Wk3 Critical Appraisal of Practice

Report the overall objective(s) of the guideline. The expected health benefits from the guideline are to be specific to the clinical problem or health topic.

COMMENTS: Rate 6

Nurses are not recognized and are underutilized in this program

Evidence-based guidelines for implementation and measurement of antibiotic stewardship interventions in inpatient populations including long-term care (Barlam et al, 2016). Wk3 Critical Appraisal of Practice

The purpose of this guideline is to comprehensively evaluate the wide range of interventions that can be implemented by ASPs in emergency department, acute inpatient, and long- term care settings as they determine the best approaches to influence the optimal use of antibiotics within their own institutional environments. In addition, this guideline addresses approaches to measure the success of these interventions (Barlam et al, 2016).

The guidelines emphasize the importance of physician and pharmacist leadership for an ASP, the need for infectious diseases expertise, and the role of measurement and feedback as critical components of ASPs (Barlam et al, 2016).

Expected benefit(s) or outcome(s)

The benefits of antibiotic stewardship include improved patient outcomes, reduced adverse events including Clostridium difficile infection (CDI), improvement in rates of antibiotic susceptibilities to targeted antibiotics, and optimization of resource utilization across the continuum of care (Barlam et al, 2016).

Target(s) (e.g., patient population, society

Health Professionals in the following areas: internal medicine, emergency medicine, microbiology, critical care, surgery, epidemiology, pharmacy, and adult and pediatric infectious diseases specialties (Barlam et al, 2016).

Report the health question(s) covered by the guideline, particularly for the key recommendations.

COMMENTS: 7

Antibiotic stewardship is strongly needed in all health care settings

Guideline for Implementing an Antibiotic Stewardship Program in inpatient populations including long-term care (Barlam et al, 2016).

3. POPULATION

Describe the population (i.e., patients, public, etc.) to whom the guideline is meant to apply.

COMMENTS: Rate 7

For Health care professionals who work with inpatient populations including long-term care (Barlam et al, 2016).

Report all individuals who were involved in the development process. This may include members of the steering group, the research team involved in selecting and reviewing/rating the evidence and individuals involved in formulating the final recommendations.

COMMENTS: Rate 6

Nurses are not recognized and are underutilized in this program

· Discipline/content expertise

· Institution

· Geographical location

· A description of the member’s role in the guideline development group

Evidence-based guidelines for implementation and measurement of antibiotic stewardship interventions in inpatient populations including long-term care were prepared by a multidisciplinary expert panel of the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America (Barlam et al, 2016).

Led by Co-chairs Tamar Barlam and Sara Cosgrove, a panel of 18 multidisciplinary experts in the management of ASPs was convened per the IDSA Handbook on Clinical Practice Guide- line Development in 2012. In addition to members of IDSA and the SHEA, representatives from diverse geographic areas, pediatric and adult practitioners, and a wide breadth of specialties representing major medical societies were included among the panel’s membership (American College of Emergency Physicians [ACEP], American Society of Health-System Pharmacists [ASHP], American Society for Microbiology [ASM], PIDS, Society for Academic Emergency Medicine [SAEM], Society of Infectious Diseases Pharmacists [SIDP], and the Surgical Infection Society [SIS]). A guideline methodologist and member of the GRADE Working Group and a medical writer were added to assist the panel (Barlam et al, 2016). Wk3 Critical Appraisal of Practice

COMMENTS: Rate 7

· Methods by which preferences and views were sought (e.g., evidence from literature, surveys, focus groups)

· Outcomes/information gathered on patient/public information

· How the information gathered was used to inform the guideline development process and/or formation of the recommendations

The expert panel followed a process used in the development of other IDSA guidelines, which included a systematic weighting of the strength of recommendation and quality of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system (IDSA, 2015).

PubMed, which includes Medline (1946 to present), was searched to identify relevant studies for each of the antibiotic stewardship guideline PICO (population/patient, intervention/ indicator, comparator/control, outcome) questions. Search strategies were developed and built by 2 independent health sciences librarians from the Health Sciences Library System, University of Pittsburgh. For each PICO question, the librarians developed the search strategies using PubMed’s command language and appropriate search fields. Medical Subject Headings terms and keywords were used for the main search concepts of each PICO question Barlam et al, 2016).

