William G. Elder, PhD Niki Munk, PhD, LMT UK Family and Community Medicine IU School of Health and...
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Transcript of William G. Elder, PhD Niki Munk, PhD, LMT UK Family and Community Medicine IU School of Health and...
William G. Elder, PhDNiki Munk, PhD, LMT
UK Family and Community MedicineIU School of Health and Rehabilitation Sciences
KYPROS: A KAN STUDY METHODS, RESULTS AND
NEXT STEPS
MAY 9, 2014
Support:National Center for Complementary and Alternative Medicine (NCCAM) grant #R21AT004544National Center for Advancing Translational Sciences. National Institutes of Health (NIH) grant #UL1 TR000117
KYPROS: INTRODUCTION
First “real world” study to examine massage therapy (MT) and progressive muscle relaxation therapy (PMR) for patients with CLBP when referred in conjunction with usual care from PCPs.
Evaluate for improvements in health-related outcomes.
Demonstrate the feasibility of this type of study.
KYPROS RESULTS
Clinical massage therapy (CMT) delivered during a 12 week period resulted in significant statistical and clinical improvement of functional health related outcomes for chronic low back pain (CLBP) patients of primary care providers.
Feasibility demonstrated with many lessons learned.
1. Recognition and thanks2. Discuss practice based research and study
methodology What makes practice based research
unique? What conclusions does it permit?3. Describe study results for benefit of
treatment of CLBP patients4. Examine next steps of this research
PRESENTATION OBJECTIVES
Community FacultyDevelopment of research questionDevelopment of methodology
Maureen Flannery, MDDavid Greene, MD
Primary Care Providers (PCPs)67 PCPs consented to participate in the study.
10 were in rural areas48 PCPs returned at least one pocketcard in 18 sites that participated
OBJECTIVE 1 - THANK YOU!
Thomas J. Burchett, MDLexington Family MedicineWinchester Medical
AssociatesChevy Chase Primary CareFamily Practice AssociatesKentucky Clinic SouthBaptist Internal Medicine –
LeestownBaptist Internal Medicine –
Furlow and AssociatesBaptist Internal Medicine –
Beaumont Center
KYPROS KAN PRACTICES
Midway Center for Integrative Medicine
Winchester Family PracticeEnlow and ShahzadUK Family Medical Center
@ Kentucky ClinicBaptist Family Physicians at
Tates CreekBaptist Family Physicians in
Scott CountyBerea Primary Care ClinicWhite House Clinic -
RichmondWhite House Clinic - Berea
Design:Two-armed, repeated measures, observational trial and feasibility study.
“Real world study”
AIM of REAL WORLD STUDIES: Do the interventions of interest work in
practice?
KYPROS:
Examined extensively
High quality Cochrane systematic review Massage therapies are beneficial for CLBP. Recommended more studies to assess impact on functioning and quality
of life. Recent high quality RCT
Massage effects for CLBP last up to fifty-two weeks Very strict exclusion criteria.
EFFICACY OF CMT
Furlan AD, Imamura M, Dryden T, Irvin E. Massage for low-back pain. The Cochrane database of systematic reviews. 2008(4)
Cherkin DC, Sherman KJ, Kahn J, Wellman R, Cook AJ, Johnson E, et al. A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial. Ann Inter Med. 2011;155(1):1-9.
WHAT FACTORS AFFECT TREATMENT CHOICE?
All of these, plus research design issues, add up to an expectation that a treatment will
work in practice
For nonspecific acute LBP advise patients to remain active and perform self-care; medication selection should consider the poor long-term efficacy and safety data for opioids, with acetaminophen and NSAIDs as first-line medication options.
For patients not improving with self-care, the guidelines recommend addition of nonpharmacological approaches
LEVEL OF EVIDENCEAMERICAN COLLEGE OF PHYSICIANS
AND AMERICAN SPINE SOCIETY GUIDELINES
Chou, Quaseem, Snow, Cassey, Cross, Sheckle. Ann Int Med, 2007
For CLBP, Intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy, or progressive muscle relaxation (PMR). However, the guideline authors and others expressed concern that the effectiveness of these approaches had not yet been evaluated in primary care settings and, thus placed this recommendation at a lower tier (weak recommendation, moderate evidence) in comparison, for example, to prescribing NSAIDS.
