Sterilization Recommended Practice: Based on Evidence

Recommended Practices Next
Generation: Rating the Evidence
Ramona Conner, MSN, RN, CNOR
Paula Graling, DNP, RN, CNS, CNOR
August 7, 2012

Objectives
• 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

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 practice
ONS 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
Research Non-Research Recommendation ONS Evidence Requirements

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
IVA Recommended for institutional site, and that included a sample size of at least 100
IA participants.
Regulatory Practice
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.

Recommendation ONS Evidence Requirements
Research Non-Research

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.
Not Evidence from a single well-conducted trial that showed a
IVA prominent and unacceptable pattern of adverse events and
IA Recommended
Regulatory serious toxicities (CTCAE Grade III/IV).
for Practice
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.

Recommendation ONS Evidence Requirements
Research Non-Research

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
Likely to Be incorporated quality ratings in the analysis and included
IB IVB fewer than 100 patients, or had no estimates of effect size
Effective
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.

Research Non-Research Recommendation ONS Evidence Requirements

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
Effectiveness which showed no benefit for the intervention.
IB IVB
Unlikely
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 • Support
• Staff resources recommendations

• Resistance to change • Education

• Fear of showing lower • Resource allocation
levels of evidence • Starting small with
realistic timeline

Implementing Evidence Rating


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

The RP Development Process
RP Manager Conduct
Team creates Authors create
creates the RP literature search,
a project plan draft
project team review and score

RP Manager review RP Manager posts
Edit for public
Rate evidence and quality check for 30 day
comment
for: comment period

• Adherence to AORN style
• Adherence to RP content outline
• All references scored and interventions rated Edit for Advisory
• Consistency within the RP and across the RP Board review and
collection approval
• Consistent use of approved glossary terms
• Appropriate and consistent reference to related
AORN content Initiate
• Completeness, logical organization, and clinical publication
appropriateness. process

AORN Authoring System™
http://rpauthor.aorn.org

Step 2: Appraisal
Johns Hopkins Evidence Appraisal Tools

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 for
Sterilization, 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.

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
Planning Committee:
Speaker: Ramona Conner, MSN, RN, CNOR Ellice Mellinger MS, BSN, RN, CNOR
Paula R. Graling, DNP, RN, CNOR, CNS Perioperative Education Specialist, AORN
Both Disclose No Conflict

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

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AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019.

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Sterilization Recommended Practice: Based on Evidence

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Editor's Notes