Decision aids for people facing health treatment or screening decisions - PubMed (original) (raw)
Review
Decision aids for people facing health treatment or screening decisions
Dawn Stacey et al. Cochrane Database Syst Rev. 2017.
Update in
- Decision aids for people facing health treatment or screening decisions.
Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, Pacheco-Brousseau L, Finderup J, Gunderson J, Barry MJ, Bennett CL, Bravo P, Steffensen K, Gogovor A, Graham ID, Kelly SE, Légaré F, Sondergaard H, Thomson R, Trenaman L, Trevena L. Stacey D, et al. Cochrane Database Syst Rev. 2024 Jan 29;1(1):CD001431. doi: 10.1002/14651858.CD001431.pub6. Cochrane Database Syst Rev. 2024. PMID: 38284415 Review.
Abstract
Background: Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values.
Objectives: To assess the effects of decision aids in people facing treatment or screening decisions.
Search methods: Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008.
Selection criteria: We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids.
Data collection and analysis: Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision-making process.Secondary outcomes were behavioural, health, and health system effects.We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random-effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence.
Main results: We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high-quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate-quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low-quality evidence) compared to usual care.Regarding attributes related to the decision-making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD -9.28/100; 95% CI -12.20 to -6.36; 27 studies; N = 5707; high-quality evidence), indecision about personal values (MD -8.81/100; 95% CI -11.99 to -5.63; 23 studies; N = 5068; high-quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate-quality evidence).Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and/or the preparation for decision making compared to usual care.Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate-specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition-specific health outcomes. Studies did not report adverse events associated with the use of decision aids.In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup.
Authors' conclusions: Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost-effectiveness, and use with lower literacy populations.
Conflict of interest statement
Several of the investigators have developed patient decision aids (DS, FL, HL, MHR, MB, KE, RT, LT, KL), but none reviewed their own studies.
Within the last five years, two investigators (HL, MB) have received financial support from the not‐for‐profit Informed Medical Decisions Foundation (IMDF). MB serves on the Board of and received salary and grant support as President of the Foundation. In 2014, the Foundation merged with another not‐for‐profit, Healthwise. MB continues to receive salary and grant support as Chief Science Officer at Healthwise. Healthwise develops, licenses, and distributes patient decision aids. Several investigators (DS, FL, HL, MHR, MB, KE, RT, LT) who were involved in a special issue in BMC Medical Informatics and Decision Making that included a series of 14 papers focused on the theoretical and empirical evidence underlying the International Patient Decision Aid Standards (IPDAS), received partial funding from the Foundation to cover publishing costs.
Figures
1
Study flow diagram.
2
Risk of bias summary as percentages across all included studies.
3
Risk of bias summary for each included study.
4
Funnel plot of comparison: 1 Knowledge, outcome: 1.1 Knowledge ‐ all studies.
5
Funnel plot of comparison: 4.1 Decisional conflict: DA vs usual care ‐ all studies, outcome: 4.1.2 Uninformed subscale
6
Funnel plot of comparison: 4.1 Decisional conflict: DA vs usual care ‐ all studies, outcome: 4.1.3 Unclear subscale
1.1. Analysis
Comparison 1 Knowledge, Outcome 1 Knowledge ‐ all studies.
1.2. Analysis
Comparison 1 Knowledge, Outcome 2 Knowledge ‐ subgroup by timing of intervention (in consultation versus in preparation for consultation).
1.3. Analysis
Comparison 1 Knowledge, Outcome 3 Knowledge ‐ studies without high risk of bias.
2.1. Analysis
Comparison 2 Accurate risk perceptions, Outcome 1 Accurate risk perceptions ‐ all studies.
2.2. Analysis
Comparison 2 Accurate risk perceptions, Outcome 2 Accurate risk perceptions ‐ subgroup by timing of intervention (in consultation versus in preparation for consultation).
2.3. Analysis
Comparison 2 Accurate risk perceptions, Outcome 3 Accurate risk perceptions ‐ studies without high risk of bias.
3.1. Analysis
Comparison 3 Informed values‐choice congruence, Outcome 1 Informed values‐choice congruence ‐ all studies.
3.2. Analysis
Comparison 3 Informed values‐choice congruence, Outcome 2 Informed values‐choice congruence ‐ actual choice only.
3.3. Analysis
Comparison 3 Informed values‐choice congruence, Outcome 3 Informed values‐chose congruence ‐using MMIC.
3.4. Analysis
Comparison 3 Informed values‐choice congruence, Outcome 4 Informed values‐chose congruence ‐ heterogeneous measures.
3.5. Analysis
Comparison 3 Informed values‐choice congruence, Outcome 5 Informed values‐choice congruence ‐ without studies of high risk of bias.
4.1. Analysis
Comparison 4 Decisional conflict, Outcome 1 Decisional conflict ‐ all studies.
4.2. Analysis
Comparison 4 Decisional conflict, Outcome 2 Decisional conflict ‐ in consultation.
4.3. Analysis
Comparison 4 Decisional conflict, Outcome 3 Decisional conflict ‐ in preparation for consultation.
4.4. Analysis
Comparison 4 Decisional conflict, Outcome 4 Decisional conflict ‐ without studies having high risk of bias.
5.1. Analysis
Comparison 5 Participation in decision making, Outcome 1 Participation in decision making ‐ all studies.
5.2. Analysis
Comparison 5 Participation in decision making, Outcome 2 Participation in decision making ‐ in consultation.
5.3. Analysis
Comparison 5 Participation in decision making, Outcome 3 Participation in decision making ‐ in preparation for consultation.
