EvidenceBased Care

1
Evidence-Based Care

• Robert Cooperstein, MA, DC
• Cooperstein_r_at_palmer.edu
• http//www.Chiropraxis.com

Palmer Florida, 2008
2
Part I EBC

• What?
• Why?
• How?

3
Purpose of Chiropractic Research

• To improve the science of chiropractic
• To improve the profession of chiropractic
• To add to mankinds store of knowledge
• To improve the quality of chiropractic patient
  care, above all

4
Primum non nocere
First do no harm Hippocrates
5
Quality care

• Patient centered
• Scientifically-based
• Population outcome based
• Refined through quality improvement and
  benchmarking
• Individualized to each patient
• Compatible with system policies and resources
• Brown 2001, cited by Bussières et al, JMPT 2008

Referring to the health status of a population
6
Why guidelines for care?

• Describe quality care based on best evidence and
  broad consensus
• Reduce inappropriate practice variation
• Provide a more rational base for referral
• Provide a focus for continuing education
• Promote efficient use of resources
• Act as a focus to quality control, including
  audit
• Highlight shortcomings of existing literature and
  suggest appropriate future research
• Bussières, JMPT 2008

7
What do evidence-based practice guidelines mean?
Do I really have to change the procedures I use?
Practitioners dont like changing practices, and
tend to ignore guidelines. They want research
more to prove chiropractic than improve clinical
interventions.
8
What is evidence?

• A product of scholarly inquiry
• Published works from funded research
• Teaching
• Writing
• Practicing (clinician-scientist)
• Research the process of gathering, evaluating
  interpreting information
• To answer a question or solve a problem
• Research can be original or bibliographic

9
Evidence Who cares about it?

• Patients/consumers
• Payors (insurance/case managers)
• Other providers
• Government
• Academic institutions
• Allied health professions

10
Patients want evidence

• Not necessarily about chiropractic, but about any
  issues that affect their health
• They use the Internet, books, magazines, journals
• They need the chiropractors help in interpreting
  and evaluating it

11
Evidence-based clinical practice (EBP)

• An approach to clinical decision making that
  integrates the best available evidence, clinical
  expertise, and patient values to decide upon
  health care options which suit each patient best
  (Sackett, 2000)
• the conscientious use of current best evidence
  in making decisions about the care of individual
  patients

12
EBC is not

• Opinion-based decision making, nor beliefs nor
  philosophies nor theories
• Cookbook health care
• eg, as in some chiro tech systems
• Simply applying findings of research publications
• Each case, each patient, is unique
• Simply adhering to guidelines
• Guidelines may be used and abused.

13
Five steps of EBC (Sackett, 2000)

• 1. Create an answerable question (hypothesis)
  about the healthcare problem confronting you
• 2. Find the best evidence to answer the
  particular question
• 3. Critically appraise the question for quality
• 4. Integrate critical appraisal with clinical
  expertise, patients needs circumstances, and
  apply the integration to the case
• 5. Evaluate the effectiveness of your decision
  and look for ways to improve

14
Evidence-based Chiropractic

• Same fundamental ideas practices as other HC
  providers using EBP
• Uses chiropractic philosophy to interpret
  research scholarship
• Integrates evidence, chiropractic expertise and
  previous experiences to make decisions

15
Are chiropractic philosophy and evidence
compatible?
Lenny the Cat is evidence, Aflak the duckling
is philosophy.
16
What do you mean It Works ?

• Patient
• convenient effective, satisfying
• Clinician
• efficient, effective, safe, satisfying
• Clinical Scientist
• quantify effect size, efficacy compared to
  placebo, no tx, safety

17
Haldeman Are Your Treatment Protocols
Evidenced-Based?

• The cost of treating back pain has gone up
  exponentially, while the impact of this increased
  cost and amount of care on such pain appears to
  have been minimal.
• Although in a research setting it is commonly
  stated that lack of evidence is not evidence of
  lack, this does not carry over very well into a
  third party payment setting, where lack of
  evidence often translates into lack of
  reimbursement.

18
Pitfalls of EBC

• To truly have ebc, you must have RCTs
• Practicing evidence-based care is easy, provided
  there is evidence.
• Our natural tendency is to support only those
  treatments with which we are familiar, and
  dismiss the others.
• Enthusiasm for ones preferred treatment is often
  proportional to the lack of evidence
• Then there is extensive discussion of the
  theoretical basis of the treatment.
• Sometimes we have to be realistic and use
  evidence-informed rather than evidence-based
  treatment.

19
A skeptical view of EBC
20
RCT not always best design . . .
"As with many interventions intended to prevent
ill health, the effectiveness of parachutes has
not been subjected to rigorous evaluation by
using randomised controlled trials . . . We think
that everyone might benefit if the most radical
protagonists of evidence based medicine organised
and participated in a double blind, randomised,
placebo controlled, crossover trial of the
parachute. Smith and Pell
21
New study designs coming in

• There is a new study design in which patients can
  elect, rather than being randomized to one of two
  treatments, to be assigned to one of them.
• Then, the outcomes are analyzed as such.
• See the study by Deyo et al on acupuncture vs. SMT

22
Evidence-informed Care

• Be aware of and use research evidence where
  available
• Base recommendations on personal experience when
  it is not
• Be transparent about the process
• Take into account patient-centered principles

23
When to deviate from EBC

• Physicians must have sufficient elbowroom to
  deviate for good reason from the current EBM. EBM
  has to be seen through the filter of personal
  training and experience precisely because EBM
  does not and cannot control for all variables and
  personal experience provides those variables.
• Loewy EH, MedGenMed 2007, cited by Winterstein,
  JMPT 2007

24
Researchersvs. clinicians

• Clinicians tend to be overly enthusiastic, and
  researchers overly skeptical, especially when the
  evidence base is lacking (low quality,
  contradictory, incomplete).
• Clinicians tend to discount negative research,
  whereas researchers often overlook clinical
  experience.

