Head to head randomized trial of two decision aids for prostate cancer.
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ABSTRACT: Background
While many studies have tested the impact of a decision aid (DA) compared to not receiving any DA, far fewer have tested how different types of DAs affect key outcomes such as treatment choice, patient-provider communication, or decision process/satisfaction. This study tested the impact of a complex medical oriented DA compared to a more simplistic decision aid designed to encourage shared decision making in men with clinically localized prostate cancer.Methods
1028 men at 4 VA hospitals were recruited after a scheduled prostate biopsy. Participants completed baseline measures and were randomized to receive either a simple or complex DA. Participants were men with clinically localized cancer (N = 285) by biopsy and who completed a baseline survey. Survey measures: baseline (biopsy); immediately prior to seeing the physician for biopsy results (pre- encounter); one week following the physician visit (post-encounter). Outcome measures included treatment preference and treatment received, knowledge, preference for shared decision making, decision making process, and patients' use and satisfaction with the DA.Results
Participants who received the simple DA had greater interest in shared decision making after reading the DA (p = 0.03), found the DA more helpful (p's < 0.01) and were more likely to be considering watchful waiting (p = 0.03) compared to those receiving the complex DA at Time 2. While these differences were present before patients saw their urologists, there was no difference between groups in the treatment patients received.Conclusions
The simple DA led to increased desire for shared decision making and for less aggressive treatment. However, these differences disappeared following the physician visit, which appeared to change patients' treatment preferences. Trial registration This trial was pre-registered prior to recruitment of participants.
SUBMITTER: Fagerlin A
PROVIDER: S-EPMC8117645 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The conflicting recommendations for prostate cancer (PCa) screening and the mixed messages communicated to the public about screening effectiveness make it critical to assist men in making informed decisions.To assess the effectiveness of 2 decision aids in helping men make informed PCa screening decisions.A racially diverse group of male outpatients aged 45 to 70 years from 3 sites were interviewed by telephone at baseline, 1 month, and 13 months, from 2007 through 2011. We conducted intention-to-treat univariate analyses and multivariable linear and logistic regression analyses, adjusting for baseline outcome measures.Random assignment to print-based decision aid (n?=?628), web-based interactive decision aid (n?=?625), or usual care (UC) (n?=?626).Prostate cancer knowledge, decisional conflict, decisional satisfaction, and whether participants underwent PCa screening.Of 4794 eligible men approached, 1893 were randomized. At each follow-up assessment, univariate and multivariable analyses indicated that both decision aids resulted in significantly improved PCa knowledge and reduced decisional conflict compared with UC (all P <.001). At 1 month, the standardized mean difference (Cohen’s d) in knowledge for the web group vs UC was 0.74, and in the print group vs UC, 0.73. Decisional conflict was significantly lower for web vs UC (d?=?0.33) and print vs UC (d?=?0.36). At 13 months, these differences were smaller but remained significant. At 1 month, high satisfaction was reported by significantly more print (60.4%) than web participants (52.2%; P?=?.009) and significantly more web (P?=?.001) and print (P?=?.03) than UC participants (45.5%). At 13 months, differences in the proportion reporting high satisfaction among print (55.7%) compared with UC (49.8%; P?=?.06) and web participants (50.4%; P?=?.10) were not significant. Screening rates at 13 months did not differ significantly among groups.Both decision aids improved participants’ informed decision making about PCa screening up to 13 months later but did not affect actual screening rates. Dissemination of these decision aids may be a valuable public health tool.clinicaltrials.gov Identifier: NCT00196807.
| S-EPMC3992617 | biostudies-literature
Project description:BACKGROUND:Australian clinicians are advised to 'offer evidence-based decisional support to men considering whether or not to have a PSA test'. This randomised trial compared the performance and acceptability of two new decision aids (DAs) to aid men in making informed choices about PSA screening. METHODS:~3000 Australian men 45-60 years with varying educational attainment were recruited via an online panel and randomised to view one of two online decision aids (one full length, one abbreviated) and completed a questionnaire. The primary outcome was informed choice about PSA screening. FINDINGS:Significantly more men in the long DA group (38%) made an informed choice than men who received the shorter DA (33%) (95% CI 1.1% to 8.2%; p = 0.008). On knowledge, the long DA group scored, on average, 0.45 points higher than the short DA group (95% CI 0.14 to 0.76; p = 0.004) and 5% more of the participants achieved an adequate knowledge score (95% CI 1.9% to 8.8%; p = 0.002). Men allocated the long DA were less likely to intend to have a PSA test in the future (53%) than men in the short DA group (59%). Both DAs rated highly on acceptability. CONCLUSIONS:Both DAs were useful and acceptable to men regardless of education level and both supported informed decision making. The long version resulted in higher knowledge, and a higher proportion of men able to make an informed choice, but the differences were small. Long DAs may be useful for men whose informational needs are not satisfied by a short DA.
