Sterilization Recommended Practice: Based on Evidence

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This presentation is from a webinar on AORN's new Sterilization Recommended Practices and new evidence rating processes. AORN Recommended Practices, although extensively referenced, will now be truly …

This presentation is from a webinar on AORN's new Sterilization Recommended Practices and new evidence rating processes. AORN Recommended Practices, although extensively referenced, will now be truly evidence-based. Where there is evidence, it will be indicated. Where evidence is lacking, that too will be indicated.

Listen to the webinar replay by registering for free at http://bit.ly/UhG3F7. One contact hour is available for this webinar through June 7, 2013 using this free evaluation: http://bit.ly/W775sR. Learn more about AORN events at www.aorn.org/Events.

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  • Could we add meta-analyses as the highest level?
  • Ramona’s slides to follow
  • All RPs are created and maintained in the RP authoring web-based system
  • Lead author creates lit search request.
  • Search results are loaded into database. Initial refinement of search performed by lead author.
  • Each reference is appraised by a team composed of : Lead author, AB member(s), Research Committee member. See appraisal tools in handout. Med Safety=216 references
  • Full definitions included in handout.
  • 1.The clinical practice guideline contains systematically developed statements that include recommendations, strategies, or information that assists physicians and/or other health care practitioners and patients to make decisions about appropriate health care for specific clinical circumstances. 2.The clinical practice guideline was produced under the auspices of medical specialty associations; relevant professional societies, public or private organizations, government agencies at the Federal, State, or local level; or health care organizations or plans. A clinical practice guideline developed and issued by an individual not officially sponsored or supported by one of the above types of organizations does not meet the inclusion criteria for NGC. 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. A guideline is not excluded from NGC if corroborating documentation can be produced and verified detailing specific gaps in scientific evidence for some of the guideline's recommendations. 4. The full text guideline is available upon request in print or electronic format (for free or for a fee), in the English language. The guideline is current and the most recent version produced. Documented evidence can be produced or verified that the guideline was developed, reviewed, or revised within the last five years.

