(non)specific effects 2014 9 15oialliance.org/.../10/foell-nonspecific-effects.pdf · ballatt, j....
TRANSCRIPT
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The dirty drug
Never say never again
Elena’s spider diagram
Kelley JM, Kraft-Todd G, Schapira L, et al. The Influence of the Patient-Clinician Relationship on Healthcare Outcomes:
A Systematic Review and Meta-Analysis of Randomized Controlled Trials. PLoS ONE 2014;9(4):e94207.
• 13 RCTs
• Random-effects-model
• “Small but significant effect on health outcomes” (p =
0.02)
Kelley, J. M., et al. (2009). "Patient and Practitioner Influences on the Placebo Effect in Irritable Bowel Syndrome." Psychosomatic
Medicine: SY.
Perfectmatch.com
Witt, C. M., et al. (2012). "Can I help you?
Physicians' expectations as predictor for
treatment outcome." European Journal of
Pain 16(10): 1455-1466.
Witt, C. M., et al. (2010). "Physician Characteristics and Variation in
Treatment Outcomes: Are Better Qualified and Experienced Physicians More
Successful in Treating Patients With Chronic Pain With Acupuncture?" The
Journal of Pain 11(5): 431-435.
Witt, C. M., et al. (2011). "Patient Characteristics and
Variation in Treatment Outcomes: Which Patients Benefit
Most From Acupuncture for Chronic Pain?" Clin J Pain.
Conboy, L. A., et al. (2010). "Which patients
improve: characteristics increasing sensitivity to a
supportive patient-practitioner relationship." Soc
Sci Med. 70(3): 479-484. doi:
410.1016/j.socscimed.2009.1010.1024. Epub 2009
Nov 1010.
Suarez-Almazor, M. E., et al. (2010). "A
randomized controlled trial of acupuncture for
osteoarthritis of the knee: Effects of patient-
provider communication." Arthritis Care &
Research 62(9): 1229-1236.
Kelley, J. M., et al. (2009).
"Patient and Practitioner
Influences on the Placebo Effect
in Irritable Bowel Syndrome."
Psychosomatic Medicine: SY.
White, P., et al. (2012).
"Practice, practitioner, or
placebo? A multifactorial,
mixed-methods randomized
controlled trial of
acupuncture." PAIN 153(2):
455-462.
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Efficacy/effectiveness
Witt, C. (2011). "Clinical research on acupuncture — Concepts and guidance on efficacy and effectiveness research." Chinese
Journal of Integrative Medicine 17(3): 166-172.
Linde, K., K. Niemann, et al. (2010). "How large are the nonspecific effects of acupuncture? A meta-analysis of randomized
controlled trials." BMC Medicine 8(1): 75.
Components of the patients' benefit
and aspects of efficacy and effectivenessn= 800 needed for efficacy study
Individual patient data meta-analysis
17 922
patients
Vickers A CAMMAC, et al. Acupuncture for chronic pain: Individual patient data meta-analysis. Archives of Internal Medicine 2012;172(19):1444-53
Background
Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain.
Methods
We conducted a systematic review to identify randomized controlled trials (RCTs) of acupuncture for chronic pain in which allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible RCTs, with a total of 17 922 patients analyzed.
Cure
Effect size 1
Comfort
“Moderate effect”
ES 0.5 - 0.8
“Mild effect “
ES 0.3 – 0.5
Consolation
“Small effect “
ES < 0.3
“Cure
sometimes,
comfort often,
console
always”
Individual metaanalysis n=17922
Acupuncture vs usual care Acupuncture vs sham
Vickers A CAMMAC, et al. Acupuncture for chronic pain: Individual patient data meta-analysis. Archives of Internal Medicine 2012;172(19):1444-53
0.55 (95% CI, 0.51-0.58)
0.57 (95% CI, 0.50-0.64)
0.42 (95% CI, 0.37-0.46)
0.23 (95% CI, 0.13-0.33)
0.16 (95% CI, 0.07-0.25)
0.15 (95% CI, 0.07-0.24)
Individual metaanalysis n=17922
Acupuncture vs usual care Acupuncture vs sham
Vickers A CAMMAC, et al. Acupuncture for chronic pain: Individual patient data meta-analysis. Archives of Internal Medicine 2012;172(19):1444-53
Comfort Consolation
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The acupuncture trialists state:
“However, these differences are
relatively modest, suggesting
that factors in addition to the
specific effects of needling are
important contributors to the
therapeutic effects of
acupuncture.”
“About a half of the reviewed trials showed superiority of the surgical procedure over placebo intervention, but the magnitude of the effect directly related to the crucial surgical element was generally small. The majority of the trials showed an improvement in the surgical group as
well as in the placebo group, which would suggest that some surgical procedures may have a placebo effect and that some of the benefits of surgery are related to factors other than the crucial surgical element.”
Wartolowska, K., et al. (2014). "Use of placebo controls in the evaluation of surgery: systematic review."
BMJ: British Medical Journal 348.
Wartolowska, K., et al. (2014). "Use of placebo controls in the evaluation of surgery: systematic review."
BMJ: British Medical Journal 348.
Wartolowska, K., et al. (2014). "Use of placebo controls in the evaluation of surgery: systematic review."
BMJ: British Medical Journal 348.
Wartolowska, K., et al. (2014). "Use of placebo controls in the evaluation of surgery: systematic review."
BMJ: British Medical Journal 348.
Nocebo effect
• “Voodoo death is most
extreme form of nocebo
effect
“Not to Charing
Cross, the hospital
of death ! ”
Baumeister, R. F., et al. (2001). "Bad is stronger than good." Review of General Psychology 5(4): 323-370.
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The overall magnitude of the nocebo effect was moderate to large (lowestg = 0.62 [0.24–1.01] and highest g = 1.03 [0.63–1.43]) and highly variable (range of g = −0.43 to 4.05). The magnitudes and range of effect sizes was similar to those of placebo effects (d = 0.81) in mechanistic studies. In studies in which nocebo effects were induced by a combination of verbal suggestions and conditioning, the effect size was larger (lowest g = 0.76 [0.39–1.14] and highest g = 1.17 [0.52–1.81]) than in studies in which nocebo effects were induced by verbal suggestions alone (lowest g = 0.64 [−0.25 to 1.53] and highest g = 0.87
[0.40–1.34]). These findings are similar to those in the placebo literature. As the magnitude of the nocebo effect is variable and sometimes large, this meta-analysis demonstrates the importance of minimizing nocebo effects in clinical practice.
Petersen, G. L., et al. (2014). "The magnitude of nocebo effects in pain: A meta-analysis." PAIN® 155(8): 1426-1434. James Bond “Never say never again”
James Bond “Never say never again” James Bond “Never say never again”
“emotional labor as the
process of regulating
experienced and displayed
emotions to present a
professionally desired
image during interpersonal
transactions at work”
Larson, E. B. and X. Yao (2005). "Clinical Empathy as Emotional Labor in the Patient-Physician
Relationship." JAMA: The Journal of the American Medical Association 293(9): 1100-1106.
Organisational climate
Team dynamics
Self in role
Ballatt, J. and P. Campling (2011). Intelligent kindness - Reforming the culture of healthcare. London RCPsych Publications.
Sense of autonomy bear the patient in mind understanding of own role/input skillful and compassionate work
Brutality Perversity Coercion Suspicion Disengagement Anxiety Preoccupation Disempowerment Fragmentation Distraction
Organisation
Team
Role
Self
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