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Browsing by Author "Schmidt, Karen K."
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Item Adding Natural Frequency Data to a Decision Aid for Colorectal Cancer Screening: Results of a Randomized Trial(2013-10-22) Schwartz, Peter H.; Muriello, Paul F.; Perkins, Susan M.; Schmidt, Karen K.; Rawl, Susan M.Guidelines recommend that decision aids provide natural frequency data regarding baseline risk, risk reduction, and chances of false positives and negatives. Such quantitative information may confuse patients, especially those with low numeracy. We conducted a randomized trial to compare effects of 2 colorectal cancer (CRC) screening decision aids—one with and one without natural frequency data.Item An Arts-Based Educational Exhibit on Menopausal Hot Flashes(Wolters Kluwer, 2019) Carpenter, Janet S.; Kesling, Mark; Schmidt, Karen K.; School of NursingObjective: The aim of this study was to describe the development process, science, and symbolism of an arts-based educational exhibit designed to address myths, misinformation, negative imagery, and use of unproven treatments related to menopausal hot flashes. Methods: The development process included iterative and informal feedback from a variety of individuals, a partnership with an experienced exhibit designer, and collaborations between artists and scientists. Results: The resulting exhibit creates an environment where the public is immersed in accurate information about hot flashes. Although based on an iterative process, the resulting exhibit content reflects an estimated 500+ scientific studies, including those referenced in The North American Menopause Society position statements on hormone and nonhormone management of hot flashes. The seven main exhibit pieces convey scientific information and symbolize various aspects of women's experiences. Conclusions: This innovative exhibit has high potential to be a disruptive innovation to address the preponderance of myths, misinformation, and negative imagery surrounding menopausal hot flashes and potentially decrease the use of unproven therapies.Item Discussions of Life Expectancy Moderate Relationships between Prognosis and Anxiety or Depression in Men with Advanced Cancer(2012-01) Cripe, Larry D.; Rawl, Susan M.; Schmidt, Karen K.; Tong, Yan; Monahan, Patrick O.; Rand, Kevin L.Purpose: Oncologists avoid prognostic discussions due to concerns about increasing patients' anxiety or depression. We sought to determine if perceived prognosis or extent of prognostic discussions predicted anxiety or depression and whether prognostic discussions moderated the relationship between prognosis and anxiety or depression. Methods: Men with advanced cancer and their oncologists estimated the likelihood of survival at 6 months and reported extent of prognostic discussions. Anxiety and depression were measured by the Hospital Anxiety and Depression Scale (HADS). Results: Men who died within 6 months reported higher scores on depression but not anxiety. Men who estimated a lower (10%–75%) likelihood of surviving at least 6 months were more depressed and anxious than men who estimated a higher (>90%) likelihood of survival. A similar relationship was seen with oncologists' prognostications. Men who reported having had full prognostic discussions with their oncologist had less depression compared with men who reported having had brief or no discussions. Men for whom the oncologists reported a full discussion had greater anxiety. The relationships between patient-perceived prognosis and depression or anxiety were moderated by extent of prognostic discussions as reported by the patient or oncologist, respectively. Conclusion: Full prognostic discussions are associated with less depression among men who perceive a poor prognosis. Anxiety is increased in men if the oncologists report a full discussion. Oncologists should engage in prognostic discussions but assess for increased anxiety to facilitate coping with advanced cancer.Item Impact of including quantitative information in a decision aid for colorectal cancer screening: A randomized controlled trial(Elsevier, 2019) Schwartz, Peter H.; Imperiale, Thomas F.; Perkins, Susan M.; Schmidt, Karen K.; Althouse, Sandra; Rawl, Susan M.; Medicine, School of MedicineObjective: Guidelines recommend that decision aids provide quantitative information about risks and benefits of available options. Impact of providing this information is unknown. Methods: Randomized trial comparing two decision aids about colorectal cancer (CRC) screening with colonoscopy or fecal immunochemical test (FIT). 688 primary care patients due for CRC screening viewed a decision aid that uses words only (Verbal arm) vs. one that provides quantitative information (Quantitative arm). Main outcomes included perceived CRC risk, intent to be screened, and test preference, measured before and after viewing decision aid, and screening uptake at six months. Analyses were performed with ANCOVA and logistic regression. Results: Compared to the Verbal arm, those in the Quantitative arm had a larger increase in intent to undergo FIT (p = 0.011) and were more likely to switch their preferred test from non-FIT to FIT (28% vs. 19%, p = .010). There were decreases in perceived risk in the Verbal Arm but not the Quantitative Arm (p = 0.004). There was no difference in screening uptake. Numeracy did not moderate any effects. Conclusions: Quantitative information had relatively minor impact and no clearly negative effects, such as reducing uptake. Practice implications: Quantitative information may be useful but not essential for patients viewing decision aids.Item