Dataset Information

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.

SUBMITTER: Dellson P

PROVIDER: S-EPMC6542135 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 P Carlsson Christina C Nilbert Mef M Jernström Helena H

Trials 20190529 1

<h4>Background</h4>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 ...[more]

PMID: 31142346

Similar Datasets

Project description:BackgroundRisk knowledge and active role preferences are important for patient involvement in treatment decision-making and adherence. Although knowledge about stroke warning signs and risk factors has received considerable attention, objective knowledge on secondary prevention and further self-esteem subjective knowledge have rarely been studied. The aim of our study was to investigate knowledge and treatment decisional role preferences in cerebrovascular patients compared to controls.MethodsWe performed a survey on subjective and objective stroke risk knowledge and autonomy preferences in cerebrovascular patients from our stroke outpatient clinic (n=262) and from pedestrians on the street taken as controls during a "World Stroke Day" (n=274). The questionnaire includes measures for knowledge and decisional role preferences from previously published questionnaires and newly developed measures, for example, subjective knowledge, revealed on a visual analog scale.ResultsThe overall stroke knowledge was low to moderate, with no differences between patients and controls. Knowledge about secondary prevention was particularly low. Only 10%-15% of participants correctly estimated the stroke absolute risk reduction potential of aspirin. The medical data interpretation competence was moderate in both groups. Age and basic mathematical and statistical understanding (numeracy) were the only independent predictors of objective stroke knowledge, whereas previous stroke had no impact on stroke knowledge. However, patients were thought to be better informed than controls. Approximately 60% of both patients and controls claimed to prefer a shared decision-making approach in treatment decisions.ConclusionThe level of stroke risk knowledge in patients with cerebrovascular diseases was as low as in randomly selected pedestrians, although patients felt better informed. Both groups preferred involvement in treatment decision-making. We conclude that educational concepts for increasing awareness of knowledge gaps as well as for stroke risk and for prevention strategies are needed.

Project description:BackgroundPost-traumatic trigeminal neuropathy (PTN) can have a substantial effect on patient well-being. However, the relation between the neuropathic symptoms and their effect on psychosocial functioning remains a matter of debate. The purpose of this study was to evaluate the association between objective and subjective assessments of neurosensory function in PTN and predict neurosensory outcome using baseline measurements.MethodsThis prospective observational cohort study included patients diagnosed with PTN at the Department of Oral and Maxillofacial Surgery, University Hospital Leuven, Belgium, between April 2018 and May 2020. Standardized objective and subjective neurosensory examinations were recorded simultaneously on multiple occasions during the follow-up period. Correlation analyses and principal component analysis were conducted, and a prediction model of neurosensory recovery was developed.ResultsQuality of life correlated significantly (P < 0.05) with percentage of affected dermatome (ρ = - 0.35), the presence of brush stroke allodynia (ρ = - 0.24), gain-of-function sensory phenotype (ρ = - 0.41), Medical Research Council Scale (ρ = 0.36), and Sunderland classification (ρ = - 0.21). Quality of life was not significantly correlated (P > 0.05) with directional discrimination, stimulus localization, two-point discrimination, or sensory loss-of-function. The prediction model showed a negative predictive value for neurosensory recovery after 6 months of 87%.ConclusionsWe found a strong correlation of subjective well-being with the presence of brush stroke allodynia, thermal and/or mechanical hyperesthesia, and the size of the neuropathic area. These results suggest that positive symptoms dominate the effect on affect. In patients reporting poor subjective well-being in the absence of positive symptoms or a large neuropathic area, additional attention towards psychosocial triggers might enhance treatment outcome. The prediction model could contribute to establishing realistic expectations about the likelihood of neurosensory recovery but remains to be validated in future studies.

