Presentation on theme: "Putting Evidence into Practice:"— Presentation transcript:
1 Putting Evidence into Practice: Using evidence-based strategies to improve wound care practiceLinda Cowan, PhD, ARNP, FNP-BC, CWSResearch Health Scientist, Research Service, Department of Veterans Affairs Medical Center, North Florida/South Georgia Veterans Health System Gainesville, FloridaAssociate Professor, UF College of NursingGainesville, Florida
2 Financial Disclosures: Research projects funded by:Veterans AdministrationBiomondeHealthpointCellerationMedlineHollisterEmployed by or Consultant for:University of Florida College of NursingWHS Consultants, Inc.CEUFAST, Inc.
3 ObjectivesDescribe Evidence Based Practice “processes” vs. “practices”Identify key differences between EBP, PI/QI, and Research toolsDiscuss ways to appraise and apply research evidence to clinical practiceReview examples of wound related research evidence (venous leg ulcers, biofilm, pressure ulcers)
5 When clinicians have access to information, it changes their patient care management decisions: In 1998, Dr. David Sackett, using an "evidence cart" on rounds, reported using information searches to answer 71 clinical questions:37 (52%) Evidence confirmed the management decision,18 (25%) Evidence lead to a new therapy or diagnostic test16 (23%) Evidence corrected (changed) the previous plan.
6 What is Evidence-Based Practice? EBP is a problem solving approach to clinical practice that integrates the conscientious use of best evidence in combination with a clinician’s expertise as well as patient preferences and values to make decisions about the type of care that is provided.
7 Types of Clinical Evidence External Evidence:Generated from rigorous researchImportant question: Does the evidencegenerated by rigorous research still hold true when translated to the real world?Internal Evidence:Generated from outcomes management;“practice-based evidence” (PI/QI/QA) projectsOther Sources:Text books, expert opinion, professional organizations
8 Getting Started: The Five A’s* Ask good clinical questionAcquire best evidenceEnough evidence to answer question?Appraise that evidence (level/strength)Is evidence strong?ApplyDoes evidence support practice change?Can practice change be implemented?Assess/Re-assessHow did practice change impact outcomes?*Modified from Duke University’s “The Five A’s of the Evidence Cycle” available at:
9 Process of “evidence-based practice” PatientdilemmaAssess & ReassessAskAcquireProcess of“evidence-basedpractice”ActAppraiseHierarchyof evidenceEvidence alone does notdecide – add clinical experience and pt. values!ApplyRichardson, 2007;
10 Accessed from:Titler, M.G., Kleiber, C., Steelman, V.J., Rakel, B.A., Budreau, G., Everett, L.Q., Buckwalter, K.C.,Tripp-Reimer, T., & Goode C. (2001).The Iowa Model of Evidence-Based Practice to Promote QualityCare. Critical Care Nursing Clinics of North America, 13(4),(Used with permission).
12 ALL PI/QI, Research, & Evidence Summaries start with: Asking a questionAcquiring the EvidenceAppraising /evaluating the Evidence (critical appraisal)Determining how the evidence may be Applied to the question we have asked. . .
13 Asking a Searchable Question: USING PICO… Population/problemIntervention (if there is one)or E = exposureComparison (if there is one)Outcome of interestPICOT (T=Time span)
14 THERAPY QUESTION:Jean is a 55 y/o woman who quite often crosses the Atlantic to visit her elderly mother. She tends to get swollen legs on these flights and is worried about her risk of developing deep vein thrombosis (DVT), because she has read quite a bit about this in the newspaper lately. She asks you if she should wear elastic stockings on her next trip to reduce her risk of this.Glasziou et al, 2007
15 USING PICO… Population/problem = passengers on long-haul flights Intervention = wearing elastic compression stockingsComparison = no elastic stockingsOutcome = development of DVT
16 After you ask the question, then what? Asking a questionAcquiring the Best EvidenceAppraising /evaluating the Evidence (critical appraisal)Determining how the evidence may be Applied to the question we have asked. . .Great Resource: Glasziou, How do we nurture Evidence-Based Practice?
