Controlled trial of pretest education approaches to enhance informed decision-making for BRCA1 gene testing. Randomized trial of a portable, self-administered decision aid for postmenopausal women considering long-term preventive hormone therapy. A randomized trial of choice of treatment in prostate cancer: the effect of intervention on the treatment chosen. Applying decision analysis to facilitate informed decision making about prenatal diagnosis for Down syndrome: a randomised controlled trial. Does informed consent alter elderly patients' preferences for colorectal cancer screening? Results of a randomized trial. A tailored intervention to aid decision-making about hormone replacement therapy. A randomized trial of a computerized versus an audio-booklet decision aid for women considering post-menopausal hormone replacement therapy. Videotape-based decision aid for colon cancer screening. A randomized, controlled trial. Patient education on prostate cancer screening and involvement in decision making. Randomised trial comparing an interactive multimedia decision aid with a leaflet and a video to give information about prenatal screening for Down syndrome. Impact of patient information booklet on treatment decision--a randomized trial among women with heavy menstruation. A randomized controlled trial comparing internet and video to facilitate patient education for men considering the prostate specific antigen test. Contextual factors in shared decision making: a randomised controlled trial in women with a strong suspicion of breast cancer. Internet patient decision support: a randomized controlled trial comparing alternative approaches for men considering prostate cancer screening. Randomized trial of a decision aid for individuals considering genetic testing for hereditary nonpolyposis colorectal cancer risk. Randomized trial of a decision aid for patients with cystic fibrosis considering lung transplantation. Guiding individual decisions: a randomized, controlled trial of decision analysis. Informed decision making and prostate specific antigen (PSA) testing for prostate cancer: a randomised controlled trial exploring the impact of a brief patient decision aid on men's knowledge, attitudes and intention to be tested. Improving informed decision-making for patients with knee pain. Shared decision making and long-term outcome in schizophrenia treatment. Should clinicians deliver decision aids? Further exploration of the statin choice randomized trial results. Increasing patient involvement in choosing treatment for early breast cancer. Effects of decision aids for menorrhagia on treatment choices, health outcomes, and costs: a randomized controlled trial. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Who uses decision aids? Subgroup analyses from a randomized controlled effectiveness trial of two prostate cancer screening decision support interventions. Impact of a patient decision aid on care among patients with nonvalvular atrial fibrillation: a cluster randomized trial. Patient decision aid on natural health products for menopausal symptoms: randomized controlled trial. An interactive computer program can effectively educate patients about genetic testing for breast cancer susceptibility. 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. A randomized controlled trial of shared decision making for prostate cancer screening. A factorial randomised controlled trial of decision analysis and an information video plus leaflet for newly diagnosed hypertensive patients. Two decision aids for mode of delivery among women with previous caesarean section: randomised controlled trial. A decision aid for autologous pre-donation in cardiac surgery--a randomized trial. A randomized controlled trial of a decision aid for women at increased risk of ovarian cancer. Randomized trial of a patient decision aid for choice of surgical treatment for breast cancer. Facilitating informed decision making about breast cancer risk and genetic counseling among women calling the NCI's Cancer Information Service. Making choices for childbirth: a randomized controlled trial of a decision-aid for informed birth after cesarean. The effect of decision aids on the agreement between women's and physicians' decisional conflict about hormone replacement therapy. The influence of video imaging on patients' perceptions and expectations. A chairside aid for shared decision making in dentistry: a randomized controlled trial. A randomised controlled trial of a decision-aid leaflet to facilitate women's choice between pregnancy termination methods. The effects of an 'explicit' values clarification exercise in a woman's decision aid regarding postmenopausal hormone therapy. Effect of a computer-based decision aid on knowledge, perceptions, and intentions about genetic testing for breast cancer susceptibility: a randomized controlled trial. Computerized prenatal genetic testing decision-assisting tool: a randomized controlled trial. Randomized trial of a self-administered decision aid for colorectal cancer screening. Parental information and circumcision in highly motivated couples with higher education. Entertainment education for prostate cancer screening: a randomized trial among primary care patients with low health literacy. Randomized trial of a shared decision-making intervention consisting of trade-offs and individualized treatment information for BRCA1/2 mutation carriers. A randomized trial of a breast/ovarian cancer genetic testing decision aid used as a communication aid during genetic counseling. A randomized controlled trial of a decision aid for women considering genetic testing for breast and ovarian cancer risk. Helping patients make informed choices: a randomized trial of a decision aid for adjuvant chemotherapy in lymph node-negative breast cancer. Randomised controlled trial of an interactive multimedia decision aid on hormone replacement therapy in primary care. Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial. Randomised controlled trial of an interactive multimedia decision aid on benign prostatic hypertrophy in primary care. [Making a decision about hormone replacement therapy. A randomized controlled trial]. Pilot trial of a computerized decision aid for breast cancer prevention. Videotape increases parent knowledge about poliovirus vaccines and choices of polio vaccination schedules. Informed shared decision making about immunotherapy for patients with multiple sclerosis (ISDIMS): a randomized controlled trial. Preference-based electronic decision aid to promote colorectal cancer screening: results of a randomized controlled trial. The impact of informed consent on patient interest in prostate-specific antigen screening. An educational intervention as decision support for menopausal women. Effectiveness of a computerized decision aid in primary care on decision making and quality of life in menorrhagia: results of the MENTIP randomized controlled trial. Does evidence-based information about screening for prostate cancer enhance consumer decision-making? A randomised controlled trial. A community-based randomised controlled trial of three different educational resources for men about prostate cancer screening. Randomized controlled trial of a patient decision aid for colorectal cancer screening. Informed choice in mammography screening: a randomized trial of a decision aid for 70-year-old women. A patient decision aid regarding antithrombotic therapy for stroke prevention in atrial fibrillation: a randomized controlled trial. Empowerment of men newly diagnosed with prostate cancer. The effect of an illustrated pamphlet decision-aid on the use of prostate cancer screening tests. Decision-making at menopause: a randomized controlled trial of a computer-based hormone therapy decision-aid. Impact of educational print materials on knowledge, attitudes, and interest in BRCA1/BRCA2: testing among Ashkenazi Jewish women. Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458]. Interactive digital education aid in breast reconstruction. Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers: impact on measures of decision making and satisfaction. Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease. The diabetes mellitus medication choice decision aid: a randomized trial. Preparing African-American men in community primary care practices to decide whether or not to have prostate cancer screening. A randomized controlled trial of information-giving to patients referred for coronary angiography: effects on outcomes of care. A randomized trial comparing alternative approaches to prenatal diagnosis counseling in advanced maternal age patients. Medical communication and technology: a video-based process study of the use of decision aids in primary care consultations.
In response to the isolation of the BRCA1 gene, a breast-ovarian cancer-susceptibility gene, biotechnology companies are already marketing genetic tests to health care providers and to the public. Initial studies indicate interest in BRCA1 testing in the general public and in populations at high risk. However, the optimal strategies for educating and counseling individuals have yet to be determined.
                Our goal was to evaluate the impact of alternate strategies for pretest education and counseling on decision-making regarding BRCA1 testing among women at low to moderate risk who have a family history of breast and/or ovarian cancer.
                A randomized trial design was used to evaluate the effects of education only (educational approach) and education plus counseling (counseling approach), as compared with a waiting-list (control) condition (n = 400 for all groups combined). The educational approach reviewed information about personal risk factors, inheritance of cancer susceptibility, the benefits, limitations, and risks of BRCA1 testing, and cancer screening and prevention options. The counseling approach included this information, as well as a personalized discussion of experiences with cancer in the family and the potential psychological and social impact of testing. Data on knowledge of inherited cancer and BRCA1 test characteristics, perceived risk, perceived benefits, limitations and risks of BRCA1 testing, and testing intentions were collected by use of structured telephone interviews at baseline and at 1-month follow-up. Provision of a blood sample for future testing served as a proxy measure of intention to be tested (in the education and counseling arms of the study). The effects of intervention group on study outcomes were evaluated by use of hierarchical linear regression modeling and logistic regression modeling (for the blood sample outcome). All P values are for two-sided tests.
                The educational and counseling approaches both led to significant increases in knowledge, relative to the control condition (P < .001 for both). The counseling approach, but not the educational approach, was superior to the control condition in producing significant increases in perceived limitations and risks of BRCA1 testing (P < .01) and decreases in perceived benefits (P < .05). However, neither approach produced changes in intentions to have BRCA1 testing. Prior to and following both education only and education plus counseling, approximately one half of the participants stated that they intended to be tested; after the session, 52% provided a blood sample.
                Standard educational approaches may be equally effective as expanded counseling approaches in enhancing knowledge. Since knowledge is a key aspect of medical decision-making, standard education may be adequate in situations where genetic testing must be streamlined. On the other hand, it has been argued that optimal decision-making requires not only knowledge, but also a reasoned evaluation of the positive and negative consequences of alternate decisions. Although the counseling approach is more likely to achieve this goal, it may not diminish interest in testing, even among women at low to moderate risk. Future research should focus on the merits of these alternate approaches for subgroups of individuals with different backgrounds who are being counseled in the variety of settings where BRCA1 testing is likely to be offered. Although practice guidelines suggest that postmenopausal women learn about the benefits and risks and consider their values when deciding about hormone therapy, the optimal decision-support method has not been established. In a randomized controlled trial, the authors compared the efficacy of a general educational pamphlet with that of a tailored decision aid. The pamphlet briefly summarized benefits, risks, and likely beneficiaries in general terms. The decision aid, delivered via booklet and audiotape, provided: detailed benefits and risks using functional terms and probabilities tailored to clinical risk; and steps for considering the issue in a woman's own situation, including a value-clarification exercise. Compared with the pamphlet group, the decision-aid group had statistically significant (p < 0.05) improvements in terms of realistic personal expectations of the benefits and risks, decisional conflict, and perceived acceptability of the intervention. Levels of general knowledge about the main benefits and risks were comparable for the two interventions. It is concluded that tailored decision aids prepare women for decision making better than do general pamphlets. To determine whether different approaches in the choice of treatment affect the treatment chosen by the patient for prostate cancer.
                We conducted a randomized trial with 210 men who had a histologically confirmed diagnosis of prostate cancer in 1993-94 at four major hospitals in Finland. After obtaining informed consent the men were randomized either to an intervention arm, in which there was greater patient participation in the choice of treatment following a structured procedure, or a control arm in which the standard approach, i.e. a standardized treatment protocol, was used. The main outcome measure of the analysis was the primary treatment chosen for prostate cancer.
                In the enhanced participation arm patients not eligible for radical prostatectomy chose orchidectomy less frequently and favoured nonsurgical endocrine treatment than in the treatment protocol arm. Radical prostatectomy was the most commonly chosen treatment option in both arms among men with operable cancer. The way treatment options were presented affected the treatment chosen for prostate cancer.
                Patients with prostate cancer are willing and able to take an active role in making decisions. The preferences of patients with prostate cancer in the choice of treatment may differ from the priorities of the physicians. To evaluate decision analysis as a technique to facilitate women's decision-making about prenatal diagnosis for Down syndrome using measures of effective decision-making.
                Randomised controlled trial in a UK hospital's prenatal diagnosis clinic.
                Routine versus routine consultation structured by decision analysis.
                117/132 women receiving a screen-positive maternal serum screening result participated (58 routine, 59 decision analysis).
                Consultations were audio tape-recorded, transcribed and coded; questionnaires were completed after the consultation and one month later after receipt of a diagnostic test and/or the 19-week scan result.
                Test decision, subjective expected utilities, knowledge, informed decision-making, risk perception, decisional conflict, anxiety, perceived usefulness and directiveness of consultation information.
                48/59 in the decision-aided group and 47/58 in the routine group underwent prenatal diagnosis. Informed decision-making was higher, perceived risk more realistic and decisional conflict over time lower in the decision analysis group. Decision analysis had no impact on knowledge or SEU scores, and was no more or no less directive, useful or anxiety provoking than the routine care. Consultations were six minutes longer.
                Decision analysis consultations enable women to make more informed prenatal diagnosis decisions. Professionals will need training to use this technique effectively.
                Copyright 2004 John Wiley & Sons, Ltd. To assess the impact of informed consent on elderly patients' colorectal cancer (CRC) screening preferences.
                Randomized, controlled trial.
                Four general internal medicine practices.
                We studied 399 elderly patients visiting their primary care provider for routine office visits.
                Patients were randomized to receive either a scripted control message briefly describing CRC screening methods or one of two informational interventions simulating an informed consent presentation about CRC screening. One intervention described CRC mortality risk reduction in relative terms; the other, in absolute terms.
                The main outcome measure was intent to begin or continue fecal occult blood testing (FOBT), flexible sigmoidoscopy, or both. There was no difference in screening interest between the control group and the two information groups (p =.8). The majority (63%) of patients intended to begin or continue CRC screening. Informed patients were able to gauge more accurately the positive predictive value of screening (p =.0009). Control patients rated the efficacy of screening higher than did patients receiving relative risk reduction information, who rated it higher than did patients receiving absolute risk reduction information (p =.0002).
