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A decision aid for women at increased risk for ovarian cancer.

This paper reviews changes that have occurred within and without the medical profession that have fostered an increasing demand for decision aids as adjuncts to practitioners' counseling to prepare patients for decision making. In the absence of data on the efficacy of ovarian cancer screening and prophylactic strategies, decisions about optimal care are difficult for both women and their doctors. Because surveillance and preventive options are an area of great uncertainty, a decision aid has been developed specifically aimed at facilitating decisions involving ovarian cancer risk management options. This was achieved by reviewing and integrating the available literature on models of medical decision making, patient preferences for information and involvement in decision making, the utility of decision aids, and management options for ovarian cancer risk. Findings indicate that patients wish to be informed participants in the decision-making process and that decision aids are an acceptable and effective method of providing quality information in a format that facilitates an inclusive model of shared decision making. A decision aid designed for women at increased risk of ovarian cancer that facilitates informed decision making may be a valuable addition to patient support. A randomized controlled trial of this type of educational material will provide timely and much needed evidence on its acceptability and efficacy.

Adult↗

Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598].

OBJECTIVES: To evaluate the effectiveness of a decision aid for women with a breech presentation compared with usual care. DESIGN: Randomised controlled trial. SETTING: Tertiary obstetric hospitals offering external cephalic version (ECV). POPULATION: Women with a singleton pregnancy were diagnosed antenatally with a breech presentation at term, and were clinically eligible for ECV. METHODS: Women were randomised to either receive a decision aid about the management options for breech presentation in addition to usual care or to receive usual care only with standard counselling from their usual pregnancy care provider. The decision aid comprised a 24-page booklet supplemented by a 30-minute audio-CD and worksheet that was designed for women to take home and review with a partner. MAIN OUTCOME MEASURES: Decisional conflict (uncertainty), knowledge, anxiety and satisfaction with decision making, and were assessed using self-administered questionnaires. RESULTS: Compared with usual care, women reviewing the decision aid experienced significantly lower decisional conflict (mean difference -8.92; 95% CI -13.18, -4.66) and increased knowledge (mean difference 8.40; 95% CI 3.10, 13.71), were more likely to feel that they had enough information to make a decision (RR 1.30; 95% CI 1.14, 1.47), had no increase in anxiety and reported greater satisfaction with decision making and overall experience of pregnancy and childbirth. In contrast, 19% of women in the usual care group reported they would have made a different decision about their care. CONCLUSIONS: A decision aid is an effective and acceptable tool for pregnant women that provides an important adjunct to standard counselling for the management of breech presentation.

Adolescent↗

Decision aids for triage of patients with chest pain: a systematic review of field evaluation studies.

We performed an overview of published controlled trials to assess the overall effectiveness of decision aids directed at improving triage of patients with acute chest pain. Searches of the Medline database identified 11 randomized or quasi-randomized controlled trials testing various decision aids: risk stratification system (n = 6), practice guidelines (n = 3), and formalized protocols of care (n = 2). Sensitivity, specificity of the decision aid and length of stay (LOS) in the intensive care unit (ICU) were the main outcomes. Decision aids slightly modified sensitivity and specificity (available in 5 studies), but sensitivity was already high in reference groups. Among the 9 studies providing information on LOS, 7 showed a statistically significant difference favoring the decision aid. The level of evidence concerning the efficacy of decision aids in this domain is relatively low. Larger and appropriately designed clinical trials are required to show an impact on acute cardiac ischaemia complications and mortality.

Chest Pain↗

Decision aids for triage of patients with chest pain: a systematic review of field evaluation studies.

We performed an overview of published controlled trials to assess the overall effectiveness of decision aids directed at improving triage of patients with acute chest pain. Searches of the Medline database identified 11 randomized or quasi-randomized controlled trials testing various decision aids: risk stratification system (n = 6), practice guidelines (n = 3), and formalized protocols of care (n = 2). Sensitivity, specificity of the decision aid and length of stay (LOS) in the intensive care unit (ICU) were the main outcomes. Decision aids slightly modified sensitivity and specificity (available in 5 studies), but sensitivity was already high in reference groups. Among the 9 studies providing information on LOS, 7 showed a statistically significant difference favoring the decision aid. The level of evidence concerning the efficacy of decision aids in this domain is relatively low. Larger and appropriately designed clinical trials are required to show an impact on acute cardiac ischaemia complications and mortality.