Report the target (or intended) users of the guideline.

COMMENTS: Rate 6

Nurses are not recognized and are underutilized in this program

· How the guideline may be used by its target audience (e.g., to inform clinical decisions, to inform policy, to inform standards of care)

For Health care professionals who with inpatient populations including long-term care. That is considered for use in pediatrics, oncology, community hospitals, small hospitals, and nursing home and long-term care environments, and not limited to acute care facilities Barlam et al, 2016).

This guideline discusses a broad range of possible ASP interventions. They emphasized the need for each site to assess its clinical needs and available resources and individualize its ASP with that assessment in mind Barlam et al, 2016).

Report details of the strategy used to search for evidence.

COMMENTS: Rate 7

· Time periods searched (e.g., January 1, 2004 to March 31, 2008)

· Search terms used (e.g., text words, indexing terms, subheadings)

· Full search strategy included (e.g., possibly located in appendix)

PubMed, which includes Medline (1946 to present), was searched to identify relevant studies for each of the antibiotic stewardship guideline PICO (population/patient, intervention/ indicator, comparator/control, outcome) questions. Search strategies were developed and built by 2 independent health sciences librarians from the Health Sciences Library System, University of Pittsburgh. For each PICO question, the librarians developed the search strategies using PubMed’s command language and appropriate search fields. Medical Subject Headings terms and keywords were used for the main search concepts of each PICO question. A data supplement that includes search strings can be found following publication on the IDSA website. Articles in all languages and all publication years were included. Initial searches were created and confirmed with input from the guideline committee chairs and group leaders from February through mid-July 2013. The searches were finalized and delivered between late July and September 2013. After the literature searches were performed, authors continued to review the literature and added relevant articles as needed Barlam et al, 2016).

Report the criteria used to select (i.e., include and exclude) the evidence. Provide rationale, where appropriate.

COMMENTS: Rate 7

· Study design

· Comparisons (if relevant)

· Outcomes

· Language (if relevant)

· Context (if relevant)

To evaluate evidence, the panel followed a process consistent with other IDSA guidelines. The process for evaluating the evidence was based on the IDSA Handbook on Clinical Practice Guideline Development and involved a systematic weighting of the quality of the evidence and the grade of re- commendation using the GRADE system. Unless otherwise stated, each PICO comparator was usual practice Barlam et al, 2016).

Describe the strengths and limitations of the evidence. Consider from the perspective of the individual studies and the body of evidence aggregated across all the studies. Tools exist that can facilitate the reporting of this concept.

COMMENTS: Rate 7

· Study methodology limitations (sampling, blinding, allocation concealment, analytical methods)

· Appropriateness/relevance of primary and secondary outcomes considered

· Consistency of results across studies

· Direction of results across studies

· Magnitude of benefit versus magnitude of harm

· Applicability to practice context

Panel members were divided into 5 subgroups: (1) interventions, (2) optimization of antibiotic administration, (3) micro- biology and laboratory diagnostics, (4) measurement and analysis, and (5) antibiotic stewardship in special populations. Each author was asked to review the literature, evaluate the evidence, and determine the initial strength of the re- commendations along with an evidence summary supporting each recommendation in his/her assigned subgroup. The evidence was graded based on the effectiveness of the antibiotic stewardship intervention, not the underlying data that provided the groundwork for the intervention. The panel reviewed all recommendations, along with their strength and the quality of the evidence. Discrepancies were discussed and resolved, and all panel members are in agreement with the final recommendations (Barlam et al, 2016).

Describe the methods used to formulate the recommendations and how final decisions were reached. Specify any areas of disagreement and the methods used to resolve them.

