Challenges Conveying Clinical Equipoise and Exploring Patient Treatment Preferences in an Oncology Trial Comparing Active Monitoring with Radiotherapy (ROAM/EORTC 1308)

Abstract

Introduction. Providing balanced information that emphasizes clinical equipoise (i.e., uncertainty regarding the relative merits of trial interventions) and exploring patient treatment preferences can improve informed consent and trial recruitment. Within a trial comparing adjuvant radiotherapy versus active monitoring following surgical resection for an atypical meningioma (ROAM/EORTC-1308), we explored patterns in communication and reasons why health practitioners may find it challenging to convey equipoise and explore treatment preferences. Materials and Methods. Qualitative study embedded within ROAM/EORTC-1308. Data were collected on 40 patients and 18 practitioners from 13 U.K. sites, including audio recordings of 39 patients' trial consultations, 23 patient interviews, and 18 practitioner interviews. Qualitative analysis drew on argumentation theory. Results. Practitioners acknowledged the importance of the research question that the trial aimed to answer. However, they often demonstrated a lack of equipoise in consultations, particularly with eligible patients who practitioners believed to be susceptible to side effects (e.g., cognitive impairment) or inconvenienced by radiotherapy. Practitioners elicited but rarely explored patient treatment preferences, especially if a patient expressed an initial preference for active monitoring. Concerns about coercing patients, loss of practitioner agency, and time constraints influenced communication in ways that were loaded against trial participation. Conclusions. We identified several challenges that practitioners face in conveying equipoise and exploring patient treatment preferences in oncology, and particularly neurooncology, trials with distinct management pathways. The findings informed communication about ROAM/EORTC-1308 and will be relevant to enhancing trial communication in future oncology trials. Qualitative studies embedded within trials can address difficulties with communication, thus improving informed consent and recruitment. ROAM/EORTC-1308 RCT: ISRCTN71502099. The Oncologist 2020;25:e691-e700 Implications for Practice: Oncology trials can be challenging to recruit to, especially those that compare treatment versus monitoring. Conveying clinical equipoise and exploring patient treatment preferences can enhance recruitment and patient understanding. This study focused on the challenges that practitioners encounter in trying to use such communication strategies and how practitioners may inadvertently impede patient recruitment and informed decision making. This article provides recommendations to support practitioners in balancing the content and presentation of trial management pathways. The results can inform training to optimize communication, especially for neuro-oncology trials and trials comparing markedly different management pathways.

Recruitment, Recruitment, Recruitment – But Do We Collect and Report All The Information We Should? A Retrospective Review of Ovarian Cancer Trials in A 10-Year Period

“…Trust in the doctor and the institution is one of the most frequently cited facilitators for clinical trial participation, yet there are few interventions published that aim to address this and assess its effect on recruitment rates 26,29,33 ). The most successful to date is the Quintet Recruitment Intervention (QRI) 22,24,40,42 but this focuses mainly on the discussion between the patient and doctor rather than who the recruiter is or alliance building between the two. Further studies are recommended to address this knowledge gap.…”

The impact of authors’ medical specialty on publication patterns and published results of adjuvant radiotherapy for WHO grade 2 meningiomas—a systematic review

“…A recent qualitative study addresses challenges that clinicians face when communicating that there is no good basis for a choice between two or more treatments to patients. Interestingly, the study reported that neurosurgeons not involved in the trial advised patients not to participate in the trial [ 25 ]. Another study has demonstrated a significant difference of opinion about the role of adjuvant radiotherapy after resection of WHO grade 2 meningiomas in different centers in the UK and the Republic of Ireland [ 18 ].…”

Distinctive aspects of consent in pilot and feasibility studies

“…As participants are being asked to agree to being allocated to one of two or more treatments, investigators face the task of explaining a belief in the equivalent effectiveness of these interventions-a challenging task at the best of times. 42,43 However, they must at the same time make it clear that the goal of a pilot study is not about determining the relative effectiveness of the treatments involved. Both of these considerations-the presence of equipoise and the specific purpose of the study-are likely to be relevant to a participant's decision on whether to consent, 35,38 and should therefore be communicated.…”

“…Herein lies a particular challenge in the specific case of randomized pilot studies. As participants are being asked to agree to being allocated to one of two or more treatments, investigators face the task of explaining a belief in the equivalent effectiveness of these interventions—a challenging task at the best of times 42,43 . However, they must at the same time make it clear that the goal of a pilot study is not about determining the relative effectiveness of the treatments involved.…”