6.1. Analysis
Comparison 6 Proportion undecided, Outcome 1 Proportion undecided ‐ all studies.
7.1. Analysis
Comparison 7 Satisfaction, Outcome 1 Satisfaction with the choice ‐ all studies.
7.2. Analysis
Comparison 7 Satisfaction, Outcome 2 Satisfaction with the choice ‐ in consultation.
7.3. Analysis
Comparison 7 Satisfaction, Outcome 3 Satisfaction with the choice ‐ in preparation for consultation.
7.4. Analysis
Comparison 7 Satisfaction, Outcome 4 Satisfaction with the decision making process ‐ all studies.
7.5. Analysis
Comparison 7 Satisfaction, Outcome 5 Satisfaction with the decision making process ‐ in consultation.
7.6. Analysis
Comparison 7 Satisfaction, Outcome 6 Satisfaction with the decision making process ‐ in preparation for consultation.
8.1. Analysis
Comparison 8 Choice, Outcome 1 Choice: surgery over conservative option.
8.2. Analysis
Comparison 8 Choice, Outcome 2 Choice for screening.
8.3. Analysis
Comparison 8 Choice, Outcome 3 Choice: diabetes medication (uptake new medication).
Update of
- Decision aids for people facing health treatment or screening decisions.
Stacey D, Légaré F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Stacey D, et al. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4. Cochrane Database Syst Rev. 2014. PMID: 24470076 Updated. Review.
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Mullan 2009 {published data only}
- Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, et al. The diabetes mellitus medication choice decision aid: a randomized trial. Archives of Internal Medicine 2009;169(17):1560‐8. - PubMed
Murray 2001a {published and unpublished data}
Murray 2001b {published and unpublished data}
Nagle 2008 {published data only}
- Nagle C, Gunn J, Bell R, Lewis S, Meiser B, Metcalfe S, et al. Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial. BJOG: An International Journal of Obstetrics and Gynaecology 2008;115(3):339‐47. - PubMed
Nassar 2007 {published data only}
- Nassar N, Roberts CL, Raynes‐Greenow CH, Barratt A, Peat B, Decision Aid for Breech Presentation Trial Collaborators. Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598]. BJOG: An International Journal of Obstetrics & Gynaecology 2007;114(3):325‐33. - PMC - PubMed
Oakley 2006 {published data only}
- Oakley S, Walley T. A pilot study assessing the effectiveness of a decision aid on patient adherence with oral bisphosphonate medication. Pharmaceutical Journal 2006;276(7399):536‐8.
Ozanne 2007 {published data only}
- Ozanne EM, Annis C, Adduci K, Showstack J, Esserman L. Pilot trial of a computerized decision aid for breast cancer prevention. Breast Journal 2007;13(2):147‐54. - PubMed
Partin 2004 {published and unpublished data}
Pignone 2000 {published data only}
- Pignone M, Harris R, Kinsinger L. Videotape‐based decision aid for colon cancer screening. A randomized, controlled trial. Annals of Internal Medicine 2000;133(10):761‐9. - PubMed
Protheroe 2007 {published data only}
- Protheroe J, Bower P, Chew‐Graham C. The use of mixed methodology in evaluating complex interventions: identifying patient factors that moderate the effects of a decision aid. Family Practice 2008;24(6):594‐600. - PubMed
- Protheroe J, Bower P, Chew‐Graham C, Peters TJ, Fahey T. Effectiveness of a computerized decision aid in primary care on decision making and quality of life in menorrhagia: results of the MENTIP randomized controlled trial. Medical Decision Making 2007;27(5):575‐84. - PubMed
Rubel 2010 {published data only}
- Rubel SK, Miller JW, Stephens RL, Xu Y, Scholl LE, Holden EW, et al. Testing the effects of a decision aid for prostate cancer screening. Journal of Health Communication 2010;15(3):307‐21. - PubMed
Ruffin 2007 {published data only}
- Ruffin MT, Fetters MD, Jimbo M. Preference‐based electronic decision aid to promote colorectal cancer screening: results of a randomized controlled trial. Preventive Medicine 2007;45(4):267‐73. - PubMed
Sawka 2012 {published and unpublished data}
- Sawka AM, Straus S, Rotstein L, Brierley JD, Tsang RW, Asa S, et al. Randomized controlled trial of a computerized decision aid on adjuvant radioactive iodine treatment for patients with early‐stage papillary thyroid cancer. Journal of Clinical Oncology 2012;30(23):2906‐11. - PubMed
Schroy 2011 {published data only}
Schwalm 2012 {published data only}
- Schwalm JD, Stacey D, Pericak D, Natarajan MK. Radial artery versus femoral artery access options in coronary angiogram procedures: randomized controlled trial of a patient‐decision aid. Circulation: Cardiovascular Quality and Outcomes 2012;5(3):260‐6. - PubMed
Schwartz 2001 {published data only}
- Schwartz MD, Benkendorf J, Lerman C, Isaacs C, Ryan‐Robertson A, Johnson L. Impact of educational print materials on knowledge, attitudes, and interest in BRCA1/BRCA2: testing among Ashkenazi Jewish women. Cancer 2001;92(4):932‐40. - PubMed
Schwartz 2009a {published data only}
Sheridan 2006 {published data only}
Sheridan 2011 {published data only}
- Sheridan SL, Draeger LB, Pignone MP, Rimer B, Bangdiwala SI, Cai J, Gizlice Z, Keyserling TC, Simpson RJ. The effect of a decision aid intervention on decision making about coronary heart disease risk reduction: secondary analyses of a randomized trial. BMC Medical Informatics and Decision Making 2014;14(14):1‐11. - PMC - PubMed