Project description:IntroductionUncertainty surrounding the accurate assessment of the early-stage Alzheimer's disease (AD) may cause delayed care and inappropriate patient access to new AD therapies.MethodsTo analyze clinical assessments of patients with AD in the Veteran's Affairs (VA) Healthcare System and evaluate concordance between subjective and objective assessments, we processed clinical notes extracted by text integration utilities between April 1, 2008 and October 14, 2021. Veterans who had mild, moderate, or severe AD with clinical notes documenting both clinician's judgement of AD severity and objective test scores from the Mini-Mental State Examination or the Montreal Cognitive Assessment were included. Using clinician-defined severity cohorts, we determined concordance between the clinician's (subjective) assessments and the test-derived (objective) assessments of AD severity. Concordance was assessed over time and by selected symptoms and comorbidities, as well as healthcare system factors.ResultsA total of 8888 notes were initially extracted; the final analysis sample included 7514 notes corresponding to 4469 unique patients (mean [standard deviation] age of 78 [9] years; 96.5% male; 77.8% White). Subjective and objective assessments were concordant in approximately half (53%) of overall notes. In the mild Alzheimer's cohort, patients were assessed to have more severe disease by objective test scores in 40% of notes. Concordance varied about 21-73%, 47-58%, and 40-64% across symptoms/comorbidities, clinician types, and Veteran's Integrated Service Networks, respectively. The proportion of concordant notes was higher in visits to dementia (61%) instead of non-dementia clinics (53%).ConclusionsWe found higher concordance between clinician's assessment and test-based assessment of Alzheimer's disease severity in dementia specialty clinics. Discordance is especially high for the subjectively assessed mild AD cohort where objective assessments showed a higher severity level in 40% of notes. These data indicate a critical need for improved understanding of clinical assessments and decision-making to identify appropriate patients for anti-amyloid therapy.

Project description:BACKGROUNDIn case of untreatable suffering at the end of life, palliative sedation may be chosen to assure comfort by reducing the patient's level of consciousness. An important question here is whether such sedated patients are completely free of pain. Because these patients cannot communicate anymore, caregivers have to rely on observation to assess the patient's comfort. Recently however, more sophisticated techniques from the neurosciences have shown that sometimes consciousness and pain are undetectable with these traditional behavioral methods. The aim of this study is to better understand how unconscious palliative sedated patients experience the last days of their life and to find out if they are really free of pain.METHODSIn this study we will observe 40 patients starting with initiation of palliative sedation until death. Assessment of comfort based on behavioral observations will be related with the results from a NeuroSense monitor, an EEG-based monitor used for evaluation of the adequacy of anesthesia and sedation in the operating room and an ECG-based Analgesia Nociception Index (ANI) monitor, which informs about comfort or discomfort condition, based on the parasympathetic tone. An innovative and challenging aspect of this study is its qualitative approach; "objective" and "subjective" data will be linked to achieve a holistic understanding of the study topic. The following data will be collected: assessment of pain/comfort by the patients themselves (if possible) by scoring a Visual Analogue Scale (VAS); brain function monitoring; monitoring of parasympathetic tone; caregivers' assessment (pain, awareness, communication); relatives' perception of the quality of the dying process; assessment by 2 trained investigators using observational scales; video and audio registration.DISCUSSIONMeasuring pain and awareness in non-communicative dying patients is both technically and ethically challenging. ANI and EEG have shown to be promising technologies to detect pain that otherwise cannot be detected with the "traditional" methods. Although these technologies have the potential to provide objective quantifiable indicators for distress and awareness in non-communicative patients, strikingly they have not yet been used to check whether the current assessments for non-communicative patients are reliable.TRIAL REGISTRATIONThe study is registered on ClinicalTrials.gov (Identifier: NCT03273244 ; registration date: 7.9.2017).

Project description:In research and clinical contexts, parents' report and sleep diary filled in by parents are often used to characterize sleep-wake rhythms in children. The current study aimed to investigate children self-perception of their sleep, by comparing sleep diaries filled in by themselves, actigraphic sleep recordings, and parental subjective estimation. Eighty children aged 8-9 years wore actigraph wristwatches and completed sleep diaries for 7 days, while their parents completed a sleep-schedule questionnaire about their child' sleep. The level of agreement and correlation between sleep parameters derived from these three methods were measured. Sleep parameters were considered for the whole week and school days and weekends separately and a comparison between children with high and low sleep efficiency was carried out. Compared to actigraphy, children overestimated their sleep duration by 92 min and demonstrated significant difficulty to assess the amount of time they spent awake during the night. The estimations were better in children with high sleep efficiency compared to those with low sleep efficiency. Parents estimated that their children went to bed 36 min earlier and obtained 36.5 min more sleep than objective estimations with actigraphy. Children and parents' accuracy to estimate sleep parameters was different during school days and weekends, supporting the importance of analyzing separately school days and weekends when measuring sleep in children. Actigraphy and sleep diaries showed good agreement for bedtime and wake-up time, but not for SOL and WASO. A satisfactory agreement for TST was observed during school days only, but not during weekends. Even if parents provided more accurate sleep estimation than children, parents' report, and actigraphic data were weakly correlated and levels of agreement were insufficient. These results suggested that sleep diary completed by children provides interesting measures of self-perception, while actigraphy may provide additional information about nocturnal wake times. Sleep diary associated with actigraphy could be an interesting tool to evaluate parameters that could contribute to adjust subjective perception to objective sleep values.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets