RESUMEN
This Viewpoint describes the benefits and challenges of active surveillance as a clinical approach to monitor low-risk cancers with favorable prognoses.
RESUMEN
Importance: Decisions about whether to stop colorectal cancer (CRC) screening tests in older adults can be difficult and may benefit from shared decision-making (SDM). Objective: To evaluate the effect of physician training in SDM and electronic previsit reminders (intervention) vs reminders only (comparator) on receipt of the patient-preferred approach to CRC screening and on overall CRC screening rates of older adults at 12 months. Design, Setting, and Participants: This was a secondary analysis of the Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED) cluster randomized clinical trial. In the PRIMED trial, primary care physicians (PCPs) from 36 primary care practices in Massachusetts and Maine were enrolled between May 1 and August 30, 2019, and were randomized to the intervention group or the comparator group. Patients aged 76 to 85 years who were overdue for CRC screening and did not have a prior diagnosis of CRC enrolled between October 21, 2019, and April 8, 2021. Data analysis was performed between May 24, 2022, and May 10, 2023. Interventions: Primary care physicians in the intervention group completed an SDM training course and received previsit reminders of patients eligible for CRC testing discussion, whereas PCPs in the comparator group received reminders only. Main Outcomes and Measures: The primary outcome was concordance, or the percentage of patients who received their preferred screening approach. Postvisit surveys were administered to assess patient preference for testing, and electronic health record review was used to assess CRC testing at 12 months. Heterogeneity of treatment effect analyses examined interaction between study groups and different factors on concordance rates. Results: This study included 59 physicians and 466 older adults. Physicians had a mean (SD) age of 52.7 (9.4) years and a mean (SD) of 21.6 (10.2) years in practice; 30 (50.8%) were women and 16 (27.1%) reported prior training in SDM. Patients had a mean (SD) age of 80.3 (2.8) years; 249 (53.4%) were women and 238 (51.1%) reported excellent or very good overall health. Patients preferred stool-based tests (161 [34.5%]), followed by colonoscopy (116 [24.8%]) or no further screening (97 [20.8%]); 75 (16.1%) were not sure. The distribution of patient preferences was similar across groups (P = .36). At 12 months, test uptake was also similar for both the intervention group (29 [12.3%] for colonoscopy, 62 [26.3%] for stool-based tests, and 145 [61.4%] for no testing) and the comparator group (32 [13.9%] for colonoscopy, 35 [15.2%] for stool-based tests, and 163 [70.9%] for no testing; P = .08). Approximately half of patients in the intervention group received their preferred approach vs the comparator group (115 of 226 [50.9%] vs 103 of 223 [46.2%]; P = .47). Heterogeneity of treatment effect analyses found significantly higher rates with the intervention vs the comparator for patients with a strong intention to follow through with the preferred approach (adjusted odds ratio [AOR], 1.79 [95% CI, 1.11-2.89]; P = .02, P = .05 for interaction) and for patients who reported more than 5 minutes (AOR, 3.27 [95% CI, 1.25-8.59]; P = .02, P = .05 for interaction) of discussion with their PCP regarding screening. Higher rates were also observed among patients who reported 2 to 5 minutes of discussion with their PCP, although this finding was not significant (AOR, 1.89 [95% CI, 0.93-3.84]; P = .08, P = .05 for interaction). Conclusions and Relevance: In this secondary analysis of a cluster randomized clinical trial, approximately half of older patients received their preferred approach to CRC screening. Physician training in SDM did not result in higher concordance rates overall but may have benefitted some subgroups. Future work to refine and evaluate clinical decision support (in the form of an electronic advisory or reminder) as well as focused SDM skills training for PCPs may promote high-quality, preference-concordant decisions about CRC testing for older adults. Trial Registration: ClinicalTrials.gov Identifier: NCT03959696.
