When a Clinical Guideline Is Problematic
When a Clinical Guideline Is Problematic
Editor's Note:
Many doctors believe that optimal patient care means closely adhering to the standard of care detailed in clinical practice guidelines (CPGs) issued by their specialty societies, a practice assumed to be universally accepted and therefore ironclad protection against a lawsuit for medical malpractice. Not so, as a recent Medscape article by a physician and attorney pointed out. "The most judicious use of guidelines is to treat them as general outlines subject to change as our knowledge of medicine evolves, rather than as strict directives of medical diagnosis and management," the author wrote.
With that perspective, Medscape explored the thinking behind the American Academy of Orthopaedic Surgeons' (AAOS) decision to update its 2008 CPG on knee osteoarthritis (OA) in 2013, 2 years early, and its importance for orthopedists today.
CPGs are typically revised every 5 years. That's what the National Guideline Clearinghouse, maintained as a public resource by the Agency for Healthcare Research and Quality (AHRQ), recommends to specialty societies. This is to give them adequate time to evaluate and incorporate new evidence since their previous guidelines were issued for the treatment of various clinical conditions.
That's what the AAOS did in 2008, when the academy revised its previous CPG on knee OA. The subsequent revision was due to begin 5 years later, in 2013, when new evidence that had accumulated since the 2008 guideline was issued was to be reviewed and evaluated—an elaborate process with many stakeholders that can take 1.5-2 years.
However, the AAOS began the updating process—including developing new standards for what the academy considered acceptable evidence—3 years early, in 2010. Its literature review eventually spanned March 2010 through March 2012. Final recommendations went to the vote on August 25, 2012, and the updated guideline was published in 2013.
What prompted the expedited update? AAOS members were concerned about the methodology used for the 2008 CPG, and higher-quality data had become available that had important implications for the recommendations, David S. Jevsevar, MD, MBA, chair of AAOS's Committee on Evidence-Based Quality and Value, which oversees the development of CPGs, told Medscape.
The 2008 guideline was based in part on previous systematic reviews, including the AHRQ evidence report "Treatment of Primary and Secondary Osteoarthritis of the Knee"; the Osteoarthritis Research Society International guidelines; and the Cochrane Database of Systematic Reviews.
However, Dr Jevsevar, who is interim chair of the Department of Orthopaedics at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, said that the 2013 update reflected the AAOS's current policy not to use previous systematic reviews in evidence analysis. He added that the earlier approach had been plagued by significant variability in the included studies, uncertain clinical applicability of the previous reviews, and an additional potential for bias with regard to how studies were selected for inclusion in a systematic review.
Dr Jevsevar said that the AAOS updated search inclusion criteria for selecting studies to include in systematic reviews and guideline development included:
"Studies showing potential efficacy at 2 weeks after the intervention were not included in the update," Dr Jevsevar said.
The AAOS guideline committee reviewed more than 10,000 separate pieces of literature during evidence analysis and used only higher-quality evidence in the meta-analysis that produced the 2013 update.
The proposed guideline was then reviewed by peer reviewers representing multiple specialty societies. Among them were the American Academy of Family Physicians; American Association of Hip and Knee Surgeons; Arthroscopy Association of North America; American Orthopaedic Society for Sports Medicine; American Academy of Physical Medicine and Rehabilitation; American Physical Therapy Association; Eastern Orthopaedic Association; Orthopaedic Trauma Association; Arthritis Foundation; Knee Society; American College of Sports Medicine; Southern Orthopaedic Association; Mid-America Orthopaedic Association; and Western Orthopaedic Association.
Editor's Note:
Many doctors believe that optimal patient care means closely adhering to the standard of care detailed in clinical practice guidelines (CPGs) issued by their specialty societies, a practice assumed to be universally accepted and therefore ironclad protection against a lawsuit for medical malpractice. Not so, as a recent Medscape article by a physician and attorney pointed out. "The most judicious use of guidelines is to treat them as general outlines subject to change as our knowledge of medicine evolves, rather than as strict directives of medical diagnosis and management," the author wrote.
With that perspective, Medscape explored the thinking behind the American Academy of Orthopaedic Surgeons' (AAOS) decision to update its 2008 CPG on knee osteoarthritis (OA) in 2013, 2 years early, and its importance for orthopedists today.
A Concern About Methodology
CPGs are typically revised every 5 years. That's what the National Guideline Clearinghouse, maintained as a public resource by the Agency for Healthcare Research and Quality (AHRQ), recommends to specialty societies. This is to give them adequate time to evaluate and incorporate new evidence since their previous guidelines were issued for the treatment of various clinical conditions.
That's what the AAOS did in 2008, when the academy revised its previous CPG on knee OA. The subsequent revision was due to begin 5 years later, in 2013, when new evidence that had accumulated since the 2008 guideline was issued was to be reviewed and evaluated—an elaborate process with many stakeholders that can take 1.5-2 years.
However, the AAOS began the updating process—including developing new standards for what the academy considered acceptable evidence—3 years early, in 2010. Its literature review eventually spanned March 2010 through March 2012. Final recommendations went to the vote on August 25, 2012, and the updated guideline was published in 2013.
What prompted the expedited update? AAOS members were concerned about the methodology used for the 2008 CPG, and higher-quality data had become available that had important implications for the recommendations, David S. Jevsevar, MD, MBA, chair of AAOS's Committee on Evidence-Based Quality and Value, which oversees the development of CPGs, told Medscape.
The 2008 guideline was based in part on previous systematic reviews, including the AHRQ evidence report "Treatment of Primary and Secondary Osteoarthritis of the Knee"; the Osteoarthritis Research Society International guidelines; and the Cochrane Database of Systematic Reviews.
However, Dr Jevsevar, who is interim chair of the Department of Orthopaedics at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, said that the 2013 update reflected the AAOS's current policy not to use previous systematic reviews in evidence analysis. He added that the earlier approach had been plagued by significant variability in the included studies, uncertain clinical applicability of the previous reviews, and an additional potential for bias with regard to how studies were selected for inclusion in a systematic review.
More Stringent Criteria for Selecting Studies
Dr Jevsevar said that the AAOS updated search inclusion criteria for selecting studies to include in systematic reviews and guideline development included:
Minimum sample size of 30 participants to limit the "small-study" effect of lower-powered clinical trials and to reduce the risk for publication bias; and
Minimum follow-up period of at least 4 weeks.
"Studies showing potential efficacy at 2 weeks after the intervention were not included in the update," Dr Jevsevar said.
The AAOS guideline committee reviewed more than 10,000 separate pieces of literature during evidence analysis and used only higher-quality evidence in the meta-analysis that produced the 2013 update.
The proposed guideline was then reviewed by peer reviewers representing multiple specialty societies. Among them were the American Academy of Family Physicians; American Association of Hip and Knee Surgeons; Arthroscopy Association of North America; American Orthopaedic Society for Sports Medicine; American Academy of Physical Medicine and Rehabilitation; American Physical Therapy Association; Eastern Orthopaedic Association; Orthopaedic Trauma Association; Arthritis Foundation; Knee Society; American College of Sports Medicine; Southern Orthopaedic Association; Mid-America Orthopaedic Association; and Western Orthopaedic Association.
