Virtual Library
Start Your Search
Visanee Vicky Musigdilok
Author of
-
+
FP02 - Health Services Research/Health Economics (ID 120)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Health Services Research/Health Economics
- Presentations: 2
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
-
+
FP02.01 - Patient Responses to Passive Enrollment into a Large, Pragmatic Clinical Trial: A Qualitative Content Analysis (ID 1064)
00:00 - 00:00 | Author(s): Visanee Vicky Musigdilok
- Abstract
- Presentation
Introduction
The Watch the Spot Trial is a cluster-randomized, pragmatic clinical trial comparing two guideline-based strategies for surveillance of small lung nodules. The study utilizes a passive enrollment approach in which eligible patients are notified of the study and given the opportunity to opt-out. While such pragmatic trials enable large studies to be efficiently implemented in real-world settings, they pose unique ethical considerations. In this exploratory study, we provide a summary of patient questions and concerns that may be useful for future studies.
Methods
Throughout the enrollment period, we documented incoming patient contacts in a database by copying emails verbatim and taking notes for phone calls. To analyze these contacts, we performed a conventional content analysis. After creating an initial codebook, we first identified simple requests to opt-out. For the remaining contacts that contained questions or comments, one primary and two secondary coders independently applied the codes to a random 10% sample of patient contacts. We discussed results to achieve consensus on discordant cases, revised the codebook, and repeated this process with another sample to ensure inter-coder reliability. The primary coder applied final codes to all contacts. We calculated the proportion of contacts for which each code was present.
Results
Of the 17,291 patients that were notified of the study, 857 (5%) reached out to the study team. Of these, there were 248 simple requests to opt-out. There were 609 with questions or comments eligible for the content analysis, 111 of whom also opted out. The most common reasons for patient contacts included opt-outs, clarification about study procedures, and being unaware of the lung nodule prior to research notification (Table 1). Some patients expressed anger or stress around learning about their lung nodule this way. Relatively few patients expressed concerns about the access to and sharing of protected health information (PHI).
ConclusionTable 1 – Conventional Content Analysis Results Code number Code description Contacts containing code
(n, %)*Example of patient contact notes 1 Simple opt-out 248, 28.9 Patient left message stating they opt out. 1.1 Opt-out with other questions or concerns 111, 13.0 Patient wishes to opt-out (in addition to other questions or concerns in codes listed below). 2 Study procedures clarification 292, 34.1 Asked if participating would mean additional traveling and CT scans. 2.1 Explicit consent provided 40, 4.7 Replied to notification “I agree to participate.” 3 Nodule care 84, 9.8
Said their doctor described their nodule as scar tissue and are unsure if we’re referring to the same thing. 3.1 Unaware of nodule 115, 13.4 Had not heard about the nodule until receiving notification letter. 4.1 PHI sharing with research team 20, 2.3 Asked how the study team got this information about them. 4.2 PHI sharing outside of health system 22, 2.6 Said they did not want their personal information transferred. 5 Ineligible 7, 0.8 Doctor told patient there was no lung nodule. After looking into the case the team realized they were erroneously enrolled due to programming error . 6 Survey technical support 38, 4.4 Patient could not figure out how to electronically sign their survey consent form. 7 Deceased 13, 1.5 Family member let us know the patient had recently passed away. 8 Non-member 7, 0.8 Let us know they recently left the health care system. 9 Misc 16, 1.9 Sent a long email complaining about a health care issue unrelated to the study. 10 Unknown or undocumented 15, 1.8 Left a voicemail saying they had questions, but we were unable to ever reach them. E.1** Angry or upset 32, 3.7 Said they are angered by the fact that they are finding out this way. E.2** Stress, worry, or anxiety 24, 2.8 Said that they are very worried about their nodule and need to speak someone. *% of out 857 total contacts. Codes are not mutually exclusive. **E codes were used as supplemental codes only, most often to augment code groups 3 and 4.
We identified several insights based on patient contact issues. Confusion about study procedures reinforces the importance of having dedicated study staff to respond to inquiries. Patients being previously unaware of and sometimes distressed about their nodule highlights the need to include the whole care team when implementing trials in real-world settings. The few concerns about PHI access and sharing warrant close involvement of an institutional review board. Even when the public health benefits of well-designed, pragmatic, passive enrollment trials are thought to outweigh the ethical risks, patient perspectives are an invaluable resource for minimizing inconveniences and miscommunications when designing future studies.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
FP02.08 - Importance of Stakeholder Engagement in a Patient-Centered Outcomes Research Trial (ID 2393)
00:00 - 00:00 | Presenting Author(s): Visanee Vicky Musigdilok
- Abstract
- Presentation
Introduction
The Watch the Spot Trial is a Patient-Centered Outcomes Research Institute (PCORI)- funded, multi-center, pragmatic, comparative effectiveness trial comparing a more- versus less-intensive surveillance strategies for small lung nodules. As a PCORI-funded study, engagement with patients and other stakeholders is an essential aspect of the Watch the Spot Trial. A key component, the Stakeholder Advisory Group (SAG), provides oversight and guidance regarding research methodology, publications, communications, survey development and recruitment, and dissemination of study results.