| S-EPMC6961909 | biostudies-literature
Project description:PURPOSE:Shared decision making is recommended in regard to prostate cancer screening. Decision aids may facilitate this process but the impact of decision aids on screening preferences is poorly understood. MATERIALS AND METHODS:In an online survey we randomized a national sample of adults to the online decision aids of 1 of 6 professional societies. We compared survey responses before and after decision aid exposure. The primary outcome was the change in participant likelihood of undergoing or recommending prostate cancer screening on a scale of 1-unlikely to 100-extremely likely. Secondary outcomes included change in participant comfort with prostate cancer screening based on the average of 6, 5-point Likert-scale questions. RESULTS:Median age was 53 years in the 1,336 participants and 50% were men. The randomized groups did not differ significantly by race, age, gender, income, marital status or education level. The likelihood of undergoing or recommending prostate cancer screening decreased from 83 to 78 following decision aid exposure (p <0.001). Reviewing the decision aid from the Centers for Disease Control or the American Academy of Family Physicians did not alter the likelihood (each p >0.2). However, the decision aid from the United States Preventive Services Task Force was associated with the largest decrease in screening preference (-16.0, p <0.001). Participants reported increased comfort (from 3.5 to 4.1 of 5) with the decision making process of prostate cancer screening following exposure to a decision aid (p <0.001). CONCLUSIONS:Exposure to a decision aid decreased the participant likelihood of undergoing or recommending prostate cancer screening and increased comfort with the screening process.
| S-EPMC6203648 | biostudies-other
Project description:Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center's website.Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center's website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions.Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p < .0001) and less uncertainty (LS mean = 24.3 vs. 36.4, p = .025). The DA group had higher objective knowledge than the UC group's (LS mean = 69.8 vs. 55.8, p < .0001). There were no differences between groups in intent to participate.Improvements on key decision outcomes including knowledge, self-efficacy, certainty about choice, and values clarity among participants who viewed the DA suggest web-based DAs can support informed decisions about trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention.This paper describes evidence regarding a decision tool to support patients' decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients' preferences, promoting patient-centered care and the ethical conduct of clinical research.
| S-EPMC5153351 | biostudies-literature
Project description:BackgroundSymptom checker apps are patient-facing decision support systems aimed at providing advice to laypersons on whether, where, and how to seek health care (disposition advice). Such advice can improve laypersons' self-assessment and ultimately improve medical outcomes. Past research has mainly focused on the accuracy of symptom checker apps' suggestions. To support decision-making, such apps need to provide not only accurate but also trustworthy advice. To date, only few studies have addressed the question of the extent to which laypersons trust symptom checker app advice or the factors that moderate their trust. Studies on general decision support systems have shown that framing automated systems (anthropomorphic or emphasizing expertise), for example, by using icons symbolizing artificial intelligence (AI), affects users' trust.ObjectiveThis study aims to identify the factors influencing laypersons' trust in the advice provided by symptom checker apps. Primarily, we investigated whether designs using anthropomorphic framing or framing the app as an AI increases users' trust compared with no such framing.MethodsThrough a web-based survey, we recruited 494 US residents with no professional medical training. The participants had to first appraise the urgency of a fictitious patient description (case vignette). Subsequently, a decision aid (mock symptom checker app) provided disposition advice contradicting the participants' appraisal, and they had to subsequently reappraise the vignette. Participants were randomized into 3 groups: 2 experimental groups using visual framing (anthropomorphic, 160/494, 32.4%, vs AI, 161/494, 32.6%) and a neutral group without such framing (173/494, 35%).ResultsMost participants (384/494, 77.7%) followed the decision aid's advice, regardless of its urgency level. Neither anthropomorphic framing (odds ratio 1.120, 95% CI 0.664-1.897) nor framing as AI (odds ratio 0.942, 95% CI 0.565-1.570) increased behavioral or subjective trust (P=.99) compared with the no-frame condition. Even participants who were extremely certain in their own decisions (ie, 100% certain) commonly changed it in favor of the symptom checker's advice (19/34, 56%). Propensity to trust and eHealth literacy were associated with increased subjective trust in the symptom checker (propensity to trust b=0.25; eHealth literacy b=0.2), whereas sociodemographic variables showed no such link with either subjective or behavioral trust.ConclusionsContrary to our expectation, neither the anthropomorphic framing nor the emphasis on AI increased trust in symptom checker advice compared with that of a neutral control condition. However, independent of the interface, most participants trusted the mock app's advice, even when they were very certain of their own assessment. Thus, the question arises as to whether laypersons use such symptom checkers as substitutes rather than as aids in their own decision-making. With trust in symptom checkers already high at baseline, the benefit of symptom checkers depends on interface designs that enable users to adequately calibrate their trust levels during usage.Trial registrationDeutsches Register Klinischer Studien DRKS00028561; https://tinyurl.com/rv4utcfb (retrospectively registered).
