Translating Evidence into Practice The case of Neuroreflexotherapy in the

Translating Evidence into Practice

The case of Neuroreflexotherapy in the

Spanish National Health Service

Francisco Kovacs, MD, PhD

Spanish Back Pain Research Network

[email protected]

Neuroreflexotherapy Intervention (NRT)

Surgical single use, sterile material:• Dermic burins, fall out alone ≈ 10 days• Surgical staples, extracted at 90 days

Implantation of surgical material into the skin, to deactivate the neurons involved in Pain, Muscle Contracture and Neurogenic Inflammation

Without anesthesia, on an outpatient basis

To Practice

From Evidence

The Process: Implementing a Health Technology… in an “ideal world” scenario

RCT(s) vs. Placebo / “Sham”: Efficacy + Safety


RCT(s) vs. Existing Treatments: Effectiveness + Efficiency + Safety


Planning: Application Conditions + Surveillance

Mechanisms


Mechanisms

Generalization + Surveillance:Results + Optimization

+ Safety


+ Safety

Pilot:Feasibility + Safety


Review of EvidenceReview of Evidence

Med Clin (Barc) 1993; 101: 570-5, Spine1997;22:786-97

Spine 2002;27: 1149-1159

Cochrane Database of Systematic Reviews 2004;2:CD003009, Spine 2005;30:E148–53, Agencies for HTA: ISCIII; AATRM, Avalia-t 1996-2002 Scientific societies 1996-2002

INSALUD 2002Ib-Salut 2004, SESPA 2005, SMS 2007SERMAS 2008 CatSalut 2006-2010

Gaceta Sanitaria 2004;18:275–86

Health Policy 2006; 79:345-357 (Feasiblity + Results + Safety + Satisfaction)

Spine 2007;32:1621-1628 (prognostic factors for refinment of indication criteria)

The Implementation Processwhich NRT followed






Mechanisms


Mechanisms


+ Safety


+ Safety



Review of EvidenceReview of Evidence

RCTs and Review of EvidenceThe Cochrane Systematic Review:

RCTs and Review of EvidenceThe Cochrane Systematic Review:

Cochrane Database of Systematic Reviews 2004;2:CD003009

“The main finding of this review is that NRT appears to be a safe

and effective intervention for the short-term treatment of chronic

nonspecific LBP”

PlanningApplication conditions in the Spanish NHS

Application conditions consistent with those used in the RCTs:

Indication criteria = neck or back pain:

• ≥ 3 VAS points• ≥ 14 days • Not caused by fracture, systemic diseases or neurogenic

claudication due to lumbar spinal stenosis

Interventions performed:

• By certified physicians

• In Certified Units which incorporate:

o Mechanisms for quality control (% of missing data, time spent with patients, anonimous patients’ satisfaction survey, etc.)

o Standardized mechanisms for post-implementation surveillance

Standardized referral protocol from primary care

Pilot Study & Post-Implementation SurveillanceThe process

Independent analysis

Gac Sanitaria 2004;18:275–86 Health Policy 2006; 79:345-357 Spine 2007;32:1621-1628

Referral Intervention Discharge

Application conditions, consistent with those in RCTs All methods, previously validated and pilot tested

Pilot Study & Post-Implementation SurveillanceThe process

Independent analysis

• Age, gender• Duration of the

episode and time elapsed since first diagnosis

• Previous diagnostic tests and findings

• Previous treatments

• Pain (VAS)• Referred pain

(VAS)• Disability (RMQ,

NDI)• Results of

physical examination

Gac Sanitaria 2004;18:275–86 Health Policy 2006; 79:345-357 Spine 2007;32:1621-1628

Referral Intervention Discharge

• Appropriate-ness of referral

• Waiting time• Technical

characteristics of NRT intervention

• Skin sensitivity tests

• Immediate adverse events

• Tolerance to pain from implantation of the material

• Diagnostic tests

• Other treatments

• Number of NRT interventions

• Pain (VAS)• Referred pain

(VAS)• Disability

(RMQ, NDI)• Adverse

events

• Process duration

• Diagnostic tests• Physical

examination• Treatments• Pain (VAS)• Referred pain

(EVA)• Disability (RMQ,

NDI)• Patients’

satisfaction (anonymous patient satisfaction survey, 11 items)

• Rates (appropriate referral, refusal, re-intervention, etc.)

• Clinical evolution

• Prognostic factors

• Satisfaction:o Referring

physicianso Patient

telephone survey (random sample)

Application conditions, consistent with those in RCTs All methods, previously validated and pilot tested

Post-implementation SurveillanceAnalysis conducted by Health Authorities

Post-implementation SurveillanceMain results in the routine practice of the Spanish NHS

Gac Sanit 2004;18:275–86 , Health Policy 2006; 79:345-357, IX Intnal Forum on LBP Research 2007, Spine 2007;32:1621-1628

Effectiveness:

Organizational and economic results:

Appropriate referral from primary care: 95.5%

3 € for each euro invested3 Million per year / 1 Million inhabitants (constant 2007 €)

Safety:

