scholarly journals ACTA A Tool for Argumentative Clinical Trial Analysis

2019 ◽  
Author(s):  
Tobias Mayer ◽  
Elena Cabrio ◽  
Serena Villata
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Online Discussion ◽  
Trial Analysis ◽  
Persuasive Essays

Argumentative analysis of textual documents of various nature (e.g., persuasive essays, online discussion blogs, scientific articles) allows to detect the main argumentative components (i.e., premises and claims) present in the text and to predict whether these components are connected to each other by argumentative relations (e.g., support and attack), leading to the identification of (possibly complex) argumentative structures. Given the importance of argument-based decision making in medicine, in this demo paper we introduce ACTA, a tool for automating the argumentative analysis of clinical trials. The tool is designed to support doctors and clinicians in identifying the document(s) of interest about a certain disease, and in analyzing the main argumentative content and PICO elements.

Increasing Health Literacy to Improve Clinical Trial Recruitment

2018 ◽  
pp. 94-108
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy ◽  
Trial Recruitment ◽  
Negative Perception ◽  
Consent Forms ◽  
Clinical Trial Recruitment ◽  
And Training

Health literacy has been found to be linked to healthcare understanding and decision making. Therefore, it makes sense why individuals who do not understand clinical trials will be less likely to want to enroll in one. In fact, three major barriers found in the literature that prevent potential participants from enrolling in clinical trials include a distrust or negative perception, lack of understanding, and lack of accessible and affordable healthcare. Hence, there is a need to increase potential participants' healthcare understanding so that they can make the best healthcare decisions for themselves. Strategies suggested to help increase potential participants' health literacy include revising informed consent forms, utilizing culturally targeted statements, using a variety of material, and training investigative site personnel. These proposed strategies may help increase health literacy, which in turn could improve clinical trial recruitment. Furthermore, these strategies focus on different elements of health literacy and coupled together may bring the most improvement.

Simulation Modeling as a Decision-Making Aid in Economic Evaluation for Randomized Clinical Trials

2011 ◽  
pp. 1738-1758
Author(s):  
Tillal Eldabi ◽  
Robert D. Macredie ◽  
Ray J. Paul
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Economic Evaluation ◽  
Simulation Model ◽  
Randomized Clinical Trial ◽  
Simulation Modeling ◽  
Randomized Clinical Trials ◽  
Healthcare Systems ◽  
Modeling Process

This chapter reports on the use of simulation in supporting decision-making about what data to collect in a randomized clinical trial (RCT). We show how simulation also allows the identification of critical variables in the RCT by measuring their effects on the simulation model’s “behavior.” Healthcare systems pose many of the challenges, including difficulty in understanding the system being studied, uncertainty over which data to collect, and problems of communication between problem owners. In this chapter we show how simulation also allows the identification of critical variables in the RCT by measuring their effects on the simulation model’s “behavior.” The experience of developing the simulation model leads us to suggest simple but extremely valuable lessons. The first relates to the inclusion of stakeholders in the modeling process and the accessibility of the resulting models. The ownership and confidence felt by stakeholders in our case is, we feel, extremely important and may provide an example to others developing models.

scholarly journals Provider Recommendations for Phase I Clinical Trials Within a Shared Decision-Making Model in Phase I Cancer Clinical Trial Discussions

2020 ◽  
Vol 16 (9) ◽  
pp. e859-e867
Author(s):  
Rachel S. Hianik ◽  
Gavin P. Campbell ◽  
Eli Abernethy ◽  
Colleen Lewis ◽  
Christina S. Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Phase I ◽  
Shared Decision Making ◽  
Phase I Trial ◽  
Performance Status ◽  
Shared Decision ◽  
Phase I Clinical Trials ◽  
Decision Making Model