| S-EPMC9115664 | biostudies-literature
Project description:BackgroundAn important question in the development of decision aids about colon cancer (CRC) screening is whether to include an explicit discussion of the option of not being screened. We examined the effect of including or not including an explicit discussion of the option of deciding not to be screened in a CRC screening decision aid on subjective measures of decision aid content; interest in screening; and knowledge.MethodsAdults ages 50-85 were assigned to view one of two versions of the decision aid. The two versions differed only in the inclusion of video segments of two men, one of whom decided against being screened. Participants completed questionnaires before and after viewing the decision aid to compare subjective measures of content, screening interest and intent, and knowledge between groups. Likert response categories (5-point) were used for subjective measures of content (eg. clarity, balance in favor/against screening, and overall rating), and screening interest. Knowledge was measured with a three item index and individual questions. Higher scores indicated favorable responses for subjective measures, greater interest, and better knowledge. For the subjective balance, lower numbers were associated with the impression of the decision aid favoring CRC screening.Results57 viewed the "with" version which included the two segments and 49 viewed the "without" version. After viewing, participants found the "without" version to have better subjective clarity about benefits of screening ("with" 3.4, "without" 4.1, p < 0.01), and to have greater clarity about downsides of screening ("with" 3.2, "without" 3.6, p = 0.03). The "with" version was considered to be less strongly balanced in favor of screening. ("with" 1.8, "without" 1.6, p = 0.05); but the "without" version received a better overall rating ("with" 3.5, "without" 3.8, p = 0.03). Groups did not differ in screening interest after viewing a decision aid or knowledge.ConclusionA decision aid with the explicit discussion of the option of deciding not to be screened appears to increase the impression that the program was not as strongly in favor of screening, but decreases the impression of clarity and resulted in a lower overall rating. We did not observe clinically important or statistically significant differences in interest in screening or knowledge.
| S-EPMC2275224 | biostudies-literature
Project description:CONTEXT:Although screening recommendations for prostate cancer using prostate-specific antigen testing often include shared decision making, the effect of patient decision aids on patients' intention and uptake is unclear. This study aimed to review the effect of decision aids on men's screening intention, screening utilization, and the congruence between intentions and uptake. EVIDENCE ACQUISITION:Data sources were searched through April 6, 2018, and included MEDLINE, Scopus, CENTRAL, CT.gov, Cochrane report, PsycARTICLES, PsycINFO, and reference lists. This study included RCTs and observational studies of decision aids that measured prostate screening intention or behavior. The analysis was completed in April 2018. EVIDENCE SYNTHESIS:Eighteen studies (13 RCTs, four before-after studies, and one non-RCT) reported data on screening intention for ?8,400 men and screening uptake for 2,385 men. Compared with usual care, the use of decision aids in any format results in fewer men (aged ?40 years) planning to undergo prostate-specific antigen testing (risk ratio=0.88, 95% CI=0.81, 0.95, p=0.006, I2=66%, p<0.001, n=8). Many men did not follow their screening intentions during the first year after using a decision aid; however, most men who were planning to undergo screening did so (probability that men who wanted to be screened would receive screening was 95%). CONCLUSIONS:Integration of decision aids in clinical practice may result in a decrease in the number of men who elect prostate-specific antigen testing, which may in turn reduce screening uptake. To ensure high congruence between intention and screening utilization, providers should not delay the shared decision-making discussion after patients use a decision aid.