17 Using PICO to Help Search 1Population/problem = passengers on long-haul flightsIntervention = wearing elastic compression stockingsComparator/control = no elastic stockingsOutcome = development of DVT342Underline the key termsNumber the order of importance from 1 to 4Think of alternate spellings, synonyms, & TruncationsGlasziou, 2007;
18 Computerized decision support systems linking patient needs to best evidence Specialized documentation softwareNICE (www.nice.org.uk/guidance/)Integrates best evidence from synthesis to provide comprehensive options and GuidelinesClinical Evidence (www.clinicalevidence.com)PIER (http://pier.acponline.org/index.html)Up-to-Date (www.uptodate.com)Guidelines (www.guidelines.gov)Systematic reviews (SRs) and Meta AnalysesBmjupdates+ (http://bmjupdates.com)Cochrane LibraryWorldviews on evidence-based NursingPubMed Clinical Queries (http://www.ncbi.nlm.nih.gov/entrez/query/static/clinical.shtml)Succinct descriptions of an individual study or an SRACP Journal Club (www.acpjc.org)EBM (www.evidence-basedmedicine.com)EBN (http://ebn.bmj.com/)Original research articlesBmjupdates+PubMed Clinical Queries
19 After you acquire the evidence, then what? Asking a questionAcquiring the Best EvidenceAppraising /evaluating the Evidence (critical appraisal)Determine how evidence can be applied…
20 Critical Appraisal Tools & Skills Systematic Reviews/Meta AnalysesCEBM (www.cebm.net) has free CAT tools to useCommon questionsIs the question of the research or SR clearly stated?Does the SR answer the specific question you asked?Is the info current?Is it likely relevant articles/studies were missed?Are results applicable to your population of interest?Were appropriate methods used in research or SR?Large enough samples?Valid/reliable tools?Homogeneous results vs. heterogeneous resultsMeaningful results?Levels of evidence and strength of recommendations?
21 Clinical Pearls about Evaluating Research Evidence Know where to look in articlesGehlbach’s book: “Interpreting Medical Literature” 2006Read methodology section first (not abstract)Sample large enough? Sample size power analysis reported?Appropriate study design for clinical question?Outcome measures described adequately; valid, reliable?Is enough detail given so that study could be reproduced?Abstract: Research question/population same as yours?Methods: Sampling techniques? Robust methods?Results: Believable and can be applied to your situation?
22 Know about some “Crud” detectors Heterogeneity of Meta-analysis results?Quick look at stem and leaf plotsOdds ratio: measure of relative risk95% Confidence IntervalsShould never contain “1”Study1 T(25/152) C(2/160)Study2 T(2/16) C(1/15)Study3 T(35/200) C(3/185)Combined T(80/368) C(6/360)(Combined sample n= 728)-----X OR 0.6(95%CI )-----X--- OR 1.0(95%CI )--X— OR 0.5(95%CI )-X- OR 0.5 (95%CI )
23 After you appraise the evidence, then what? Asking a questionAcquiring the Best EvidenceAppraising /evaluating the Evidence (critical appraisal)Determining how evidence may be Applied. .Is there sufficient evidence to suggest a recommendation for practice change? orAre PI or research methods/tools needed?
25 Evidence Summaries Ask Acquire Appraise Apply High level (current) evidenceLook for syntheses / summaries / guidelinesSystematic reviews/meta-analysesAppraiseWorkgroup summarizes appraised evidenceCritical appraisal tools (CATs) – AGREE for GuidelinesApplyMake recommendations for applying to practicePolicy/procedure need to be changed/updated?Practice need to be changed?Present report to change facilitators
26 Evidence Summary & Recommendations Examples Ear irrigation in ambulatory careWith what device, how much solution, what solution?Acute urinary retention presenting to ERShould you clamp Foley catheter every 500cc?CAUTI question for admissions with FoleysShould you change Foley if admitted w/existing Foley?
