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: A pharmacist-led intervention re-aligned oral anticoagulant therapy to the latest evidence based guidelines for stroke prophylaxis, whilst simultaneously correcting the over-utilisation of antiplatelet therapy.
Abstract: Background Updated evidence-based guidelines for the management of atrial fibrillation (AF) necessitate patient review, particularly with respect to oral anticoagulants, to ensure maximum health gain around stroke prophylaxis. Objective To quantify the level of anticoagulation utilisation in patients with a CHA2DS2-VASc ≥1/≥2 (male/female) according to evidence-based guidelines and to assess the impact of a pharmacist-led intervention to optimise therapy. Setting Fifteen general medical practices in Liverpool, North-West England with a practice population of 99,129. Method GRASP-AF software was employed to interrogate patient electronic medical records to identify and risk stratify AF patients (using CHA2DS2-VASc). A pharmacist then reviewed the medical records of those of patients not anticoagulated and with a CHA2DS2-VASc ≥1/≥2 (male/female). Recommendations were discussed with a general practitioner (GP) and those patients in whom the need for anticoagulation was agreed were invited for a consultation with either the pharmacist or GP and therapy optimised where appropriate. The GPs were responsible for managing those patients referred for diagnosis confirmation or further specialist opinion. Main outcome measure Proportion of patients eligible/not eligible for anticoagulation; proportions in whom anticoagulants initiated, refused, antiplatelets discontinued. Results Five hundred and twenty-three patients (31% of patients identified with AF and a CHA2DS2-VASc ≥1/≥2 (male/female)) were not receiving an anticoagulant (26 subsequently died or left the practice leaving 497). Three hundred and eighty-two (77%) pharmacist recommendations to a GP were agreed without modification. Following outcomes of diagnostic investigations and specialist referrals, 202 (41%) patients were candidates for anticoagulation, 251 (51%) were not eligible for anticoagulation, 103 (21%) were anticoagulated (56 warfarin, 47 DOAC). Conclusion A pharmacist-led intervention re-aligned oral anticoagulant therapy to the latest evidence based guidelines for stroke prophylaxis, whilst simultaneously correcting the over-utilisation of antiplatelet therapy.
14 citations
Cites background from "Influence of decision aids on patie..."
...In a randomised trial of AF thromboprophylaxis, 36% of patients changed their original decision to be treated with a blinded drug once the name had been unblinded as warfarin [45]....
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Journal Article•
TL;DR: The DA to allow patients to make an informed decision with their physician regarding dabigatran versus warfarin in AF, proved understandable, comprehensive and helpful.
Abstract: Background Decision aids have been helpful to support patients in decision-making including anticoagulation. With the introduction of new oral anticoagulants (NOACs), it will be important to assist patients and physicians in shared decision-making about NOACs and warfarin. Objectives To validate a patient decision aid (DA) for warfarin versus dabigatran, the first NOAC approved for atrial fibrillation (AF). Methods Participants without AF and not taking anticoagulants were recruited for the validation exercise. The decision aid described AF, stroke, and hemorrhagic events in terms of incidence, clinical presentation, and prognosis. Warfarin and dabigatran were then compared on multiple clinical and process outcomes as outlined in the pivotal clinical trial. Our primary outcome was confidence in making a treatment decision, using a decisional conflict scale. Secondary outcomes were change in knowledge scores and ratings of clarity, helpfulness and comprehensiveness. Results 35 patients (mean age 62.7 [SD 9.68], 37.1% female) participated. After use of the decision aid, the mean total decisional conflict score was low at 18.9 (SD: 14.2). Mean knowledge score improved significantly from 4.60 (SD 1.48) to 6.42 (SD 0.80) out of a total score of 7. Only one participant (2.9%) found the decision aid difficult to understand. All 35 participants rated the DA as helpful for making a decision about anticoagulant treatment for AF. Two participants (5.7%) requested more information on adverse effects of the two drugs. Conclusion Our DA to allow patients to make an informed decision with their physician regarding dabigatran versus warfarin in AF, proved understandable, comprehensive and helpful.
14 citations
TL;DR: Despite evidence reporting a powerful effect on patients' decisions, decision aids are not subject to quality control, leading to potentially enormous ethical implications.
Abstract: Shared decision-making is a recent priority in neonatology. However, its implementation is at an early stage. Decision aids are tools designed to assist in shared decision-making. They help patients competently participate in making healthcare decisions. There are limited studies in neonatology on the formal use of decision aids as used in adult medicine. Decision aids are relatively new, even in adult medicine where they were pioneered; therefore, there is a lack of systematic oversight to their development and use. Despite evidence reporting a powerful effect on patients' decisions, decision aids are not subject to quality control, leading to potentially enormous ethical implications. These include: (i) possible introduction of developers' biases; (ii) use of outdated or incorrect information; (iii) misuse to steer a patient towards less expensive treatments; (iv) clinician liability if negative patient outcomes occur, since decision aids are currently not standard of care.
