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The Institute of Medicine (IOM) has defined clinical practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.”1
The overarching goals of guideline-based practice are to improve the quality, efficiency, and value of care delivery. Interest in guideline-based practice largely lies in well-known challenges to the U.S. healthcare system. Healthcare spending in the United States continues to grow, with the U.S. spending nearly 2.5 times more per capita on healthcare than any other developed country.
Despite this investment, care in the U.S. fails to produce superior outcomes with regard to life expectancy and disease-specific mortality when compared to other nations.2 There are numerous explanations for the observed disparities in healthcare costs between industrialized countries; however, many believe that the most important contributor to disproportionate spending is overutilization.3
Indeed, there is ample evidence to suggest that increased spending is inversely associated with various quality measures in numerous disease states.4,5
While overutilization is commonplace in the U.S. healthcare environment, in many disease states, including bladder cancer, underutilization is equally (if not more) common. Proponents of guideline-based practices believe that the routine incorporation of clinical practice guidelines will reduce variation in care by closing the gap on inappropriate delivery, whether over- or underuse.
Toward improving patient care
While clinical practice guidelines have been touted as a means to reduce cost and improve overall healthcare efficiency, one must not discount the level of patient benefits with guideline implementation. It is well known that the implementation of clinical practice guidelines improves both the process of care as well as observed outcomes in numerous disease states. Grimshaw and Russell reviewed 59 studies evaluating the effect of clinical practice guidelines and found that 55 of the 59 studies documented improvements in the process of care after guideline implementation.
Furthermore, nine of 11 studies evaluating outcome, documented improvements after guideline implementation.6 Addtionally, there is clear evidence in the surgical literature that guideline implementation improves outcomes. Stulberg et al. recently reported that adherence to the Surgical Care Improvement Project (SCIP) process-of-care improvement measures reduced the rate of surgical site infections (SSI) from 14.2 to 6.8 per 1,000 discharges.7 Berenguer et al. also reported significant reductions in SSI rates after colorectal surgery following the implementation of SCIP measures.8
Taken together, these data indicate that the implementation of clinical practice guidelines has the potential to directly improve both the processes and outcomes of patient care.
In addition, there are ancillary benefits to guideline-based practice that frequently go unrecognized. Many clinical guidelines offer lay versions that inform patients of treatment options as well as the expected risks and benefits associated with different therapies.
Practice guidelines also allow patients to make informed choices and to consider personal utility when evaluating diagnostic and therapeutic treatment paradigms.9 Finally, clinical practice guidelines may improve patient care by influencing healthcare policy, as they frequently improve public awareness of under-recognized diseases, preventative interventions, and other at-risk or high-risk groups.9
Shortcomings in development
Clinical practice guidelines have the ability to improve the quality of care at both the population and patient levels; however, there a number of shortcomings in the development and implementation of guidelines that deserve mention. Wolf et al. recently reviewed the development of clinical practice guidelines and discuss, in detail, the process of guideline development.10 Various organizations have published their specific process of guideline development, and each of these processes consists of some combination of evidence assessment and expert opinion.11-13
Unfortunately, there remains little high-quality evidence upon which to base guidelines. Harpole et al. evaluated the published guidelines for the management of lung cancer and found that only 53% of the lung cancer guidelines were evidence-based, and furthermore, only 29% of the recommendations furnished in these guidelines were evidence-based.14
More recently, Poonacha and Go studied the levels of evidence and consensus upon which National Comprehensive Cancer Network (NCCN) Guidelines are based and found a varied degree of high-quality evidence driving recommendations in the 10 most common cancers.15 One must consider the biases of those responsible for guideline development, which may affect the recommendations furnished by panels.
These biases can range from one scientist’s “stake” in a particular issue to a direct financial conflict of interest.16,17 To address many of these issues, the IOM recently released a report identifying standards for developing trustworthy clinical practice guidelines.18 Incorporating these standards into guideline development will hopefully result in improved transparency and, ultimately, improved implementation.