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Journal ArticleDOI

Influence of decision aids on patient preferences for anticoagulant therapy: a randomized trial

22 May 2007-Canadian Medical Association Journal (Canadian Medical Association)-Vol. 176, Iss: 11, pp 1583-1587
TL;DR: The decision aid led to significant improvement in patients' knowledge regardless of the format or graphic representation of data, and Revealing the name of the treatment options led tosignificant shifts in declared treatment preferences.
Abstract: Background: Decision aids have been shown to be useful in selected situations to assist patients in making treatment decisions. Important features such as the format of decision aids and their graphic presentation of data on benefits and harms of treatment options have not been well studied. Methods: In a randomized trial with a 3 × 2 factorial design, we investigated the effects of decision aid format (decision board, decision booklet with audiotape, or interactive computer program) and graphic presentation of data (pie graph or pictogram) on patients9 comprehension and choices of 3 treatments for anticoagulation, identified initially as “treatment A” (warfarin), “treatment B” (acetylsalicylic acid) and “treatment C” (no treatment). Patients aged 65 years or older without known atrial fibrillation and not currently taking warfarin were included. The effect of blinding to the treatment name was tested in a before–after comparison. The primary outcome was change in comprehension score, as assessed by the Atrial Fibrillation Information Questionnaire. Secondary outcomes were treatment choice, level of satisfaction with the decision aid, and decisional conflict. Results: Of 102 eligible patients, 98 completed the study. Comprehension scores (maximum score 10) increased by an absolute mean of 3.1 ( p p Interpretation: The decision aid led to significant improvement in patients9 knowledge regardless of the format or graphic representation of data. Revealing the name of the treatment options led to significant shifts in declared treatment preferences.

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Citations
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Journal ArticleDOI
TL;DR: Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication, and those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and the preparation for decision making compared to usual care.
Abstract: Background Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty. Objectives To assess the effects of decision aids for people facing treatment or screening decisions. Search methods For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008). Selection criteria We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions. Data collection and analysis Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were: A) 'choice made' attributes; B) 'decision-making process' attributes. Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model. Main results This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each. Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies). A) Criteria involving 'choice made' attributes: Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13). B) Criteria involving 'decision-making process' attributes: Decision aids compared to usual care interventions resulted in: a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18); b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); and c) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18). Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice. C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable. The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. Authors' conclusions There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values. New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.

5,042 citations

Journal ArticleDOI
TL;DR: The main aim of the document was to summarise 'best practice' in dealing with bleeding risk in AF patients when approaching antithrombotic therapy, by addressing the epidemiology and size of the problem, and review established bleeding risk factors.
Abstract: In this executive summary of a Consensus Document from the European Heart Rhythm Association, endorsed by the European Society of Cardiology Working Group on Thrombosis, we comprehensively review the published evidence and propose a consensus on bleeding risk assessments in atrial fibrillation (AF) patients The main aim of the document was to summarise ‘best practice’ in dealing with bleeding risk in AF patients when approaching antithrombotic therapy, by addressing the epidemiology and size of the problem, and review established bleeding risk factors We also summarise definitions of bleeding in the published literature Patient values and preferences balancing the risk of bleeding against thromboembolism as well as the prognostic implications of bleeding are reviewed We also provide an overview of published bleeding risk stratification and bleeding risk schema Brief discussion of special situations (eg periablation, peri-devices such as implantable cardioverter defibrillators [ICD] or pacemakers, presentation with acute coronary syndromes and/or requiring percutanous coronary interventions/stents and bridging therapy) is made, as well as a discussion of the prevention of bleeds and managing bleeding complications Finally, this document puts forwards consensus statements that may help to define evidence gaps and assist in everyday clinical practice

261 citations

Journal ArticleDOI
01 Feb 2012-Chest
TL;DR: Patient values and preferences regarding thromboprophylaxis treatment appear to be highly variable and it should be standard for clinical practice guidelines to conduct systematic reviews of patient values and preference in the specific content area.

