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Importance: Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials., Objective: To examine cancer clinical trial (CCT) participants' perceptions of informed consent processes and variations in perceptions by cancer type., Design and Setting and Participants: Cross-sectional survey from mixed-methods study at National Cancer Institute-designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer ( N  = 334)., Main Outcome Measures: Percentages satisfied with consent process and information provided; and assessing participation's perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type., Results: Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did-47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT., Conclusions and Relevance: Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making.

Purpose: Overdiagnosis is a concept central to making informed breast cancer screening decisions, and yet some people may react to overdiagnosis with doubt and skepticism. The present research assessed 4 related reactions to overdiagnosis: reactance, self-exemption, disbelief, and source derogation (REDS). The degree to which the concept of overdiagnosis conflicts with participants' prior beliefs and health messages (information conflict) was also assessed as a potential antecedent of REDS. We developed a scale to assess these reactions, evaluated how those reactions are related, and identified their potential implications for screening decision making., Methods: Female participants aged 39 to 49 years read information about overdiagnosis in mammography screening and completed survey questions assessing their reactions to that information. We used a multidimensional theoretical framework to assess dimensionality and overall domain-specific internal consistency of the REDS and Information Conflict questions. Exploratory and confirmatory factor analyses were performed using data randomly split into a training set and test set. Correlations between REDS, screening intentions, and other outcomes were evaluated., Results: Five-hundred twenty-five participants completed an online survey. Exploratory and confirmatory factor analyses identified that Reactance, Self Exemption, Disbelief, Source Derogation, and Information Conflict represent unique constructs. A reduced 20-item scale was created by selecting 4 items per construct, which showed good model fit. Reactance, Disbelief, and Source Derogation were associated with lower intent to use information about overdiagnosis in decision making and the belief that informing people about overdiagnosis is unimportant., Conclusions: REDS and Information Conflict are distinct but correlated constructs that are common reactions to overdiagnosis. Some of these reactions may have negative implications for making informed screening decisions., Highlights: Overdiagnosis is a concept central to making informed breast cancer screening decisions, and yet when provided information about overdiagnosis, some people are skeptical.This research developed a measure that assessed different ways in which people might express skepticism about overdiagnosis (reactance, self-exemption, disbelief, source derogation) and also the perception that overdiagnosis conflicts with prior knowledge and health messages (information conflict).These different reactions are distinct but correlated and are common reactions when people learn about overdiagnosis.Reactance, disbelief, and source derogation are associated with lower intent to use information about overdiagnosis in decision making as well as the belief that informing people about overdiagnosis is unimportant., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Financial support for this study was provided entirely by a grant from the National Cancer Institute, R37CA254926. The funding agreement ensured the authors’ independence in designing the study, interpreting the data, writing, and publishing the report.

Objective: This study examines the effects of a mammography decision intervention on perceived susceptibility to breast cancer (PSBC) and emotion and investigates how these outcomes predict mammography intentions., Design: Randomised between-subjects online experiment. Participants were stratified into two levels of risk. Within each stratum, conditions included a basic information condition and six decision intervention conditions that included personalised risk estimates and varied according to a 2 (amount of information: brief vs. extended) × 3 (format: expository vs. untailored exemplar vs. tailored exemplar) design. Participants included 2465 US women ages 35-49., Main Outcome Measures: PSBC as a percentage, PSBC as a frequency, worry, fear and mammography intentions., Results: The intervention resulted in significant reductions in PSBC as a percentage for women in both strata and significant increases in worry and fear for women in the upper risk stratum. Of the possible mediators examined, only PSBC as a percentage was a consistent mediator of the effect of the intervention on mammography intentions., Conclusion: The results provide insight into the mechanism of action of the intervention by showing that PSBC mediated the effects of the intervention on mammography intentions.

