Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Medical Informatics and Decision Making
Published in: BMC Medical Informatics and Decision Making 2/2013

Open Access 01-11-2013 | Review

Establishing the effectiveness of patient decision aids: key constructs and measurement instruments

Authors: Karen R Sepucha, Cornelia M Borkhoff, Joanne Lally, Carrie A Levin, Daniel D Matlock, Chirk Jenn Ng, Mary E Ropka, Dawn Stacey, Natalie Joseph-Williams, Celia E Wills, Richard Thomson

Published in: BMC Medical Informatics and Decision Making | Special Issue 2/2013

Login to get access

Abstract

Background

Establishing the effectiveness of patient decision aids (PtDA) requires evidence that PtDAs improve the quality of the decision-making process and the quality of the choice made, or decision quality. The aim of this paper is to review the theoretical and empirical evidence for PtDA effectiveness and discuss emerging practical and research issues in the measurement of effectiveness.

Methods

This updated overview incorporates: a) an examination of the instruments used to measure five key decision-making process constructs (i.e., recognize decision, feel informed about options and outcomes, feel clear about goals and preferences, discuss goals and preferences with health care provider, and be involved in decisions) and decision quality constructs (i.e., knowledge, realistic expectations, values-choice agreement) within the 86 trials in the Cochrane review; and b) a summary of the 2011 Cochrane Collaboration’s review of PtDAs for these key constructs. Data on the constructs and instruments used were extracted independently by two authors from the 86 trials and any disagreements were resolved by discussion, with adjudication by a third party where required.

Results

The 86 studies provide considerable evidence that PtDAs improve the decision-making process and decision quality. A majority of the studies (76/86; 88%) measured at least one of the key decision-making process or decision quality constructs. Seventeen different measurement instruments were used to measure decision-making process constructs, but no single instrument covered all five constructs. The Decisional Conflict Scale was most commonly used (n = 47), followed by the Control Preference Scale (n = 9). Many studies reported one or more constructs of decision quality, including knowledge (n = 59), realistic expectation of risks and benefits (n = 21), and values-choice agreement (n = 13). There was considerable variability in how values-choice agreement was defined and determined. No study reported on all key decision-making process and decision quality constructs.