PURPOSE: Debate continues over whether explicit recommendations for a clinical trial should be included as an element of shared decision making within oncology. We aimed to determine if and how providers make explicit recommendations in the setting of phase I cancer clinical trials. METHODS: Twenty-three patient/provider conversations about phase I trials were analyzed to determine how recommendations are made and how the conversations align with a shared decision-making framework. In addition, 19 providers (9 of whose patient encounters were observed) were interviewed about the factors they consider when deciding whether to recommend a phase I trial. RESULTS: We found that providers are comprehensive in the factors they consider when recommending clinical trials. The two most frequently stated factors were performance status (89%) and patient preferences (84%). Providers made explicit recommendations in 19 conversations (83%), with 12 of those being for a phase I trial (12 [63%] of 19). They made these recommendations in a manner consistent with a shared decision-making model; 18 (95%) of the 19 conversations during which a recommendation was made included all steps, or all but 1 step, of shared decision making, as did 11 of the 12 conversations during which a phase I trial was recommended. In 7 (58%) of these later conversations, providers also emphasized the importance of the patient’s opinion. CONCLUSION: We suggest that providers not hesitate to make explicit recommendations for phase I clinical trials, because they are able to do so in a manner consistent with shared decision making. With further research, these results can be applied to other clinical trial settings.

scholarly journals INFORMED CONSENT IN CLINICAL TRIALS FOR PERSONS WITH DEMENTIA

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S28-S28 ◽  
Author(s):  
Joan G Carpenter
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Nursing Homes ◽  
Decision Maker ◽  
Surrogate Decision Maker ◽  
Decision Making Capacity ◽  
Consent Document ◽  
Surrogate Decision

Abstract Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were required by the IRB; (3) the required legal wording was difficult to understand and deterred potential participants; and (4) the primary mode of communication was via phone. We tailored assent and informed consent procedures to persons with dementia and their legally authorized representative/surrogate decision maker to avoid risking an incomplete trial and to improve generalizability of trial results to all persons with dementia.

Entering a Clinical Trial: Is It Right For You?–A randomized study of the Clinical Trials Video and its impact on the informed consent process

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9072-9072
Author(s):  
S. Hitchcock-Bryan ◽  
B. Hoffner ◽  
S. Joffe ◽  
M. Powell ◽  
C. Parker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Randomized Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Provider Communication ◽  
Patient Provider Communication ◽  
Source Of Information

9072 Background: In an effort to improve the informed consent process for subjects considering participation in a clinical trial, we created an educational video: “Entering a Clinical Trial: Is it Right for You?” In this randomized study, we assessed the effect of the video on patients’ understanding and perceptions of clinical trials. We also assessed patient satisfaction with the video and how the video impacted decision-making and patient-provider communication. Methods: We recruited 90 adults considering cancer clinical trials of whom 77 participated. After discussing the trial with the physician and reading the trial consent form, patients were randomized to receive (n=38) or not receive (n=39) the study video. Using a validated questionnaire, we interviewed subjects to assess objective understanding of the trial, our primary endpoint, and self-reported understanding of clinical trials. All subjects completed a second interview assessing secondary endpoints, including patient-provider communication, satisfaction with video, and decision-making. We used linear regression (two-sided tests) to conduct the primary analysis and the Wilcoxon rank-sum test and descriptive statistics to analyze the secondary aims. Results: Neither objective nor self-reported understanding of clinical trials differed between the two groups (Mean 86.5 vs. 87, p=0.75). 85% (61/72) indicated the video was an important source of information about clinical trials; 89% of those who watched the video with their family/friends (n=37) said the video helped loved ones better understand clinical trials; 73% indicated it helped their family accept their decision about participation. 81% (58/72) felt better prepared to discuss the trial with their physician after watching the video. Of those who found the video helpful with decision- making, 80% (21/26) were considering a trial for the first time compared with 19% (5/26) veterans who had previously participated in a clinical trial. Conclusions: The video did not measurably improve subjects’ understanding of their clinical trials. However, subjects reported that the video was an important source of information, helped them educate their families, and enhanced patient-provider communication. No significant financial relationships to disclose.

