How best to obtain consent to thrombolysis: Individualized decision-making.

OBJECTIVE: To investigate the factors that influence the preferences of patients and their proxies concerning thrombolytic therapy and to determine how best to convey information. METHODS: A total of 613 participants were randomly assigned to a positively or negatively framed group. Each participant completed a series of surveys. We applied latent class analysis (LCA) to explore participants' patterns of choices of thrombolysis and to classify the participants into different subgroups. Then we performed regression analyses to investigate predictors of classification of the participants into each subgroup and to establish a thrombolytic decision-making model. RESULTS: LCA indicated an optimal 3-subgroup model comprising intermediate, favorable to thrombolysis, and aversion to thrombolysis subgroups. Multiple regression analysis revealed that 10 factors predicted assignment to the intermediate subgroup and 4 factors predicted assignment to the aversion to thrombolysis subgroup compared with the favorable to thrombolysis subgroup. The χ(2) tests indicated that the information presentation format and the context of thrombolysis influenced participants' choices of thrombolysis and revealed a framing effect in different subgroups. CONCLUSIONS: The preference for thrombolysis was influenced by the positive vs negative framing scenarios, the format of item presentation, the context of thrombolysis, and individual characteristics. Inconsistent results may be due to participant heterogeneity and the evaluation of limited factors in previous studies. Based on a decision model of thrombolysis, physicians should consider the effects of positive vs negative framing and should seek a neutral tone when presenting the facts, providing an important reference point for health persuasion in other clinical domains.

Factors influencing risky decision-making in patients with cerebral infarction.

Numerous studies have found that the framing effect is common in medical scenarios, but few studies have examined the influence of the framing effect upon thrombolytic therapy for cerebral infarction. In this study, 1040 inpatients and outpatients in the department of neurology were recruited to explore whether there is a framing effect in decision-making within thrombolytic therapy, and if so, which factors influence that effect. The findings from Study 1 indicate that the framing effect occurred in patients both with and without cerebral infarction (χ(2) = 7.90, p = .005; χ(2) = 5.16, p = .023, respectively), with both groups displaying risk-seeking behavior (thrombolytic therapy) in the positive frame and no risk aversion or risk seeking in the negative frame. The results of Study 2 show that the patients preferred risk seeking in both collaborative and individual decision-making. In the collaborative decision-making group, the patients in the senior group showed the framing effect (χ(2) = 5.35, p < .05), with the patients in the positive frame (G) showing more significant risk seeking than both those in the negative frame (H) and those in the other positive frame (A, C, and E). In summary, decision-making about thrombolytic therapy in patients with cerebral infarction is influenced by the framing effect, and some influencing factors should be attended in clinical practice. Further research is necessary to guide the treatment of cerebral infarction.

Patient refusal of thrombolytic therapy for suspected acute ischemic stroke.

OBJECTIVE: To determine factors associated with patients refusing IV t-PA for suspected acute ischemic stroke (AIS), and to compare the outcomes of patients who refused t-PA (RT) with those treated with t-PA. METHODS: Patients who were treated with and refused t-PA at our stroke center were identified retrospectively. Demographics, clinical presentation, and outcome measures were collected and compared. Clinical outcome was defined as excellent (mRS: 0-1), good (mRS: 0-2), and poor (mRS: 3-6). RESULTS: Over 7·5 years, 30 (4·2%) patients refused t-PA. There were no demographic differences between the treated and RT groups. The rate of RT decreased over time (OR 0·63, 95% CI 0·50-0·79). Factors associated with refusal included a later symptom onset to emergency department presentation time (OR 1·02, 95% CI 1·01-1·03), lower NIHSS (OR 1·11, 95% CI 1·03-1·18), a higher proportion of stroke mimics (OR 17·61, 95% CI 6·20-50·02) and shorter hospital stay (OR 1·32, 95% CI 1·09-1·61). Among patients who were subsequently diagnosed with ischemic stroke, only length of stay was significantly shorter for refusal patients (OR 1·37, 95% CI 1·06-1·78). After controlling for mild strokes and stroke mimics, clinical outcome was not different between the groups (OR 1·61, 95% CI 0·69-3·73). CONCLUSION: The incidence of patients refusing t-PA has decreased over time, yet it may be a cause for t-PA under-utilization. Patients with milder symptoms were more likely to refuse t-PA. Refusal patients presented later to the hospital and had shorter hospital stays. One out of six refusal patients (16·6%) had a stroke mimic.

