Background. Men diagnosed with localized prostate cancer (LPC) often face a dilemma in choosing between available treatment options that have similar survival rates but for which the perceived advantages and disadvantages of each treatment differ. The Navigate decision aid was created to assist Australian men with LPC in making informed decisions about treatment that align with their personal values and preferences. Navigate presents current, unbiased information, including an interactive values clarification exercise. Objective. This study was a qualitative investigation of men's treatment decision making for LPC, and their experiences using the Navigate Web site, to identify areas for improvement and inform implementation. Methods. Semi-structured interviews were conducted with 20 men diagnosed with LPC who completed the intervention arm of the Navigate randomized controlled trial. Interview transcripts were thematically analyzed. Results: Five main themes emerged: 1) diagnosis experiences varied, although men were strongly influenced by their clinician to make an early initial treatment decision; 2) men sought resources and support they trusted; 3) men valued Navigate's multiformatted content and design; 4) men suggested more content was needed on a) the diagnosis journey and b) new treatment updates; and 5) men identified design flaws in the values clarification exercise on Navigate but appreciated the tool being available. Conclusions. Specialist authority influenced men to make an early treatment decision. However, Navigate was helpful in supporting men's ongoing treatment decision making, particularly men on active surveillance who may face further treatment decisions if their cancer progresses. To gain trust and improve engagement from Navigate users, credentials and sources of information need to be prominent. Trustworthiness, timing of access, and the clinician's role in empowering men to use available decision aids are crucial elements to be considered when implementing Navigate in clinical settings.
Highlights: The Navigate decision aid Web site was created to help Australian men diagnosed with localized prostate cancer (LPC) make an informed decision about their treatment.Navigate was helpful in supporting men's ongoing treatment decision making for LPC.Men's treatment decision making for LPC was greatly influenced by perceived authority and trust in their clinician.Trustworthiness, timing of access, and the clinician's role in empowering men to use available decision aids are crucial.
Background. Older and sicker adults with type 2 diabetes (T2D) were underrepresented in randomized trials of glucagon-like peptide 1 receptor-agonist (GLP1RA) and sodium-glucose cotransporter 2 inhibitors (SGLT2I), and thus, health benefits are uncertain in this population. Objective. To assess the impact of age, health status, and life expectancy in older adults with T2D on health benefits of GLP1RA and SGLT2I. Design. We used the United Kingdom Prospective Diabetes Study (UKPDS) model to simulate lifetime health outcomes. We calibrated the UKPDS model to improve mortality prediction in older adults using a common geriatric prognostic index. Participants. National Health and Nutrition Examination Survey 2013-2018 participants 65 y and older with T2D, eligible for GLP1RA or SGLT2I according to American Diabetes Association guidelines. Interventions. GLP1RA or SGLT2I use versus no additional medication. Main Measures. Lifetime complications and weighted life-years (LYs) and quality-adjusted life-years (QALYs) across overall treatment arms and life expectancies. Key Results. The overall older adult population was predicted to experience significant health benefits from GLP1RA (+0.29 LY [95% confidence interval: 0.27, 0.31], +0.15 QALYs [0.14, 0.16]) and SGLT2I (+0.26 LY [0.24, 0.28], +0.13 QALYs [0.12, 0.14]) as compared with no added medication. However, expected benefits declined in subgroups with shorter life expectancies. Participants with <4 y of life expectancy had minimal gains of <0.05 LY and <0.03 QALYs from added medication. Accounting for injection-related disutility, GLP1RA use reduced QALYs (-0.03 QALYs [-0.04, -0.02]). Conclusions. While GLP1RA and SGLT2I have substantial health benefits for many older adults with type 2 diabetes, benefits are not clinically significant in patients with <4 y of life expectancy. Life expectancy and patient preferences are important considerations when prescribing newer diabetes medications.
Highlights: On average, older adults benefit significantly from SGLT2I and GLP1RA use. However, the benefits of these drugs are not clinically significant among older patients with life expectancy less than 4 y.There is potential harm in injectable GLP1RA use in the oldest categories of adults with type 2 diabetes.Heterogeneity in life expectancy and patient preferences for injectable versus oral medications are important to consider when prescribing newer diabetes medications.
Background. A portion of the Functional Assessment of Cancer Therapy-Lung (FACT-L) instrument contributed to a previously published utility index, the FACT Lung Utility Index or FACT-LUI. Six FACT items representing lung cancer quality of life covered fatigue, pain, dyspnea, cough, anxiety, and depression. Two FACT items had been previously combined by the index authors into one for nausea and/or appetite loss, resulting in 7 final domains. Methods. The objective was to perform measurement invariance testing within a confirmatory factor analysis (CFA) framework to support the feasibility of using the FACT-LUI for non-preference-based psychometric applications. The original index patients comprised group 1, and similar FACT patient data (n = 249) from another published study comprised group 2. One 2-factor model and two 1-factor CFA models were evaluated to assess measurement invariance across groups, using varying degrees of item parceling and a small number of residual covariances, all justified by the literature. Results. The 1-factor models were most optimal. A 1-factor model with 1 pair of items parceled showed invariance to the partial scalar level using usual fit criteria across groups, requiring 2 unconstrained intercepts. A 1-factor model with 3 pairs of justified parcels showed full configural, metric, and scalar invariance across groups. Conclusions. The FACT-LUI items fit a partially to fully invariant 1-factor model, suggesting feasibility for non-preference-based applications. Implications. Results suggest useful incorporation of the FACT-LUI into clinical trials with no substantial increased respondent burden, allowing preference-based and other psychometric applications from the same index items.
Highlights: This work suggests that in addition to being originally designed for use as a utility index, the 7 FACT-LUI items together also fit simple CFA and measurement invariance models. This less expected result indicates that these items as a group are also potentially useful in non-preference-based applications.Clinical trials can make for challenging decisions concerning which patient-reported outcome measures to include without being burdensome. However, the literature suggests a need for improved reporting of quality of life in lung cancer in particular as well as cancer in general. Inclusion of more disease-specific items such as the FACT-LUI may allow for information gathering of both preference-based and non-preference-based data with less demand on patients, similar to what has been done with some generic instruments.
Introduction: Decision aids (DAs) are helpful instruments used to support shared decision making (SDM). Patients with atrial fibrillation (AF) face complex decisions regarding stroke prevention strategies. While a few DAs have been made for AF stroke prevention, an encounter DA (EDA) and patient DA (PDA) have not been created to be used in conjunction with each other before.
Design: Using iterative user-centered design, we developed 2 DAs for anticoagulation choice and stroke prevention in AF. Prototypes were created, and we elicited feedback from patients and experts via observations of encounters, usability testing, and semistructured interviews.
Results: User testing was done with 33 experts (in AF and SDM) and 51 patients from 6 institutions. The EDA and PDA underwent 1 and 4 major iterations, respectively. Major differences between the DAs included AF pathophysiology and a preparation to meet with the clinician in the PDA as well as different language throughout. Content areas included personalized stroke risk, differences between anticoagulants, and risks of bleeding. Based on user feedback, developers 1) addressed feelings of isolation with AF, 2) improved navigation options, 3) modified content and flow for users new to AF and those experienced with AF, 4) updated stroke risk pictographs, and 5) added structure to the preparation for decision making in the PDA.
Limitations: These DAs focus only on anticoagulation for stroke prevention and are online, which may limit participation for those less comfortable with technology.
Conclusions: Designing complementary DAs for use in tandem or separately is a new method to support SDM between patients and clinicians. Extensive user testing is essential to creating high-quality tools that best meet the needs of those using them.
Highlights: First-time complementary encounter and patient decision aids have been designed to work together or separately.User feedback led to greater structure and different experiences for patients naïve or experienced with anticoagulants in patient decision aids.Online tools allow for easier dissemination, use in telehealth visits, and updating as new evidence comes out.
Background: Economic evaluations have suggested that risk-stratified breast cancer screening may be cost-effective but have used assumptions to estimate the cost of risk prediction. The aim of this study was to identify and quantify the resource use and associated costs required to introduce a breast cancer risk-stratification approach into the English national breast screening program.
Methods: A micro-costing study, conducted alongside a cohort-based prospective trial (BC-PREDICT), identified the resource use and cost per individual (£; 2021 price year) of providing a risk-stratification strategy at a woman's first mammography. Costs were calculated for 3 risk-stratification approaches: Tyrer-Cuzick survey, Tyrer-Cuzick with Volpara breast-density measurement, and Tyrer-Cuzick with Volpara breast-density measurement and testing for 142 single nucleotide polymorphisms (SNP). Costs were determined for the intervention as implemented in the trial and in the health service.
Results: The cost of providing the risk-stratification strategy was calculated to be £16.45 for the Tyrer-Cuzick survey approach, £21.82 for the Tyrer-Cuzick with Volpara breast-density measurement, and £102.22 for the Tyrer-Cuzick with Volpara breast-density measurement and SNP testing.
Limitations: This study did not use formal expert elicitation methods to synthesize estimates.
Conclusion: The costs of risk prediction using a survey and breast density measurement were low, but adding SNP testing substantially increases costs. Implementation issues present in the trial may also significantly increase the cost of risk prediction.
Implications: This is the first study to robustly estimate the cost of risk-stratification for breast cancer screening. The cost of risk prediction using questionnaires and automated breast density measurement was low, but full economic evaluations including accurate costs are required to provide evidence of the cost-effectiveness of risk-stratified breast cancer screening.
Highlights: Economic evaluations have suggested that risk-stratified breast cancer screening may be a cost-effective use of resources in the United Kingdom.Current estimates of the cost of risk stratification are based on pragmatic assumptions.This study provides estimates of the cost of risk stratification using 3 strategies and when these strategies are implemented perfectly and imperfectly in the health system.The cost of risk stratification is relatively low unless single nucleotide polymorphisms are included in the strategy.