Asunto(s)
Neoplasias Colorrectales , Toma de Decisiones Conjunta , Detección Precoz del Cáncer , Humanos , Neoplasias Colorrectales/diagnóstico , Anciano , Femenino , Masculino , Detección Precoz del Cáncer/métodos , Detección Precoz del Cáncer/estadística & datos numéricos , Anciano de 80 o más Años , Sistemas Recordatorios , Massachusetts , Atención Primaria de Salud , Médicos de Atención Primaria/educación , Médicos de Atención Primaria/estadística & datos numéricos , MaineRESUMEN
Genomic tumor testing (GTT) is an emerging technology aimed at identifying variants in tumors that can be targeted with genomically matched drugs. Due to limited resources, rural patients receiving care in community oncology settings may be less likely to benefit from GTT. We analyzed GTT results and observational clinical outcomes data from patients enrolled in the Maine Cancer Genomics Initiative (MCGI), which provided access to GTTs; clinician educational resources; and genomic tumor boards in community practices in a predominantly rural state. 1603 adult cancer patients completed enrollment; 1258 had at least one potentially actionable variant identified. 206 (16.4%) patients received a total of 240 genome matched treatments, of those treatments, 64% were FDA-approved in the tumor type, 27% FDA-approved in a different tumor type and 9% were given on a clinical trial. Using Inverse Probability of Treatment Weighting to adjust for baseline characteristics, a Cox proportional hazards model demonstrated that patients who received genome matched treatment were 31% less likely to die within 1 year compared to those who did not receive genome matched treatment (HR: 0.69; 95% CI: 0.52-0.90; p-value: 0.006). Overall, GTT through this initiative resulted in levels of genome matched treatment that were similar to other initiatives, however, clinical trials represented a smaller share of treatments than previously reported, and "off-label" treatments represented a greater share. Although this was an observational study, we found evidence for a potential 1-year survival benefit for patients who received genome matched treatments. These findings suggest that when disseminated and implemented with a supportive infrastructure, GTT may benefit cancer patients in rural community oncology settings, with further work remaining on providing genome-matched clinical trials.
RESUMEN
OBJECTIVE: Understand how physicians' uncertainty tolerance (UT) in clinical care relates to their personal characteristics, perceptions and practices regarding shared decision making (SDM). METHODS: As part of a trial of SDM training about colorectal cancer screening, primary care physicians (n = 67) completed measures of their uncertainty tolerance in medical practice (Anxiety subscale of the Physician's Reactions to Uncertainty Scale, PRUS-A), and their SDM self-efficacy (confidence in SDM skills). Patients (N = 466) completed measures of SDM (SDM Process scale) after a clinical visit. Bivariate regression analyses and multilevel regression analyses examined relationships. RESULTS: Higher UT was associated with greater physician age (p = .01) and years in practice (p = 0.015), but not sex or race. Higher UT was associated with greater SDM self-efficacy (p < 0.001), but not patient-reported SDM. CONCLUSION: Greater age and practice experience predict greater physician UT, suggesting that UT might be improved through training, while UT is associated with greater confidence in SDM, suggesting that improving UT might improve SDM. However, UT was unassociated with patient-reported SDM, raising the need for further studies of these relationships. PRACTICE IMPLICATIONS: Developing and implementing training interventions aimed at increasing physician UT may be a promising way to promote SDM in clinical care.