Humans↗

Protocol for the evaluation of a decision aid for women with a breech-presenting baby [ISRCTN14570598].

BACKGROUND: There is now good evidence about the management options for pregnant women with a breech presentation (buttocks or feet rather than head-first) at term; external cephalic version (ECV) - the turning of a breech baby to a head-down position and/or planned caesarean section (CS). Each of these options has benefits and risks and the relative importance of these vary for each woman, subject to her personal values and preferences, a situation where a decision aid may be helpful.Decision aids are designed to assist patients and their doctors in making informed decisions using information that is unbiased and based on high quality research evidence. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed and consistent with personal values.The ECV decision aid was developed using the Ottawa Decision Support Framework, including a systematic review of the evidence about the benefits and risks of the options for breech pregnancy. It comprises an audiotape with a supplementary booklet and worksheet, a format that can be taken home and discussed with a partner. This project aims to evaluate the ECV decision aid for women with a breech presenting baby in late pregnancy. STUDY DESIGN: We aim to evaluate the effectiveness of the decision aid compared with usual care in a randomised controlled trial in maternity hospitals that offer ECV. The study group will receive the decision aid in addition to usual care and the control group will receive standard information on management options for breech presentation from their usual pregnancy care provider. Approximately 184 women with a single breech-presenting baby at greater than 34 weeks gestation and who are clinically eligible for ECV will be recruited for the trial.The primary outcomes of the study are knowledge, decisional conflict, anxiety and satisfaction with decision-making that will be assessed using self-administered questionnaires. The decision aid is not intended to influence either the uptake of either ECV or planned CS, however we will monitor health service utilisation rates and maternal and perinatal outcomes.

Journal Article↗

DATA: a decision aid for management of the patient with stable angina pectoris.

OBJECTIVE: The patient with stable disabling angina must choose between bypass surgery, coronary angioplasty, or medical therapy. Estimation of comparative outcomes of these alternative therapies is difficult. DESIGN: Utilizing Artificial Intelligence, an expert-system computerized decision aid, DATA (Decision Aid for Therapy of Angina), was developed to run on a personal computer and to calculate the probability of each possible clinical event based on individual patient characteristics. For each therapeutic option, relative clinical outcomes and anticipated charges are computed. Ten patients were evaluated retrospectively by DATA and by a group of cardiologists. RESULTS: DATA agreed with the primary therapy given to all patients. The physician group underestimated the value of alternative therapies and underestimated charges for all therapies. CONCLUSIONS: This decision aid allows comparison of alternative therapies in terms of relative patient outcome and anticipated costs can be better estimated.

Angina Pectoris↗

Helping smokers to decide on the use of efficacious smoking cessation methods: a randomized controlled trial of a decision aid.

AIMS: Most smokers attempt to stop smoking without using help. We evaluated the efficacy of a decision aid to motivate quitters to use efficacious treatment. SETTING AND PARTICIPANTS, A total of 1,014 were recruited from a convenience sample of 3,391 smokers who intended to quit smoking within 6 months. DESIGN AND Smokers were assigned randomly to either receive the decision aid or no intervention. The decision aid was expected to motivate quitters to use efficacious cessation methods and contained neutral information on treatment methods, distinguishing between efficacious and non-efficacious treatments. MEASUREMENTS Baseline questionnaire and follow-ups were used 2 weeks and 6 months after the start of the intervention. FINDINGS: The decision aid increased knowledge of cessation methods and induced a more positive attitude towards these methods. Furthermore, 45% reported increased confidence about being able to quit and 43% said it helped them to choose between treatments. However, no clear effect on usage of treatment aids was found, but the intervention group had more quit attempts (OR=1.52, 95% CI 1.14-2.02) and higher point prevalence abstinence at 6-month follow-up (20.2% versus 13.6%; OR=1.51, 95% CI=1.07-2.11). CONCLUSIONS An aid to help smokers decide to use efficacious treatment when attempting to quit smoking had a positive effect on smoking cessation, while failing to increase the usage of efficacious treatment. This finding lends support to the notion that the mere promotion of efficacious treatments for tobacco addiction might increase the number of quit attempts, irrespective of the actual usage of treatment.