25
Systematic reviewsvs. qualitative reviews

• Systematic reviews
• A systematic review is a summary of healthcare
  research that uses explicit methods to perform a
  thorough literature search and critical appraisal
  of individual studies to identify the valid and
  applicable evidence. It often, but not always,
  uses appropriate techniques (meta-analysis) to
  combine these valid studies, or at least uses
  grading of the levels of evidence depending on
  the methodology used.

26
Qualitative reviews

• Comprehensive and cover a wide range of issues
  within a given topic, but they do not necessarily
  state or follow rules about the search for
  evidence.
• Also, typical narrative reviews do not reveal how
  the decisions were made about relevance of
  studies and the validity of the included studies.

27
Which is better?

• Depends on purpose
• Since decisions have to be made on a daily basis
  as to how to treat, systematic reviews are not
  always helpful.
• Moreover, it is simply too difficult and
  expensive to conduct RCTs for every conceivable
  treatment, under every conceivable clinical
  situation.

28
Haldeman writes
Although narrative reviews are helpful in
providing useful recommendations in the absence
of solid evidence, they rarely evaluate evidence
in a transparent manner, and often omit many
aspects that are relevant to those making
decisions. And while systematic reviews are
often cited as the gold standard of evidence in
EBM, strict adherence to rigorous methodology
often leaves many questions unanswered. Haldeman
, Spine Journal 2008
29
Diagnosing and treating low back conditions

• Today is not a good example of a chirocentric
  approach
• My emphasis is usually on which chiropractic
  treatments work best, but today we are going to
  discuss what the evidence says about all the
  treatment approaches to low back and cervical
  conditions.

30
Part II

• Special issue of The Spine Journal

31
Epidemiology of LBP

• A recent study reported that the point prevalence
  of LBP in the general adult population is
  estimated at 37
• Whereas the 1-year prevalence is 76 and
• The lifetime prevalence is 85
• Approximately 20 of sufferers describe their
  pain as severe or disabling
• Schmidt, Spine 2007

32
Haldemans supermarket analogy
There is a supermarket selling treatments for
CLBP with 10 aisles

• Injection
• Minimally-invasive treatments
• Surgery
• Lifestyle therapies

• Pharmacological
• Minus vitorin?
• Manual therapy
• Exercise
• PT
• Education/psychological
• CAM

And each aisle has many products - Drug aisle
60 products - Manual therapy aisle 100 brands
33
Treatment approaches for CLBP

• Acupuncture
• Adjunctive analgesics
• Back school, brief education, fear avoidance
• Cognitive behavioral training
• Epidural steroid injection
• Extensor Exercises
• Facet injections and radiofrequency neurotomy
• Functional restoration
• Herbs, vitamins, homeopathy
• IDET
• Lumbar Stabilization Exercises
• Manipulation/Mobilization
• Massage
• McKenzie Method
• Medicine-assisted manipulation
• NSAIDs, muscle relaxants, analgesics
• Nuclear decompression
• Opiod analgesics
• Physical activity, smoking cessation, weight loss

34
Atlas of contemporary methods . . . Or Autopsy?
35
Format for reviews

• Description
• Terminology
• History
• Subtypes
• Reimbursement
• Theory
• Mechanism of action
• Diagnostic testing required
• Evidence of efficacy
• SRs, RCTs, observational studies
• Harm
• Summary

36
Acupuncture

• There appears to be some evidence for the use of
  acupuncture for the treatment of CLBP
• Evidence suggests that acupuncture is no more
  effective than other treatment methods
• The most consistent evidence suggests that the
  addition of acupuncture to other therapies
  improves outcomes
• Moderate evidence that acupuncture may be better
  than massage especially if combined with exercise
• Inconclusive evidence for the effectiveness of
  acupuncture when compared to sham acupuncture
  (real sham acupuncture gt placebo)

37
Functional restoration

• Multidisciplinary, individualized approach
  involving
• Psychosocial and socioeconomic components
• Multimodal disability management using cognitive
  behavioral training
• Psychopharmacological use (for those in need)
• Complemented by ongoing outcome assessment and
  communication among all involved.
• The team
• Medical director
• Nurse
• Occupational therapist
• Pain mgt specialist
• Physical Therapist
• Psychologist or psychiatrist

38
Functional Restoration, outcomes, CLBP

• Strong evidence that functional restoration
  reduces pain and improves function more than less
  intensive programs or usual care.
• Guzman et al
• Van Tulder et al, using Cochrane Collaboration
  rules
• Carragee, NEJM 2005
• Observational studies
• Results have been positive in different workers
  compensation and socioeconomic systems
• Major deterrent to wider use is reluctance of
  third-party payers due to perceived high cost,
  ignoring potential savings

