1. 1 Translating evidence for patient decision making using international standards Dawn Stacey RN, PhD Assistant Professor University of Ottawa STIRRHS KT Workshop, April 2007

2. 2 Outline VBAC case example Patient decision aids IPDAS standards for patient decision aids Tools to facilitate translating evidence for patient decision making Future directions

3. 3 Case study A 31 year old relative is pregnant with her 2 nd child. Eighteen months ago she had an emergency cesarean because the infant was breech with the cord around its neck. Her physician said she can have a vaginal birth but there are risks to consider. She is concerned about the recovery from another cesarean now that she is also having to care for a toddler. She is not sure what to do and asks you to help her with the decision.

4. 4

5. 5 Decisional Conflict uncertainty about which course of action to take when choice among competing actions involves risk, loss, regret, or challenge to personal life values NANDA, 2002 yes no

6. 6 ‘Modifiable’ contributing factors Knowledge & Expectations Values Clarity Support & Resources

7. 7 Consequences: unresolved decisional conflict & related factors 59 times more likely to change mind 23 times more likely to delay decision 5 times more likely to have regret 3 times more likely to fail knowledge test 19% more likely to blame practitioner for bad outcomes Sun, Q. [MSc thesis]. University of Ottawa, 2005. Gattelari & Ward J Med Screen 2004;11:165-169

8. 8 Decision Quality Researcher opinions Mulley, Sepucha Health Affairs, 2004;Suppl Web Exclusive:VAR54-62 Briss, Rimer, Reilley, Coates, Lee, Mullen, ( US-CDC) Am J Prev Med 2004;26:67-80 Ratliff, Angell, Dow, Kupperman, Nease, Fisher, Fisher, Redelmeier, Faughnan, Rimer, Pauker, Pauker, Sox. Effective Clinical Practice 1999;2:185-97 O’Connor Med Decision Making 1995;15:25-30.; Nursing Diagnosis and Interventions 1989; JNCI 1999 Public survey Health Expectations 2003;6:97-109 Physician survey Patient Education and Counseling. 30:143-153, 1997 International Patient Decision Aids Standards Collaboration 2005 www.ohri.ca/decisionaid informed values-based

9. Inform Provide facts Condition, options, benefits, harms Communicate probabilities Clarify values Patient experience Ask which benefits/harms matters most Facilitate communicationSupport Guide in steps in deliberation/communication Worksheets, list of questions Patient Decision Aids Patient Decision Aids adjuncts to counseling

10. 10 CochraneSystematic review of 55 trials of patient decision aids O’Connor et al., Cochrane Library, 2007

11. Topics of Decision Aids Topics of Decision Aids (N=51) Medical: –9 HRT –2 atrial fib. anti-coag. –1 hypertension –1 osteoporosis –1 chemotherapy Surgical: –4 mastectomy –3 prostatectomy –2 hysterectomy –2 dental –1 circumcision Screening: –8 PSA –4 BRCA1/2 gene –3 Colon cancer –2 prenatal Obstetrics: –1 VBAC –1 termination Vaccine –1 infant –1 hepatitis B Other: –1 pre-op autologous blood donation O’Connor et al., Cochrane Library, 2007

12. 12 Compared to standard care, PtDAs… Improve decision quality 15% higher knowledge scores 70% more realistic expectations (probabilities) better match between values & choices Reduce decisional conflict (9 points) Help undecided to decide (50%) Patients 40% less passive in decisions Reduce over-use -25% surgery; -20% PSA; -29% HRT Potential to reduce under- use O’Connor et al., Cochrane Library, 2007

13. 13 Decisional Conflict Breast Ca Surgery Decisional Conflict Breast Ca Surgery n=187 T1 base T2 Post video T3 Post consult with surgeon DHMC data source: Collins 2007

14. Other Results More conservative results when detailed PtDAs compared to simpler ones Minimal/no impact –Satisfaction –Anxiety –Health outcomes, not linked to values

15. 15 Kennedy et al. JAMA2002; 288: 2701-2708

16. 16 International Patient Decision Aid Standards (IPDAS) Collaboration What was the goal of the project? To establish an internationally approved set of criteria to determine the quality of patient decision aids. These criteria are helpful to a wide variety of individuals and organizations that use and/or develop patient decision aids. For example: –Patients –Practitioners –Developers –Researchers –Policy makers or payers To learn more about the process visit us at: www.ohri.ca/decisionaid www.ohri.ca/decisionaid Home What are Patient Decision Aids? Who’s Involved? Contact Us (Elwyn et al., (2006) in BMJ 333(7565):417)

17. 17 Essential ContentEssential Content –Information –Probabilities –Values clarification –Guidance Effectiveness CriteriaEffectiveness Criteria –Decision process –Decision quality Generic CriteriaGeneric Criteria –Development process –Disclosure –Balance presentation –Plain language –Up to date evidence –Internet delivery International Patient Decision Aid Standards (IPDAS) Collaboration: Quality Criteria International Patient Decision Aid Standards (IPDAS) Collaboration: Quality Criteria (Elwyn et al., (2006) in BMJ 333(7565):417)

18. 18 Translating the evidence for patient decision making

19. 19 IPDAS Template for Developing Patient Decision Aids 1.Clarifies the decision 2.Provides information on options, including probabilities if available 3.Helps patients consider their values associated with the benefits and risks of each option 4.Assesses decision quality 5.Plans the next steps