Adolescent↗

Physicians' opinions about decision aids for patients considering systemic adjuvant therapy for axillary-node negative breast cancer.

PURPOSE: To examine variations in physicians' opinions about the appropriateness and content of decision aids for women with breast cancer and criteria for their evaluation. METHODS: Cross-sectional survey of all 144 Ontario oncologists by Dillman's mailed survey design. The response rate was 87%. RESULTS: The predominant current practice pattern was to spontaneously inform patients about the treatment recommendations, degree of certainty regarding the recommendations, treatment regime, benefits and side effects. Most respondents (94%) endorsed patient decision aids, particularly when there was high uncertainty about providing adjuvant treatment. Over three-quarters endorsed measuring the following outcomes of decision aids: patients' clarity of trade-offs involved (e.g. survival vs. side effects); comprehension of treatment alternatives, risks and benefits; accuracy of expectations; decision satisfaction; anxiety; commitment to the decision; length of time to complete the decision aid; and decision uncertainty. The least support was for the use of the decision itself as an outcome measure. CONCLUSIONS: There is considerable consensus regarding the indications for, content and criteria for evaluating decision aids which should be considered when developing aids relevant to the needs of clinicians and patients.

Adult↗

Decision aids for familial breast cancer: exploring women's views using focus groups.

BACKGROUND: There is increasing need for accessible information about familial breast cancer for those facing complex decisions around genetic testing, screening and treatment. Information currently includes leaflets and computerized decision aids, offering interactive interfaces to clarify complex choices. OBJECTIVE: Exploration of users' views and reactions to three decision aids for genetic testing for breast cancer using focus groups. SETTING: A regional cancer genetics service in the UK. PARTICIPANTS: Women over 18 years of age who had been referred to Cancer Genetics Service for Wales (CGSW) and had received a risk assessment for familial breast cancer. METHODS: Qualitative study involving one pilot and six extended focus groups with 39 women at high, moderate and population risk. Two CD-ROMs and one paper-based aid evaluated for: clarity of presentation, ease of handling, emotive response, increased knowledge and greater informed choice. RESULTS: Women reported variable preferences for different types of decision aids and mixed emotions, indicating the sensitivity of raising issues in decision support tools, lack of consensus over the most appropriate aid and no systematic differences between risk groups. Women remarked that aids increased their knowledge, particularly about breast cancer genes and risk and wanted a decision aid designed within the context of the NHS, in both paper-based and CD-ROM formats from an authoritative source. Mixed views about presentation styles suggest decision aids would be most effective with a user-selected range of formats. CONCLUSIONS: Decision aid development should be informed by users and should meet the needs of those concerned about their risk of breast cancer in the UK. Without such aids, patients will continue to search for information from a variety of sources of varying quality.

Adult↗

A randomized controlled trial of a decision aid for women at increased risk of ovarian cancer.

PURPOSE: To carry out a randomized controlled trial of a decision aid for women at increased risk of developing ovarian cancer to facilitate decision making regarding risk management options. METHODS: This randomized trial, conducted through 6 familial cancer centers, compared the efficacy of tailored decision aid to that of a general educational pamphlet in preparing women for decision making. PARTICIPANTS: 131 women with a family history of breast and/or ovarian cancer or of hereditary nonpolyposis colorectal cancer. OUTCOME MEASURES: Decisional conflict, knowledge about ovarian cancer risk management options, and psychological adjustment were reassessed at 3 time points. RESULTS: Compared to those who received the pamphlet (control), women who received the decision aid (intervention) were significantly more likely to report a high degree of acceptability of the educational material at both follow-up assessment time points. Findings indicate neither group experienced significant increases in psychological distress at either follow-up assessment time points relative to baseline. Two weeks postintervention, the intervention group demonstrated a significant decrease in decisional conflict compared to the control group (t = 2.4, P < 0.025) and a trend for a greater increase in knowledge about risk management options (t = 2.1, P = 0.037). No significant differences were found 6 months postintervention. CONCLUSION: This form of educational material is successful in increasing knowledge about risk management options and in reducing decisional conflict in the shorter term. The decision aid is an effective and acceptable strategy for patient education to facilitate an inclusive and informed decision-making process about managing ovarian cancer risk.