39
Manipulation/mobilization

• For CLBP, there is moderate evidence that SMT
  with strengthening exercise is similar in effect
  to prescription NSAIDs with exercise in both the
  short and long term
• Flexion-distraction MOB is superior to exercise
  in the short term and superior/similar in the
  long term
• High dose SMT is superior to low dose SMT in the
  very short term
• There is limited to moderate evidence that SMT is
  better than PT and home exercise in both the
  short and long term
• SMT and MOB are at least as effective as other
  efficacious and commonly used interventions

40
Massage

• Soft-tissue manipulation using the hands or a
  mechanical device precise physiological
  mechanism unknown
• Strong evidence that massage is effective for
  non-specific CLBP, long lasting
• Moderate evidence that massage provides short-
  and long-term relief of symptoms
• Standard massage has the same effects as
  traditional Thai massage, but acupressure massage
  gt Swedish massage

41
McKenzie Model

• Assessment and treatment based on patient
  responses to end-range loading (singular
  sustained or repetitive)
• Based on evoked responses, not palpatory findings
• Pain and/or paresthesia is
• Increased or decreased
• Centralized or peripheralized
• Range of motion lost due to
• Pain and/or fear
• Mechanical impedance
• Shortened tissue (premature)
• Obstruction (blockage)

42
Centralization and Peripheralization
The principle of directional preference
43
Provocation testing

• Attempts to guide interventions based on patient
  responses to clinical provocations
• Mostly straightforward, but mild to moderate
  increase local pain equivocal

44
McKenzie exercises
45
Sagittal plane considerations in lumbar
side-posture manipulation

• Segmental thrusts have regional implications
• Thrusting may extend, flex, or leave the spine
  posturally neutral

Body neutral
In flexion
In extension
46
McKenzie conclusions

• Produces better short-term outcomes than
  nonspecific guideline-based care
• Produces equal or marginally better outcomes than
  stabilization or strengthening exercises
• System of assessment and classification can help
  predict outcomes
• Non-centralization is associated with a poor
  behavioral response

47
NSAIDs, etc.

• Authorities advocate the use of an analgesic pain
  medication, an antidepressant, or a combination
  of the two for CLBP
• No one medication in a class is better than
  another
• It is unpredictable which patient will respond
  best to which medication within that class
• Trial and error is unavoidable

48
Physical activity, etc.

• A number of systematic reviews have strongly
  recommended staying active and avoiding bed rest
  in acute LBP and sciatica
• There is no evidence, either in the form of
  comparative studies or observational studies, on
  smoking cessation or nonoperative weight loss as
  an intervention for CLBP, however, there are few
  trials available
• Moderate evidence that physical activity with
  general aerobic and strengthening exercise or
  aquafitness was more effective than nonactive
  controls for long-term reduction of disability
  and limited evidence for improvements in worst
  pain, medication use, work status, and mood
• Moderate evidence that different types of
  physical activity programs were equally effective

49
Physiotherapy

• No eligible studies were found by the group for
  interferential current, electrical muscle
  stimulation, ultrasound, or hot/cold pack/ice
• Although electrotherapeutic modalities and
  physical agents are frequently used in the
  management of CLBP, few studies were found to
  support their use
• There is limited evidence that TENS appears to
  have an immediate impact on pain intensity
• Results of these studies suggest that TENS should
  probably be used as an adjunct tool for immediate
  to short-term pain relief, with no impact on
  perceived disability or long-term pain

50
Surgery

• There is insufficient evidence on the
  effectiveness of surgery on clinical outcomes to
  draw any firm conclusions
• Lumbar fusion for common degenerative changes
  appears to offer limited relative benefits
• Artificial disc replacements have approximately
  the same outcomes as fusion in the short term

51
What CSI has to say
ROBBINS Pulled it from the L4-L5 interspace.
Cobalt chromium molybdenum alloy with a titanium
coating and an ultra high molecular weight
polyethylene component. An artificial spinal
disc. If you can recreate a spine the
possibilities are endless. CATHERINE I thought,
uh, disc replacement surgery involved fusing bone
to bone. ROBBINS Eh, typically, but it can
limit mobility. With that little disc, your body
doesn't know the difference. ROBBINS Matches
range of motion, flexibility and an axial
rotation of a normal spine. ROBBINS Still in
clinical trials. Less than a thousand surgeries
have been performed in this country. CATHERINE
Oh, well, I like those odds. ROBBINS You'll like
this even better. Medium endplate, size 12,
polyethylene component and a six-degree lordosis
angle. Narrowed it down to one. Amy Ennis.
Austin, Texas.
52
Other treatments (I)

• Adjunctive analgesics
• Tricyclics, antiepileptics, etc.
• Limited evidence
• Back school, brief education, fear avoidance
  training
• Limited evidence back school lt exercise
• Cognitive behavioral training
• Epidural steroids
• Short-term benefit, non-specific rather than
  discogenic pain
• Extensor exercises
• Not better than traditional exercise
• Facet injections
• Steroid not better than placebo
• Radiofrequency neurotomy
• Mmedial branch nerve blocks
• Pain relief, 1 yr)
• Nutritional supplements and homeopathy
• Salicin, B12, C, lavender oil