Asunto(s)
Toma de Decisiones Conjunta , Médicos de Atención Primaria , Humanos , Lactante , Incertidumbre , Toma de Decisiones , Participación del Paciente , Relaciones Médico-PacienteRESUMEN
INTRODUCTION: The U.S. Preventive Services Task Force recommends that all adults be screened for alcohol use and those with hazardous use be provided a brief discussion. However, it is unclear to what extent healthcare providers screen for and discuss alcohol use with cancer survivors. METHODS: Frequency and content of alcohol prescreening and provider discussion about alcohol use was examined comparing cancer survivors and non-cancer controls in the 2015-2019 National Survey on Drug Use and Health. Multivariable Poisson regression with robust variance and complex survey procedures were used to estimate prevalence ratios (PR) adjusted for demographic characteristics. Data were analyzed in 2022. RESULTS: The prevalence of alcohol prescreening in a healthcare setting (78.4% vs 74.3%; PR: 1.05 [95% CI: 1.03-1.08]) and self-report of an in-person discussion about alcohol use with a healthcare provider (58.7% vs 55.0%; PR: 1.07 [95% CI: 1.03-1.10]) was higher among cancer survivors compared with non-cancer controls. Among those who had a discussion, the prevalence of being asked about drinking quantity was higher among cancer survivors compared with non-cancer controls (PR: 1.05 [95% CI: 1.02-1.08]). Among cancer survivors who reported usually consuming 3+ drinks per day in the past 30 days, only 15% (95% CI: 10.8-20.5) reported that a healthcare provider advised them to cut down on their drinking. CONCLUSIONS: Cancer survivors are being screened for alcohol use, but heavier users are infrequently advised by healthcare providers to reduce their consumption.
Asunto(s)
Consumo de Bebidas Alcohólicas , Supervivientes de Cáncer , Neoplasias , Humanos , Masculino , Femenino , Persona de Mediana Edad , Consumo de Bebidas Alcohólicas/epidemiología , Supervivientes de Cáncer/estadística & datos numéricos , Supervivientes de Cáncer/psicología , Adulto , Neoplasias/epidemiología , Anciano , Estados Unidos/epidemiología , Tamizaje Masivo/estadística & datos numéricos , Relaciones Médico-Paciente , Adulto Joven , Autoinforme , PrevalenciaRESUMEN
Multicancer detection (MCD) tests use a single, easily obtainable biospecimen, such as blood, to screen for more than one cancer concurrently. MCD tests can potentially be used to improve early cancer detection, including cancers that currently lack effective screening methods. However, these tests have unknown and unquantified benefits and harms. MCD tests differ from conventional cancer screening tests in that the organ responsible for a positive test is unknown, and a broad diagnostic workup may be necessary to confirm the location and type of underlying cancer. Among two prospective studies involving greater than 16,000 individuals, MCD tests identified those who had some cancers without currently recommended screening tests, including pancreas, ovary, liver, uterus, small intestine, oropharyngeal, bone, thyroid, and hematologic malignancies, at early stages. Reported MCD test sensitivities range from 27% to 95% but differ by organ and are lower for early stage cancers, for which treatment toxicity would be lowest and the potential for cure might be highest. False reassurance from a negative MCD result may reduce screening adherence, risking a loss in proven public health benefits from standard-of-care screening. Prospective clinical trials are needed to address uncertainties about MCD accuracy to detect different cancers in asymptomatic individuals, whether these tests can detect cancer sufficiently early for effective treatment and mortality reduction, the degree to which these tests may contribute to cancer overdiagnosis and overtreatment, whether MCD tests work equally well across all populations, and the appropriate diagnostic evaluation and follow-up for patients with a positive test.
Asunto(s)
Detección Precoz del Cáncer , Neoplasias , Humanos , Neoplasias/diagnóstico , Detección Precoz del Cáncer/métodos , Investigación Biomédica Traslacional , Sensibilidad y Especificidad , Tamizaje Masivo/métodosRESUMEN
Individuals with severe combined immunodeficiency (SCID), a group of rare, genetic conditions, are at risk for life-threatening illnesses unless diagnosed and treated early. Even after early identification through newborn screening, parents of children with SCID embark on a complex journey marked by a variety of informational and emotional support needs. This paper explored the types of uncertainties experienced by parents of a child with SCID diagnosed through newborn screening. We conducted semi-structured interviews with 26 parents to discuss the types of uncertainty experienced, including scientific, practical, personal, and existential. Each interview was recorded, transcribed, and coded. Using deductive and inductive content analysis, we describe the type of uncertainty experienced across each stage of the SCID journey. We found that uncertainties in the SCID journey were chronic and multifaceted. Some uncertainties were more prominent at certain points of the journey whereas others spanned multiple stages. Parents expressed a variety of negative emotional reactions to uncertainty, from anxiety, worry, and fear, to doubt, guilt, or grief, and even anger, frustration, and depression. The results speak to the need for healthcare providers to prepare parents for the SCID journey by providing resources to help manage and cope with uncertainty.
