):785-789.
8. Verhoef MJ, Lewith G, Ritenbaugh C, Thomas K, Boon H, Fonnebo V. Whole systems research: moving forward. Focus on Alternative and Complementary Therapies 2004, 9(2):87-90.
9. Bell IR, Koithan M, Gorman MM, Baldwin CM. Homeopathic practitioner views of changes in patients undergoing constitutional treatment for chronic disease. The Journal of Alternative & Complementary Medicine 2003, 9(1):39-50. 10.1089/107555303321222937, 22210098.
10. Elder C, Aickin M, Bauer V, Cairns J, Vuckovic N. Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. Alternative Therapies in Health and Medicine 2006, 12(5):24-30.
11. Elder C, Ritenbaugh C, Mist S, Aickin M, Schneider J, Zwickey H, Elmer P. Randomized Trial of Two Mind-Body Interventions for Weight-Loss Maintenance. The Journal of Alternative & Complementary Medicine 2007, 13(1):67-78. 10.1089/acm.2006.6237, 22210098.
12. Hsu C, Bluespruce J, Sherman K, Cherkin D. Unanticipated benefits of CAM therapies for back pain: An exploration of patient experiences. Journal of Alternative and Complementary Medicine 2010, 16(2):157-163.
13. Koithan M, Verhoef M, Bell IR, White M, Mulkins A, Ritenbaugh C. The Process of Whole Person Healing: Unstuckness and Beyond. The Journal of Alternative and Complementary Medicine 2007, 13(6):659-668. 10.1089/acm.2007.7090, 17718649.
14. Mulkins AL, Verhoef MJ. Supporting the Transformative Process: Experiences of Cancer Patients Receiving Integrative Care. Integrative Cancer Therapies 2004, 3(3):230-237. 10.1177/1534735404268054, 15312264.
15. Paterson C, Britten N. Acupuncture for People with Chronic Illness: Combining Qualitative and Quantitative Outcome Assessment. The Journal of Alternative and Complementary Medicine 2003, 9(5):671-681. 10.1089/107555303322524526, 14629845.
16. Paterson C, Britten N. Acupuncture as a Complex Intervention: A Holistic Model. The Journal of Alternative and Complementary Medicine 2004, 10(5):791-801.
17. Verhoef MJ, Mulkins A, Boon H. Integrative health care: how can we determine whether patients benefit?. Journal of Alternative and Complementary Medicine 2005, 11:57-65.
18. White M, Verhoef M, Davison BJ, Gunn H, Cooke K. Seeking mind, body and spirit health: Why some men with prostate cancer choose CAM (Complementary and Alternative Medicine) over conventional cancer treatments. Integrative Medicine Insights 2008, 3:1-11. 3046021, 21614154.
19. Elder C, Ritenbaugh C. Transforming medicines. The Permanente Journal 2007, 11(3):79-82. 3048447, 21412489.
20. Caspi O, Bootzin RR. Evaluating how placebos produce change. Logical and causal traps and understanding cognitive explanatory mechanisms. Evaluation and the Health Professions 2002, 25(4):436-464.
21. Eton DT, Koffler K, Cella D, Eisenstein A, Astin JA, Pelletier KR, Riley D. Developing a self-report outcome measure for complementary and alternative medicine. Explore 2005, 1(3):177-185. 10.1016/j.explore.2005.02.007, 16781527.
22. Eton DT, Temple LM, Koffler K. Pilot validation of a self-report outcome measure of complementary and alternative medicine. Explore 2007, 3(6):592-599. 10.1016/j.explore.2007.08.004, 18005911.
23. Kaptchuk TJ. Placebo studies and ritual theory: A comparative analysis of Navajo, acupuncture and biomedical healing. Philosophical Transactions of the Royal Society B: Biological Sciences 2011, 366(1572):1849-1858.
24. Kirsch I. Placebo psychotherapy: synonym or oxymoron?. Journal of Clinical Psychology 2005, 61(7):791-803. 10.1002/jclp.20126, 15827992.