Advance preferences regarding thrombolysis in patients at risk for stroke: a cross-sectional study.

BACKGROUND: It is difficult to obtain informed consent for thrombolysis in stroke patients given the emergency setting, the need for a speedy decision and the effects of neurological deficits. AIM: To determine the advance preferences for thrombolysis of patients at risk for stroke following discussion of the potential risks and benefits. DESIGN: Cross-sectional survey. METHODS: Data on benefits and risks of thrombolysis within 3 h and between 3 and 4.5 h after stroke were presented orally, in writing and pictorially to patients attending geriatric and stroke services in a teaching hospital with specified stroke risk factors and preferences for thrombolysis were recorded. RESULTS: Of the 121 participants, 108 (89.3%; 95% confidence interval [CI] 82.4-93.7) would opt for thrombolysis within the 3-h period and 100 (82.6%; 95% CI 74.9-88.4) within the 3- to 4.5-h period after acute stroke (P = 0.04, McNemar's test for correlated proportions). Previous stroke or transient ischaemic attack was more common among those who agreed to thrombolysis (54.1% vs. 30.4%, P = 0.04) and those who opted for thrombolysis were significantly more likely to agree to have their preferences recorded and used in the event of a stroke than those who refused thrombolysis (88.8% vs. 30.4%, P = 0.002). CONCLUSION: Advance discussion of the potential risks and benefits of thrombolysis in at-risk patients may improve decision making if thrombolysis is being considered and the patient can no longer make a decision.

Women's interpretation of and cognitive and behavioral responses to the symptoms of acute ischemic stroke.

Delay seeking medical assistance for acute ischemic stroke remains a barrier to the provision of optimal care, including the administration of tissue plasminogen activator. Although women report greater knowledge of stroke symptoms and stroke risk factors than men, earlier hospital arrival in women has not been consistently reported. The purposes of this study were to examine women's interpretation of stroke symptoms and compare cognitive and behavioral responses between women who arrived at the hospital within 3 hours of symptom onset and women who arrived after 3 hours. More than half of the participants arrived at the hospital greater than 3 hours after first noticing symptoms. Most women did not recognize the cause of symptoms. Knowledge about a treatment of stroke was limited, and a minority of the women knew they were at risk for stroke despite having known risk factors. Maladaptive responses to symptoms were reported more frequently by women with hospital arrival greater than 3 hours after symptom onset than by women with earlier arrival. Efforts are needed to reduce maladaptive responses to stroke onset that may contribute to delay seeking medical assistance for the symptoms of acute ischemic stroke.

The outcome wheel: a potential tool for shared decision-making in ischemic stroke thrombolysis.

A stroke can be a catastrophic experience. Patients are confronted with alarming symptoms and then a devastating diagnosis, after which they are expected to make an "informed decision" regarding intervention. Informed decision-making is a term that, unlike informed consent, implies that the decision is made by the physician, the patient and the family based on available evidence and information. The 3-hour treatment window for thrombolysis in ischemic stroke imparts very little time for a clinician to sit down with a patient and present information in an unbiased, useful manner. The purpose of this paper is to offer a tool that may assist the physician, the patient and the family in making an informed decision in a time-sensitive manner for thrombolytic intervention in stroke. This tool visually displays outcomes and the role of chance in an intuitive "spin the wheel" type fashion. Until at least May 2011, an interactive version of this clinical tool kit will be available for download at www.sem-bc.com/cvatoolkit.

Calling 911 in response to stroke: a nationwide study assessing definitive individual behavior.

BACKGROUND AND PURPOSE: Stroke treatment is time-dependent, yet no study has systematically examined response to individual stroke symptoms in the general population. This nationwide study identifies which specific factors prompt correct response (calling 911) to stroke. METHODS: Between November and December of 2005, a survey using a 3-stage random-sampling method including area, household, and household member sampling was conducted throughout the Czech Republic. Participants >40 years old were personally interviewed via a structured and standardized questionnaire concerning general knowledge and correct response to stroke as assessed by the Stroke Action Test (STAT). Predictors of scoring >50% on STAT were identified by multiple regression. RESULTS: A total of 650 households were contacted, yielding 592 interviews (response rate 91%). Mean age was 58+/-12, 55% women. Sixty-nine percent thought stroke was serious condition, and 57% thought it could be treated. Also 54% correctly named >/=2 risk factors, and 46% named >/=2 warning signs. Eighteen percent of respondents scored >50% on STAT. The predictors of such a score were age (for each 10-year increment, OR 1.4, 95% CI 1.2 to 1.7), secondary school education (OR 1.7, 95% CI 1.1 to 2.6), knowing that stroke is a serious disease (OR 1.8, 95% CI 1.1 to 3.1), and knowing that stroke is treatable (OR 2.0, 95% CI 1.2 to 3.2). CONCLUSIONS: Knowledge about stroke in the Czech Republic was fair, yet response to warning signs was poor. Our study is the first to identify that calling 911 was influenced by knowledge that stroke is a serious and treatable disease and not by recognition of symptoms.

