Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements

Abstract

Background: Informed consent is a prerequisite for patients included in clinical trials. Trial design, inclusion criteria and legal requirements are increasingly complex. This complexity challenges design and delivery of written and oral trial information to ensure understandable information. To evaluate the level of concordance between patients' and informing physicians' assessments regarding patient understanding of trial information, we carried out a study based on paired questionnaire data from patients and their physicians. These assessments of patient understanding were further correlated with patients' factual knowledge of the information provided. Methods: This pilot study included patients and physicians immediately after the patients had received information on one of 23 ongoing phase III randomised cancer trials at two Swedish sites. In total, 46 patients and 17 physicians contributed data based on two new questionnaires with seven mirroring questions, where concordance was analysed with McNemar's test. These assessments of patients' self-estimated understanding were further correlated with the Patient Understanding of Research (Q-PUR) questionnaire that assesses factual knowledge of the information provided. Results: For each question, 47-61% of the patient-physician pairs were in concordance regarding their assessments of patients' 'fully understanding' or 'not fully understanding' various aspects of the trial information. For the discordant pairs, the physicians rated patient understanding lower than the patients themselves, for all seven questions. This difference was significant for five of the questions (P ≤ 0.017). The median Q-PUR knowledge score was 11 out of 12, but this score did not significantly correlate with the assessments, either from patients or from physicians. Conclusions: This study demonstrated a trend for physicians to rate the level of understanding of trial information among potential trial patients lower than the patients themselves. Application of Q-PUR revealed high knowledge scores, but without correlation to the assessments. These findings need validation in an independent setting, with an improved instrument with mirroring questions, and a better-matched measurement of patients' factual knowledge. These results suggest that physicians need to improve their ability to assess patient understanding of clinical trial information, in order to be able to tailor the patients' information individually.

Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology

“…However, some of them claim to have perfectly understood the terminology used and the proposal. The physicians mostly highlighted the participants' lack of understanding, as in previous research [6,7,11,13]. If we compare the point of view of trial participants with that of physicians, it is interesting to note that there is some generalization by physicians regarding their patients' lack of understanding of randomization and, in general, on the understanding of the IC.…”

“…However, all the physicians expressed difficulties in choosing the best words to explain to trial participants some concepts, such as randomization. In line with the literature [13], their requests were coherent with the participants' expectations and needs, i.e., that more time be spent with patients to explain the trial's rationale and to be trained in communication skills.…”

“…This means that they have well understood. Physicians' underestimation of their patients' understanding has been tracked also in the study by Dellson et al [13]. Furthermore, it is important to remember that refusal to participate in a clinical trial should not be understood as a lack of understanding (as some physicians claim) or a failure but, on the contrary, as one of the possible outcomes of a correct management of the IC.…”

“…The literature is unanimous in recognizing that ICs for RCTs in oncology pose some important challenges such as ensuring participants correctly understand the information presented. However, Dellson and colleagues [13] reported that trial participants and physicians were in concordance with understanding of IC in 47-61% of cases and that physicians generally attribute less understanding about RCTs than trials participants reported. Some studies show that the greatest difficulties in understanding lie in awareness of nonstandard treatment, the unproven nature of treatment, the potential for incremental risk or discomfort, and the uncertainty of benefits to oneself [14].…”

Why ‘understanding’ of research may not be necessary for ethical emergency research

“…Participants may show inability to recognize minor study related risks, and presume treatments to be standard as they trusted the doctor or institution conducting the study [39]. Besides, investigators and participants may comprehend the same clinical trial information differently [40].…”