Rhetoric of research: a call for renaming the clinical research partnership.

OBJECTIVE: Research cannot advance without the voluntary participation of human participants. SUMMARY OF ARGUMENTS: Full participation of research participants is often restrained by the traditional research framework, which relegates them to a predefined participant role and allows them only quasi-scripted opportunities to contribute to research processes and outcomes. Terms commonly used to refer to research participants do not reflect their significant role or send a clear message about their value. The authors propose a shift from 'patient participant' to 'participant partner.' Recognition of the true partnership between the participant and the research team, from the consent process to the trial's end, will encourage and enable fuller participation. CONCLUSION: Changing the rhetoric of research in the labelling of research participants will require dialogue. 'Respect for persons' demands it, and the research process will be better for it.

"There's not enough studies": Views of black breast and ovarian cancer patients on research participation.

BACKGROUND: Black breast and ovarian cancer patients are underrepresented in clinical cancer trials disproportionate to the prevalence of these cancers in Black females. Historically, lower enrollment has been attributed to individualized factors, including medical mistrust, but more recently structural factors, including systemic racism, have received additional scrutiny. We interviewed Black women with a personal or family history of breast and ovarian cancer to understand their views and experiences related to research participation. METHODS: Qualitative interviews were conducted via telephone or video conference and transcribed verbatim. Transcripts were qualitatively analyzed for iterative themes related to the offer and participation in cancer clinical trials and research studies, impact on cancer care, and recommendations to increase enrollment of Black patients. RESULTS: Sixty-one Black women completed an interview. Participants expressed that Black women are underrepresented in cancer research, and that this negatively impacted their own care. Many cited past historical abuses, including the Tuskegee syphilis trial, as a potential factor for lower enrollment but suggested that lower enrollment was better understood in the context of the entirety of their healthcare experiences, including present-day examples of patient mistreatment or dismissal. Participants suggested that proactive community engagement, transparency, and increased representation of Black research team members were strategies likely to foster trust and bolster research participation. CONCLUSION(S): Medical mistrust is only a partial factor in the lower participation of Black patients in cancer research. Researchers should implement the strategies identified by our participants to promote diverse enrollment and ensure that Black patients are included in future therapeutic advances.

Willingness of Women with Endometriosis Planning to Undergo IVF to Participate in a Randomized Clinical Trial and the Effects of the COVID-19 Pandemic on Potential Participation.

The Pre-IVF Treatment with a GnRH Antagonist in Women with Endometriosis (PREGnant) Trial (clinicaltrials.gov no. NCT04173169) was designed to test the hypothesis that 60-day pre-treatment with an oral GnRH antagonist in women with documented endometriosis and planning an IVF cycle will result in a superior live birth rate to placebo. Eight hundred fourteen women are required from 4 national sites. To determine the feasibility of using an electronic medical record (EMR)-based strategy to recruit 204 participants at the Colorado site, we conducted a survey of women within the UCHealth system. Eligible women, identified using relevant ICD-10 codes, were invited to complete a 6-question survey to assess planned utilization of IVF, potential interest in participation, and whether delays in treatment due to COVID-19 would influence their decision to participate. Of 6354 age-eligible women with an endometriosis diagnosis, 421 had a concurrent infertility diagnosis. After eliminating duplicates, 212 were emailed a survey; 76 (36%) responded, 6 of whom reported no endometriosis diagnosis. Of the remaining 70, 29 (41%) were planning fertility treatment; only 19 planned IVF. All 19 expressed interest in participation. COVID-19 delays in treatment were not considered as a factor affecting participation by 8/19; the remaining 11 felt that it would "somewhat" affect their decision. None reported that they would not consider participation because of COVID-19. EMR-based recruitment for an endometriosis clinical trial is feasible although the overall yield of participants is low. Delays in treatment due to COVID-19 did not appear to overly influence potential recruitment.

