Transcript NEW - Introduction to Evidence Based Practice Class ppt

Putting Evidence into Practice:
Using evidence-based strategies to improve wound care practice
Linda Cowan, PhD, ARNP, FNP-BC, CWS
Research Health Scientist, Research Service,
Department of Veterans Affairs Medical Center, North
Florida/South Georgia Veterans Health System
Gainesville, Florida
Associate Professor, UF College of Nursing
Gainesville, Florida
Financial Disclosures:
Research projects funded by:
• Veterans Administration
• Biomonde
• Healthpoint
• Celleration
• Medline
• Hollister
Employed by or Consultant for:
• University of Florida College of Nursing
• WHS Consultants, Inc.
• CEUFAST, Inc.
Objectives
 Describe
Evidence Based Practice
“processes” vs. “practices”
 Identify key differences between EBP,
PI/QI, and Research tools
 Discuss ways to appraise and apply
research evidence to clinical practice
 Review examples of wound related
research evidence (venous leg ulcers,
biofilm, pressure ulcers)
Value of Evidence in
Clinical Care
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 test
 16 (23%) Evidence corrected (changed)
the previous plan.
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.
Types of Clinical Evidence
External Evidence:
◦ Generated from rigorous research
Important question: Does the evidence
generated by rigorous research still hold
true when translated to the real world?
 Internal Evidence:

◦ Generated from outcomes management;
“practice-based evidence” (PI/QI/QA) projects

Other Sources:
◦ Text books, expert opinion, professional organizations
Getting Started: The Five A’s*
Ask good clinical question
 Acquire best evidence

◦ Enough evidence to answer question?

Appraise that evidence (level/strength)
◦ Is evidence strong?

Apply
◦ Does evidence support practice change?
◦ Can practice change be implemented?

Assess/Re-assess
◦ How did practice change impact outcomes?
*Modified from Duke University’s “The Five A’s of the Evidence Cycle” available at:
http://eno.duhs.duke.edu/sites/eno.duhs.duke.edu/files/public/guides/evidencecycle.pdf
Patient
dilemma
Assess & Reassess
Ask
Acquire
Process of
“evidence-based
practice”
Act
Appraise
Hierarchy
of evidence
Apply
Richardson, 2007; http://www.cebm.net/?o=1021
Evidence alone does not
decide – add clinical
experience and pt. values!
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 Quality
Care. Critical Care
Nursing Clinics of North
America, 13(4), 497509.
(Used with permission).
Toolboxes:
Rules and
Tools
EBP
Research
QI / PI
Generates
External
Evidence
Generates
Internal
Evidence
Evidence Based
Evidence
Summary &
Recommendation
Evidence
Utilization
ALL PI/QI, Research, & Evidence
Summaries start with:
Asking a question
 Acquiring the Evidence
 Appraising /evaluating the Evidence (critical
appraisal)
 Determining how the evidence may be Applied
to the question we have asked. . .

Asking a Searchable Question: USING
PICO…
Population/problem
 Intervention (if there is one)

◦ or E = exposure
Comparison (if there is one)
 Outcome of interest


PICOT (T=Time span)
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
USING PICO…
Population/problem = passengers on long-haul
flights
 Intervention = wearing elastic compression
stockings
 Comparison = no elastic stockings
 Outcome = development of DVT

After you ask the question, then
what?
Asking a question
 Acquiring the Best Evidence
 Appraising /evaluating the Evidence (critical
appraisal)
 Determining how the evidence may be Applied
to the question we have asked. . .

Great Resource: Glasziou, 2007. How do we nurture
Evidence-Based Practice? http://www.cebm.net/?o=1021
Using PICO to Help Search
• Population/problem = passengers on
long-haul flights
3
• Intervention = wearing elastic
compression stockings
• Comparator/control = no elastic 4
stockings
• Outcome = development of DVT 2
1.
2.
3.
1
Underline the key terms
Number the order of importance from 1 to 4
Think of alternate spellings, synonyms, & Truncations
Glasziou, 2007; http://www.cebm.net/?o=1021
Computerized decision support
systems linking patient needs to
best evidence
Specialized documentation software
NICE (www.nice.org.uk/guidance/)
Integrates best evidence from
synthesis to provide
comprehensive options and
Guidelines
Clinical 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 Analyses
Bmjupdates+ (http://bmjupdates.com)
Cochrane Library
Worldviews on evidence-based Nursing
http://www.blackwell-synergy.com/loi/wvn
PubMed Clinical Queries
(http://www.ncbi.nlm.nih.gov/entrez/query/static/clinic
al.shtml)
Succinct descriptions of an
individual study or an SR
ACP Journal Club (www.acpjc.org)
EBM (www.evidence-basedmedicine.com)
EBN (http://ebn.bmj.com/)
Original research articles
Bmjupdates+
PubMed Clinical Queries
After you acquire the evidence,
then what?
Asking a question
 Acquiring the Best Evidence
 Appraising /evaluating the Evidence (critical
appraisal)
 Determine how evidence can be applied…