Results consistent with those from previous RCTs and the Pilot Study

Significant reduction in the use of other Health Resources: Net savings

Pain Ref. Pain Disability

Median improvement of scores 87.5% 85.7% 92.0%

% of patients with clinically relevant improvement 92.2% 91.8% 92.1%

Referring physicians: 92.5% Patients: 95.8%

Satisfaction: would recommend NRT to a relative:

The Evidence:

Clinical and ethical aspects:

• Very few treatments have proven to be effective and safe for subacute and chronic low back pain

• NRT improves effectiveness of usual treatment (by between 289% and 636%)

Economic reasons:

• NRT improves cost/effectiveness (by between 1,385% and 2,180%)

• NRT saves 3 € for each euro invested, every year

• Estimated savings in Spain: 130 M €, every year

Feasibility:

• NRT has been successfully implemented in routine practice, in the application conditions in which it was assessed

• Consistent satisfactory results, across the Health Services where it has been implemented

Evidence suggests NRT should be generalized across the Spanish NHS

The Reality:

• The Balearic Islands

• Asturias

• Catalonia

NRT is currently implemented in only three regions within the Spanish National Health Service

Key Obstacles: Review of EvidenceIncongruities and double standards (1/2)

“NRT is only performed by a few highly trained

practitioners in Spain”

“NRT is only performed by a few highly trained

practitioners in Spain”

“No data are available on the ease and timeframe needed to achieve the

required level of expertise”

“No data are available on the ease and timeframe needed to achieve the

required level of expertise”

“Doubts remain on reproducibility of results...”

“Doubts remain on reproducibility of results...”

♦ Would it be better if performed by untrained individuals?

♦ Isn’t this common to all interventional procedures?

♦ What is wrong with Spain?

♦ Were these data requested for any other interventional procedures (surgery, CBT, injections, etc.)?

♦ In fact, education and training standards set by the corresponding Society are publicly available (www.AEMEN.es)

♦ Consistent results across: RCTs and routine clinical practice, different practitioners, Primary Care and Hospital settings, different geographical locations and Health Services

♦ … Is this still a “Spain issue”?

“Doubts remain on reproducibility of results

outside Spain”

“Doubts remain on reproducibility of results

outside Spain”

♦ Disability may be influenced by cultural factors, but differences in pain perception are mainly genetic. Are we suggesting that Spanish patients are genetically different from the French, Portuguese, Italians, etc.?

♦ Were similar doubts raised when psychological treatments for disability were assessed in Northern Europe (CBT, graded activity, etc.)?

“The principal investigator (who is also a leading NRT practitioner) was involved in all of the

published RCTs (albeit with different research

teams)”

“The principal investigator (who is also a leading NRT practitioner) was involved in all of the

published RCTs (albeit with different research

teams)”

♦ Would it have been preferable if no trained practitioner had participated in the design or conduction of the RCTs?

♦ All mechanisms to prevent the “principal investigator” from influencing results were put into practice:

• Conduction of RCTs, monitored by independent researchers from governmental agency

• Audit of tape recorded conversations with patients • He did not have access to recruitment, treatment

allocation, data or statistical analysis

Key Obstacles: Review of EvidenceIncongruities and double standards (2/2):

“Lack of clarity regarding scarring from staples”

“Lack of clarity regarding scarring from staples”

♦ Not requested for other procedures (e.g., surgery)

♦ Consistent results across RCTs, despite different practitioners, different research teams, and different settings

… What do we mean by “Scarring”?

Key Obstacles: Review of EvidenceLets put this comment into perspective…

NRT SURGERY

Key Obstacles: The Red TapeHow should NRT be generalized across the Spanish NHS? Two mechanisms are possible:

Option I. At the regional level: one region at a time

The decision is made in each region, and rolled out gradually across the 17 regions, one region at a time.

Option II. At the National level: all regions simultaneously

The decision is made in centrally, and rolled out across all 17 regions simultaneously

Each regional government

Key Obstacles: The Red TapeThe process at the regional level:

• Decides which health technologies it will cover

• May (or may not) request a report from its own “Agency for

Health Technology Assessment” or equivalent regional

Department

• If it requests a report, may (or may not) take recommendations

on board

The process must be repeated 17 times

Key Obstacles: The Red TapeThe process at the National level:

For non-pharmacological technologies (diagnostic or therapeutic), decisions on coverage must be approved by the National Health Board

National Health Board• Minister of Health • Regional Ministers of Health (17)• Senior officials of the Ministry (political appointments)


Committee for Coverage of Health Technologies• Politically appointed members (56, from national and

regional health ministries)



• Members can send subordinate (attendees vary)• Meeting agenda and docs provided 48 hrs. before meeting



regional health ministries)• Members can send subordinate (attendees vary)• Meeting agenda and docs provided 48 hrs. before meeting

Health Technology Assessment Agencies• Five HTA agencies in Spain• + Several regions with additional “micro”-versions

(“Assessment services”)• + One Directoriate in each of the 17 regions

?





regional health ministries)• Members can send subordinate (attendees vary)• Meeting agenda and docs provided 48 hrs. before meeting

Health Technology Assessment Agencies• Five HTA agencies in Spain• + Several regions with additional “micro”-versions

(“Assessment services”)• + One Directoriate in each of the 17 regions

?