Del discurso capitalista al neoliberalismo: apuntes sobre la producción del sujeto / From capitalist discourse to neoliberalism: notes on the production of the subject

Las economías globalizadas de mercado conllevan consecuencias de inequidad social basadas en la privatización de sectores laborales y productivos donde los sujetos se involucran en modos singulares de concebirse y construir la realidad. Propone el psicoanálisis lacaniano que el discurso capitalista deshace el lazo social, al obrar con una lógica que consiste en gozar del consumo que supone felicidad. El neoliberalismo promueve un sistema aparentemente horizontal que incorpora las capacidades empoderadas del sujeto promoviéndolo a ser emprendedor y, por tanto, convirtiendo a cada uno en gestor de su propio bienestar pero impedidos para forjar lazos solidarios. No porque el sujeto pueda consumir más, queda desprovisto de su falta constitutiva; paradójicamente, la subjetividad neoliberal reproduce incesantemente un vacío que socava el reconocimiento de las diferencias del otro

Globalized market economies entail consequences of social inequality, based on the privatization of labor and productive sectors, where subjects engage in unique ways of conceiving and constructing reality. Lacanian psychoanalysis proposes that capitalist discourse undoes the social bond, by acting with a logic that consists in enjoying the consumption that supposes happiness. Neoliberalism promotes an apparently horizontal system that incorporates the empowered capacities of the subject by promoting him to be an entrepreneur and, therefore, turning each one into a manager of his own well-being, but prevented from forging solidarity ties. Not because the subject can consume more, he is devoid of his constitutive lack; paradoxically, neoliberal subjectivity incessantly reproduces a vacuum that undermines the recognition of each other's differences.

Research Involving Participants With Impaired Consent Capacity: An Examination of Methods to Determine Capacity to Consent.

OBJECTIVE: To examine methods of assessing consent capacity in research protocols involving participants with impaired consent capacity, and examine instruments used to evaluate research consent capacity. METHODS: A retrospective review of 330 active research protocols involving participants lacking capacity to consent over a 10-year period (January 1, 2009, through March 1, 2019) was conducted to collect protocol characteristics (medical specialty, level of risk and type of study, consent and assent procedures, and type of vulnerable or protected population). Methods to assess consent capacity are described, and instruments to assess consent capacity are summarized. RESULTS: The specialties most frequently involving participants with impaired consent capacity in research were Neurology (27.3%), Critical Care (16.7%), and Surgery (10%). Type of studies are observational (43.9%), clinical trials (33%), chart review (11.5%), biobank (6.1%), and biomarker (5.5%). Minimal risk (53.3%) outnumbered greater than minimal risk (46.7%) studies. Most obtained written informed consent (77%) and assent (40.9%). The most common method to assess consent capacity was direct assessment by investigators (32.7%). Only 86 (26%) studies used instruments to assess consent capacity. Of the 13 instruments used, the most common was the Evaluation of Decision-Making Capacity for Consent to Act as a Research Subject, and is the only instrument that assesses all four components of decisional capacity: understanding, appreciation, reasoning, and choice. CONCLUSION: Generally, there was lack of uniformity in determining capacity to consent to research participation. Very few studies used instruments to assess consent capacity. Institutional review boards can provide greater guidance for research consent capacity determination.

Effectiveness and Ethics of Incentives for Research Participation: 2 Randomized Clinical Trials.