                Elderly patients appeared to understand CRC screening information and use it to gauge the efficacy of screening, but provision of information had no impact on their preferences for screening. In view of the large proportion who preferred not to be screened, we conclude that elderly patients should be involved in the screening decision. However, factors other than provision of information must determine their CRC screening preferences. nan Decision aids (DAs) are increasingly being developed to help patients make shared health care decisions with their practitioners. There are no formal comparisons of the efficacy of different delivery methods. Interactive computerized delivery methods have the advantage of allowing patients control over flow of information and to receive feedback on their comprehension. The purpose of this study was to compare the efficacy of an interactive computerized DA for women considering long-term hormone replacement therapy, to that of a validated audio-booklet version of the same intervention. Fifty-one peri-menopausal women were randomized to use either the computerized or the standard audio-booklet version of the DA. The computerized version presented identical information with the addition of feedback modules to reinforce the participant's understanding. The patients were interviewed with a pre- and post-intervention questionnaire. The computerized DA improved realistic expectations by 52.7% over baseline versus 27.6% with the audio-booklet (P=0.015). Knowledge (Kn) scores improved by 17.5 and 8.4% for the computer and standard DA groups, respectively (P=0.019). The results of this study have implications for future DA design, and other areas where patient Kn and understanding are important, such as in the setting of informed consent. Rates of colon cancer screening in the United States are low, in part because of poor communication between patients and providers about the availability of effective screening options.
                To test whether a decision aid consisting of an educational video, targeted brochure, and chart marker increased performance of colon cancer screening in primary care practices.
                Randomized, controlled trial.
                Three community primary care practices in central North Carolina.
                1657 consecutive adult patients 50 to 75 years of age were contacted. Of these, 651 (39%) agreed to participate; 249 of the 651 participants (38%) were eligible. Eligible patients had no personal or family history of colon cancer and had not had fecal occult blood testing in the past year or flexible sigmoidoscopy, colonoscopy, or barium enema in the past 5 years.
                The 249 participants were randomly assigned to view an 11-minute video about colon cancer screening (intervention group) or a video about automobile safety (control group). After viewing the video, intervention group participants chose a color-coded educational brochure (based on stages of change) to indicate their degree of interest in screening. A chart marker of the same color was attached to their charts. Controls received a generic brochure on automobile safety, and no chart marker was attached.
                Frequency of screening test ordering as reported by participants and frequency of completion of screening tests as verified by chart review.
                Fecal occult blood testing or flexible sigmoidoscopy was ordered for 47.2% of intervention participants and 26.4% of controls (difference, 20.8 percentage points [95% CI, 8.6 to 32.9 percentage points]). Screening tests were completed by 36.8% of the intervention group and 22.6% of the control group (difference, 14.2 percentage points [CI, 3.0 to 25.4 percentage points]).
                A decision aid consisting of an educational video, brochure, and chart marker increased ordering and performance of colon cancer screening tests. Many clinicians lack resources to engage patients in shared decision making for prostate cancer screening. We sought to evaluate whether previsit educational decision aids facilitate shared decision making.
                This randomized controlled study compared a Web-based and a paper-based decision aid with no previsit education. Men aged 50 to 70 years undergoing a health maintenance examination at a large family practice were enrolled. The primary outcome was patient-reported level of control over the decision to be screened. Secondary outcomes included frequency of screening, patient knowledge, decisional conflict, and time spent discussing screening.
                A total of 497 men participated (75 control, 196 brochure, 226 Web site). Patients exposed to either aid were no more likely than control patients to report a collaborative decision: 36% of patients in each group reported equally sharing decision responsibility. Exposure to either decision aid increased patients' involvement in decision making compared with the control condition (Web site, P = .03; brochure, P = .03). Only 46% of control patients reported an active decision-making role, compared with 56% of Web site and 54% of brochure patients. Patients exposed to a decision aid answered a greater percentage of knowledge questions correctly (54% control vs 69% Web site, P <.001, and vs 69% brochure, P <.001) and were less likely to be screened (94% control vs 86% Web site, P = .06, and vs 85% brochure, P = .04).
                Patients in the decision aid groups were more informed and more engaged in the screening decision than their control counterparts. Exposure did not promote shared decision-making control, however. Whether shared decision making is the ideal model and how to measure its occurrence are subjects for further research. (1)To compare an interactive multimedia decision aid (IMDA) with a leaflet and a video to give information about prenatal screening for Down syndrome and (2) to determine the women's acceptance of IMDA.
                Two hundred and one women were recruited from the prenatal clinic of a university teaching hospital and randomised into the intervention group (IMDA, video, and information leaflet) or the control group (video and information leaflet).
                There were no significant differences in the initial decision for and the final uptake of the prenatal screening test between the control and intervention groups. The proportion of women who were undecided was less than 10% in both groups. Of the women in the intervention group, 86.6% and 78.9% agreed that IMDA was user-friendly and acceptable, respectively. Significantly more women aged < 35 (88.1%) accepted IMDA than women aged > or = 35 (68.3%) (P = 0.030), but the logistic regression analysis did not confirm this finding after adjusting for other factors (computer knowledge and usage of computer).
                The use of IMDA did not affect the women's overall uptake rate of the prenatal screening test for Down syndrome. More women less than 35 years accepted IMDA probably because they used computer more frequently and had more computer knowledge.
                Copyright 2004 John Wiley & Sons, Ltd. Does a patient information booklet influence treatment for menorrhagia?
                Randomized trial and a pre-trial prospective cohort study.
                Gynaecology outpatient clinics in 14 Finnish hospitals.
                A total of 363 (randomized trial) plus 206 (cohort study) patients with menorrhagia.
                An information booklet about menorrhagia and treatment options, mailed before the first visit to the outpatient clinic.
                Distribution of treatment modalities, knowledge about treatment options, satisfaction with communication with personnel and anxiety.
                Treatment decision within 3 months was made more often in the intervention group than in the control group (96% and 89% respectively, P = 0.02). Oral medication was more frequently chosen, and newly introduced treatments (minor surgery, hormonal intrauterine system) were less frequently used in the intervention group (at 3-month follow-up 21% and 29%, respectively). The differences persisted at the 12-month follow-up. In the pre-trial group, new treatment methods were less frequently chosen and used than in the control group. Additional information did not increase the number of surgical procedures used, improve knowledge, or influence satisfaction or anxiety.
                Additional information led to an increase in specific treatment decisions and changed the distribution of used treatments without increasing the number of surgical procedures. The study suggests that well-informed women adopting an active role may counteract physicians' emphasis on newly introduced treatments. Little is known about the relative advantages of video versus internet-based decision aids to facilitate shared medical decision making. This study compared internet and video patient education modalities for men considering the prostate specific antigen (PSA) test.
                Two hundred and twenty-six men, aged 50 years or older, and scheduled to complete a physical examination at an HMO Health Appraisal Clinic were randomly assigned to access a website (N = 114) or view a 23-minute videotape in the clinic (N = 112) prior to deciding whether they wanted to be screened for prostate cancer.
                There were no between-groups differences in participants' ratings of convenience, effort, or satisfaction following exposure to the decision aid. Participants assigned to the video group were more likely to review the materials than individuals assigned to the internet group (98.2% vs 53.5%). Participants in the video group showed significantly greater increases in PSA knowledge and were more likely to decline the PSA test than individuals assigned to the internet group. However, participants in the internet group who reviewed the entire online presentation showed similar increases in PSA knowledge as video participants. Only 5% of all participants visited other websites to inform themselves about the PSA test.
                Overall, the video was significantly more effective than the Internet in educating participants about benefits and risks of PSA screening. Decision aids in North American breast cancer outpatients have been shown to assist with treatment decision making and reduce decisional conflict. To date, appropriate delivery formats to effectively increase patient participation in newly diagnosed breast cancer inpatients have not been investigated in the context of German health care provision. The impact of a decision aid intervention was studied in patients (n=111) with a strong suspicion of breast cancer in a randomised controlled trial. The primary outcome variable was decisional conflict. Participants were followed up 1 week post-intervention with a retention rate of 92%. Analyses revealed that the intervention group felt better informed (eta(p)(2)=0.06) but did not experience an overall reduction in decisional conflict as compared with the control group. The intervention had no effect on uptake rates of treatment options, length of consultation with the surgeon, time point of treatment decision making, perceived involvement in decision making, neither decision related nor general patient satisfaction. Patients who received the decision aid intervention experienced a small benefit with regards to how informed they felt about advantages and disadvantages of relevant treatment options. Results are discussed in terms of contextual factors and individual differences as moderators of treatment decision aid effectiveness. We conducted a randomized controlled trial to evaluate the effects of patient decision support Web sites on decision quality for men considering prostate cancer screening.
                Men older than 50 years (N = 611) were randomly assigned to 1 of 4 Internet conditions: traditional didactic decision aid providing information about prostate-specific antigen (PSA) screening options and outcomes; chronic disease trajectory model for prostate cancer followed by a time-trade-off exercise; both the didactic decision aid and the chronic disease trajectory model; or links to public prostate cancer-specific Web sites from credible sources (control condition). Participants completed questionnaires at baseline and after their physical examination. Primary outcome measures were PSA test choice, prostate cancer treatment preferences, knowledge and concern about prostate cancer, and decisional conflict.
                Participants assigned to view public Web sites were less likely to review information (116 participants [76.8%] reviewed) than those assigned to experimental groups (399 [86.7%] reviewed; P = .004). Greater reductions in PSA screening from pretest to posttest were observed among participants assigned to the traditional decision aid (-9.1%) or chronic disease trajectory model (-8.7%), compared with participants assigned to the combination (-5.3%) or control (-3.3%) groups (P = .047). Preferences for watchful waiting increased significantly in all 4 groups (baseline, 219 [35.8%]; follow-up, 303 [66.2%]; P < .001). Knowledge scores were lowest for those assigned to public Web sites (mean [SD] score, 7.49 [0.19] of questions correct) and highest for the traditional decision aid (8.65 [0.18] of questions correct; P = .005).
                Public Web sites about prostate cancer provide less effective decision support than a specially designed Internet decision aid. Despite the potential benefits of genetic testing for hereditary nonpolyposis colorectal cancer (HNPCC) risk, individuals can find the genetic testing decision-making process complicated and challenging. The goal of the current study was to measure the effectiveness of a tailored decision aid designed specifically to assist individuals to make informed decisions regarding genetic testing for HNPCC risk.
                In all, 153 individuals were randomized to receive the decision aid or a control pamphlet at the end of their first genetic counseling consultation. Of these, 109 (71.2%) completed the first questionnaire 1 week after consultation, whereas 95 (62.1%) completed the 6-month follow-up questionnaire.
                Although the decision aid had no significant effect on postdecisional regret or actual genetic testing decision, the trial results demonstrated that participants who received the decision aid had significantly lower levels of decisional conflict (ie, uncertainty) regarding genetic testing (chi-square(1) = 8.97; P = .003) and were more likely to be classified as having made an informed choice concerning genetic testing (chi-square(1) = 4.37; P = .037) than participants who received a control pamphlet. Also, men who received the decision aid had significantly higher knowledge levels regarding genetic testing compared with men who received the control pamphlet, whereas no such differences were found for women (chi-square(2) = 6.76; P = .034).
                A decision aid for individuals considering genetic testing for HNPCC is an effective intervention to reduce uncertainty and assist individuals to make an informed choice regarding genetic testing for HNPCC after genetic counseling.
                (c) 2008 American Cancer Society. We developed an evidence-based decision aid for patients with advanced cystic fibrosis considering referral for lung transplantation.
                To prospectively evaluate whether use of the decision aid increased knowledge about the options, improved realistic expectations, and decreased decisional conflict in adult patients.
                We performed a single-blind randomized controlled trial involving 149 adult patients with cystic fibrosis with an FEV(1) <or= 40% predicted from 14 Canadian and Australian centers. All participants received an education and counseling session from their cystic fibrosis team and were then randomized to receive the decision aid or usual care. The decision aid is available online at http://decisionaid.ohri.ca/decaids.html.
                The primary end points measured were participants' knowledge, realistic expectations, and decisional conflict evaluated 3 weeks after randomization. Patients randomized to the decision aid had greater knowledge about their options (P < 0.0001) and had more realistic expectations about the benefits and risks of lung transplantation (P < 0.0001) compared with those randomized to usual care. The total decisional conflict score was significantly lower in the decision aid group 3 weeks postrandomization compared with the usual care group (11.6 vs. 20.4; P = 0.0007). Decisions were durable; 88% of patients in the decision aid group and 75% in the usual care group maintained the same choice 12 months after randomization (P = 0.06).
