Sterilization Recommended Practice: Based on Evidence

Recommended Practices Next Generation: Rating the Evidence

Ramona Conner, MSN, RN, CNOR

Paula Graling, DNP, RN, CNS, CNORAugust 7, 2012

• Illustrate the Johns Hopkins Nursing Evidence Based Practice tools used to appraise each reference

• Describe the Oncology Nursing Society Putting Evidence into Practice (PEP) schema

• Demonstrate the adaption of these models into the RP authoring system for evidence rating of the AORN Recommended Practices

Objectives

Strengthening Recommendations...the why factor?

• Other professional organizations have adopted rating the strength of scientific evidence

• Inclusion only of documents with strength of evidence rated

• Difficulty during discussions with other surgical team members who question level of evidence supporting RPs- surgical attire

ONS Evidence-Rating Method• Putting Evidence into Practice (PEP) schema

• Includes 6 levels for rating the collective evidence supporting a recommendation• Recommended for practice

• Likely to be effective

• Benefits balanced with harms

• Effectiveness not established

• Effectiveness unlikely

• Not recommended for practiceONS PEP (Putting Evidence into Practice) WEIGHT OF EVIDENCE CLASSIFICATION SCHEMA Decision Rules for Summative Evaluation of a Body of Evidence S.A. Mitchell, MScN, CRNP, AOCN® and C.R. Friese, PhD, MS, RN, AOCN® on behalf of the ONS Oncology Nursing Interventions for Patient Outcomes Project Team

Evidence or Research?...

Learning an appraisal method for individual types of evidence was the basis for starting our work.

• The ability to incorporate evidence-based nursing into clinical care requires a basic understanding of the main research designs underlying the published evidence.

Perform a systematic evidence search

Independently evaluate the type of research study or guideline

• Johns Hopkins EBP Model Appraisal Tools Research

Non-Research

Research Appraisal Tool (pg 1)

Research Appraisal Tool (pg 2)

Non-Research Appraisal Tool (pg 1)

Non-Research Appraisal Tool (pg 2)

Systems Approach

• Focus on specific topic - 32 different RPs• Develop a comprehensive search strategy• Critically appraise relevant studies• Rate collective evidence in support• Synthesize into meaningful summary

Then….

• Recommend practice based on synthesis of the evidence; published as an AORN Recommended Practice

The Evidence Pyramid

http://ebp.lib.uic.edu, Evidence- Based Nursing Practice in the Health Sciences

JOHNS HOPKINS APPRAISAL to ONCOLOGY NURSES SOCIETY RATING CROSSWALK

JH Appraisal Score ONS Level of Recommendation ONS Evidence Requirements

Research Non-Research

IA IVARegulatory

Recommended for Practice

Interventions for which effectiveness had been demonstrated by strong evidence from rigorously-designed studies, meta-analyses, or systematic reviews, and for which expectation of harms is small compared with the benefits.

Supportive evidence from at least two well-conducted randomized controlled trials that were performed at more than one institutional site, and that included a sample size of at least 100 participants.

Evidence from a meta-analysis or systematic review of research studies that incorporated quality ratings in the analysis and included a total of 100 patients or more in its estimate of effect size and confidence intervals.

Recommendations from a panel of experts, that derive from an explicit literature search strategy, and include thorough analysis, quality rating, and synthesis of the evidence.

JOHNS HOPKINS APPRAISAL to ONCOLOGY NURSES SOCIETY RATING CROSSWALK

JH Appraisal Score ONS Level of Recommendation ONS Evidence Requirements

Research Non-Research

IA IVARegulatory

Not Recommended

for Practice

Interventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence, or the cost or burden necessary for the intervention exceeds anticipated benefit.

Evidence from two or more well-conducted randomized trials with at least 100 participants or conducted at more than one site and which showed no benefit for the intervention, and excessive costs or burden expected.

Evidence from a single well-conducted trial that showed a prominent and unacceptable pattern of adverse events and serious toxicities (CTCAE Grade III/IV).

Evidence from a meta-analysis or systematic review of research studies that incorporated quality ratings in the analysis, included a total of 100 patients or more in its estimate of effect size and confidence intervals with demonstrated lack of benefit or prominent and unacceptable toxicities.