LEVEL OF EVIDENCEAMERICAN COLLEGE OF PHYSICIANS
AND AMERICAN SPINE SOCIETY GUIDELINES
Chou, Quaseem, Snow, Cassey, Cross, Sheckle. Ann Int Med, 2007
However, Guideline authors and others expressed concern that
the effectiveness of these approaches had not yet been evaluated in primary care settings.
Placed this recommendation at a lower tier (weak recommendation, moderate evidence) in comparison, for example, to prescribing NSAIDS.
LEVEL OF EVIDENCEAMERICAN COLLEGE OF PHYSICIANS
AND AMERICAN SPINE SOCIETY GUIDELINES
Chou, Quaseem, Snow, Cassey, Cross, Sheckle. Ann Int Med, 2007
GOAL OF OUR RESEARCH AND ITS METHODOLOGY
Examine CMT to see if merits higher level of evidence?Make new treatments available to offer CLBP patients.
Efficacy In controlled conditions, does a specific input result in a specific outcome?
EffectivenessDoes a treatment work in practice?
EffectBoth of these deal with effect.That is, what is the effect of X on Y?
The question is where and under what conditions?
EFFICACY AND EFFECTIVENESS
Studies to Demonstrate Clinically Meaningful
Signal
Intervention Development,
Refinement and
Standardization
Pilot Feasibility
Studies Intervention
Efficacy Studies with Appropriate
Comparison
Staged Process for DevelopingNon-Pharmacological Interventions
Iterative process
Dissemination & Implementation
Studies
Collaboration or Partnership with “Real-
World” Setting
Controlled Clinical Setting
From W Weber; NCCAM, May 16, 2012
Effectiveness or Comparative Effectiveness
Research
ExplanatoryWhat are the effects of an intervention under ideal circumstances?
Efficacy
PragmaticWhat are the effects of an intervention under usual circumstances where applied?
Effectiveness
EXPLANATORY VS. PRAGMATIC
“Among patients with angiographically-confirmed, symptomatic 70-99% stenosis of a carotid artery, can the addition of carotid endarterectomy (performed by an expert vascular or neurosurgeon with an excellent track record) to best medical therapy, vs. best medical therapy alone, reduce the risk of major or fatal stroke over the next two years of rigorous follow-up?”(NASCET:NEJM 1991;325:445-53)
EXAMPLE OF AN EXPLANATORY TRIAL
From: http://support-collaboration.org/precis.pdf
AdvantageIf negative, you can abandon the treatment (it won’t work anywhere)
DisadvantageIf positive, you still don’t know whether it will work in usual health care conditions
EXPLANATORY TRIAL: PROS AND CONS
From: http://support-collaboration.org/precis.pdf
Among women at 12-32 weeks gestation whose clinicians thought they were at sufficient risk for pre-eclampsia or IUGR to be uncertain whether they should be prescribed low-dose aspirin, does simply prescribing aspirin (compared with placebo), and with no study follow-up visits, reduce the risk of a composite of bad outcomes for her or her baby?(CLASP:Lancet 1994;343:619-29)
EXAMPLE OF AN PRAGMATIC TRIAL
From: http://support-collaboration.org/precis.pdf
PRAGMATIC TRIAL: PROS AND CONS
AdvantageIf positive, it really works and you can implement the treatment just about everywhere.
DisadvantageIf negative, you can’t distinguish a worthless treatment from an efficacious treatment that isn’t applied/accepted widely enough.
From: http://support-collaboration.org/precis.pdf
1. Participant eligibility criteria2. Intervention flexibility
i. Experimental interventionii. Comparison intervention
3. Intervention practitioner expertisei. Experimental intervention practitionerii. Comparison intervention practitioner
4. Follow-up intensity5. Primary trial outcome6. Compliance/Adherence
i. Participant to interventionii. Practitioner to study protocol
7. Analysis of the primary outcome
PRECIS DOMAINS/COMPONENTS
Each spoke is defined in terms of restrictions on an otherwise totally pragmatic trial.