                Use of a decision aid for patients with cystic fibrosis considering referral for lung transplantation, in addition to usual education and counseling, improves patient knowledge, realistic expectations, decisional conflict, and patient satisfaction. Clinical trial registered with www.clinicaltrials.gov (NCT00345449). In early 1983, all 1,280 faculty and resident physicians at one hospital who were eligible to be vaccinated against hepatitis B were divided randomly into three groups: Group 1 physicians received general information about the risks and benefits of alternative vaccine decisions; Group 2 physicians were additionally invited to provide personal information for an individualized decision analysis (12.6 percent responded); and Group 3 physicians, who served as controls, were not contacted. In one year's follow-up, 20 percent of physicians were screened for hepatitis B antibody or vaccinated. More Group 2 physicians whose decision analyses recommended screening or vaccination took these actions (39 percent) than any other group. Group assignment remained significantly associated with vaccine decisions after analyzing results by the "intention to treat" principle, and after adjusting for training status, exposure to blood and blood products, and pre-study intentions about the vaccine. Despite the low overall vaccine acceptance rate, it is concluded that individualized decision analysis can influence the clinical decisions taken by knowledgeable and interested patients. To examine the impact of a brief patient decision aid (pDA) on men's knowledge, attitudes and intention to have a prostate specific antigen (PSA) test. To explore the important predictors of intention to be tested in men who received the brief pDA.
                A brief pDA designed to facilitate informed decision-making for men considering PSA testing was developed for the NHS Prostate Cancer Risk Management Programme. Men aged 40-75 years selected from 11 General Practices in England and Wales were randomised to receive either a mailed copy of the brief pDA and a questionnaire (intervention group), or a questionnaire alone (control group). The questionnaire assessed knowledge, attitudes, perceived risk and intention to have a PSA test and, for the intervention group, their perceptions of the brief pDA.
                Nine hundred and ninety of the men who were eligible for the study returned completed questionnaires (response rate=54%). Men who received the brief pDA had significantly higher knowledge scores (p<0.0001) and less positive attitudes (p<0.0001) regarding PSA testing than men in the control group. There was no significant difference between the two groups in intention to be tested within the next 12 months. 87% of men found the brief pDA was easy to read, 94% considered it contained about the right amount of detail and 94% felt the information was presented in a balanced way. Multivariate analysis identified perceived risk (p<0.0001), perceived benefits of PSA testing (p<0.0001), knowledge (p=0.004), attitude (p=0.007) and age (p=0.01) as the most important independent predictors of intention to be tested amongst men in the intervention group.
                The brief pDA was shown to dramatically increase men's knowledge of the benefits and risks of the PSA test. Men who received the brief pDA were significantly less positive about the PSA test, although there was no difference between the two groups regarding their intention to be tested within the next year.
                This brief pDA could serve as an acceptable and low cost adjunct to counselling by the General Practitioner (GP), and should promote informed decision making regarding the PSA test. Further research is required to ascertain the utility of the decision aid during the consultation. Studies have shown that patients with knee pain are not well informed of their potential treatment options and that patient preferences are often discordant with physician practices. The objective of this pilot study was to test the efficacy of a computer tool to improve informed decision-making for patients with knee pain in an outpatient primary care clinic setting.
                Patients with knee pain were randomized to receive an information pamphlet or to perform a computer task. The latter was designed to elicit preferences based on patient tradeoffs for route of administration, benefits, and side effects of commonly used treatment options for knee pain. After performing the task, participants were given a printed handout illustrating their preferences.
                In total, 87 patients were randomized. Decisional self-efficacy, preparedness to participate in decision-making, and arthritis self-efficacy were greater in participants randomized to the intervention arm compared to those receiving the information pamphlet (p < 0.05 for all comparisons).
                Participants using a tool designed to increase patient awareness of choice and evaluate the tradeoffs related to available treatment options were more confident in their ability to obtain information about available treatment options, were better prepared to participate in their visit, and had better arthritis related self-efficacy compared to patients receiving an information pamphlet. The results of this pilot study justify future large-scale trials to determine the effectiveness of similar interventions. Compliance with antipsychotic medication is a major issue in schizophrenia treatment, and noncompliance with antipsychotic treatment is closely related to relapse and rehospitalization. An enhanced involvement of patients with schizophrenia in treatment decisions ("shared decision making") is expected to improve long-term compliance and reduce rehospitalizations. The aim of the present analysis was to study whether shared decision making (SDM) in antipsychotic drug choice would influence long-term outcome.
                From February 2003 to January 2004, psychiatric state hospital inpatients with a diagnosis of schizophrenia (ICD-10; N = 107) were recruited for the trial using a cluster-randomized controlled design. An SDM program on antipsychotic drug choice consisting of a decision aid and a planning talk between patient and physician was compared with routine care with respect to long-term compliance and rehospitalizations (6-month and 18-month follow-up).
                On the whole, we found high rates of noncompliance and rehospitalization. There were no differences between intervention and control groups in the univariate analyses. However, when controlling for confounding factors in a multivariate analysis, there was a positive trend (p = .08) that patients in the SDM intervention had fewer rehospitalizations. Additionally, a higher desire of the patient for autonomy and better knowledge at discharge were associated with higher hospitalization rates.
                The intervention studied showed a positive trend but no clear beneficial effect on long-term outcomes. A more thorough implementation of SDM (e.g., iterative administration of decision aid) might yield larger effects. Those patients with higher participation preferences are at higher risk for poor treatment outcomes and therefore require special attention. Strategies to match these patients' needs might improve compliance and long-term outcomes. Statin Choice is a decision aid about taking statins. The optimal mode of delivering Statin Choice (or any other decision aid) in clinical practice is unknown.
                To investigate the effect of mode of delivery on decision aid efficacy, the authors further explored the results of a concealed 2 x 2 factorial clustered randomized trial enrolling 21 endocrinologists and 98 diabetes patients and randomizing them to 1) receive either the decision aid or pamphlet about cholesterol, and 2) have these delivered either during the office visit (by the clinician) or before the visit (by a researcher). We estimated between-group differences and their 95% confidence intervals (CI) for acceptability of information delivery (1-7), knowledge about statins and coronary risk (0-9), and decisional conflict about statin use (0-100) assessed immediately after the visit. Follow-up was 99%.
                The relative efficacy of the decision aid v. pamphlet interacted with the mode of delivery. Compared with the pamphlet, patients whose clinicians delivered the decision aid during the office visit showed significant improvements in knowledge (difference of 1.6 of 9 questions, CI 0.3, 2.8) and nonsignificant trends toward finding the decision aid more acceptable (odds ratio 3.1, CI 0.9, 11.2) and having less decisional conflict (difference of 7 of 100 points, CI -4, 18) than when a researcher delivered the decision aid just before the office visit.
                Delivery of decision aids by clinicians during the visit improves knowledge and shows a trend toward better acceptability and less decisional conflict. This investigation examined factors affecting patient involvement in consultations to decide local treatment for early breast cancer and the effectiveness of two methods of preconsultation education aimed at increasing patient participation in these discussions.
                Sixty patients with Stage I or II breast cancer (1) were pretested on their knowledge about breast cancer treatment and optimism for the future, (2) were randomly assigned to one of two methods for preconsultation education: interactive multimedia program or brochure, (3) completed knowledge and optimism measures, (4) consulted with a medical oncologist, radiation oncologist, and general surgeon, and (5) completed self-report measures assessing their involvement in the consultations and control over decision-making. The consultations were audiorecorded and analyzed to identify behavioral indicators of patient involvement (question-asking, opinion-giving, and expressing concern) and physician utterances encouraging patient participation.
                College-educated patients younger than 65 years of age were more active participants in these consultations than were older, less educated patients. In addition, patients showed more involvement when they interacted with physicians who encouraged and facilitated patient participation. The method of education did not affect patient involvement although patients tended to learn more about breast cancer treatment after using the multimedia program than after reading the brochure.
                Although patients vary in their expressiveness, physicians may be able to increase patient participation in deciding treatment by using patient-centered behavior. Also, preconsultation education appears to be an effective clinical strategy for helping patients gain an accurate understanding of their treatment options before meeting with physicians. Decision aids can increase patient involvement in treatment decision making. However, questions remain regarding their effects and cost implications.
                To evaluate the effects of information, with and without a structured preference elicitation interview, on treatment choices, health outcomes, and costs.
                A randomized controlled trial with 2 years of follow-up. Between October 1996 and February 1998, 894 women with uncomplicated menorrhagia were recruited from 6 hospitals in southwest England. Women were randomized to the control group, information alone group (information), or information plus interview group (interview).
                Women in both intervention groups were sent an information pack (a booklet and complementary videotape) 6 weeks before their specialist consultation. Immediately before their consultation, women in the interview group underwent structured interview, to clarify and elicit their preferences.
                Self-reported health status was the main outcome; secondary outcomes included treatments received and costs. Cost analyses adopted a UK health service (payer) perspective, and were based on patient-reported resource use data and are reported in 1999-2000 US dollars.
                The interventions had no consistent effect on health status. Hysterectomy rates were lower for women in the interview group (38%) (adjusted odds ratio [OR], 0.60; 95% confidence interval [CI], 0.38-0.96) than in the control group (48%) and women who received the information alone (48%) (adjusted OR, 0.52; 95% CI, 0.33-0.82). The interview group had lower mean costs ($1566) than the control group ($2751) (mean difference, $1184; 95% CI, $684-$2110) and the information group $2026 (mean difference, $461; 95% CI, $236-$696).
                Neither intervention had an effect on health status. Providing women with information alone did not affect treatment choices; however, the addition of an interview to clarify values and elicit preferences had a significant effect on women's management and resulted in reduced costs. Back surgery rates are rapidly rising in the United States. This surgery is usually elective, so patient preferences are important in the treatment decision.
                The objective of this study was to determine the impact on outcomes and surgical choices of an interactive, diagnosis-specific videodisk program for informing patients about treatment choices.
                This was a randomized, controlled trial at 2 sites comparing the interactive video plus a booklet with the booklet alone.
                Elective surgery candidates (n = 393) included 171 patients with herniated disks, 110 with spinal stenosis, and 112 with other diagnoses.
                Mailed questionnaires were used to assess outcomes and satisfaction; surgery rates were determined by questionnaires and automated records.
                Symptom and functional outcomes at 3 months and 1 year were similar between study groups. The overall surgery rate was 22% lower in the videodisk group (26% versus 33%, P = 0.08). Among patients with herniated disks, those in the video group underwent significantly less surgery (32% versus 47%, P = 0.05 by Kaplan-Meier test). Among patients with spinal stenosis, surgery rates in the video group were higher (39% for the video group, 29% for the booklet group; P = 0.4). There was little effect on patient satisfaction, but patients in the video group felt better informed.
                The program appears to facilitate decision making and may help to ensure informed consent. For patients with herniated disks, it reduced the surgery rate without diminishing patient outcomes. Its impact on costs of care depends on the proportion of patients with various diagnoses and on local surgery rates. To examine who reported using unsolicited prostate cancer screening decision aids distributed as part of a randomized controlled trial, whether reported use varied by type of aid (video or pamphlet), and what affect reported use had on study outcomes.
                A total of 1,152 men aged 50 and older from four medical facilities in the United States were randomly assigned to pamphlet, video or usual care (control). Materials were mailed 2 weeks prior to clinic appointments in general internal medicine. Outcomes were assessed by phone survey 1 week after appointments. Analyses examined the reported use of materials by study group, the association between patient characteristics and reported use, and the impact of reported use (adjusting for patient characteristics) on a 10-item knowledge index.
                Fifty-six percent of those randomized to receive the video and 50% of those randomized to receive the pamphlet reported using the materials. Reported use of the video was higher for patients who had greater than a high school education (OR 1.73), were married (OR 2.20), and reported no prior abnormal prostate cancer screening test results (OR 3.39). Reported use of the pamphlet did not vary by patient characteristics. In intent-to-treat analyses (ignoring reported use), individuals randomized to the video and pamphlet groups had significantly higher knowledge scores relative to the control group (7.44, 7.26 and 6.90 respectively). Adjusting for reported use modestly increased the estimated differences across treatment groups but did not substantially change conclusions about the relative effects of these aids on knowledge.
                Only half of men receiving unsolicited prostate cancer screening decision aids before a visit reported using the aids, and who reported using them varied by type of aid. Efforts to broadly implement decision aids may need to offer a variety of approaches, and incorporate creative strategies to enhance reaching all population subgroups. Too few patients with nonvalvular atrial fibrillation (NVAF) receive appropriate antithrombotic therapy. We tested the short-term (primary outcome) and long-term (secondary outcome) effect of a patient decision aid on the appropriateness of antithrombotic therapy among patients with NVAF.
                We conducted a cluster randomized trial with blinded outcome assessment involving 434 NVAF patients from 102 community-based primary care practices. Patients in the intervention group received a self-administered booklet and audiotape decision aid tailored to their personal stroke risk profile. Patients in the control group received usual care. The primary outcome measure was change in antithrombotic therapy at 3 months. Appropriateness of therapy was defined using the American College of Chest Physicians (ACCP) recommendations.