Asunto(s)
Tamizaje Neonatal , Inmunodeficiencia Combinada Grave , Recién Nacido , Niño , Humanos , Tamizaje Neonatal/métodos , Inmunodeficiencia Combinada Grave/diagnóstico , Inmunodeficiencia Combinada Grave/genética , Incertidumbre , Padres/psicología , EmocionesAsunto(s)
Supervivientes de Cáncer , Neoplasias , Humanos , Obesidad , Ejercicio Físico , Neoplasias/terapiaRESUMEN
OBJECTIVE: Identify if primary care physicians (PCPs) accurately understand patient preferences for colorectal cancer (CRC) testing, whether shared decision making (SDM) training improves understanding of patient preferences, and whether time spent discussing CRC testing improves understanding of patient preferences. METHODS: Secondary analysis of a trial comparing SDM training plus a reminder arm to a reminder alone arm. PCPs and their patients completed surveys after visits assessing whether they discussed CRC testing, patient testing preference, and time spent discussing CRC testing. We compared patient and PCP responses, calculating concordance between patient-physician dyads. Multilevel models tested for differences in preference concordance by arm or time discussing CRC. RESULTS: 382 PCP and patient survey dyads were identified. Most dyads agreed on whether CRC testing was discussed (82%). Only 52% of dyads agreed on the patient's preference. SDM training did not impact accuracy of PCPs preference diagnoses (55%v.48%,p = 0.22). PCPs were more likely to accurately diagnose patient's preferences when discussions occurred, regardless of length. CONCLUSION: Only half of PCPs accurately identified patient testing preferences. Training did not impact accuracy. Visits where CRC testing was discussed resulted in PCPs better understanding patient preferences. PRACTICE IMPLICATIONS: PCPs should take time to discuss testing and elicit patient preferences.
Asunto(s)
Neoplasias del Colon , Neoplasias Colorrectales , Médicos , Humanos , Neoplasias del Colon/diagnóstico , Neoplasias Colorrectales/diagnóstico , Detección Precoz del Cáncer/métodos , Prioridad del PacienteRESUMEN
PURPOSE: To introduce a method of inducing Bloch-Siegert shift and magnetization Transfer Simultaneously (BTS) and demonstrate its utilization for measuring binary spin-bath model parameters free pool spin-lattice relaxation ( T 1 F $$ {T}_1^{\mathrm{F}} $$ ), macromolecular fraction ( f $$ f $$ ), magnetization exchange rate ( k F $$ {k}_{\mathrm{F}} $$ ) and local transmit field ( B 1 + $$ {B}_1^{+} $$ ). THEORY AND METHODS: Bloch-Siegert shift and magnetization transfer is simultaneously induced through the application of off-resonance irradiation in between excitation and acquisition of an RF-spoiled gradient-echo scheme. Applying the binary spin-bath model, an analytical signal equation is derived and verified through Bloch simulations. Monte Carlo simulations were performed to analyze the method's performance. The estimation of the binary spin-bath parameters with B 1 + $$ {B}_1^{+} $$ compensation was further investigated through experiments, both ex vivo and in vivo. RESULTS: Comparing BTS with existing methods, simulations showed that existing methods can significantly bias T 1 $$ {T}_1 $$ estimation when not accounting for transmit B 1 $$ {B}_1 $$ heterogeneity and MT effects that are present. Phantom experiments further showed that the degree of this bias increases with increasing macromolecular proton fraction. Multi-parameter fit results from an in vivo brain study generated values in agreement with previous literature. Based on these studies, we confirmed that BTS is a robust method for estimating the binary spin-bath parameters in macromolecule-rich environments, even in the presence of B 1 + $$ {B}_1^{+} $$ inhomogeneity. CONCLUSION: A method of estimating Bloch-Siegert shift and magnetization transfer effect has been developed and validated. Both simulations and experiments confirmed that BTS can estimate spin-bath parameters ( T 1 F $$ {T}_1^{\mathrm{F}} $$ , f $$ f $$ , k F $$ {k}_{\mathrm{F}} $$ ) that are free from B 1 + $$ {B}_1^{+} $$ bias.