The more restrictive the trial, the lower its PRECIS score; the lower its PRECIS score, the smaller the population for generalizability.
PRECIS SPOKES
Informed by : http://support-collaboration.org/precis.pdf
BASELINE RESULTS
Variable AllN=100*
PMRn=15 (%)
CMTn=85 (%)
Patient CharacteristicsAge (years)
Mean (SD)Range
Younger (<50)Older (50+)
51.4 (12.2)23-82
4753
53 (9.0)41-72
5 (33.3)10 (66.7)
51 (12.7)23-82
42 (49.4)43 (50.6)
GenderFemale 71 15 (100)** 56 (65.9)**
RaceNon-White 10 4 (26.7)** 6 (7.1)**
Duration of CLBP Interference
Mean Years (SD)Range
10.5 (8.9)0.3 – 40.0
8.0 (7.9)1.0-30.0
11.0 (9.1)0.25-40.0
Expected Improvement‡Mean (SD) 5.9 (2.1) 5.2 (2.7) 6.1 (2.0)
Expected Helpfulness‡Mean (SD) 6.9 (2.1) 6.2 (2.6) 7.1 (2.0)
PCP ReportedCLBP Severity†
Mean (SD)Range
6.1 (1.5)3-9
6.7 (1.1)5-8
6.0 (1.5)3-9
PCP Treatment Expectation Mean (SD)
Range7.9 (1.5)
4-107.9 (1.6)
5-107.9 (1.5)
4-10
Pain Related MedsMean Number (SD)
RangeOn Scheduled Medications
2.1 (1.4)0-744
1.9 (1.5)0-5
7 (46.7)
2.1 (1.4)0-7
37 (43.5)
Variable AllN=100*
PMRn=15 (%)
CMTn=85 (%)
Patient BMI (Missing=9)Mean (SD)
RangeObese
32.1 (7.4)
16.9-55.152 (57.1)
37.5 (8.6)**
23.2-53.69 (81.8)
31.3 (6.9)**
16.9 (55.1)43 (53.8)
OUTCOMESODI Score†
Mean Percent Disabled % (SD)
Range
37.6 (15.2)10.0-78.0
42.3 (15.7)16-64
36.8 (15.1)10-78
SF-36 ‡±Physical Health Component Score
Mean (SD)Range
Mental Health Component Score
Mean (SD)Range
Bodily PainMean (SD)
Range
34.4 (8.8)16.9-52.7
44.7 (11.8)19.8-72.3
33.1 (6.6)21.7-51.5
32.3 (9.6)19.6-52.7
39.4 (8.3)21.1-52.3
30.5 (7.0)21.7-46.7
34.8 (8.7)16.9-51.8
45.6 (12.1)19.8-72.3
33.6 (6.4)21.7-51.5
Notes: *Percentages excluded due to redundancy (N=100). **Indicates statistical differences of >0.05. †Higher number indicates worse outcome. ‡Higher number indicates better outcome/higher expectation. ±Scores are normalized such that those above 50% are better than average and those below 50% are worse than average.