Critical Appraisal Tools & Skills


Systematic Reviews/Meta Analyses
CEBM (www.cebm.net) has free CAT tools to use
◦ Common questions











Is 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 results
Meaningful results?
Levels of evidence and strength of recommendations?
Clinical Pearls about Evaluating
Research Evidence


Know where to look in articles
Gehlbach’s book: “Interpreting Medical Literature”
2006





Read 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?

Know about some “Crud” detectors
◦ Heterogeneity of Meta-analysis results?
 Quick look at stem and leaf plots
◦ Odds ratio: measure of relative risk
◦ 95% Confidence Intervals
 Should never contain “1”
Study1 T(25/152) C(2/160)
Study2 T(2/16) C(1/15)
Study3 T(35/200) C(3/185)
-----X----
Combined T(80/368)
C(6/360)
(Combined sample n= 728)
-X-
--X—
OR 0.6(95%CI 0.4-0.8)
-----X--- OR 1.0(95%CI 0.8-1.5)
OR 0.5(95%CI 0.4-0.6)
OR 0.5 (95%CI 0.5-0.6)
0.2 0.4 0.6 0.8 1.0 3.0 5.0 7.0
After you appraise the evidence,
then what?
Asking a question
 Acquiring the Best Evidence
 Appraising /evaluating the Evidence (critical
appraisal)
 Determining how evidence may be Applied. .

 Is there sufficient evidence to suggest a
recommendation for practice change? or
 Are PI or research methods/tools needed?
Remember our Toolboxes?
Research
Generates
External
Evidence
QI / PI
Generates
Internal
Evidence
Evidence Based
Evidence
Summary
Evidence User
Evidence Summaries


Ask
Acquire
◦ High level (current) evidence
◦ Look for syntheses / summaries / guidelines
◦ Systematic reviews/meta-analyses

Appraise
◦ Workgroup summarizes appraised evidence
◦ Critical appraisal tools (CATs) – AGREE for Guidelines

Apply
◦
◦
◦
◦
Make recommendations for applying to practice
Policy/procedure need to be changed/updated?
Practice need to be changed?
Present report to change facilitators
Evidence Summary &
Recommendations Examples

Ear irrigation in ambulatory care
◦ With what device, how much solution, what solution?

Acute urinary retention presenting to ER
◦ Should you clamp Foley catheter every 500cc?

CAUTI question for admissions with Foleys
◦ Should you change Foley if admitted w/existing Foley?
Utilizing the PI/QI Toolbox
Research
Generates
External
Evidence
QI / PI
Generates
Internal
Evidence
Evidence Based
Evidence
Summary
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/methods
 PI/QI language

Newhouse, 2007
Common PI/QI/QA Language












Plan-Do-Check-Act (PDCA/PDSA)
Improve
Project, change activity
Systems / Processes
Satisfaction
Local/unit specific
Work flow / work around
Barriers / Facilitators
Reduce time/cost
Collect and evaluate data
Lessons learned
Information found (outcomes):
PI/QI approach
often in response
to national
mandates, quality
indicators, skills
competency &
educational needs
 Not generally a risk to pts, not generalizable (no intent to publish)
 If any of these are potential issues, will need IRB review
PI/QI Examples

CHF ‘teach back’ method for discharge
instructions
◦ Reduced re-admissions

CABG/Valve replacement clinical pathway
◦ Improved interdisciplinary communication, care
consistency, patient communication

Pharmacy Lock Box
◦ Eliminating unnecessary RN visits
What if there is not enough
evidence to answer the clinical
question (evidence summary)
or support an improvement
activity (PI/QI)?
Research
Utilizing the Research Toolbox
North Florida/South Georgia Veterans Health System
Nursing Service
Restraints: An Evidence-based Literature Review
August 2007
Reviewers: Jackie Beane, Tami Bryan, Beverly B. Childress, Cheri Coleman,
Arlene Davis, & Cynthia Northsea
Research
QI / PI
Generates
External Evidence
Evidence Based
Evidence
Summaries
RESEARCH