Asunto(s)
Encéfalo , Imagen por Resonancia Magnética , Imagen por Resonancia Magnética/métodos , Encéfalo/diagnóstico por imagen , Fantasmas de Imagen , Método de Montecarlo , AlgoritmosRESUMEN
BACKGROUND: The COVID-19 pandemic has engendered widespread fear and skepticism about recommended risk-reducing behaviors including vaccination. Health agencies are faced with the need to communicate to the public in ways that both provide reassurance and promote risk-reducing behaviors. Communication strategies that promote prosocial (PS) values and hope are being widely used; however, the existing research on the persuasiveness of these strategies has offered mixed evidence. There is also very little research examining the comparative effectiveness of PS and hope-promoting (HP) strategies. OBJECTIVE: The aim of this study is to evaluate the comparative effectiveness of PS and HP messages in reassuring the public and motivating COVID-19 risk-reducing behaviors. METHODS: A web-based factorial experiment was conducted in which a diverse sample of the US public was randomized to read messages which adapted existing COVID-19 information from a public website produced by a state government public health department to include alternative framing language: PS, HP, or no additional framing (control). Participants then completed surveys measuring COVID-19 worry and intentions for COVID-19 risk-reducing behaviors and vaccination. RESULTS: COVID-19 worry was unexpectedly higher in the HP than in the control and PS conditions. Intentions for COVID-19 risk-reducing behaviors did not differ between groups; however, intentions for COVID-19 vaccination were higher in the HP than in the control condition, and this effect was mediated by COVID-19 worry. CONCLUSIONS: It appears that HP communication strategies may be more effective than PS strategies in motivating risk-reducing behaviors in some contexts but with the paradoxical cost of promoting worry.
RESUMEN
BACKGROUND: Few studies have investigated how doctors in Norway deal with medical uncertainty. The purpose of the study was to explore how first year junior doctors perceive and manage uncertainty in clinical practice. MATERIAL AND METHODS: Ten first year junior doctors at two hospitals in Norway were recruited for interviews following response pattern analysis from a mapping questionnaire. The interviews were analysed using systematic text condensation. RESULTS: The analysis revealed three main themes in the interviews: dealing with medical uncertainty, personal response to medical uncertainty, and working environment, feedback and preparation. Within all three thematic areas, the informants used the words 'certain/uncertain' and 'secure/insecure' interchangeably. INTEPRETATION: The first year junior doctors struggled with the inherent uncertainty of medicine and felt a marked sense of insecurity, particularly at the start of their training period. How the doctors were welcomed in the workplace and the feedback they were given were important factors. Their undergraduate medical education had not sufficiently prepared the first year junior doctors for how to deal with medical uncertainty in clinical practice.