53
Other treatments (II)

• IDET
• modest pain relief
• Success varies from 14 (randomized) to 63
  (non-randomized) studies
• Lumbar stabilization exercises
• Strong evidence no better than general exercise
  or manual therapy
• MAM (medicine-assisted smt)
• Weak evidence for results
• Nuclear decompression (nucleoplasty)
• minimally invasive bipolar radiofrequency device
  for vaporizing disc nucleus and lowering disc
  pressure, allowing protrusion to implode
• Better than fusion, when there is leg pain, not
  merely axial pain
• Opioids
• Effective, with side effects
• Improvement in pain is more substantiated than
  function
• Addiction is rare

54
Other treatments (III)

• Physical activity, smoking cessation, weight loss
• Little evidence re. smoking or weight loss
• Moderate evidence PA effective, no one type best
• Physiotherapy
• No evidence interferential, muscle stim, US,
  hot/cold tx
• TENS ? reduced pain
• Prolotherapy
• Effective if used with exercise and SMT
• Traction
• Mixed, limited evidence for Vax-d, DRX9000 same
  as standard traction?
• Trigger point injections
• Short-term pain relief, lidocainesaline

55
Part iii

• Annals of internal medicine
• American Pain Society
• American College of Physicians
• Consists of
• Treatment review
• Non-pharmacological
• Non-surgical
• Not solely back education or advice
• Mostly a review of systematic reviews
• And high quality systematic reviews are less
  likely to report positive results
• Algorithm for low back management

56
Annals article
57
Study methodology

• Through Nov. 2006
• Systematic reviews and RCTs of therapies
  not-included in systematic reviews
• Consulted studies that reported pain and
  function outcomes
• Qualitative (narrative) analysis of quantitative
  reviews

58
Results, Annals, CLBP I

• Good evidence that the following are moderately
  effective for chronic or sub-acute LBP
• Cognitive-behavioral
• SMT
• Interdisciplinary rehab

• Benefits over placebo, sham, and no treatment
• (10-20)/100 Oswestry
• 2-4 points Roland-Morris Disability

59
Results, Annals CLBP II

• Fair evidence that the following are moderately
  effective for chronic LBP
• Acupuncture
• Massage
• Yoga
• Functional restoration

60
Results, Annals, acute LBP

• Only non-pharmacological therapies with evidence
  of efficacy
• Superficial heat (good evidence, moderate
  benefit)
• SMT (fair evidence, small to moderate benefits)

61
Annals, weak evidence or unsupported

• Massage
• Acupuncture
• Exercise therapy, yoga, back schools
• Physical therapy
• Interferential
• Low level laser
• Lumbar supports
• Shortwave diathermy
• Traction
• TENS
• Ultrasound

62
Annals study, not known

• Serious harms appear rare
• Optimum sequencing of therapies
• Tailoring treatment to individuals
• Sciatica

63
Part iv

• Bone and Joint Decade 2000-2010 Task Force on
  Neck Pain and Its Associated Disorders
• Spine. 33(4S) SupplementS199-S213, February 15,
  2008.
• 31,878 citations
• 1203 were relevant to the mandate of the Neck
  Pain Task Force
• 552 studies (46) were judged scientifically
  admissible and were compiled into the best
  evidence synthesis

64
Bone Joint Decade
65
Neck patients triaged

• Grade I neck pain with no signs of major
  pathology and no or little interference with
  daily activities
• Grade II neck pain with no signs of major
  pathology, but interference with daily
  activities
• Grade III neck pain with neurologic signs of
  nerve compression
• Grade IV neck pain with signs of major pathology

66
Treatment recommedations by grade

• Grades I and II
• Exercises and mobilization have been shown to
  provide some degree of short-term relief after a
  motor vehicle collision.
• Exercises, mobilization, manipulation,
  analgesics, acupuncture, and low-level laser may
  be useful if no trauma.
• Grade III
• Those with severe persistent radicular symptoms
  might benefit from corticosteroid injections or
  surgery.
• Grade IV
• Those with pain require management specific to
  the diagnosed pathology

67
The stroke issue

• Risk of Vertebrobasilar Stroke and Chiropractic
  Care Results of a Population-Based Case-Control
  and Case-Crossover Study (Cassidy et al)
• Cases included eligible incident VBA strokes
  admitted to Ontario hospitals from April 1, 1993
  to March 31, 2002
• 818 VBA strokes hospitalized in a population of
  more than 100 million person-years.
• In those aged lt45 years, cases were about three
  times more likely to see a chiropractor or a PCP
  before their stroke than controls.
• There was no increased association between
  chiropractic visits and VBA stroke in those older
  than 45 years.
• Positive associations were found between PCP
  visits and VBA stroke in all age groups.

68
Stroke study conclusions

• VBA stroke is a very rare event in the
  population.
• The increased risks of VBA stroke associated with
  chiropractic and PCP visits is likely due to
  patients with headache and neck pain from VBA
  dissection seeking care before their stroke.
• No evidence of excess risk of VBA stroke
  associated chiropractic care compared to primary
  care.