                The mean patient age was 72 years, and the median duration of NVAF was 5 years. In the control group, there was a 3% decrease over 3 months in the number of patients receiving therapy appropriate to their risk of stroke (40% [85/215] at baseline v. 37% [79/215] at 3 months). In the intervention group, the number of patients receiving therapy appropriate to their stroke risk increased by 9% (32% [69/219] at baseline v. 41% [89/219] at 3 months). Although the proportion of patients whose therapy met the ACCP treatment recommendations did not differ between study arms at baseline (p = 0.11) or 3 months (p = 0.44), there was a 12% absolute improvement in the number of patients receiving appropriate care in the intervention group compared with the control group at 3 months (p = 0.03). The beneficial effect of the decision aid did not persist (p = 0.44 for differences between study arms after 12 months).
                There was short-term improvement in the appropriateness of antithrombotic care among patients with NVAF who were exposed to a decision aid, but the improvement did not persist. To evaluate the impact of a patient decision aid (PDA) regarding the use of natural health products (NHPs) at menopause on decisional conflict, knowledge of NHPs, congruence between values and choice, persistence with an option, intention to disclose the use of NHPs to a physician or a pharmacist and intention to use decision support interventions in the future.
                A randomized controlled trial in which 90 women, aged 45-64 years, facing a decision about using NHPs for menopausal symptoms, received a PDA (experimental group) or a general information brochure about menopause (control group). Main outcome Decisional conflict. Measures Women were evaluated at baseline and after a two-week period using the decisional conflict scale (DCS). Analysis of covariance was used to determine the differences between both groups on the DCS.
                Both groups experienced a statistically significant reduction on the DCS (-0.55 +/- 0.59, P < 0.0001 versus -0.52 +/- 0.73, P < 0.0001). However, there was no statistically significant difference between the groups (P = 0.32). Both groups experienced a statistically significant improvement in knowledge of NHPs (0.86 +/- 1.77, P = 0.002 versus 0.51 +/- 1.47, P = 0.031). However, there was no statistically significant difference between the groups (P = 0.162).
                A PDA regarding the use of NHPs for menopausal symptoms impacted favourably on women's decisional conflict, but was not superior to a general information brochure on menopause. As genetic testing for susceptibility to breast cancer becomes more widespread, alternative methods for educating individuals prior to testing will be needed. Our objective was to compare face-to-face education and counseling by a genetic counselor with education by an interactive computer program, assessing the effects of each on knowledge of breast cancer genetics and intent to undergo genetic testing. We used a randomized, controlled trial. Seventy-two self-referred women with a first-degree relative with breast cancer received outpatient education and counseling at the Clinical Center of the National Institutes of Health (NIH). Twenty-nine received individualized counseling from a genetic counselor (counseling group), 29 received education from an interactive computer program followed by individualized counseling (computer group), and 14 were controls. Both pre- and postintervention assessment of knowledge about breast cancer genetics and intent to undergo genetic testing were measured. The control group participants correctly answered 74% of the knowledge questions; the counselor group, 92%; and the computer group, 96% (P <.0001). Unadjusted mean knowledge scores were significantly higher in the computer group than the counselor group (P =.048), but they were equivalent when adjusted for demographic differences (P = 0.34). Intent to undergo genetic testing was influenced by the interventions: preintervention, a majority in all groups (69%) indicated that they were likely (definitely and most likely) to undergo testing; after either intervention coupled with counseling, only 44% indicated that they were likely to do so (P =.0002; odds ratio = 2.8, 95% CI = 1.7-4.9). We concluded that a computer program can successfully educate patients about breast cancer susceptibility, and, along with genetic counseling, can influence patients' intentions to undergo genetic testing.
                Copyright 2001 Wiley-Liss, Inc. 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.
                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.
                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).
                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. To evaluate a patient-educational approach to shared decision making for prostate cancer screening.
                Randomized controlled trial with preoffice visit assessment and 2-week follow-up.
                University-based family practice center.
                Men aged 45 through 70 years with no history of prostate cancer or treatment for prostate disease (N = 160). Two patients were unavailable for follow-up.
                Twenty-minute educational videotape on advantages and disadvantages of prostate-specific antigen (PSA) screening for prostate cancer.
                A measure of patients' core knowledge of prostate cancer developed for this study, reported preferences for PSA testing, and ratings of the videotape.
                Patients' core knowledge at baseline was poor. At 2-week follow-up, subjects undergoing videotape intervention showed a 78% improvement in the number of knowledge questions answered correctly (P = .001), and knowledge increased about mortality due to early-stage prostate cancer, PSA screening performance, treatment-related complications, and disadvantages of screening. No overall change was observed for control subjects. At follow-up, 48 (62%) of 78 intervention patients planned to have the PSA test compared with 64 (80%) of 80 control patients (18.5% absolute reduction; 95% confidence interval, 4.6%-32.4%; P = .009). Intervention subjects rated favorably the amount of information provided and the clarity, balance, and length of the videotape and would recommend the videotape to others.
                Patient education regarding the potential benefits and harms of early detection of prostate cancer can lead to more informed decision making. Incorporating the PSA videotape into the periodic health examination for asymptomatic men aged 50 years and older is recommended. There is a lack of evidence regarding the value of tools designed to aid decision making in patients with newly diagnosed hypertension.
                To evaluate two interventions for assisting newly diagnosed hypertensive patients in the decision whether to start drug therapy for reducing blood pressure.
                Factorial randomised controlled trial.
                Twenty-one general practices in south-west England, UK.
                Adults aged 32 to 80 years with newly diagnosed hypertension were randomised to receive either: (a) computerised utility assessment interview with individualized risk assessment and decision analysis; or (b) information video and leaflet about high blood pressure; or (c) both interventions; or (d) neither intervention. Outcome measures were decisional conflict, knowledge, state anxiety, intentions regarding starting treatment, and actual treatment decision.
                Of 217 patients randomised, 212 (98%) were analysed at the primary follow-up (mean age = 59 years, 49% female). Decision analysis patients had lower decisional conflict than those who did not receive this intervention (27.6 versus 38.9, 95% confidence interval [CI] for adjusted difference = -13.0 to -5.8, P < 0.001), greater knowledge about hypertension (73% versus 67%, adjusted 95% CI = 2% to 9%, P = 0.003) and no evidence of increased state anxiety (34.8 versus 36.8, adjusted 95% CI = -5.6 to 0.1, P = 0.055). Video/leaflet patients had lower decisional conflict than corresponding controls (30.3 versus 36.8, adjusted 95% CI = -7.4 to -0.6, P = 0.021), greater knowledge (75% versus 65%, adjusted 95% CI = 6% to 13%, P < 0.001) and no evidence of increased state anxiety (35.7 versus 36.1, adjusted 95% CI = -3.9 to 1.7, P = 0.46). There were no differences between either of the interventions and their respective controls in the proportion of patients prescribed antihypertensive medication (67%).
                This trial demonstrates that, among patients facing a real treatment decision, interventions to inform patients about hypertension and to clarify patients' values concerning outcomes of treatment are effective in reducing decisional conflict and increasing patient knowledge, while not resulting in any increases in state anxiety. To determine the effects of two computer based decision aids on decisional conflict and mode of delivery among pregnant women with a previous caesarean section.
                Randomised trial, conducted from May 2004 to August 2006.
                Four maternity units in south west England, and Scotland.
                742 pregnant women with one previous lower segment caesarean section and delivery expected at >or=37 weeks. Non-English speakers were excluded.
                Usual care: standard care given by obstetric and midwifery staff. Information programme: women navigated through descriptions and probabilities of clinical outcomes for mother and baby associated with planned vaginal birth, elective caesarean section, and emergency caesarean section. Decision analysis: mode of delivery was recommended based on utility assessments performed by the woman combined with probabilities of clinical outcomes within a concealed decision tree. Both interventions were delivered via a laptop computer after brief instructions from a researcher.
                Total score on decisional conflict scale, and mode of delivery.
                Women in the information programme (adjusted difference -6.2, 95% confidence interval -8.7 to -3.7) and the decision analysis (-4.0, -6.5 to -1.5) groups had reduced decisional conflict compared with women in the usual care group. The rate of vaginal birth was higher for women in the decision analysis group compared with the usual care group (37% v 30%, adjusted odds ratio 1.42, 0.94 to 2.14), but the rates were similar in the information programme and usual care groups.
                Decision aids can help women who have had a previous caesarean section to decide on mode of delivery in a subsequent pregnancy. The decision analysis approach might substantially affect national rates of caesarean section. Trial Registration Current Controlled Trials ISRCTN84367722. The objective of this randomized, controlled study was to determine the usefulness of a decision aid on pre-donation of autologous blood before elective open heart surgery.
                The decision aid (DA) group received a tape and booklet which described the options for peri-operative transfusion in detail. The no decision aid (NDA) group received information usually given to patients about autologous donation.
                A total of 120 patients were randomized. The DA group rated themselves better prepared for decision making and showed significant improvements in knowledge (p = 0.001) and realistic risk perceptions (p = 0.001). In both groups there was an increase in the proportion of patients choosing allogeneic blood between baseline and follow-up (p = 0.001). Patients in the DA group were significantly more satisfied with the amount of information they received, how they were treated and with the decision they made, than patients in the NDA group.
                The decision aid is useful in preparing patients for decision making.
                The next stage is to explore strategies to make it available to all appropriate patients. 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.
                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.
                131 women with a family history of breast and/or ovarian cancer or of hereditary nonpolyposis colorectal cancer.
                Decisional conflict, knowledge about ovarian cancer risk management options, and psychological adjustment were reassessed at 3 time points.
                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.
                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. 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. Despite increased interest among the public in breast cancer genetic risk and genetic testing, there are limited services to help women make informed decisions about genetic testing. This study, conducted with female callers (N = 279) to the National Cancer Institute's (NCI's) Atlantic Region Cancer Information Service (CIS), developed and evaluated a theory-based, educational intervention designed to increase callers' understanding of the following: (a) the kinds of information required to determine inherited risk; (b) their own personal family history of cancer; and (c) the benefits and limitations of genetic testing. Callers requesting information about breast/ovarian cancer risk, risk assessment services, and genetic testing were randomized to either: (1) standard care or (2) an educational intervention. Results show that the educational intervention reduced intention to obtain genetic testing among women at average risk and increased intention among high-risk women at 6 months. In addition, high monitors, who typically attend to and seek information, demonstrated greater increases in knowledge and perceived risk over the 6-month interval than low monitors, who typically are distracted from information. These findings suggest that theoretically designed interventions can be effective in helping women understand their cancer risk and appropriate risk assessment options and can be implemented successfully within a service program like the CIS. 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.
                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.
                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.
                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. The aim of this secondary analysis was to compare the effects of a tailored decision aid (DA) with those of a pamphlet on the agreement between women's and physicians' decisional conflict about hormone replacement therapy (HRT). A total of 40 physicians and 184 women provided data. The agreement between women's and physicians' decisional conflict scores was measured using the intraclass correlation coefficient (ICC). The ICC was higher for dyads in the DA group (ICC=0.44; 95% confidence interval (CI)=0.25-0.59) compared to the pamphlet group (ICC=0.28; 95% CI=0.06-0.47). When the average score of decisional conflict of women nested within a physician and of each physician were used, the ICC for the DA group and the pamphlet group was 0.41 (95% CI=-0.04 to 0.72) and 0.06 (95% CI=-0.41 to 0.49), respectively. Compared to pamphlets, DAs appear to improve the agreement between women's and physicians' decisional conflict about HRT. Seventy-four patients, ranging in age from 15 to 50 and presenting with a moderate to severe dentofacial deformity requiring orthognathic surgery, were randomly assigned to a video imaging or a standard case presentation (CP) group. Motives for treatment did not differ significantly between the video image and standard CP groups. Two weeks after the case presentation, 60% of the standard CP group and 74% of the video image group ranked the anticipated change in facial appearance as an important factor in making a treatment decision. Seventy percent of the standard CP group and 83% of the video image group agreed with the statement that surgery would be necessary to correct their problem. In the standard CP group, 47% of the patients ranked dental casts as the most helpful physical record in making a treatment decision, and 46% said the acetate profile tracing was the most helpful tool for understanding what to expect from treatment. In the video imaging group, 42% of the patients said the video imaging presentation was the most helpful tool in making a treatment decision, and 39% of the patients said it was the most helpful tool for understanding treatment expectations. The proportion of patients in the video image case presentation group with elevated self-image expectations following treatment was significantly higher (P = .045) than in the standard case presentation group. The presentation of video images appears to be a valuable information source for conveying treatment options to patients, but caution may be needed to prevent elevated or possibly unrealistic treatment expectations. The concept of shared decision making (SDM) is an important emerging trend in clinical medicine but has received little or no attention in the dental literature. Decision aids can play a useful role in SDM by helping patients and clinicians choose among reasonable alternative treatment options. The purpose of this study was to develop and test an Endodontic Decision Board (EndoDB) for chairside use to help clarify treatment alternatives, benefits, risks, prognosis, and costs when root canal therapy or extraction of a tooth was indicated. The hypothesis was that the use of the EndoDB would lead to improved patient knowledge, greater satisfaction with the decision-making process, and no difference in anxiety when compared to the standard discussion and informed consent process (usual care). The EndoDB was tested in a randomized controlled trial in a postgraduate endodontics clinic. After treatment discussion, a brief questionnaire was completed by the patient to measure knowledge, satisfaction, and anxiety. Patients in the EndoDB group (n=32) demonstrated a small, but statistically significant, increase in knowledge (t-test; difference=+0.37; p=0.03) compared to the usual care group (n=35). There was no difference between groups in the measures of satisfaction or anxiety (Mann-Whitney U-test; p>0.05). Decision aids may emerge as a useful tool to facilitate SDM and evidence-based clinical practice. To evaluate the effectiveness of a decision aid to help women choose between surgical and medical methods of pregnancy termination.