Objective: Improved outcomes realized by patients treated at high-volume institutions have led to a call for centralization of ovarian cancer care. However, it is unknown whether centralization respects patients' preferences regarding treatment location. This study's objective was to determine how patients balance survival benefit against the burdens of travel to a distant treatment center., Methods: Patients presenting for evaluation of adnexal masses completed two discrete choice experiments (DCEs) assessing 1) the 5-year survival benefit required to justify 50miles of additional travel, and 2) the additional distance patients would travel for a 6% 5-year survival benefit. Demographic data were collected with measures of health numeracy, social support, and comfort with travel. t-Tests were performed to test for significant differences between group means., Results: 81% (50/62) of participants required a 5-year survival benefit of ≤6% to justify 50miles of additional travel (DCE#1). These participants were less likely to be employed (56% vs 83%, p=0.05) and more likely to rate their health as good to excellent (86% vs 50%, p=0.04) than those requiring >6% benefit to travel 50miles. 80% (44/55) of participants would travel ≥50miles for a set 5-year survival benefit of 6% (DCE#2). No association was identified in DCE#2 between willingness to travel and collected sociodemographic covariates., Conclusions: 1 in 5 patients with ovarian cancer may prefer not to travel to a referral center, even when aware of the survival benefits of doing so. Policymakers should consider patients' travel preferences in designing referral structures for care., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Cancer treatment decisions are complex and may be challenging for patients, as multiple treatment options can often be reasonably considered. As a result, decisional support tools have been developed to assist patients in the decision-making process. A commonly used intervention to facilitate shared decision-making is a decision aid, which provides evidence-based outcomes information and guides patients towards choosing the treatment option that best aligns with their preferences and values. To ensure high quality, systematic frameworks and standards have been proposed for the development of an optimal aid for decision making. Studies have examined the impact of these tools on facilitating treatment decisions and improving decision-related outcomes. In radiation oncology, randomized controlled trials have demonstrated that decision aids have the potential to improve patient outcomes, including increased knowledge about treatment options and decreased decisional conflict with decision-making. This article provides an overview of the shared-decision making process and summarizes the development, validation, and implementation of decision aids as patient educational tools in radiation oncology. Finally, this article reviews the findings from decision aid studies in radiation oncology and offers various strategies to effectively implement shared decision-making into clinical practice.

Rationale: Radiographic lung cancer screening guidelines and coverage requirements warrant a shared decision-making process. Guidance is needed regarding how to conduct shared decision making effectively. A useful organizing theme should include consideration of a patient's response to and tolerance of uncertainty associated with lung cancer screening., Objectives: The objectives of this study are to: (1) describe how patients respond to specific categories of uncertainty in the context of lung cancer screening, and (2) inform strategies for addressing concerns about uncertainty as part of the shared decision making., Methods: We performed two series of structured interviews on participants in a convenience sample of current or former cigarette smokers recruited from primary care and pulmonary practices in Philadelphia. An interview guide included prompts related to benefits, harms, and responses to general and specific types of uncertainty (stochastic, statistical, and evidentiary) associated with lung cancer screening. Interviews were audio-recorded, transcribed, and independently coded by two investigators. An inductive analysis was conducted, and major themes were identified., Measurements and Main Results: Twenty-two adults participated in the study. Sixty-eight percent were men, 72% were black or African American, and 50% met U.S. Preventive Services Task Force criteria for lung cancer screening. The primary themes to emerge from our study were: (1) the desire to decrease uncertainty may motivate lung cancer screening decisions; (2) uncertainty is an attribute of health states that impacts how patients weigh benefits and harms of lung cancer screening; (3) patient understanding and tolerance of uncertainty varies across stochastic, statistical, and evidentiary uncertainty; and (4) provider-patient communication may mitigate intolerance of uncertainty in the context of lung cancer screening., Conclusions: A systematic approach to understanding and addressing patients' concerns about uncertainty in the context of lung cancer screening can guide a patient-centered approach to shared decision making. The results of this study can inform provider-patient communication strategies regarding the decision to perform radiographic lung cancer screening.