241 citations

Journal ArticleDOI
01 May 2011-Europace
TL;DR: This Position Document comprehensively review the published evidence and proposes a consensus on bleeding risk assessments in AF patients, with a view to summarizing 'best practice' when approaching antithrombotic therapy inAF patients.
Abstract: Despite the clear net clinical benefit of oral anticoagulation (OAC) in atrial fibrillation (AF) patients at risk for stroke, major bleeding events (especially intra-cranial bleeds) may be devastating events when they do occur. The decision for OAC is often based on a careful assessment of both stroke risk and bleeding risk, but clinical scores for bleeding risk estimation are much less well validated than stroke risk scales. Also, the estimation of bleeding risk is rendered difficult since many of the known factors that increase bleeding risk overlap with stroke risk factors. As well as this, many factors that increase bleeding risk are transient, such as variable international normalized ratio values, operations, vascular procedures, or drug-drug and food-drug interactions. In this Position Document, we comprehensively review the published evidence and propose a consensus on bleeding risk assessments in AF patients, with a view to summarizing 'best practice' when approaching antithrombotic therapy in AF patients. We address the epidemiology and size of the problem of bleeding risk in AF and review established bleeding risk factors. We also summarize definitions of bleeding in the published literature. Patient values and preferences balancing the risk of bleeding against thrombo-embolism is reviewed, and the prognostic implications of bleeding are discussed. We also review bleeding risk stratification and currently published bleeding risk schema. A brief discussion of special situations [e.g. peri-ablation, peri-devices (implantable cardioverter-defibrillator, pacemakers) and presentation with acute coronary syndromes and/or requiring percutaneous coronary interventions/stents and bridging therapy], as well as a discussion of prevention of bleeds and managing bleeding complications, is made. Finally, this document also puts forwards consensus statements that may help to define evidence gaps and assist in everyday clinical practice. Bleeding risk is almost inevitably lower than stroke risk in patients with atrial fibrillation. Nonetheless, identification of patients at high risk of bleeding and delineation of conditions and situations associated with bleeding risk can help to refine antithrombotic therapy to minimize bleeding risk.

211 citations


Cites background from "Influence of decision aids on patie..."

  • ...Patients appear to trade-off the risks associated with antithrombotic treatment in order to avoid death.(117,119) Overall, these studies appear to suggest that patients place greater emphasis on avoidance of stroke and are willing to accept a higher risk of bleeding to achieve this, although this may represent a lack of patient understanding of the disability associated with major bleeding, particularly intracranial haemorrhage....

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  • ...Presenting patients with decision aids makes them more likely to be able to make a decision regarding antithrombotic therapy and improves their knowledge of AF and the need for such therapy.(105,108,113,116,117) However, research suggests that the use of decision aids results in fewer patients choosing to take OAC and that incorporating patient preferences would lead to fewer patients choosing to take oral anticoagulants than the current guidelines would recommend....

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Journal ArticleDOI
09 Sep 2013-PLOS ONE
TL;DR: A theory-driven educational intervention significantly improves time within therapeutic range (TTR) in AF patients initiating warfarin during the first 6-months, and adverse clinical outcomes may potentially be reduced by improving patients’ understanding of the necessity ofwarfarin and reducing their perception of treatment harm.
Abstract: Background: Stroke prevention in atrial fibrillation (AF), most commonly with warfarin, requires maintenance of a narrow therapeutic target (INR 2.0 to 3.0) and is often poorly controlled in practice. Poor patient-understanding surrounding AF and its’ treatment may contribute to patient’s willingness to adhere to recommendations. Method: A theory-driven intervention, developed using patient interviews and focus groups, consisting of a one-off group session (1-6 patients) utilising an ‘expert-patient’ focussed DVD, educational booklet, self-monitoring diary and worksheet, was compared in a randomised controlled trial (ISRCTN93952605) against usual care, with patient postal follow-ups at 1, 2, 6, and 12-months. Ninety-seven warfarin-naive AF patients were randomised to intervention (n=46, mean age (SD) 72.0 (8.2), 67.4% men), or usual care (n=51, mean age (SD) 73.7 (8.1), 62.7% men), stratified by age, sex, and recruitment centre. Primary endpoint was time within therapeutic range (TTR); secondary endpoints included knowledge, quality of life, anxiety/depression, beliefs about medication, and illness perceptions. Main findings: Intervention patients had significantly higher TTR than usual care at 6-months (76.2% vs. 71.3%; p=0.035); at 12-months these differences were not significant (76.0% vs. 70.0%; p=0.44). Knowledge increased significantly across time (F (3, 47) = 6.4; p<0.01), but there were no differences between groups (F (1, 47) = 3.3; p = 0.07). At 6-months, knowledge scores predicted TTR (r=0.245; p=0.04). Patients’ scores on subscales representing their perception of the general harm and overuse of medication, as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months. Conclusions: A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months. Adverse clinical outcomes may potentially be reduced by improving patients’ understanding of the necessity of warfarin and reducing their perception of treatment harm. Improving education provision for AF patients is essential to ensure efficacious and safe treatment.