Conclusions

Evidence of PtDA effectiveness in improving the quality of the decision-making process and decision quality is strong and growing. There is not, however, consensus or standardization of measurement for either the decision-making process or decision quality. Additional work is needed to develop and evaluate measurement instruments and further explore theoretical issues to advance future research on PtDA effectiveness.
Literature
1.
Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T: Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006, 333: 417-10.1136/bmj.38926.629329.AE.PubMedCentralCrossRefPubMed
2.
Entwistle V, Mulley A, O'Connor A, Marteau T, Kennedy A, Sepucha K: Establishing the Effectiveness. In the International Patient Decision Aid Standard (IPDAS) Collaboration's. 2005, [see http://​www.​ipdas.​ohri.​ca/​resources], Original Background Document
3.
Bennett C, Graham I, Kristjansson E, Kearing S, Clay KF, O'Connor A: Validation of a preparation for decision making scale. Patient Educ Couns. 2010, 78: 130-133. 10.1016/j.pec.2009.05.012.CrossRefPubMed
4.
O'Connor AM: Validation of a decisional conflict scale. Med Decis Making. 1995, 15: 25-30. 10.1177/0272989X9501500105.CrossRefPubMed
5.
Lerman C, Brody D, Caputo G, Smith D, Lazaro C, Wolfson H: Patients' perceived involvement in care scale: relationship to attitudes about illness and medical care. J Gen Intern Med. 1990, 5: 29-33. 10.1007/BF02602306.CrossRefPubMed
6.
Degner LF, Sloan JA: Decision making during serious illness: what role do patietns really want to play?. J Clin Epidemiol. 1992, 45: 941-950. 10.1016/0895-4356(92)90110-9.CrossRefPubMed
7.
O'Connor A, Drake E, Wells G, Tugwell P, Laupacis A, Elmslie T: A survey of the decision-making needs of Canadians faced with complex health decisions. Health Expect. 2003, 6: 97-109. 10.1046/j.1369-6513.2003.00215.x.CrossRefPubMed
8.
O'Connor AM, Stacey D, Entwistle V, Llewellyn-Thomas H, Rovner D, Holmes-Rovner M, Tait V, Tetroe J, Fiset V, Barry M, Jones J: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2003, 2: CD001431-PubMed
9.
Briss P, Rimer B, Reilley B, Coates RC, Lee NC, Mullen P, Corso P, Hutchinson AB, Hiatt R, Kerner J, George P, White C, Gandhi N, Saraiya M, Breslow R, Isham G, Teutsch SM, Hinman AR, Lawrence R: Promoting informed decisions about cancer screening in communities and healthcare systems. Am J Prev Med. 2004, 26: 67-80. 10.1016/j.amepre.2003.09.012.CrossRefPubMed
10.
O'Connor A, Llewellyn-Thomas H, Sawka C, Pinfold S, To T, Harrison D: Physicians' opinions about decision aids for patients considering systemic adjuvant therapy for axillary-node negative breast cancer. Patient Educ Couns. 1997, 30: 143-153. 10.1016/S0738-3991(96)00948-2.CrossRefPubMed
11.
Ratliff A, Angell M, Dow RW, Kuppermann M, Nease RF, Fisher R, Fisher ES, Redelmeier DA, Faughnan ME, Rimer BK, Pauker SP, Pauker SG, Sox HC: What is a good decision?. Effective clinical practice. 1999, 2: 185-197.PubMed
12.
Sepucha K, Fowler FJ, Mulley AG: Policy support for patient-centered care: the need for measurable improvements in decision quality. Health Aff (Millwood). 2004, VAR54-62-Suppl Web Exclusive
13.
Sepucha KR, Levin CA, Uzogara EE, Barry MJ, O'Connor AM, Mulley AG: Developing instruments to measure the quality of decisions: early results for a set of symptom-driven decisions. Patient Educ Couns. 2008, 73: 504-510. 10.1016/j.pec.2008.07.009.CrossRefPubMed
14.
Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Légaré F, Thomson R: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011, CD001431-10.1002/14651858.CD001431.pub3. 10
15.
King JS, Moulton BW: Rethinking informed consent: the case for shared medical decision-making. Am J Law Med. 2006, 32: 529-501.
16.
Thomson R, Murtagh M, Khaw FM: Tensions in public health policy: patient engagement, evidence-based public health and health inequalities. Qual Saf Health Care. 2005, 14: 398-400. 10.1136/qshc.2005.014175.PubMedCentralCrossRefPubMed
17.
Politi M, Clark M, Ombao H, Dizon D, Elwyn G: Communicating uncertainty can lead to less decision satisfaction: a necessary cost of involving patients in shared decision making?. Health Expect. 2011, 14: 84-91. 10.1111/j.1369-7625.2010.00626.x.PubMedCentralCrossRefPubMed
18.
Say R, Murtagh M, Thomson R: Patients' preference for involvement in medical decision making: a narrative review. Patient Educ Couns. 2006, 60: 102-10.1016/j.pec.2005.02.003.CrossRefPubMed
19.
Quill T, Cassel C: Non-abandonment: a central obligation for physicians. Ann Intern Med. 1995, 122: 368-74. 10.7326/0003-4819-122-5-199503010-00008.CrossRefPubMed
20.
Von Neumann J, Morgenstern O: Theory of Games and Economic Behavior. 1947, New York: Wiley
21.
22.
Tversky A, Kahneman D: Judgement under uncertainty: heuristrics and biases. Science. 1974, 185: 1124-1131. 10.1126/science.185.4157.1124.CrossRefPubMed
23.