Anxiety↗

A treatment trade-off based decision aid for patients with locally advanced non-small cell lung cancer.

Purpose To describe the structure and use of a decision aid for patients with locally advanced non-small cell lung cancer (LA-NSCLC) who are eligible for combined-modality treatment (CMT) or for radiotherapy alone (RT). METHODS: The aid included a structured description of the treatment options and trade-off exercises designed to help clarify the patient's values for the relevant outcomes by determining the patient's survival advantage threshold (the increase in survival conferred by CMT over RT that the patient deemed necessary for choosing CMT). Additional outcome measures included each patient's strength of treatment preference, decisional conflict, objective understanding of survival information, decisional role preference, and evaluation of the aid itself. RESULTS: Twenty-five patients met the eligibility criteria for study. Of these, seven declined the decision aid because they had a clear treatment preference (four chose CMT and three chose RT). The remaining 18 participants completed the decision aid; 16 chose CMT and two chose RT. All 18 patients wished to participate in the decision to some extent. All patients reported that using the decision support was useful to them and recommended its use for others. No patient or physician reported that the aid interfered with the physician-patient relationship. Patients' 3-year survival advantage thresholds, and their median survival advantage thresholds, were each strongly correlated with their strengths of treatment preference (rho=0.80, P < 0.001 and rho=0.77, P < 0.001, respectively). For all but one patient, either their 3-year or median survival threshold was consistent with their final treatment choice. Eight patients reported a stronger treatment preference after using the decision aid. CONCLUSIONS: We conclude that a treatment trade-off based decision aid for patients with locally advanced non-small cell lung cancer is feasible, that it demonstrates internal consistency and convergent validity, and that it is favourably evaluated by patients and their physicians. The aid seems to help patients understand the benefits and risks of treatment and to choose the treatment that is most consistent with their values.

Journal Article↗

Evaluation of a decision aid for prenatal testing of fetal abnormalities: a cluster randomised trial [ISRCTN22532458].

BACKGROUND: By providing information on the relative merits and potential harms of the options available and a framework to clarify preferences, decision aids can improve knowledge and realistic expectations and decrease decisional conflict in individuals facing decisions between alternative forms of action. Decision-making about prenatal testing for fetal abnormalities is often confusing and difficult for women and the effectiveness of decision aids in this field has not been established. This study aims to test whether a decision aid for prenatal testing of fetal abnormalities, when compared to a pamphlet, improves women's informed decision-making and decreases decisional conflict. METHODS/DESIGN: A cluster designed randomised controlled trial is being conducted in Victoria, Australia. Fifty General Practitioners (GPs) have been randomised to one of two arms: providing women with either a decision aid or a pamphlet. The two primary outcomes will be measured by comparing the difference in percentages of women identified as making an informed choice and the difference in mean decisional conflict scores between the two groups. Data will be collected from women using questionnaires at 14 weeks and 24 weeks gestation. The sample size of 159 women in both arms of the trial has been calculated to detect a difference of 18% (50 to 68%) in informed choice between the two groups. The required numbers have been adjusted to accommodate the cluster design, miscarriage and participant lost--to--follow up. Baseline characteristics of women will be summarised for both arms of the trial. Similarly, characteristics of GPs will be compared between arms. Differences in the primary outcomes will be analysed using 'intention-to-treat' principles. Appropriate regression techniques will adjust for the effects of clustering and include covariates to adjust for the stratifying variable and major potential confounding factors. DISCUSSION: The findings from this trial will make a significant contribution to improving women's experience of prenatal testing and will have application to a variety of maternity care settings. The evaluation of a tailored decision aid will also have implications for pregnancy care providers by identifying whether or not such a resource will support their role in providing prenatal testing information.

Cluster Analysis↗

Development and evaluation of a decision aid for patients with stage IV non-small cell lung cancer.