Shorten 2005 {published and unpublished data}
- 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(4):252‐61. - PubMed
Shourie 2013 {published data only}
Smith 2010 {published data only}
- Smith SK, Barratt A, Trevana L, Simpson JM, Jansen J, McCaffery KJ. A theoretical framework for measuring knowledge in screening decision aid trials. Patient Education and Counseling 2012;89:330‐6. - PubMed
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Stacey 2014a {published and unpublished data}
Steckelberg 2011 {published data only}
Taylor 2006 {published data only}
- Taylor KL, Davis JL 3rd, Turner RO, Johnson L, Schwartz MD, Kerner JF, et al. Educating African American men about the prostate cancer screening dilemma: a randomized intervention. Cancer Epidemiology, Biomarkers & Prevention 2006;15(11):2179‐88. - PubMed
Thomson 2007 {published data only}
Trevena 2008 {published data only}
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Vandemheen 2009 {published data only}
- Vandemheen KL, O'Connor A, Bell SC, Freitag A, Bye P, Jeanneret A, et al. Randomized trial of a decision aid for patients with cystic fibrosis considering lung transplantation. American Journal of Respiratory & Critical Care Medicine 2009;180(8):761‐8. - PubMed
Van Peperstraten 2010 {published data only}
- Kreuwel I, Peperstraten A, Hulscher M, Kremer J, Grol R, Nelen W, Hermens R. Evaluation of an effective multifaceted implementation strategy for elective single‐embryo transfer after in vitro fertilization. Human Reproduction 2013;28(2):336‐42. - PubMed
Vodermaier 2009 {published data only}
Volk 1999 {published and unpublished data}
- Volk RJ, Cass AR, Spann SJ. A randomized controlled trial of shared decision making for prostate cancer screening. Archives of Family Medicine 1999;8(4):333‐40. - PubMed
Vuorma 2003 {published data only}
Watson 2006 {published data only}
- Watson E, Hewitson P, Brett J, Bukach C, Evans R, Edwards A, et al. Informed decision making and prostate specific antigen (PSA) testing for prostate cancer: a randomised controlled trial exploring the impact of a brief patient decision aid on men's knowledge, attitudes and intention to be tested. Patient Education and Counseling 2006;63(3):367‐79. - PubMed
Weymiller 2007 {published data only}
- Jones LA, Weymiller AJ, Shah N, Bryant SC, Christianson TJH, Guyatt GH, et al. Should clinicians deliver decision aids? further exploration of the statin choice randomized trial results. Medical Decision Making 2009;29(4):468‐74. - PubMed
- Weymiller AJ, Montori VM, Jones LA, Gafni A, Guyatt GH, Bryant SC, et al. Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Archives of Internal Medicine 2007;167(10):1076‐82. - PubMed
Whelan 2003 {published and unpublished data}
- Whelan T, Sawka C, Levine M, Gafni A, Reyno L, Willan A, et al. Helping patients make informed choices: a randomized trial of a decision aid for adjuvant chemotherapy in lymph node‐negative breast cancer. Journal of the National Cancer Institute 2003;95(8):581‐7. - PubMed
Whelan 2004 {published and unpublished data}
- Whelan T, Levine M, Willan A, Gafni A, Sanders K, Mirsky D, et al. Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial. JAMA 2004;292(4):435‐41. - PubMed
Williams 2013 {published and unpublished data}
- Williams RM, Davis KM, Luta G, Edmond SN, Dorfman CS, Schwartz MD, et al. Fostering informed decisions: A randomized controlled trial assessing the impact of a decision aid among men registered to undergo mass screening for prostate cancer. Patient Education and Counseling 2013;91:329‐36. - PMC - PubMed
Wolf 1996 {published data only}
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Wolf 2000 {published and unpublished data}
Wong 2006 {published data only}
- Wong SS, Thornton JG, Gbolade B, Bekker HL. A randomised controlled trial of a decision‐aid leaflet to facilitate women's choice between pregnancy termination methods. BJOG: An International Journal of Obstetrics & Gynaecology 2006;113(6):688‐94. - PubMed
References to studies excluded from this review
Abadie 2009 {published data only}
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Adab 2003 {published data only}
Alegría 2014 {published data only}
Al Saffar 2008 {published data only}
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Bakken 2014 {published data only}
Becker 2009 {published data only}
Belkora 2012 {published data only}
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Branda 2013 {published data only}
Brenner 2014 {published data only}
Breslin 2008 {published data only}
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Brown 2004 {published data only}
Brundage 2001 {published data only}
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Burton 2007 {published data only}
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Campbell 2014 {published data only}
- Campbell SR, Holter MC, Manthey TJ, Rapp CA. The effect of CommonGround Software and Decision Support Center. American Journal of Psychiatric Rehabilitation 2014;17(2):166‐80.
