William G. Elder, PhD Niki Munk, PhD, LMT UK Family and Community Medicine IU School of Health and Rehabilitation Sciences KYPROS: A KAN STUDY METHODS,

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

KentuckY Pain Research Outcomes Studies

KYPROS

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

Practice Based Research&

KYPROS Methodology

OBJECTIVE 2

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:

Efficacy

WHAT FACTORS AFFECT TREATMENT CHOICE?

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.




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.




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


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


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.


PRECIS

PR pragmatic (to) E explanatory C continuum I indicator S summary

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

KYPROS MethodologyVia PRECIS Context

OBJECTIVE 2: CONTINUED

KYPROS PRECIS

KYPROS PRECIS: MT ONLY

Describe study results for benefit of treatment of CLBP patients

OBJECTIVE 3

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.

SECONDARY ANALYSIS:AGE DIFFERENCES

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%)


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.


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%)

SECONDARY ANALYSIS: STARTING POINT DIFFERENCES

Next Steps

OBJECTIVE 4

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

Documents

William G. Elder, PhD Niki Munk, PhD, LMT UK Family and Community Medicine IU School of Health and Rehabilitation Sciences KYPROS: A KAN STUDY METHODS,