Background. To explore preferred and actual involvement in chemotherapy decision making among stage II and III colon cancer (CC) patients by sociodemographic, interpersonal, and intrapersonal communication factors. Methods. Cross-sectional exploratory study collecting self-reported survey data from stage II and III CC patients from 2 cancer centers located in northern Manhattan. Results. Of 88 patients approached, 56 completed the survey. Only 19.3% reported shared involvement in their chemotherapy decisions. We observed significant differences in preferred involvement by gender, with women preferring more physician-controlled decisions. CC patients with higher levels of decisional self-efficacy significantly preferred shared decisions (F = 4.4 [2], P = 0.02). Actual involvement in decisions differed by race (physician controlled 33% for White v. 67% for Other, P < 0.01), age (shared control 18% for ≤55 y, 55% for 55-64 y, and 27% for 65+ y, P = 0.04), and perception of choice (shared control 73% "yes" v. 27% "no,"P = 0.02). Actual or preferred involvement did not differ by stage. Significantly higher levels of medical mistrust (discrimination t = 2.8 [50], P = 0.01; lack of support t = 3.6 [49], P < 0.01), and lower levels of decisional self-efficacy (t = 2.5 [49], P = 0.01) were reported among women. Discussion. Reports of shared involvement around chemotherapy decisions is limited among CC patients. Factors influencing preferred versus actual chemotherapy decision making are complex and may differ; hence, more research is needed to understand and address factors contributing to discordance between preferred and actual involvement in chemotherapy decision making for CC patients.
Highlights: Shared involvement around chemotherapy decisions remains limited for patients diagnosed with colon cancer.Sociodemographic (age, race, gender), interpersonal (medical mistrust), and intrapersonal (decisional self-efficacy, perception of choice) factors that influence preferred involvement in chemotherapy decision making may differ from those influencing actual involvement in chemotherapy decision making.Shared involvement in chemotherapy decisions may look different than currently conceptualized, notably when uncertainty around the benefits exists.
Background. Existing colorectal cancer (CRC) screening models mostly focus on the adenoma pathway of CRC development, overlooking the serrated neoplasia pathway, which might result in overly optimistic screening predictions. In addition, Bayesian inference methods have not been widely used for model calibration. We aimed to develop a CRC screening model accounting for both pathways, calibrate it with approximate Bayesian computation (ABC) methods, and validate it with large CRC screening trials. Methods. A discrete event simulation (DES) of the CRC natural history (DECAS) was constructed using the adenoma and serrated pathways in R software. The model simulates CRC-related events in a specific birth cohort through various natural history states. Calibration took advantage of 74 prevalence data points from the German screening colonoscopy program of 5.2 million average-risk participants using an ABC method. CRC incidence outputs from DECAS were validated with the German national cancer registry data; screening effects were validated using 17-y data from the UK Flexible Sigmoidoscopy Screening sigmoidoscopy trial and a German screening colonoscopy cohort study. Results. The Bayesian calibration rendered 1,000 sets of posterior parameter samples. With the calibrated parameters, the observed age- and sex-specific CRC prevalences from the German registries were within the 95% DECAS-predicted intervals. Regarding screening effects, DECAS predicted a 41% (95% intervals 30%-51%) and 62% (95% intervals 55%-68%) reduction in 17-y cumulative CRC mortality for a single screening sigmoidoscopy and colonoscopy, respectively, falling within 95% confidence intervals reported in the 2 clinical studies used for validation. Conclusions. We presented DECAS, the first Bayesian-calibrated DES model for CRC natural history and screening, accounting for 2 CRC tumorigenesis pathways. The validated model can serve as a valid tool to evaluate the (cost-)effectiveness of CRC screening strategies.
Highlights: This article presents a new discrete event simulation model, DECAS, which models both adenoma-carcinoma and serrated neoplasia pathways for colorectal cancer (CRC) development and CRC screening effects.DECAS is calibrated based on a Bayesian inference method using the data from German screening colonoscopy program, which consists of more than 5 million first-time average-risk participants aged 55 years and older in 2003 to 2014.DECAS is flexible for evaluating various CRC screening strategies and can differentiate screening effects in different parts of the colon.DECAS is validated with large screening sigmoidoscopy and colonoscopy clinical study data and can be further used to evaluate the (cost-)effectiveness of German colorectal cancer screening strategies.
Direct and indirect costs of care influence patients' health choices and the ability to implement those choices. Despite the significant impact of care costs on patients' health and daily lives, patient decision aid (PtDA) and shared decision-making (SDM) guidelines almost never mention a discussion of costs of treatment options as part of minimum standards or quality criteria. Given the growing study of the impact of costs in health decisions and the rising costs of care more broadly, in fall 2021 we organized a symposium at the Society for Medical Decision Making's annual meeting. The focus was on the role of cost information in PtDAs and SDM. Panelists gave an overview of work in this space at this virtual meeting, and attendees engaged in rich discussion with the panelists about the state of the problem as well as ideas and challenges in incorporating cost-related issues into routine care. This article summarizes and extends our discussion based on the literature in this area and calls for action. We recommend that PtDA and SDM guidelines routinely include a discussion of direct and indirect care costs and that researchers measure the frequency, quality, and response to this information.
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