Published 6/1/2009
Michael W. Keith, MD

What do we do while waiting for clinical standards?

The nature of orthopaedic quality is changing

Orthopaedic surgeons are assessing and improving our professional practice quality. Clinical research has shown the impact of errors in medical training, management, record keeping, drug dispensing, medical decision making, and system-wide disparities. As a result, payors, governmental regulators, industry programs, and others interested in controlling healthcare costs have focused on eliminating reimbursement for poor quality care as the first step in optimizing the national healthcare budget.

Healthcare costs now consume an unprecedented percentage of the U.S. gross domestic product. They are blamed for undermining the stability of industry, employee retirement plans, and international competitiveness. In such a milieu, the justification for optimizing the clinical part of the payment formula seems clear.

Orthopaedics and quality measures
The elimination of waste, redundancy, error, bureaucratic overhead, and practice costs due to litigation expenses and insurance can bring opportunities to invest in better professional education and modern medical electronic records, leading to better outcomes for patients. As a profession, orthopaedics has always been invested in quality measurement activities and has developed many of the most widely used and translated quality instruments.

The clinical knowledge paradigm is changing. Once, the historical knowledge passed on through experience and hands-on fellowship training was the gold standard for education. Now, evidence-based decision support, high quality literature studies, and clinical practice guidelines are seen as the best ways to disseminate information and reduce bias. Often, the same authors and thought leaders are involved, but in a wider forum.

Two things are needed now—direction regarding studies to be done and funding to get them completed so that they meet the highest standards for review and inclusion in guidelines, performance measures, and clinical quality indicators.

Orthopaedic surgeons can no longer tolerate the regional differences in the kind and quality of health care identified by the Dartmouth Atlas of Health Care nationally based payors, and the federal government. We must rely on stronger methodologies for analyzing medical evidence from prospective, multicenter clinical trials. We must raise the standards of study design and expect international impact from our work.

Also significant is the fact that payors make benefit determinations from the evidence base and reference clinical practice guidelines. Unless specialty societies contribute quality assessments on disease diagnosis and therapeutics, management, health technology assessment, and surgical procedure approval, these decisions might become strictly financially driven. A high quality evidence base is the best defense against arbitrary discounting.

The changing clinical paradigm
As the focus shifts to addressing the root causes of unhealthiness rather than the subdivided diseases and injuries that derive from them, healthcare systems can have a larger impact by intervening earlier in the disease process.

For example, the World Health Organization has changed its International Classification of Functioning, Disability, and Health to reflect the impact of disease in a societal context rather than focusing on the individual organ or system level. Using this viewpoint, the elimination of landmines will help reduce the number of amputations.

The clinical evaluation paradigm is changing as well. Clinical studies are expected to include outcomes data, representing the point of view of the patient/customer in the evaluation of the effect of surgical care.

Expert panels, using standardized protocols for evidence analysis, assemble outcome studies into clinical practice guidelines. Published guidelines represent strong decision support that complements good classical training, mentoring, and experience.

Unfortunately, recommendations are not always built solely on the best designed studies and evidence, because not enough exists. Today’s standards still depend on less stringent levels of evidence and expert opinion. A major objective of the quality movement is to identify research opportunities and recommend new research directions that will lead to high quality evidence.

Guidelines and government
Surgical procedures are being scrutinized by the scientific means previously reserved for drugs and devices seeking approval from the U.S. Food and Drug Administration. High quality studies can be designed to establish the level of “comparative effectiveness” between alternative methods of achieving a good clinical outcome.

Guidelines are being used to write “performance measures,” quality indicators of practitioner adherence to patient management techniques that provide the best clinical outcomes. Payors and government are experimenting with structuring professional compensation and rewarding practice performance through incentives to the best quality practitioners.

Through participation in the Physician Consortium for Performance Improvement, the AAOS and the American Medical Association are setting the standards for intervention. The National Quality Forum has endorsed incentives for physician performance. A recent Institute of Medicine report endorses pay for performance (P4P) leverage. The American Quality Alliance is seeking to speak as a leadership voice for all surgeons regarding quality programs.

Studies geared to measuring efficiency (the ratio of outcomes or benefit to cost) help determine which best practices deliver cost savings.

Studies of the impact of healthcare policy evolution are needed to continue to justify the costs of regulation to achieve these paradigm changes. For example, in the area of electronic medical records (EMR), the voluntary Doctor’s Office Quality–Information Technology initiative, the Physician Quality Reporting Initiative within the Centers for Medicare & Medicaid Services, the Leapfrog Group, and the Premiere P4P programs have been initiated to demonstrate the quality improvement value of EMRs and to measure reporting quality. Under the American Recovery and Reinvestment Act, the federal stimulus program provides direct financial incentives for practitioners to adopt an EMR in the next several years.

We, the AAOS membership, can take the responsibility to be the originators of quality measurement standards by leading the way in defining and incentivizing quality in education, clinical research, clinical practice, and legislation. The creation and adoption of national standards are not finished.

The cost of creating each step of this quality process is daunting and largely uncompensated. Nonetheless, the volunteer contributions of surgeons in study design, evidence analysis, publication of studies, and dissemination of guidelines, performance measures, or other clinical standards are growing. Both regulation and the pressure of surgical specialty societies will continue to support this growth. The focus of quality rewards will be directed to those groups that are making the effort to show their programs work at the highest levels of organization and academic sophistication.

The challenge will be in implementing practice-level versions of these new standards. They are under construction, and now is the time to be influential. I urge the AAOS fellowship to continue supporting efforts to keep the orthopaedic surgeon at the forefront of quality improvement and to recognize the impact of these paradigm shifts in their professional lives and the national economy.

Additional References:

Dartmouth Atlas of Health Care

AAOS Clinical Practice Guidelines

Institute of Medicine

Library of Congress

Michael W. Keith, MD, is chair of the AAOS Evidence-Based Practice Committee and an ex-officio member of the AAOS Guidelines Oversight Committee. He can be reached at mwk4@case.edu

AAOSClinical Practice Guidelines
The following clinical practice guidelines have been developed and approved by the AAOS:

  • Guideline on the Treatment of Osteoarthritis (OA) of the Knee
  • Guideline on the Treatment of Carpal Tunnel Syndrome
  • Guideline on the Diagnosis of Carpal Tunnel Syndrome
  • Guideline on the Prevention of Pulmonary Embolism

Clinical practice guidelines in the following areas are currently in development:

  • The Treatment of Pediatric Diaphyseal Femur Fractures
  • The Treatment of Glenohumeral Joint Osteoarthritis
  • The Treatment of Distal Radius Fractures
  • The Diagnosis and Treatment of Achilles Tendon Rupture
  • The Diagnosis and Treatment of Periprosthetic Infections of the Hip and Knee
  • The Treatment of Insufficiency/Compression Fractures of the Spine
  • The Treatment of Osteochondritis Dissecans
  • The Surgical Treatment of Ankle Arthritis

For more information on clinical practice guidelines, visit www.aaos.org/guidelines