Importance: Incentivizing research participation is controversial and variably regulated because of uncertainty regarding whether financial incentives serve as undue inducements by diminishing peoples' sensitivity to research risks or unjust inducements by preferentially increasing enrollment among underserved individuals. Objective: To determine whether incentives improve enrollment in real randomized clinical trials (RCTs) or serve as undue or unjust inducements. Design, Setting, and Participants: Two RCTs of incentives that were embedded in 2 parent RCTs, 1 comparing smoking cessation interventions (conducted at smoking cessation clinics in 2 health systems) and 1 evaluating an ambulation intervention (conducted across wards of the Hospital of the University of Pennsylvania) included all persons eligible for the parent trials who did not have prior knowledge of the incentives trials. Recruitment occurred from September 2017 to August 2019 for the smoking trial and January 2018 through May 2019 for the ambulation trial; data were analyzed from January 2020 to July 2020. Interventions: Patients were randomly assigned to incentives of $0, $200, or $500 for participating in the smoking cessation trial and $0, $100, or $300 for the ambulation trial. Main Outcomes and Measures: The primary outcome of each incentive trial was the proportion of people assigned to each recruitment strategy that consented to participate. Each trial was powered to test the hypotheses that incentives served neither as undue inducements (based on the interaction between incentive size and perceived research risk, as measured using a 10-point scale, on the primary outcome), nor unjust inducements (based on the interaction between incentive size and participants' self-reported income). Noninferiority methods were used to test whether the data were compatible with these 2 effects of incentives and superiority methods to compare the primary and other secondary outcomes. Results: There were a total of 654 participants (327 women [50.0%]; mean [SD] age, 50.6 [12.1] years; 394 Black/African American [60.2%], 214 White [32.7%], and 24 multiracial individuals [3.7%]) in the smoking trial, and 642 participants (364 women [56.7%]; mean [SD] age, 46.7 [15.6] years; 224 Black/African American [34.9%], 335 White [52.2%], and 5 multiracial individuals [0.8%]) in the ambulation trial. Incentives significantly increased consent rates among those in the smoking trial in 47 of 216 (21.8%), 78 of 217 (35.9%), and 104 of 221 (47.1%) in the $0, $200, and $500 groups, respectively (adjusted odds ratio [aOR] for each increase in incentive, 1.70; 95% CI, 1.34-2.17; P < .001). Incentives did not increase consent among those in the ambulation trial: 98 of 216 (45.4%), 102 of 212 (48.1%), and 92 of 214 (43.0%) in the $0, $100, and $300 groups, respectively (aOR, 0.88; 95% CI, 0.64-1.22; P = .45). In neither trial was there evidence of undue or unjust inducement (upper confidence limits of ORs for undue inducement, 1.15 and 0.99; P < .001 showing noninferiority; upper confidence limits of ORs for unjust inducement, 1.21 and 1.26; P = .01 and P < .001, respectively). There were no significant effects of incentive size on the secondary outcomes in either trial, including time spent reviewing the risk sections of consent forms, perceived research risks, trial understanding, perceived coercion, or therapeutic misconceptions. Conclusions and Relevance: In these 2 randomized clinical trials, financial incentives increased trial enrollment in 1 of 2 trials and did not produce undue or unjust inducement or other unintended consequences in either trial. Trial Registration: ClinicalTrials.gov Identifier: NCT02697799.

O próximo e o ódio: questões da psicanálise na atualidade / The neighbour and the hatred: Our time psychoanalysis' issues / El prójimo y el odio: cuestiones de psicoanálisis en la actualidad

Na contemporaneidade, acirram-se os efeitos estruturais do mal-estar da civilização discutidos por Freud. Nos deteremos naquele que advém da relação com o próximo. Quando a pulsão de morte reproduz uma forma de insatisfação reiterada, o tratamento desse excesso pode recair sobre o corpo do outro que guarda uma diferença de gozo. A maneira como o gozo íntimo ganha forma de estrangeiro habitando, como o pior, o próximo, configura uma suposição de suspeita que sustenta um modo de laço social. Lacan chega a falar que, na matriz de toda fraternidade, está a segregação. Formamos comunidades de gozo e excluímos toda a forma diferente de satisfação que nos ameace. Na atualidade, com o acúmulo do capital, aliado aos efeitos do avanço científico, algo se modificou no laço social e produziu, dessa matriz, uma nova gramática de inimigo, que denominamos sujeito suposto suspeito como um dos nomes do pior. Contra essa lógica, a emancipação e as saídas possíveis que a psicanálise aponta para uma vida em-comum, na solidão da responsabilidade do gozo de cada um, dizem respeito às soluções éticas que enfrentam, desde dentro, todo o idealismo superegóico.

In contemporary times, the structural effects discussed by Freud in the malaise of civilization are intensified. We will dwell on what comes from the relationship with the neighbor. When the death drive reproduces a form of repeated dissatisfaction, the treatment for this excess can fall on the body of the other who has a different satisfaction. The way intimate satisfaction takes shape as a foreigner inhabiting, like the worst, the neighbor, determines an assumption of suspicion that supports a mode of social bonding. Lacan even says that segregation is in the matrix of all fraternity. We create communities of satisfaction and exclude any different form of enjoyment that threatens us. Currently, the accumulation of capital mixed with the effects of scientific advancement brought changes to social bonding and produced, from this matrix, a new grammar for what's enemy. Suspected subject is a naming for the worse. Against this logic, the emancipation and the possible solutions that psychoanalysis suggests for a life in common, in the solitude and responsibility of each one's satisfaction, concerns the ethical solutions that face, from within, all the superegoic idealism.