The purpose of this study is to explore the experience and perspective of patients regarding scientific evidence in health and the degree that this information impacts health behavior and medical decision making. A focus group study was conducted. Participants were recruited from an urban primary-care practice. The focus group discussions were audio-recorded, transcribed verbatim, and coded by two independent investigators. Emergent themes were identified. Participants (n = 30) ranged in age from 30 to 79 years, 60% were female, 77% were black, and 50% had at least some college experience. Three thematic areas informed a wide range in level of interest regarding scientific study design and result information: (1) scientific literacy, (2) medical decision making style, and (3) impact of culture and community on decision making. Our findings indicate that communication strategies that incorporate key elements of scientific study design, methods, and results will most effectively translate findings from comparative effectiveness research to patient-informed decision making regarding evidence-based health interventions., (© The Author(s) 2014.)

Recent physicians' guidelines for postmenopausal osteoporosis emphasize the use of fracture-risk scores. To determine whether adherence to the guidelines has potential to improve targeting of care, we examined survey results from a random sample of US primary care physicians prior to the new guidelines. Survey measures included physicians' knowledge, attitudes, and perceived barriers to care. Physicians' estimates of 5-yr and lifetime absolute hip fracture risks and their treatment decisions were examined for patient vignettes depicting postmenopausal women of varying ages, weights, and bone mineral density (BMD) results. The 360 US physician respondents were accurate in their estimates of lifetime fracture risk for all 4 vignettes, but overestimated 5-yr hip fracture risk by a factor of 10 or more; 36-45% of the physicians recommended treatment for patients whose history and BMD placed them below guideline-recommended treatment thresholds, and 5-yr risk estimates were strongly associated with prescription treatment decisions for 2 of 3 such vignettes (both p<0.01). Other potential barriers to care include medication costs and adverse effects. Our findings suggest efforts to improve targeting of osteoporosis care are appropriately addressing physicians' risk estimation. Evidence from other conditions suggests these efforts must be intensive and available at the point of care., (Copyright © 2012 The International Society for Clinical Densitometry. All rights reserved.)

Background: A contextual error occurs when a physician overlooks elements of a patient's environment or behavior that are essential to planning appropriate care. In contrast to biomedical errors, which are not patient-specific, contextual errors represent a failure to individualize care., Objective: To explore the frequency and circumstances under which physicians probe contextual and biomedical red flags and avoid treatment error by incorporating what they learn from these probes., Design: An incomplete randomized block design in which unannounced, standardized patients visited 111 internal medicine attending physicians between April 2007 and April 2009 and presented variants of 4 scenarios. In all scenarios, patients presented both a contextual and a biomedical red flag. Responses to probing about flags varied in whether they revealed an underlying complicating biomedical or contextual factor (or both) that would lead to errors in management if overlooked., Setting: 14 practices, including 2 academic clinics, 2 community-based primary care networks with multiple sites, a core safety net provider, and 3 U.S. Department of Veterans Affairs facilities., Measurements: Primary outcomes were the proportion of visits in which physicians probed for contextual and biomedical factors in response to hints or red flags and the proportion of visits that resulted in error-free treatment plans., Results: Physicians probed fewer contextual red flags (51%) than biomedical red flags (63%). Probing for contextual or biomedical information in response to red flags was usually necessary but not sufficient for an error-free plan of care. Physicians provided error-free care in 73% of the uncomplicated encounters, 38% of the biomedically complicated encounters, 22% of the contextually complicated encounters, and 9% of the combined biomedically and contextually complicated encounters., Limitations: Only 4 case scenarios were used. The study assessed physicians' propensity to make errors when every encounter provided an opportunity to do so and did not measure actual error rates that occur in primary care settings because of inattention to context., Conclusion: Inattention to contextual information, such as a patient's transportation needs, economic situation, or caretaker responsibilities, can lead to contextual error, which is not currently measured in assessments of physician performance., Primary Funding Source: U.S. Department of Veterans Affairs Health Services Research and Development Service