Implicit bias among physicians and its prediction of thrombolysis decisions for black and white patients.

CONTEXT: Studies documenting racial/ethnic disparities in health care frequently implicate physicians' unconscious biases. No study to date has measured physicians' unconscious racial bias to test whether this predicts physicians' clinical decisions. OBJECTIVE: To test whether physicians show implicit race bias and whether the magnitude of such bias predicts thrombolysis recommendations for black and white patients with acute coronary syndromes. DESIGN, SETTING, AND PARTICIPANTS: An internet-based tool comprising a clinical vignette of a patient presenting to the emergency department with an acute coronary syndrome, followed by a questionnaire and three Implicit Association Tests (IATs). Study invitations were e-mailed to all internal medicine and emergency medicine residents at four academic medical centers in Atlanta and Boston; 287 completed the study, met inclusion criteria, and were randomized to either a black or white vignette patient. MAIN OUTCOME MEASURES: IAT scores (normal continuous variable) measuring physicians' implicit race preference and perceptions of cooperativeness. Physicians' attribution of symptoms to coronary artery disease for vignette patients with randomly assigned race, and their decisions about thrombolysis. Assessment of physicians' explicit racial biases by questionnaire. RESULTS: Physicians reported no explicit preference for white versus black patients or differences in perceived cooperativeness. In contrast, IATs revealed implicit preference favoring white Americans (mean IAT score = 0.36, P < .001, one-sample t test) and implicit stereotypes of black Americans as less cooperative with medical procedures (mean IAT score 0.22, P < .001), and less cooperative generally (mean IAT score 0.30, P < .001). As physicians' prowhite implicit bias increased, so did their likelihood of treating white patients and not treating black patients with thrombolysis (P = .009). CONCLUSIONS: This study represents the first evidence of unconscious (implicit) race bias among physicians, its dissociation from conscious (explicit) bias, and its predictive validity. Results suggest that physicians' unconscious biases may contribute to racial/ethnic disparities in use of medical procedures such as thrombolysis for myocardial infarction.

A qualitative study of paramedics' attitudes to providing prehospital thrombolysis.

OBJECTIVES: To explore paramedics' attitudes to administering prehospital thrombolysis (PHT). METHOD: In-depth interviews with 20 paramedics were recorded and transcribed and analysed for emergent themes using the constant comparative method. RESULTS: Although there was a will to provide PHT because of its benefits to patients, its associated risks, aspects of pay and working conditions, and certain organisational factors undermined the willingness of some paramedics to administer thrombolysis. The eight minute response time standard is a competing imperative which can delay thrombolysis. CONCLUSIONS: A minority of paramedics are likely to be unwilling to deliver PHT unless countervailing imperatives are addressed.

What are the beliefs and attitudes of paramedics to prehospital thrombolysis? A questionnaire study.

BACKGROUND: The Ambulance Services have a critical role in the management of acute myocardial infarction (AMI). Paramedic delivered prehospital thrombolysis (PHT) has been proposed. To the authors' knowledge there has been no research carried out to ascertain the views of paramedics. METHODS: The authors conducted a postal questionnaire study of 250 paramedics in the West Yorkshire Metropolitan Ambulance Service (WYMAS). This included the knowledge of risks and benefits of AMI treatments, and their views on possible paramedic delivered PHT. RESULTS: 193 paramedics replied (77%); of these 83% felt paramedics could deliver PHT, 67% felt thrombolysis was safe, and only 12% felt that paramedics should not carry out PHT. There was a similar preference towards autonomous PHT (42%) and telemetry with physician directed PHT (46%). 96% wanted a nationally recognised certificate. There were concerns regarding the risks of AMI treatment, with underestimates of the benefits of aspirin, and overestimates of the benefits of thrombolysis. They also greatly overestimated the risks of thrombolysis in terms of extra deaths (71%), and bleeding (90%). CONCLUSION: The majority of paramedics in WYMAS responding to the questionnaire supported the principle of PHT. Concerns included the risks of thrombolytic treatment, training, and the medico-legal implications for them as individual paramedics. Models for paramedic thrombolysis for each ambulance service should include the views of paramedics.