69
Does stroke incidence covary with chiropractic
utilization?

• Examining Vertebrobasilar Artery Stroke in Two
  Canadian Provinces (Boyle et al)
• All hospitalizations with discharge diagnoses of
  VBA stroke were extracted from administrative
  databases for Saskatchewan and Ontario.
• Diagnosed between January 1993 and December 2004
  for Saskatchewan and from April 1993 to March
  2002 for Ontario

70
Stroke/chiro utilization results and conclusions

• Results
• Incidence rate of VBA stroke was 0.855 per
  100,000 person-years for Saskatchewan and 0.750
  per 100,000 person-years for Ontario.
• Incidence rate spiked 360 increase for
  Saskatchewan in 2000, and 38 increase in
  Ontario.
• The rate of chiropractic utilization did not
  increase significantly during the study period.
• Conclusion
• In VBA stroke does not seem to be associated with
  an increase in the rate of chiropractic
  utilization.

71
The verdict on surgery

• Surgical treatment and limited injection
  procedures for cervical radicular symptoms may be
  reasonably considered in patients with severe
  impairments.
• Percutaneous and open surgical treatment for neck
  pain alone, without radicular symptoms or clear
  serious pathology, seems to lack scientific
  support.

72
Non-invasive interventions

• Treatment of Neck Pain Noninvasive Interventions
  (Hurwitz et al)
• Whiplash
• educational videos, mobilization, and exercises
  appear more beneficial than usual care or
  physical modalities
• Other neck pain
• Manual and supervised exercise interventions,
  low-level laser therapy, and perhaps acupuncture
  are more effective than no treatment, sham, or
  alternative interventions

73
Non-invasive interventions Conclusions

• None of the treatments was clearly superior,
  short- or long-term.
• For both whiplash and other neck pain without
  radicular symptoms, interventions to regain
  function asap relatively more effective
• Therapies involving manual therapy and exercise
  are more effective than alternative strategies

74
Neck pain non-invasive treatments

• Treatment of Neck Pain Noninvasive txs (Hurwitz
  et al)

• Winners
• Exercise
• Exercise smt
• Nsaids exercise
• Smtmobex-ercise
• Acupuncture
• Lasers
• Magnets
• Combination therapies

• Losers
• Education/advice alone
• PT modalities, passive
• Strengthening exercises

75
Whiplash

• Course and Prognostic Factors for Neck Pain in
  Whiplash-Associated Disorders (WAD) (Carroll et
  al)
• 50 of WAD will report neck pain symptoms 1 year
  after injuries.
• Greater initial pain, more symptoms, and greater
  initial disability predicted slower recovery.
• Few collision-related factors mattered (eg,
  direction of the collision, headrest type)
• Postinjury psychological factors (passive coping
  style, depressed mood, fear of movement)
  prognostic for slower or less complete recovery.
• Preliminary evidence that the prevailing
  compensation system is prognostic for recovery in
  WAD.

76
Prognostic factors

• Course and Prognostic Factors for Neck Pain in
  the General Population (Carroll et al)
• ½ to ¾ of those with neck pain will report neck
  pain again 1 to 5 years later.
• Younger age predicted better outcome.
• General exercise was unassociated with outcome,
  although regular bicycling predicted poor outcome
  in 1 study.
• Psychosocial factors, including psychologic
  health, coping patterns, and need to socialize,
  were the strongest prognostic factors.
• Not studied degenerative changes, genetic
  factors, compensation policies.
• Conclusion.
• General exercise was not prognostic of better
  outcome however, several psychosocial factors
  were prognostic of outcome.

77
Repeat whiplash study

• The Burden and Determinants of Neck Pain in
  Whiplash-Associated Disorders (Holm et al)
• Previous best evidence synthesis on WAD has noted
  a lack of evidence regarding incidence of and
  risk factors for WAD. Therefore there was a
  warrant of a reanalyze of this body of research

78
WAD findings

• Incidence of WAD differed substantially between
  countries
• Seat position and collision impact direction were
  associated with WAD in one study.
• Eliminating insurance payments for pain and
  suffering were associated with a lower incidence
  of WAD injury claims in one study
• Younger age, female predictive
• Despite many years of research, the evidence
  regarding risk factors for WAD is sparse but
  seems to include personal, societal, and
  environmental factors.

79
Risk factors

• The Burden and Determinants of Neck
  Pain(Hogg-Johnson et al)
• 12-month pain prevalence ranged between 30 and
  50
• 12-month prevalence of activity-limiting pain was
  1.7 to 11.5
• More prevalent in women and in middle age.
• Risk factors genetics, poor psychological
  health, and exposure to tobacco.
• Disc degeneration was not identified as a risk
  factor.

80
Part VGuidelines for radiology

• PCCRP (Harrison et al) vs. CCEC (Bussières et al)

81
Indications for x-ray

• Diagnostic radiology
• Identify medical spinal pathology that might
  contraindicate manipulation or require referral
• Osteomyelitis
• Fracture
• Tumor
• Analytic radiology
• Determine chiropractic listings that are
• Technique specific
• Suggest segmental or regional misalignment
  subluxation, postural faults

82
Routine radiographs

• Radiographs taken in absence of red flags
• Radiographs used as screening procedure for
  essentially all new patients, unrelated to
  symptoms or signs of disease (clinical conditions)

83
Pro-routine x-rays

• Screen for and prevent rare complications of smt
• Non-clinical motives (patient preference,
  medicolegal, etc.)
• Postural and biomechanical analysis, pre/post
  care
• More accurate prognosis
• Belief that ionizing radiation has negligible
  adverse health consequences