Our objective of this study is to develop a conceptual framework for the construct of health numeracy based on patient perceptions, using a cross-sectional, qualitative design. Interested participants (n=59) meeting eligibility criteria (age 40-74, English speaking) were assigned to one of six focus groups stratified by gender and educational level (low, medium, high). Fifty-three percent were male, and 47% were female. Sixty-one percent were white non-Hispanic, and 39% were of minority race or ethnicity. Participants were randomly selected from three primary care sites associated with an academic medical center. Focus group discussions were held in May 2004 and focused on how numbers are used in the health care setting. Data were presented from clinical trials to further explore how quantitative information is used in health communication and decision making. Focus groups were audio and videotaped; verbatim transcripts were prepared and analyzed. A framework of health numeracy was developed to reflect the themes that emerged. Three broad conceptual domains for health numeracy were identified: primary numeric skills, applied health numeracy, and interpretive health numeracy. Across domains, results suggested that numeracy contains an emotional component, with both positive and negative affect reflected in patient numeracy statements. We conclude that health numeracy is a multifaceted construct that includes applied and interpretive components and is influenced by patient affect.

The development of a videotape for patients considering treatment options for clinically localized prostate cancer is described. The effectiveness of videotape in improving short-term recall of treatment options and outcomes was assessed quantitatively; qualitative analysis was used to assess the likelihood of patient's active participation in the decision-making process. (Author/EMK)

Background: Communication of statistics and probability is challenging in the cancer care setting. The objectives of this study are to evaluate a novel approach to cancer communication through the use of a computer assessment of patient health numeracy. Methods: We conducted a pilot study of the Computer Adapted Test of Numeracy Understanding in Medicine Instrument (CAT-NUMi) before the cancer treatment consultation for women with stage 0–3 breast cancer. Patient outcomes included the interpersonal processes of care (IPC) and the decisional conflict scale. We evaluated clinician use of numeric information in the cancer consultation and assessed feasibility outcomes from the clinician and patient perspective. Results: Patient participants (n = 50) had a median (interquartile range) age of 51 years (46–61), 70% were English speaking, and 30% Spanish speaking. Decisional conflict was low with a mean (standard deviation [SD]) decisional conflict score of 17.4 (12.3). The lack of clarity score (range 1–5) on the IPC was low (mean, SD),1.70 (0.71), indicating clear communication. Clinicians more often used percentages in communicating prognosis among those with higher numeracy scores (median, range): high (2, 0–8), medium (1, 0–7), and low (0, 0–8); p = 0.04. The patient experience of taking the CAT-NUMi was rated as very good or excellent by 65%, fair by 33%, and poor by 2% of patients. Conclusion: Screening for health numeracy with a short computer-based test may be a feasible strategy to optimize clear communication in the cancer treatment consultation. Further studies are needed to evaluate this strategy across cancer treatment clinical settings and populations. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the perceived usefulness of publicly reported nursing home quality indicators.Study Setting: Primary data were collected from October 2013 to August 2014 among a convenience sample of persons (or family member) recently admitted or anticipating admission to a nursing home within 75 miles of the city of Philadelphia.Study Design: Structured interviews were conducted to assess the salience of data on the Medicare Nursing Home Compare website, including star ratings, clinical quality measures, and benchmarking of individual nursing home quality with state and national data.Data Collection: Interviews were transcribed verbatim, independently coded by two reviewers, and agreement determined. A thematic analysis of transcripts was undertaken.Principal Findings: Thirty-five interviews were completed. Eighty-three percent (n = 29) were caregivers and 17 percent (n = 6) were residents. Star ratings, clinical quality measures, and benchmarking information were salient to decision making, with preferred formats varying across participants. Participants desired additional information on the source of quality data. Confusion was evident regarding the relationship between domain-specific and overall star quality ratings.Conclusions: The Nursing Home Compare website provides salient content and formats for consumers. Increased awareness of this resource and clarity regarding the definition of measures could further support informed decision making regarding nursing home choice. [ABSTRACT FROM AUTHOR]