Research is a systematic investigation, including
research development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge
◦ Theory building / testing
Federal regulatory definitions available in document 38
CFR 16.102(d) http://www.gpo.gov/fdsys/pkg/CFR-2004title38-vol1/pdf/CFR-2004-title38-vol1-sec16-103.pdf
Common Research Language










Generate new knowledge
Investigate / research / study
Testing / trial / develop / theory / hypothesis
Randomize / random allocation
Intervention / experiment / experimental
Sample / Sampling / Controls / Cases
Inclusion criteria/exclusion criteria
Informed consent / subjects / n=x
Retrospective chart review / prospective design
Cohort / case controls / comparison group
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!
Typical Research Proposals
Writing the proposal
Be 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 Investigators
 Project Abstract
 Background & Significance
 Specific Aims
 Research 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 investigators
 References
Wound Research Team Members
Qingping Yang, MS
Randal Wolcott, MD, CWS
Joyce Stechmiller, PhD, ARNP, FAAN
Gregory Schultz, PhD
Priscilla Phillips, PhD
Daniel Gibson, PhD
Micah Flores, PhD
Cyndi Garvan, PhD
Briana Foerman, BS
Joshua Yarrow, PhD
Linda Cowan, PhD, ARNP, CWS
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
outcomes
◦ Support clinical practice guidelines and performance
measures, and
◦ Guide the direction for future research to address
gaps in clinical knowledge
National Evidence Example
Advanced Wound Care Therapies for NonHealing Diabetic, Venous, and Arterial Ulcers:
A Systematic Review
 Completed November 2012, Published May
2013
 Full-length report available on ESP website:
 http://www.hsrd.research.va.gov/publications/es
p/reports.cfm

MEDLINE Search – 1995 through August 2012
plus hand-search of references lists in eligible
trials and recent systematic reviews
SR Review and Appraisal
Team:
Expert Panel/Reviewers
Leads: Neal Foman &
Nancy Greer (Minneapolis
VA)
Jeffrey Robbins, DPM
Leonard Pogach, MD
James Wrobel, DPM, MS
Clifford Buckley, MD
Lucille Beck, PhD
Margaret Cary, MD
Roya Mirmiran, DPM
David Margolis, MD, PhD
Co-Authors/Collaborators
 Timothy J. Wilt, MD, MPH
 James Dorrian, MD
 Roderick MacDonald, MS
 Patrick Fitzgerald, MPH
 Indulis Rutks, BS
Specific Purpose of This Review
Evaluate published, RCTs of efficacy & harms of
advanced wound care therapies compared to
either usual care or other advanced therapy
 Therapies 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)
Inclusion/exclusion
Randomized, controlled trials enrolling human
subjects age 18 and over and published in
English language
 Non-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

VA Evidence-based Synthesis Program
(ESP) 2012
Literature Search Flow
 1,230 Titles and Abstracts
◦ 1,053 Excluded

177 Full Text Review
 130 Excluded
21 from Hand Search
 Final: 68 Articles (64 Trials)

◦ Diabetic: 35 trials ;Venous: 20 trials; Arterial: 1 trial
Other: 8 trials
Outcomes Examined
Main Outcomes:
 Proportion of ulcers healed at study completion
 Time to complete ulcer healing
 Patient global assessment
 Return to daily activities
Secondary Outcomes:
 Ulcer infection
 Amputation
 Revascularization surgery
 Ulcer recurrence
 Time to recurrence
Pain
Quality of life
All-cause mortality
Adverse events
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”
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 standard
therapies in majority of studies
 - Methodological quality of studies was fair or poor
 - Don’t know how effective standard care was prior
to entering trials

Future Studies Needed:
That will compare advanced therapies to each
other
 To examine microvascular disease to more
clearly distinguish diabetic from arterial ulcers
 On advanced wound care therapies in patients
with strictly arterial disease

Several organizations have outlined overall
methodological standards for future research of
wound healing therapies
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 alone




Valle et al. (Johns Hopkins University)
Literature reviewed: Jan 1980 thru July 2012
10,676 total studies initially reviewed
Only 37 met criteria (3,990 patients)
◦ 0.34% of studies available
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.