Carling 2008 {published data only}
Causarano 2015 {published data only}
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Chadwick 1991 {published data only}
Chan 2011 {published data only}
- Chan EC, McFall SL, Byrd TL, Mullen PD, Volk RJ, Ureda J, et al. A community‐based intervention to promote informed decision making for prostate cancer screening among Hispanic American men changed knowledge and role preferences: a cluster RCT. Patient Education and Counseling 2011;84(2):e44‐51. - PubMed
Chewning 1999 {published data only}
- Chewning B, Mosena P, Wilson D, Erdman H, Potthoff S, Murphy A, et al. Evaluation of a computerized contraceptive decision aid for adolescent patients. Patient Education and Counseling 1999;38(3):227‐39. - PubMed
Chiew 2008 {published data only}
Clouston 2014 {published data only}
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Col 2007 {published data only}
- Col NF, Ngo L, Fortin JM, Goldberg RJ, O'Connor AM. Can computerized decision support help patients make complex treatment decisions? A randomized controlled trial of an individualized menopause decision aid. Medical Decision Making 2007;27(5):585‐98. - PubMed
Colella 2004 {published data only}
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Costanza 2011 {published data only}
Coulter 2003 {published data only}
Cox 2012 {published data only}
Crang‐Svalenius 1996 {published data only}
- Crang‐Svalenius E, Dykes AK, Jorgensen C. Women's informed choice of prenatal diagnosis: early ultrasound examination‐routine ultrasound examination‐age‐independent amniocentesis. Fetal Diagnosis & Therapy 1996;11(1):20‐5. - PubMed
Davison 1999 {published data only}
- Davison BJ, Kirk P, Degner LF, Hassard TH. Information and patient participation in screening for prostate cancer. Patient Education and Counseling 1999;37(3):255‐63. - PubMed
Davison 2007 {published data only}
- Davison BJ, Goldenberg SL, Wiens KP, Gleave ME. Comparing a generic and individualized information decision support intervention for men newly diagnosed with localized prostate cancer. Cancer Nursing 2007;30(5):E7‐15. - PubMed
De Boer 2012 {published data only}
- Boer JC, Blijderveen G, Dijk G, Duivenvoorden HJ, Williams M. Implementing structured, multiprofessional medical ethical decision‐making in a neonatal intensive care unit. Journal of Medical Ethics 2012;38(10):596‐601. - PubMed
Deen 2012 {published data only}
- Deen D, Lu WH, Weintraub MR, Maranda MJ, Elshafey S, Gold MR. The impact of different modalities for activating patients in a community health center setting. Patient Education and Counseling 2012;89(1):178‐83. - PubMed
De Haan 2013 {published data only}
- Haan MC, Wijkerslooth TR, Stoop E, Bossuyt P, Fockens P, Thomeer M, et al. Informed decision‐making in colorectal cancer screening using colonoscopy or CT‐colonography. Patient Education and Counseling 2013;91(3):318‐25. - PubMed
Deinzer 2009 {published data only}
Denig 2014 {published data only}
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Deschamps 2004 {published and unpublished data}
- Deschamps MA, Taylor JG, Neubauer SL, Whiting S, Green K. Impact of pharmacist consultation versus a decision aid on decision making regarding hormone replacement therapy. International Journal of Pharmacy Practice 2004;12(1):21‐8.
Deyo 2000 {published and unpublished data}
- Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley AG. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Medical Care 2000;38(9):959‐69. - PubMed
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Diefenbach 2012 {published data only}
- Diefenbach MA, Mohamed NE, Butz BP, Bar‐Chama N, Stock R, Cesaretti J, et al. Acceptability and preliminary feasibility of an internet/CD‐ROM‐based education and decision program for early‐stage prostate cancer patients: randomized pilot study. Journal of Medical Internet Research 2012;14(1):e6. - PMC - PubMed
Dobke 2008 {published data only}
- Dobke MK, Bhavsar D. Pilot trial of telemedicine as a decision aid for patients with chronic wounds. Telemedicine Journal and e‐health 2008;14(3):245‐9. - PubMed
Dodin 2001 {published and unpublished data}
Donovan 2012 {published data only}
Driscoll 2008 {published data only}
- Driscoll DL, Rupert DJ, Golin CE, McCormack LA, Sheridan SL, Welch BM. Promoting prostate‐specific antigen informed decision‐making. Evaluating two community‐level interventions. American Journal of Preventive Medicine 2008;35(2):87‐94. - PubMed
Dunn 1998 {published and unpublished data}
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Eaton 2011 {published data only}
Eden 2009 {published data only}
- Eden KB, Dolan JG, Perrin NA, Kocaoglu D, Anderson N, Case J, et al. Patients were more consistent in randomized trial at prioritizing childbirth preferences using graphic‐numeric than verbal formats. Journal of Clinical Epidemiology 2009;62(4):415‐24. - PubMed
Eden 2014 {published data only}
- Eden KB, Perrin NA, Vesco KK, Guise JM. A randomized comparative trial of two decision tools for pregnant women with prior cesareans. Journal of Obstetric, Gynecologic, & Neonatal Nursing 2014;43:568‐79. - PubMed
Eden 2015 {published data only}
Edwards 2012 {published data only}
- Edwards JA, Snyder FJ, Allen PM, Makinson KA, Hamby DM. Decision making for risk management: a comparison of graphical methods for presenting quantitative uncertainty. Risk Analysis 2012;32(12):2055‐70. - PubMed
El‐Jawahri 2010 {published data only}
Ellison 2008 {published data only}
Elwyn 2004 {published data only}
- Elwyn G, Edwards A, Hood K, Robling M, Atwell C, Russell I, et al. Achieving involvement: process outcomes from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Family Practice 2004;21(4):337‐46. - PubMed
Emery 2007 {published data only}
Emmett 2007 {published data only}
Feldman‐Stewart 2006 {published data only}
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Feldman‐Stewart 2012 {published data only}