25. Bell I, Koithan M, Pincus D, Niemeyer K. Research Methodological Implications of Nonlinear Dynamical Systems Models for Whole Systems of Complementary and Alternative Medicine. Forschende Komplementarmedizin 2012, 19(Supp 1).
26. Koithan M, Bell I, Niemeyer K, Pincus D. A Complex Systems Science Perspective for Whole Systems of CAM Research. Forschende Komplementarmedizin 2012, 19:(Supp 1).
27. Howerter A, Hollenstein T, Boon H, Brule D, Niemeyer K. State-Space Grid Analysis: Applications for Clinical WS-CAM Research. Forschende Komplementarmedizin 2012, 19(Supp 1).
28. Fredrickson BL, Losada MF. Positive Affect and the Complex Dynamics of Human Flourishing. American Psychologist 2005, 60(7):678-686. 3126111, 16221001.
29. Seligman MEP. Authentic happiness: using the new positive psychology to realize your potential for deep fulfillment. 2008, London: Nicholas Brealey.
30. Snyder CR, Lopez SJ, Pedrotti JT. Positive psychology: the scientific and practical explorations of human strengths. 2007, Thousand Oaks, Calif.: SAGE.
31. USFDA, USDHHS, FDACDER, FDACBER, Health FSDo Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health and Quality of Life Outcomes 2006, 4:79. 1629006, 17034633, USFDA, USDHHS, FDACDER, FDACBER, Health FSDo.
32. McHorney CA. Generic health measurement: past accomplishments and a measurement paradigm for the 21st century. Annals of Internal Medicine 1997, 127(8 Pt 2):743-750.
33. Wiklund I. Assessment of patient-reported outcomes in clinical trials: the example of health-related quality of life. Fundamental and Clinical Pharmacology 2004, 18(3):351-363. 10.1111/j.1472-8206.2004.00234.x, 15147288.
34. Ritenbaugh C, Hammerschlag R, Calabrese C, Mist S, Aickin M, Sutherland E, Leben J, DeBar L, Elder C, Dworkin SF. A Pilot Whole Systems Clinical Trial of Traditional Chinese Medicine and Naturopathic Medicine for the Treatment of Temporomandibular Disorders. The Journal of Alternative & Complementary Medicine 2008, 14(5):475-487. 10.1089/acm.2007.0738, 22210098.
35. Sutherland EG, Ritenbaugh C, Kiley SJ, Vuckovic N, Elder C. An HMO-Based Prospective Pilot Study of Energy Medicine for Chronic Headaches: Whole-Person Outcomes Point to the Need for New Instrumentation. The Journal of Alternative & Complementary Medicine 2009, 15(8):819-826. 10.1089/acm.2008.0592, 22210098.
36. Warber SL, Cornelio D, Straughn J, Kile G. Biofield Energy Healing from the Inside. The Journal of Alternative & Complementary Medicine 2004, 10(6):1107-1113. 10.1089/acm.2004.10.1107, 22210098.
37. Burns N, Grove SK. Understanding nursing research. 2007, Philadelphia, Pa.: Saunders.
38. Lincoln YS, Guba EG. Establishing Trustworthiness. Naturalistic Inquiry 1985, 289-331. Thousand Oaks, CA.: Sage.
39. Mays N, Pope C. Qualitative research in health care: Assessing quality in qualitative research. British Medical Journal 2000, 320(7226):50-52. 10.1136/bmj.320.7226.50, 1117321, 10617534.
40. Russel BH. Research Methods in Anthropology: Qualitative and Quantitative Approaches. 2002, Walnut Creek: AltaMira.
41. Sprangers MA, Schwartz CE. The challenge of response shift for quality-of-life-based clinical oncology research. Annals of Oncology: official journal of the European Society for Medical Oncology/ESMO 1999, 10(7):747-749.
42. Hill LG, Betz DL. Revisiting the Retrospective Pretest. American Journal of Evaluation 2005, 26(4):501-517.
43. Willis GB. Cognitive interviewing: a tool for improving questionnaire design. 2005, Thousand Oaks, Calif.: Sage Publications.