                A randomised controlled trial comparing a decision-aid leaflet about termination methods with a control leaflet about contraception.
                An NHS regional centre for pregnancy termination.
                All women less than 9 weeks of gestation referred for termination of pregnancy over 7 months in 2002.
                Participants were given an envelope containing either the decision-aid or the control leaflet prior to choosing between medical and surgical termination methods and completed two questionnaires, one immediately after this consultation and another after the termination procedure.
                Choice of termination method; measures of effective decision making including risk perception, attitudes and knowledge of both the medical and surgical methods; decisional conflict; anxiety and usefulness of the leaflet.
                Three hundred and twenty-eight women participated. There was no difference in the method chosen between the groups (60/162 women in the decision-aided group chose a medical method versus 54/164 women in the control group (OR 1.2; 95% CI 0.76-1.9). Women in the decision-aided group had higher knowledge and lower risk-perception scores about both methods, more positive attitudes about the medical method, lower decisional conflict, more stable evaluations of the decision information over time and higher perceived usefulness of information ratings. Anxiety was high but unrelated to leaflet type.
                Women made more informed decisions when provided with an evidence-based decision-aid leaflet preceding a routine consultation about choices of termination method. OBJECTIVE: To evaluate the incremental effect of a graphic weigh-scale values clarification exercise to explicitly consider the personal importance of the benefits versus the risks in a woman's decision aid regarding postmenopausal hormone therapy. DESIGN: Randomized controlled trial. Intervention Decision aid including information on options, benefits and risks, and their probabilities either followed by: (1) a graphic weigh-scale values clarification exercise to explicitly consider the personal importance of each benefit and risk; or (2) a summary of the main benefits and risks to implicitly consider benefits versus the risks. SAMPLE: Two-hundred and one women aged 50-69 years from Ottawa, Canada, who had never used hormone therapy. OUTCOME: Perceived clarity of values, a sub-scale of the decisional conflict scale; congruence between personal values of benefits and risks (measured on 0-10 importance rating scale) and choices (accept, decline, unsure regarding preventive hormone therapy [HRT]) using discriminant function analysis. RESULTS: There were no statistically significant differences between interventions in perceived clarity of values and overall congruence between values and choices. Amongst those choosing HRT, there was a trend in those exposed to the graphic weigh-scale exercise to have better congruence between values and choices compared to implicit values clarification (P = 0.06). CONCLUSION: The use of the graphic weigh-scale exercise in a decision aid conveys no overall short-term benefit. Further study is needed to specifically determine effects in those changing the status quo and on the quality of patient-practitioner communication and persistence with decisions. As the availability of and demand for genetic testing for hereditary cancers increases in primary care and other clinical settings, alternative or adjunct educational methods to traditional genetic counseling will be needed.
                To compare the effectiveness of a computer-based decision aid with standard genetic counseling for educating women about BRCA1 and BRCA2 genetic testing.
                Randomized controlled trial conducted from May 2000 to September 2002.
                Outpatient clinics offering cancer genetic counseling at 6 US medical centers enrolled 211 women with personal or family histories of breast cancer.
                Standard one-on-one genetic counseling (n = 105) or education by a computer program followed by genetic counseling (n = 106).
                Participants' knowledge, risk perception, intention to undergo genetic testing, decisional conflict, satisfaction with decision, anxiety, and satisfaction with the intervention. Counselor group measures were administered at baseline and after counseling. Computer group measures were administered at baseline, after computer use, and after counseling. Testing decisions were assessed at 1 and 6 months. Outcomes were analyzed by high vs low risk of carrying a BRCA1 or BRCA2 mutation.
                Both groups had comparable demographics, prior computer experience, medical literacy, and baseline knowledge of breast cancer and genetic testing, and both counseling and computer use were rated highly. Knowledge scores increased in both groups (P<.001) regardless of risk status, and change in knowledge was greater in the computer group compared with the counselor group (P =.03) among women at low risk of carrying a mutation. Perception of absolute risk of breast cancer decreased significantly after either intervention among all participants. Intention to undergo testing decreased significantly after either intervention among low-risk but not high-risk women. The counselor group had lower mean scores on a decisional conflict scale (P =.04) and, in low-risk women, higher mean scores on a satisfaction-with-decision scale (P =.001). Mean state anxiety scores were reduced by counseling but were within normal ranges for both groups at baseline and after either intervention, regardless of risk status.
                An interactive computer program was more effective than standard genetic counseling for increasing knowledge of breast cancer and genetic testing among women at low risk of carrying a BRCA1 or BRCA2 mutation. However, genetic counseling was more effective than the computer at reducing women's anxiety and facilitating more accurate risk perceptions. These results suggest that this computer program has the potential to stand alone as an educational intervention for low-risk women but should be used as a supplement to genetic counseling for those at high risk. Guidelines for fetal aneuploidy testing recommend that screening and diagnostic testing be made available to pregnant women of all ages and that providers explain the differences between these tests to help their patients make informed testing decisions. We sought to estimate the effect of a computerized, interactive prenatal testing decision tool on prenatal testing decision making.
                Four hundred ninety-six English- or Spanish-speaking women at 20 or fewer weeks of gestation were randomly assigned to view the interactive prenatal testing decision tool or the California Department of Health Services' educational booklet. Primary outcomes were knowledge, risk awareness, intervention satisfaction, decisional conflict, and among women aged at least 35 years, use of invasive diagnostic testing.
                Women assigned to the interactive prenatal testing decision tool had higher knowledge scores (79.5% compared with 64.9%, P<.001), were more likely to correctly estimate their risk of procedure-related miscarriage (64.9% compared with 48.1%, P=.002) and carrying a Down syndrome-affected fetus (63.5% compared with 15.1%, P<.001), were more satisfied with the intervention (P<.001), and had less decision uncertainty (P<.001) than controls after viewing the intervention. Most of these differences persisted over time. Among women aged at least 35 years, the interactive prenatal testing decision tool viewers who were originally less inclined to undergo invasive testing were ultimately more likely than similarly inclined controls to have amniocentesis or chorionic villus sampling (44.8% compared with 29.2%), whereas those who were originally more inclined to undergo an invasive procedure ultimately were less likely than similarly inclined controls to have a diagnostic procedure (84.6% compared with 94.9%; P=.015 for interaction).
                Using an interactive prenatal testing decision tool results in more informed prenatal genetic testing decisions than viewing standard educational booklets.
                Clinicaltrials.gov, www.clinicaltrials.gov, NCT00686062
                I. Previous studies have not assessed whether evidence-based information about the outcomes of colorectal cancer screening increases informed choice among people from a range of socioeconomic backgrounds nor have they assessed whether this can be administered away from a health-care provider.
                Randomized controlled trial in six primary care locations. Three hundred and fourteen people aged 50-74 years received a self-administered decision aid (DA) booklet about outcomes of biennial faecal occult blood testing (FOBT) screening or government consumer guidelines (G).
                Significantly more DA recipients (20.9%) were 'informed' compared with G recipients (5.8%) (P = 0.0001, OR 4.32; 95% CI 2.49 to 7.52); the DA did not affect values clarity (61.9% clear after DA versus 59.1% after G) nor screening decisions overall (87.3% would screen after DA versus 90.5% after G). Test uptake at one month was uniformly low (5.2% DA versus 6.6% G); mostly due to being 'too busy'. DA recipients were more likely to make decisions 'integrating' knowledge with values (10.4% DA versus 1.5% G). Decisions not to screen were equally uncommon in both groups but more likely to be uninformed in G (P = 0.03). More DA recipients from all education levels were 'informed' (P = 0.02), particularly in lower education (50.0% DA versus 17.8% G) and university-educated groups (79.4% DA versus 32.1% G).
                Detailed absolute risk and benefit information about FOBT screening can be effectively used at home by people to increase informed choice. The DA was effective in people with lower education levels.
                Unique Protocol ID 211705 ClinicalTrials.gov ID NCT 00148226. nan To evaluate an entertainment-based patient decision aid for prostate cancer screening among patients with low or high health literacy.
                Male primary care patients from two clinical sites, one characterized as serving patients with low health literacy (n=149) and the second as serving patients with high health literacy (n=301), were randomized to receive an entertainment-based decision aid for prostate cancer screening or an audiobooklet-control aid with the same learner content but without the entertainment features. Postintervention and 2-week follow-up assessments were conducted.
                Patients at the low-literacy site were more engaged with the entertainment-based aid than patients at the high-literacy site. Overall, knowledge improved for all patients. Among patients at the low-literacy site, the entertainment-based aid was associated with lower decisional conflict and greater self-advocacy (i.e., mastering and obtaining information about screening) when compared to patients given the audiobooklet. No differences between the aids were observed for patients at the high-literacy site.
                Entertainment education may be an effective strategy for promoting informed decision making about prostate cancer screening among patients with lower health literacy.
                As barriers to implementing computer-based patient decision support programs decrease, alternative models for delivering these programs should be explored. To evaluate a shared decision-making intervention (SDMI) for BRCA1/2 mutation carriers who have to make a choice between screening and prophylactic surgery for breasts and/or ovaries.
                The SDMI consisted of two value assessment sessions, using the time trade-off method, followed by individualized treatment information based on (quality-adjusted) life expectancy. After the baseline assessment (2 weeks after a positive DNA test result), women were randomly assigned to the SDMI group (n = 44), receiving the SDMI 2 months after the test result, or to the control group (n = 44). The short- and long-term effects, 3 and 9 months after the test result, were assessed using questionnaires. Data were collected on well-being, treatment choice, and decision-related outcomes.
                In the short term, the SDMI had no effect. In the long term, with respect to well-being, patients in the SDMI group had less intrusive thoughts (P =.05) and better general health (P =.01) and tended to be less depressed (P =.07). With respect to decision-related outcomes for the breasts, the SDMI group held stronger preferences (P =.02) and agreed more strongly to having weighed the pros and cons (P =.01). No effect was found on treatment choice. In the long term, interaction effects between the SDMI and cancer history were found. The SDMI showed an overall beneficial effect for unaffected women, whereas affected women tended to experience detrimental effects.
                We conclude that the SDMI improved decision making in unaffected BRCA1/2 mutation carriers. Supporting decision making in a systematic way using trade-offs is beneficial for these women. To evaluate the impact of a decision aid for women considering genetic testing for breast/ovarian cancer risk given during genetic counseling.
                One hundred and forty-eight women were randomized to receive the decision aid or a control pamphlet at the beginning of their first consultation with a genetic counselor. When the patient received the decision aid, it was used to complement consultation discussions about genetic testing. One hundred and ten (74.3%) women completed the first questionnaire designed to elicit information about women's levels of decisional conflict and knowledge about genetic testing. Of these, 105 (70.9%) completed a second questionnaire to assess longer-term outcomes, 6 months postconsultation.
                Results showed that women who received the decision aid felt more informed about genetic testing (chi(2)(1)=8.69; P=0.003), had clearer values (chi(2)(1)=6.90; P=0.009) and had higher knowledge levels (chi(2)(2)=6.49; P=0.039) than women who received the control pamphlet.
                The developed decision aid improved patient outcomes better than a control pamphlet when implemented during genetic counseling and given to the patient to take home. To measure the effectiveness of a tailored decision aid (DA) designed to help women make informed decisions about genetic testing for breast/ovarian cancer risk.
                A total of 145 women were randomized to receive the DA or a control pamphlet at the end of their first genetic counseling consultation. Of these, 120 (82.8%) completed two questionnaires, 1 week and 6 months post-consultation.
                While the DA had no effect on informed choice, post-decisional regret or actual genetic testing decision, the trial showed that women who received the DA had higher knowledge levels and felt more informed about genetic testing than women who received the control pamphlet (chi(2)(2) = 6.82; P = 0.033; chi(2)(1) = 4.86; P = 0.028 respectively). The DA also helped women who did not have blood drawn at their first consultation to clarify their values with regards to genetic testing (chi(2)(1) = 5.27; P = 0.022). Women who received the DA were less likely to share the information with other family members than women in the control condition (chi(2)(1) = 8.78; P = 0.003).
