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Understanding why decision aids work: linking process with outcome.

Decision aids help patients make treatment choices. There is little empirical evidence to explain how they work. The results from this randomised controlled trial comparing routine with decision-aided consultations in the prenatal diagnosis for Down's syndrome context are used to describe the strategies employed during decision making, to assess the impact of a decision aid on decision processes, and to investigate decision process and outcome associations. Data were elicited from two content analyses of consultation transcripts and questionnaires assessing knowledge, anxiety, decisional conflict, reasons, and information usefulness. 68/106 women completed measures at consultation and follow-up. Decision-aided women employed more cognitive and emotional strategies during decision making. More negative evaluations during decision making were associated with better outcomes. Decision-aided consultations facilitated the employment of strategies associated with more effective choices. These consultations take longer and elicit greater expressions of negative affect, so may be less rewarding encounters for health professionals.

Adult↗

Reduction in uptake of PSA tests following decision aids: systematic review of current aids and their evaluations.

A man's decision to have a prostate-specific antigen (PSA) test should be an informed one. We undertook a systematic review to identify and appraise PSA decision aids and evaluations. We searched 15 electronic databases and hand-searched key journals. We also contacted key authors and organisations. All decision aids and evaluations that discussed PSA were included, with meta-analyses performed on two outcomes from the evaluations: PSA testing and patient knowledge of PSA and related issues. Seven decision aids and 11 evaluations were included. The meta-analysis showed a significantly reduced probability in PSA testing after a decision aid: -3.5% (95% confidence interval: 0.0 to 7.2%; P = 0.050). There were significant improvements in knowledge within 2 weeks after a decision aid: 19.5% (95% confidence interval: 14.2 to 24.8%; P < 0.001). The effect on knowledge was less pronounced within 12-18 months after a decision aid: 3.4% (95% confidence interval: -0.7 to 7.4%; P = 0.10). PSA decision aids improve knowledge about PSA testing, at least in the short term. Men given these decision aids seem to be less likely to have the PSA test.

Biomarkers, Tumor↗

The evaluation of decision aids: the role of the decision owner.

This paper is a discussion of the role patient preferences should play in the evaluation of medical decision aids. The use of 'practitioner acceptability' as an unproblematic criterion in the evaluation of such aids is questioned, along with the wider imbalance in resource allocation between research relevant to the 'technical' and 'value' aspects of medical decision-making.

Decision Making, Computer-Assisted↗

Reducing unnecessary coronary care unit admissions: a comparison of three decision aids.

OBJECTIVE: To determine whether published decision rules for ischemic heart disease have practical value in reducing unnecessary admissions to coronary care units. DESIGN: Prospective cohort study. SETTING: A community hospital emergency room. PATIENTS: 235 consecutive patients presenting to an emergency room with a chief complaint of chest pain. MEASUREMENTS: Clinical information, including observations needed to use previously published decision aids, was collected on special forms at the time of the emergency room visit. Follow-up information was obtained from the medical records of patients who were admitted and by telephone interviews with patients who were discharged. The authors compared the residents' actual decisions with the predictions of the decision aids regarding their ability to predict complications (that is, to identify patients who needed admission or intensive care). MAIN RESULTS AND CONCLUSIONS: None of the decision aids could reduce unnecessary admissions without seriously increasing the rate of inappropriate discharges. However, within the clinically relevant subgroup of patients for whom the decision to admit or discharge was not obvious on clinical grounds (those without complications on presentation whom the residents chose not to discharge), the decision aids examined, used in combination to verify the need for admission, might have safely averted some unnecessary admissions.

Clinical Protocols↗

A decision aid to assist in adjuvant therapy choices for breast cancer.

BACKGROUND: Decision aids are tools that help patients make specific and deliberative choices among options. This study was a group randomized controlled trial of a novel decision aid to help patients with breast cancer make adjuvant therapy (AT) decisions. METHODS: Fourteen oncology practices (n=58 physicians) were randomized to receive the decision aid or a control pamphlet. Complete data were obtained from 405 patient-oncologist pairs. Eligible patients had stage I-III disease and had completed their primary treatment. The decision aid is a simple to use computer program, titled Adjuvant!, that provides estimates of outcome with and without AT. Graphical representations of outcome are shared with patients. Consultations were audiotaped, patients interviewed, and physicians completed a self-administered survey. RESULTS: In a multivariable model, the 54 patients (13.3%) who took no AT were more likely to have received the decision aid (p=0.02). A differential effect of the Adjuvant! Decision Guide was noted between node negative and positive patients. It was stated by 86.2% of patients that the decision aid was influential when making their treatment decision. Over 95% of patients reported that the Adjuvant Decision Guide was easy to understand and 75% of physicians believed that it helped them understand their patient's treatment preferences and 81.4% reported the information as useful for themselves. CONCLUSIONS: This study showed that a decision aid made a difference in the choice of whether or not to take AT. The decision aid allowed patients and physicians to consider the benefits of AT in an easy to understand format. Treatment decisions were more individualized for patients in the intervention than in the control group. The use of the decision aid was acceptable to both patients and physicians.