27 Utilizing the PI/QI Toolbox ResearchQI / PIEvidence SummaryGenerates External EvidenceGenerates Internal EvidenceEvidence Based
28 Quality Improvement (QI) Process Improvement (PI) A process by which individuals work together to improve systems and processes with the intention to improve outcomes (unit/facility/organization specific)A data driven systematic approach to improving care (typically with a local or organizational focus)Utilizes the PDCA (PDSA), Systems Redesign, Lean Six Sigma (or similar) framework/methodsPI/QI languageNewhouse, 2007
29 Common PI/QI/QA Language Plan-Do-Check-Act (PDCA/PDSA)ImproveProject, change activitySystems / ProcessesSatisfactionLocal/unit specificWork flow / work aroundBarriers / FacilitatorsReduce time/costCollect and evaluate dataLessons learnedInformation found (outcomes):Not generally a risk to pts, not generalizable (no intent to publish)If any of these are potential issues, will need IRB reviewPI/QI approach often in response to national mandates, quality indicators, skills competency & educational needs
31 What if there is not enough evidence to answer the clinical question (evidence summary) or support an improvement activity (PI/QI)?Research
32 Utilizing the Research Toolbox QI / PIEvidence SummariesGeneratesExternal EvidenceEvidence Based
33 RESEARCHResearch is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledgeTheory building / testingFederal regulatory definitions available in document 38 CFR (d)
34 Common Research Language Generate new knowledgeInvestigate / research / studyTesting / trial / develop / theory / hypothesisRandomize / random allocationIntervention / experiment / experimentalSample / Sampling / Controls / CasesInclusion criteria/exclusion criteriaInformed consent / subjects / n=xRetrospective chart review / prospective designCohort / case controls / comparison group
35 Research vs. Non-Research Activity If you are not sure, consider:Is anything outside of usual care being done/proposed?Any potential risk to patient, pt’s info, corporate info?What kind of data? How will data be collected, stored, reported?Is there a goal to generalize/publish/present this data?IF YES even if it is being done as a PI project/activity, IRB and human subject protection review will be necessary.Each Federal agency may have their own additional layers of approvals: All VA Research must be reviewed by the IRB and VA Privacy officer, Information security officer, safety committee and R & D Committees before research can begin!
36 Typical Research Proposals Writing the proposalBe specific about methods, who will: Have access to data, use the data, where will data be stored (VA server!) etc. Typical components of proposals for UF IRB follow something like this:Project Title and List of InvestigatorsProject AbstractBackground & SignificanceSpecific AimsResearch Plan(Sample, Inclusion/Exclusion criteria, Methods of data collection, Variables, Methods of data analysis, Project Management Plan, Dissemination Plan, Budget, Timeline)Possible Discomforts and Risks and Possible Benefits(Human Subjects protection, data safety monitoring plan)Conflict of Interest of investigatorsReferences
38 Purpose of Evidence Syntheses Provides reports of body of evidence on important clinical practice topics relevant to patients and these reports help:Develop clinical policies informed by evidence,Implement effective services to improve patient outcomesSupport clinical practice guidelines and performance measures, andGuide the direction for future research to address gaps in clinical knowledge
39 National Evidence Example Advanced Wound Care Therapies for Non- Healing Diabetic, Venous, and Arterial Ulcers: A Systematic ReviewCompleted November 2012, Published May 2013Full-length report available on ESP website:p/reports.cfmMEDLINE Search – 1995 through August plus hand-search of references lists in eligible trials and recent systematic reviews
41 Specific Purpose of This Review Evaluate published, RCTs of efficacy & harms of advanced wound care therapies compared to either usual care or other advanced therapyTherapies Reviewed:Collagen Platelet-derived growth factors (PDGF); Negative pressure wound therapy (NPWT); Biological dressings (BD); Platelet-rich plasma (PRP); Electromagnetic therapy (EMT); Biological skin equivalents (BSE); Silver products; Oxygen therapies (hyperbaric [HBOT], topical, ozone); Keratinocytes; Intermittent pneumatic compression (IPC)
42 Inclusion/exclusionRandomized, controlled trials enrolling human subjects age 18 and over and published in English languageNon-healing, lower extremity, diabetic, venous, or arterial ulcers (excluded acute wounds, surgical wounds, or pressure ulcers)Included only studies reporting percentage of ulcers healed at study completion or time to complete ulcer healing as an outcome