Incorporating Biobank Consent into a Healthcare Setting: Challenges for Patient Understanding(Taylor & Francis, 2021) Kasperbauer, T. J.; Schmidt, Karen K.; Thomas, Ariane; Perkins, Susan M.; Schwartz, Peter H.; Medicine, School of MedicineBiobank participants often do not understand much of the information they are provided as part of the informed consent process, despite numerous attempts at simplifying consent forms and improving their readability. We report the first assessment of biobank enrollees’ comprehension under an "integrated consent” process, where patients were asked to enroll in a research biobank as part of their normal healthcare experience. A number of healthcare systems have implemented similar integrated consent processes for biobanking, but it is unknown how much patients understand after enrolling under these conditions. Methods: We recruited patients who enrolled in a biobank while in a healthcare setting when receiving ordinary care. We assessed knowledge of consent materials using 11 true/false questions drawn from a well-known biobank knowledge test. After reviewing the results from 114 participants, we revised the consent form and repeated the knowledge assessment with 144 different participants. Results: Participants scored poorly on the knowledge test in both rounds, with no significant differences in overall scores or individual items between the rounds. In Phase 1, participants answered 53% of the questions correctly, 25% incorrectly, and 22% “I don’t know.” In Phase 2, participants answered 53% of questions correctly, 24% incorrectly, and 23% “I don’t know.” Participants scored particularly poorly on questions about data sharing and accessing medical records. Conclusions: Enrollees under an integrated consent model had significant misunderstandings that persisted despite an attempt to improve information specifically about those topics in a consent form. These results raise challenges for current approaches that attribute misunderstanding to overly complex consent forms. They also suggest that the pressures of the clinic may compound other problems with patient understanding of biobank consent. As health systems increasingly blend research and care, they may need to rethink their approach to educating patients about participation in a biobank.Item Layperson Views about the Design and Evaluation of Decision Aids: A Public Deliberation(Sage, 2021-07) Schwartz, Peter H.; O’Doherty, Kieran C.; Bentley, Colene; Schmidt, Karen K.; Burgess, Michael M.; Medicine, School of MedicinePurpose: We carried out the first public deliberation to elicit lay input regarding guidelines for the design and evaluation of decision aids, focusing on the example of colorectal ("colon") cancer screening. Methods: A random, demographically stratified sample of 28 laypeople convened for 4 days, during which they were informed about key issues regarding colon cancer, screening tests, risk communication, and decision aids. Participants then deliberated in small and large group sessions about the following: 1) What information should be included in all decision aids for colon screening? 2) What risk information should be in a decision aid and how should risk information be presented? 3) What makes a screening decision a good one (reasonable or legitimate)? 4) What makes a decision aid and the advice it provides trustworthy? With the help of a trained facilitator, the deliberants formulated recommendations, and a vote was held on each to identify support and alternative views. Results: Twenty-one recommendations ("deliberative conclusions") were strongly supported. Some conclusions matched current recommendations, such as that decision aids should be available for use with and without providers present (conclusions 1-4) and should support informed choice (conclusion 9). Some conclusions differed from current recommendations, at least in emphasis-for example, that decision aids should disclose cost of screening (conclusion 11) and should be kept simple and understandable (conclusion 14). Deliberants recommended that decision aids should disclose the baseline risk of getting colon cancer (conclusions 15, 17). Limitations: Single location and medical decision. Conclusions: Guidelines for design of decision aids should consider putting a greater focus on disclosing cost and keeping decision aids simple, and they possibly should recommend disclosing less extensive amounts of quantitative information than currently recommended.Item Measuring the Impact of Quantitative Information on Patient Understanding: Approaches for Assessing the Adequacy of Patient Knowledge about Colorectal Cancer Screening(Sage, 2022) Rager, Joshua B.; Althouse, Sandra; Perkins, Susan M.; Schmidt, Karen K.; Schwartz, Peter H.; Medicine, School of MedicineBackground. Guidelines recommend that decision aids disclose quantitative information to patients considering colorectal cancer (CRC) screening, but the impact on patient knowledge and decision making is limited. An important challenge for assessing any disclosure involves determining when an individual has “adequate knowledge” to make a decision. Methods. We analyzed data from a trial that randomized 213 patients to view a decision aid about CRC screening that contained verbal information (qualitative arm) versus one containing verbal plus quantitative information (quantitative arm). We analyzed participants’ answers to 8 “qualitative knowledge” questions, which did not cover the quantitative information, at baseline (T0) and after viewing the decision aid (T1). We introduce a novel approach that defines adequate knowledge as correctly answering all of a subset of questions that are particularly