Adult↗

[Formal decision aids in surgery--results of a survey].

Even though many decision-aids have been developed in the past, the application of these systems in clinical practice is still rare. There are many reasons for this, including the reservations of potential users. A survey in three university surgery clinics was conducted to assess the experience and attitudes towards decision-aids among physicians. Seventy-two of the 102 physicians approached (71%) filled out and returned the short questionnaire that was sent to them. More than half of the 72 survey participants already use decision-aids. Among them, guidelines are used most often (46%), whereas other instruments (algorithms, scores, decision trees) are used less frequently (10-17%). Computer-based decision-aids are hardly used at all (7%). These results are in contrast to the strong request for more decision-aids, especially for computer-based systems (40%). Physicians who already use decision-aids are more interested in additional systems. More than 70% of all participants are interested in more information about the topic. The standardized question about attitudes towards computer-based decision-aids reveals more positive than negative appraisal, whereas the answers to open questions focus more on objections. The substantial differences between the three survey locations in parts of the survey results show that attitudes towards decision-aids are influenced by the way the instruments are introduced and the way the users are informed and involved in the process of implementation. A successful implementation of decision-aids in clinical practice should therefore try to integrate the future users as much as possible.

Academic Medical Centers↗

Making choices for childbirth: a randomized controlled trial of a decision-aid for informed birth after cesarean.

BACKGROUND: Decision-making about mode of birth after a cesarean delivery presents challenges to women and their caregivers and requires a balance of risks and benefits according to individual circumstances. The study objective was to determine whether a decision-aid for women who have experienced previous cesarean birth facilitates informed decision-making about birth options during a subsequent pregnancy. METHOD: A prospective multicenter randomized controlled trial of 227 pregnant women was conducted within 3 prenatal clinics and 3 private obstetric practices in New South Wales, Australia. Women with 1 previous cesarean section and medically eligible for trial of vaginal birth were recruited at 12 to 18 weeks' gestation; 115 were randomized to the intervention group and 112 to the control group. A decision-aid booklet describing risks and benefits of elective repeat cesarean section and trial of labor was given to intervention group women at 28 weeks' gestation. Main outcome measures included level of knowledge, decisional conflict score, women's preference for mode of birth, and recorded mode of birth. RESULTS: Women who received the decision-aid demonstrated a significantly greater increase in mean knowledge scores than the control group (increasing by 2.17 vs 0.42 points on a 15-point scale) (p < 0.001, 95% CI for difference = 1.15-2.35). The intervention group demonstrated a reduction in decisional conflict score (p < 0.05). The decision-aid did not significantly affect the rate of uptake of trial of labor or elective repeat cesarean section. Preferences expressed at 36 weeks were not consistent with actual birth outcomes for many women. CONCLUSION: A decision-aid for women facing choices about birth after cesarean section is effective in improving knowledge and reducing decisional conflict. However, little evidence suggested that this process led to an informed choice. Strategies are required to better equip organizations and practitioners to empower women so that they can translate informed preferences into practice. Further work needs to examine ways to enhance women's power in decision-making within the doctor-patient relationship.

Adult↗

Development and preliminary testing of a patient decision aid to assist pharmaceutical care in the prevention of cardiovascular disease.