Metastatic colorectal cancer (mCRC) patterns of care: Implications for clinical trial design

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4079-4079 ◽  
Author(s):  
C. S. Denlinger ◽  
M. A. Collins ◽  
Y. Wong ◽  
S. Litwin ◽  
N. J. Meropol
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
New Drugs ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Treatment Change ◽  
Therapy Regimen

4079 Background: New approaches have expanded options for patients (pts) with mCRC. To characterize current practice paradigms that might bear on clinical trial design, we analyzed decision-making and treatment patterns in pts treated at a Comprehensive Cancer Center since the introduction of cetuximab (CET), and bevacizumab (BV). Methods: A retrospective review of all pts diagnosed with mCRC between 3/1/04 and 8/28/06 treated at Fox Chase Cancer Center. Results: 160 pts were treated, with 157 pts receiving at least one therapy regimen by 10 attending oncologists. There were 350 changes in therapy with 246 (70%) including continuation of at least one prior drug (92 BV, 111 fluoropyrimidines, 43 other). The most common reasons for treatment change were toxicity (33%), progressive disease (PD) (29%), treatment breaks (15%), and metastasectomy (11%) ( Table ). PD was a more common cause for treatment discontinuation in later phases of treatment (18% initial regimen vs. 36% subsequent regimens, p=0.0002). 24% of pts treated with oxaliplatin (OX) discontinued due to neuropathy. Hypersensitivity caused discontinuation in 5% of pts with OX and 7% of pts with CET. Resection of metastases was undertaken in 38% of pts. 43% of these pts received neoadjuvant therapy, and 56% received adjuvant therapy. 30% of pts have died, 29% remain on active treatment, 28% are on a treatment break, 3% are on hospice, and 11% are lost to follow-up. Conclusions: PD is no longer the primary reason for change of therapy in pts with mCRC. Metastasectomy is common and OX neuropathy is often treatment-limiting. These findings have important implications for endpoint selection and design of clinical trials in mCRC. Future clinical trials in mCRC must recognize treatment complexities and capture key components of decision-making that may result in prolonged survival. Furthermore, treatment breaks represent a potential window for the evaluation of new drugs. [Table: see text] No significant financial relationships to disclose.

scholarly journals Financial Concerns About Participation in Clinical Trials Among Patients With Cancer

2016 ◽  
Vol 34 (5) ◽  
pp. 479-487 ◽  
Author(s):  
Yu-Ning Wong ◽  
Mark D. Schluchter ◽  
Terrance L. Albrecht ◽  
Al Bowen Benson ◽  
Joanne Buzaglo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Sex Education ◽  
Self Efficacy ◽  
Secondary Data ◽  
Decisional Conflict ◽  
Decision Quality ◽  
Patients With Cancer ◽  
Financial Concern

Purpose The decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials. Methods We conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): “How much of a burden on you is the cost of your medical care?,” “I'm afraid that my health insurance won't pay for a clinical trial,” and “I’m worried that I wouldn’t be able to afford the costs of treatment on a clinical trial.” Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics. Results One thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models). Conclusion Financial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients’ financial needs and concerns may reduce distress and improve patient decision making.

Why Cancer Patients Enter Randomized Clinical Trials: Exploring the Factors That Influence Their Decision

2004 ◽  
Vol 22 (21) ◽  
pp. 4312-4318 ◽  
Author(s):  
James R. Wright ◽  
Timothy J. Whelan ◽  
Susan Schiff ◽  
Sacha Dubois ◽  
Dauna Crooks ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Logistic Regression ◽  
Cancer Patients ◽  
Randomized Clinical Trials ◽  
Univariate Analysis ◽  
Multivariate Logistic Regression Model ◽  
Decision Making Process ◽  
Trial Entry

