Scope and purpose of the clinical practice guideline
The scope of these clinical guidelines aims to demonstrate evidence-based practices to Prevent Dangerous Surgical Site Infections and Avoid Antibiotic Resistance (Bratzler et al., 2013). These guidelines are meant to provide healthcare workers with a consistent approach to “logical, safe and efficient use of antimicrobial agents for the elimination of surgical-site infections (SSIs) by considering the currently available clinical evidence and other emerging challenges” (Bratzler et al., 2013, p. 195).
The CDC noted that surgical site infections are critical sources of health challenges for healthcare facilities and patients. Surgical site infections are most likely to take place in every 100 procedures and contribute to significant rates of mortality. Such infections contribute to hospital-acquired infections and related morbidity, mortality, and additional costs for the affected patients.
The new guidelines contain significant improvements on the previous clinical practices, and they were developed to assist healthcare professionals to ascertain the optimal antimicrobial usage to aid in inhibiting infections in patients undergoing surgical procedures. These clinical guidelines were developed through a multidisciplinary, professional panel by relying on evidence-based strategies, and they accounted for aspects of reliability, validity, and clinical use of available studies. The new guidelines have replaced the previous versions of “the American Society of Health-System Pharmacists (ASHP) on therapeutic, which were first published in 1992 and revised seven years later” (Bratzler et al., 2013, p.195). In addition, they have also replaced other versions from IDSA and SIS.
Prophylaxis is the prevention of infections, and there are primary prophylaxis, secondary prophylaxis, and eradication (Bratzler et al., 2013). The primary prophylaxis focuses on “the prevention of the first infection” (Bratzler et al., 2013, p. 195). On the other hand, secondary prophylaxis focuses on the prevention of subsequent or reactivation of previously existing infections while eradication concentrates on complete removal of a colonized organism to inhibit potential infections. The guidelines have been developed for primary perioperative prophylaxis (Bratzler, 2013).
Stakeholder involvement
The guidelines were developed through a consultative process. Four various bodies, including the American Society of Health-System Pharmacists (ASHP), the Infectious Diseases Society of America (IDSA), the Surgical Infection Society (SIS), and the Society for Healthcare Epidemiology of America (SHEA) formed a panel that developed these guidelines (Bratzler et al., 2013).
Members of these four professional bodies were selected to form a panel of experts created to ensure that final guidelines were reliable, valid, and could be utilized.
To facilitate the role of the panel in developing these guidelines, “the University of Pittsburgh School of Pharmacy and Medical Center Drug Use and Disease State Management Program were the project researchers and project writers” (Bratzler et al., 2013, p. 197).
Members of the panel and contractors from the university had to “declare any potential conflicts of interests before undertaking any role in the study and during the guideline development stages” (Bratzler et al., 2013, p. 195).
The document was drafted to cover specific surgical procedures for further review by an expert panel. It was later revised, submitted for public comments and inputs through the ASHP Web site. The guidelines were later revised to account for submitted comments from reviewers. The expert panel and boards of directors from all four organizations approved the final guidelines.
Rigor of Development
As previously mentioned, the four above-mentioned organizations formed a panel of experts to develop the guidelines. In addition, various stages that accounted for the development have been mentioned in the previous section. On this note, the rigor of development for these guidelines is reflected in the strength of evidence and grading of different recommendations made by the panel of experts.
To make these guidelines more effective, the panel of experts reviewed the literature previously used to develop the replaced guidelines on Antimicrobial Prophylaxis in Surgery. In addition, they also evaluated literature published between the year 1999 and 2010. Literature was obtained from a database such as “MEDLINE, the Cochrane Database of Systematic Reviews and the EMBASE” (Bratzler et al., 2013, p. 198). Specifically, the panel of experts focused on study designs, but with the greatest attention paid to randomized, controlled, double-blind studies (Bratzler et al., 2013). During the literature review, the panel of experts observed that few available randomized studies that focused on the efficacy of antimicrobial prophylaxis in surgical procedures were available. Thus, the new guidelines had to account for “validity, reliability, clinical applicability, flexibility, clarity, and a multidisciplinary nature as consistent with ASHP’s philosophy on therapeutic guidelines” (Bratzler et al., 2013, p. 195).
These guidelines also accounted for limitations observed in the evidence base used. For instance, all areas evaluated in the guidelines have been assessed for evidence of weakness. In addition to published literature, the panel of experts also reviewed other available guidelines that focus on the same issue. Some of these guidelines included “American College of Obstetricians and Gynecologists [ACOG]) and noted general guidelines (e.g., Centers for Disease Control and Prevention [CDC], Scottish Intercollegiate Guidelines Network, Medical Letter, SIS, SHEA/IDSA)” (Bratzler et al., 2013, p. 195).