Transcript

  • 1. Recommended Practices NextGeneration: Rating the Evidence Ramona Conner, MSN, RN, CNOR Paula Graling, DNP, RN, CNS, CNOR August 7, 2012
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. Evidence or Research?...Learning an appraisal method for individual types ofevidence 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
  • 6. Research Appraisal Tool (pg 1)
  • 7. Research Appraisal Tool (pg 2)
  • 8. Non-Research Appraisal Tool (pg 1)
  • 9. Non-Research Appraisal Tool (pg 2)
  • 10. 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
  • 11. The Evidence Pyramidhttp://ebp.lib.uic.edu, Evidence- Based Nursing Practice in the Health Sciences
  • 12. JOHNS HOPKINS APPRAISAL to ONCOLOGY NURSES SOCIETY RATING CROSSWALK JH Appraisal Score ONS Level ofResearch 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.
  • 13. JOHNS HOPKINS APPRAISAL to ONCOLOGY NURSES SOCIETY RATING CROSSWALK JH Appraisal Score ONS Level of Recommendation ONS Evidence RequirementsResearch 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.
  • 14. JOHNS HOPKINS APPRAISAL to ONCOLOGY NURSES SOCIETY RATING CROSSWALK JH Appraisal Score ONS Level of Recommendation ONS Evidence RequirementsResearch 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.
  • 15. JOHNS HOPKINS APPRAISAL to ONCOLOGY NURSES SOCIETY RATING CROSSWALK JH Appraisal Score ONS Level ofResearch 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).
  • 16. Barriers and Facilitators• Knowledge deficit • Support• Staff resources recommendations• Resistance to change • Education• Fear of showing lower • Resource allocationlevels of evidence • Starting small with realistic timeline
  • 17. Implementing Evidence Rating Ramona Conner, MSN, RN, CNOR
  • 18. RPs: Where we were – Where we are going
  • 19. Making it Happen• Create Recommended Practices Advisory Board (RPAB)• Establish evidence rating processes• Upgrade RP authoring system• Revise RP format
  • 20. RP Development Team• Lead author• Co-author(s)• Advisory Board Member• Research Committee Member• Evidence Rating TF Member*• Board of Directors Member
  • 21. The RP Development Process RP Manager Conduct Team creates Authors createcreates the RP literature search, a project plan draft project team review and score RP Manager review RP Manager posts Edit for publicRate 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
  • 22. AORN Authoring System™ http://rpauthor.aorn.org
  • 23. Step 1: Literature Search
  • 24. RefWorks
  • 25. Step 2: AppraisalJohns Hopkins Evidence Appraisal Tools
  • 26. Document Consensus Scores
  • 27. ONS Rating• Recommended for Practice• Likely to Be Effective• Benefits Balanced with Harms• Effectiveness Not Established• Effectiveness Unlikely• Not Recommended for Practice
  • 28. 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]
  • 29. 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]
  • 30. New Recommended Practices for Sterilization, June 15, 2012I.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]
  • 31. 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
  • 32. Next StepSubmission to the AHRQ NationalGuideline Clearing House
  • 33. NGC Inclusion Criteria1. Systematically developed statements2. Produced under the auspices of a relevant professional society3. 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 development4. The current full text is available upon request
  • 34. 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
  • 35. Contact Hours You must complete the Learner Evaluation online to earn the 1.0 nursing contact hour.Not Registered for this Webinar?Follow the below instructions to obtain access to the evaluation:o Visit www.aorn.org and login using your AORN Web Login.o From the drop-down menu in the top navigation, go to: AORN Store > Product Catalog > Select Evaluation under Browse By Topic > Find the webinar you just attended and add it to your shopping cart.o Follow the shopping cart instructions to complete your transaction.o You will then receive an e-mail containing a link to the online evaluation.o You may complete the evaluation by using the link in the purchase confirmation e-mail or by visiting the AORN website: www.aorn.org > Navigate to My AORN > select “Manage Your Education”.o Earn your Contact Hour by selecting and completing the appropriate webinar evaluation.Once you have submitted your evaluation, you can print your certificate immediately, or you can visitMY AORN > View All Contact Hours > select the session > click Print Your Certificate at any time.Contact Hours are free of charge for this independent study.
  • 36. Ramona Conner, MSN, RN, CNORRamona is Manager of Standards and Recommended Practices for AORN and Clinical Editor of thePerioperative Standards and Recommended Practices. Her responsibilities include providingprofessional expertise regarding perioperative nursing practice to the Board of Directors, AORNnational committees, staff, members, specialty assemblies, and standard setting/regulatory bodies,accreditation agencies, and professional associations. Ramona represents AORN as a member of theAAMI Sterilization Standards Committee and is a co-chair of ST-79. She is also a member of theFacility Guidelines Institutes Health Care Guidelines Revision Committee (HGRC) for the Guidelinesfor Design and Construction of Health Care Facilities, 2006 and 2010 editions. She has been electedto 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 toemployment at AORN, Ramona was the Ambulatory Surgical Services Director at Swedish MedicalCenter in Englewood, Colorado. Before joining Swedish Medical Center, Mrs. Conner was Director ofSurgical Services at Mercy Medical Center in Denver, Colorado. Mrs. Conner held variousperioperative nursing roles at Lutheran Medical Center in Wheat Ridge, Colorado, including staffnurse, educator, and interim manager. She began her perioperative nursing career at the Universityof Colorado Health Sciences Center. Mrs. Conner earned her diploma in nursing from PresbyterianSchool of Nursing in Denver, and her bachelor of science-nursing from the University of Phoenix. Shegraduated in 1993 from Regis University with a masters in nursing science.
  • 37. Paula R. Graling, DNP, RN, CNOR, CNSPaula has been a perioperative nurse for over 28 years. She received her BSN (1982) and herMSN (1996) from George Mason University in Fairfax, Virginia, and her doctoral degree in2010 at Johns Hopkins University in Baltimore, Maryland. Paula is the clinical nurse specialistof perioperative services at Inova Fairfax Hospital in Falls Church, Virginia. She has authoredseveral journal articles and textbook chapters pertaining to perioperative care and nursingpractice. She has lectured nationally and internationally on perioperative nursing topics. Sheserved on the AORN Board of directors and as President of AORN from 2006-2007.
  • 38. 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 Accreditation Statement AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Centers Commission on Accreditation. AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019.AORN IS PLEASED TO PROVIDE THIS WEBINAR ON THIS IMPORTANT TOPIC. HOWEVER, THE VIEWS EXPRESSED IN THIS WEBINAR ARETHOSE OF THE PRESENTERS AND DO NOT NECESSARILY REPRESENT THE VIEWS OF, AND SHOULD NOT BE ATTRIBUTED TO AORN.