Intervention discouraged from use by a panel of experts in the related subject, after conducting a systematic examination, quality rating and synthesis of the available evidence.

JOHNS HOPKINS APPRAISAL to ONCOLOGY NURSES SOCIETY RATING CROSSWALK

JH Appraisal Score ONS Level of Recommendation ONS Evidence Requirements

Research Non-Research

IB IVB Likely to Be Effective

Interventions for which the evidence is less well established than for those listed under “recommended for practice.”

Supportive evidence from a single well-conducted randomized controlled trial that included fewer than 100 patients or was conducted at one or more institutions.

Evidence from a meta-analysis or systematic review that incorporated quality ratings in the analysis and included fewer than 100 patients, or had no estimates of effect size and confidence intervals.

Evidence from a synthetic review of randomized trials that incorporated quality ratings in the analysis.

Guidelines developed largely by consensus/expert opinion rather than primarily based on the evidence and published by a panel of experts that are not supported by synthesis and quality rating of the evidence.

JOHNS HOPKINS APPRAISAL to ONCOLOGY NURSES SOCIETY RATING CROSSWALK

JH Appraisal Score ONS Level of Recommendation ONS Evidence Requirements

Research Non-Research

IB IVB Effectiveness Unlikely

Interventions for which lack of effectiveness is less well established than for those listed under “not recommended for practice.”

Evidence from a single well-conducted randomized trial with at least 100 participants or conducted at more than one site which showed no benefit for the intervention.

Evidence from a well-conducted case control study, a poorly controlled or uncontrolled study, a randomized trial with major methodologic flaws, or an observational study (eg., case series with historical controls) that showed no benefit and a prominent and unacceptable pattern of adverse events and serious toxicities (CTCAE Grade III/IV).

Barriers and Facilitators

• Knowledge deficit

• Staff resources

• Resistance to change

• Fear of showing lower levels of evidence

• Support recommendations

• Education

• Resource allocation

• Starting small with

realistic timeline

Implementing Evidence Rating

Ramona Conner, MSN, RN, CNOR

RPs: Where we were – Where we are going

Making it Happen

• Create Recommended Practices Advisory Board (RPAB)

• Establish evidence rating processes• Upgrade RP authoring system• Revise RP format

RP Development Team

• Lead author• Co-author(s)• Advisory Board Member• Research Committee Member• Evidence Rating TF Member*• Board of Directors Member

RP Manager creates the RP project team

Team creates a project plan

Conduct literature search, review and score

Authors create draft

RP Manager review and quality check

for:

Edit for public comment

RP Manager posts for 30 day

comment period

Edit for Advisory Board review and

approval

Initiate publication

process

The RP Development Process

Rate evidence

• Adherence to AORN style • Adherence to RP content outline • All references scored and interventions rated• Consistency within the RP and across the RP

collection• Consistent use of approved glossary terms • Appropriate and consistent reference to related

AORN content• Completeness, logical organization, and clinical

appropriateness.

http://rpauthor.aorn.

orgAORN Authoring System™

Step 1: Literature Search

RefWorks

Step 2: AppraisalJohns Hopkins Evidence Appraisal Tools

Research Non-Research

Document Consensus Scores

ONS Rating

• Recommended for Practice • Likely to Be Effective • Benefits Balanced with Harms • Effectiveness Not Established• Effectiveness Unlikely • Not Recommended for Practice

RP Format• Introduction• Purpose• Evidence Review• Recommendation ( I )

• Intervention ( I.a )• Activity ( I.a.1)

•Glossary•References Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities,

2008. [IVA]

RP Format Changes• Introduction• Purpose• Evidence Review• Recommendation• Intervention…[ONS Rating]

• Activity

• Glossary• References

Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. [Appraisal Score: IVA]

New Recommended Practices forSterilization, June 15, 2012

I.a. Items that enter sterile tissue or the vascular system are categorized as critical and should be sterile when used.1,6 [Recommended for Practice]

1. Rutala WA, Weber DJ; Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Atlanta, GA: Centers for Disease Control and Prevention; 2008. [IVA]

6. Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010/ A2:2011: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI; 2011. [IVB]

More Evidence Rating Examples:

V.b. The total weight of an instrument set should not exceed 25 lb.6,17 [Likely to be Effective]

