We live forwards, but we understand backwards. William James - - PDF document

▶
we live forwards but we understand backwards
SMART_READER_LITE
LIVE PREVIEW

We live forwards, but we understand backwards. William James - - PDF document

Mar 23, 2024 304 likes •450 views

We live forwards, but we understand backwards. William James Alternative Medicine must be held to the same standards of evidence as conventional medicine. Various 1 Integrative Medicine must be held to the higher standards of evidence than

slide-1
SLIDE 1

1

We live forwards, but we understand backwards.

William James

Alternative Medicine must be held to the same standards of evidence as conventional medicine.

Various

slide-2
SLIDE 2

2

Integrative Medicine must be held to the higher standards of evidence than either alternative or conventional medicine alone.

Jonas

Additional Quality Criteria for Integrated Medicine

  • Methods - “model validity”
  • Ethical - “your grandmother”
  • Strategies - “building a house”
slide-3
SLIDE 3

3

Evaluation of Evidence Evaluation of Evidence

Research Quality Research Quality

  • Internal Validity

How likely is it that the effects reported are due to the independent variable (the treatment)?

  • External Validity

How likely is it that the observed effects would occur outside the study and in different settings?

  • Model Validity

How likely is it that the study accurately reflects the system under investigation?

Evaluation of CAM Evaluation of CAM

Internal Validity Internal Validity

  • Randomization

(Was subject assignment to treatment groups done randomly and in a concealed manner?)

  • Baseline comparability

(Where gender, age, and prognostic factors balanced?)

Change of intervention

(Was there loss to follow-up, contamination, poor compliance)

  • Blinding

(Did the patients, practitioners, evaluators, analysts know who got the treatment?)

  • Outcomes

(Was the objectivity, reliability, and sensitivity of the outcome assessed?)

  • Analysis

(Was the number treated large? Where p. values significant? Was there multiple outcomes measured and analyzed?)

slide-4
SLIDE 4

4

Evaluation of CAM Evaluation of CAM

External Validity External Validity

  • Generalizability

(Was there a range of patients as they would be seen in practice

  • r where there multiple or narrow inclusions and exclusions?

Was the study done at several sites with similar results?)

  • Reproducibility

(Was what was done clear? Where Confidence Intervals reported? Was the treatment transferable to other practitioners?)

  • Clinical Significance

(Was the effect size big enough to make a difference? Is the condition in need of this type of treatment? Were any preferences determined? Was adherence good?)

  • Therapeutic Interference

(Was there flexibility in varying the treatment? Was feedback on the outcomes available? Is the treatment feasible in most (or your) practice settings?)

  • Outcomes

(Were the outcomes clinically relevant? Were the outcomes checked for importance with the patients? Were any important outcomes missing?)

“Rigorous”Evidence Hierarchy “Rigorous”Evidence Hierarchy

Reviews Reviews Meta Meta-

  • analysis

analysis Health Health Services Services Research Research Randomized Randomized Controlled Controlled Trials Trials Observational Observational Outcomes Outcomes Laboratory Laboratory Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes

slide-5
SLIDE 5

5

“Rigorous”Evidence for Acupuncture “Rigorous”Evidence for Acupuncture

Stroke rehab., Stroke rehab., osteoarthritis

  • steoarthritis, drug addiction

, drug addiction Depression, ADHD, Asthma Depression, ADHD, Asthma WHO list of 34 conditions for which acupuncture is safe and effe WHO list of 34 conditions for which acupuncture is safe and effective ctive Post Post-

  • operative pain
  • perative pain

Nausea and vomiting Nausea and vomiting Obesity Obesity Smoking Cessation Smoking Cessation (Back Pain) (Back Pain)

Effective Effective Ineffective Ineffective

Evaluation of CAM Evaluation of CAM

Model Validity Model Validity

  • Representativeness/accuracy

(Were the therapists well trained and experienced? Was the treatment strategy adequate? Was the treatment clearly described?)

  • Model congruity

(Were the patients classified, was the treatment determined and were the outcomes assessed according to the system of the practice being assessed? )

  • Context/Meaning

(Did the patients/practitioners believe in the therapy? What was the impact of informed consent? How well was the intervention adapted to the culture, family, meaning of the patient?)