84
Argument against routine radiography

• Conventional radiography does not appear to be
  clinically useful as a screening test due to low
  prevalence of serious spinal pathologies such as
  cancer and infection
• And poor sensitivity, predictive values, and
  likelihood ratios for many msk conditions
• Bussières, JMPT 2008

True positives Probability of obtaining a
true positive How much test result changes
likelhood of having disease
85
Bussières et al
86
Origin of PCCRP Guidelines

• PCCRP is the acronym for Practicing
  Chiropractors Committee for Radiology Protocols
• A cofounder of CBP declined invitation to
  participate in CCEC guidelines, opting to develop
  other guidelines
• PCCRP Guidelines are In direct
  competition/opposition to current attempts to
  restrict Chiropractic Radiography to Red Flag
  Only conditions or diagnosis
• PCCRP website, cited by Bussières, JMPT 2008

87
CCEC Process

• To develop evidence-based guidelines for imaging
  by chiropractors and others
• Literature search
• Literature assessment (QUADAS, AGREE, SPREAD
  instruments)
• Guideline development
• External review
• Expert consensus panel (Delphi, n76)
• Pubic website (n35-50)
• Second external review
• Final draft of guidelines
• Recommendations
• Strength of evidence
• Dissemination and implementation

88
Sample of CCEC guidelines

• Trauma
• Adult patient with thoracolumbar, lumbar, pelvic,
  sacral, or thoracic spine blunt trauma or acute
  injuries (falls, motor-vehicle accidents,
  motorcycle, pedestrian, cyclists, etc) YES
• Adult patient with acute neck injury and negative
  CCSR NO
• Adult patient with acute neck and positive CCSR
  YES

CCSRCanadian Cervical Spine Rule for Radiography
in Alert and Stable Trauma Patients, validated,
20 standardized clinical findings
89
Lumbar spine

• Non-traumatic
• Adult patient with acute uncomplicated LBP (lt4
  wk's duration) NO
• Adult patient with uncomplicated subacute (4-12
  wk's duration) or persistent LBP (gt12 wk's
  duration) AND no previous treatment trial NO
• Adult patient reevaluation in the absence of
  expected treatment response or worsening after 4
  to 6 wk YES

90
Radiology required, CCEC

• Adults with complicated (ie, red flag) LBP and
  indicators of contraindication to SMT
  (relative/absolute) YES
• Patient lt20, gt50
• Absence of expected tx response
• Significant activity restriction
• Non-mechanical pain
• Suspected compression fracture, neoplasia,
  inflammation, infection, failed surgical fusion
• Painful structural deformity
• Positive lab values

91
PCCRP website
92
PCCRP basic premises (Brussieres)

• Linear-no-threshold risk model and current
  radiation exposure guidelines are based on faulty
  or inadequate science
• Low levels of radiation actually offer beneficial
  health effects (radiation hormesis) rather than
  posing health risks
• Current guidelines aimed at limiting radiation
  exposure to levels as low as reasonably
  achievable should be abandoned.

93
Radiation hormesis (Oakley et al)
Linear indicates the LNT Model, which is a
linear extrapolation from the high dose
(dose-rate) of atomic bombs dropped on Japan,
drawn linearly down to zero. This model assumes
that any exposure has a cancer risk, and the
greater the exposure, the greater the cancer
risk. Hormesis is the quadratic shaped curve
(U-shaped curve), where between zero and the zero
equivalent point (ZEP), there is less risk of
cancer or a benefit. However, doses greater
than the ZEP (a threshold) indicate a near linear
increased risk of cancer with increasing doses.
(Oakley et al JCCA)
94
CCEC basic premises (Harrison et al)

• Normal spinal position does not exist
• acute m. spasm gt cervical/lumbar hypolordosis
• Normal variants mimic spinal subluxation
• X-rays not indicated for biomechanical analysis
  or screening
• No follow-up x-rays warranted
• X-ray line marking unreliable
• X-ray analysis lacks predictive validity and
  biological plausibility
• X-rays do not result in improved patient outcomes

95
Purposes of PCCRP guidelines

• (1) locate and rate the evidence for
  Biomechanical Assessment of Spinal Subluxation
  in Chiropractic Clinical Practice Using
  Radiography and
• (2) assist the practicing Chiropractor in making
  sound, fundamental clinical decisions when using
  radiology in clinical practice.

96
Aims of PCCRP guidelines

• 1. Provide evidence from the literature,
  identifying if the routine use of radiography in
  chiropractic practice . . . is valid practice.
• 2. Determine the health risk of spinal
  radiography use.
• 3. Identify the radiographic views utilized in
  most Chiropractic Technique systems.
• 4. Determine the clinical utility of common
  radiographic views for Chiropractic clinical
  practice.
• 5. Determine the reliability, validity, and
  efficacy of common radiological views utilized in
  chiropractic clinical practice.
• 6. Identify, with evidence, if the routine use of
  radiography in pediatric cases is valid.
• 7. Define chiropractic spinal subluxation from a
  structural/displacement view point and provide
  spinal radiographic normal values for alignment.
• 8. Review spinal radiographic guidelines from
  other professions.
• 9. Provide Chiropractic College Instructors with
  the actual, updated, evidence on x-ray usage in
  Chiropractic clinical practice, in order that the
  current information be shared with prospective
  chiropractors.

