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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 kovacs@kovacs.org. 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 kovacs@kovacs.org
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