Asunto(s)
Médicos , Humanos , Incertidumbre , Cuerpo Médico de Hospitales/educación , Investigación Cualitativa , Lugar de Trabajo , Actitud del Personal de SaludRESUMEN
Health behaviors are critical determinants of the well-being of individuals and populations, and understanding the determinants of these behaviors has been a major focus of research. One important determinant that has received little direct attention in past health research is uncertainty: a complex phenomenon that pertains not only to scientific issues regarding the diagnosis, prognosis, prevention, and treatment of health problems, but also to personal issues regarding other important health-related concerns. Here, we make the case for greater attention to uncertainty in health behavior theory and research, and especially to personal uncertainties. We discuss three exemplary types of personal uncertainty-value uncertainty, capacity uncertainty, and motive uncertainty-which relate, respectively, to moral values, capacities to enact or change behaviors, and the motives and intentions of other persons or institutions. We argue that that personal uncertainties such as these influence health behaviors, but their influence has historically been obscured by a focus on other constructs such as self-efficacy and trust. Reconceptualizing and investigating health behavior as a problem of uncertainty can advance both our understanding of the determinants of healthy behaviors and our ability to promote them.
RESUMEN
BACKGROUND: Discordance between physicians' and patients' prognostic perceptions in advanced cancer care threatens informed medical decision-making and end-of-life preparation, yet this phenomenon is poorly understood. We sought to: (1) describe the extent and direction of prognostic discordance, patients' prognostic information preferences in cases of prognostic discordance, and physicians' awareness of prognostic discordance; and (2) examine which patient, physician, and caregiver factors predict prognostic discordance. MATERIALS AND METHODS: Oncologists and advanced cancer patients (median survival ≤12 months; n = 515) from 7 Dutch hospitals completed structured surveys in a cross-sectional study. Prognostic discordance was operationalized by comparing physicians' and patients' perceptions of the likelihood of cure, 2-year mortality risk, and 1-year mortality risk. RESULTS: Prognostic discordance occurred in 20% (likelihood of cure), 24%, and 35% (2-year and 1-year mortality risk) of physician-patient dyads, most often involving patients with more optimistic perceptions than their physician. Among patients demonstrating prognostic discordance, the proportion who preferred not knowing prognosis varied from 7% (likelihood of cure) to 37% (1-year mortality risk), and 45% (2-year mortality risk). Agreement between physician-perceived and observed prognostic discordance or concordance was poor (kappa = 0.186). Prognostic discordance was associated with several patient factors (stronger fighting spirit, self-reported absence of prognostic discussions, an information source other than the healthcare provider), and greater physician-reported uncertainty about prognosis. CONCLUSION: Up to one-third of the patients perceive prognosis discordantly from their physician, among whom a substantial proportion prefers not knowing prognosis. Most physicians lack awareness of prognostic discordance, raising the need to explore patients' prognostic information preferences and perceptions, and to tailor prognostic communication.
Asunto(s)
Neoplasias , Médicos , Humanos , Pronóstico , Prevalencia , Estudios Transversales , Relaciones Médico-Paciente , Neoplasias/diagnóstico , Neoplasias/epidemiología , Neoplasias/terapiaRESUMEN
PURPOSE: Social determinants of health, such as rurality, income, and education, may widen health disparities by driving variation in patients' knowledge and perceptions of medical interventions. This effect may be greatest for medical technologies that are hard to understand and less accessible. This study explored whether knowledge and perceptions (expectations and attitudes) of patients with cancer toward large-panel genomic tumor testing (GTT), an emerging cancer technology, vary by patient rurality independent of other socioeconomic characteristics (education and income). METHODS: Patients with cancer enrolled in a large precision oncology initiative completed surveys measuring rurality, sociodemographic characteristics, and knowledge and perceptions of GTT. We used multivariable linear models to examine differences in GTT knowledge, expectations, and attitudes by patient rurality, education, and income level. Models controlled for age, sex and clinical cancer stage and type. RESULTS: Rural patients had significantly lower knowledge of GTT than urban patients using bivariate models (P = .025). However, this association disappeared when adjusting for education and income level: patients with lower educational attainment and lower income had lower knowledge and higher expectations (P ≤ .002), whereas patients with higher income had more positive attitudes (P = .005). Urban patients had higher expectations of GTT compared with patients living in large rural areas (P = .011). Rurality was not associated with attitudes. CONCLUSION: Patients' education and income level are associated with knowledge, expectations, and attitudes toward GTT, whereas rurality is associated with patient expectations. These findings suggest that efforts to promote adoption of GTT should focus on improving knowledge and awareness among individuals with low education and income. These differences may lead to downstream disparities in GTT utilization, which should be explored in future research.