En los tiempos contemporáneos, los efectos estructurales del malestar de la civilización discutidos por Freud se intensifican. Nos detendremos en el que proviene de la relación con los demás. Cuando el pulsion de la muerte reproduce una forma de insatisfacción repetida, el tratamiento de este exceso puede recaer en el cuerpo del otro, que tiene una diferencia de goce. El goce íntimo es proyectado como extranjero habitando en el prójimo, como si encarnara lo peor que proyectaba sobre él, configura una presunción de sospecha que sustenta un modo de vínculo social. Lacan llega al extremo de decir que la segregación está en el corazón de cada fraternidad. Formamos comunidades de goce y excluimos cualquier forma diferente de satisfacción que nos amenace. Hoy en día, con la acumulación de capital, combinada con los efectos del avance científico, algo ha cambiado en el vínculo social y ha producido, a partir de esta matriz, una nueva gramática del enemigo, que llamamos el sujeto supuesto sospechoso como uno de los nombres de lo peor. Contra esta lógica, la emancipación y las posibles soluciones que apunta el psicoanálisis en una vida común, en la soledad de la responsabilidad del goce de cada uno, conciernen a las soluciones éticas que enfrentan, desde adentro, todo idealismo superegoico.

Taming Time: Configuring Cancer Patients as Research Subjects.

This article explores how incurable cancer patients in the affluent Danish welfare state are recruited to clinical trials. We show that patients' impending death constitutes their potential for being configured as research subjects. To produce valuable data, patients who enroll in trials and health care professionals must engage in daily "time practices" that prolong the threshold between life and death. When death becomes inevitable, the limit of configuring dying cancer patients as research subjects is reached. Navigating this temporal logic, health care professionals balance the boundary between patients' instrumental worth as research subjects and their intrinsic worth as dying cancer patients. Whereas previous studies have critically uncovered how clinical trials operate at socioeconomic margins, we point to the ways in which clinical trials operate through temporal margins. We argue that clinical trials are dependent on configuring marginal societal spaces and marginal bodies from which to produce knowledge.

The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute.

Interventions designed to limit the spread of coronavirus disease 2019 (COVID-19) are having profound effects on the delivery of health care, but data showing the impact on oncology clinical trial enrollment, treatment, and monitoring are limited. We prospectively tracked relevant data from oncology clinical trials at Dana-Farber Cancer Institute from January 1, 2018, to June 30, 2020, including the number of open trials, new patient enrollments, in-person and virtual patient visits, dispensed investigational infusions, dispensed or shipped oral investigational agents, research biopsies, and blood samples. We ascertained why patients came off trials and determined on-site clinical research staffing levels. We used 2-sided Wilcoxon rank sum tests to assess the statistical significance of the reported changes. Nearly all patients on interventional treatment trials were maintained, and new enrollments continued at just under one-half the prepandemic rate. The median number of investigational prescriptions shipped to patients increased from 0 to 74 (range = 22-107) per week from March to June 2020. The median number of telemedicine appointments increased from 0 to 107 (range = 33-267) per week from March to June 2020. Research biopsies and blood collections decreased dramatically after Dana-Farber Cancer Institute implemented COVID-19-related policies in March 2020. The number of research nurses and clinical research coordinators on site also decreased after March 2020. Substantial changes were required to safely continue clinical research during the pandemic, yet we observed no increases in serious adverse events or major violations related to drug dosing. Lessons learned from adapting research practices during COVID-19 can inform industry sponsors and governmental agencies to consider altering practices to increase operational efficiency and convenience for patients.

Cuerpo y síntoma: diferencias en las concepciones según el discurso médico y el discurso analítico ¿Qué cuerpo para el psicoanálisis? / Body and symptom: conception´s differences according the medical discourse and the analytical discourse. What body for the psychoanalysis?