Therefore, all recommendations made for the use of antimicrobial prophylaxis were based on the strength of the available evidence from various sources. It also showed the strength of evidence for or against prophylaxis and not any other factors related to dose, dose regimen, and the antimicrobial agent.
Significant limitations of the used literature on antimicrobial prophylaxis have impaired abilities to understand imperative variations in “effectiveness between prophylactic antimicrobial agents and controls because of differences in study designs and low rates of usability for many procedures” (Bratzler et al., 2013, p. 195). In addition, sample variations may affect outcomes through a Type II error. As a result, it can be difficult to notice any differences between “the antimicrobial agent and placebo when indeed the antimicrobial has a positive effect” (Bratzler et al., 2013, p. 196).
It is imperative to note that recommendations for prophylaxis for some specific cases depend on the severity of conditions of postoperative infection and therefore precautionary interventions are required even without evidence from studies. In this case, infected devices are of important consideration.
Recommendations for these clinical guidelines were meant to enhance patient care outcomes (Smith & Dahlen, 2013). These clinical guidelines are effective because they are informed by a thorough review of available studies from various sources. Further, they present both benefits and drawbacks of different care options.
Nursing clinical practice guidelines provide defined best practice modalities that assist nurses in “the diagnosis, management, or prevention of specific healthcare conditions while including recommendations that are derived from the highest levels of evidence” (Smith & Dahlen, 2013, p. 241). These levels of evidence include high-quality systematic reviews of current literature, meta-analyses, or well-designed clinical trials (Smith & Dahlen, 2013).
Recommendations
Recommendations for the use of the guidelines were made for the application of antimicrobial prophylaxis based on the strength of evidence used. For the recommendations, the supporting studies were based on “level 1 to level 7 with various forms of study designs and experts’ opinions” (Bratzler et al., 2013, p. 196).
Recommendations account for all patients. Both adult (age 19 years and over) and pediatric (age 1–18 years) patients are considered in these guidelines (Bratzler et al., 2013, p. 198). However, the guidelines do not specifically provide any provisions for “the newborns, both premature and full-term infants” (Bratzler et al., 2013, p. 198).
The guidelines were developed to be used in clinical settings. Healthcare workers however must use their judgment to support decisions that follow recommendations about “individual patient condition and resources available for interventions” (Bratzler et al., 2013, p. 198).
The guidelines only show current knowledge of antimicrobial prophylaxis in surgery and therefore it is imperative to engage in “further research, periodic reviews, revisions updates and finally consider influences of scientific information and technologies” (Bratzler et al., 2013, p. 198).
In addition, the panel of experts also identified common processes and evidence applied in other procedures. Consequently, there were recommendations with other possible alternatives, particularly when the experts could not have a common opinion.
Implementation / Application
The guidelines are intended to be used by healthcare workers in healthcare settings to support the use of evidence-based practices. On this note, they can be used for both pediatric and adult patients. However, these guidelines do not account for newborns and there are clear differences between recommendations for pediatric and adult patients. Clinicians must be responsible for the implementation and application of their guidelines in their specific clinical settings (Bucher, Warner, & Dillon, 2011). The guidelines are useful for supporting clinicians’ judgment for patient interventions. Implementations using various strategies have often resulted in favorable outcomes (Pantoja & Soto, 2014).
Some specific issues have been identified in these guidelines and they require immediate reviews (Odrobina & Grzybowski, 2013).
References
Bratzler, D. W., Dellinger, P., Olsen, K. M., Perl, T. M., Auwaerter, P. G., Weinstein, M. K… Robert, A. (2013). Clinical practice guidelines for antimicrobial prophylaxis in surgery. American Journal of Health-System Pharmacy, 70(3), 195-283.
Bucher, B. T., Warner, B. W., & Dillon, P. A. (2011). Antibiotic prophylaxis and the prevention of surgical site infection. Current Opinion Pediatrics, 23(3), 334-8.
Odrobina, D., & Grzybowski, A. (2013). Intracameral cefuroxime in the prophylaxis of postoperative endophthalmitis. Web.
Pantoja, T., & Soto, M. (2014). Clinical practice guidelines development and implementation: an introduction. Rev Med Chil., 42(1), 98-104.
Smith, M. A., & Dahlen, N. (2013). Introduction: NAON Surgical Site Infection Prevention Clinical Practice Guideline. Orthopedic Nursing, 32(5), 241.