relevant because of the participant’s test choice (“Choice-Based Knowledge Assessment”). Results. Participants in the quantitative arm answered a higher mean number of knowledge questions correctly at T1 than did participants in the qualitative arm (7.3 v. 6.9, P < 0.05), and they more frequently had adequate knowledge at T1 based on a cutoff of 6 or 7 correct out of 8 (94% v. 83%, P < 0.05, and 86% v. 71%, P < 0.05, respectively). Members of the quantitative group also more frequently had adequate knowledge at T1 when assessed by Choice-Based Knowledge Assessment (87% v. 76%, P < 0.05). Conclusions. Patients who viewed quantitative information in addition to verbal information had greater qualitative knowledge and more frequently had adequate knowledge compared with those who viewed verbal information alone, according to most ways of defining adequate knowledge. Quantitative information may have helped participants better understand qualitative or gist concepts.Item Presenting Stool Testing as the Default Option for Colorectal Cancer Screening: Results of a Randomized Trial(2015-01) Schwartz, Peter H.; Perkins, Susan M.; Schmidt, Karen K.; Muriello, Paul F.; Althouse, Sandra; Rawl, Susan M.Individuals eligible for colorectal cancer (CRC) screening can choose from multiple approved tests, including colonoscopy and stool testing. The existence of multiple options allows patients to choose a preferred strategy but also may lead to indecision and delay. Behavioral economics suggests presenting one option as a default choice, i.e. the one that patients should receive if they do not wish to decide. We conducted a randomized trial to measure the impact of describing stool testing as the default option for CRC screening in a decision aid (DA).Item Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial(SAGE, 2017-08-01) Schwartz, Peter H.; Perkins, Susan M.; Schmidt, Karen K.; Muriello, Paul F.; Althouse, Sandra; Rawl, Susan M.; Medicine, School of MedicineBackground. Guidelines recommend that patient decision aids should provide quantitative information about probabilities of potential outcomes, but the impact of this information is unknown. Behavioral economics suggests that patients confused by quantitative information could benefit from a “nudge” towards one option. We conducted a pilot randomized trial to estimate the effect sizes of presenting quantitative information and a nudge. Methods. Primary care patients (n = 213) eligible for colorectal cancer screening viewed basic screening information and were randomized to view (a) quantitative information (quantitative module), (b) a nudge towards stool testing with the fecal immunochemical test (FIT) (nudge module), (c) neither a nor b, or (d) both a and b. Outcome measures were perceived colorectal cancer risk, screening intent, preferred test, and decision conflict, measured before and after viewing the decision aid, and screening behavior at 6 months. Results. Patients viewing the quantitative module were more likely to be screened than those who did not (P = 0.012). Patients viewing the nudge module had a greater increase in perceived colorectal cancer risk than those who did not (P = 0.041). Those viewing the quantitative module had a smaller increase in perceived risk than those who did not (P = 0.046), and the effect was moderated by numeracy. Among patients with high numeracy who did not view the nudge module, those who viewed the quantitative module had a greater increase in intent to undergo FIT (P = 0.028) than did those who did not. Limitations. The limitations of this study were the limited sample size and single healthcare system. Conclusions. Adding quantitative information to a decision aid increased uptake of colorectal cancer screening, while adding a nudge to undergo FIT did not increase uptake. Further research on quantitative information in decision aids is warranted.Item Rationale, Design, and Baseline Characteristics of a Community-based Comparative Effectiveness Trial to Prevent Type 2 Diabetes in Economically Disadvantaged Adults: The RAPID Study(Elsevier, 2014-01) Ackermann, Ronald T.; Finch, Emily A.; Schmidt, Karen K.; Hoen, Helena M.; Hays, Laura M.; Marrero, David G.; Saha, Chandan; Department of Medicine, IU School of MedicineReaching Out and Preventing Increases in Diabetes (RAPID) is a community-based randomized trial evaluating the comparative costs and effectiveness of a group-based adaption of the DPP lifestyle intervention developed and implemented in partnership with the YMCA. RAPID enrolled adult primary care patients, with BMI 24 kg/m2 or higher and abnormal glucose metabolism (HbA1c 5.7–6.9% or fasting plasma glucose 100–125 mg/dL). 509 participants were enrolled and randomized to one of two groups: standard clinical advice plus free-of-charge access to a group-based adaption of the DPP offered by the Y, versus standard clinical advice alone. Key outcomes for future analysis will include differences in body weight and other cardiovascular risk factors over a 24-month intervention period. At baseline, RAPID participants had a mean (SD) age of 51 ± 12.1 years, weight of 225.1 ± 56.2 lbs, and BMI of 36.9 ± 8.6 kg/m2. 70.7% were women, 57.2% were African American, 35.4% were non-Hispanic White, and 3.2% were Hispanic. Mean HbA1c was 6.05 ± 0.34%. Additionally, 55.4% of participants had a baseline systolic blood pressure of ≥ 130 mm Hg, 33.1% had a total blood cholesterol exceeding 200 mg/dL, and 74% reported a household income of < $25,000. The RAPID Study successfully randomized a large cohort of participants with a wide distribution of age, body weight, and race who are at high risk for developing type 2 diabetes.