12 citations
TL;DR: Overall satisfaction with the AF-DST was high and the tool effectively communicated recommendations and uncertainty; design issues and potential errors caused by decision-support tool use should be addressed prior to clinical implementation.
Abstract: INTRODUCTION In individuals with nonvalvular atrial fibrillation, anticoagulant therapy with warfarin reduces the rate of thromboembolic events but increases the risk of bleeding. Treatment decisions frequently are inconsistent with guidelines. A new web-based atrial fibrillation decision-support tool (AF-DST) provides patient-specific information on the risk-benefit tradeoff of anticoagulation. METHODS The authors performed a pilot usability testing study of the AF-DST with 4 medical house officers and 4 attending physicians by simulating 9 outpatient clinical encounters involving tradeoffs between risks and benefits of anticoagulation. They recorded positive and negative critical incidents in the simulations and assessed satisfaction with use of the AF-DST by the Computer System Usability Questionnaire (CSUQ; score range on each item: 1 = strongly disagree to 7 = strongly agree). RESULTS Users found the AF-DST to be helpful and had high CSUQ scores (mean item score, 6.3). Usability testing identified 6 positive and 14 negative critical incidents. Participants felt that the AF-DST guided them toward the correct decision. Nevertheless, they desired more information on the "black box" calculations and ignored alerts. Training level appeared to affect how the AF-DST was used, in particular, how users interacted with the AF-DST. CONCLUSIONS Overall satisfaction with the AF-DST was high and the tool effectively communicated recommendations and uncertainty. Usability testing identified design issues and potential errors caused by decision-support tool use; these gaps should be addressed prior to clinical implementation.
10 citations
Cites methods from "Influence of decision aids on patie..."
...The AF-DST differs from tools described in other studies, as we have focused decision support primarily on the clinician and have used QALYs as the main outcome measure rather than yearly risk and patient decisional conflict and knowledge.(24-26) As a result, we chose not to incorporate elicitation of individual patient preferences in this AF-DST version....
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TL;DR: The authors examined the effect of incentives on decision-aided performance and showed that incentives do not necessarily decrease performance in the presence of decision aids, rather, the effect depends on other contextual factors such as the absence or presence of additional contextual information.
Abstract: This study examines the effect of incentives on decision-aided performance. In particular, the study provides further insight into whether, when, and how incentives affect task performance in the presence of decision aids by (1) replicating previous research showing the negative effects of incentives on performance; (2) investigating whether this effect generalizes to a more realistic scenario in which decision makers have access to additional contextual information not captured by the decision aid; and (3) applying an effort-based framework to explain the link between incentives and performance. In contrast to the findings of prior research, our study shows that incentives do not necessarily decrease performance in the presence of decision aids. Rather, we demonstrate that the effect of incentives on decision-aided performance depends on other contextual factors such as the absence or presence of additional contextual information. By further specifying the conditions under which incentives result in increases or decreases to decision-aided task performance, our results have implications for both future research and the design of incentive systems in practice. Copyright © 2010 John Wiley & Sons, Ltd.
9 citations
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TL;DR: A simplified, scored form of the cognitive mental status examination, the “Mini-Mental State” (MMS) which includes eleven questions, requires only 5-10 min to administer, and is therefore practical to use serially and routinely.
76,181 citations
"Influence of decision aids on patie..." refers background in this paper
...Eligible participants were at least 65 years of age, able to read and understand English and cognitively intact.(44) Patients were excluded from the study if they had received a diagnosis of atrial fibrillation or if they were currently taking warfarin....
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01 Jan 2002
TL;DR: The Mini-Mental State (MMS) as mentioned in this paper is a simplified version of the standard WAIS with eleven questions and requires only 5-10 min to administer, and is therefore practical to use serially and routinely.
Abstract: EXAMINATION of the mental state is essential in evaluating psychiatric patients.1 Many investigators have added quantitative assessment of cognitive performance to the standard examination, and have documented reliability and validity of the several “clinical tests of the sensorium”.2*3 The available batteries are lengthy. For example, WITHERS and HINTON’S test includes 33 questions and requires about 30 min to administer and score. The standard WAIS requires even more time. However, elderly patients, particularly those with delirium or dementia syndromes, cooperate well only for short periods.4 Therefore, we devised a simplified, scored form of the cognitive mental status examination, the “Mini-Mental State” (MMS) which includes eleven questions, requires only 5-10 min to administer, and is therefore practical to use serially and routinely. It is “mini” because it concentrates only on the cognitive aspects of mental functions, and excludes questions concerning mood, abnormal mental experiences and the form of thinking. But within the cognitive realm it is thorough. We have documented the validity and reliability of the MMS when given to 206 patients with dementia syndromes, affective disorder, affective disorder with cognitive impairment “pseudodementia”5T6), mania, schizophrenia, personality disorders, and in 63 normal subjects.
