Randomized controlled trial of a patient decision aid for colorectal cancer screening.

PURPOSE: To conduct a pilot test of a decision aid designed to help patients choose among currently recommended colorectal cancer screening programs. METHODS: Randomized controlled trial comparing a patient decision aid based on multicriteria decision-making theory with a simple educational intervention. PATIENT POPULATION: 96 patients at average risk for colorectal cancer seen in an Internal Medicine practice in Rochester, New York. OUTCOME MEASURES: 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. RESULTS: 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). CONCLUSIONS: 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.     

A cross-cultural consumer-based decision aid for screening mammography

BACKGROUND: "Women should have mammograms" is the usual perspective of educational interventions about screening. The perspective that "women should be informed" about potential risks and benefits so they can make value- and evidence-integrated personal decisions has recently been advocated. However, this perspective has not previously been operationalized. We developed an evidence-based cross-cultural mammography decision aid (MDA), for European American and Mexican American women who are 50-70 years old, at average risk of breast cancer, of varying educational levels, and English- or Spanish-speaking. METHODS: MDA development included: (1) content development by a multidisciplinary team and lay women and (2) testing for validity and reliability. Four parts include: (1) introduction; (2) information about logistics (cost, time, discomfort) and risks (sequelae of false-positive or negative results; (3) probability of developing breast cancer; and (4) benefit of mammography regarding breast cancer outcomes (e.g., death and recurrence). We assessed reliability (stability of decisions with the same information) after 1-2 weeks. We assessed validity (comprehension of information) quantitatively (probabilities were changed to see whether preferences changed predictably) and qualitatively (focus groups, standardized probes for comprehension). Subjects were a convenience sample of 49 European American (50-81 years old) and 54 Mexican American (49-89 years old) women from administrative staff at a medical school, the waiting room of an indigent primary care clinic, and a community center. RESULTS: Reliability was 100%. In quantitative validity testing, 22 of 28 women (89%) changed preference as predicted with changed probabilities. Comprehension was confirmed qualitatively in all phases of testing with both Spanish and English versions. CONCLUSION: The decision aid is valid and reliable in English and Spanish for southwestern Mexican American and European American women at average risk of breast cancer, including those of low educational levels.     

Provider perspectives on the utility of a colorectal cancer screening decision aid for facilitating shared decision making

Background Decision aids for colorectal cancer (CRC) screening have been shown to enable patients to identify a preferred screening option, but the extent to which such tools facilitate shared decision making (SDM) from the perspective of the provider is less well established. Objective Our goal was to elicit provider feedback regarding the impact of a CRC screening decision aid on SDM in the primary care setting. Methods Cross‐sectional survey. Participants Primary care providers participating in a clinical trial evaluating the impact of a novel CRC screening decision aid on SDM and adherence. Main outcomes Perceptions of the impact of the tool on decision‐making and implementation issues. Results Twenty‐nine of 42 (71%) eligible providers responded, including 27 internists and two nurse practitioners. The majority (>60%) felt that use of the tool complimented their usual approach, increased patient knowledge, helped patients identify a preferred screening option, improved the quality of decision making, saved time and increased patients’ desire to get screened. Respondents were more neutral is their assessment of whether the tool improved the overall quality of the patient visit or patient satisfaction. Fewer than 50% felt that the tool would be easy to implement into their practices or that it would be widely used by their colleagues. Conclusion Decision aids for CRC screening can improve the quality and efficiency of SDM from the provider perspective but future use is likely to depend on the extent to which barriers to implementation can be addressed.     

Trials of decision aids for prostate cancer screening: a systematic review

BACKGROUND: Patient decision aids are used to promote informed decision making. This review examines the methods and findings of studies that have evaluated the impact of prostate cancer screening decision aids on patient outcomes. METHODS: MEDLINE, the Cochrane Registry, reference lists, and abstracts from professional meetings were searched through December 2006. Search terms included prostate cancer screening and decision making. Studies were included if a patient education intervention for prostate cancer screening had been evaluated against a control condition. RESULTS: Eighteen eligible trials, involving 6221 participants, were identified. Sixteen studies enrolled primary care patients, while the remaining two studies were community-based. All the prostate cancer screening decision aids were in English, with varied reading levels. Consistent with previous reviews, the patient decision aids improved patient knowledge and made patients more confident about their decisions. The aids appeared to decrease interest in prostate-specific antigen testing and screening behavior among patients seeking routine care (relative risk [RR]=0.88, 95% confidence interval [CI]=0.81-0.97, p=0.008); the aids had no impact on the screening behavior of patients seeking screening services. Additionally, patients who received patient decision aids were more likely to prefer watchful waiting as a treatment option if they were found to have prostate cancer than were controls (RR=1.53, 95% CI=1.31-1.77, p<0.001). CONCLUSIONS: Prostate cancer screening decision aids enhance patient knowledge, decrease decisional conflict, and promote greater involvement in decision making. The absence of outcome measures that reflect all elements of informed decision making continues to limit the field.     

