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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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
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
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
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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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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TL;DR: The decision aid reduced decisional conflict in men with benign prostatic hypertrophy, and the patients played a more active part in decision making, particularly for conditions in which patient utilities are important.
Abstract: OBJECTIVE: To determine whether a decision aid on benign prostatic hypertrophy influences decision making, health outcomes, and resource use. DESIGN: Randomised controlled trial. SETTING: 33 general practices in the United Kingdom. PARTICIPANTS: 112 men with benign prostatic hypertrophy. INTERVENTION: Patients' decision aid consisting of an interactive multimedia programme with booklet and printed summary. OUTCOME MEASURES: Patients' and general practitioners' perceptions of who made the decision, decisional conflict scores, treatment choice and prostatectomy rate, American Urological Association symptom scale, costs, anxiety, utility, and general health status. RESULTS: Both patients and general practitioners found the decision aid acceptable. A higher proportion of patients (32% v 4%; mean difference 28%, 95% confidence interval 14% to 41%) and their general practitioners (46% v 25%; 21%, 3% to 40%) perceived that treatment decisions had been made mainly or only by patients in the intervention group compared with the control group. Patients in the intervention group had significantly lower decisional conflict scores than those in the control group at three months (2.3 v 2.6; -0.3, -0.5 to -0.1, P<0.01) and this was maintained at nine months. No differences were found between the groups for anxiety, general health status, prostatic symptoms, utility, or costs (excluding costs associated with the video disc equipment). CONCLUSIONS: The decision aid reduced decisional conflict in men with benign prostatic hypertrophy, and the patients played a more active part in decision making. Such programmes could be delivered cheaply by the internet, and there are good arguments for coordinated investment in them, particularly for conditions in which patient utilities are important.
195 citations
"Influence of decision aids on patie..." refers background in this paper
...People with atrial fibrillation have been identified as patients who would benefit from a decision aid, since the benefits and harms of the treatment options (including “do nothing”) have an important impact on morbidity and mortality.(39,40) Also, patients have expressed antipathy to anticoagulation with warfarin because the name “warfarin” is associated with rat poison....
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Journal Article•
TL;DR: The author suggests a distinction between two elements of choice: problem solving and decision making, which helps in identifying appropriate roles for patient and provider, thereby leading to genuine shared decision making.
Abstract: How reasonable are expectations that patients will participate in care decisions? The previous article in this series reviewed models of the patient-physician relationship and views on the extent to which patients want to be informed; it also described one information tool--the interactive videodisc. This article reviews literature on the extent to which patients wish to be involved in making decisions about their care. Neither "sensitive paternalism" nor "informed consent" appears to be ideal. The author suggests a distinction between two elements of choice: problem solving and decision making. This distinction helps in identifying appropriate roles for patient and provider, thereby leading to genuine shared decision making.
181 citations
TL;DR: Patients' unwillingness to take warfarin seemed to be a major factor in limiting the number who would eventually take it, and Qualitative data obtained during the interviews suggested that patients' health beliefs were important factors in determining their choice of treatment.
Abstract: Objective: To determine the extent to which implementation of an evidence based treatment, antithrombotic treatment in atrial fibrillation, is possible in general practice. Design: Audit and qualitative study of patients with atrial fibrillation and an educational intervention for patients judged eligible for antithrombotic treatment. Setting: South east England. Subjects: 56 patients with a history of atrial fibrillation. Interventions: Assessment and interview to ascertain patients9 views on antithrombotic treatment. Main outcome measures: Number of patients receiving antithrombotic treatment. Results: Out of 13 239 patients, 132 had a history of atrial fibrillation of which 100 were at risk of thromboembolism. After the study, 52 patients were taking warfarin. Of the remaining 48 patients (of whom 41 were taking aspirin), eight were too ill to participate, 16 were unable to consent, four refused the interview, and 20 declined warfarin. Patients declining warfarin were inclined to seek a higher level of benefit than those taking it, as measured by the minimal clinically important difference. Qualitative data obtained during the interviews suggested that patients9 health beliefs were important factors in determining their choice of treatment. Conclusion: Patients9 unwillingness to take warfarin seemed to be a major factor in limiting the number who would eventually take it.
167 citations
TL;DR: An interactive multimedia decision aid in the NHS would be popular with patients, reduce decisional conflict, and let patients play a more active part in decision making without increasing anxiety.
Abstract: Objective: To determine whether a decision aid on hormone replacement therapy influences decision making and health outcomes. Design: Randomised controlled trial. Setting: 26 general practices in the United Kingdom. Participants: 205 women considering hormone replacement therapy. Intervention: Patients9 decision aid consisting of an interactive multimedia programme with booklet and printed summary. Outcome measures: Patients9 and general practitioners9 perceptions of who made the decision, decisional conflict, treatment choice, menopausal symptoms, costs, anxiety, and general health status. Results: Both patients and general practitioners found the decision aid acceptable. At three months, mean scores for decisional conflict were significantly lower in the intervention group than in the control group (2.5 v 2.8; mean difference −0.3, 95% confidence interval −0.5 to −0.2); this difference was maintained during follow up. A higher proportion of general practitioners perceived that treatment decisions had been made “mainly or only” by the patient in the intervention group than in the control group (55% v 31%; 24%, 8% to 40%). At three months a lower proportion of women in the intervention group than in the control group were undecided about treatment (14% v 26%; −12%, −23% to −0.4%), and a higher proportion had decided against hormone replacement therapy (46% v 32%; 14%, 1% to 28%); these differences were no longer apparent by nine months. No differences were found between the groups for anxiety, use of health service resources, general health status, or utility. The higher costs of the intervention were largely due to the video disc technology used. Conclusions: An interactive multimedia decision aid in the NHS would be popular with patients, reduce decisional conflict, and let patients play a more active part in decision making without increasing anxiety. The use of web based technology would reduce the cost of the intervention. What is already known on this topic Patients want more information about their conditions and treatment options, and many want to play an active part in decision making Decision aids improve patients9 knowledge of their conditions and treatment options What this study adds The decision aid was acceptable to both the patients and their general practitioners Decisional conflict was reduced in the intervention group Patients who viewed the programme played a more active part in the decision making process and were no more anxious than control patients Such aids could be introduced throughout the NHS at relatively low cost by using the internet
151 citations
"Influence of decision aids on patie..." refers background in this paper
...People with atrial fibrillation have been identified as patients who would benefit from a decision aid, since the benefits and harms of the treatment options (including “do nothing”) have an important impact on morbidity and mortality.(39,40) Also, patients have expressed antipathy to anticoagulation with warfarin because the name “warfarin” is associated with rat poison....
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