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The combined annual meeting of the AAOS Outcomes Special Interest Group and the HWB Foundation, San Diego, 2007. The relative value of “all-inclusive” registries vs. Focused prospective clinical research of all designs - not just RCT's. Henrik Malchau Professor, MD, PhD.

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The combined annual meeting of the AAOS Outcomes Special Interest Group and the HWB Foundation, San Diego,2007

The relative value of “all-inclusive” registries vs.

Focused prospective clinical research of all designs - not just RCT's

Henrik Malchau

Professor, MD, PhD

Orthopaedic Biomechanics and

Biomaterials Laboratory

Massachusetts General Hospital


DisclosureResearch grants from:Biomet IncZimmer IncSmith&Nephew IncRSA Biomedical


AcknowledgmentAll co-workers in Sweden&MGH Orthopedic Staff & The Orthopedic Surgeons in Sweden


The Presentation

  • Introduction.

  • How the Register has changed the results of THR surgery in Sweden.

  • Registries in Sweden.

  • The Harris Joint Register @MGH.

  • Cost benefit of Registries

  • Conclusions.


Conclusion

  • In the (not too far) future Registries will be the main source of scientific information for decision support for both health administrators, physicians and patients in the field of reconstructive joint surgery.


HWB Mission Statement

  • "The mission of the HWB foundation is to find methods to routinely collect well-specified, structured and privacy-protected clinical data from reliable sources and make that data, in quantities of statistical significance, available in the public domain where it may be interpreted from all points of view."


We are all obliged to build the clinical

treatment on evidence based principles


Nothing ruins a good result as decent and long-term follow-up!


Evidence based medicine

  • Evidence based medicine and patient-derived outcomes assessment movements entered the scene in the 1980s and 1990s.

  • In the late 80s and early 90s critical research suggested that 40% of surgical procedures might be inappropriate and up to 85% of common medical treatments were not adequate validated.


The Mission

  • To improve the outcome of total hip replacement.

  • Quality control with focus on the procedure - not an implant register!


The Hypothesis

  • Feed-back of analysed data stimulates the participating clinics to reflect and improve in accordance with the principle of the good example.


The Internet has substantially facilitated

feedback of information

Available in English,

German, Italian, French,

Spanish and Swedish on: www.jru.orthop.gu.se


Base line (level I) Data

  • ID number (links to coming reoperations)

  • Gender, Age

  • Diagnose (ICD 10)

  • Implant details based on catalog numbers (scroll menu or barcode scanning).

  • Type of cement.

  • Type of incision & surgical technique.


Base line Data

  • Simple and easily available in the medical record.

  • Physician compliance hardly needed to report the data.


The Swedish THA Register1979 - 2005

  • 256.298 primary THR

  • 24.476 revision THR


Outcome results

  • The Swedish experience is based on all performance in the country.

  • In USA 50% of the primary THR procedures are done by surgeons performing < 10 THR's annually.

  • The scientific results are typically presented from centers of excellence with dedicated, high volume surgeons (HHS, Mayo, MGH) – often with innovators in key roles.


Logistics of the study

  • All departments in Sweden participate

  • The cohorts are the national production of primary and revision procedures.

  • The Registry is owned by the profession.


Failure definitions in Registries

  • Most commonly used is revision.

  • Patient satisfaction and patient reported outcome used in Sweden since 2002.

  • Radiographic outcome based on large cohorts soon possible with modern image analysis tools.


Epidemiology of THR in Sweden


The Swedish THA Register1979 - 2005


Results of individual units All patients 1979-1991

National average

1979-1991: (89,4%)

Proportion of units: Above 44%.

Below 19%.


Results of individual unitsAll patients 1992-2004

National average

1992-2004: (92,5%)

Proportion of units: Above 34%.

Below 13%.


The “National result” improved to 92.5% survival @ 12 years

-all comers and cement!!!


Revision burden (%):

Revision THA/

the total sum of primary and revision THA


Revision burden


Crude revision rate

(JBJS(Am) 87-A, July 2005, 1487-1497)

Prevalence of Primary and Revision Total Hip and Knee Arthroplasty in the United States From 1990 Through 2002

Kurtz S, Mowat F, Ong K,Chan N, Lau E, and Halpern M.


Crude revision rate

(JBJS(Am) 87-A, July 2005, 1487-1497)

Prevalence of Primary and Revision Total Hip and Knee Arthroplasty in the United States From 1990 Through 2002

Kurtz S, Mowat F, Ong K,Chan N, Lau E, and Halpern M.


We need Registries as an instrument to monitor performance.