Background: Health numeracy can be defined as the ability to use numeric information in the context of health. The interpretation and application of numbers in health may vary across cultural groups.Objective: To explore the construct of health numeracy among persons who identify as Mexican American.Design: Qualitative focus group study. Groups were stratified by preferred language and level of education. Audio-recordings were transcribed and Spanish groups (n = 3) translated to English. An analysis was conducted using principles of grounded theory.Participants: A purposeful sample of participants from clinical and community sites in the Milwaukee and Chicago metropolitan areas.Main Measures: A theoretical framework of health numeracy was developed based upon categories and major themes that emerged from the analysis.Key Results: Six focus groups were conducted with 50 participants. Initial agreement in coding was 59-67% with 100% reached after reconciliation by the coding team. Three major themes emerged: 1) numeracy skills are applied to a broad range of communication and decision making tasks in health, 2) affective and cognitive responses to numeric information influence use of numbers in the health setting, and 3) there exists a strong desire to understand the meaning behind numbers used in health. The findings informed a theoretical framework of health numeracy.Conclusions: Numbers are important across a range of skills and applications in health in a sample of an urban Mexican-American population. This study expands previous work that strives to understand the application of numeric skills to medical decision making and health behaviors. [ABSTRACT FROM AUTHOR]

A multi-attribute utility (MAU) decision model for menopausal hormone replacement therapy (HRT) was developed using structured interviews (n=40) to identify decision factors, and a telephone survey (n=97) to ascertain utility scores. Utility scores for individual factors and composite scores reflecting the HRT decision were compared according to HRT use. Composite utility scores (range of −1.0 to 1.0, with higher values supporting HRT use) were 0.55, −0.27, and −0.19 for the 48 HRT users, 23 former users, and 26 never users, respectively (P<0.0001). Among HRT current users, the main factors supporting use were concerns about heart disease, osteoporosis, and symptoms of menopause. Among former users, side effects weighed heavily against use, and among never users breast cancer concerns weighed heavily against use. Linear regression methods were used to identify the utilities most predictive of current HRT use. The decision model provided insight regarding how personal expectations and values influence HRT use. [Copyright &y& Elsevier]

Background. The communication of probabilistic outcomes is an essential aspect of shared medical decision making.Methods. The authors conducted a qualitative study using focus groups to evaluate the response of women to various formats used in the communication of breast cancer risk.Findings. Graphic discrete frequency formats using highlighted human figures had greater salience than continuous probability formats using bar graphs. Potential biases in the estimation of risk magnitude were associated with the use of highlighted human figures versus bar graphs and the denominator size in graphics using highlighted human figures. The presentation of uncertainty associated with risk estimates caused some to loose trust in the information, whereas others were accepting of uncertainty in scientific data.Conclusion. The qualitative study identified new constructs with regard to how patients process probabilistic information. Further research in the clinical setting is needed to provide a theoretical justification for the format used when presenting risk information to patients. [ABSTRACT FROM PUBLISHER]

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. [ABSTRACT FROM AUTHOR]

The article discusses a study published in the issue, focusing on shared decision-making (SDM) implementation for lung cancer screening. Topics discussed include several aspects of SDM including information sharing, deliberation and the use of decision aids; the issue of overdiagnosis in detecting lung cancer; and the ethical mandate to inform patients about the outcome of screening.

Objective: This experiment tested the effects of an individualized risk-based online mammography decision intervention. The intervention employs exemplification theory and the Elaboration Likelihood Model of persuasion to improve the match between breast cancer risk and mammography intentions.Methods: 2918 women ages 35-49 were stratified into two levels of 10-year breast cancer risk (<1.5%; ≥1.5%) then randomly assigned to one of eight conditions: two comparison conditions and six risk-based intervention conditions that varied according to a 2 (amount of content: brief vs. extended) x 3 (format: expository vs. untailored exemplar [example case] vs. tailored exemplar) design. Outcomes included mammography intentions and accuracy of perceived breast cancer risk.Results: Risk-based intervention conditions improved the match between objective risk estimates and perceived risk, especially for high-numeracy women with a 10-year breast cancer risk ≤1.5%. For women with a risk≤1.5%, exemplars improved accuracy of perceived risk and all risk-based interventions increased intentions to wait until age 50 to screen.Conclusion: A risk-based mammography intervention improved accuracy of perceived risk and the match between objective risk estimates and mammography intentions.Practice Implications: Interventions could be applied in online or clinical settings to help women understand risk and make mammography decisions. [ABSTRACT FROM AUTHOR]