American Heart Association and American Stroke Association national survey of stroke risk awareness among women.

BACKGROUND: Stroke is the third leading cause of death in the United States and a major cause of morbidity in women. Awareness of risk may be an important first step in stroke prevention. The purpose of this study was to assess knowledge and awareness about stroke in a nationally representative sample of women. METHODS AND RESULTS: An American Heart Association-sponsored telephone survey using random-digit dialing was conducted in June and July of 2003. Respondents were 1024 women > or =25 years of age, including an oversampling of racial/ethnic minorities (68% white, 12% black, 12% Hispanic). Participants were given a standardized questionnaire about heart disease and stroke risk. Only 26% of women > or =65 years of age reported being well informed about stroke, even though this group carries the highest incidence of stroke. Overall, 20% of women stated that they worried a lot about stroke. Among women aged 25 to 34 years, 37% stated that they were not at all informed about stroke, which was significantly higher than for women between 45 and 64 years (13%, P<0.05) and those > or =65 years of age (14%, P<0.05). More Hispanics reported being not at all informed about stroke compared with whites (32% versus 19%, P<0.05) and blacks (32% versus 20%, P<0.05). More white women were aware that at the onset of a stroke, treatment could be given to break up blood clots compared with blacks (92% versus 84%, P<0.05) and Hispanics (92% versus 79%, P<0.05). Correct identification of the warning signs of stroke was low among all racial/ethnic and age groups. More white respondents correctly identified sudden 1-sided weakness or numbness of the face or a limb as a warning sign compared with Hispanics (39% versus 29%, P<0.05). Whites identified difficulty talking or understanding speech as a sign of stroke significantly more often than did Hispanics (29% versus 17%, P<0.05). CONCLUSIONS: Results of this national survey document that awareness and knowledge about stroke is suboptimal among women, especially among racial/ethnic minorities, who are at highest risk. These data support the need for targeted educational programs about stroke risk and symptoms and underscore the importance of public health programs to improve awareness of stroke among women.

Informed consent for thrombolytic therapy for patients with acute ischemic stroke treated in routine clinical practice.

BACKGROUND AND PURPOSE: Little is known about informed consent for tissue plasminogen activator (tPA). Our objectives were to determine how frequently informed consent is obtained when tPA is given to stroke patients in clinical practice and whether the person providing consent (patient or surrogate) was the appropriate decision-maker. METHODS: This retrospective cohort included acute stroke patients given tPA in 10 Connecticut hospitals (1996-1998). Consent was defined as any documentation of discussion about risks and benefits of tPA. Patients had adequate decision-making capacity if they were alert, oriented, and without aphasia or neglect (patient was appropriate decision-maker). Patients with any of these deficits were considered to have diminished capacity (surrogate was appropriate decision-maker). RESULTS: Among 63 patients who received tPA, 53 (84%) had informed consent documented; 16/53 (30%) gave their own consent. Among patients with adequate decision-making capacity, 5/8 (63%) had consent by surrogate. Among patients with diminished capacity, 7/38 (18%) provided their own consent. CONCLUSIONS: A substantial percentage of patients who received tPA for stroke had no consent documented. Surrogates often provided consent when the patients had capacity; conversely, patients with diminished capacity sometimes provided their own consent. Given the urgency and weight of the decision regarding tPA, more explicit informed consent and capacity assessment should be considered for treatment protocols.

Patient knowledge of thrombolysis in acute myocardial infarction.

A convenience sample of 50 patients admitted for treatment or ruling out of acute myocardial infarction were asked about their knowledge of thrombolysis. Some 44 of 50 knew nothing of thrombolysis and interestingly 30 of these 44 had been previously diagnosed as having ischaemic heart disease. Greater knowledge of the benefit and timeliness of thrombolysis may provide an important incentive for earlier presentation of this group.

Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial.