43 VA Evidence-based Synthesis Program (ESP) 2012 Literature Search Flow1,230 Titles and Abstracts1,053 Excluded177 Full Text Review130 Excluded21 from Hand SearchFinal: 68 Articles (64 Trials)Diabetic: 35 trials ; Venous: 20 trials; Arterial: 1 trial Other: 8 trials
44 Outcomes Examined Main Outcomes: Proportion of ulcers healed at study completionTime to complete ulcer healingPatient global assessmentReturn to daily activitiesSecondary Outcomes:Ulcer infection PainAmputation Quality of lifeRevascularization surgery All-cause mortalityUlcer recurrence Adverse eventsTime to recurrence
45 Major Findings“Our systematic review of randomized controlled trials found discouragingly LOW strength of evidence regarding the effectiveness of advanced wound care therapies for treatment of lower extremity ulcers”
46 Limitations of many of the reviewed studies: - Narrow patient population, i.e. limited enrollment- Many of the trials were industry sponsored- Definitions of “chronic” ulcers vary widely- Few studies were of long duration- Advanced therapies compared only to standardtherapies in majority of studies- Methodological quality of studies was fair or poor- Don’t know how effective standard care was prior to entering trials
47 Future Studies Needed: That will compare advanced therapies to each otherTo examine microvascular disease to more clearly distinguish diabetic from arterial ulcersOn advanced wound care therapies in patients with strictly arterial diseaseSeveral organizations have outlined overall methodological standards for future research of wound healing therapies
48 Comparative Effectiveness SR: Treatments for VLU Systematic Review:benefits & harms of advanced wound dressings on wound healing, mortality, quality of life, pain, condition of wound bed, and adverse events for patients with chronic VLU compared with compression aloneValle et al. (Johns Hopkins University)Literature reviewed: Jan 1980 thru July 201210,676 total studies initially reviewedOnly 37 met criteria (3,990 patients)0.34% of studies available
50 Limited evidence on comparative effectiveness and safety in this comprehensive systematic review. Of thousands of citations reviewed, just 38 met criteria.Five studies generated moderate levels of evidence from which conclusions were drawn on CVU healing.Poor quality of study design and heterogeneity among studies limited ability to draw meaningful conclusions related to QOL, pain, condition of the wound bed, and most adverse events.Improved healing rates were observed in trials that evaluated allogeneic bilayered cultured human skin equivalent, Apligraf®. Three times more rapid healing of CVUs than compression alone, especially for recalcitrant ulcers that were present for over 1 year. However, no added benefit was seen in recurrence rates.
51 Cadexomer iodine provided a significant advantage in wound healing rates in one trial Silver-impregnated dressings and Manuka honey did not significantly affect healing rates of CVUs.More studies are needed to further explore the role of antimicrobial dressings in management of CVUs.Hydrocolloid dressings do not appear more effective than compression alone in healing the chronic venous leg ulcers. However, all hydrocolloids are not exactly the same, and the lack of standardization in water vapor transmission rates among hydrocolloid dressings could potentially affect wound healing.Low strength of evidence on hydrocolloids indicates cannot rule out possibility of a benefit, but better studies would be needed to show a benefit.
52 Conclusions“A few AWDs may be helpful in improving wound healing, but other important effectiveness and safety outcomes are still understudied for these AWDs.”“Our findings do not imply that AWDs have no merit in the treatment of the CVU. Rather, they indicate that there is insufficient data to support such claims, and re-evaluation of the standards for conducting research on AWDs for CVUs is imperative.”“We speculate that because many wound dressings are classified as medical devices, the existing evidence is partly a response to the less rigorous standards set forth by the Food and Drug Administration for medical devices.”
54 Evidence Biofilms in chronic wounds Biofilm Research Dowd, James, WolcottBiofilm ResearchWound Research at University of Florida and North Florida/South Georgia VA:Pigskin explant biofilm modelTopical antimicrobial agentsNon-contact non thermal USLarval debridement therapy (LDT or MDT)
55 Cadexomer iodineP. Phillips, Q. Yang, E. Sampson, G. Schultz. Effects of Antimicrobial Agents on an In Vitro Biofilm Model of Skin Wounds, Advances Wound Care, 1: , 2010.
