Medical Decision Making最新文献

BackgroundSurvival extrapolation is used to predict patients' overall survival beyond clinical trial follow-up. It can significantly affect the results of a cost-effectiveness analysis and subsequent pricing and reimbursement decisions. However, selecting an appropriate model involves subjectivity, leading to discrepancies between methods submitted by manufacturers and those accepted by health technology assessment (HTA) agencies. This review describes the acceptance and criticisms of overall survival extrapolation methods by HTA agencies in England, France, and Australia.MethodsElectronic searches conducted on September 4, 2022, identified HTA evaluations for oncology therapies indicated for the treatment of solid tumors from the National Institute for Health and Care Excellence (NICE) in England, the Haute Autorité de Santé (HAS) in France, and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, published between August 2017 and August 2022. Information on the overall survival extrapolation model submitted by the manufacturer was extracted. The acceptance decision of the HTA agency and the key criticisms were also recorded.ResultsA total of 140 HTA evaluations were identified. The initial overall survival extrapolation method was accepted in 21% of cases. The most frequently cited criticisms related to a lack of or inappropriate incorporation of treatment effect waning over time (31%). Other criticisms included choice of parametric distribution, in which multiple distributions were often considered plausible (24%); immaturity of survival data (15%); and concerns about the proportional hazards assumption, which lacked clinical validity (8%).ConclusionThis review highlights the low acceptance of survival extrapolation methods and the areas of discordance between manufacturers and HTA agencies in England, France, and Australia. Low acceptance rates of survival extrapolation methods by HTA bodies can affect pricing and reimbursement decisions of new therapies, delaying patient access.HighlightsThis review found that the survival extrapolation methods initially submitted by companies were accepted in only 21% of cases.The most common areas of discordance between companies and HTA agencies were inappropriate modeling of treatment effect over time, choice of parametric distribution, immaturity of survival data, and concerns about the proportional hazards assumption.There is a need for more consistent guidance on the selection of an appropriate extrapolation method to limit the inherent subjectivity surrounding survival curve selection.

BackgroundStatin Choice is a shared decision-making encounter tool embedded in the electronic health record.ObjectiveTo describe the association between the use of Statin Choice, statin prescriptions by clinicians, prescription fills (primary adherence), and statin adherence at 12 mo (secondary adherence).DesignObservational cohort study at the Cleveland Clinic Health System.SubjectsStatin-naïve adults aged 40 to 75 y with a 10-y atherosclerotic cardiovascular disease (ASCVD) risk of ≥5% and a primary care appointment between January 2020 and July 2021.Main MeasuresThe primary exposure was the use of Statin Choice during a clinical encounter. We measured whether the use of Statin Choice was associated with statin prescriptions. We measured statin adherence based on pharmacy fill data at 60 d (primary adherence) and 12 mo (secondary adherence). We used mixed-effects logistic regression to estimate the adjusted odds of statin prescriptions and adherence at the 3 time points by the use of Statin Choice.Key ResultsAmong 17,001 statin-naïve patients, 13% viewed Statin Choice and 7% were prescribed a statin. The median ASCVD risk was 10%. Patients who were shown Statin Choice had 9.04 higher odds of being prescribed a statin compared with patients not shown Statin Choice (95% confidence interval [CI]: 7.86-10.4). Among patients prescribed a statin, the use of Statin Choice was associated with 5.75 higher odds of primary adherence compared with usual care (95% CI: 4.22-7.83). At 12 mo, Statin Choice use was significantly associated with adherence in the unadjusted analysis (OR: 1.58; 95% CI: 1.05-2.08) but was not significant after adjustment for patient factors. Patients shown Statin Choice had an average of 12 mg/dL reduction in low-density lipoprotein cholesterol at 12 mo (95% CI: -16 mg/dL, -10) compared with those not shown Statin Choice.ConclusionIn this observational study, Statin Choice use was strongly associated with statin prescription and fills and weakly associated with adherence to statins for up to 1 y. A randomized trial is needed to confirm causality.HighlightsStatin Choice is an electronic health record-embedded shared decision-making encounter tool available for free in many health care systems.Small randomized controlled trials have found modest associations between the use of Statin Choice and statin adherence using patient-reported data.In our large study using pharmacy fill data, clinician use of Statin Choice during a medical encounter was associated with significantly greater patient adherence with statins up to 1 y later.Exposure to Statin Choice was associated with a significant reduction in low-density lipoprotein cholesterol over 1 y.