Purpose Few interventions have been designed and tested to improve recruitment to clinical trials in oncology. The multiple factors influencing patients' decisions have made the prioritization of specific interventions challenging. The present study was undertaken to identify the independent predictors of a cancer patient's decision to enter a randomized clinical trial. Methods A list of factors from the medical literature was augmented with a series of focus groups involving cancer patients, physicians, and clinical research associates (CRAs). A series of questionnaires was developed with items based on these factors and were administered concurrently to 189 cancer patients, their physicians, and CRAs following the patient's decision regarding trial entry. Forward logistic regression modeling was performed using the items significantly correlated (by univariate analysis) with the decision to enter a clinical trial. Results A number of items were significantly correlated with the patient's decision. In the multivariate logistic regression model, the patient's perception of personal benefit was the most important, with an odds ratio (OR) of 3.08 (P < .05). CRA-related items involving supportive aspects of the decision-making process were also important. These included whether the CRA helped with the decision (OR = 1.71; P < .05), and whether the decision was hard for the patient to make (OR = 0.52; P < .05). Conclusion Strategies that better address the potential benefits of trial entry may result in improved accrual. Interventions or aids that focus on the supportive aspects of the decision-making process while respecting the need for information and patient autonomy may also lead to meaningful improvements in accrual.

scholarly journals Perceptions of Participation in a Phase I, II, or III Clinical Trial Among African American Patients With Cancer: What Do Refusers Say?

2013 ◽  
Vol 9 (6) ◽  
pp. 287-293 ◽  
Author(s):  
Richard F. Brown ◽  
Debbie L. Cadet ◽  
Robert H. Houlihan ◽  
Maria D. Thomson ◽  
Emily C. Pratt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
African American ◽  
Phase I ◽  
Family Members ◽  
Patients With Cancer ◽  
Aid Decision ◽  
Physician Recommendations

Low rates of physician recommendations of African American patients to clinical trials warrant further investigation. Interventions to reduce misunderstandings and aid decision making need to target both patients and family members.

Randomized trial of a web-based intervention to address barriers to clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6500-6500 ◽  
Author(s):  
Neal J. Meropol ◽  
Terrance Lynn Albrecht ◽  
Yu-Ning Wong ◽  
Al Bowen Benson ◽  
Joanne S. Buzaglo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Randomized Trial ◽  
Large Scale ◽  
College Education ◽  
Phase Iii ◽  
Post Intervention ◽  
Web Based ◽  
Attitudinal Barriers

6500 Background: Cancer patients (pts) have knowledge and attitudinal barriers to participation in clinical trials (CT). We developed PRE-ACT (Preparatory Education About Clinical Trials), a tailored, interactive, web-based intervention to address these barriers and improve preparation for consideration of CT as a treatment option. Methods: We conducted a prospective, randomized, multicenter, phase III clinical trial of PRE-ACT vs. control (general text about CT excerpted from NCI materials). All assessments and interventions were conducted online. Cancer pts >18 years old were enrolled before initial oncologist consultation. Pts completed a baseline assessment including CT knowledge (19-item); CT attitudes (28-item); preparation for decision making (10-item); and validated measures of preferences for shared decision making and quality/length of life. PRE-ACT pts received a summary of their preferences and a list of their top CT barriers. Based on ranking of individual barriers, pts were presented with a video library of 30-90 second clips addressing their top barriers (10 maximum). After the educational intervention a follow up survey reassessed CT barriers and preparation. Results: 1255 pts were randomized; median age 59 (range 20-88); 58% female; 12% non-white / 2% Hispanic; 76.4% some college education. 1081 pts completed baseline and post-intervention assessments. The control and PRE-ACT groups both had improved knowledge, reduced attitudinal barriers, and improved preparation (p<.0001 for all comparisons). PRE-ACT was more effective than control in improving knowledge (p=.0006) and attitudes (p<.0001). Furthermore, pts in the PRE-ACT arm were more satisfied with the amount (p=.002) and format (<.0001) of information, and felt more prepared to consider CT (p=.0003). Conclusions: This large-scale randomized trial of a tailored, web-based, video intervention demonstrates that educational information delivered online before the oncologist visit can significantly reduce knowledge barriers and attitudinal barriers and improve preparation for consideration of clinical trials. Both text and PRE-ACT are effective, with greater improvements and satisfaction in the PRE-ACT group. Clinical trial information: NCT00750009.

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