Asunto(s)
Neoplasias , Humanos , Neoplasias/diagnóstico , Neoplasias/genética , Medicina de Precisión , Encuestas y Cuestionarios , Factores Socioeconómicos , GenómicaRESUMEN
INTRODUCTION: Rural residents are at elevated risk for lung cancer and related mortality, yet limited research has explored their perspectives on cancer risk or prevention options, including tobacco treatment and lung cancer screening with low-dose computed tomography (LDCT). This qualitative study examined attitudes and beliefs among rural adults who reported either current or former tobacco use, as well as disengagement from the health care system. METHODS: We conducted 6 focus groups with rural Maine residents at risk for lung cancer based on age and smoking history (n = 50). Semistructured interviews explored participants' knowledge, perceptions, and attitudes regarding lung cancer risk, LDCT screening, and patient provider relationships. Inductive qualitative analysis of interview transcripts was conducted to identify key themes. RESULTS: Participants were cognizant of their elevated lung cancer risk, yet few were aware of LDCT screening. When informed about LDCT, most participants indicated a willingness to undergo screening, although a substantial minority indicated reluctance related to fear and fatalism. Participants generally expressed the belief that relationships with a primary care provider could support their health and identified several provider factors that influence these relationships, including attention and time for patient concerns; respect and non-judgmental, nonstigmatizing attitudes; treating patients as individuals; and provider empathy and emotional support. CONCLUSIONS: Rural residents at risk for lung cancer report limited knowledge and substantial ambivalence regarding LDCT screening, but identify provider behaviors that may promote patient-provider relationships and greater engagement with their health. More research is needed to confirm these findings and understand how to help rural residents and healthcare providers work together to reduce lung cancer risk.
Asunto(s)
Neoplasias Pulmonares , Adulto , Humanos , Neoplasias Pulmonares/prevención & control , Neoplasias Pulmonares/diagnóstico , Detección Precoz del Cáncer/métodos , Tomografía Computarizada por Rayos X/métodos , Grupos Focales , Atención a la SaludRESUMEN
Blood-based assays using various technologies and biomarkers are in commercial development for the purpose of detecting multiple cancer types concurrently at an early stage of disease. These multicancer early detection (MCED) assays have the potential to improve the detection of cancers, particularly those for which no current screening modality exists. However, the unknown clinical benefits and harms of using MCED assays for cancer screening necessitate the development and implementation of a randomized controlled trial (RCT) to ascertain their clinical effectiveness. This was the consensus of experts at a National Cancer Institute-hosted workshop to discuss initial design concepts for such a trial. Using these assays to screen simultaneously for multiple cancers poses novel uncertainties for patient care compared with conventional screening tests for single cancers, such as establishing the diagnostic workup to confirm the presence of cancer at any organ site; clarifying appropriate follow-up for a positive assay for which there is no definitive diagnosis; identifying potential harms such as overdiagnosis of indolent disease; determining clinically effective and efficient strategies for disseminating MCED screening in real-world practice; and understanding the ethical implications, such as potentially alleviating or exacerbating existing health disparities. These assays present new and complex challenges for designing an RCT. Issues that emerged from the meeting centered around the need for a flexibly designed, clinical utility RCT to rigorously capture the evidence required to fully understand the net benefit of this promising technology. Specific topic areas were endpoints, screening protocols, recruitment, diagnostic pathway, pilot phase, data elements, specimen collection, and ethical considerations.