IV.a. Instruments should be inspected for cleanliness and function before packaging and sterilization. [Effectiveness Not Established]

V.a. Manufacturers of packaging systems should be consulted for package preparation, configuration, and sterilization. [Not Rated] Note there are no reference numbers

Next Step

Submission to the AHRQ National Guideline Clearing House

NGC Inclusion Criteria

1. Systematically developed statements

2. Produced under the auspices of a relevant professional society

3. Corroborating documentation can be produced and verified that a systematic literature search and review of existing scientific evidence published in peer reviewed journals was performed during the guideline development

4. The current full text is available upon request

Summary

• Perioperative nurses have a professional responsibility to use evidence-based practice

• Rating the level of evidence provides valuable information to readers and helps with discussions

• The appraisal methodology and rating system selected by AORN was considered the most appropriate for AORN recommendations

• This change for our organization will proceed…with lots of work, from lots of people… over the next several years

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Ramona is Manager of Standards and Recommended Practices for AORN and Clinical Editor of the Perioperative Standards and Recommended Practices. Her responsibilities include providing professional expertise regarding perioperative nursing practice to the Board of Directors, AORN national committees, staff, members, specialty assemblies, and standard setting/regulatory bodies, accreditation agencies, and professional associations. Ramona represents AORN as a member of the AAMI Sterilization Standards Committee and is a co-chair of ST-79. She is also a member of the Facility Guidelines Institute's Health Care Guidelines Revision Committee (HGRC) for the Guidelines for Design and Construction of Health Care Facilities, 2006 and 2010 editions. She has been elected to the HGRC Steering Committee for the 2014 edition. Ramona has authored "Clinical Issues" columns and other articles published in AORN Journal and other professional publications. Prior to employment at AORN, Ramona was the Ambulatory Surgical Services Director at Swedish Medical Center in Englewood, Colorado. Before joining Swedish Medical Center, Mrs. Conner was Director of Surgical Services at Mercy Medical Center in Denver, Colorado. Mrs. Conner held various perioperative nursing roles at Lutheran Medical Center in Wheat Ridge, Colorado, including staff nurse, educator, and interim manager. She began her perioperative nursing career at the University of Colorado Health Sciences Center. Mrs. Conner earned her diploma in nursing from Presbyterian School of Nursing in Denver, and her bachelor of science-nursing from the University of Phoenix. She graduated in 1993 from Regis University with a master's in nursing science.

Ramona Conner, MSN, RN, CNOR

Paula R. Graling, DNP, RN, CNOR, CNS

Paula has been a perioperative nurse for over 28 years. She received her BSN (1982) and her MSN (1996) from George Mason University in Fairfax, Virginia, and her doctoral degree in 2010 at Johns Hopkins University in Baltimore, Maryland. Paula is the clinical nurse specialist of perioperative services at Inova Fairfax Hospital in Falls Church, Virginia. She has authored several journal articles and textbook chapters pertaining to perioperative care and nursing practice. She has lectured nationally and internationally on perioperative nursing topics. She served on the AORN Board of directors and as President of AORN from 2006-2007.

Disclosure Information

AORN’s policy is that the subject matter experts for this product must disclose any financial relationship in a company providing grant funds and/or a company whose product(s) may be discussed or used during the educational activity. Financial disclosure will include the name of the company and/or product and the type of financial relationship, and includes relationships that are in place at the time of the activity or were in place in the 12 months preceding the activity. Disclosures for this activity are indicated according to the following numeric categories:

1. Consultant/Speaker’s Bureau 2. Employee

3. Stockholder 4. Product Designer

5. Grant/Research Support 6. Other relationship (specify)

7. Has no financial interest

Speaker: Ramona Conner, MSN, RN, CNOR Paula R. Graling, DNP, RN, CNOR, CNSBoth Disclose No Conflict

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AORN IS PLEASED TO PROVIDE THIS WEBINAR ON THIS IMPORTANT TOPIC. HOWEVER, THE VIEWS EXPRESSED IN THIS WEBINAR ARE THOSE OF THE PRESENTERS AND DO NOT NECESSARILY REPRESENT THE VIEWS OF, AND SHOULD NOT BE ATTRIBUTED TO AORN.

Planning Committee: Ellice Mellinger MS, BSN, RN, CNORPerioperative Education Specialist, AORN