En el siguiente trabajo se intentará realizar un recorrido sobre las diferentes consideraciones del "cuerpo" para la teoría psicoanalítica, buscando diferenciarlas de la conceptualización que sostiene el discurso de la ciencia. Desde una perspectiva clínica con orientación psicoanalítica freudiana-lacaniana, se realizarán las caracterizaciones necesarias y posibles de los diferentes cuerpos que el psicoanálisis intenta abordar en su práctica; intentando así demostrar que hay un cuerpo que se ubica mucho más allá del campo de universales que sostiene el discurso científico

The following paper is an attempt to review the different conceptualizations of the 'body' for the psychoanalytical theory, seeking to point out the differences that this concept has for the medical discourse. From a clinical Freudian Lacanian perspective, there will be performed the necessary and possible characterizations of the different issues the psychoanalysis seeks to adress in its practice; thus, trying to demonstrate there's a body located beyond the universal field supported by the scientific discourse

Implementation considerations for offering personal genomic risk information to the public: a qualitative study.

BACKGROUND: Genomic risk information, based on common genomic susceptibility variants associated with risk of complex diseases such as cancer, may be incorporated into personalised prevention and screening strategies. We aimed to engage with members of the public, who are important stakeholders in this process, to further inform program development and other implementation outcomes such as acceptability and appropriateness. METHODS: Semi-structured interviews were undertaken with 30 participants (aged 24-69 years, 50% female) recruited from a pilot trial in which they received personalised genomic risk information for melanoma. We explored participants' views and attitudes towards offering general personal genomic risk information to the broader population. The data were analysed thematically. RESULTS: Two overarching themes relevant to implementation considerations were identified. Firstly, participants' preferences for accepting an offer of genomic risk information were based on family history, disease incidence and the possibility of prevention. Secondly, participants felt that the processes for offering risk information should be based on individual preferences, triaged according to risk and be supported by a health professional trained in genomics. CONCLUSIONS: Participants felt that offering personal genomic risk information to the general population to inform prevention and early detection recommendations is acceptable, particularly for common, complex conditions such as cancer. Understanding participants' preferences for receiving genomic risk information will assist with communication strategies and health workforce planning. We anticipate that these findings will contribute to the development of implementation strategies for incorporating genomic risk information into routine clinical practice.

Formative research to design a culturally-appropriate cancer clinical trial education program to increase participation of African American and Latino communities.

BACKGROUND: Addressing knowledge deficiencies about cancer clinical trials and biospecimen donation can potentially improve participation among racial and ethnic minorities. This paper describes the formative research process used to design a culturally-appropriate cancer clinical trials education program for African American and Latino communities. We characterized community member feedback and its integration into the program. METHODS: We incorporated three engagement approaches into the formative research process to iteratively develop the program: including community-based organization (CBO) leaders as research team members, conducting focus groups and cognitive interviews with community members as reviewers/consultants, and interacting with two community advisory groups. An iterative-deductive approach was used to analyze focus group data. Qualitative data from advisory groups and community members were compiled and used to finalize the program. RESULTS: Focus group themes were: 1) Community Perspectives on Overall Presentation; 2) Community Opinions and Questions on the Content of the Presentation; 3) Culturally Specific Issues to Participation in Cancer Clinical Trials; 4) Barriers to Clinical Trial Participation; and 5) Perspectives of Community Health Educators. Feedback was documented during reviews by scientific experts and community members with suggestions to ensure cultural appropriateness using peripheral, evidential, linguistic, sociocultural strategies, and constituent-involving. The final program consisted of two versions (English and Spanish) of a culturally-appropriate slide presentation with speaker notes and videos representing community member and researcher testimonials. CONCLUSIONS: Incorporating multiple community engagement approaches into formative research processes can facilitate the inclusion of multiple community perspectives and enhance the cultural-appropriateness of the programs designed to promote cancer clinical trial participation among African Americans and Latinos.

[Citizens who volunteer as participants for cancer research-results of the Seintinelles Barometer 2018]. / Ces citoyen(nes) qui se portent volontaires pour participer aux recherches dans le champ du cancer ­ résultats du Baromètre Seintinelles 2018.