                Decision aids are an effective decision-support strategy for women considering genetic testing for breast/ovarian cancer risk, and are most effective before the patient has made a decision, which is generally at the point of having blood drawn. In recent years, patients have indicated a desire for more information about their disease and to be involved in making decisions about their care. We developed an aid called the "Decision Board" to help clinicians inform patients with lymph node-negative breast cancer of the risks and benefits of adjuvant chemotherapy. We determined whether adding the Decision Board to the medical consultation improved patient knowledge and satisfaction compared with the medical consultation alone.
                Between October 1995 and March 2000, 176 women with lymph node-negative breast cancer who were candidates for adjuvant chemotherapy were randomly assigned to receive the Decision Board plus the medical consultation (83 patients) or the medical consultation alone (93 patients). One week after the consultation, patients completed a questionnaire assessing their knowledge about breast cancer and chemotherapy. Satisfaction with decision making was assessed 1 week and 3, 6, and 12 months after randomization, and differences between groups were analyzed by a repeated measures analysis of variance. All statistical tests were two-sided.
                Patients in the Decision Board arm were better informed about breast cancer and adjuvant chemotherapy than patients in the control arm (mean knowledge score = 80.2 [on a scale of 0-100], 95% confidence interval [CI] = 77.1 to 83.3, and 71.7, 95% CI = 69.0 to 74.4, respectively; P<.001). Over the entire study period, satisfaction with decision making was higher for patients in the Decision Board arm than for patients in the control arm (P =.032). There was no statistically significant difference between the two groups in the number of patients who chose adjuvant chemotherapy (77% and 70% for patients in the Decision Board arm and those in the control arm, respectively; P =.303).
                When making decisions regarding adjuvant chemotherapy, patients with early breast cancer who had been exposed to the Decision Board had better knowledge of the disease and treatment options and greater satisfaction with their decision making than those who received the standard consultation. To determine whether a decision aid on hormone replacement therapy influences decision making and health outcomes.
                Randomised controlled trial.
                26 general practices in the United Kingdom.
                205 women considering hormone replacement therapy. Intervention: Patients' decision aid consisting of an interactive multimedia programme with booklet and printed summary.
                Patients' and general practitioners' perceptions of who made the decision, decisional conflict, treatment choice, menopausal symptoms, costs, anxiety, and general health status.
                Both patients and general practitioners found the decision aid acceptable. At three months, mean scores for decisional conflict were significantly lower in the intervention group than in the control group (2.5 v 2.8; mean difference -0.3, 95% confidence interval -0.5 to -0.2); this difference was maintained during follow up. A higher proportion of general practitioners perceived that treatment decisions had been made "mainly or only" by the patient in the intervention group than in the control group (55% v 31%; 24%, 8% to 40%). At three months a lower proportion of women in the intervention group than in the control group were undecided about treatment (14% v 26%; -12%, -23% to -0.4%), and a higher proportion had decided against hormone replacement therapy (46% v 32%; 14%, 1% to 28%); these differences were no longer apparent by nine months. No differences were found between the groups for anxiety, use of health service resources, general health status, or utility. The higher costs of the intervention were largely due to the video disc technology used.
                An interactive multimedia decision aid in the NHS would be popular with patients, reduce decisional conflict, and let patients play a more active part in decision making without increasing anxiety. The use of web based technology would reduce the cost of the intervention. The long-term results of randomized trials have demonstrated equivalent survival rates for mastectomy and breast-conserving therapy for the treatment of early stage breast cancer. Consequently, the choice of treatment should be based on a patient's preferences.
                To evaluate the impact of a decision aid regarding the different surgical treatment options on patient decision making.
                A cluster randomized trial for which general surgeons in the communities of central-west, and eastern Ontario, Canada, were randomly assigned to use the decision aid or not in the surgical consultation. Patients received the decision aid or not based on the surgeon seen.
                Twenty surgeons participated in the study. Of the 208 eligible women with newly diagnosed clinical stage I or II breast cancer seen by study surgeons, 201 agreed to be evaluated: 94 were assigned to the decision board and 107 to usual practice. Patients were recruited from November 1999 to April 2002.
                The decision board is a decision aid designed to help physicians inform their patients about different treatment options and to enable patients to express a preference for treatment.
                Patient knowledge about the surgical treatment of breast cancer; decisional conflict; satisfaction with decision making; and the treatment decision following the consultation.
                Patients in the decision board group had higher knowledge scores about their treatment options (66.9 vs 58.7; P<.001), had less decisional conflict (1.40 vs 1.62, P =.02), and were more satisfied with decision making (4.50 vs 4.32, P =.05) following the consultation. Patients who used the decision board were more likely to choose BCT (94% vs 76%, P =.03).
                The decision board was helpful in improving communication and enabling women to make a choice regarding treatment. Such instruments should be considered by surgeons when communicating the different surgical options to women with breast cancer. To determine whether a decision aid on benign prostatic hypertrophy influences decision making, health outcomes, and resource use.
                Randomised controlled trial.
                33 general practices in the United Kingdom.
                112 men with benign prostatic hypertrophy. Intervention: Patients' decision aid consisting of an interactive multimedia programme with booklet and printed summary.
                Patients' and general practitioners' perceptions of who made the decision, decisional conflict scores, treatment choice and prostatectomy rate, American Urological Association symptom scale, costs, anxiety, utility, and general health status.
                Both patients and general practitioners found the decision aid acceptable. A higher proportion of patients (32% v 4%; mean difference 28%, 95% confidence interval 14% to 41%) and their general practitioners (46% v 25%; 21%, 3% to 40%) perceived that treatment decisions had been made mainly or only by patients in the intervention group compared with the control group. Patients in the intervention group had significantly lower decisional conflict scores than those in the control group at three months (2.3 v 2.6; -0.3, -0.5 to -0.1, P<0.01) and this was maintained at nine months. No differences were found between the groups for anxiety, general health status, prostatic symptoms, utility, or costs (excluding costs associated with the video disc equipment).
                The decision aid reduced decisional conflict in men with benign prostatic hypertrophy, and the patients played a more active part in decision making. Such programmes could be delivered cheaply by the internet, and there are good arguments for coordinated investment in them, particularly for conditions in which patient utilities are important. To compare the efficacy of a decision-making aid with an information document from the Society of Obstetricians and Gynaecologists of Canada (SOGC) with regard to decisions about hormone replacement therapy (HRT).
                Randomized clinical trial.
                Quebec city region.
                Menopausal Francophone women 45 to 69 years old.
                Subjects were given a manual and an audiocassette describing a six-step approach to making a decision about HRT.
                Amount of anxiety over the decision (main outcome), general knowledge of the risks and benefits of HRT, personal expectations and values concerning these risks and benefits, and women's views on HRT.
                Anxiety levels were significantly reduced in both groups, but the difference between the effectiveness of the two interventions was not significant (P = .77). Percentages of women whose general knowledge increased and of women with realistic expectations were significantly higher in the experimental group (P < .003 and P < .0001, respectively). Congruence between personal values and decisions about HRT increased significantly more in the experimental group (P < or = .003).
                The six-step approach to decision making was more helpful than the SOGC's information document in increasing subjects' knowledge of the risks and benefits of HRT, in creating more realistic expectations of HRT, and in increasing the congruence between subjects' personal values and their decisions on HRT. This study sought to evaluate a shared decision-making aid for breast cancer prevention care designed to help women make appropriate prevention decisions by presenting information about risk in context. The decision aid was implemented in a high-risk breast cancer prevention program and pilot-tested in a randomized clinical trial comparing standard consultations to use of the decision aid. Physicians completed training with the decision aid prior to enrollment. Thirty participants enrolled (15 per group) and completed measures of clinical feasibility and effectiveness prior to, immediately after, and at 9 months after their consultations. The decision aid was feasible to use during the consultations as measured by consultation duration, user satisfaction, patient knowledge, and decisional conflict. The mean consultation duration was not significantly different between groups (24 minutes for intervention group versus 21 minutes for control group, p = 0.42). The majority found the decision aid acceptable and useful and would recommend it to others. Both groups showed an improvement in breast cancer prevention knowledge postvisit, which was significant in the intervention group (p = 0.01) but not the control group (p = 0.13). However, the knowledge scores returned to baseline at follow-up in both groups. Decision preference for patients who chose chemoprevention post consultations remained constant at follow-up for the intervention group, but not for the control group. The decision framework provides access to key information during consultations and facilitates the integration of emerging biomarkers in this setting. Initial results suggest that the decision aid is feasible for use in the consultation room. The tendency for the decision choices and knowledge scores to return to baseline at follow-up suggests the need for initial and ongoing prevention decision support. To study the effect of an educational videotape about poliovirus vaccines and choices of schedules for parents/guardians of children starting the polio vaccination series.
                Prospective, randomized trial comparing two educational interventions.
                Five pediatric offices (two university-based, two health maintenance organization staff models, and one private practice) and a local health department immunization clinic in the greater Lansing, MI, area.
                A total of 287 parents/guardians of 2- to 3-month-olds presenting for well-child care and due for the first set of immunizations including poliovirus vaccine.
                Parents/guardians were randomized to read the vaccine information statement (VIS) alone or to read the VIS and view a 15-minute videotape about polio vaccination and choices of schedules produced by Michigan State University. The intervention groups were similar by race/ethnicity, education, and relationship to the child.
                Change in knowledge about the risk of poliomyelitis in the United States, transmission of poliomyelitis, characteristics of the two poliovirus vaccines, and choices of polio vaccination schedules; and parent opinion on effectiveness of the interventions, as measured by pre- and postintervention questionnaires.
                Both interventions resulted in increased test scores of knowledge. However, videotape viewers scored significantly higher on their posttest compared with parents/guardians assigned to VIS only. This significant increase was noted across all practice types, two of three major racial/ethnic groups, and educational levels. (The increase for Hispanic parents/guardians approached significance). Reading the VIS did not improve posttest scores for videotape viewers. Reading the VIS did improve posttest scores for those assigned to VIS only, but these scores still were not as high as for videotape viewers who did not read the VIS.
                This study demonstrated that a complicated discussion of risks/benefits of two vaccines and their schedules of administration could be communicated effectively via a videotaped presentation. In addition, the videotape was more effective than VIS alone in increasing short-term knowledge, regardless of practice type, race/ethnicity, or educational level. As immunization schedules increase in complexity and parents are asked to make more choices, videotaped information may be a better method to achieve the goal of truly informed consent. To evaluate the effects of an evidence-based patient decision aid (DA) on multiple sclerosis (MS) immunotherapy.
                Two hundred and ninety-seven MS patients who were considering or reconsidering immunotherapy participated in a randomized community-based controlled trial in Germany. An intervention group (IG) received the DA and a control group (CG) received standard information. Primary outcome measure was the match between the patient's preferred and actual roles during consultation with the physician. Secondary end-point was treatment choice. The course of the decision-making process and patients; evaluation of the decision were also evaluated. Data were collected at baseline, after receiving the information, after consultation with the physician and 6 months after baseline.
                The percentage of preference matches did not differ between groups (IG 49%, CG 51%, P = 0.71). There were no differences in immunotherapy choices between groups. IG patients temporarily became more critical of immunotherapy and rated the information as significantly more helpful.
                Although the intervention led to intensified processing of the information it affected neither the roles adopted in physician-patient encounters nor the immunotherapy choices made. Providing patients with balanced information may not be sufficient to alter the decision-making process. Despite the burden of colorectal cancer and improved health care outcomes with early detection and treatment, screening rates among eligible adults are low. We previously developed through a series of studies an interactive electronic tool, Colorectal Web, to promote colorectal cancer screening.
                From May 2002 to December 2003, we conducted a randomized controlled trial of Colorectal Web compared to a standard Web site on colorectal cancer screening in urban, suburban, and rural communities in Michigan with high colorectal cancer burden. Study participants were age 50 years and older, with no previous colorectal cancer screening. Major outcome was screened for colorectal cancer by 24 weeks post-intervention.
                174 eligible adults were randomized and participated. Immediately post-intervention, Colorectal Web participants were significantly more likely to have a preferred colorectal cancer screening method, but this difference did not persist at subsequent follow-up. Eighty-nine participants had been screened for colorectal cancer by 24 weeks post-intervention. The probability of being screened for the Colorectal Web intervention study arm compared to the control is OR=3.23 (2.73-3.50 95% Confidence Interval).
                Colorectal Web is more effective than a standard colorectal cancer Web site at prompting previously unscreened individuals to choose a preferred colorectal cancer screening test and to be screened for colorectal cancer. Because of the many uncertainties surrounding screening for prostate cancer, authorities recommend that patients be involved in the screening decision.
                To determine the impact of informed consent on patient interest in undergoing prostate-specific antigen (PSA) screening.
                Men 50 years or older with no prior PSA testing and no history of prostate cancer presenting to 1 of 4 university-affiliated primary care practices were eligible for enrollment. Patients were randomized to receive either a scripted informational intervention simulating an informed consent presentation (intervention group, n = 103) or a single sentence about the PSA (control group, n = 102). The main outcome measure was patient interest in undergoing PSA screening measured on a 5-point Likert scale.