Elwyn G, Miran-Shatz T: Deliberation before determination: the definition and evaluation of good decision making. Health Expect. 2010, 13: 139-47.CrossRefPubMed
24.
Feldman-Stewart D, Tong C, Siemens R, Alibhai S, Pickles T, Robinson J, Brundage M: The impact of explicit values clarification exercises in a patient decision aid emerges after the decision is actually made: evidence from a randomized controlled trial. Med Decis Making. 2012, 32: 616-626. 10.1177/0272989X11434601.CrossRefPubMed
25.
National Research Council: Crossing the Quality Chasm: A New Health System for the 21st Century. 2001, Washington DC: The National Academies Press
26.
27.
28.
29.
Anonymous: Health and Social Care Bill. 2011, 132-EN(House of Commons)
30.
31.
Harter M, van der Weijden T, Elwyn G: Policy and practice developments in the implementation of shared decision making: An international perspective. Z Evid Fortbild Qual Gesundhwes. 2011, 227-326.
32.
Arterburn D, Wellman R, Westbrook E, Rutter C, Ross T, McCulloch D, Handley M, Jung C: Introducing decision aids at group health was linked to sharply lower hip and knee surgery rates and costs. Health Aff (Millwood). 2012, 31: 2094-2104. 10.1377/hlthaff.2011.0686.CrossRef
33.
Degner L, Sloan JA, Venkatesh P: The control preferences scale. Can J Nurs Res. 1997, 29: 21-43.PubMed
34.
Ende J, Kazis L, Ash A, Moskowitz M: Measuring patients' desire for autonomy: decision making and information-seeking preferences among medical patients. J Gen Intern Med. 1989, 4: 23-30. 10.1007/BF02596485.CrossRefPubMed
35.
Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I: The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003, 50: 311-322. 10.1016/S0738-3991(03)00055-7.CrossRefPubMed
36.
Lalonde L, O'Connor A, Duguay P, Brassard J, Drake E, Grover S: Evaluation of a decision aid and a personal risk profile in community pharmacy for patients considering options to improve cardiovascular health: the OPTIONS pilot study. Int J Pharm Pract. 2006, 14: 51-62. 10.1211/ijpp.14.1.0007.CrossRef
37.
England S, Evans J: Patients' choices and perceptions after an invitation to participate in treatment decisions. Soc Sci Med. 1992, 34: 1217-1225. 10.1016/0277-9536(92)90314-G.CrossRef
38.
Deber R, Kraetschmer N, Irvine J: What role do patients wish to play in treatment decision making?. Arch Intern Med. 1996, 156: 1414-1420. 10.1001/archinte.1996.00440120070006.CrossRefPubMed
39.
Barry MJ, Cherkin DC: A randomized trial of a multimedia shared decision-making program for men facing a treatment decision for benign prostatic hyperplasia. Dis Manag Clin Outcome. 1997, 1: 5-14.CrossRef
40.
Holmes-Rovner M, Kroll J, Schmitt N, Rovner D, Breer M, Rothert M, Padonu G, Talarczyk G: Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996, 16: 58-64. 10.1177/0272989X9601600114.CrossRefPubMed
41.
Bekker H, Hewison J, Thornton JG: Applying decision analysis to facilitate informed decision making about prenatal diagnosis for Down syndrome: a randomised controlled trial. Prenat Diagn. 2004, 24: 265-275. 10.1002/pd.851.CrossRefPubMed
42.
43.
Ward S, Griffin J: Developing a test of knowledge of surgical options for breast cancer. Cancer Nurs. 1990, 13: 191-196. 10.1097/00002820-199006000-00009.CrossRefPubMed
44.
Stalmeier P, Unic I, Verhoef L, Van Daal W: Evaluation of a shared decision making program for women suspected to have a genetic predisposition to breast cancer: preliminary results. Med Decis Making. 1999, 19: 230-241. 10.1177/0272989X9901900302.CrossRefPubMed
45.
Mathieu E, Barratt A, Davey H, McGeechan K, Howard K, Houssami N: Informed choice in mamography screening: a randomized trial of a decision aid for 70-year-old women. Arch Intern Med. 2007, 167: 2039-2046. 10.1001/archinte.167.19.2039.CrossRefPubMed
46.
Nagle C, Gunn J, Bell R, Lewis S, Meiser B, Metcalfe S, Ukoumunne O, Halliday J: Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial. BJOG. 2008, 115: 339-347. 10.1111/j.1471-0528.2007.01576.x.CrossRefPubMed
47.
Wakefield C, Meiser B, Homewood J, Taylor A, Gleeson M, Williams R, Tucker K, Australian GENetic testing Decision Aid Collaborative Group: A randomized trial of a breast/ovarian cancer genetic testing decision aid used as a communication aid during genetic counseling. Psychooncology. 2008, 17: 844-854. 10.1002/pon.1353.CrossRefPubMed
48.
Wakefield C, Meiser B, Homewood J, Ward R, O'Donnell S, Kirk J, Australian GENetic testing Decision Aid Collaborative Group: Randomised trial of a decision aid for individuals considering genetic testing for hereditary nonpolyposis colorectal cancer risk. Cancer. 2008, 115: 956-965.CrossRef
49.
Wakefield C, Meiser B, Homewood J, Peate M, Taylor A, Lobb E, Kirk J, Young M, Williams R, Dudding T, Tucker K, AgenDA Collaborative Group: A randomized controlled trial of a decision aid for women considering genetic testing for breast and ovarian cancer risk. Breast Cancer Res Treat. 2008, 107: 289-301. 10.1007/s10549-007-9539-2.CrossRefPubMed
50.