Reports from HTA Agencies may or may not be requested by political entities

Conclusions may or may not be taken on board

Most reports, of poor quality (not peer-reviewed, not published)

Technical reports … or post hoc alibis for non-evidence based decisions?

Reports remain confidential (undisclosed)

Key Obstacles: The Red TapeExamples of rationale offered in some regions for delaying NRT:

“We cant implement this technology: it would reveal that the process we used for implementing the rest, is inadequate”

“Never innovate in times of crisis”

“The evidence is robust, but none of the private providers in this community would benefit from implementing this technology” (net saving per inhabitant per year: 3€ –Spine 2002;27:1149-1159-)

… once someone else does it first”

“The evidence is clearly in favor, so we will implement this technology

“If NRT reduces the need for surgery, it could vex orthopedic surgeons”

(satisfaction among physicians: 92.5%

-Gac Sanit 2004;18:275-86-)

“We should repeat the RCTs here, before applying this technology in our region”

“We can’t afford this technology”

(it costs 30% of the net savings it generates –Spine 2002;27:1149-

1159-)

”Have a think about whether we can set up a franchise for this technology together, in the public hospitals

of this region”








-Gac Sanit 2004;18:275-86-)




1159-)


of this region”









-Gac Sanit 2004;18:275-86-)




1159-)


of this region”


Evidence on safety and effectiveness:

Med Clin (Barc) 1993; 101: 570-5, Spine 1997;22:786-97 Spine 2002;27: 1149-1159, Cochrane Database of Systematic Reviews 2004;2: CD003009, Eur Spine J 2006;15:S192-299, Gac Sanit 2004;18:275–86 , Health Policy 2006; 79:345-357, IX Intnal Forum on LBP Research 2007, Spine 2007;32:1621-1628

“Authorization to use surgical staples on open wounds exists, but no authorization has been issued for use of staples on healthy skin”

Spanish Ministry of Health, 2011

Key Obstacles: The Red TapeRationale offered at the National level for delaying NRT:

Lessons learned from the NRT case:Assessing and implementing Health Technologies

♦ It is feasible for a non-pharmacological tecnology to be:

• Rigorously assessed (step-by-step process)

♦ It is feasible for a non-pharmacological tecnology to be:

• Rigorously assessed (step-by-step process)

• Implemented successfully in clinical routine practice, as long as:• Implemented successfully in clinical routine practice, as long as:

Application conditions are consistent with those in which it was assessed

Application conditions are consistent with those in which it was assessed

Post-implementation surveillance is implemented from the start Post-implementation surveillance is implemented from the start

Feasibility is test-piloted before implementation in routine practice Feasibility is test-piloted before implementation in routine practice

♦ Following this process leads to positive (health and economic) results in clinical practice

♦ Following this process leads to positive (health and economic) results in clinical practice

But, in practice, all of the above is useless if…

1. The law is irrational or disregards patients’ and taxpayers’ interests

2. Decision-makers lack the skills needed to make decisions

But, in practice, all of the above is useless if…

1. The law is irrational or disregards patients’ and taxpayers’ interests

2. Decision-makers lack the skills needed to make decisions

Improving the translation of research into practiceAspects on which researchers can act

♦ RCTs: Reject RCTs if they are clinically useless or misleading e.g.:♦ RCTs: Reject RCTs if they are clinically useless or misleading e.g.:

• Low quality• Low quality

♦ SRs:♦ SRs:

• Improve organizational efficiency (e.g. 3 years for reviewing 3 RCTs)• Improve organizational efficiency (e.g. 3 years for reviewing 3 RCTs)

• Prioritize clinical usefulness over academic interest or personal CV:• Prioritize clinical usefulness over academic interest or personal CV:

• Focusing on inappropriate comparisons (e.g., comparative effectiveness of procedures when neither has shown to be better than sham)

• Focusing on inappropriate comparisons (e.g., comparative effectiveness of procedures when neither has shown to be better than sham)

• Be consistent, avoid double standards (e.g. scarring, practitioners’ training)• Be consistent, avoid double standards (e.g. scarring, practitioners’ training)

“Nuances” to be addressed by further research, should not be used as an excuse for holding back evidence-based, applicable conclusions

“Nuances” to be addressed by further research, should not be used as an excuse for holding back evidence-based, applicable conclusions

Bring on board clinical wisdom (unbiased clinicians without vested interests) Bring on board clinical wisdom (unbiased clinicians without vested interests)

It is normal that future research will nuance or change conclusions: It is normal that future research will nuance or change conclusions:

Applicable conclusions based on the “best evidence which is available now”, is better than waiting for “perfect evidence” in an utopian world

Applicable conclusions based on the “best evidence which is available now”, is better than waiting for “perfect evidence” in an utopian world

Thank you!

Dr. D. Francisco M. Kovacs

Red Española de Investigadores en Dolencias de la Espalda (REIDE)Fundación Kovacs

www.REIDE.org www.kovacs.org

Documents

Translating Evidence into Practice The case of Neuroreflexotherapy in the