192 citations


Cites background from "Influence of decision aids on patie..."

  • ...Many AF patients may have preconceived ideas about how harmful warfarin is for example patients are more willing to take warfarin when they are blinded to the name of the treatment [39,40], highlighting the negative connotations associated with warfarin (e....

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References
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Journal ArticleDOI
TL;DR: Warfarin was prescribed infrequently to these patients with nonrheumatic atrial fibrillation, especially the older patients and even the patients for whom warfar in was judged appropriate, indicating a substantial opportunity to prevent stroke.
Abstract: OBJECTIVE: To determine how often warfarin was prescribed to patients with nonrheumatic atrial fibrillation in our community in 1992 when randomized trials had demonstrated that warfarin could prevent stroke with little increase in the rate of hemorrhage, and to determine whether warfarin was prescribed less frequently to older patients—the patients at highest risk of stroke but of most concern to physicians in terms of the safety of warfarin. DESIGN: Cross-sectional study. Appropriateness of warfarin was classified for each patient based on the independent judgments of three physicians applying relevant evidence and guidelines. SETTING: Two teaching hospitals and five community-based practices. PATIENTS: Consecutive patients with nonrheumatic atrial fibrillation (n=189). MEASUREMENTS AND MAIN RESULTS: Warfarin was prescribed to 44 (23%) of the 189 patients. Warfarin was judged appropriate in 98 patients (52%), of whom 36 (37%) were prescribed warfarin. Warfarin was prescribed to 11 (14%) of 76 patients aged 75 years or older with hypertension, diabetes mellitus, or past stroke, the group at highest risk of stroke. In a multivariable logistic regression model controlling for appropriateness of warfarin and other patient characteristics, patients aged 75 years or older were less likely than younger patients to be treated with warfarin (odds ratio 0.25; 95% confidence interval 0.10, 0.65). CONCLUSIONS: Warfarin was prescribed infrequently to these patients with nonrheumatic atrial fibrillation, especially the older patients and even the patients for whom warfarin was judged appropriate. These findings indicate a substantialopportunity to prevent stroke.

124 citations

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TL;DR: The rates of complications associated with medical therapy for secondary stroke prevention for all patients with first episodes of cerebral ischemia or amaurosis fugax in a defined community are determined to assess the generalizability of complication rates derived from clinical trials for these therapies.
Abstract: In this study, complication rates for warfarin and intravenous heparin given for secondary stroke prevention were lower than rates reported from earlier trials and observational studies. For warfar...

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23 Oct 1993-BMJ
TL;DR: Five randomised controlled trials show that warfarin reduces the risk of ischaemic strokes and death in patients with atrial fibrillation.
Abstract: Five randomised controlled trials show that warfarin reduces the risk of ischaemic strokes and death in patients with atrial fibrillation.' We suspected that many such patients were not receiving warfarin and therefore reviewed the records of previous inpatients with atrial fibrillation to see how many were receiving warfarin or aspirin and whether those who were not had a specific contraindication.

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Journal ArticleDOI
TL;DR: Compared to pamphlets, DAs appear to improve the agreement between women's and physicians' decisional conflict about HRT.

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