COMMENTS: Rate 7

· Outcomes of the recommendation development process (e.g., extent to which consensus was reached using modified Delphi technique, outcome of voting procedures)

· How the process influenced the recommendations (e.g., results of Delphi technique influence final recommendation, alignment with recommendations and the final vote)

The panel met face to face on 3 occasions and conducted numerous teleconferences to complete the work of the guideline. The purpose of the meetings and teleconferences was to develop and discuss the clinical questions to be addressed, assign topics for review and writing of the initial draft, and develop recommendations. The whole panel reviewed all sections. The guide- line was reviewed and approved by the IDSA Standards and Practice Guidelines Committee (SPGC), the IDSA Board of Di- rectors, the SHE Guidelines Committee, and the SHEA Board of Directors, and was endorsed by ACEP, ASHP, ASM, PIDS, SAEM, SIDP, and SIS (Barlam et al, 2016). Wk3 Critical Appraisal of Practice

Report the health benefits, side effects, and risks that were considered when formulating the recommendations.

COMMENTS: Rate 1

No information available.

· Supporting data and report of harms/side effects/risks

· Reporting of the balance/trade-off between benefits and harms/side effects/risks

· Recommendations reflect considerations of both benefits and harms/side effects/risks

Describe the explicit link between the recommendations and the evidence on which they are based.

COMMENTS: Rate 7

· Link between each recommendation and key evidence (text description and/or reference list)

· Link between recommendations and evidence summaries and/or evidence tables in the results section of the guideline

A powerful way to support antibiotic stewardship is to improve the scientific basis for ASP interventions. As outlined in Section XIII, ASPs can successfully intervene to reduce the duration of therapy for many infections because well-constructed, randomized controlled clinical trials have demonstrated that clinical outcomes are equivalent. Rigorous published evidence is often needed to convince clinicians to alter well-established, albeit suboptimal, practice Barlam et al, 2016). Wk3 Critical Appraisal of Practice

Report the methodology used to conduct the external review

COMMENTS: Rate 7

· Methods taken to undertake the external review (e.g., rating scale, open-ended questions)

· Description of the external reviewers (e.g., number, type of reviewers, affiliations)

· Outcomes/information gathered from the external review (e.g., summary of key findings)

· How the information gathered was used to inform the guideline development process and/or formation of the recommendations (e.g., guideline panel considered results of review in forming final recommendations)

To evaluate evidence, the panel followed a process consistent with other IDSA guidelines. The process for evaluating the evidence was based on the IDSA Handbook on Clinical Practice Guideline Development and involved a systematic weighting of the quality of the evidence and the grade of re- commendation using the GRADE system (Barlam et al, 2016). Wk3 Critical Appraisal of Practice

Describe the procedure for updating the guideline.

COMMENTS: 7

· Methodology for the updating procedure

At annual intervals, the panel chair, the SPGC liaison advisor, and the chair of the SPGC will determine the need for revisions to the guideline based on an examination of current literature. If necessary, the entire panel will reconvene to discuss potential changes. When appropriate, the panel will recommend revision of the guideline to the IDSA SPGC and SHEA guidelines committees (IDSA, 2015).

COMMENTS: 7

· Intent or purpose of the recommended action (e.g., to improve quality of life, to decrease side effects)

· Relevant population (e.g., patients, public)

· Caveats or qualifying statements, if relevant (e.g., patients or conditions for whom the recommendations would not apply)

· If there is uncertainty about the best care option(s), the uncertainty should be stated in the guideline

The benefits of antibiotic stewardship include improved patient outcomes, reduced adverse events including Clostridium difficile infection (CDI), improvement in rates of antibiotic susceptibilities to targeted antibiotics, and optimization of resource utilization across he continuum of care (Barlam et al, 2016). Wk3 Critical Appraisal of Practice

Describe the different options for managing the condition or health issue.

Present the key recommendations so that they are easy to identify.

COMMENTS: Rate 7

· Specific recommendations grouped together in one section

· Preauthorization and prospective review of antibiotics are among the many recommendations to ensure antibiotic stewardship programs are most effective, suggest new guidelines from IDSA/SHEA.

· Antibiotic stewardship programs should be led by physicians and pharmacists, including ID specialists, who have the expertise and education to ensure the right drug is being prescribed at the right time for the right diagnosis.