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.

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.”
Antibiofilm Strategies
Evidence

Biofilms in chronic wounds
◦ Dowd, James, Wolcott

Biofilm Research
◦ Wound Research at University of Florida and North
Florida/South Georgia VA:
 Pigskin explant biofilm model
 Topical antimicrobial agents
 Non-contact non thermal US
 Larval debridement therapy (LDT or MDT)
Cadexomer
iodine
P. Phillips, Q. Yang, E. Sampson, G. Schultz. Effects of Antimicrobial Agents on an
In Vitro Biofilm Model of Skin Wounds, Advances Wound Care, 1: 299-304, 2010.
Non-contact non-thermal ultrasound
Bacteria rods
3 day mature PA
biofilm before US
3 day mature PA
biofilm after US
Value of medicinal larvae
(maggots) or Larval
Debridement Therapy (LDT) as
an anti-biofilm strategy
Results
1.00E+08
CFU/5mm Biopsy
1.00E+07
PA01
1.00E+06
SA35556
1.00E+05
1.00E+04
1.00E+03
1.00E+02
1.00E+01
1.00E+00
Total
bacterial
Antibiotic
Tolerant
Biofilm
1 day larvae 2 day larvae
treatment
treatment
L. Cowan, J. Stechmiller, P. Phillips, Q.P. Yang and G. Schultz. Chronic Wounds, Biofilms and Use of
Medicinal Larvae, Ulcers, Article ID 487024, 7 pages; http://dx.doi.org/10.1155/2013/487024, 2013.
Before Larval Debridement
SA35556 3 day mature biofilm culture on pig skin explant
After Larval Debridement
SA35556 biofilm culture 24 hours after LDT
Before Larval Debridement
PA01 (3 day mature biofilm culture on pig skin explant)
After Larval Debridement
PA01 biofilm culture 24 hours after LDT
Evidence for larval therapy





Enzymatic secretions
Antimicrobial secretions
Effective debridement of necrotic tissue
Not disruptive of healthy tissue
No known bacterial resistance
Innovation: Biofilm Detector Dye
Cowan, L., Schultz, G., Gibson, D., Yang, Q.,
 Proof of concept in vitro studies completed
April 2014
 Using dental plaque dye to stain biofilm for
clinical visualization
 Visualization of biofilm allows more effective
treatment (removal of biofilm) and treatment
monitoring

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
• 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.
Future directions
Effective wound bed
preparation
T-I-M-E* principles in practice
Anti-biofilm strategies
Including Larval Debridement Therapy (LDT)
Biofilm Detector Dye
Animal studies and human studies
Targeted multiple factor approach
Combination therapies: disruption or removal of biofilm
(such as LDT) + antimicrobials
Human RCT in progress: LDT vs. bedside sharp
debridement against biofilm
Schultz, G & Dowsett, C. (2012). Wound bed preparation revisited. Wounds International, 3(1). Available
at: http://www.woundsinternational.com/practice-development/wound-bed-preparation-revisited/page-2 )
PU Treatment
PU Treatments
AHRQ: Pressure Ulcer Treatment Strategies:
Comparative Effectiveness Review Number 90 (May
8, 2013).
 Interprofessional team of expert authors. Contains
488 pages.
 http://effectivehealthcare.ahrq.gov/search-forguides-reviews-andreports/?pageaction=displayproduct&productID=14
91


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.
Evidence for Tx
Moderate






Air-fluidized beds
Alternating pressure
beds
Protein-containing
nutritional supplements
Hydrocolloid compared
to foam
Radiant heat compared
with other dressings
(stage III-IV ulcers)
Electrical stimulation
Low










NPWT
Low air loss beds vs. foam
Vitamin C
Platelet derived growth
factor
Topical collagen compared
to hydrocolloid or standard
care
Therapeutic ultrasound
Electromagnetic therapy
Light therapy
Laser therapy
Hydrotherapy
Insufficient Evidence







Alternating pressure chair cushions
Zinc
Comparison of different wound dressings
Debriding enzymes compared with dressings or
other topical therapies (few studies)
Topical phenytoin
Biological 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!)
Summary
Maggots are our friends
PU prevention starts with education and
appropriate risk assessment
 Preventive interventions should be
Evidence-Based and will likely never replace
attentive care & repositioning
 PU 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.