STUDY OBJECTIVE: To develop and test a decision aid for patients with hypertension and/or dyslipidemia because a decision aid may assist in pharmaceutical care by providing relevant evidence-based information. DESIGN: Before and after use of a decision aid. SETTING: Hypertension clinic of a university hospital and a specialized coronary heart disease-prevention clinic. PATIENTS: A convenience sample of 16 patients receiving pharmacologic treatment for hypertension and/or dyslipidemia. INTERVENTION: A face-to-face interview was conducted before using the decision aid. This was followed by a telephone interview after the patient used the decision aid to assess the acceptability of the decision aid to the patient, as well as the patient's knowledge, risk perception, and decisional conflict. MEASUREMENTS AND MAIN RESULTS: The decision aid consists of a booklet containing general, evidence-based information and a personal worksheet. The worksheet provides information on patient risk factors, personal estimates of cardiovascular disease (CVD) risk, the benefits of treatment options, and values clarification exercise. It invites patients to specify an action plan and follow their own progress over time. Most patients (86-93%) rated the presentation of the information as excellent or very good, 80% judged the information about lifestyle changes and drug therapy to be balanced, 93% rated the amount of information "just right," and 100% found the decision aid useful. After using the decision aid, patients had higher knowledge scores for general risk factors (before, 91%; after, 100%, p=0.014), personal risk factors (73%, 92%, p=0.016), and treatment options (68%, 99%, p<0.001). More patients were able to estimate correctly their CVD risk category (50%, 93%, p=0.03) and their absolute 10-year CVD risk (0%, 93%, p<0.001), whereas the overall decisional conflict score decreased (p=0.007). CONCLUSION: The decision aid was acceptable to patients and improved their knowledge, risk perception, and decisional conflict. Therefore, the feasibility and impact of using the decision aid in community pharmacies and medical clinics should be assessed.

Cardiovascular Diseases↗

Randomized trial of a patient decision aid for choice of surgical treatment for breast cancer.

A decision aid for the surgical treatment of early breast cancer was evaluated in a randomized controlled trial. The decision aid, a tape and workbook, includes explicit presentation of probabilities, photographs and graphics, and a values clarification exercise. Community surgeons were randomized to use the decision aid or a control pamphlet. Patients completed a questionnaire prior to using the decision aid, after reviewing it but prior to surgery, and 6 months after enrollment. There was no difference in anxiety, knowledge, or decisional regret across the 2 groups. There was a nonsignificant trend toward lower decisional conflict in the decision aid group. A subgroup of women who were initially leaning toward mastectomy or were unsure had lower decisional conflict. Although the decision aid had minimal impact on the main study outcomes, a subgroup may have benefited. Such subgroups should be identified, and appropriate decision support interventions should be developed and evaluated.

Breast Neoplasms↗

Evidence-based patient choice: a prostate cancer decision aid in plain language.

BACKGROUND: Decision aids (DA) to assist patients in evaluating treatment options and sharing in decision making have proliferated in recent years. Most require high literacy and do not use plain language principles. We describe one of the first attempts to design a decision aid using principles from reading research and document design. The plain language DA prototype addressed treatment decisions for localized prostate cancer. Evaluation assessed impact on knowledge, decisions, and discussions with doctors in men newly diagnosed with prostate cancer. METHODS: Document development steps included preparing an evidence-based DA in standard medical parlance, iteratively translating it to emphasize shared decision making and plain language in three formats (booklet, Internet, and audio-tape). Scientific review of medical content was integrated with expert health literacy review of document structure and design. Formative evaluation methods included focus groups (n = 4) and survey of a new sample of men newly diagnosed with prostate cancer (n = 60), compared with historical controls (n = 184). RESULTS: A transparent description of the development process and design elements is reported. Formative evaluation among newly diagnosed prostate cancer patients found the DA to be clear and useful in reaching a decision. Newly diagnosed patients reported more discussions with doctors about treatment options, and showed increases in knowledge of side effects of radiation therapy. CONCLUSION: The plain language DA presenting medical evidence in text and numerical formats appears acceptable and useful in decision-making about localized prostate cancer treatment. Further testing should evaluate the impact of all three media on decisions made and quality of life in the survivorship period, especially among very low literacy men.

Choice Behavior↗

Three-year follow-up of a factorial randomised controlled trial of two decision aids for newly diagnosed hypertensive patients.

This study is a 3-year follow-up of a factorial randomised controlled trial of two decision aids - decision analysis and information video plus leaflet - for newly diagnosed hypertensive patients. We found no evidence of differences for either of the two decision aids compared with controls for the primary outcome of blood pressure control at follow-up. There were also no differences in any of the secondary outcomes measured - the proportion taking blood pressure lowering drugs, self-reported medication adherence, or consulting behaviour. The randomised controlled trial cohort as a whole, irrespective of randomised group, demonstrated substantial reductions in blood pressure and 10-year cardiovascular risk over the follow-up period.