                Patients who received the informational intervention were significantly less interested in undergoing PSA screening than controls (mean difference in interest, 0.8 on 5-point scale, P < .001). Informed patients were much less likely to indicate high interest in screening (odds ratio, 0.34; 95% confidence interval, 0.19-0.60; P < .001). In a multivariate model, family history of prostate cancer was associated with increased interest and advancing age with decreased interest in PSA screening, but the informational intervention remained the strongest predictor of interest.
                Among primary care patients of predominantly lower socioeconomic status, those who received informed consent were significantly less interested in PSA screening than those who did not. For physicians who offer the PSA as a screening test, this finding highlights the importance of apprising patients of the associated benefits, burdens, and uncertainties and allowing them to participate in the screening decision. The purpose of this study was to develop and test a decision support intervention (DSI) to assist women to make and act on informed decisions that are consistent with their values in the area of menopause and hormone replacement therapy (HRT). Mode and intensity of intervention were tested in midlife women (N = 248), randomly assigned to one of three intervention formats: written information only, guided discussion, or personalized decision exercise. Data were collected over 12 months. Knowledge, decisional conflict, satisfaction with health care provider, and self-efficacy improved following intervention and were maintained for 12 months for all groups. Women's adherence to their own plans over 12 months was 59% (exercise), 76% (calcium intake), and 89% (HRT). Carefully written information is effective in promoting knowledge, adherence, and satisfaction among well-educated, interested women. It was concluded that women can understand complex information, including tradeoffs regarding treatment options. Women will adhere to their own plans, suggesting that consumer rather than provider plans may be the more appropriate gold standard for measuring adherence. Computerized decision aids have the potential to increase patient involvement in the decision-making process. However, most published evidence concerning the effectiveness of decision aids is from secondary care.
                To evaluate whether the addition of a computerized decision aid to written information improves decision making in women consulting their general practitioner with menorrhagia compared with written information alone.
                of study. Randomized controlled trial.
                Nineteen general practices in the North of England.
                One hundred forty-nine women presenting with menorrhagia were randomized to receive written information and access to a computerized decision aid or written information alone. Outcomes were assessed using postal questionnaires. These were scores on the Decisional Conflict Scale and State-Trait Anxiety Inventory anxiety scale at 2 weeks and the Menorrhagia Specific Utility quality-of-life scale, knowledge about menorrhagia, and anxiety and process measures at 6 months.
                Two weeks after the intervention, there was significantly less decisional conflict in the intervention group (adjusted difference = -16.6; 95% confidence interval [CI] = -21.5 to -11.7; P < 0.001). At 6 months, the intervention group showed better knowledge about menorrhagia (adjusted difference = 9.3 ; 95% CI = 1.9 to 16.6; P = 0.014) and menorrhagia quality of life (adjusted difference = 10.9; 95% CI = 0.9 to 21.0; P = 0.033). There was no difference in anxiety scores at either 2 weeks or 6 months.
                A computerized decision aid, used outside of the primary care consultation, is effective in increasing patient involvement in decision making in primary care. Efforts to educate men about the controversy surrounding prostate cancer screening are well intended but rarely evaluated rigorously. We evaluated an evidence-based (EB) booklet for men designed to promote informed decision-making. We also determined whether men's preference for involvement in decision-making ("passive", "collaborative" or "active") modified its impact.
                Men aged 40-70 years were recruited from the practices of 13 local general practitioners (GPs) in Sydney, Australia. They completed a self-administered questionnaire before seeing their GP, who, according to pre-randomised codes, distributed either our EB booklet or conventional information. Post-test questionnaires were mailed to men three days later. Of the 248 eligible men recruited, 214 (86% response rate) returned post-test questionnaires. Knowledge of evidence and of risk of developing and dying from prostate cancer, attitudes, interest in screening for prostate-specific antigen (PSA), worry and decisional conflict were the main outcome measures.
                Compared with those receiving conventional information, men receiving the EB booklet had significantly improved knowledge (50% of items correct, 95% CI 46-53%; vs 45% correct, 95% CI 42-48%) (p = 0.048) and lower levels of decisional conflict (mean 21.6, 95% CI 20.7-22.5; vs mean 24.3, 95% CI 23.4-25.2) (p < 0.001). Interest in PSA screening was significantly reduced in both groups at post-test (p < 0.001). Men preferring a "passive" approach to decision-making gained as much from our EB booklet as those with "active" or "collaborative" preferences.
                Our findings show the benefits of providing evidence-based information to men about PSA screening. Our EB booklet facilitated informed choice, even among "passive" decision-makers. Randomised evaluations of resources to facilitate informed decisions about prostate cancer screening are rarely conducted. In this study, 421 men recruited from the community were randomly allocated to receive a leaflet (n = 140) or one of two resources meeting criteria for a decision-aid: a video (n = 141) or an evidence-based booklet, developed by the authors (n = 140). Men in all three groups demonstrated significant increases in knowledge scores from pre to post-test. Scores were significantly higher at post-test amongst those who had received our evidence-based booklet compared with men who received the leaflet or video (P < 0.001). Scores were significantly modified by men's preferences for decisional control (P = 0.002). Decisional conflict was significantly lower amongst men receiving the evidence-based booklet (P = 0.038). Men receiving the evidence-based booklet also were less likely to accept a recommendation by a GP to undergo prostate-specific-antigen (PSA) screening (P = 0.003). Men require detailed information about the pros and cons of PSA screening in order to make an informed decision. Resources are not equivalent in achieving these outcomes. To conduct a pilot test of a decision aid designed to help patients choose among currently recommended colorectal cancer screening programs.
                Randomized controlled trial comparing a patient decision aid based on multicriteria decision-making theory with a simple educational intervention.
                96 patients at average risk for colorectal cancer seen in an Internal Medicine practice in Rochester, New York.
                The two primary outcome measures were patient decision process and the decision outcome. Patient decision process was assessed using the decisional conflict scale. Decision outcome was defined as the proportion of colorectal cancer screening plans carried out.
                After controlling for the effects of the physicians in a factorial analysis of variance, patients who used the decision aid had lower decisional conflict regarding colorectal cancer screening decisions (F ratio 6.47, P = 0.01) due to increased knowledge, better clarity of values, and higher ratings of the quality of the decisions they made. There was no difference between the groups in decision outcomes: 52% of patients in the control group and 49% in the experimental group completed planned screening tests (P = 1.0).
                In a pilot study, a multicriteria-based patient decision aid for colorectal cancer screening improved patients' decision-making processes but had no effect on the implementation of screening plans. Many women who have participated in mammography screening are now approaching 70 years of age. These women are advised to consider both the benefits and harms of continuing to be screened. Doing so may be difficult for individual women, and there are no evaluated decision support tools to assist them.
                To assess the effect of a decision aid (DA) about whether to continue or stop mammography screening for women aged 70 years, a population-based, randomized controlled trial was conducted in New South Wales, Australia. Women aged 70 years who had regularly participated in mammography screening were eligible to participate in the trial. Women received a DA providing balanced, quantitative information or standard information available from the screening program. The main outcomes were the percentage of women making an informed choice about whether to continue or stop screening and the percentage of women participating in the screening.
                Women who received the DA (the intervention group) were better informed than the control group (mean increase in knowledge score out of 10, 2.62 for the intervention group vs 0.68 for the control group; P < .001), and a significantly greater percentage made an informed choice (73.5% vs 48.8%; P < .001). The DA did not increase anxiety and slightly reduced decisional conflict. There was no difference in the percentage of women who participated in screening within 1 month.
                This DA increased knowledge and assisted women to make an informed choice. It did not alter participation in screening. The DA is an effective way to assist women to make a decision about continuing mammography screening and seems to be a feasible intervention within a population screening program. Decision aids are tools designed to help patients participate in the clinical decision-making process.
                To determine whether use of an audiobooklet (AB) decision aid explaining the results of a clinical trial affected the decision-making process of study participants.
                Randomized controlled trial conducted from May 1997 to April 1998.
                Fourteen centers that participated in the Stroke Prevention in Atrial Fibrillation (SPAF) III trial.
                A total of 287 patients from the SPAF III aspirin cohort study, in which patients with atrial fibrillation and a relatively low risk of stroke received 325 mg/d of aspirin and were followed up for a mean of 2 years.
                At the end of SPAF III, participants were randomized to be informed of the study results with usual care plus use of an AB (AB group) vs usual care alone (control group). The AB included pertinent information to help patients decide whether to continue taking aspirin or switch to warfarin.
                Patients' ability to make choices regarding antithrombotic therapy, and 6-month adherence to these decisions. Their knowledge, expectations, decisional conflict (the amount of uncertainty about the course of action to take), and satisfaction with the decision-making process were also measured.
                More patients in the AB group made a choice about antithrombotic therapy than in the control group (99% vs 94%; P = .02). Patients in the AB group were more knowledgeable and had more realistic expectations about the risk of stroke and hemorrhage (in the AB group, 53%-80% correctly estimated different risks; in the control group, 16%-28% gave correct estimates). Decisional conflict and satisfaction were similar for the 2 groups. After 6 months, a similar percentage of patients were still taking their initial choice of antithrombotic therapy (95% vs 93%; P = .44).
                For patients with atrial fibrillation who had participated in a major clinical trial, the use of an AB decision aid improved their understanding of the benefits and risks associated with different treatment options and helped them make definitive choices about which therapy to take. Further studies are necessary to evaluate the acceptability and impact of decision aids in other clinical settings. The purpose of this study was to explore the hypothesis that assisting men with prostate cancer to obtain information would enable them to assume a more active role in treatment decision making and decrease their levels of anxiety and depression. Respondents were recruited from one community urology clinic in Winnipeg, Manitoba. Sixty newly diagnosed men were randomly assigned to receive either a self-efficacy information intervention that consisted of a written information package with discussion, a list of questions they could ask their physician, and an audiotape of the medical consultation (n = 30), or a written information package alone (n = 30). Men completed measures of preferred decisional role as the pretest; anxiety and depression before the intervention, and at 6 weeks post-intervention; and assumed decisional role at 6 weeks post-intervention. Results demonstrated that men in the intervention group assumed a significantly more active role in treatment decision making, and had lower state anxiety levels at 6 weeks. Levels of depression were similar for both groups at 6 weeks. This group of older men do want to be informed and participate in medical decisions. Further efforts are required to evaluate the efficacy of such an intervention in other community urology clinics. Prostate cancer screening with serum prostate-specific antigen (PSA) and digital rectal examination (DRE) continues to increase. Our goal was to test the effect of a prostate cancer screening decision-aid on patients' knowledge, beliefs, and use of prostate cancer screening tests.
                Our study was a randomized controlled trial of a prostate cancer screening decision-aid consisting of an illustrated pamphlet as opposed to a comparison intervention. We included 257 men aged 50 to 80 years who were receiving primary care at a Department of Veterans Affairs Hospital in Milwaukee, Wisconsin. The decision-aid provided quantitative outcomes of prostate cancer screening with DRE and PSA. We subsequently evaluated prostate cancer screening knowledge, beliefs, and test use.
                The illustrated pamphlet decision-aid was effective in improving knowledge of prostate cancer screening tests: 95% of the experimental group were aware of the possibility of false-negative test results compared with 85% of the comparison group (P <.01). Ninety-one percent of the experimental group were aware of the possibility of a false-positive screening test result compared with 65% of the comparison group (P <.01). However, there was no difference in the use of prostate cancer screening between the experimental (82%) and comparison (84%) groups, (P >.05).
                When used in a primary care setting, an illustrated pamphlet decision-aid was effective in increasing knowledge of prostate cancer screening tests but did not change the use of these tests. Decision-making at menopause remains a challenge for women and their health care providers as the paradigm for hormone therapy continues to evolve. The role of decision-support for this process remains to be defined.
                A randomized controlled trial of a computer-based hormone therapy (HT) decision-aid versus a control intervention consisting of a printed pamphlet among 177 post-menopausal women receiving care in a Veterans Affairs Medical Center.
                Participants found the computer-based decision-aid easy to use and retained risk information incorporated from emerging scientific data. There was no difference between groups with respect to the primary outcomes of knowledge, satisfaction with decision, decisional conflict or HT use. A trend was reported towards decreased decisional conflict in the evidence in decision-making (p=0.07) and factors of uncertainty (p=0.06) domains among the subset of participants who were on HT at baseline and used the computer-based decision-aid.
                The computer-based decision-aid was able to effectively incorporate emerging scientific information but was no more effective than a printed pamphlet control with regard to improving decision-process outcomes.
