Patients' and physicians' disagreement on patients' understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements
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Patients' and physicians' disagreement on patients' understanding of clinical cancer trial information : a pairwise pilot study of mirroring subjective assessments compared with objective measurements. / Dellson, Pia; Carlsson, Christina; Nilbert, Mef; Jernström, Helena.
In: Trials, Vol. 20, 301, 2019.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Patients' and physicians' disagreement on patients' understanding of clinical cancer trial information
T2 - a pairwise pilot study of mirroring subjective assessments compared with objective measurements
AU - Dellson, Pia
AU - Carlsson, Christina
AU - Nilbert, Mef
AU - Jernström, Helena
PY - 2019
Y1 - 2019
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Clinical Trials as Topic
KW - Female
KW - Humans
KW - Informed Consent
KW - Knowledge
KW - Male
KW - Middle Aged
KW - Neoplasms/therapy
KW - Physician-Patient Relations
KW - Physicians
KW - Pilot Projects
KW - Research Design
KW - Surveys and Questionnaires
U2 - 10.1186/s13063-019-3416-2
DO - 10.1186/s13063-019-3416-2
M3 - Journal article
C2 - 31142346
VL - 20
JO - Trials
JF - Trials
SN - 1745-6215
M1 - 301
ER -
ID: 234152673