- Feldman‐Stewart D, Tong C, Siemens R, Alibhai S, Pickles T, Robinson J, Brundage MD. 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. Medical Decision Making 2012;32(4):616‐26. - PubMed
Fiks 2013a {published data only}
Flood 1996 {published data only}
- Flood AB, Wennberg JE, Nease RF Jr, Fowler FJ Jr, Ding J, Hynes LM. The importance of patient preference in the decision to screen for prostate cancer. Prostate Patient Outcomes Research Team. Journal of General Internal Medicine 1996;11(6):342‐9. - PubMed
Francis 2009 {published data only}
Fraval 2015 {published data only}
Frosch 2001 {published data only}
Frosch 2003 {published data only}
Frosch 2008b {published data only}
Frosch 2011 {published data only}
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Frost 2009 {published data only}
- Frost J, Shaw A, Montgomery A, Murphy DJ. Women's views on the use of decision aids for decision making about the method of delivery following a previous caesarean section: qualitative interview study. BJOG: An International Journal of Obstetrics & Gynaecology 2009;116(7):896‐905. - PubMed
Fujiwara 2015 {published data only}
Garvelink 2013 {published data only}
- Garvelink MM, ter Kuile MM, Fischer MJ, Louwé LA, Hilders CG, Kroep JR, et al. Development of a decision aid about fertility preservation for women with breast cancer in the Netherlands. Journal of Psychosomatic Obstetrics and Gynecology 2013;34(4):170‐8. - PubMed
Genz 2012 {published data only}
- Genz J, Haastert B, Müller H, Verheyen F, Cole D, Rathmann W, et al. Blood glucose testing and primary prevention of Type 2 diabetes ‐ evaluation of the effect of evidence‐based patient information: a randomized controlled trial. Diabetic Medicine 2012;29(8):1011‐20. - PubMed
Giordano 2014 {published data only}
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Goel 2001 {published and unpublished data}
- Goel V, Sawka CA, Thiel EC, Gort EH, O'Connor AM. Randomized trial of a patient decision aid for choice of surgical treatment for breast cancer. Medical Decision Making 2001;21(1):1‐6. - PubMed
Graham 2000 {published data only}
Gray 2009 {published data only}
- Gray SW, O'Grady C, Karp L, Smith D, Schwartz JS, Hornik RC, et al. Risk information exposure and direct‐to‐consumer genetic testing for BRCA mutations among women with a personal or family history of breast or ovarian cancer. Cancer Epidemiology, Biomarkers & Prevention 2009;18(4):1303‐11. - PMC - PubMed
Green 2001b {published data only}
- Green MJ, McInerney AM, Biesecker BB, Fost N. Education about genetic testing for breast cancer susceptibility: patient preferences for a computer program or genetic counselor. American Journal of Medical Genetics 2001;103(1):24‐31. - PubMed
Green 2004 {published data only}
Greenfield 1985 {published data only}
- Greenfield S, Kaplan S, Ware JE Jr. Expanding patient involvement in care. Effects on patient outcomes. Annals of Internal Medicine 1985;102(4):520‐8. - PubMed
Griffith 2008a {published data only}
Griffith 2008b {published data only}
Gruppen 1994 {published data only}
- Gruppen LD, Margolin J, Wisdom K, Grum CM. Outcome bias and cognitive dissonance in evaluating treatment decisions. Academic Medicine 1994;69(10 Suppl):S57‐9. - PubMed
Gummersbach 2015 {published data only}
- Gummersbach E, in der Schmitten J, Mortsiefer A, Abholz HH, Wegscheider K, Pentzek M. Willingness to participate in mammography screening ‐ a randomized controlled questionnaire study of responses to two patient information leaflets with different factual content. Deutsches Ärzteblatt International 2015;112(5):61‐8. - PMC - PubMed
Hacking 2013 {published data only}
- Hacking B, Wallace L, Scott S, Kosmala‐Anderson J, Belkora J, McNeill A. Testing the feasibility, acceptability and effectiveness of a 'decision navigation' intervention for early stage prostate cancer patients in Scotland ‐ a randomised controlled trial. Psycho‐Oncology 2013;22(5):1017‐1024. - PubMed
Hall 2007 {published data only}
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Hall 2011 {published data only}
Hamann 2014 {published data only}
- Hamann J, Maris N, Iosifidou P, Mendel R, Cohen R, Wolf P, Kissling W. Effects of a question prompt sheet on active patient behaviour: a randomized controlled trial with depressed outpatients. International Journal of Social Psychiatry 2014;60(3):227‐35. - PubMed
Harmsen 2014 {published data only}
Harwood 2011 {published data only}
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Healton 1999 {published data only}
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Henderson 2013 {published data only}
- Henderson C, Brohan E, Clement S, Williams P, Lassman F, Schauman O, et al. Decision aid on disclosure of mental health status to an employer: feasibility and outcomes of a randomised controlled trial. British Journal of Psychiatry 2013;203(5):350‐7. - PubMed
Herrera 1983 {published data only}
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Hewison 2001 {published data only}
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Heyn 2013 {published data only}
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Hickish 1995 {published data only}
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Hochlehnert 2006 {published data only}
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Hofbauer 2008 {published data only}
- Hofbauer GFL, Buhler RPN, French LE, Brockes M, Scheuer E. Patient‐centered care in dermatology: an online system that provides accessible and appropriate information to guide patients' decision making. Archives of Dermatology 2008;144(9):1225‐7. - PubMed
Hoffman 2009 {published data only}
Holbrook 2007 {published data only}
Hollen 2013 {published data only}
Holloway 2003 {published data only}
Holmes‐Rovner 2011 {published data only}
- Holmes‐Rovner M, Kelly‐Blake K, Dwamena F, Dontje K, Henry R, Olomu A, et al. Shared decision making guidance reminders in practice (SDM‐GRIP). Patient Education and Counseling 2011;85(2):219‐24. - PubMed