INTRODUCTION: Health researchers often face difficulties related to participants' recruitment for their research. However, a new strategy emerges: offering patients-but also citizens who are not ill-the possibility to volunteer as participants to hasten research processes. The French platform "Seintinelles" aims to fulfill this goal and bring together citizens who volunteered to participate to cancer related research. The "Seintinelles Barometer" aims to describe these volunteers' profile. METHODS: The Seintinelles Barometer data were collected through a web-based auto-questionnaire proposed to the "Seintinelles" members from June 2017 to November 2018. RESULTS: The sample presents a high level of overrepresentation of women. Participants are characterized by a high level of education. About a third of the participants had suffered from cancer. Two profile of volunteers emerged: the « patients ¼ and the « supportive citizens ¼. DISCUSSION: The Seintinelles Barometer participants manifest a strong wish to be involved in cancer related research. Therefore, this platform seems to be a promising tool for the development of community-based research in the field of cancer.

How do people with rheumatoid arthritis experience participation in a smoking cessation trial: a qualitative study.

Purpose: The aim of this study was to gain more knowledge on how people with rheumatoid arthritis (RA) experienced participation in a randomized controlled trial (RCT) testing the effect of a smoking cessation intervention since this intervention have not been tested on an RA population beforeMethods: We conducted a qualitative study with semi-structured individual interviews with 12 participants from the intervention group in the RCT.Results: Through thematic analysis we identified four themes: Instilling hope for smoking cessation, referring to the initial invitation to participate in the RCT; Various components of importance in the intervention, referring to cooperation with the smoking cessation counsellor, improved carbon monoxide levels, fear of becoming addicted to nicotine replacement therapy, and suggestions for additional components in the intervention which could promote motivation; Breaking habits, referring to ongoing reflection on quitting smoking; and Increased awareness of health, arthritis and smoking, referring to the lack of information on smoking and RA from health professionals, and the impact of smoking on RA symptoms and overall health.Conclusion: The results reflect the participants' perspective on what is meaningful to them when trying to quit smoking and adds important knowledge to future smoking cessation studies in this patient group.

Are the MORECare guidelines on reporting of attrition in palliative care research populations appropriate? A systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Palliative care trials have higher rates of attrition. The MORECare guidance recommends applying classifications of attrition to report attrition to help interpret trial results. The guidance separates attrition into three categories: attrition due to death, illness or at random. The aim of our study is to apply the MORECare classifications on reported attrition rates in trials. METHODS: A systematic review was conducted and attrition classifications retrospectively applied. Four databases, EMBASE; Medline, CINHAL and PsychINFO, were searched for randomised controlled trials of palliative care populations from 01.01.2010 to 08.10.2016. This systematic review is part of a larger review looking at recruitment to randomised controlled trials in palliative care, from January 1990 to early October 2016. We ran random-effect models with and without moderators and descriptive statistics to calculate rates of missing data. RESULTS: One hundred nineteen trials showed a total attrition of 29% (95% CI 28 to 30%). We applied the MORECare classifications of attrition to the 91 papers that contained sufficient information. The main reason for attrition was attrition due to death with a weighted mean of 31.6% (SD 27.4) of attrition cases. Attrition due to illness was cited as the reason for 17.6% (SD 24.5) of participants. In 50.8% (SD 26.5) of cases, the attrition was at random. We did not observe significant differences in missing data between total attrition in non-cancer patients (26%; 95% CI 18-34%) and cancer patients (24%; 95% CI 20-29%). There was significantly more missing data in outpatients (29%; 95% CI 22-36%) than inpatients (16%; 95% CI 10-23%). We noted increased attrition in trials with longer durations. CONCLUSION: Reporting the cause of attrition is useful in helping to understand trial results. Prospective reporting using the MORECare classifications should improve our understanding of future trials.

The challenges of making informed decisions about treatment and trial participation following a cancer diagnosis: a qualitative study involving adolescents and young adults with cancer and their caregivers.