Asunto(s)
Detección Precoz del Cáncer , Neoplasias , Humanos , Biomarcadores , Detección Precoz del Cáncer/métodos , Neoplasias/diagnóstico , Proyectos de Investigación , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto , Congresos como AsuntoRESUMEN
BACKGROUND: For adults aged 76-85, guidelines recommend individualizing decision-making about whether to continue colorectal cancer (CRC) testing. These conversations can be challenging as they need to consider a patient's CRC risk, life expectancy, and preferences. OBJECTIVE: To promote shared decision-making (SDM) for CRC testing decisions for older adults. DESIGN: Two-arm, multi-site cluster randomized trial, assigning physicians to Intervention and Comparator arms. Patients were surveyed shortly after the visit to assess outcomes. Analyses were intention-to-treat. PARTICIPANTS AND SETTING: Primary care physicians affiliated with 5 academic and community hospital networks and their patients aged 76-85 who were due for CRC testing and had a visit during the study period. INTERVENTIONS: Intervention arm physicians completed a 2-h online course in SDM communication skills and received an electronic reminder of patients eligible for CRC testing shortly before the visit. Comparator arm received reminders only. MAIN MEASURES: The primary outcome was patient-reported SDM Process score (range 0-4 with higher scores indicating more SDM); secondary outcomes included patient-reported discussion of CRC screening, knowledge, intention, and satisfaction with the visit. KEY RESULTS: Sixty-seven physicians (Intervention n=34 and Comparator n=33) enrolled. Patient participants (n=466) were on average 79 years old, 50% with excellent or very good self-rated overall health, and 66% had one or more prior colonoscopies. Patients in the Intervention arm had higher SDM Process scores (adjusted mean difference 0.36 (95%CI (0.08, 0.64), p=0.01) than in the Comparator arm. More patients in the Intervention arm reported discussing CRC screening during the visit (72% vs. 60%, p=0.03) and had higher intention to follow through with their preferred approach (58.0% vs. 47.1, p=0.03). Knowledge scores and visit satisfaction did not differ significantly between arms. CONCLUSION: Physician training plus reminders were effective in increasing SDM and frequency of CRC testing discussions in an age group where SDM is essential. TRIAL REGISTRATION: The trial is registered on clinicaltrials.gov (NCT03959696).
Asunto(s)
Neoplasias Colorrectales , Médicos , Humanos , Anciano , Detección Precoz del Cáncer , Neoplasias Colorrectales/diagnóstico , Participación del Paciente , Toma de DecisionesRESUMEN
The COVID-19 crisis has exposed the public to considerable scientific uncertainty, which may promote vaccine hesitancy among individuals with lower tolerance of uncertainty. In a national sample of US adults in May-June 2020, we examined how both perceptions of uncertainty about COVID-19 and trait-level differences in tolerance of uncertainty arising from various sources (risk, ambiguity, and complexity) are related to vaccine hesitancy-related outcomes, including trust in COVID-19 information, COVID-19 vaccine intentions, and beliefs that COVID-19 vaccines should undergo a longer testing period before being released to the public. Overall, perceptions of COVID-19 uncertainty were not associated with trust in information, vaccine intentions, or beliefs about vaccine testing. However, higher tolerance of risk was associated with lower intentions to get vaccinated, and lower tolerance of ambiguity was associated with lower intentions to get vaccinated and preferring a longer period of vaccine testing. Critically, perceptions of COVID-19 uncertainty and trait-level tolerance for uncertainty also interacted as predicted, such that greater perceived COVID-19 uncertainty was more negatively associated with trust in COVID-19 information among individuals with lower tolerance for risk and ambiguity. Thus, although perceptions of uncertainty regarding COVID-19 may not reduce trust and vaccine hesitancy for all individuals, trait-level tolerance of uncertainty arising from various sources may have both direct and moderating effects on these outcomes. These findings can inform public health communication or other interventions to increase COVID-19 vaccination uptake.