Trevena L, Irwig L, Barratt A: Randomized trial of a self-administered decision aid for colorectal cancer screening. J Med Screen. 2008, 15: 76-82. 10.1258/jms.2008.007110.CrossRefPubMed
51.
Rothert M, Holmes-Rovner M, Rovner D, Kroll J, Breer L, Talarczyk G, Schmitt N, Padonu G, Wills C: An educational intervention as decision support for menopausal women. Res Nurs Health. 1997, 20: 377-387. 10.1002/(SICI)1098-240X(199710)20:5<377::AID-NUR2>3.0.CO;2-L.CrossRefPubMed
52.
Shorten A, Shorten B, Keogh J, West S, Morris J: Making choices for childbirth: a randomized controlled trial of a decision-aid for informed birth after cesarean. Birth. 2005, 32: 252-261. 10.1111/j.0730-7659.2005.00383.x.CrossRefPubMed
53.
Frosch D, Bhatnagar V, Tally S, Hamori C, Kaplan R: Internet patient decision support: a randomized controlled trial comparing alternative approaches for men considering prostate cancer screening. Arch Intern Med. 2008, 168: 363-369. 10.1001/archinternmed.2007.111.CrossRefPubMed
54.
O'Connor A, Wells G, Tugwell P, Laupacis A, Elmslie T, Drake E: The effects of an 'explicit' values clarification exercise in a women's decision aid regarding postmenopausal hormone therapy. Health Expect. 1999, 2: 21-32. 10.1046/j.1369-6513.1999.00027.x.CrossRefPubMed
55.
Legare F, Dodin S, Stacey D, Leblanc A, Tapp S: Patient decision aid on natural health products for menopausal symptoms: randomized controlled trial. Menopause Int. 2008, 14: 105-110. 10.1258/mi.2008.008014.PubMed
56.
Sepucha KR, Stacey D, Clay CF, Chang Y, Cosenza C, Dervin G, Dorrwachter J, Feibelmann S, Katz JN, Kearing SA, Malchau H, Taljaard M, Tomek I, Tugwell P, Levin CA: Decision quality instrument for treatment of hip and knee osteoarthritis: A psychometric evaluation. BMC Musculoskelet Disord. 2011, 12: 1-12.CrossRef
57.
Sepucha KR, Feibelmann S, Abdu W, Clay CF, Cosenza C, Kearing S, Levin CA, Atlas SJ: Psychometric Evaluation of a Decision Quality Instrument for Treatment of Lumbar Herniated Disc. Spine. 2012, 37: 1609-1616. 10.1097/BRS.0b013e3182532924.CrossRefPubMed
58.
Sepucha KR, Belkora JK, Chang Y, Cosenza C, Levin CA, Moy B, Partridge A, Lee CN: Measuring decision quality: A psychometric evaluation of new instrument for breast cancer surgery. BMC Med Inform Decis Mak. 2012, 12: 51-10.1186/1472-6947-12-51.PubMedCentralCrossRefPubMed
59.
Scholl I, Koelewijn-van Loon M, Sepucha K, Elwyn G, Härter M, Dirmaier J: Measurement of shared decision-making - a review of instruments. Z Evid Fortbild Qual Gesundhwes. 2011, 105: 314-324.CrossRef
60.
Murtagh M, Thomson R, May C, Rapley T, Heaven B, Graham RH, Kaner EF, Stobbart L, Eccles M: Qualitative methods in a randomised controlled trial: the role of an integrated qualitative process evaluation in providing evidence to discontinue the intervention in one arm of a trial of a decision support tool. QSHC. 2007, 16: 224-229.
61.
Lewin S, Glenton C, Oxman AD: Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009, 339 (b3496):
62.
Fitzpatrick R, Davey C, Buxton MJ, Jones DR: Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998, 2: 1-74.PubMed
63.
Sepucha K, Fagerlin A, Couper M, Levin C, Singer E, Zikmund-Fisher B: How does feeling informed related to being informed? Results from the DECISIONS study. Med Decis Making. 2010, 30: 77S-84S. 10.1177/0272989X10379647.CrossRefPubMed
64.
Wunderlich T, Cooper G, Divine G, Flocke S, Oja-Tebbe N, Stange K, Elston-Lafata J: Inconsistencies in patient perceptions and observer ratings of shared decision making: the case of colorectal cancer screening. Patient Educ Couns. 2010, 80: 358-363. 10.1016/j.pec.2010.06.034.PubMedCentralCrossRefPubMed
65.
Moser RP, Shaikh AR, Courtney P, Morgan G, Auguston E, Kobrin S, Levin KY, Helbra C, Garner DDM, Coa K: Grid-enabled measures: using Science 2.0 to standardize measures and share data. Am J Prev Med. 2011, 50: S134-S143.CrossRef
Metadata
Title
Establishing the effectiveness of patient decision aids: key constructs and measurement instruments
Authors
Karen R Sepucha
Cornelia M Borkhoff
Joanne Lally
Carrie A Levin
Daniel D Matlock
Chirk Jenn Ng
Mary E Ropka
Dawn Stacey
Natalie Joseph-Williams
Celia E Wills
Richard Thomson
Publication date
01-11-2013
Publisher
BioMed Central
DOI
https://doi.org/10.1186/1472-6947-13-S2-S12

Other articles of this Special Issue 2/2013

BMC Medical Informatics and Decision Making 2/2013 Go to the issue

Review

Delivering patient decision aids on the Internet: definitions, theories, current evidence, and emerging research areas

Review

Coaching and guidance with patient decision aids: A review of theoretical and empirical evidence

Review

Disclosing conflicts of interest in patient decision aids

Review

Providing information about options in patient decision aids

Review

Do personal stories make patient decision aids more effective? A critical review of theory and evidence

Review

Balancing the presentation of information and options in patient decision aids: an updated review