BackgroundIncorporating clinician and patient perspectives in the measurement of shared decision making (SDM) is aligned with SDM's inherently dyadic nature. There are no tools measuring SDM in pediatrics from multiple perspectives. The objective of this study was to develop a tool to measure SDM from the perspectives of both clinicians and parents of young children.DesignWe used a stepwise iterative approach to tool development beginning with de novo item generation and followed by augmentation of the item pool by adapting items from existing instruments. After the study team removed redundant items, 3 parents and 3 SDM experts rated the remaining items for their ability to capture SDM in pediatrics; items with the lowest mean ratings were removed. To assess the preliminary tool's face validity, usability, and item understandability, we pretested it, revising it iteratively, with sequential cohorts of English-speaking parents and clinicians from 2 US children's hospitals.ResultsWe generated an initial list of 28 items for the parent and clinician versions of the tool, which we reduced to 20 items after preliminary review. After review by parents and SDM experts, we cut 9 items and added 1 additional item for a total of 12 items. We pretested the preliminary tool with 31 clinicians and 30 parents across 3 sequential cohorts. The final tool contained 12 items and an optional free-text item.LimitationsAll participants were English speaking, limiting its generalizability.ConclusionsWe have developed a usable preliminary tool for measuring the dyadic process of SDM in pediatrics.ImplicationsThis tool represents an important first step toward addressing the measurement of SDM in pediatrics from multiple perspectives.HighlightsIn this study, we have developed the first shared decision making (SDM) tool specifically for use with parents of young children.Although further study is needed to determine the psychometric properties of this tool, it has the potential to address an important gap in our ability to measure SDM in pediatrics from multiple perspectives.

BackgroundValues clarification methods may be particularly appropriate for decision support in lung cancer screening (LCS), for which patients must consider a complex tradeoff of benefits and harms. Values clarification methods that are explicit and use theory-based methods may best support decision making.PurposeTo characterize values clarification methods in decision support tools for LCS and explore associations with behavioral and decisional outcomes.Data SourcesPubMed, Cochrane Library, CINAHL, APA PsycINFO, and Embase, supplemented with gray literature and hand searches.Study SelectionStudies evaluating patient-facing LCS decision support tools.Data ExtractionWe extracted information on study characteristics and the decision support tools evaluated in each study, including method of values clarification (explicit, implicit, or none). Study quality was evaluated using an adapted version of the SUNDAE Checklist.Data SynthesisWe identified 48 studies (10,233 participants) evaluating 32 unique decision support tools for LCS. More than 80% of tools included values clarification methods, split between explicit (n = 13) and implicit (n = 13) methods. Only 1 explicit values clarification used a theory-based method. Meta-analysis of randomized controlled trials indicated that using a decision support tool doubled the odds of receiving LCS (pooled odds ratio 1.98, 95% confidence interval 1.21-3.25, 9 studies), a pattern driven by increased uptake of screening following use of tools with explicit or no values clarification. Studies lacking values clarification were of lower quality than those with explicit or implicit methods (P = 0.04).LimitationsAlmost no tools applied theory-based methods for explicit values clarification, limiting conclusions about their impact.ConclusionsLCS decision support tools routinely incorporate values clarification methods and appear to enhance screening uptake. However, theory-based values clarification methods, which may further improve decision support quality, remain underutilized.HighlightsValues clarification is a core aspect of shared decision making. It may be especially valuable for decision making regarding lung cancer screening (LCS), as patients must weigh a complex balance of benefits and harms.This systematic review identified 48 studies assessing 32 unique decision support tools for LCS. More than 80% of these tools incorporated values clarification methods, with an equal distribution of explicit and implicit methods.Among the subset of studies using a randomized controlled trial, the use of a decision support tool doubled the odds of an individual undergoing LCS.Decision support tools designed to support shared decision making in LCS commonly incorporate values clarification methods. However, they infrequently use theory-based methods, which are increasingly thought to provide high-quality decision support.

BackgroundRecent studies show that low-risk pancreatic cysts may require less frequent monitoring. Future guidelines will likely adapt their recommendations accordingly. Our goal was to explore the willingness of individuals with a low-risk pancreatic cyst to undergo less frequent surveillance and to identify associated characteristics with such willingness.MethodsThis is a side study of the international PACYFIC study, which prospectively collects data on cyst surveillance, including questionnaires to assess participants' attitude toward surveillance. Individuals with low-risk cysts at baseline, without given standardized information by the study protocol, were enrolled. Their responses to the baseline question, "Would you prefer less frequent surveillance? Yes/No," were correlated with baseline characteristics using multivariable logistic regression, namely, age, country of residence, symptoms, medical and family history, time since first cyst detection, and Hospital Anxiety Depression Scale score.ResultsOf the 215 participants included from the Netherlands (n = 185) and Italy (n = 30), only 47 (22%) were willing to undergo less surveillance. Characteristics positively associated with this willingness were older age (odds ratio [OR] 1.87 per 10 y, 95% confidence interval [CI]: 1.15-3.04) and Italian residency (OR 16.35, 95% CI: 5.65-47.31). A medical history of cancer was negatively associated (OR 0.28, 95% CI: 0.09-0.90). No other associations were observed.ConclusionMost participants appear unwilling to undergo less frequent cyst surveillance. Older age and residing in Italy were associated with a greater willingness toward less rigorous surveillance, while a history of cancer did the opposite. Identifying which individuals are hesitant to undergo less frequent surveillance may help clinicians tailor their counseling and can support implementation of future guideline with fewer surveillance recommendations.HighlightsMost low-risk individuals were reluctant toward less frequent pancreatic cyst surveillance.Older age and residency in Italy were associated with a higher willingness.A medical history of cancer was associated with an unwillingness.Standardized patient information may increase the willingness, but such information has yet to be developed.