OBJECTIVES: To determine whether consumer involvement would help to solve some of the ethical problems associated with research into thrombolysis for acute ischaemic stroke, with its inherent risk of fatal intracranial haemorrhage. DESIGN: Quantitative and qualitative research. SETTING AND PARTICIPANTS: CONSULTATION PHASE: three meetings were held to discuss the planned research, and participants completed a questionnaire. QUALITATIVE WORK: focus group meetings explored the issues raised during the consultation phase. Design of information leaflets for patients and relatives: trial materials were drafted during the consultation phase and revised in the light of feedback from the focus group meetings and review by patients and carers on a stroke rehabilitation unit. RESULTS: 54 people attended the consultation meetings. Four (9%) participants considered the risks of thrombolysis too great, but most (89%) were prepared to accept the treatment in a clinical trial. Nearly all would accept treatment if it was shown to be effective. Most (85%) would give their consent to enter the planned trial. The focus group meetings and feedback from patients and carers led to significant changes in the information leaflets. The revised trial materials were considered ethical by a national multicentre research ethics committee. CONCLUSIONS: Consumers generally supported a planned trial, and their involvement helped to refine trial consent procedures and led to an ethically acceptable trial design.

Thrombolysis for acute ischemic stroke: the patient's point of view.

BACKGROUND: The use of thrombolytic therapy for acute ischemic stroke is still controversial. A major problem is balancing the improvement in functional ability against the risk of early death from cerebral hemorrhage. Our aim was to assess whether patients who have had a stroke, and their proxies, would give consent to thrombolysis if this therapy were introduced into clinical practice for acute ischemic stroke in Italy. METHODS: A 10-item questionnaire was administered by personnel not directly involved in the care of patients in 12 Italian hospitals. Interviews were carried out with at least 10 consecutive stroke inpatients per center in the postacute phase and to their proxies. RESULTS: There were 685 responders (377 female), median age 58 years (range 18-98); 332 were patients and 353 proxies. Responders were representative of the Italian population as a whole as regards mean age and sex, education and marital status; 59% of responders (95% confidence interval 55-62%) would agree to thrombolysis in the case of stroke. There was more uncertainty among proxies than patients, especially when the decision had to be taken for a relative (41 vs. 17% could not decide, p < 0.001). The preference for thrombolysis was higher among more educated people (p = 0.001) and was not influenced by sex, age and marital status. Overall, 81% of responders would prefer to risk dying rather than remain severely disabled. CONCLUSION: Thrombolytic therapy is feasible in Italy as there is ample willingness to trade off a better functional outcome with a higher risk of death. Education is the main sociodemographic determinant of independent decision-making, as only those with an adequate cultural level are able to discriminate between one treatment option and another. The proxy's uncertainty about how to interpret a patient's preference regarding consent to thrombolytic therapy should be tackled, since proxies play a key role in making patients' preferences known in case of incompetence after an acute stroke.

Treatment decision making in mature adults: gender differences.

Studies have shown that women are less likely to receive several specific medical interventions, including organ transplantation, cardiac diagnostic studies, and coronary artery bypass surgery. This study investigates the hypothesis that this inequity may be explained by gender differences in treatment decisions made by older adults. A self-report questionnaire using hypothetical situations, treatment choices, and influencing factors was designed based on literature review and interviews with key informants. The questionnaire was administered to 250 nonpatient adults over the age of 50 in urban and rural settings in Ontario, Canada. Results revealed no significant gender differences in hypothetical treatment decisions made by patients nor in the factors affecting those decisions. In the absence of evidence that patient choice accounts for gender differences in utilization rates, physicians need to carefully examine their assumptions about patient preference and gender in the provision of specific interventions to male and female patients.

Quality management within a cost-constrained service.

AIM: To examine the meaning of quality and ways in which quality can be improved despite budgetary limitations. KEY ISSUES: Definitions of quality are discussed, comparing the development from industrial concepts of quality to that contained within the Department of Health's A First CLASS SERVICE: The relationship of cost and quality is examined and the effects of changing treatments on healthcare costs explored. Clinical error is identified as a cause of increased cost through failure to maintain quality. A variety of quality tools are discussed in identifying ways in which quality can be improved within a cost-limited service. Thrombolysis is used as an exemplar and the effects on nursing discussed. CONCLUSION: There is research evidence which demonstrates that some areas of quality are amenable to improvement despite budgetary constraints.