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- Holt CL, Wynn TA, Litaker MS, Southward P, Jeames S, Schulz E. A comparison of a spiritually based and non‐spiritually based educational intervention for informed decision making for prostate cancer screening among church‐attending African‐American men. Urologic Nursing 2009;29(4):249‐58. - PMC - PubMed
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Isebaert 2007 {published data only}
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Jackson 2011 {published data only}
Jerant 2007 {published data only}
- Jerant A, Kravitz RL, Rooney M, Amerson S, Kreuter M, Franks P. Effects of a tailored interactive multimedia computer program on determinants of colorectal cancer screening: a randomized controlled pilot study in physician offices. Patient Education and Counseling 2007;66(1):67‐74. - PubMed
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Kaplan 2014b {published data only}
Kassan 2012 {published data only}
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Köpke 2009 {published data only}
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Lairson 2011 {published data only}
Lalonde 2006 {published data only}
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Lewis 2012 {published data only}
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Miller 2014b {published data only}
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O'Connor 2011 {published data only}
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Thornton 1995 {published data only}
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Tinsel 2013 {published data only}
Tomko 2015 {published data only}
Ukoli 2013 {published data only}
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- Tol‐Geerdink JJ, Leer JW, Weijerman PC, Oort IM, Vergunst H, Lin EN, et al. Choice between prostatectomy and radiotherapy when men are eligible for both: a randomized controlled trial of usual care vs decision aid. BJU International 2013;111(4):564‐73. - PubMed
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Volandes 2009 {published data only}
Volandes 2011 {published data only}
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Volandes 2013 {published data only}
Volk 2008 {published data only}
Von Wagner 2011 {published data only}
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Wakefield 2008a {published data only}
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Wakefield 2008c {published data only}
- Wakefield CE, Meiser B, Homewood J, Taylor A, Gleeson M, Williams R. A randomized trial of a breast/ovarian cancer genetic testing decision aid used as a communication aid during genetic counseling. Psycho‐Oncology 2008;17(8):844‐54. - PubMed
Wallston 1991 {published data only}
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- Wang C, Gonzalez R, Milliron KJ, Strecher VJ, Merajver SD. Genetic counseling for BRCA1/2: a randomized controlled trial of two strategies to facilitate the education and counseling process. American Journal of Medical Genetics. Part A 2005;134(1):66‐73. - PubMed
Warner 2015 {published data only}
Watts 2014 {published data only}
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Welschen 2012 {published data only}
Wennberg 2010 {published data only}
- Wennberg DE, Marr A, Lang L, O'Malley S, Bennett G. A randomized trial of a telephone care‐management strategy. New England Journal of Medicine 2010;363(13):1245‐55. - PubMed
Westermann 2013 {published data only}
- Westermann GM, Verheij F, Winkens B, Verhulst FC, Oort FV. Structured shared decision‐making using dialogue and visualization: a randomized controlled trial. Patient Education and Counseling 2013;90(1):74‐81. - PubMed
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Wilhelm 2009 {published data only}
- Wilhelm D, Gillen S, Wirnhier H, Kranzfelder M, Schneider A, Scmidt A, et al. Extended preoperative patient education using a multimedia DVD: impact on patients receiving a laparoscopic cholecystectomy: a randomised controlled trial. Langenbeck's Archives of Surgery 2009;394(2):227‐33. - PubMed
Wilkes 2013 {published data only}
Wilkie 2013 {published data only}
Wilkins 2006 {published data only}
- Wilkins EG, Lowery JC, Copeland LA, Goldfarb SL, Wren PA, Janz NK. Impact of an educational video on patient decision making in early breast cancer treatment. Medical Decision Making 2006;26(6):589‐98. - PubMed
Willemsen 2006 {published data only}
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Williamson 2014 {published data only}
- Williamson LEA, Lawson KL, Downe PJ, Pierson RA. Informed reproductive decision‐making: The impact of providing fertility information on fertility knowledge and intentions to delay childbearing. Journals of Obstetrics and Gynaecology Canada 2014;36(5):400‐5. - PubMed
Williams‐Piehota 2008 {published data only}
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- Woltmann EM, Wilkniss SM, Teachout A, McHugo GJ, Drake RE. Trial of an electronic decision support system to facilitate shared decision making in community mental health. Psychiatric Services 2011;62(1):54‐60. - PubMed
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- Wroe AL, Turner N, Owens RG. Evaluation of a decision‐making aid for parents regarding childhood immunizations. Health Psychology 2005;24(6):539‐47. - PubMed
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Yun 2011 {published data only}
- Yun YH, Lee MK, Park S, Lee JL, Park J, Choi YS, et al. Use of a decision aid to help caregivers discuss terminal disease status with a family member with cancer: a randomized controlled trial. Journal of Clinical Oncology 2011;29(36):4811‐9. - PubMed
Zajac 2012 {published data only}
- Zajac LE. Making Difficult Health Decisions: A Motivated Decision Processing Model [PhD thesis]. Pittsburgh: University of Pittsburgh, 2012.