Antihypertensive Agents↗

Is anxiety a suitable measure of decision aid effectiveness: a systematic review?

Several trials have employed anxiety measures to assess decision aid effectiveness. This study employed a systematic review method to integrate their findings. The affective impact of decision aids and the appropriateness of anxiety as a measure of decision aid effectiveness are explored. From 11,361 citations generated from searching electronic databases and journals, 26 randomised controlled trials evaluated patient decision aids; 10 included anxiety measures (HADS; STAI). The data were too heterogeneous to integrate statistically. No studies showed an increase in anxiety from exposure to decision aids versus usual care. Some patterns emerged between level of anxiety and characteristics of the decision. As raised levels of anxiety are associated with both more effective decision strategies and stressful health interventions, anxiety is an inappropriate measure to employ when evaluating decision aids. Future research needs to investigate the relationship between affect, cognition and decision aids in order to facilitate effective patient decision making.

Adolescent↗

Development of a patient decision aid for choice of surgical treatment for breast cancer.

PURPOSE: A patient decision aid for the surgical treatment of early stage breast cancer was developed and evaluated. The rationale for its development was the knowledge that breast conserving therapy (lumpectomy followed by breast radiation) and mastectomy produce equivalent outcomes, and the current general agreement that the decision for the type of surgery should rest with the patient. METHODS: A decision aid was developed and evaluated in sequential pilot studies of 18 and 10 women with newly diagnosed breast cancer who were facing a decision for breast conserving therapy or mastectomy. Both qualitative (general reaction, self-reported anxiety, clarity, satisfaction) and quantitative (knowledge and decisional conflict) measures were assessed. RESULTS: The decision aid consists of an audiotape and workbook and takes 36 min to complete. Based on qualitative comments and satisfaction ratings, 17 of 18 women reported a positive reaction to the decision aid, and all 18 reported that it helped clarify information given by the surgeon. Women did not report an increase in anxiety and 17 of 18 women were either satisfied or very satisfied with the decision aid. CONCLUSION: This pilot study supports the hypothesis that this decision aid may be a helpful adjunct in the decision for surgical management of early stage breast cancer. We are currently conducting a randomized trial of the decision aid versus a simple educational pamphlet to evaluate its efficacy as measured by knowledge, decisional conflict, anxiety and post-decisional regret.

Journal Article↗

Medical communication and technology: a video-based process study of the use of decision aids in primary care consultations.

BACKGROUND: Much of the research on decision-making in health care has focused on consultation outcomes. Less is known about the process by which clinicians and patients come to a treatment decision. This study aimed to quantitatively describe the behaviour shown by doctors and patients during primary care consultations when three types of decision aids were used to promote treatment decision-making in a randomised controlled trial. METHODS: A video-based study set in an efficacy trial which compared the use of paper-based guidelines (control) with two forms of computer-based decision aids (implicit and explicit versions of DARTS II). Treatment decision concerned warfarin anti-coagulation to reduce the risk of stroke in older patients with atrial fibrillation. Twenty nine consultations were video-recorded. A ten-minute 'slice' of the consultation was sampled for detailed content analysis using existing interaction analysis protocols for verbal behaviour and ethological techniques for non-verbal behaviour. RESULTS: Median consultation times (quartiles) differed significantly depending on the technology used. Paper-based guidelines took 21 (19-26) minutes to work through compared to 31 (16-41) minutes for the implicit tool; and 44 (39-55) minutes for the explicit tool. In the ten minutes immediately preceding the decision point, GPs dominated the conversation, accounting for 64% (58-66%) of all utterances and this trend was similar across all three arms of the trial. Information-giving was the most frequent activity for both GPs and patients, although GPs did this at twice the rate compared to patients and at higher rates in consultations involving computerised decision aids. GPs' language was highly technically focused and just 7% of their conversation was socio-emotional in content; this was half the socio-emotional content shown by patients (15%). However, frequent head nodding and a close mirroring in the direction of eye-gaze suggested that both parties were active participants in the conversation CONCLUSION: Irrespective of the arm of the trial, both patients' and GPs' behaviour showed that they were reciprocally engaged in these consultations. However, even in consultations aimed at promoting shared decision-making, GPs' were verbally dominant, and they worked primarily as information providers for patients. In addition, computer-based decision aids significantly prolonged the consultations, particularly the later phases. These data suggest that decision aids may not lead to more 'sharing' in treatment decision-making and that, in their current form, they may take too long to negotiate for use in routine primary care.

