Background Sacubitril/valsartan improves health outcomes for heart failure with reduced ejection fraction relative to angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, but it ...carries higher out-of-pocket costs. Neither the impact of cost nor how to integrate cost into medical decisions is well studied. Methods and Results To evaluate the impact of out-of-pocket costs and a novel cost-priming intervention on willingness to take sacubitril/valsartan for heart failure with reduced ejection fraction, participants with self-reported heart disease were surveyed using the online Ipsos Knowledge Panel. Participants were presented with a modified decision aid for sacubitril/valsartan and then, in a 3×2 factorial design, randomly assigned to 1 of 3 cost conditions ($10, $50, or $100/month) and to a control group or cost-priming intervention, defined by being asked questions about their financial situation before learning about the benefits of sacubitril/valsartan. Of the 1013 participants included in the analysis, 85% of respondents were willing to take sacubitril/valsartan at $10, 62% at $50, and 33% at $100 (
<0.0001). In a multivariable logistic regression model, participants were more likely to take sacubitril/valsartan at $10 versus $100 (odds ratio OR, 14.3 95% CI, 9.4-21.8) and $50 compared with $100 (OR, 3.6 95% CI, 2.5-5.1). Overall, participants in the cost-primed group were more willing to take sacubitril/valsartan than those not primed to consider their financial situation (63% versus 56%,
=0.04). There was no statistically significant interaction between cost conditions and cost priming. Perceived benefit of sacubitril/valsartan over angiotensin-converting enzyme inhibitors or angiotensin receptor blockers decreased as cost increased but did not vary by cost priming. Conclusions Commonly encountered out-of-pocket costs of sacubitril/valsartan may impact individuals' willingness to take the medication even when recommended by their physicians. Priming individuals to consider personal finances before learning about the drug increased willingness to take sacubitril/valsartan.
There is limited data regarding how clinicians operationalize shared decision-making (SDM) with athletes with cardiovascular diagnoses. This study was designed to explore sports cardiologists' ...conceptions of SDM and approaches to sports eligibility decisions.
20 sports cardiologists were interviewed by telephone or video conference from October 2022 to May 2023. Qualitative descriptive analysis was conducted with the transcripts.
All participants endorsed SDM for eligibility decisions, however, SDM was defined and operationalized heterogeneously. Only 6 participants specifically referenced eliciting patient preferences during SDM. Participants described variable roles for the physician in SDM and variable views on athletes' understanding, perception, and tolerance of risk. Participants thresholds for prohibitive annual risk of sudden cardiac death ranged from <1 % to >10 %.
These findings reinforce the general acceptance of SDM for sports eligibility decisions and highlight the need to better understand this process and identify the most effective approach for operationalization.
Transcatheter mitral valve repair for functional mitral regurgitation: Evaluating the evidence Gelijns, Annetine C.; Moskowitz, Alan J.; O'Gara, Patrick T. ...
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
11/2021, Letnik:
162, Številka:
5
Journal Article, Conference Proceeding
Recenzirano
Odprti dostop
Two trials (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation Trial and Percutaneous Repair with the MitraClip ...Device for Severe Functional/Secondary Mitral Regurgitation Trial) were published in 2018 evaluating the effectiveness and safety of transcatheter repair for patients with heart failure with significant functional mitral regurgitation, which yielded different results. This article reviews the strength of the evidence, differences in trial designs, ethical and implementation implications, and delineates future research needs to help guide the appropriate dissemination of transcatheter repair for functional patients with mitral regurgitation.
The National Heart, Lung, and Blood Institute convened a workshop of interdisciplinary experts to address these objectives.
Transcatheter repair of functional mitral regurgitation can provide significant benefits in terms of heart failure hospitalizations, survival, and quality of life when appropriate heart failure candidates with moderate to severe or severe mitral regurgitation while on optimal guideline-directed medical therapy can be identified. Key ingredients for success are preoperative evaluation and management and postoperative care by an interdisciplinary heart team.
