CLINICAL EFFICACY: KNOWING WHAT WORKS

1. CLINICAL EFFICACY: KNOWING WHAT WORKS Laura Bolton, PhD, FAPWCA Adj. Assoc. Professor  Department of Surgery (Bioengineering) UMDNJ, New Brunswick, NJ

2. Rationale •  Clinicians use evidence to supplement clinical judgment to improve… • Consistency and quality of care • Patient and wound outcomes • Clear scientific method proves efficacy • Misuse of the term “efficacy” confuses all • More accurate efficacy communication helps: • Professionals support and implement care decisions • Patients receive care that works • Institutions deliver consistent high quality care

3. Educational Objectives Of this Literature Review • Define wound care efficacy • Locate evidence of efficacy • Recognize good quality efficacy evidence • List example aspects of chronic wound care with sound evidence of efficacy

4. Methods • Study Design: Literature review • Procedure: • Literature search of MEDLINE, Cochrane, AHRQ, and Google databases for terms: • “definition clinical (or wound) efficacy” • “clinical (or wound) evidence source” • “strength of evidence” and “evidence criteria” • “improve wound care outcomes”. • Included references on efficacy • Excluded those on safety only

5. Efficacy Evidence defined1 • “That which proves or disproves something; • ground for belief; • proof” 1RWebster’s College Dictionary, Random House, McGraw-Hill Edition, 1976

6. Definitions of Efficacy in Health Care AHRQ1: Whether a drug or other treatment works under the best possible conditions: • Study participants carefully selected: May differ from general public who have the disease • Agent applied and stored properly. • Treatment with efficacy under best conditions may not work as well in a different group with same disease. FDA2 : A properly conducted randomized controlled trial (RCT) compares test intervention to a standard of care as proof of its comparative efficacy. IOM3: Efficacy RCTs answer: “Does Agent A work?” Effectiveness trials answer: “Is A better than B in practice?” • www.effectivehealthcare.ahrq.gov/index.cfm/glossary-of-terms/ • www.fda.gov/cder/guidance/ 5512/fnl.pdf ;Accessed May 1, 2009 • www.annals.org/content/151/3/203.full; Accessed April 2, 2010

7. AHRQ Criteria for Distinguishing Between Efficacy and Effectiveness (sensitivity =0.83; specificity = 0.721 Gartlehner G, et al. AHRQ Publication No. 06-0046. Rockville, MD: Agency for Healthcare Research and Quality. April 2006

8. Results: Mining the treasure that proves efficacy: http://…. • Cochrane Initiative: Systematic reviews, reports • www.cochrane.org/ • Joanna Briggs Initiative: Best practice summaries • joannabriggs.www.edu.au/pubs/best_practice.php • Core Library of Evidence Based Practice: Articles • http://74.125.93.132/search?q=cache:O-z76YXoSKYJ: www.shef.ac.uk/scharr/ir/core.html+UK+evidence • Agency for Healthcare Research&Quality: Initiatives • www.ahrq.gov/clinic/epcix.htm • National Library of Med. (MEDLINE): Abstracts • www.ncbi.nlm.nih.gov/PubMed/ • National Guideline Clearinghouse: Guidelines • www.guideline.gov/ • Clinical trials: clinicaltrials.gov

9. Results: Recognizing efficacy evidence that is treasure to improve patient outcomes1,2 • Treatment effects compared to • Consistent best practice standard • Well-blinded sham or placebo control • Patients assigned randomly to treatment • Independent blinded comparison • Efficacy and safety measured and reported • Valid outcomes measured reliably • Clinically relevant, patient-centered • Representative, relevant patient samples • Adequate timing and scope of follow up 1Jaeschke R et al. Adv Wound Care, 1998; 11(5):214-218 2Van Rijswijk L. Pediatric Nursing, 1990; 2(3):158-161.

10. Results: “Grading” Efficacy EvidenceMore detail at AHRQ Website: http://www.ahrq.gov/clinic/epcsums/strengthsum.htm RCTs SR, MA Convenience or Historical Controlled CT Or Relevant Animal CT Case Controlled Studies, Case Studies, Uncontrolled Models (Usually in vivo > in vitro) Systematically Validated Opinion Consensus Statement Individual Opinion

11. Results: Wielding Efficacy Evidence Use of current best evidence to inform decisions about the care of an individual patient.1 1Sackett DL et al. Br Med J, 1997; 312:71-77.

12. Results:Evidence Quality and How to Use It LOW Generate Research Support Practice • Opinion or consensus of opinion • Observation or description • Measured observation • " on defined set of patients • " on " given standard practice • " on " comparing >1 standard " • " on " " randomly assigned " See also: Meakins J. Amer J Surgery 2002;183:399 Gray M. et al. JWOCN 2004; 31(2):53-61. HIGH

13. Conclusions: Example Steps with Efficacy in Chronic Wound Management: Pressure Ulcers1-4 • Address causes of tissue damage • prolonged pressure, friction, sheer1-4 • nutritional deficiencies1-4 • Wound bed • Debride necrotic tissue4 • Treat local or distant infection2 • Protect skin from • excess moisture or dryness1,3,4 • chemical or physical trauma1,3,4 • Maintain a moist wound environment1-4 Pressure ulcer treatment & prevention guidelines: AHRQ,1 WHS2 and WOCN3 4Kerstein et al. Disease Management Health Outcomes, 2001; 9(11):651-663

14. Conclusions continuedSteps with Venous Ulcer Management Efficacy1,2,3 • Diagnose and correct the cause • Rule out arterial cause: • Ankle/brachial index (ABI) > 0.9 • ABI 0.7-0.9 compress with care • Sustained, graduated, high, 2- to 4- layer elastic compression • Elevate limb, flex ankle or walk • Elastic stockings prevent recurrence • Manage exudate and dermatitis • Moist wound environment4 Pressure ulcer treatment & prevention guidelines: AAWC,1 WHS2 and WOCN3 4Kerstein et al. Disease Management Health Outcomes, 2001; 9(11):651-663

15. Conclusions, continued: Steps with Arterial Ulcer Management Efficacy1,2 • Diagnose, correct related conditions1,2 • Peri-wound TcPO2 < 20 mmHg predicts non-healing1 • Vascular specialist locate, correct arterial blockage • Prompt referral if rest pain and/or gangrene2 • Remove necrotic tissue • limit microorganisms2 • Avoid nicotine1,2 1Hopf H. et al.Wound Rep Regen, 2006; 14: 693-710. (WHS Guideline) 2Kerstein MD. Ostomy/Wound Mgmt 1996; 42(10A Suppl):19S-35S

16. Conclusions, continued: Steps with Diabetic Foot Ulcer Care Efficacy1,2,3,4 • Diagnose and correct the cause • Control diabetes (HbA1c < 6.5%) • ABI > 0.9 rules out arterial insufficiency • ABI > 1.3  rigid vessel wall; use great toe • No ABI, use TcPO2 > 40 mmHg • Check for neuropathy • Semmes-Weinstein 10 g (#5.07) fiber • Protect skin and off load consistently • Wound/Skin: • Gel debridement speeds DFU healing4 • No healing progress: suspect infection • Moist wound environment3 1Steed et al. Wound Rep Reg (2006) 14 680–692 (WHS Guideline) 2Crawford et al. WOCN Guideline 3 Lower extremity neuropathic disease 3Boulton et al. Wound Rep Reg 1999;7:7-16 42Smith J, Thow J. The Diabetic Foot 2003; 6(1):12-16