Zapka 2004 {published data only}
- Zapka JG, Lemon SC, Puleo E, Estabrook B, Luckmann R, Erban S. Patient education for colon cancer screening: a randomized trial of a video mailed before a physical examination. Annals of Internal Medicine 2004;141(9):683‐92. - PubMed
Zikmund‐Fisher 2008 {published data only}
Zoffman 2012 {published data only}
- Zoffman V, Kirkevold M. Realizing empowerment in difficult diabetes care: a guided self‐determination intervention. Qualitative Health Research 2012;22(1):103‐18. - PubMed
References to ongoing studies
ACTRN12615000523505 {published data only}
- ACTRN12615000523505. The Motherhood Choices Decision Aid for Women with Rheumatoid Arthritis Increases Knowledge and Reduces Decisional Conflict: A Randomized Controlled Study. http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ACTRN12615000523505 (first received May 25, 2015). - PMC - PubMed
ACTRN12615000843550 {published data only}
- ACTRN12615000843550. Evaluation of decision aids for parents about the benefits and harms of antibiotic use for coughs and colds in children [Pilot randomised controlled trial of decision aids for parents about the benefit and harm of antibiotics for common acute respiratory infections in children to aid informed decision making]. http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ACTRN12615000843550 (first received August 13, 2015).
Al‐Itejawi 2015 {published data only}
- Al‐Itejawi HH, Uden‐Kraan CF, Vis AN, Nieuwenhuijzen JA, Hofstee MJ, Moorselaar RJ, Verdonck‐de Leeuw IM. Development of a patient decision aid for the treatment of localised prostate cancer: a participatory design approach. J Clin Nurs 2016;25(7‐8):1131‐1144. - PubMed
Anderson 2014 {published data only}
Aslani 2014 {published data only}
- Aslani A, Tara F, Ghalichi L, Eslami S. The impact of computerized decision aid on mode of delivery ‐ a study protocol. Studies in Health Technology and Informatics 2014;200:170‐2. - PubMed
Buhse 2013 {published data only}
Carroll 2012 {published data only}
- Carroll SL, McGillion M, Stacey D, Healey JS, Browne G, Arthur HM, Thabane L. Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial. Trials 2013;14(346):1‐9. - PMC - PubMed
Chambers 2008 {published data only}
Coylewright 2012 {published data only}
Cuypers 2015 {published data only}
Den Ouden 2015 {published data only}
- Ouden H, Vos RC, Reidsma C, Rutten GEHM. Shared decision making in type 2 diabetes with a support decision tool that takes into account clinical factors, the intensity of treatment and patient preferences: design of a cluster randomised (OPTIMAL) trial. BMC Family Practice 2015;16:27. - PMC - PubMed
Dirmaier 2013 {published data only}
Geiger 2011 {published data only}
Hersch 2014 {published data only}
Hess 2014 {published data only}
Jimbo 2012 {published data only}
Layton 2012 {published data only}
- Effects of a web‐based decision aid on African American men's prostate screening knowledge and behavior. Ongoing study —.
LeBlanc 2013 {published data only}
- LeBlanc A, Bodde AE, Branda ME, Yost KJ, Herrin J, Williams MD, et al. Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial. Trials 2013;14(127):1‐8. - PMC - PubMed
Mann 2012 {published data only}
NCT00813033 {published data only}
- NCT00813033. Use of a Patient Decision Aid for Gastrologic Endoscopy in a Pediatric Setting [Creation and Pilot Evaluation of a Patient Decision Aid as an Adjunct to the Consenting Process for Gastrointestinal Endoscopy in a Pediatric Setting]. https://clinicaltrials.gov/show/NCT00813033 (first received December 19, 2008).
NCT01077037 {published data only}
- NCT01077037. Impact of a Decision Aid on Patient Decision Making in Emergency Department Chest Pain Patients [Impact of a Decision Aid on Patient Participation in Decision Making and Resource Use in Low Risk Chest Pain Patients: A Randomized Trial]. clinicaltrials.gov/show/NCT01077037 (first received February 24, 2010).
NCT01152294 {published data only}
- NCT01152294. Measuring Quality of Decisions About Treatment of Menopausal Symptoms [Measuring Quality of Decisions About Treatment of Menopausal Symptoms]. clinicaltrials.gov/show/NCT01152294 (first received June 22, 2010).
NCT01152307 {published data only}
- NCT01152307. Measuring Quality of Decisions About Treatment of Depression [Measuring Quality of Decisions About Treatment of Depression]. clinicaltrials.gov/show/NCT01152307 (first received June 22, 2010).
NCT01447186 {published data only}
- NCT01447186. Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men [Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men]. clinicaltrials.gov/show/NCT01447186 (first received October 3, 2011).
NCT01618097 {published data only}
- NCT01618097. Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy. clinicaltrials.gov/show/NCT01618097 (first received May 29, 2012).
NCT01713894 {published data only}
- NCT01713894. Decision Aid ‐ Extreme Prematurity [Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery]. clinicaltrials.gov/show/NCT01713894 (first received October 22, 2012).
NCT01771536 {published data only}
- NCT01771536. The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease. clinicaltrials.gov/show/NCT01771536 (first received December 15, 2012).
NCT01851785 {published data only}
- NCT01851785. African American Preference for Knee Replacement: A Patient‐Centered Intervention (ACTION) [Behavioral & Social Science Research on Understanding and Reducing Health Disparities]. clinicaltrials.gov/show/NCT01851785 (first received May 8, 2013).
NCT01941186 {published data only}
- NCT01941186. A Family Centered Intervention to Promote Optimal Child Development [A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community]. clinicaltrials.gov/show/NCT01941186 (first received September 9, 2013).
NCT01976325 {published data only}
- NCT01976325. Evaluating the Ottawa Malaria Decision Aid (OMDA) [Incorporation of the 'Ottawa Malaria Decision Aid' Into the Pre‐travel Consultation Process: Assessment of Travelers' Knowledge, Decisional Conflict, Preparation for Decision‐making and Medication Adherence Compared to Standard Care]. clinicaltrials.gov/show/NCT01976325 (first received October 29, 2013).