Although guidelines for treating stage IV non-small cell lung cancer suggest that the patient's values should be considered in decision-making, there are no practical tools available to assist them with their decision-making. OBJECTIVE: To develop and evaluate a decision aid that incorporates patient values. DESIGN AND SAMPLE: (1) Before/after evaluation with patients referred to a regional cancer centre. (2) Mailed survey of thoracic surgeons and respirologists in Ontario. INTERVENTION: An audio-tape guided individuals to review a booklet describing stage IV non-small cell lung cancer, its impact and possible coping strategies, treatment options, benefits and risks, and examples of the decision-making of others. Patients then used a worksheet to consider and communicate personal issues involved in the choice, including: personal values using a 'weigh-scale'; questions; preferred role in decision-making; and predisposition. MEASURES: (1) Patient questionnaires eliciting knowledge, the decision, decisional conflict and acceptability of the decision aid. (2) Physician questionnaires eliciting attitudes toward the decision aid. RESULTS: (1) Twenty of 30 patients used the aid in decision-making. Users thought that the aid was acceptable and significantly improved their knowledge about options and outcomes (P < 0.001), and reduced their decisional conflict (P < 0.001). (2) The majority of the 29 physicians who reviewed the decision aid found it acceptable, were comfortable providing it to patients and said that they were likely to use it. CONCLUSION: The decision aid is a useful and acceptable adjunct to personal counselling.

Journal Article↗

Development of a decision aid for atrial fibrillation who are considering antithrombotic therapy.

With patients demanding a greater role in the clinical decision-making process, many researchers are developing and disseminating decision aids for various medical conditions. In this article, we outline the essential elements in the development and evaluation of a decision aid to help patients with atrial fibrillation choose, in consultation with their physicians, appropriate antithrombotic therapy (warfarin, aspirin, or no therapy) to prevent stroke. We also outline possible future directions regarding the implementation and evaluation of this decision aid. This information should enable clinicians to better understand the role that decision aids may have in their interactions with patients.

Anticoagulants↗

Decision aids: are they worth it? A systematic review.

OBJECTIVES: The field of consumer decision support interventions has grown rapidly in the last 20 years, particularly since the increased formalization of evidence-based decision-making in health care. However, little is known as yet about the effect these decision aids have on relevant outcomes. To identify outcomes influenced by consumer decision aids (CDAs) and the particular effects of CDAs on those outcomes. METHOD: Published reports of randomized controlled trials and other designs in English identified from searches of Medline, Cancerlit, CINAHL, PsycINFO, Social Science Abstracts, the Cochrane Library and Current Contents, and from ancestry searches, hand searches and consultation with key informants. Studies were included if consumers were the decision-makers, decisions were real and not hypothetical, the intervention met a strict definition of a CDA and decisions involved treatment or screening. Data on setting, subjects, decision types, decision aid features and outcomes were extracted. The validity of each study included was evaluated by two team members. Summative ratings were calculated and categorized as high, medium and low. RESULTS: Over 500 titles were initially assessed; 96 study reports were obtained and screened for inclusion. Twenty-two reports representing 20 studies met the inclusion criteria. Eight studies with a low rating were excluded. Results were synthesized from the remaining 12 studies. Published studies of CDAs are increasing although still few in number. Outcomes such as knowledge and decision-making processes are influenced by CDAs but effects on treatment preferences, the actual decision or other outcomes have yet to be clearly established. CONCLUSIONS: Improved outcomes result from the use of CDA in some categories of outcome but insufficient evidence exists yet to support improved outcomes in all categories or to evaluate whether, given the considerable costs of many CDAs, funding for extensive ongoing development and testing can be sustained.

Canada↗

The impact of a decision aid about heart disease prevention on patients' discussions with their doctor and their plans for prevention: a pilot randomized trial.