Given the discordance observed between trials, ongoing innovation in patient management, and potential expansion of indications for use, the evidence base must be expanded to optimize appropriate implementation of this complex therapy. This will require more complete capture of outcome data in real-world settings for all eligible candidates whether or not they receive this therapy. Inevitably, the indications for use of this therapy will expand, as will the devices and therapeutic approaches for this population, necessitating the study of comparative effectiveness through randomized trials or observational studies. Moreover, given the substantial variations in care delivery, conducting implementation research to delineate characteristics of the optimal care model would be of benefit.
Shared decision-making has become a new focus of health policy. Though its core elements are largely agreed upon, there is little consensus regarding which outcomes to prioritize for policy-mandated ...shared decision-making.
In this paper, we address how the COVID-19 pandemic has impacted informed consent for clinical research through examining experiences within Clinical and Translation Science Award (CTSA) ...institutions. We begin with a brief overview of informed consent and the challenges that existed prior to COVID-19. Then, we discuss how informed consent processes were modified or changed to address the pandemic, consider what lessons were learned, and present research and policy steps to prepare for future research and public health crises. The experiences and challenges for CTSA institutions offer an important perspective for examining what we have learned about informed consent and determining the next steps for improving the consent process.
Background Informed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to ...participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data are crucial to making consent processes more context appropriate. Methods and Results We conducted a qualitative interview study with 27 patients and surrogates enrolled in acute myocardial infarction and stroke trials in the past 5 years. Purposive sampling from the P-CARE (Patient-Centered Approaches to Research Enrollment) study was based on participant characteristics and responses to initial patient-centered interviews. In-depth interviews used open-ended questions to explore factors influencing consent experiences. Qualitative descriptive analysis was performed utilizing a multilevel coding strategy. Participants identified specific researcher behaviors as important, including expressions of respect, professionalism, and nonpressuring communication. Participants preferred consent conversations focused on risks/benefits and the trial protocol. They had varying views of consent forms and communicated several reasons the form was valuable unrelated to informational content. Participants also valued postenrollment interactions as opportunities to ask questions and learn about the study. Conclusions Barriers to consent in acute myocardial infarction and stroke trials are unavoidable, but participants identified productive ways to demonstrate respect for patients during enrollment conversations. These include key researcher behaviors, concentrating consent discussions on what participants find most important, and structured postenrollment follow-up.
Informed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. ...Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown.
Two online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial.
Likelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002).
These findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment.
Shared decision-making is mandated for patients receiving primary prevention implantable cardioverter defibrillators (ICDs). Less attention has been paid to generator exchange decisions, although at ...the time of generator exchange, patients' risk of sudden cardiac death, risk of procedural complications, quality of life, or prognosis may have changed. This study was designed to explore how patients make ICD generator exchange decisions.
Emory Healthcare patients with primary prevention ICDs implanted from 2013 to 2021 were recruited to complete in-depth interviews exploring perspectives regarding generator exchanges. Interviews were conducted in 2021. Transcribed interviews were qualitatively coded using multilevel template analytic methods. To investigate benefit thresholds for pursuing generator exchanges, patients were presented standard-gamble type hypothetical scenarios where their ICD battery was depleted but their 5-year risk of sudden cardiac death at that time varied (10%, 5%, and 1%).
Fifty patients were interviewed; 18 had a prior generator exchange, 16 had received ICD therapy, and 17 had improved left ventricular ejection fraction. As sudden cardiac death risk decreased from 10% to 5% to 1%, the number of participants willing to undergo a generator exchange decreased from 48 to 42 to 33, respectively. Responses suggest that doctor's recommendations are likely to substantially impact patients' decision-making. Other drivers of decision-making included past experiences with ICD therapy and device implantation, as well as risk aversion. Therapeutic inertia and misconceptions about ICD therapy were common and represent substantive barriers to effective shared decision-making in this context.
Strong defaults may exist to continue therapy and exchange ICD generators. Updated risk stratification may facilitate shared decision-making and reduce generator exchanges in very low-risk patients, especially if these interventions are directed toward clinicians. Interventions targeting phenomena such as therapeutic inertia may be more impactful and warrant exploration in randomized trials.
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