44. Rugg S, Paterson C, Britten N, Bridges J, Griffiths P. Traditional acupuncture for people with medically unexplained symptoms: a longitudinal qualitative study of patients' experiences. The British Journal of General Practice: the Journal of the Royal College of General Practitioners 2011, 61(587):385-386.
45. Smithson J, Britten N, Paterson C, Lewith GT, Evans M. The Experience of Using Complementary Therapies After a Diagnosis of Cancer: a qualitative synthesis. Health (London) 2012, 16(1):19-39. December 22, 2010 Online.
46. Smithson J, Paterson C, Britten N, Evans M, Lewith GT. Cancer Patient's Experiences of Using Complementary Therapies: polarization and integration. Journal of Health Services Research & Policy 2010, 15(2):54-61. 10.1258/jhsrp.2009.009104, 22211218.
47. Paterson C. Seeking the Patient's Perspective: A qualitative assessment of EuroQol, COOP-WONCA charts and MYMOP. Quality of Life Resarch 2004, 13:871-881.
48. Paterson C, Thomas K, Manasse A, Cooke H, Peace G. Measure Yourself Concerns and Wellbeing (MYCaW): An individualised questionnaire evaluating outcome in cancer support care that includes complementary therapies. Complementary Therapies in Medicine 2007, 15:38-45. 10.1016/j.ctim.2006.03.006, 17352970.
49. Kleinman A. The illness narratives: suffering, healing, and the human condition. 1988, New York: Basic Books.
50. Hyland ME, Lewith GT, Wheeler P. Do Existing Psychologic Scales Measure the Nonspecific Benefit Associated with CAM Treatment?. The Journal of Alternative and Complementary Medicine 2008, 14(2):185-189. 10.1089/acm.2007.7050, 18315505.
51. Eton DT, Bauer BA, Sood A, Yost KJ, Sloan JA. Patient-Reported Outcomes in Studies of Complementary and Alternative Medicine: Problems, Solutions, and Future Directions. Explore 2011, 7(5):314-319. 10.1016/j.explore.2011.06.002, 21907154.
52. Howard G, Ralph K, Gulanick N, Maxwell S, Nance D, Gerber S. Internal Invalidity in Pretest-Posttest of Self-Report Evaluations and a Re-evaluation of Retrospective Pretests. Applied Psychological Management 1979, 3(1):1-23.
53. Pratt CC, McGuigan WM, Katzev AR. Measuring Program Outcomes: Using Retrospective Pretest Methodology. American Journal of Evaluation 2000, 21(3):341-349.
54. Rockwell SK, Kohn H. Post-Then-Pre Evaluation. Journal of Extension 1989, 27(2). (Internet)., http://www.joe.org/joe/1989summer/a5.php
55. Skeff KM, Stratos GA, Bergen MR. Evaluation of a medical faculty development program: a comparison of traditional pre/post and retrospective pre/post self- assessment ratings. Evaluation and the Health Professions 1992, 15(3):350-366.
56. Nieuwkerk PT, Tollenaar MS, Oort FJ, Sprangers MA. Are retrospective measures of change in quality of life more valid than prospective measures?. Medical Care 2007, 45(3):199-205. 10.1097/01.mlr.0000246613.49214.46, 17304076.
57. Van Dam NT, Earleywine M, Borders A. Measuring mindfulness? An Item Response Theory analysis of the Mindful Attention Awareness Scale. Personality and Individual Differences 2010, 49(7):805-810.
58. Kvam AK, Wisloff F, Fayers PM. Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma. Health and Quality of Life Outcomes 2010, 8:79-87. 10.1186/1477-7525-8-79, 2922103, 20678240.
59. Thompson J, Kelly K, Ritenbaugh C, Hopkins A, Sims C, Coons S. Developing a Patient-Centered Outcome Measure for Complementary and Alternative Medicine Therapies II: Refining Content Validity through Cognitive Interviews. BMC Complementary and Alternative Medicine 2011, 11:136. 10.1186/1472-6882-11-136, 22206409.