                The incremental benefit of a complex versus simpler decision-aid for post-menopausal women remains to be established prior to widespread dissemination of interactive computer-based HT decision-aids. The recent identification of several BRCA1/BRCA2 founder mutations among Ashkenazi Jewish individuals has led to increased salience of BRCA1/BRCA2 testing for Jewish individuals. Little is known about interest in BRCA1/BRCA2 testing among Ashkenazi Jews from the general population. Furthermore, previous research has not generally evaluated the impact of education on interest in testing among individuals from the general population. The goal of the current study was to examine whether a brief educational booklet regarding BRCA1/BRCA2 testing would influence knowledge, attitudes, and interest in testing among Ashkenazi Jewish women from the general population.
                After a baseline telephone interview, participants were randomized to receive either genetic testing educational print materials (n = 195 women) or general breast cancer education control materials (n = 196 women). One month after receiving these materials, the authors reassessed knowledge, attitudes, and interest in BRCA1/BRCA2 gene testing.
                Relative to the breast cancer education control materials, the genetic testing education materials led to increased knowledge, increased perception of the risks and limitations of testing, and decreased interest in obtaining a BRCA1/BRCA2 mutation test.
                These data indicate that preliminary print education can be used to educate low-risk individuals about BRCA1/BRCA2 genetic testing. This approach may be used to educate low-risk individuals about the benefits and risks/limitations of BRCA1/BRCA2 testing, so that they can make informed decisions about whether to pursue genetic counseling.
                Copyright 2001 American Cancer Society. To evaluate the effectiveness of a decision aid for prenatal testing of fetal abnormalities compared with a pamphlet in supporting women's decision making.
                A cluster randomised controlled trial.
                Primary health care.
                Women in early pregnancy consulting a GP.
                GPs were randomised to provide women with either a decision aid or a pamphlet. The decision aid was a 24-page booklet designed using the Ottowa Decision Framework. The pamphlet was an existing resource available in the trial setting.
                Validated scales were used to measure the primary outcomes, informed choice and decisional conflict, and the secondary outcomes, anxiety, depression, attitudes to the pregnancy/fetus and acceptability of the resource. Outcomes were measured at 14 weeks of gestation from questionnaires that women completed and returned by post.
                Women in the intervention group were more likely to make an informed decision 76% (126/165) than those in the control group 65% (107/165) (adjusted OR 2.08; 95% CI 1.14-3.81). A greater proportion of women in the intervention group 88% (147/167) had a 'good' level of knowledge than those in the control group 72% (123/171) (adjusted OR 3.43; 95% CI 1.79-6.58). Mean (SD) decisional conflict scores were low in both groups, decision aid 1.71 (0.49), pamphlet 1.65 (0.55) (adjusted mean difference 0.10; 95% CI -0.02 to 0.22). There was no strong evidence of differences between the trial arms in the measures of psychological or acceptability outcomes.
                A tailored prenatal testing decision aid plays an important role in improving women's knowledge of first and second trimester screening tests and assisting them to make decisions about screening and diagnostic tests that are consistent with their values. An interactive digital education aid for breast reconstruction patients was developed because of a perceived need to provide patients with more education regarding the treatment so that they can make better informed treatment decisions. A prospective randomized study was conducted to assess its effectiveness.
                Breast cancer patients who were candidates for breast reconstruction were recruited and randomized into a control group and a study group. Both groups received routine assessment and education in the plastic surgery clinic, but the study group also watched the interactive digital education aid. Questionnaires assessing knowledge, anxiety, and satisfaction were administered (1) before the initial plastic surgery consultation, (2) immediately before surgery, and (3) 1 month after surgery.
                A total of 133 women participated, 66 in the control group and 67 in the study group. Women in both groups showed decreased anxiety, increased knowledge, and enhanced satisfaction with their decision-making ability associated with preoperative instructions about reconstructive surgery. However, the study group was significantly more satisfied than the control group with the method of receiving information and showed a less steep learning curve regarding the different techniques of breast reconstruction. They also tended to have a reduced mean level of anxiety and increased satisfaction with the treatment choice compared with the control group.
                An interactive digital education aid is a beneficial educational adjunct for patients contemplating breast reconstruction. Patients who use an interactive digital education aid demonstrate greater factual knowledge, reduced anxiety, and increased postoperative satisfaction compared with patients given preoperative instructions using standard methods alone. The benefit of an interactive digital education aid is expected to be higher in a broad-based practice setting outside of a comprehensive cancer center. Genetic testing is increasingly part of routine clinical care for women with a family history of breast cancer. Given their substantially elevated risk for breast cancer, BRCA1/BRCA2 mutation carriers must make the difficult decision whether or not to opt for risk reducing mastectomy. To help BRCA1/2 carriers make this decision, the authors developed a computer-based interactive decision aid that was tested against usual care in a randomized controlled trial.
                After the completion of genetic counseling, 214 female (aged 21-75) BRCA1/BRCA2 mutation carriers were randomized to Usual Care (UC; N = 114) or Usual Care plus Decision Aid (DA; N = 100) arms. UC participants received no additional intervention. DA participants were sent the CD-ROM DA to view at home.
                The authors measured final management decision, decisional conflict, decisional satisfaction, and receipt of risk reducing mastectomy at 1-, 6-, and 12-months postrandomization.
                Longitudinal analyses revealed that the DA was effective among carriers who were initially undecided about how to manage their breast cancer risk. Within this group, the DA led to an increased likelihood of reaching a management decision (OR = 3.09, 95% CI = 1.62, 5.90; p < .001), decreased decisional conflict (B = -.46, z = -3.1, p <002), and increased satisfaction (B = .27, z = 3.1, p = .002) compared to UC. Among carriers who had already made a management decision by the time of randomization, the DA had no benefit relative to UC.
                These results demonstrate that BRCA1/BRCA2 mutation carriers who are having difficulty making a breast cancer risk management decision can benefit from adjunct decision support.
                (c) 2009 APA, all rights reserved. To determine the effect of the Ischemic Heart Disease Shared Decision-Making Program (IHD SDP) an interactive videodisc designed to assist patients in the decision-making process involving treatment choices for ischemic heart disease, on patient decision-making.
                Randomized, controlled trial.
                The Toronto Hospital, University of Toronto, Toronto, Ontario, Canada.
                Two hundred forty ambulatory patients with
                The primary outcome was patient satisfaction with the decision-making process. This was measured using the 12-item Decision-Making Process Questionnaire that was developed and validated in a randomized trial of the benign prostatic hyperplasia SDP. Secondary outcomes included patient knowledge (measured using 20 questions about knowledge deemed necessary for an informed treatment decision), treatment decision, patient-angiographer agreement on decision, and general health scores. Outcomes were measured at the time of treatment decision and/or at 6 months follow-up. Shared decision-making program scores were similar for the intervention and control group (71% and 70%, respectively; 95% confidence interval [CI] for 1% difference, -3% to 7%). The intervention group had higher knowledge scores (75% vs 62%; 95% CI for 13% difference, 8% to 18%). The intervention group chose to pursue revascularization less often (58% vs 75% for the controls; 95% CI for 17% difference, 4% to 31%). At 6 months, 52% of the intervention group and 66% of the controls had undergone revascularization (95% CI for 14% difference, 0% to 28%). General health and angina scores were not different between the groups at 6 months. Exposure to the IHD SDP resulted in more patient-angiographer disagreement about treatment decisions.
                There was no significant difference in satisfaction with decision-making process scores between the IHD SDP and usual practice groups. The IHD SDP patients were more knowledgeable, underwent less revascularization (interventional therapies), and demonstrated increased patient decision-making autonomy without apparent impact on quality of life. Patient involvement in the choice of antihyperglycemic agents could improve adherence and optimize glycemic control in patients with type 2 diabetes mellitus.
                We conducted a pilot, cluster randomized trial of Diabetes Medication Choice, a decision aid that describes 5 antihyperglycemic drugs, their treatment burden (adverse effects, administration, and self-monitoring demands), and impact on hemoglobin A(1c) (HbA(1c)) levels. Twenty-one clinicians were randomized to use the decision aid during the clinical encounter and 19 to dispense usual care and an educational pamphlet. We used surveys and video analysis to assess postvisit decisional outcomes, and medical and pharmacy records to assess 6-month medication adherence and HbA(1c) levels.
                Compared with usual care patients (n = 37), patients receiving the decision aid (n = 48) found the tool more helpful (clustered-adjusted mean difference [AMD] in a 7-point scale, 0.38; 95% confidence interval [CI], 0.04-0.72); had improved knowledge (AMD, 1.10 of 10 questions; 95% CI, 0.11-2.09); and had more involvement in making decisions about diabetes medications (AMD, 21.8 of 100; 95% CI, 13.0-30.5). At 6-month follow-up, both groups had nearly perfect medication use (median, 100% of days covered), with better adherence (AMD, 9% more days covered; 95% CI, 4%-14%) and persistence (AMD, 12 more days covered; 95% CI, 3-21 days) in the usual care group, and no significant impact on HbA(1c) levels (AMD, 0.01; 95% CI, -0.49 to 0.50).
                An innovative decision aid effectively involved patients with type 2 diabetes mellitus in decisions about their medications but did not improve adherence or HbA(1c) levels. Trial Registration clinicaltrials.gov Identifier: NCT00388050. This study was a randomized trial to test the impact of an informed decision-making intervention on prostate cancer screening use.
                The study population included 242 African-American men from three primary care practices who were 40-69 years of age and had no history of prostate cancer. Participants completed a baseline survey questionnaire and were randomly assigned either to a Standard Intervention (SI) group (N=121) or an Enhanced Intervention (EI) group (N=121). An informational booklet was mailed to both groups. EI group men were also offered a screening decision education session. Two outcomes were considered: (1) complete screening (i.e., having a digital rectal exam (DRE) and prostate specific antigen (PSA) testing), and (2) complete or partial screening (i.e., having a PSA test with or without DRE). An endpoint chart audit was performed six months after initial intervention contact. The data were analyzed via exact logistic regression.
                Overall, screening use was low among study participants. EI group men had a screening frequency two times greater than that of SI group men, but the difference was not statistically significant: 8% vs. 4 % (OR = 1.94) fo rcomplete screening, and 19% vs. 10% (OR = 2.08) for complete or partial screening. Multivariable analyses showed that being in the EI group and primary care practice were significant predictors of complete or partial screening (OR = 3.9 and OR = 5.64, respectively).
                Prostate cancer screening use may be influenced by exposure to decision education and the influence of screening-related primary care practice factors. OBJECTIVE: To assess the impact of providing an educational videotape, 'Treatment Choices for Ischaemic Heart Disease: a Shared Decision-Making Program Videotape,' to patients referred for coronary angiography compared with standard patient-physician decision making (usual care). STUDY DESIGN: Randomized controlled clinical trial. SETTING: University Hospital and Veterans Affairs Hospital. PATIENTS: A consecutive sample of 217 patients referred for coronary angiography were randomized to receive 'usual care' or to receive the videotape in addition to standard patient physician decision making (videotape): 109 completed the study (50% completion rate). MAIN OUTCOME MEASURES: Knowledge of coronary artery disease, satisfaction, self-reported physical and mental health functioning, and the proportion of patients who were referred for coronary revascularization. RESULTS: Compared with patients who received 'usual care,' those who received the videotape were more knowledgeable (mean score 83 vs. 58%; P < 0.0001) but less satisfied with their treatment (79 vs. 88%; P = 0.038). There were no significant differences between the videotape and 'usual care' groups with respect to satisfaction with the decision making process (mean score 73 vs. 77%; P = 0.37), satisfaction with the decision made (mean score 73 vs. 78%; P = 0.28), physical functioning (38 vs. 38%; P = 0.76), mental health functioning (49 vs. 49%; P = 0.94), or in referral for coronary revascularization (OR 0.60; 95% CI 0.22-1.65; P = 0.33). CONCLUSION: Although the educational videotape increased patients' knowledge level, it was associated with a decrease in their level of satisfaction with treatment. Before there is wide-spread dissemination of this technology, advocates should demonstrate its effectiveness in everyday practice. Prenatal diagnosis (PND) is offered routinely as part of pregnancy care to a large number of women at increased risk of fetal anomalies. Despite an extraordinary growth in the use of PND and significant resource allocation, few studies have examined outcomes of PND counseling, and virtually no research has evaluated the relative efficacy of various approaches to genetic counseling. This study was a randomized trial that compared which counseling methods - individual, group, and use of a decision aid - are effective in PND counseling for women of advanced maternal age (>/=35 years) and their partners. Three hundred and fifty-two women and 225 partners completed pre- and post-intervention questionnaires assessing changes in knowledge, decisional conflict, state anxiety, satisfaction, use of PND, and pregnancy outcomes. All participants showed a significant increase in knowledge and a decrease in decisional conflict post intervention. Those in the group intervention showed a significantly greater increase in knowledge than those in the individual counseling intervention. While high levels of satisfaction were reported by all, those in individual counseling were significantly more satisfied than those receiving group counseling or the decision aid. This study has shown unique benefits with each type of intervention such that women and their partners preferred individual genetic counseling, while they learned best in group-counseling sessions, and experienced the least decisional conflict regarding genetic testing with a decision aid. 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.
                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.
                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
                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.