Aged↗

A randomized trial to assess the impact of an antithrombotic decision aid in patients with nonvalvular atrial fibrillation: the DAAFI trial protocol [ISRCTN14429643].

BACKGROUND: Decision aids are often advocated as a means to assist patient and health care provider decision making when faced with complicated treatment or screening decisions. Despite an exponential growth in the availability of decision aids in recent years, their impact on long-term treatment decisions and patient adherence is uncertain due to a paucity of rigorous studies. The choice of antithrombotic therapy for nonvalvular atrial fibrillation (NVAF) is one condition for which a trade-off exists between the potential risks and benefits of competing therapies, and the need to involve patients in decision making has been clearly identified. This study will evaluate whether an evidence-based patient decision aid for patients with NVAF can improve the appropriateness of antithrombotic therapy use by patients and their family physicians. DESIGN: A multi-center, two-armed cluster randomized trial based in community family practices in which patients with NVAF will be randomized to decision aid or usual care. Patients will receive one of four decision aids depending on their baseline stroke risk. The primary outcome is the provision of "appropriate antithrombotic therapy" at 3 months to study participants (appropriateness defined as per the 2001 American College of Chest Physicians recommendations for NVAF). In addition, the impact of this decision aid on patient knowledge, decisional conflict, well-being, and adherence will be assessed after 3 months, 6 months, and 12 months.

Atrial Fibrillation↗

On what basis should the effectiveness of decision aids be judged?

OBJECTIVE: Attempts to synthesize the evidence on the effects of decision aids have been hampered by the lack of consensus regarding how such effectiveness should be measured. This paper seeks to describe and critically assess the range of measures of effectiveness used in randomized controlled trials of decision aids. SEARCH STRATEGY: The published systematic reviews of the field were used to identify primary studies evaluating the effects of decision aids. INCLUSION CRITERIA: Non-randomized trials were excluded from this review. As were abstracts and theses of subsequently published studies, methodological papers and reports of subgroups of a study's main publication. MAIN RESULTS: A wide range of measures were used to evaluate the effectiveness of decision aids. The most commonly used measures sought to assess treatment decisions, patient's knowledge and the decision-making process. This pattern was repeated when primary measures of effectiveness were examined. No study attempted to measure the extent to which decisions made were consistent with patient's values. CONCLUSIONS: Within the current literature there is little consensus on what the aims of decision aids should be. If we can agree that the aim of a decision aid is to help patients make specific personal treatment choices, then evaluations of decision aids should measure the primary effectiveness of their interventions in terms of the extent to which they enable patient's to undergo treatments that agree with their values.

Decision Making↗

Shared decision making and decision aids - a literature review.

Shared decision making (SDM) is a process within a patient centred consultation that involves both the patient and doctor discussing management options and agreeing on management decisions in partnership. Decision aids are designed to help patients understand the options relating to management for certain conditions and their possible benefits and potential adverse effects. We discuss the evolution and rationale behind SDM and the evidence relating to outcomes, the types of decision aids available, and research relating to their use.

Decision Making↗

A decision aid for long-term tube feeding in cognitively impaired older persons.

OBJECTIVE: To describe the development and evaluation of a decision aid for long-term tube feeding in cognitively impaired older people. DESIGN: Before-and-after study. SETTING: Acute care hospitals in Ottawa, Canada. PARTICIPANTS: Substitute decision makers for 15 cognitively impaired inpatients 65 years and older being considered for placement of a percutaneous endoscopic gastrostomy tube. MEASUREMENTS: Questionnaires were used to compare the substitute decision makers' knowledge, decisional conflict, and predisposition regarding feeding tube placement before and after exposure to the decision aid. The acceptability of the decision aid was also assessed. RESULTS: Substitute decision makers significantly increased their knowledge (P = .004) and decreased their decisional conflict (P = .004) regarding long-term tube feeding after using the decision aid. The impact of the decision aid on predisposition toward the intervention was greatest for those who were unsure of their preferences at baseline. All substitute decision makers found the decision aid helpful and acceptable despite very difficult and emotional circumstances. CONCLUSIONS: A decision aid improves the decision-making process for long-term tube feeding in cognitively impaired older patients by decreasing decisional conflict and by promoting decisions that are informed and consistent with personal values. There are particular challenges for developing and evaluating these tools in the context of end-of-life decisions.

Aged↗