| S-EPMC6467088 | biostudies-literature
Project description:BACKGROUND:Screening with prostate-specific antigen (PSA) test for prostate cancer is considered a preference sensitive decision; meaning it does not only depend on what is best from a medical point of view, but also from a patient value standpoint. Decision aids are evidence-based tools which are shown to help people feel clearer about their values; therefore it has been advocated that decision aids should contain a specific values clarification method (VCM). VCMs may be either implicit or explicit, but the evidence concerning the best method is scarce. We aim to compare the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM. METHODS:Male factory employees from an industrial facility in the Northern region of Portugal aged 50 to 69?years old will be randomly assigned to one of three decision aid groups used to support prostate cancer screening decisions: (i) decision aid with information only (control), (ii) decision aid with information plus an implicit VCM, (iii) decision aid with information plus an explicit VCM. Men will be allowed release time from work to attend a session at their workplace. After a brief oral presentation, those willing to participate in the study will fill the baseline questionnaire, plus a 5 point-Likert scale question about intentions to undergo screening, and will then receive the intervention materials to complete. We estimated a total sample size of 276 participants; with 92 in each group. The primary outcome will be the perceived clarity of personal values assessed by the Portuguese validated translation of the three subscales of the Decisional Conflict Scale. Secondary outcomes will be intention to be screened (before and after the intervention), the total score from the Decisional Conflict Scale and the self-report of having or not undergone screening at 6?months. DISCUSSION:This study will add to the body of evidence on the role of decision aids to support health preference-sensitive choices and provide further insight on the impact of different methods for eliciting people's values embedded within a decision aid. TRIAL REGISTRATION:NCT03988673 - clinicalTrials.gov (2019/06/17).
| S-EPMC7191709 | biostudies-literature
Project description:ImportanceUS guidelines recommend that physicians engage in shared decision-making with men considering prostate cancer screening.ObjectiveTo estimate the association of decision aids with decisional outcomes in prostate cancer screening.Data sourcesMEDLINE, Embase, PsycINFO, CINAHL, and Cochrane CENTRAL were searched from inception through June 19, 2018.Study selectionRandomized trials comparing decision aids for prostate cancer screening with usual care.Data extraction and synthesisIndependent duplicate assessment of eligibility and risk of bias, rating of quality of the decision aids, random-effects meta-analysis, and Grading of Recommendations, Assessment, Development and Evaluations rating of the quality of evidence.Main outcomes and measuresKnowledge, decisional conflict, screening discussion, and screening choice.ResultsOf 19 eligible trials (12 781 men), 9 adequately concealed allocation and 8 blinded outcome assessment. Of 12 decision aids with available information, only 4 reported the likelihood of a true-negative test result, and 3 presented the likelihood of false-negative test results or the next step if the screening test result was negative. Decision aids are possibly associated with improvement in knowledge (risk ratio, 1.38; 95% CI, 1.09-1.73; I2 = 67%; risk difference, 12.1; low quality), are probably associated with a small decrease in decisional conflict (mean difference on a 100-point scale, -4.19; 95% CI, -7.06 to -1.33; I2 = 75%; moderate quality), and are possibly not associated with whether physicians and patients discuss prostate cancer screening (risk ratio, 1.12; 95% CI, 0.90-1.39; I2 = 60%; low quality) or with men's decision to undergo prostate cancer screening (risk ratio, 0.95; 95% CI, 0.88-1.03; I2 = 36%; low quality).Conclusions and relevanceThe results of this study provide moderate-quality evidence that decision aids compared with usual care are associated with a small decrease in decisional conflict and low-quality evidence that they are associated with an increase in knowledge but not with whether physicians and patients discussed prostate cancer screening or with screening choice. Results suggest that further progress in facilitating effective shared decision-making may require decision aids that not only provide education to patients but are specifically targeted to promote shared decision-making in the patient-physician encounter.
| S-EPMC6593633 | biostudies-literature
Project description:OBJECTIVE:The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice. METHODS:A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored. RESULTS:A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate -3.61; (confidence interval, -7.01, 0.22), and values clarity (estimate -3.57; confidence interval (-5.85,-1.30). Borderline effect was seen for the total decisional conflict score (estimate -1.75; confidence interval (-3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. CONCLUSION:The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.
| S-EPMC3349002 | biostudies-literature