PurposeIt is unclear whether caregivers help or hinder patients' involvement in decision making and understanding of illness. We thus investigated the extent to which caregivers' preferred level of patient involvement in decision making and understanding of treatment goals are associated with those of patients.MethodsWe used survey data from 229 patients with metastatic cancer and their family caregivers living in Singapore spanning 2 y prior to the patient's death. We used mixed-effects regressions to investigate the associations between 1) caregiver-preferred level of patient involvement (t_-1) and patient preferred and perceived level of involvement in decision making at subsequent assessments (t₁) and 2) patient and caregiver understanding of treatment goals at the same assessments (t₁).ResultsCaregivers who preferred higher levels of patient involvement in decision making at t_-1 were more likely to have patients who also preferred higher levels of involvement (odds ratio [OR] = 1.19; P = 0.03) and who perceived experiencing higher levels of involvement in decision making (OR = 1.24; P < 0.01) at t₁. Compared with an uncertain understanding of treatment goals, caregivers who had an inaccurate understanding at t₁ were more likely to have patients who had an inaccurate understanding (relative risk ratio [RRR] = 8.56; P = 0.03), and caregivers who had an accurate understanding at t₁ were more likely to have patients with an accurate understanding (RRR = 3.02; P = 0.01) at t₁.ConclusionOur findings suggest that caregiver preferences for patient involvement in decision making and understanding of treatment goals are significantly associated with those of patients. Enhancing caregiver education and involvement may be pivotal in improving patient participation and comprehension in the context of metastatic cancer care.HighlightsPatients of caregivers who preferred higher levels of patient involvement in decision making at earlier time points were more likely to prefer and experience higher levels of involvement in decision making at subsequent assessments.Patients of caregivers with an inaccurate understanding of treatment goals were more likely to have an inaccurate understanding, while patients of caregivers with an accurate understanding were also more likely to have an accurate understanding.

IntroductionEffective risk communication is essential for medical professionals to assist patients to make informed decisions. However, risk communication can be challenging as patients receive ambiguous and conflicting information.ObjectivesThis study aimed to examine how uncertainty influences individuals' perceptions and preferences and interacts with message framing in a medical treatment decision scenario.MethodsThe present study included a large representative sample of Australians (N = 805). A randomized experiment was conducted presenting a scenario about hypothetical COVID-19 treatment alternatives with varying uncertainty and framing in treatment information.ResultsThe results showed that conflicting information and loss framing had deleterious effects on participants' willingness to take a treatment and trust in the sources providing the information, compared with information that was precise, ambiguous, or in a gain frame. The effects could be stronger among participants who are risk averse, anxious, and native language speakers.ConclusionThe findings highlight that patients may be more averse to a treatment option and reduce their trust in medical professionals when they are provided with ambiguous information and particularly when information that conflicts with other sources including other medical professionals. It is important for medical professionals to be aware of other information patients have sourced that may conflict with information provided by the medical professionals during the consultation and to assist patients with high levels of risk aversion and anxiety in their decision making.HighlightsConflicting information and loss framing had deleterious effects on participants' willingness to take a treatment.Conflicting information and loss framing also reduced participants' trust in the sources of the information.The deleterious effects were stronger among participants who were native language speakers and were risk averse and anxious.