BACKGROUND: Low utilization of effective coronary heart disease (CHD) prevention strategies may be due to many factors, but chief among them is the lack of patient involvement in prevention decisions. We undertook this study to test the effectiveness of an individually-tailored, computerized decision aid about CHD on patients' discussions with their doctor and their plans for CHD prevention. METHODS: We conducted a pilot randomized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored, computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor. RESULTS: We enrolled 75 adults. Mean age was 53. 59% were female, 73% white, and 23% African-American. 66% had some college education. 43% had a 10-year CHD risk of 0-5%, 25% a risk of 6-10%, 24% a risk of 11-20%, and 5% a risk of > 20%. 78% had at least one option to reduce their CHD risk, but only 45% accurately identified the strategies best supported by evidence. 41 patients received the decision aid, 34 received usual care. In unadjusted analysis, the decision aid increased the proportion of patients who discussed CHD risk reduction with their doctor from 24% to 40% (absolute difference 16%; 95% CI -4% to +37%) and increased the proportion who had a specific plan to reduce their risk from 24% to 37% (absolute difference 13%; 95% CI -7% to +34%). In pre-post testing, the decision aid also appeared to increase the proportion of patients with plans to intervene on their CHD risk (absolute increase ranging from 21% to 47% for planned medication use and 5% to 16% for planned behavioral interventions). CONCLUSION: Our study confirms patients' limited knowledge about their CHD risk and effective risk reduction options and provides preliminary evidence that an individually-tailored decision aid about CHD prevention might be expected to increase patients' discussions about CHD prevention with their doctor and their plans for CHD risk reduction. These findings should be replicated in studies with a larger sample size and patients at overall higher risk of CHD.

Adult↗

Evaluation of a decision aid for patients considering autologous blood donation before open-heart surgery.

BACKGROUND: Patients undergoing open-heart surgery frequently require one or more blood transfusions. Because of the risks of receiving blood from volunteer donors, some patients choose to donate their own blood before surgery. This reduces their risk of exposure to volunteer-donated blood, but it increases their chance of receiving any transfusion, either of self-donated or volunteer-donated blood. Also, preoperative hemoglobin levels tend to be lower in patients who donate their own blood, and surgeons may be more likely to give transfusions to patients with self-donated blood. To help patients decide whether to donate their blood before surgery, we designed a decision aid comprising a booklet and audiotape and assessed its effectiveness. METHODS: The 59 study subjects were a sample of consecutive patients referred to the Ottawa Heart Institute between Oct. 1, 1998, and Jan. 5, 1999, for future coronary artery bypass grafting, valve surgery or combined surgery. All were eligible to donate blood. Initial questionnaires were administered in the clinic by a physician or study nurse, and follow-up questionnaires were completed at home and mailed in after use of the decision aid. Outcome measures included patients' knowledge, values (importance ratings), preferences for transfusion methods, decisional conflict (the amount of uncertainty about the course of action to take), risk perception and acceptability of the decision aid. RESULTS: Mean knowledge scores on a 15-item test increased from 67% correct responses before the decision aid to 85% correct responses after use of the aid (p < 0.001); the effect was similar when the patients were divided into subgroups according to education level. The number of patients favouring donating their own blood increased from 41 (69%) before to 45 (76%) after use of the aid. Nine (64%) of 14 initially uncertain patients preferred autologous donation after use of the aid. The overall mean score for decisional conflict was unchanged, at 1.7, which indicated a low level of uncertainty. Risk perception improved, from 0%-14% correct responses on an 8-item test before the aid to 18%-60% correct responses after use of the aid. The decision aid was acceptable to the majority of patients, and 95% indicated that they would recommend it to others. INTERPRETATION: The decision aid improved knowledge and risk perceptions of blood donation and transfusion, and it helped uncertain patients to make choices.

Adolescent↗

Understanding and overcoming the barriers of implementing patient decision aids in clinical practice.

Patient decision aids (ptDAs) have been developed to assist patients with difficult health-related decisions. Despite their proven effects on decision quality in numerous efficacy trials, we lack an evidence-based approach for implementing them as part of the process of care. Pragmatic trials of ptDAs have uncovered a myriad of implementation challenges; therefore we need a better understanding of the barriers and strategies to overcome them to facilitate their widespread uptake. The following paper provides an overview of the barriers related to the uptake of ptDAs within the process of care and the strategies, opportunities and research priorities to overcome them. This report is based on our interpretation of the literature and our collective experience in implementing ptDAs within trials and other contexts.

Communication Barriers↗