97
Structure of PCCRP process

• 25 person committee drafts guidelines, with 5 PIs
  (4/5 CBP practitioners)
• External review
• 1 12 experts, DC law, etc.
• 2 2 experts, DC MD, etc. using AGREE
  instrument
• 3 12 chiro orgs (ACA, ICA, WCA, etc.)
• 4 Chiro colleges (all)
• 5 Web availability and feedback from profession
  at large

98
PCCRP Indications for radiographic exam

• 1. Abnormal posture
• 2. Spinal Subluxation (as defined in this
  document)
• 3. Spinal deformity (eg, scoliosis,
  hyper-kyphosis, hypo-kyphosis)
• 4. Trauma, especially trauma to the spine
• 5. Birth Trauma (eg, forceps, etc)
• 6. Restricted or abnormal motion
• 7. Abnormal gait
• 8. Axial pain
• 9. Radiating pain (eg, upper extremity,
  intercostal, lower extremity)
• 10. Headache
• 11. Suspected short leg
• 12. Suspected spinal instability
• 13. Follow-up for previous deformity, previous
  abnormal posture, previous spinal
  subluxation/displacement, previous spinal
  instability
• 14. Suspected osteoporosis
• 15. Facial pain
• 16. Systemic health problems (eg, skin diseases,
  asthma, auto-immune diseases, organ dysfunction)
• 17. Neurological conditions
• 18. Delayed developmental conditions
• 19. Eye and vision problems other than corrective
  lenses

Any Red Flag Conditions covered in previous
guidelines.
99
PCCRP chapter 10Efficacy of views

• 19 common chiropractic views (9 cervical),
  assessed for supporting evidence evidence grade
• History of view
• Reliability of patient positioning
• Reliability of line marking
• Validity of the view
• Sensitivity in detecting health conditions
• Outcome studies using conservative chiropractic
  methods
• Pre-post utility, where x-ray changes reflected
  patient condition changes

100
Clinical relevanceof x-ray

• Like any other diagnostic test, radiography
  should only be considered if
• (a) it yields clinically important information
  beyond that obtained from the history and
  physical examination
• (b) this information can potentially alter
  patient management and
• (c) this altered management has a reasonable
  probability to improve patient outcomes

Bussières, JCCA, June 2006
101
Yield from routine radiographs low?

• Routine use of lumbar spine conventional
  radiography is not indicated because of
• very low incidence of unexpected findings on
  radiographs (only 1 in 2500 radiographs)
• High radiation dose to gonads
• high cost/benefit ratio
• Poor association between patient findings and LBP
  (ie, not specific).
• Anomalies of no proven clinical relevance
  include
• block vertebrae
• spina bifida occulta
• mild scoliosis
• Facet tropism
• None of which are considered contraindications to
  SMT
• Bussières, 2008, JMPT part III

102
Yield from routine radiographs high?

• 66-91 according to Oakley et al, JCCA, 2006
• Bull PW. Relative and absolute contraindications
  to spinal manipulative therapy found on spinal
  x-rays. Proceedings of the WFC 7th Biennial
  Congress Orlando, FL, May 2003, page 376.
• 28.Pryor M, McCoy M. Radiographic findings that
  may alter treatment identified on radiographs of
  patients receiving chiropractic care in a
  teaching clinic. J Chiro Ed. 200620(1)9394.
• 29.Beck RW, Holt KR, Fox MA, Hurtgen-Grace KL.
  Radiographic Anomalies That May Alter
  Chiropractic Intervention Strategies Found in a
  New Zealand Population. JMPT. 200427(9)554559.
  PubMed

103
Example, Yield high,Pryor McCoy
104
Does x-ray improve outcome of care?

• In primary medical care
• Yes, but mostly by increasing patients
  confidence in how careful the doctor was
• Kendrick et al, Health Technol Assess
  20015(30)1-69.
• Gilbert et al, Health Technol Assess
  20048(17)1-131.
• Underwood et al, UK BEAM, Rheumatology (Oxford)
  200645(6)751-6
• Type of care rendered not changed much, and
  clinical outcomes other than patient perceptions
  not changed much.

105
Part viConclusions
106
The central technique paradox
The longest running, largest scale research
project ever conducted by chiropractors . .
. The cumulative result of hundreds of
interexaminer reliability experiments
investigating practically every
analytic/diagnostic commonly used by
chiropractors . . . Convincingly demonstrates
that specific chiropractic listings are often
randomly generated . . . And yet . . .
107
Chiropractic works.

• Meeker WC, Haldeman S. Chiropractic a profession
  at the crossroads of mainstream and alternative
  medicine. Ann Intern Med 2002136(3)216-7.
• NBCE Studies on Chiropractic 2005http//nbce.org/
  pdfs/studies.pdf
• Etc, etc, etc.
• Raising the following question

108
How doeschiropractic work?
How to explain the apparent success of a great
variety of chiropractic adjustive procedures,
when the notion of a specific chiropractic
diagnosis (i.e., "listing") may be more wishful
thinking than reality? If a good treatment
outcome depends on an accurate diagnosis, then
how can we explain fairly uniformly good
outcomes, given huge variation in diagnostic
inputs?
Cooperstein R, Haas M. The listings continuum
driving a truck through a paradox. Dynamic
Chiropractic 200119(20)28-29, 36.
109
So a good chiropractic treatment outcome . . .