BACKGROUND: Limited attention has been paid to adolescents and young adults' (AYA's) experiences in the aftermath of a cancer diagnosis, despite this being a time when potentially life-changing decisions are made. We explored AYA's and caregivers' experiences of, and views about, making treatment and trial participation decisions following a cancer diagnosis, in order to understand, and help facilitate, informed treatment decision-making in this age group. METHODS: Interviews were undertaken with 18 AYA diagnosed, or re-diagnosed, with cancer when aged 16-24 years, and 15 parents/caregivers. Analysis focused on the identification and description of explanatory themes. RESULTS: Most AYA described being extremely unwell by the time of diagnosis and, consequently, experiencing difficulties processing the news. Distress and acceleration in clinical activity following diagnosis could further impede the absorption of treatment-relevant information. After referral to a specialist cancer unit, many AYA described quickly transitioning to a calm and pragmatic mind-set, and wanting to commence treatment at the earliest opportunity. Most reported seeing information about short-term side-effects of treatment as having limited relevance to their recovery-focused outlook at that time. AYA seldom indicated wanting to make choices about front-line treatment, with most preferring to defer decisions to health professionals. Even when charged with decisions about trial participation, AYA reported welcoming a strong health professional steer. Parents/caregivers attempted to compensate for AYA's limited engagement with treatment-relevant information. However, in seeking to ensure AYA received the best treatment, these individuals had conflicting priorities and information needs. CONCLUSION: Our study highlights the challenging context in which AYA are confronted with decisions about front-line treatment, and reveals how their responses make it hard to ensure their decisions are fully informed. It raises questions about the direct value, to AYA, of approaches that aim to promote decision-making by improving understanding and recall of information, though such approaches may be of value to caregivers. In seeking to improve information-giving and involvement in treatment-related decision-making at diagnosis, care should be taken not to delegitimize the preference of many AYA for a directive approach from trusted clinicians.

Clinical correlates of the ability to consent to research participation in brain metastasis.

OBJECTIVE: Impairment in the ability to provide informed consent is common in persons with brain metastasis. However, little is known about what factors contribute to this impairment in the patient group. Our objective is to determine if the associations between demographic, cognitive, and clinical variables correlate with the ability to provide informed consent in persons with brain metastasis. METHODS: We administered a comprehensive neuropsychological battery to a group of 61 persons with brain metastasis. Demographic and clinical information was also collected. All diagnoses were made by board-certified oncologists and were verified histologically. Statistical analyses included Pearson's product-moment correlations, point biserial correlations, and linear regression. RESULTS: Results indicated that combinations of education, verbal memory, executive function, whole brain radiation therapy, and chemotherapy affected various aspects of the ability to provide informed consent. Subsequent regression models demonstrated that these variables contributed a significant amount of shared variance to the ability to provide informed consent. CONCLUSION: We found that the ability of persons with brain metastasis to provide informed consent is a cognitively complex ability that is also affected by education and treatment variables. This information can help clinical researchers in identifying persons with brain metastasis at risk of an impaired ability to provide informed consent and aid in the consenting process.

Enrollment Obstacles in a Randomized Controlled Trial: A Performance Survey of Enrollment in BEST-CLI Sites.

