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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).

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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)

  • 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

  • Surgical single use, sterile material:

    • Dermic burins, fall out alone ≈ 10 days

    • Surgical staples, extracted at 90 days


The Process: Implementing a Health Technology

… in an “ideal world” scenario

RCT(s) vs. Placebo / “Sham”:

Efficacy + Safety

From

Evidence

RCT(s) vs. Existing Treatments:

Effectiveness + Efficiency + Safety

Review of Evidence

Planning:

Application Conditions + Surveillance Mechanisms

To Practice

Pilot:

Feasibility + Safety

Generalization + Surveillance:

Results + Optimization

+ Safety


The Implementation Process

which NRT followed

  • MedClin (Barc) 1993; 101: 570-5, Spine1997;22:786-97

RCT(s) vs. Placebo / “Sham”:

Efficacy + Safety

  • Spine 2002;27: 1149-1159

RCT(s) vs. Existing Treatments:

Effectiveness + Efficiency + Safety

  • 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

Review of Evidence

Planning:

Application Conditions + Surveillance Mechanisms

  • INSALUD 2002

  • Ib-Salut 2004, SESPA 2005, SMS 2007

  • SERMAS 2008 CatSalut 2006-2010

Pilot:

Feasibility + Safety

  • Gaceta Sanitaria 2004;18:275–86

  • HealthPolicy 2006; 79:345-357 (Feasiblity + Results + Safety + Satisfaction)

  • Spine 2007;32:1621-1628

  • (prognosticfactors for refinment of indicationcriteria)

Generalization + Surveillance:

Results + Optimization

+ Safety


RCTs and Review of Evidence

The Cochrane Systematic Review:


RCTs and Review of Evidence

The Cochrane Systematic Review:

  • “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”

  • Cochrane Database of Systematic Reviews 2004;2:CD003009


Planning

Application 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:

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

      • Standardized mechanisms for post-implementation surveillance

  • Standardized referral protocol from primary care


Pilot Study & Post-Implementation Surveillance

The process

  • Application conditions, consistent with those in RCTs

  • All methods, previously validated and pilot tested

Independent analysis

Referral

Intervention

Discharge

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


Pilot Study & Post-Implementation Surveillance

The process

  • Application conditions, consistent with those in RCTs

  • All methods, previously validated and pilot tested

Independent analysis

Referral

Intervention

Discharge

  • 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

  • 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:

  • Referring physicians

  • Patient telephone survey (random sample)

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


Post-implementation Surveillance

Analysis conducted by Health Authorities


Post-implementation Surveillance

Main results in the routine practice of the Spanish NHS

  • Results consistent with those from previous RCTs and the Pilot Study

  • Effectiveness:

Safety:

  • Skinirritation / infection: 3.3% Earlyextraction: 0.2%

  • Contact dermatitis: 1 case out of 162.678 patients

Satisfaction: would recommend NRT to a relative:

  • Referring physicians: 92.5% Patients: 95.8%

Organizational and economic results:

  • Appropriate referral from primary care: 95.5%

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

  • 3 € for each euro invested

  • 3 Million per year / 1 Million inhabitants (constant 2007 €)

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


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:

  • NRT iscurrentlyimplemented in onlythreeregionswithintheSpanishNationalHealthService

  • The Balearic Islands

  • Asturias

  • Catalonia


Key Obstacles: Review of Evidence

Incongruities and double standards (1/2)

  • Isn’t this common to all interventional procedures?

“NRT is only performed by a few highly trained practitioners in Spain”

  • Would it be better if performed by untrained individuals?

  • What is wrong with Spain?

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

“No data are available on the ease and timeframe needed to achieve the required level of expertise”

  • 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

“Doubts remain on reproducibility of results...”

  • … Is this still a “Spain issue”?

“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.)?


Key Obstacles: Review of Evidence

Incongruities and double standards (2/2):

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

“The principal investigator (who is also a leading NRT practitioner) was involved in all of the published RCTs (albeit with different research teams)”

  • 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

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

“Lack of clarity regarding scarring from staples”

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


Key Obstacles: Review of Evidence

Lets put this comment into perspective…

… What do we mean by “Scarring”?

NRT

SURGERY


Key Obstacles: The Red Tape

How 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


Key Obstacles: The Red Tape

The process at the regional level:

  • Each regional government

  • 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 Tape

The 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)


Key Obstacles: The Red Tape

The 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


Key Obstacles: The Red Tape

The 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

  • Health Technology AssessmentAgencies

  • Five HTA agencies in Spain

  • + Several regions with additional “micro”-versions (“Assessment services”)

  • + One Directoriate in each of the 17 regions

  • ?


Key Obstacles: The Red Tape

The process at the National level:

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

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

  • National Health Board

  • Minister of Health

  • Regional Ministers of Health (17)

  • Senior officials of the Ministry (political appointments)

  • Conclusions may or may not be taken on board

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

  • 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

  • Reports remain confidential (undisclosed)

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

  • Health Technology AssessmentAgencies

  • Five HTA agencies in Spain

  • + Several regions with additional “micro”-versions (“Assessment services”)

  • + One Directoriate in each of the 17 regions

  • ?


Key Obstacles: The Red Tape

Examples of rationale offered in some regions for delaying NRT:

  • “If NRT reduces the need for

  • surgery, it could vex orthopedic surgeons”

  • (satisfaction among physicians: 92.5%

  • -Gac Sanit 2004;18:275-86-)

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

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

  • “Never innovate in times of crisis”

  • “We can’t

  • afford this technology”

  • (it costs 30% of the net savings it generates –Spine 2002;27:1149-1159-)

  • “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-)

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

of this region”

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

… once someone else does it first”


Key Obstacles: The Red Tape

Examples of rationale offered in some regions for delaying NRT:

  • “If NRT reduces the need for

  • surgery, it could vex orthopedic surgeons”

  • (satisfaction among physicians: 92.5%

  • -Gac Sanit 2004;18:275-86-)

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

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

  • “Never innovate in times of crisis”

  • “We can’t

  • afford this technology”

  • (it costs 30% of the net savings it generates –Spine 2002;27:1149-1159-)

  • “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-)

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

of this region”

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

… once someone else does it first”


Key Obstacles: The Red Tape

Examples of rationale offered in some regions for delaying NRT:

  • “If NRT reduces the need for

  • surgery, it could vex orthopedic surgeons”

  • (satisfaction among physicians: 92.5%

  • -Gac Sanit 2004;18:275-86-)

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

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

  • “Never innovate in times of crisis”

  • “We can’t

  • afford this technology”

  • (it costs 30% of the net savings it generates –Spine 2002;27:1149-1159-)

  • “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-)

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

of this region”

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

… once someone else does it first”


Key Obstacles: The Red Tape

Rationale offered at the National level for delaying NRT:

  • “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

  • 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


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)

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

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

Decision-makers lack the skills needed to make decisions

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

  • Application conditions are consistent with those in which it was assessed

  • Post-implementation surveillance is implemented from the start

  • Feasibility is test-piloted before implementation in routine practice

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


Improving the translation of research into practice

Aspects on which researchers can act

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

  • Low quality

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

  • SRs:

  • Prioritize clinical usefulness over academic interest or personal CV:

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

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

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

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

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

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


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


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