NCT02026102 {published data only}
- NCT02026102. A Pilot Trial of Patient Decision Aids for Implantable Cardioverter‐Defibrillators (ICDs) [A Pilot Trial of Patient Decision Aids for Implantable Cardioverter‐Defibrillators (ICDs)]. clinicaltrials.gov/show/NCT02026102 (first received December 12, 2013).
NCT02084290 {published data only}
- NCT02084290. Evaluating a Shared Decision Making Program for Crohn's Disease [Evaluating a Prediction Tool and Decision Aid for Patients With Crohn's Disease]. clinicaltrials.gov/show/NCT02084290 (first received January 29, 2014).
NCT02110979 {published data only}
- NCT02110979. Validation of a Patient Decision Aid for Type 2 Diabetes [Validation of a Patient Decision Aid for Type 2 Diabetes]. clinicaltrials.gov/show/NCT02110979 (first received April 4, 2014).
NCT02145481 {published data only}
- NCT02145481. Decisional Quality for Patients With Coronary Artery Disease (DeQCAD). clinicaltrials.gov/show/NCT02145481 (first received May 15, 2014).
NCT02198690 {published data only}
- NCT02198690. Trial of a Mammography Decision Aid for Women Aged 75 and Older [Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older]. clinicaltrials.gov/show/NCT02198690 (first received July 16, 2014).
NCT02235571 {published data only}
- NCT02235571. iChoose Decision Kidney Aid for End‐Stage Renal Disease Patients [iChoose Kidney Decision Aid for Treatment Options Among End‐Stage Renal Disease (ESRD) Patients]. clinicaltrials.gov/show/NCT02235571 (first received September 6, 2014).
NCT02248974 {published data only}
- NCT02248974. Development & Testing of a Decision Aid for LVAD Placement (VADDA) [Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement]. clinicaltrials.gov/show/NCT02248974 (first received September 17, 2014).
NCT02259699 {published data only}
- NCT02259699. Ovarian Cancer Patient‐Centered Decision Aid (PCOA) [Ovarian Cancer Patient‐Centered Decision Aid]. clinicaltrials.gov/show/NCT02259699 (first received May 15, 2014).
NCT02308592 {published data only}
- NCT02308592. Patient Decision Aid for Antidepressant Use in Pregnancy [Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy]. clinicaltrials.gov/show/NCT02308592 (first received December 2, 2014).
NCT02319525 {published data only}
- NCT02319525. Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus [Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus]. clinicaltrials.gov/show/NCT02319525 (first received November 5, 2014).
NCT02326597 {published data only}
- NCT02326597. Decision Aid for Therapeutic Options In Sickle Cell Disease [Comparative Effectiveness of a Decision Aid for Therapeutic Options in Sickle Cell Disease]. clinicaltrials.gov/show/NCT02326597 (first received December 18, 2014).
NCT02344576 {published data only}
- NCT02344576. Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device (DECIDE‐LVAD) [A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End‐Stage Heart Failure]. clinicaltrials.gov/show/NCT02344576 (first received January 16, 2015).
NCT02488317 {published data only}
- NCT02488317. Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH‐RRT) (EPOCH‐RRT) [Empowering Patients On Choices for Renal Replacement Therapy (Aim 3)]. clinicaltrials.gov/show/NCT02488317 (first received June 15, 2015).
NCT02488603 {published data only}
- NCT02488603. Decision Aids for Tamoxifen Treatment in Breast Cancer Patients [Utilization of Decision Aids for Tamoxifen Treatment in Breast Cancer Patients: A Randomized Controlled Trial.]. clinicaltrials.gov/show/NCT02488603 (first received June 25, 2015).
NCT02492009 {published data only}
- NCT02492009. Patient Decision Aid for Antidepressant Use in Pregnancy [Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy: a Pilot RCT]. clinicaltrials.gov/show/NCT02492009 (first received June 22, 2015).
NCT02503553 {published data only}
- NCT02503553. Decision Aids in Cerebral Aneurysm Treatment. clinicaltrials.gov/show/NCT02503553 (first received July 17, 2015).
NCT02516449 {published data only}
- NCT02516449. Assessment of Shared Decision Making Aids in Asthma [Utility of Two Patients Decision Aids About Asthma Inhaled Controller Medication Use in Adult Patients With Asthma]. clinicaltrials.gov/show/NCT02516449 (first received July 2, 2015).
NCT02540044 {published data only}
- NCT02540044. Supporting Patient Care With Electronic Resource (SuPER) (SuPER) [Supporting Patient Care With Electronic Resource (SuPER): Efficacy of an Online Decision Aid for Patients Considering Biologic Therapy for Rheumatoid Arthritis]. clinicaltrials.gov/show/NCT02540044 (first received September 1, 2015).
NCT02611050 {published data only}
- NCT02611050. Treatment Decisions for Multi‐vessel CAD [Treatment Decisions for Multi‐vessel Coronary Artery Disease Patients]. clinicaltrials.gov/show/NCT02611050 (first received Noovember 9, 2015).
Oostendorp 2011 {published data only}
Yu 2015 {published data only}
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- Washington State Health Authority. Patient decision aid certification criteria. 2016. www.hca.wa.gov/hw/Documents/sdm_cert_criteria.pdf (accessed prior to 27 March 2017).
Weston 2001
References to other published versions of this review
O'Connor 1999b
O'Connor 2001
O'Connor 2003
O'Connor 2009b
Stacey 2011
Stacey 2014b
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