A randomized controlled trial of shared decision making for prostate cancer screening.

OBJECTIVE: To evaluate a patient-educational approach to shared decision making for prostate cancer screening. DESIGN: Randomized controlled trial with preoffice visit assessment and 2-week follow-up. SETTING: University-based family practice center. PATIENTS: 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. INTERVENTION: Twenty-minute educational videotape on advantages and disadvantages of prostate-specific antigen (PSA) screening for prostate cancer. MAIN OUTCOME MEASURES: A measure of patients' core knowledge of prostate cancer developed for this study, reported preferences for PSA testing, and ratings of the videotape. RESULTS: 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. CONCLUSIONS: 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.     

Feasibility of a patient decision aid about lung cancer screening with low-dose computed tomography

ObjectiveNew clinical guidelines endorse the use of low-dose computed tomography (LDCT) for lung cancer screening among selected heavy smokers while recommending patients be counseled about the potential benefits and harms. We developed and field tested a brief, video-based patient decision aid about lung cancer screening.MethodsSmokers in a cancer center tobacco treatment program aged 45 to 75 years viewed the video online between November 2011 and September 2012. Acceptability, knowledge, and clarity of values related to the decision were assessed.ResultsFifty-two patients completed the study (mean age = 58.5 years; mean duration smoking = 34.8 years). Acceptability of the aid was high. Most patients (78.8%) indicated greater interest in screening after viewing the aid. Knowledge about lung cancer screening increased significantly as a result of viewing the aid (25.5% of questions answered correctly before the aid, and 74.8% after; P < .01) although understanding of screening eligibility remained poor. Patients reported being clear about which benefits and harms of screening mattered most to them (94.1% and 86.5%, respectively).ConclusionsPatients have high information needs related to lung cancer screening. A video-based decision aid may be helpful in promoting informed decision-making, but its impact on lung cancer screening decisions needs to be explored.     

The effect of an illustrated pamphlet decision-aid on the use of prostate cancer screening tests

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.     

Patient-focussed decision-making in early-stage prostate cancer: insights from a cognitively based decision aid

PURPOSE: To study the cognitive processes of early-stage prostate cancer patients as they determined which treatment they preferred, using our cognitively based decision aid. METHOD: The aid was a one-to-one interview that included the structured presentation of information, listing exercises in which the patient identified attributes important to his decision, and trade-off exercises to help him weigh and integrate those attributes together. At various points of the interview, patients identified the attributes they felt were important to their decision, rated their treatment options and completed standardized assessments relating to their decision. In addition, patients participated in a follow-up interview at the time they made their actual treatment decision and again 3 months later. RESULTS: Sixty of 70 (86%) of the invited patients participated in the study. Participating patients identified a median of four important attributes (range 1-10); 36 different attributes were identified at some point in the interview by the group. During the interview, 78% of patients changed which attributes they considered important, and 72% changed their treatment ratings. Stability of treatment choice after the interview and lack of regret after the decision were each positively associated with increasing differentiation between treatment options over time. CONCLUSIONS: The decision process appears to be dynamic for the patients with great variability across patients in what is important to the decision. Increasing stability of choice and lack of regret appear to be related positively to increasing difference over time in how attractive the preferred option is over its closest competitor, rather than to the size of the difference at any one point in time.     

Toward interactive, Internet-based decision aid for vaccination decisions: better information alone is not enough

Vaccination decisions, as in choosing whether or not to immunize one's small child against specific diseases, are both psychologically and computationally complex. The psychological complexities have been extensively studied, often in the context of shaping convincing or persuasive messages that will encourage parents to vaccinate their children. The computational complexity of the decision has been less noted. However, even if the parent has access to neutral, accurate, credible information on vaccination risks and benefits, he or she can easily be overwhelmed by the task of combining this information into a well-reasoned decision. We argue here that the Internet, in addition to its potential as an information source, could provide useful assistance to parents in integrating factual information with their own values and preferences - that is, in providing real decision aid as well as information aid. We sketch one approach for accomplishing this by means of a hierarchy of interactive decision aids ranging from simple advice to full-scale decision analysis.     