70,887 citations
TL;DR: To determine the morbidity and mortality from childhood Haemophilus influenzae type b (Hib) meningitis in a well defined population, a large number of cases are diagnosed with Hib.
Abstract: OBJECTIVE To determine the morbidity and mortality from childhood Haemophilus influenzae type b (Hib) meningitis in a well defined population. DESIGN Retrospective survey 1985-1987 and prospective surveillance of hospital laboratories 1989-1990. Information on outcome of meningitis was obtained from hospital records and attending physicians and, in 1989-1990, from a survey of the children's parents. SETTING Sydney Statistical Division, which had a population of children aged 0-4 years of 229,165 in 1986 and 263,758 in 1990. PATIENTS Eligible children were aged from one month to four years and had clinical and microbiological evidence of Hib meningitis on standard criteria. RESULTS There were 229 eligible children. Twelve were excluded (seven died and five had pre-existing neurological deficits). A neurological deficit was detected at the time of hospital discharge in 45 patients (21%) and persisted for 12 months or longer in 29 patients (13%). Follow-up information was available for 165 (96%) children who were normal at the time of hospital discharge and persistent deficits were recorded in 12 (7%) of these children. Forty-one children (19%) had readily recognisable neurological or hearing problems: nine (4%) had persistent severe neurological deficits and seven (3%) had severe hearing loss requiring hearing aids or a cochlear implant. Age had a significant influence on outcome. The youngest children were significantly more likely to be admitted to intensive care. Severe neurological deficits showed a significant negative trend with increasing age (P = 0.03). Severe unilateral or bilateral sensorineural loss (odds ratio [OR] 8.0, 95% confidence interval [CI] 1.5-81) and ataxia at discharge (OR 13.3, 95% CI 2.8-128) were noticeably more common in children over two years of age, with a significant positive trend (P < or = 0.001) with increasing age. Patients requiring intensive care were much more likely to have an adverse outcome, particularly if positive pressure ventilation was needed. CONCLUSIONS These data provide population-based estimates of the minimum incidence of adverse outcomes from Hib meningitis in an urban community with good access to medical services. This is important in assessing the impact of Hib vaccination, as meningitis is responsible for most of the long-term morbidity from childhood invasive Hib disease. Determination of the relationship between morbidity and age is important for assessing alternative vaccine strategies.
8,476 citations
TL;DR: The incidence of thromboembolic complications and vascular mortality were significantly lower in the warfarin group than in the aspirin and placebo groups, which did not differ significantly.
1,636 citations
TL;DR: Aspirin and warfarin are both effective in reducing ischemic stroke and systemic embolism in patients with atrial fibrillation and patients with nonrheumatic atrialfibrillation who can safely take either aspirin or warfarIn should receive prophylactic antithrombotic therapy to reduce the risk of stroke.
Abstract: BACKGROUND Atrial fibrillation in the absence of rheumatic valvular disease is associated with a fivefold to sevenfold increased risk of ischemic stroke.
METHODS AND MAIN RESULTS The Stroke Prevention in Atrial Fibrillation Study, a multicenter, randomized trial, compared 325 mg/day aspirin (double-blind) or warfarin with placebo for prevention of ischemic stroke and systemic embolism (primary events), and included 1,330 inpatients and outpatients with constant or intermittent atrial fibrillation. During a mean follow-up of 1.3 years, the rate of primary events in patients assigned to placebo was 6.3% per year and was reduced by 42% in those assigned to aspirin (3.6% per year; p = 0.02; 95% confidence interval, 9-63%). In the subgroup of warfarin-eligible patients (most less than 76 years old), warfarin dose-adjusted to prolong prothrombin time to 1.3-fold to 1.8-fold that of control reduced the risk of primary events by 67% (warfarin versus placebo, 2.3% versus 7.4% per year; p = 0.01; 95% confidence interval, 27-85%). Primary events or death were reduced 58% (p = 0.01) by warfarin and 32% (p = 0.02) by aspirin. The risk of significant bleeding was 1.5%, 1.4%, and 1.6% per year in patients assigned to warfarin, aspirin, and placebo, respectively.
CONCLUSIONS Aspirin and warfarin are both effective in reducing ischemic stroke and systemic embolism in patients with atrial fibrillation. Because warfarin-eligible patients composed a subset of all aspirin-eligible patients, the magnitude of reduction in events by warfarin versus aspirin cannot be compared. Too few events occurred in warfarin-eligible patients to directly assess the relative benefit of aspirin compared with warfarin, and the trial is continuing to address this issue. Patients with nonrheumatic atrial fibrillation who can safely take either aspirin or warfarin should receive prophylactic antithrombotic therapy to reduce the risk of stroke.
1,594 citations