• Occurs in spite of poor reproducibility of exam
  findings, suggesting . . .
• We may not need an exact or accurate diagnosis.
• This paradox breeds cognitive dissonance
  leading to and leads to skirmishing at the
  research/technique interface

110
Technique/Research Interface

• There was a time when researchers researched, and
  technique people taught technique, and they did
  not like each other or talk to each other very
  much.
• Researchers tended to find technique people, to
  put it tactfully, uninformed, while the technique
  people found the researchers pretty ivory tower,
  oblivious if not actually allergic to the art of
  providing chiropractic care.
• None of this is true anymore. The technique and
  research communities have for all intents and
  purposes merged to become one and the same.
• Indeed, it is hard to tell the difference between
  a research conference and a technique
  meeting, since the same individuals are likely
  to show up at either to discuss matters in the
  same language and for the same goal of advancing
  evidence-based chiropractic.

111
Too many adjustive methods?

• New techniques add to existing techniques rather
  than replace them
• The chiropractic technique armamentarium is, if
  anything, overstocked!
• Solution to this problem likely to be patient
  selection, patient selection, and patient
  selection.

112
Primary questions related to adjustive methods .
. .

• What types of adjustive procedures
• Used with particular patients
• Suffering from which diagnostic entities
• At various times in their cases
• By different types of chiropractors
• Get the best outcomes
• As measured by which outcome measures?

113
And then there are the students

• We owe it to them to present a unified
  curriculum, where all facets of the college are
  following the same rhythm.
• We taught them to think critically, beginning
  with us. Therefore, we must not feel abused when
  they raise their hands demanding proof.
• Scientifically-based chiropractic professors
  should not rant and rave about "The Subluxation"
  and "The Adjustment"
• Good science by its very nature automatically
  desanctifies the standard totems.
• However, deconsecrating religious symbols has it
  price, especially if no secular model of equal
  interest is constructed.

114
Let us get used to clinical uncertainty

• It is unrealistic to expect chiropractic students
  and practitioners to become as excited about
  "Research" as they were over "Subluxation" and
  "Adjustment."
• Likewise, it is more difficult to promote generic
  technique than brand-name techniques, which bear
  the stamp of the guru and the insignia of
  religious conviction.
• The most sought-after item on today's seminar
  circuit is the promised relief from the anxiety
  of negative research findings. This mandates to
  the colleges and the journals the task of
  reconciling clinical chiropractic with clinical
  uncertainty.

115
Technique systems and the confidence gap

• Chiropractic science has developed to the point
  that it now knows what it doesn't know.
• This renders chiropractic education more
  vulnerable than ever to the sophistry and
  mercantilism of the technique vendors, and the
  overly enthusiastic (if well-intentioned)
  proselytizing of college-based technique
  enthusiasts.
• Technique demagogues offer the students
  unrealistic and absolute certainty in the
  efficacy of traditional chiropractic diagnostic
  and therapeutic methods.
• They get the students to identify their brand of
  psychomotor skills with extraneous, unrelated
  values
• Loyalty to chiropractic
• Staunch opposition to medical expropriation
• Quality service to patients
• Above all the daily accomplishment of miracles.

116
Scientism, the (bad) answer to clinical
uncertainty

• Some technique developers have resorted to what
  the economist Hayek called "scientism"
• The overly ambitious attempt to emulate the
  methods of mathematical physics in an
  inappropriate field.
• Chiropractic is a clinical science - that is, an
  art. It shares this property with medical science
  and the other fields that study man as a social
  animal (sociology, economics, anthropology,
  psychology, etc.).
• Chiropractic should not make a petrified attempt
  to apply exacting methodology to indeterminate
  systems.
• The methods of the so-called hard sciences are
  not directly applicable in situations where
  anatomical asymmetry, individual variation in
  development and in genetic endowment, racial and
  sexual differences, socioeconomic and cultural
  determination, and even pure chance preclude
  exact and universal analysis.
• The colleges are well-placed to protect their
  students from this genre of pseudo-science, which
  may grow in popularity even if the more overtly
  theological tendencies wane a bit.

117
Are the chiropractic colleges proud of what they
teach?

• The colleges' pre-eminence in research and
  commitment to normal science undermines some of
  the confidence its students would have in their
  technique programs.
• Faculty have published many papers putting in
  question the reliability and validity of the same
  diagnostic methods that they teach in the
  classrooms!
• Some instructors unfortunately make a daily
  practice of mocking historically entrenched
  chiropractic ideas, only to conclude that at the
  current time we have no really better ideas to
  replace them.
• How much of the edifice of traditional
  chiropractic thought and practice can be ripped
  down without being replaced, without alienating
  the students?
• Why would they be expected to support a college
  which accepts their tuition but does not seem
  proud of the essence of what it offers?

118
Palmer Pride

• We should proudly tell the students that we now
  know enough about our craft to safely cast off
  some of the tethers of the brand-name techniques
  
• That their rules and methodologies are too narrow
  and constraining that this casting off would
  allow the students a new freedom to practice
  chiropractic in a more creative, eclectic way,
  always consistent with the dictates of normal
  science
• And that they are encouraged to reinvent
  chiropractic technique, to usher it into its
  requisite post-technique orientation.
• They must be given a sense of thrill in
  participating in the most liberal period of
  chiropractic practice since its very inception.