Developing and testing a brief clinic‐based lung cancer screening decision aid for primary care settings

Background

Cancer screening‐related decisions require patients to evaluate complex medical information in short time frames, often with primary care providers (PCPs) they do not know. PCPs play an essential role in facilitating comprehensive shared decision making (SDM).

Objective

To develop and test a decision aid (DA) and SDM strategy for PCPs and high‐risk patients.

Design

The DA was tested with 20 dyads. Each dyad consisted of one PCP and one patient eligible for screening. A prospective, one‐group, mixed‐method study design measured fidelity, patient values, screening intention, acceptability and satisfaction.

Results

Four PCPs and 20 patients were recruited from an urban academic medical centre. Most patients were female (n = 14, 70%), most had completed high school (n = 15, 75%), and their average age was 65 years old. Half were African American. Patients and PCPs rated the DA as helpful, easy to read and use and acceptable in terms of time frame (observed t = 11.6 minutes, SD 2.7). Most patients (n = 16, 80%) indicated their intent to be screened. PCPs recommended screening for most patients (n = 17, 85%).

Conclusions

Evidence supports the value of lung cancer screening with LDCT for select high‐risk patients. Guidelines endorse engaging patients and their PCPs in SDM discussions. Our findings suggest that using a brief, interactive, plain‐language, culturally sensitive, theory‐based DA and SDM strategy is feasible, acceptable and may be essential to effectively translate and sustain the adoption of LDCT screening recommendations into the clinic setting.     

Preference-based electronic decision aid to promote colorectal cancer screening: results of a randomized controlled trial

OBJECTIVE: 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. METHOD: 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. RESULTS: 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). CONCLUSION: 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.     

Optimal healthcare decision making under multiple mathematical models: application in prostate cancer screening

Important decisions related to human health, such as screening strategies for cancer, need to be made without a satisfactory understanding of the underlying biological and other processes. Rather, they are often informed by mathematical models that approximate reality. Often multiple models have been made to study the same phenomenon, which may lead to conflicting decisions. It is natural to seek a decision making process that identifies decisions that all models find to be effective, and we propose such a framework in this work. We apply the framework in prostate cancer screening to identify prostate-specific antigen (PSA)-based strategies that perform well under all considered models. We use heuristic search to identify strategies that trade off between optimizing the average across all models’ assessments and being “conservative” by optimizing the most pessimistic model assessment. We identified three recently published mathematical models that can estimate quality-adjusted life expectancy (QALE) of PSA-based screening strategies and identified 64 strategies that trade off between maximizing the average and the most pessimistic model assessments. All prescribe PSA thresholds that increase with age, and 57 involve biennial screening. Strategies with higher assessments with the pessimistic model start screening later, stop screening earlier, and use higher PSA thresholds at earlier ages. The 64 strategies outperform 22 previously published expert-generated strategies. The 41 most “conservative” ones remained better than no screening with all models in extensive sensitivity analyses. We augment current comparative modeling approaches by identifying strategies that perform well under all models, for various degrees of decision makers’ conservativeness.     

A decision aid for men with early stage prostate cancer: theoretical basis and a test by surrogate patients

Background We developed a decision aid for patients with curable prostate cancer based on Svenson’s DiffCon Theory of Decision Making. This study was designed to determine if surrogate patients using the aid could understand the information presented, complete all tasks, show evidence of differentiation, and arrive at a preferred treatment choice. Methods Men, at least 50 years old and never diagnosed with prostate cancer, were recruited through local advertisements. Participants were asked to imagine that they were a case‐scenario patient. Then they completed the decision aid interview, which included three components: (i) information presentation, with comprehension questions, (ii) exercises to help identify attributes important to the decision, and (iii) value‐clarification exercises. Results Sixty‐nine men volunteered. They had a mean age of 61.2 (range 50–83) years, 37% had no formal education beyond high school, and 87% were living with a partner. All participants completed all aspects of the interview. They answered an average of 10 comprehension questions each, with a mean of 94.7% correct without a prompt. Each attribute in the information presented was identified by at least one participant as important to his decision. Participants identified a median of five attributes as important (ranges 1–14) at each of three points during the interview; 75% changed at least one important attribute during the interview. Forty‐nine per cent of participants also identified attributes as important that were not included in the presented information. Participants showed a wide range of values in each of seven trade‐off exercises. Eighty‐eight per cent of participants showed evidence of differentiation; 75% had a clear treatment preference by the end of the interview. Conclusions Our decision aid appears to meet its goals for surrogate patients and illustrates the strengths of the DiffCon theory. The ability of the aid to accommodate wide variability, both in information needs and in important attributes, is a particular strength of the decision aid. It now requires testing in patients with prostate cancer.