Methods
Twenty stakeholders, including six patient stakeholders who previously underwent evaluation for a pulmonary nodule, have participated in the SAG over the course of the study. Stakeholders were actively involved in the conception, design, planning and execution of the trial. Currently, the SAG is comprised of thirteen stakeholders, including five patient stakeholders and eight stakeholders representing professional societies and advocacy groups. Members of the SAG meet on a recurring basis, monthly during Years 1 to 4 and quarterly from Year 5 onwards. In addition to the SAG meeting, stakeholders were also offered the opportunity to share their perspective in a variety of other workgroups: Intervention Design Workgroup, Patient Survey Workgroup, Provider Survey Workgroup, and a number of manuscript writing workgroups. All engagement from patient stakeholders were recorded in meeting minutes and highlighted in all progress reports to the funder.
Results
Key contributions of patient stakeholders include: developing the study protocol; designing the interventions being compared, developing scripts to communicate with study participants, participating in survey development, and writing manuscripts. Patient stakeholder feedback was important in the selection and adaptation of the guideline-based protocols that were compared in the trial. Patient stakeholders were also very involved in the creation and review of all study materials for patient communication and education. This includes the patient brochure, patient notification letter, and radiology reporting templates. SAG members helped identify brochure sections and tailor content to fit the general health literacy level of patients and their families. Similarly, they also vetted and refined a letter used to notify patients about the trial, and helped to define the timeline for notification. Recommendations for patient survey design from patient stakeholders helped prevent any undue anxiety and improved survey user friendliness. Moreover, their participation in survey development ensured that items for patient-reported outcomes and other domains of interest for patients were included. Additionally, their suggestions for survey recruitment strategies improved provider survey response rates as well. For dissemination efforts, patient stakeholders have served as contributors on all manuscripts to date.
Conclusion
Input from the SAG, especially from patient stakeholders, has been instrumental to the trial’s start-up and progress. Active participation from patient stakeholders has made important contributions to study design and execution. Most importantly, the patient perspective helped the trial anticipate and address patient concerns. Representation from the SAG committee across study workgroups allowed for patient engagement to be present throughout all aspects of the Watch the Spot Trial. This level of engagement is necessary to produce impactful patient-centered outcomes research.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
P09 - Health Services Research/Health Economics - Real World Outcomes (ID 121)
- Event: WCLC 2020
- Type: Posters
- Track: Health Services Research/Health Economics
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
-
+
P09.37 - Pragmatic Trial Design to Compare Surveillance Strategies for Patients with Small Pulmonary Nodules: The Watch the Spot Trial (ID 2416)
00:00 - 00:00 | Author(s): Visanee Vicky Musigdilok
- Abstract
Introduction
The Watch the Spot (WTS) trial is a multicenter, pragmatic, comparative-effectiveness trial comparing strategies of more- versus less-intensive surveillance for patients with small lung nodules. The study’s goal is to generate evidence in usual-care settings to identify optimal computed tomography surveillance intervals. As one of the first large, pragmatic trials funded by the Patient-Centered Outcomes Research Institute, this study’s unique design will be of interest to researchers and clinicians. The design emphasizes integrating study procedures into existing clinical workflows with site-specific enrollment procedures. We successfully completed enrollment and the study continues until 2024 with data collection, cancer registry linkages and analyses. This poster will use the PRECIS-2 criteria to illustrate the pragmatic features of WTS and describe site variation in study procedures.
Methods
The PRECIS-2 criteria informed the WTS trial design across 9 domains along a continuum of pragmatic and explanatory (Fig 1). The prime awardee manages study progress by regularly engaging key stakeholders to ensure milestone completion and procedural adherence. In accordance with pragmatic design, study teams were established at 14 healthcare organizations throughout the nation and site-specific protocols were created. Variation in implementation was documented and site-level factors will be controlled for in analyses.
Results
Study procedures were successfully integrated into existing workflows in alignment with PRECIS-2 criteria. Institutional Review Boards (IRB) at 12 sites required direct oversight while 2 ceded. IRB approvals took longer than anticipated, delaying study launch, particularly at the 12 sites without reliance mechanisms in place. Identification of eligible patients varied by site and included insertion of unique text strings in radiology reports or manual transcript reviews. Sites passively enrolled patients with all but one providing the option to decline participation. Site-specific radiology and ordering provider educational materials were developed, and some sites also utilized patient information brochures. A central data coordinating center (DCC) was established to manage all sites’ baseline, follow-up, and survey data. The DCC will also perform cancer registry linkages for 10 of the 14 sites.
Conclusion
The pragmatic WTS trial takes place in real-world settings while successfully balancing experimental control with naturalistic study conduct. Sites were successful at adapting procedures to suit their respective health systems. Our observations also suggest that prime awardee sites play an integral role in documentation while providing oversight and ensuring fidelity to established protocols. Additionally, the delay in study launch, due to multiple institutional IRBs, supports current initiatives to rely on a central IRB for human subjects oversight.