  • Methodology matching

(Were the goals of the study clear and limited? Did the investigators select the correct research method to achieve the goals?)*

slide-6
SLIDE 6

6

Evaluation of CAM Evaluation of CAM “ “Model validity

Model validity”

”

  • Diagnostic taxonomy - “works” for X
  • Double classification - dual selection
  • Adequacy of treatment - standardization
  • Placebo and meaning effects - “proof”
  • Outcome selection - patient relevant?

Diagnostic Taxonomy

Osteoarthritis Depression TCM TCM Ayurveda Ayurveda Homeopathy Homeopathy Patient Patient Excess Spleen Excess Spleen Deficient Liver Deficient Liver etc. etc. Pitta Pitta Imbalance Imbalance etc. etc. Aurum Aurum Rhus Rhus. . Tox Tox. . Sepia Sepia etc. etc. “Stress” “Stress” Bad diet Bad diet Genes Genes

Sadness Sadness, , Joint Pain and Stiffness Joint Pain and Stiffness, , Fatigue Fatigue, , Sleep Difficulty Sleep Difficulty, , Hair Combing Hair Combing

slide-7
SLIDE 7

7

Of course, I am always reluctant to contradict anyone’s grandmother except when the advice might be dangerous.

Cortlandt Forum 1997 February p.122

The Audience and the Evidence The Audience and the Evidence

  • Public
  • Practitioners
  • Clinical Investigators
  • Basic scientists
  • Policy and payment
  • Stories
  • Probabilities
  • Comparative Effects
  • Mechanisms
  • Certainty, “proof”
slide-8
SLIDE 8

8

Evidence Hierarchy Evidence Hierarchy

SCIENCE

Reviews Reviews Meta Meta-

  • analysis

analysis Health Health Services Services Research Research Randomized Randomized Controlled Controlled Trials Trials Observational Observational Outcomes Outcomes Laboratory Laboratory Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes

PRACTICE PATIENTS POLICY

Decision Points in Medicine Decision Points in Medicine

  • Patient
  • Practitioner
  • Scientist
  • Payer/Policy

Jonas, WB. And Levin, JS. Essentials of Complementary andAlternative Medicine. Littincott Williams & Wilkins. 1999; p. 34.

slide-9
SLIDE 9

9

Treatment of Allergies with Treatment of Allergies with Homeopathy Homeopathy

A patient with seasonal allergies says that her daughter recommended a homeopathic remedy from a health food store for

  • allergies. Her daughter said it worked great

for her and had no side effects. Your patient says she would like to stop her conventional drugs, which make her

  • sleepy. She wants to know if this is

alright? Is she harming herself or wasting her money?

Evidence Hierarchy Evidence Hierarchy

Reviews Reviews Meta Meta-

  • analysis

analysis Health Health Services Services Research Research Randomized Randomized Controlled Controlled Trials Trials Observational Observational Outcomes Outcomes Laboratory Laboratory Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes

PATIENTS

slide-10
SLIDE 10

10

Homeopathic Galphimia glauca in Pollinosis

Estimated Success Rates and 95% confidence Intervals

Year of study Performance Year of study Performance

1 1 0.9 0.9 0.8 0.8 0.7 0.7 0.6 0.6 0.5 0.5 0.4 0.4 ë80 ë80 ë81a ë81a ë81b ë81b ë82 ë82 ë83 ë83 ë84 ë84 ë85 ë85 ë86 ë86 ë87 ë87 ë88 ë88 ë89 ë89 common common

Relative Chance Relative Chance

0.3 Wiesenauer, Forsch. Kompl. 3:230 (1996)

Evidence Hierarchy Evidence Hierarchy

Reviews Reviews Meta Meta-

  • analysis

analysis Health Health Services Services Research Research Randomized Randomized Controlled Controlled Trials Trials Observational Observational Outcomes Outcomes Laboratory Laboratory Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes

PRACTICE PATIENTS

slide-11
SLIDE 11

11

Year of study Performance Year of study Performance

2.8 2.8 2.4 2.4 2 2 1.6 1.6 1.2 1.2 0.8 0.8 0.4 0.4 ë80 ë80 ë81a ë81a ë81b ë81b ë82 ë82 ë83 ë83 ë84 ë84 ë85 ë85 ë86 ë86 ë87 ë87 ë88 ë88 ë89 ë89 common common

Relative Chance Relative Chance

Wiesenauer, Forsch. Kompl. 3:230 (1996)

Homeopathic Galphimia glauca in Pollinosis

Estimated Success Rates and 95% confidence Intervals

Evidence Hierarchy Evidence Hierarchy

SCIENCE

Reviews Reviews Meta Meta-

  • analysis

analysis Health Health Services Services Research Research Randomized Randomized Controlled Controlled Trials Trials Observational Observational Outcomes Outcomes Laboratory Laboratory Qualitative, Case Reports, Anecdotes Qualitative, Case Reports, Anecdotes

PRACTICE PATIENTS POLICY

slide-12
SLIDE 12

12 Meta-analysis of Clinical Trials of Homeopathy

Pooled odds ratios and 95% confidence intervals (random effects model)

n studies OR (95%CI) all studies 89 2.45 (2.05-2.93) SENSITIVITY ANALYSES high quality studies 26 1.66 (1.33-2.08) adequate concealment 34 1.93 (1.51-2.47) double-blinding stated 81 2.17 (1.83-2.57) adequate follow up 28 3.18 (2.14-4.73) predefined main outcome 21 2.27 (1.62-3.18) Medline listed studies 23 1.70 (1.31-2.20) corrected for publ. bias 89 1.78 (1.03-3.10) worst case scenario 5 1.97 (1.04-3.75) SUBGROUP ANALYSES high potencies only 31 2.66 (1.83-3.87) high/medium potencies 51 2.77 (2.09-3.67) classical homoeopathy 13 2.91 (1.57-5.37) clinical homoeopathy 49 2.00 (1.60-2.51) isopathy 7 5.04 (2.24-11.32) complex homoeopathy 20 1.94 (2.12-2.08) 0.1 1 10

Meta-analysis of the association between beta-carotene intake and cardiovascular mortality

Observational vs. Randomized Trials

0.1 0.5 0.75 1 1.25 1.5 1.75 Male health workers Social insurance, men Male chemical workers Hyperlipidaemic men Nursing home residents Social insurance, women Male physicians Male smokers (Ex)-smokers, asbestos workers Trials Cohorts Skin cancer patients USA Finland Switzerland USA USA Finland Cohorts combined Trials combined Finland USA USA USA Relative risk (95% CI)

slide-13
SLIDE 13

13 Meta-analysis of Clinical Trials of Homeopathy

Funnel Plot

Standard error Odds ratio .01 .02 .05 .1 .2 .5 1 2 5 10 20 50 100 2 1

Meta-analysis of Clinical Trials of Homeopathy

Funnel Plot after “Trim and Fill”

Standard error Odds ratio .01 .02 .05 .1 .2 .5 1 2 5 10 20 50 100 2 1

slide-14
SLIDE 14

14

Summary Recommendations on Investigating and Dealing With Publication and Other Biases in a Meta-analysis

Examining for bias

  • Check for funnel plot asymmetry using g raphical and statisti cal methods.
  • Use meta-re gression to look

for asso ciations b etwee n k ey m easures o f trial qu ality and trea tm ent effec t si ze .

  • Use meta-re gression to

examin e oth er possibl e expl anations for heterog eneity.

  • If availabl e, examin e asso ciations b etwee n t rea tm ent effec t si ze a nd chang es in biologi

cal markers o r patients ’ adh ere nce to t rea tm ent.

Dealing with bias

  • If th ere is evid ence of bi as, report this with th e same promin ence as any combin ed estim ate
  • f treatm ent effec t.
  • Consid er sensitivity

analys es to establish wheth er th e estim ated t reatm ent effec t is robust to reason able assumptions about th e effec t o f bias.

  • Consid er e xcluding studi

es o f lower quality.

  • If sensitivity

analys es sho w th at a revi ew’ s con clusions could b e seriously affec ted by bi as, th en consid er rec omm ending th at th e evid ence to d ate be dis regarded.