BackgroundResearch suggests that the method used to determine voluntary consent (i.e., opt-in versus opt-out policies) greatly affects the number of registered organ donors in various countries. Although the concept of organ transplantation is broadly supported, the relatively low percentage of registered donors in opt-in countries is puzzling. We suggest that deviating from the status quo (such as signing an organ donor card in opt-in countries or removing oneself from the list of registered donors in opt-out countries) heightens one's sense of vulnerability.DesignWe examined our prediction in 2 online experiments involving participants from the United States (studies 1 and 2), which has an opt-in organ-donation policy, and from the United Kingdom (study 2), a country that has recently changed its policy to opt out.ResultsIn study 1, registered organ donors perceived their vulnerability as greater after being reminded of their decision, but vulnerability perceptions were not affected by such a reminder among nondonors who upheld the status quo. In study 2, imagining oneself making an organ donation decision that deviates from the status quo (signing a commitment under an opt-in policy or removing oneself from the registered donors list under an opt-out policy) increased participants' perceived personal vulnerability.ConclusionsThe decision to become an organ donor may affect individuals' sense of physical vulnerability, depending on their country's donation policy. Potentially, deviating from the status quo may curtail willingness for organ donation. Understanding the psychological barriers to organ donation may help overcome them by presenting the issue in a manner that takes such perceptions into account. We recommend future research to explore whether this heightened sense of vulnerability potentially deters organ donation in opt-in countries.HighlightsThe decision to become an organ donor may affect individuals' sense of physical vulnerability, depending on their country's donation policy (opt in versus opt out).Registered organ donors perceived their vulnerability as greater after being reminded of their decision, but vulnerability perceptions were not affected by such a reminder among nondonors who upheld the status quo.Imagining oneself making an organ donation decision that deviates from the status quo (signing a commitment under an opt-in policy or removing oneself from the registered donors list under an opt-out policy) increased participants' perceived personal vulnerability.Future research is needed to examine whether this heightened sense of vulnerability affects actual organ donation decisions.

Decision aids (DA) are more likely to be adopted if co-developed with stakeholders and culturally adapted. Using the DEVELOPTOOLS Reporting Checklist, we describe a process for rapid co-development of a culturally adapted DA prototype for population-wide cancer-screening programs. Our systematic, collaborative, and iterative methodology had 7 phases: 1) set up the process by adopting best governance practices (e.g., identify and engage stakeholders, adapt our collaborative DA design process, validate development process), with governance comprising 20 individuals from a wide range of sectors including at least 2 citizens; 2) identify and analyze existing DAs relevant to the cancerscreening of interest by conducting a systematic review; 3) share results with stakeholders and make recommendations; 4) formulate Quebec-specific DA content and consult stakeholders including users by conducting e-Delphi surveys; 5) co-design a prototype with stakeholders, including users, following international DA standards; 6) translate the DA using translation-back translation approaches and deploy; and 7) knowledge mobilization (KMb) using end-of-grant and integrated KMb activities. Using the User-Centred Design 11-Item Measure (UCD-11), our proposed process scored 10 of 11 on the UCD-11. Overall, we expect this new co-developed process to ensure that good-quality, user-centered, and culturally adapted DAs for cancer screening are produced within reasonable timeframes. We also expect it to foster the adoption of the DAs.HighlightsWe report on a 7-step process for collaborating with various stakeholders to create a culturally adapted decision aid (DA) prototype for deciding about cancer screening in Quebec, Canada.The process includes: ○ Making sure the DA prototype design includes users and other interested parties and reflects their needs, perceptions, values, and preferences.○ Finding and analyzing existing DAs on cancer screening to decide what ours should include○ Respecting international standards and criteria for DA design○ Repeated rounds of expert consensus about the exact content, with revisions between each roundThis method could help the rapid creation of DAs shaped by users' interests and will ultimately encourage shared decision making.

IntroductionSocietal preferences over different health states are used to guide service planning, but there has been little investigation of treatment preferences at the end of life. This study aimed to examine population preferences for active treatment or palliation for cancer patients when life expectancy is limited and the relative importance of time spent in hospital or with functional limitation.MethodsWe used a discrete choice experiment that presented respondents with a series of hypothetical patients who had died, describing their last few months of life. Respondents selected the end-of-life alternative they thought best. Data were collected from 1,502 Australian adults participating in an online survey panel. Latent class analysis was used to identify groups with different preference patterns.ResultsFour preference groups were identified along with an additional group that we termed inattentive, as they appeared to respond at random. Among the 1,070 respondents assigned to 1 of the 4 preference groups, 33.5% favored longer overall survival regardless of how that time was spent; 26.1% were willing to accept a shorter survival time for less time in the hospital or completely incapacitated at home, and they had a stronger preference for palliative care in older patients; 22.5% strongly supported the use of palliative care regardless of the age of the patients, preferring less time in the hospital or time at home with any functional limitations; and 17.9% had a strong preference to not use palliative care.ConclusionsOur results show distinct heterogeneity in population preferences for end-of-life care. Policy goals and service planning should acknowledge this heterogeneity and provide end-of-life support services that offer the flexibility to enhance patient choice. Many current funding approaches are not consistent with the philosophy of patient-centered care. Policy makers can and should be exploring innovative approaches to improve efficiency and equity.HighlightsSocial preferences, based on a general population survey, vary across palliative and active care approaches.Preferences for palliative care and willingness to tolerate time in hospital and time at home with activity limitations varied within the groups willing to trade quality and quantity of life.Policy, resource allocation, and funding methods should accommodate this variability.