Addressing the "It Is Just Placebo" Pitfall in CAM: Methodology of a Project to Develop Patient-Reported Measures of Nonspecific Factors in Healing

Carol M Greco, Ronald M Glick, Natalia E Morone, Michael J Schneider, Carol M Greco, Ronald M Glick, Natalia E Morone, Michael J Schneider

Abstract

CAM therapies are often dismissed as "no better than placebo;" however, this belief may be overcome through careful analysis of nonspecific factors in healing. To improve trial methodology, we propose that CAM (and conventional) RCTs should evaluate and adjust for the effects of intrapersonal, interpersonal, and environmental factors on outcomes. However, measurement of these is challenging, and there are no brief, precise instruments that are suitable for widespread use in trials and clinical settings. This paper describes the methodology of a project to develop a set of patient-reported instruments that will quantify the nonspecific or "placebo" effects that are in fact specific and active ingredients in healing. The project uses the rigorous instrument-development methodology of the NIH-PROMIS initiative. The methods include (1) integration of patients' and clinicians' opinions with existing literature; (2) development of relevant items; (3) calibration of items on large samples; (4) classical test theory and modern psychometric methods to select the most useful items; (5) development of computerized adaptive tests (CATs) that maximize information while minimizing patient burden; and (6) initial validation studies. The instruments will have the potential to revolutionize clinical trials in both CAM and conventional medicine through quantifying contextual factors that contribute to healing.

Figures

Figure 1
Figure 1
Model of domains important in healing.

References

    1. Manheimer E, Wieland S, Kimbrough E, Cheng K, Berman BM. Evidence from the cochrane collaboration for traditional chinese medicine therapies. Journal of Alternative and Complementary Medicine. 2009;15(9):1001–1014.
    1. Koes BW, Bouter LM, Van Mameren H, et al. Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up. British Medical Journal. 1992;304(6827):601–605.
    1. Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. European Journal of Pain. 2009;13(1):3–10.
    1. National Center for Complementary and Alternative Medicine Third Strategic Plan 2011–2015. Exploring the Science of Complementary and Alternative Medicine 2011. .
    1. Yeh GY, Kaptchuk TJ, Shmerling RH. Prescribing tai chi for fibromyalgia—are we there yet? The New England Journal of Medicine. 2010;363(8):783–784.
    1. Dossey L. Samueli conference on definitions and standards in healing research: working definitions and terms. Alternative Therapies in Health and Medicine. 2003;9(3):A10–A12.
    1. Mercer SW, Maxwell M, Heaney D, Watt GCM. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Family Practice. 2004;21(6):699–705.
    1. Meza JP, Fahoome GF. The development of an instrument for measuring healing. Annals of Family Medicine. 2008;6(4):355–360.
    1. Barrett B, Muller D, Rakel D, Rabago D, Marchand L, Scheder J. Placebo, meaning, and health. Perspectives in Biology and Medicine. 2006;49(2):178–198.
    1. Diederich NJ, Goetz CG. The placebo treatments in neurosciences: new insights from clinical and neuroimaging studies. Neurology. 2008;71(9):677–684.
    1. Enck P, Benedetti F, Schedlowski M. New insights into the placebo and nocebo responses. Neuron. 2008;59(2):195–206.
    1. Hyland ME, Geraghty AWA, Joy OET, Turner SI. Spirituality predicts outcome independently of expectancy following flower essence self-treatment. Journal of Psychosomatic Research. 2006;60(1):53–58.
    1. Kelner M, Wellman B. Health care and consumer choice: medical and alternative therapies. Social Science and Medicine. 1997;45(2):203–212.
    1. Walach H, Jonas WB. Placebo research: the evidence base for harnessing self-healing capacities. Journal of Alternative and Complementary Medicine. 2004;10(1):S103–S112.
    1. Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annual Review of Psychology. 2008;59:565–590.
    1. Hyland ME, Whalley B. Motivational concordance: an important mechanism in self-help therapeutic rituals involving inert (placebo) substances. Journal of Psychosomatic Research. 2008;65(5):405–413.
    1. Astin JA. Why patients use alternative medicine: results of a national study. Journal of the American Medical Association. 1998;279(19):1548–1553.
    1. Kaptchuk TJ, Kelley JM, Conboy LA, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008;336(7651):999–1003.
    1. Kirsch I. How Expectancies Shape Experience. Washington, DC, USA: American Psychological Association; 1999.
    1. Vase L, Robinson ME, Verne GN, Price DD. The contributions of suggestion, desire, and expectation to placebo effects in irritable bowel syndrome patients: an empirical investigation. Pain. 2003;105(1-2):17–25.
    1. Grenfell RF, Briggs AH, Holland WC. A double-blind study of the treatment of hypertension. The Journal of the American Medical Association. 1961;176:124–128.
    1. Kalauokalani D, Cherkin DC, Sherman KJ, Koepsell TD, Deyo RA. Lessons from a trial of acupuncture and massage for low back pain: patient expectations and treatment effects. Spine. 2001;26(13):1418–1424.
    1. Kaptchuk TJ, Friedlander E, Kelley JM, et al. Placebos without deception: a randomized controlledtrial in irritable bowel syndrome. PLoS ONE. 2010;5(12)e15591
    1. Cahill J, Barkham M, Hardy G, et al. A review and critical appraisal of measures of therapist-patient interactions in mental health settings. Health Technology Assessment. 2008;12(24):iii–ix-47.
    1. Kaptchuk TJ, Shaw J, Kerr CE, et al. “Maybe i made up the whole thing”: placebos and patients’ experiences in a randomized controlled trial. Culture, Medicine and Psychiatry. 2009;33(3):382–411.
    1. Voelker R. New trends aimed at healing by design. Journal of the American Medical Association. 1994;272(24):1885–1886.
    1. Long R. Healing by design. Eight key considerations for building therapeutic environments. Health Facilities Management. 2001;14(11):20–22.
    1. Miller WL, Crabtree BF. Healing landscapes: patients, relationships, and creating optimal healing places. Journal of Alternative and Complementary Medicine. 2005;11(1):S41–S49.
    1. Jonas WB, Chez RA. Toward optimal healing environments in health care. Journal of Alternative and Complementary Medicine. 2004;10(1):S1–S6.
    1. Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the life orientation test. Journal of Personality and Social Psychology. 1994;67(6):1063–1078.
    1. Borkovec TD, Nau SD. Credibility of analogue therapy rationales. Journal of Behavior Therapy and Experimental Psychiatry. 1972;3(4):257–260.
    1. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. Journal of Behavior Therapy and Experimental Psychiatry. 2000;31(2):73–86.
    1. Smeets RJEM, Beelen S, Goossens MEJB, Schouten EGW, Knottnerus JA, Vlaeyen JWS. Treatment expectancy and credibility are associated with the outcome of both physical and cognitive-behavioral treatment in chronic low back pain. Clinical Journal of Pain. 2008;24(4):305–315.
    1. Cella D, Riley W, Stone A, et al. The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. Journal of Clinical Epidemiology. 2010;63(11):1179–1194.
    1. Guy W. Clinical Global Impressions: ECDEU Assessment Manual for Psychopharmacology. Rockville, Md, USA: National Institute of Mental Health; 1976.
    1. Weiss DJ, editor. Latent Trait Test Theory and Computerized Adaptive Testing. New York, NY, USA: Academic Press; 1983.
    1. Reise SP, Henson JM. Computerization and adaptive administration of the NEO PI-R. Assessment. 2000;7(4):347–363.

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