In SwedenThe Sulzer/Centerpulse experience

This problem was identified

@ 8 month by the Register


In USAThe Sulzer/Centerpulse experience

This problem could have been identified

@ 4-6 month by a Register


Research opportunitiesCohort studies – “PhD projects”

  • Periprosthetic fractures

  • Primary infection

  • Re-revisions

  • Below 50


The Clinical Value Compass

Patient Satisfaction

Functional

Health

QoL

Clinical

Outcome

Cost and Utility

Batalden and Nelson,

Dartmouth Medical School.


  • Outcome that matters most

    • To patients

      • pain relief and satisfaction?

    • To health care providers

      • Cost?

    • To surgeons?

      • Documentation, follow up and evidence/result??


The Clinical Value Compass

Hypothesis

  • The Registry concept with added patient reported outcome data can potentially improve the overall process and all dimensions in the “compass”.

  • We can even perform cost-utility studies based on large cohorts.


Registries in Sweden

  • Based on the experience from the Hip Register more than 50 registries has been established in the past 15 years


Registries in Sweden

  • Cardiac

    • AMI, Bypass, pacemaker, “Heart surgery”, Stroke.

  • Diabetes

    • PCP treatment, complications.

  • Surgery

    • Vascular, Hernia,


Effect of Registries in Sweden

  • Decreased mortality after AMI and less variance among the units.

  • 50% reduction in reoperations after surgery for hernia.

  • Decreased mortality and less morbidity after stroke.

  • Significant reduction of diabetes complications.


World Progression of National Registries

Before 1975


1978 to 1987

Sweden, Finland, Norway


1988 to 1997

Denmark, New Zealand


1998 to 2003

Hungary, Australia, Canada, Romania


2003 to Present

Czech Republic, Turkey, Slovakia, Moldova, Austria, England, Wales, France, Germany(?), USA(?), Holland !


Resurfacing THA

“New” Procedure with Unanswered Questions

Short Term – Intermediate F/U Studies

More Difficult Surgical Procedures

Higher Complication Rate vs. THA

Patient selection issues


Resurfacing for the young?Revision rates by age and gender The Australian Register


Cumulative Revision in conventional Primary THR and Resurfacing Hip The Australian Register 2005


Can we obtain the needed statistical power in a conventional longitudinal study??


Harris Joint Registry @ MGH (HJR)


Outcome analyses engine @ MGH

  • IRB approved data repository at MGH.

  • Web based system collecting clinical

  • and radiographic data semi automatically.


www.jointoutcomes.org/pv


Harris Joint registry @ MGH interfaces to

  • OR scheduling (MOSAIC)

  • Anesthesia database (SATURN)

  • Longitudinal Medical Record (LMR)

  • Research Patient Data Registry (RPDR)

  • Radiology image repository (AMICAS)

  • Patient reported outcome

Patient data, medical records and radiographs available

in one data base for simultaneous review


Patient reported outcome

  • Touch-screen entry for questionnaires

    • Patients can enter questionnaires by touch-screen when they come for a clinic visit

  • Online Questionnaires

    • Patients can enter questionnaires through the Internet at home

  • Conventional paper forms


Minimize manual data entry

  • Less than 10 percent of the data will be entered manually


Projects

  • The Shoulder, Spine, Sports and Tumor services @ MGH in different stages of incorporation.

  • A state-wide register in Virginia in pilot-phase.

  • Two Industry partners:

    • Monitoring clinical multicenter studies.


There should be NO alternatives to the principles of

Evidence based Medicine


Governments have already

started to implement physician

reimbursements based on

Evidence

Netherlands, Scotland, England, Canada

Japan, Germany, Switzerland

at least for some treatment methods for a

few common disorders


Evidence Based Medicine alternatives

Eminence Based Medicine

-used by senior colleagues with ”experience"

- same mistakes again & again


Evidence Based Medicine alternatives

Nervousness Based Medicine

-fear of litigation stimulates over investigation

and over treatment


Evidence Based Medicine alternatives

Market Based Medicine

-believing what the ads tell you


Evidence Based Medicine alternatives

Profit Based Medicine

-needs no explanation


Evidence Based Medicine

  • Therefore - in order to:

    • - Globalize Evidence

  • - Localize decisions

  • - Improve information

  • - Reward proper care

  • Report to your regional/national Registry


  • Potential US “savings” Initiate a Register

    • For each percent lower (from 17.6%) the direct cost savings are estimated to $42.5 million - $112.6 million per year

    • A 10% reduction (to the Swedish level) could save $ 1 billion annually!

    Kurtz et al: NHDS data, JBJS (Am), 2005


    Conclusion

    • For the healthcare providers the potential is large savings.

    • For the patient optimal treatment modalities can be identified.

    • For the professional community the research potential is obvious.


    Take home message

    • In the (not too far) future Registries will be the main source of scientific information for decision support for both health administrators, physicians and patients in the field of reconstructive joint surgery.


    Thank You!

    Orthopaedic Biomechanics and

    Biomaterials Laboratory

    Massachusetts General Hospital


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