· Antibiotic stewardship programs must be based on the specific problems identified by the healthcare facility and a realistic examination of available resources to ensure interventions are performed with consistency.

· These programs have been shown to improve patient outcomes, reduce antibiotic resistance and save money (IDSA& SHEA, 2016).

COMMENTS: Rate 7

· Methods by which information regarding the facilitators and barriers to implementing recommendations were sought (e.g., feedback from key stakeholders, pilot testing of guidelines before widespread implementation)

· Information/description of the types of facilitators and barriers that emerged from the inquiry (e.g., practitioners have the skills to deliver the recommended care, sufficient equipment is not available to ensure all eligible members of the

Additional clinical trials that incorporate consideration of antibiotic stewardship in their design are critically needed. Another significant gap is the dearth of implementation re- search in this area Wagner et al. 2014). Although the National Action Plan for Combating Antibiotic-Resistant Bacteria will require the institution of ASPs across healthcare facilities, little effort and limited research funding have been allocated to study how best to achieve large-scale implementation (The White House, 2015). Wk3 Critical Appraisal of Practice

Qualitative assessments that can examine the impact of factors such as organizational culture, prescriber attitudes, and the self- efficacy of the antibiotic steward (ie, the extent to which he/she believes his/her goals can be reached) are lacking and are important to establish the context in which ASP implementation occurs (Pakyz et al, 2014).

Provide advice and/or tools on how the recommendations can be applied in practice.

COMMENTS: Rate 6

o Guideline summary documents o Links to checklists, algorithms o Links to how-to manuals o Solutions linked to barrier analysis(see Item 18) o Tools to capitalize on guideline facilitators (see Item 18) o Out come of pilot test and lessons learned

Despite the recognition that much more research is needed, this guideline identifies core interventions for all ASPs as well as other interventions that can be implemented based on facility- specific assessments of need and resources. Every healthcare facility is able to perform stewardship, and institution of an ASP is attainable and of great importance to public health (Barlam et al, 2016).

Describe any potential resource implications of applying the recommendations.

COMMENTS: Rate 6

· Methods by which the cost information was sought (e.g., a health economist was part of the guideline development panel, use of health technology assessments for specific drugs, etc.)

· Information/description of the cost information that emerged from the inquiry (e.g., specific drug acquisition costs per treatment course)

· How the information gathered was used to inform the guideline development process and/or formation of the recommendations

Support for these guidelines was provided by the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (Barlam et al, 2016).

Provide monitoring and/or auditing criteria to measure the application of guideline recommendations.

COMMENTS: Rate 7

· Criteria for assessing impact of implementing the recommendations

· Advice on the frequency and interval of measurement

· Operational definitions of how the criteria should be measured

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). Plus Centers for Medicare and Medicaid Services (CMS), Joint Commission on Accreditation of Healthcare Organizations (JACHO) and Center for Disease Control and Prevention (CDC) (Barlam et al, 2016).

Report the funding body’s influence on the content of the guideline.

COMMENTS: Rate 7

· A statement that the funding body did not influence the content of the guideline

Financial support for these guidelines was provided by the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (Barlam et al, 2016).

Provide an explicit statement that all group members have declared whether they have any competing interests.

COMMENTS: Rate 7

· Methods by which potential competing interests were sought

· A description of the competing interests

· How the competing interests influenced the guideline process and development of recommendations

Potential conflicts of interest. A list of the reflection of what was reported to IDSA was provided. To provide thorough transparency, IDSA requires full disclosure of all relationships, regardless of relevancy to the guide- line topic. Evaluation of such relationships as potential conflicts of interest is determined by a review process that includes assessment by the Standards and Practice Guidelines Committee (SPGC) chair, the SPGC liaison to the development panel, and the board of directors liaison to the SPGC, and, if necessary, the Conflicts of Interest (COI) Task Force of the Board (Barlam et al, 2016). Wk3 Critical Appraisal of Practice

Lowest possible quality

Highest possible quality