BACKGROUND: Although randomized controlled trials (RCTs) provide the most reliable form of scientific evidence, they are challenging to complete because of a variety of enrollment obstacles. We evaluated obstacles in a large RCT by comparing survey results at high-performing sites (HPS) and low-performing sites (LPS). METHODS: The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is a prospective, pragmatic, multicenter, and multispecialty RCT that will compare clinical outcomes, quality of life, and cost in patients with CLI randomized to surgical bypass or endovascular therapy. BEST-CLI aims to enroll 2100 patients at 160 sites in North America, Europe, and New Zealand. We surveyed the 30 HPS and 30 LPS to assess perceptions of enrollment obstacles. HPS were defined by enrollment of 0.5 subjects or more per month or more than 8 total subjects enrolled. LPS were defined by enrollment of 0.1 subjects per month or only 1 subject total. Responses were compared by site performance status. RESULTS: There were 22 of 30 (73%) HPS and 14 of 30 (47%) LPS that answered the survey (P = 0.06), including 17 investigators and 31 coordinators. The mean total enrollment and rate of enrollment at HPS and LPS were 12.5 subjects at 1.5 subjects/month and 1.0 subject at 0.1 subjects/month, respectively. The most common barrier to enrollment at HPS was difficulty convincing patients and their families to participate (36%), whereas at LPS both difficulty convincing patients and difficulty motivating investigators to enroll (29% each) were most frequently cited. At HPS, the most common obstacle to consenting patients for the trial was patient/family having strong preference toward revascularization strategy (32%) and at LPS it was patient/family not wanting to have treatment chosen at random (36%). At 55% of HPS and 43% of LPS, the trial team was reported as extremely collaborative (P = 0.73), whereas 68% of HPS and 64% of LPS reported having identified a trial champion on their team (P = 1). The most restrictive perceived enrollment criterion at HPS was prior index limb stenting with significant restenosis (32%), whereas at LPS it was excessive risk for surgical bypass (43%). Materials to aid enrollment were used equally at HPS and LPS: patient brochures at 59% HPS and 64% LPS (P = 1); investigator talking points at 45% of HPS and 36% of LPS (P = 0.73). CONCLUSIONS: Patient perceptions and investigator biases are significant challenges to enrollment in large RCTs. In the BEST-CLI trial, difficulty convincing patients and families to allow treatment randomization and difficulty in motivating investigators were major enrollment obstacles.

Phase I cancer trials: a qualitative study of specialist palliative care.

OBJECTIVE: In recent years, a simultaneous care model for advanced cancer patients has been recommended meaning that palliative care services are offered throughout their cancer journey. To inform the successful adoption of this model in a phase I trial context, the study aimed to explore patients' care needs and their perceptions of specialist palliative care. METHODS: Semi-structured interviews were conducted with 10 advanced cancer patients referred to the Experimental Cancer Medicine team. Interviews were transcribed verbatim and thematically analysed with a framework approach to data organisation. RESULTS: Despite reporting considerable physical and psychological impacts from cancer and cancer treatment, participants did not recognise a need for specialist palliative care support. Understanding of the role of specialist palliative care was largely limited to end of life care. There was perceived conflict between considering a phase I trial and receiving specialist palliative care. Participants felt specialist palliative care should be introduced earlier and educational resources developed to increase patient acceptability of palliative care services. SIGNIFICANCE OF RESULTS: Patients with advanced cancer referred for phase I trials are likely to benefit from specialist palliative care. However, this study suggests patients may not recognise a need for support nor accept this support due to misperceptions about the role of palliative care. Developing a specific educational resource about specialist palliative care for this population would help overcome barriers to engaging with a simultaneous care model.

Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2).

BACKGROUND: The Mesothelioma and Radical Surgery Trial (MARS 2) aims to evaluate a surgical procedure by comparing chemotherapy and surgery against chemotherapy alone. The pilot study for MARS 2 evaluated the viability of recruitment. Challenges have been reported in conducting clinical research into thoracic surgical treatments and evidence is required to improve our understanding of patient experiences of trial procedures, trial treatments and the factors that influence participation. METHODS: This longitudinal qualitative study was nested within the MARS 2 pilot. Semi-structured telephone interviews were conducted with 15 participants in the MARS 2 trial. Interviews were conducted post-randomisation, post-surgery (surgery arm) and at 6 and 12 months. Altogether, 41 interviews were carried out. The data were analysed using framework techniques. RESULTS: Challenges were identified regarding the volume and complexity of information given to participants, and their understanding of clinical equipoise and randomisation. Factors influencing participation included having an opportunity to undergo surgery, a self-assessment of their ability to cope with trial treatments, maintaining a positive approach and altruism. Obstacles included the logistics of traveling for treatment in an unfamiliar setting. Negative consequences of trial participation included increased uncertainty amplified by multiple care providers and unclear transition arrangements after the trial. CONCLUSIONS: Participants' descriptions provided insights that have implications for care for mesothelioma trial patients. The need for healthcare staff to be alert to the potential for misunderstanding, particularly when presenting treatment options, was identified. Patients perceived and derived benefits from taking part in the trial but experienced some negative consequences. These should be anticipated and managed proactively. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02040272 . Registered on 20 January 2014.