56 Non-contact non-thermal ultrasoundBacteria rods3 day mature PA biofilm before US3 day mature PA biofilm after US
57 Value of medicinal larvae (maggots) or Larval Debridement Therapy (LDT) as an anti-biofilm strategy
58 ResultsL. Cowan, J. Stechmiller, P. Phillips, Q.P. Yang and G. Schultz. Chronic Wounds, Biofilms and Use of Medicinal Larvae, Ulcers, Article ID , 7 pages;
59 Before Larval Debridement SA day mature biofilm culture on pig skin explant
60 After Larval Debridement SA35556 biofilm culture 24 hours after LDT
61 Before Larval Debridement PA01 (3 day mature biofilm culture on pig skin explant)
62 After Larval Debridement PA01 biofilm culture 24 hours after LDT
63 Evidence for larval therapy Enzymatic secretionsAntimicrobial secretionsEffective debridement of necrotic tissueNot disruptive of healthy tissueNo known bacterial resistance
64 Innovation: Biofilm Detector Dye Cowan, L., Schultz, G., Gibson, D., Yang, Q.,Proof of concept in vitro studies completed April 2014Using dental plaque dye to stain biofilm for clinical visualizationVisualization of biofilm allows more effective treatment (removal of biofilm) and treatment monitoring
65 Photo of non-inoculated pigskin explants (free of biofilm) Exposed for 10 seconds to one concentration of dental biofilm dye and then rinsed vigorously x 1 with 5 ml sterile water
66 This experiment demonstrated proof of concept that the dental dye does not significantly stain pigskin tissue, but did stain biofilm material.These results support the proposed research to test a similar dye in an open wound on a living rat model where living tissue and wound fluid with other proteins are present.
67 Future directions Effective wound bed preparation T-I-M-E* principles in practiceAnti-biofilm strategiesIncluding Larval Debridement Therapy (LDT)Biofilm Detector DyeAnimal studies and human studiesTargeted multiple factor approachCombination therapies: disruption or removal of biofilm (such as LDT) + antimicrobialsHuman RCT in progress: LDT vs. bedside sharp debridement against biofilmSchultz, G & Dowsett, C. (2012). Wound bed preparation revisited. Wounds International, 3(1). Available at: )
69 PU TreatmentsAHRQ: Pressure Ulcer Treatment Strategies: Comparative Effectiveness Review Number 90 (May 8, 2013).Interprofessional team of expert authors. Contains 488 pages.guides-reviews-and- reports/?pageaction=displayproduct&productID=14 91
70 Articles published between January 1, 1985, and October 17, 2012 Identified from searches of:MEDLINE® (Ovid), Embase (Elsevier), CINAHL (EBSCOhost),EBM Reviews (Ovid), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, and Health Technology Assessment.Additional studies identified by searching reference lists from included studies & systematic reviews of pressure ulcer treatments.Gray literature, including unpublished data, abstracts, dissertations, and individual product packets from manufacturers, also reviewed.
71 Evidence for Tx Moderate Low Air-fluidized beds Alternating pressure bedsProtein-containing nutritional supplementsHydrocolloid compared to foamRadiant heat compared with other dressings (stage III-IV ulcers)Electrical stimulationNPWTLow air loss beds vs. foamVitamin CPlatelet derived growth factorTopical collagen compared to hydrocolloid or standard careTherapeutic ultrasoundElectromagnetic therapyLight therapyLaser therapyHydrotherapy
72 Insufficient Evidence Alternating pressure chair cushionsZincComparison of different wound dressingsDebriding enzymes compared with dressings or other topical therapies (few studies)Topical phenytoinBiological agents (macrophage suspension, etc.)Surgical closure*Maggot studies were also listed here because only 3 poor quality studies were reviewed (but didn’t have our results published yet!)
73 Summary Maggots are our friends PU prevention starts with education and appropriate risk assessmentPreventive interventions should be Evidence-Based and will likely never replace attentive care & repositioningPU treatments should be evidence-based and patient need specific (wound characteristics & comorbidities)More research needed to determine when specific interventions are likely to succeed or fail.