20. 20 Authors and Editors: J Brownlee, M Walker, C Nimrod, Q Yang, S Wen, S Caughey, L Oppenheimer, K Eden & OHSU Evidence-based Practice Center, A O’Connor, S Khangura, C Bennett, A Saarimaki; Funder: Canadian Institutes of Health Research (CIHR) Date: 2006; For more information on this and other decision aids, visit http://decisionaid.ohri.cahttp://decisionaid.ohri.ca

21. 21 Presents probabilities of outcomes related to options

22. 22 The patient decision aid presents probabilities … No Yes 1.…using event rates… X 2. …using the same denominator X 3. …over the same period of time X 4. …with uncertainty X 5. …using visual diagrams (e.g. faces, bar charts) X 6. …using the same scales X 7. …with more than 1 way of viewing probabilities (e.g. words, numbers, diagrams). X 8. …based on patient’s own situation (e.g. specific to their age or severity of their disease) X 9. …using both positive and negative frames X IPDAS presenting probabilities (Elwyn et al., (2006) in BMJ 333(7565):417)

23. 23 Presents probabilities of outcomes related to options

24. 24 Rates Evidence Quality using STARS PLATINUM Systematic Review (meta-analysis) that is well-conducted and includes 2 or more randomised controlled trials GOLD Randomised controlled trial (1 or more) that tests at least 50 people with a treatment and 50 people without the treatment SILVER Observational studies or studies that did not assign people randomly to groups who receive or do not receive the treatment BRONZE Expert opinion or reports of specific cases    

25. 25 Helps patients clarify values by benefits and harms of options Helps patients clarify values by benefits and harms of options

26. 26 The patient decision aid… NoYes 1.…describes the procedures and outcomes to help patients imagine what it is like to experience their physical, emotional, and social effects. X 2. …asks patients to consider which positive and negative features matter most X IPDAS Clarifying Values (Elwyn et al., (2006) in BMJ 333(7565):417)

27. 27 The patient decision aid… NoYes 1.…provide steps to make a decision X 2. …include tools [worksheet, list of questions] to discuss options with others X IPDAS Guide in Deliberation (Elwyn et al., (2006) in BMJ 333(7565):417)

28. 28 Assess Decision Quality

29. 29 IPDAS Establishing effectiveness There is evidence that the pt decision aid helps patients … NoYes DECISION PROCESS 1. …recognize that a decision needs to be made 2. …know about the available options 3. …know about different features of the options 4. …understand that values affect the decision 5. …be clear about which features of options matter most to them 6. …discuss values with their health practitioners 7. …become involved in decision making in ways they prefer DECISION QUALITY 8. …improves the match between the features that matter most to the informed patient and the option that is chosen. (Elwyn et al., (2006) in BMJ 333(7565):417)

30. 30 VBAC Decision Aid – RCT in Australia 99 women decision aid vs 92 controls Women exposed to decision aid had: –increased knowledge (75% vs 61%) –lower decisional conflict (23 % vs 30%) –no diff in VBAC rates (49% vs 47%) Preferences at 36 wks were not consistent with actual birth outcomes for many women Conclusions “strategies are required to equip practitioners to empower women so that they can translate informed preferences into practice” (Shorten et al., 2005; Birth 32:4)

31. 31 Implementing Patient Decision Support Internet access Internet access to patient decision to patient decision support tools support tools Practice Settings Helplines / Call Centers Shared Decision Making Centers (CA, US, AU, Chile) (CA, US) (CA, US, UK, Chile) Health Professional Curriculum Health Professional Curriculum (UOttawa, Humber College TO, Ontario NP Program, Pontificia Universidad de Chile)

32. 32 Evidence of efficacy - Cochrane Resource Use/Costs - Cochrane Library of PtDAs - Ottawa International Standards - IPDAS Service delivery models – care plans, consent Certification: Practitioners, Organization Decision Quality Measures Future Directions: Building Infrastructure (O’Connor et al., 2007 Tipping Point in Health Affairs)

33. 33 Standards: medical necessity includes patient preferences (e.g. knee replacement) Payment strategies: reward for shared decision making (not just utilization) Legal standards: change from consent for treatment to informed patient choice Accelerating Change (O’Connor et al., 2007 Tipping Point in Health Affairs)

34. 34 When have decision aids been used? More than one option 2+ active Rx e.g. lumpectomy vs mastectomy active Rx vs watchful waiting e.g. psa screening No clear “right choice” for everyone Best choice depends on patient values Need +++ deliberation ? to engage patients to participate in decisions about recommended options

35. 35 Treatment Decisions Reproductive Decisions Investigation Decisions Other Decisions Surgery (30%) Hysterectomy Tumour removal Back surgery BPH Prostate cancer Medications (27%) HRT Atrial Fibrillation Chemotherapy Lipid lowering Antidepressants Contraception (24%) Method Sterilization Abortion Adoption Pregnancy (5%) Delivery Breast feeding Diagnostic Testing (1%) Amniocentesis Radiography Ultrasound Screening PSA Maternal serum screen End of life care (0.5%) Placement of family member in a health facility (6%) Lifestyle (5%) Nutrition Weight loss Stress Smoking cessation Alcohol or drug addiction tx (O’Connor, Drake et al., Health Expectations, 2003)

36. 36 www.ohri.ca/decisionaid