POST INTERVENTION RESULTS
Univatiate Paired t-tests for Baseline and V2 Differences: N=85
Notes: †Decrease in scores desired. ‡Increase in scores desired. ±Scores are normalized such that those above 50% are better than average and those below 50% are worse than average. * p ≤ 0.01
Outcome Variables Baseline Visit #2Mean Point Change
Score
Oswestry Disability Index (ODI) †
Mean (SD)
36.8 (15.1)
29.3 (16.5)
7.5* (10.6)
SF-36v2 (Components & Select Domain) ‡±
Physical Health Component Score
(missing=2) Mean (SD)
Mental Health Component Score
(missing=2) Mean (SD)
Bodily Pain
Mean (SD)
34.8 (8.7)
45.6 (12.1)
33.6 (6.4)
39.5 (10.4)
48.8 (9.7)
40.0 (9.0)
4.7* (7.0)
3.1* (8.7)
6.4* (8.6)
FREQUENCY OF MEANINGFUL CHANGE
Measure and Criterion n=85 (%)
Oswestry Disability Index (ODI)
ODI - Point Change
Change of ≥ 6
46 (54.1%)
SF-36v2
Physical Component
Score
Change of ≥ 3.8
46 (55.4%)
Mental Component Score
Change of ≥ 4.6
36 (43.4%)
Bodily Pain
Change of ≥ 5.5
42 (49.4%)
ODI: WHAT DOES CLBP WITH DISABILITY LOOKS LIKE…
ODI = 40% DisabilityPersonal care is normal but very painful.No sitting or standing > 1 hour.< 6 hours of sleep per night.Prevents any sex life at all.Normal social life but increases pain.Pain is bad when travels are > 2 hours.
ODI: WHAT CLINICAL BENEFIT LOOKS LIKE…
Starting with 40% disability – 30pt change and 75% improvement Normal but painful personal care to normal care with no pain. No sitting for more than an hour to sit in any chair as long as I like. No standing for more than an hour to standing as long as I like with no
pain. < 6 hours of sleep to my sleep is never disturbed by pain. No sex life at all due to pain to normal sex life with no extra pain. Normal but painful social life to normal, with no pain. Limited travels to can travel anywhere with some extra pain.
Starting with 54% disability – 14pt change and 26% improvement Pain intensity from severe to mild. Only lifting light to medium weights to heavy weights if conveniently
placed. Only walking 100 yards to walking ¼ mile. Severely restricted sex life to nearly normal but painful sex life. No 1+ hour journeys to can travel anywhere with some extra pain.
INFORMING NEXT STEPS
Starting point:
Outcome Measure
Below Normal at Baseline*
N=85Oswestry Disability Index (ODI) 83 (98%)SF-36 Physical Composite Score(missing=2)
68 (80%)
SF-36 Mental Composite Score(missing=2)
39 (46%)
SF-36 Bodily Pain Domain Score 83 (98%)
INFORMING NEXT STEPS
Outcome Measure
Reported Improvement
(Change score > 0) n (%)
Successful in Achieving Clinically Meaningful
Improvement n (%)
Below Normal at Baseline
n (%)
Transitioned from Below Normal to ≥
Normal @ TD2*n (%)
Oswestry Disability Index (ODI) 60 (71%) 46 (54%) 83 (98%) 12 (14%)SF-36 Physical Component Score (missing=2) 59 (69%) 45 (55%) 68 (80%) 17 (20%)
SF-36 Mental Component Score (missing=2) 55 (65%) 36 (43%) 39 (46%) 19 (22%)
SF-36 Bodily Pain Domain Score 54 (64%) 42 (49%) 83 (98%) 27 (32%)
Notes: * Frequency (%) for ODI scores of those who changed from ODI score of ≥ 12 at baseline to < 12 at TD2.
INFORMING NEXT STEPS
Outcome Measure
Successful in Achieving Clinically Meaningful
Improvement n (%)
Transitioned from Below Normal to ≥
Normal @ TD2*n (%)
SF-36 Mental Component Score
36 (92%) 19 (49%)
CONCLUSIONS/FUTURE PLANS
Demonstrated effectiveness research feasibility.
Larger study with more patient participants – clarify effectiveness and begin cost assessmentMental health w/ CLBPCLBP patients on scheduled medicationsMedical complexity and CLBP reflective of real world
R34/R01 Route: Feasibility (larger network/ patient complexity) - Implementation
THANK YOU!
Questions?
Acknowledgements:Maureen Flannery, MDDavid Green, MDMargaret Love, PhDGeza Bruckner, PhDKaren Roper, PhDKatie Stewart, BA, LMTKevin Pearce, MD
Contact:Bill Elder, [email protected]
NIH/NCCAM Grant #1R21AT004544-01A2