Dataset Information

Stakeholder perspectives on addressing adverse events from adjuvant cancer therapy: A qualitative study.

ABSTRACT:

Background

With increasing survival rates, a growing population of patients with cancer have received or will receive adjuvant therapy to prevent cancer recurrences. Patients and caregivers will confront the complexities of balancing the preventative benefits of adjuvant therapy with possible near-term or long-term adverse events (AEs). Adjuvant treatment-related AEs (from minimal to severe) can impact therapeutic adherence, quality of life, emotional and physical health, and survival. However, to the authors' knowledge, limited information is available regarding how stakeholders use or desire to use adjuvant-related AE information to inform the care of patients with cancer.

Methods

A qualitative, purposeful sampling approach was used to elicit stakeholder feedback via semistructured interviews (24 interviews). Drug development, drug regulatory, clinical, payer, and patient/patient advocacy stakeholders were questioned about the generation, dissemination, and use of adjuvant treatment-related AE information to inform the care of patients with cancer. Transcripts were coded independently by 2 senior health care researchers and reconciled to identify key themes.

Results

All stakeholder groups in the current study identified needed improvements in each of the following 4 areas: 1) improving the accessibility and relevance of AE-related information; 2) better integrating and implementing available information regarding AEs for decisions; 3) connecting contemporary cultural and economic value systems to the generation and use of information regarding adjuvant treatment-related AEs; and 4) addressing a lack of alignment and ownership of stakeholder efforts to improve the use of AE information in the adjuvant setting.

Conclusions

Despite commonalities in the overall needs identified by the diverse stakeholders in the current study, broad systemic change has been stymied. The current study identified the lack of alignment and the absence of a central "owner" of these diffuse efforts as a previously unrecognized hurdle to realizing the desired systemic improvements. Future initiatives aimed at improving quality of life and outcomes for patients receiving adjuvant therapy through the improved use of AE information must address this challenge through innovative collectives and novel leadership strategies.

SUBMITTER: Pettit SD

PROVIDER: S-EPMC6916390 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Stakeholder perspectives on addressing adverse events from adjuvant cancer therapy: A qualitative study.

Pettit Syril D SD Silberman Pamela P Hassmiller Lich Kristen K Kirch Rebecca A RA Lipshultz Steven E SE Teal Randall R Basch Ethan E

Cancer 20190827 24

<h4>Background</h4>With increasing survival rates, a growing population of patients with cancer have received or will receive adjuvant therapy to prevent cancer recurrences. Patients and caregivers will confront the complexities of balancing the preventative benefits of adjuvant therapy with possible near-term or long-term adverse events (AEs). Adjuvant treatment-related AEs (from minimal to severe) can impact therapeutic adherence, quality of life, emotional and physical health, and survival. H ...[more]

PMID: 31454424

Similar Datasets

Project description:The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI's cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty-eight percent felt that patients in clinical trials would be willing to self-report adverse symptoms at clinic visits via computer, and 68% felt patients would self-report weekly from home via the internet or an automated telephone system. Lack of computers and limited space and personnel were seen as potential barriers to in-clinic self-reporting, but these were judged to be surmountable with adequate funding. The PRO-CTCAE items and software are viewed by a majority of survey respondents as a means to improve adverse event data quality and comprehensiveness, enhance clinical decision-making, and foster patient-clinician communication. Research is ongoing to assess the measurement properties and feasibility of implementing this measure in cancer clinical trials.

Project description:BackgroundThe United States health care sector is one of the largest polluting industries, which has significant adverse effects on human health. Medical device reprocessing (MDR) is a sustainability solution that has the potential to decrease hospital waste, cut carbon emissions, reduce spending, and improve supply chain resiliency; however, only a small proportion of FDA-approved devices are actually reprocessed. Thus, we conducted a qualitative study to understand barriers and facilitators of scaling up MDR.Methods and findingsWe conducted in-depth interviews with 17 stakeholders (exceeding thematic saturation) at a large academic health system in New England and national MDR organizations. We also collected observations through site visits at the health system. We recruited participants from June 2021 to April 2022 through purposive sampling. Using an analytic approach guided by the Consolidated Framework for Implementation Research, we applied inductive and deductive codes related to key implementation constructs. We then conducted a thematic analysis and identified five overarching themes related to barriers and facilitators of MDR. First, respondents explained that regulatory bodies and original equipment manufacturers determine which devices can be reprocessed. For example, some respondents described that original equipment manufacturers use tactics of forced obsolescence that prevent their devices from being reprocessed. Second, respondents explained that MDR has variable compatibility with hospital priorities; for example, the potential cost savings of MDR is compatible with their priorities, while the perception of decreased functionality of reprocessed medical devices is incompatible. Third, respondents described that physician preferences influence which reprocessed devices get ordered. Fourth, respondents explained that variable staff knowledge and beliefs about MDR influence their motivations to select and collect reprocessable devices. Lastly, respondents emphasized that there was a lack of infrastructure for evaluating and maintaining MDR programs within their health system.ConclusionsBased on our findings, we have outlined a number of recommendations that target these barriers and facilitators so that the environmental and financial benefits of MDR can be realized at this health system and nationally. For example, implementing federal policies that prevent original equipment manufacturers from using tactics of forced obsolescence can facilitate the scale-up of MDR nationally. Additionally, providing life cycle assessments that compare the environmental effects of single-use disposable, reprocessable disposable, and reusable devices could facilitate health systems' purchasing decisions. Creating and disseminating audit and feedback reports to hospital staff might also facilitate their continued engagement in the program. Lastly, hiring a full-time program manager that leads MDR programs within health systems could improve program sustainability.

Project description:BACKGROUND:Attending physician preceptors are accountable to many stakeholder groups, yet stakeholders' views about what the preceptor role entails have not been sufficiently considered. OBJECTIVE:To explore stakeholder groups' unique perspectives of the preceptor role. DESIGN:Qualitative study with a constructivist orientation. PARTICIPANTS:Semi-structured interviews were conducted with 73 participants from two university teaching hospitals between October 2012 and March 2014. Participants included representatives from seven stakeholder groups: patients and their families, allied healthcare providers, bedside nurses, nurse managers, medical students, internal medicine residents, and preceptors. APPROACH:An inductive thematic analysis was conducted where researchers coded transcripts, abstracted codes into themes, and then mapped themes onto six focus areas: role dimensions, role performance, stressors and rewards, mastery, fulfillment, and impact on others. Two authors then identified "recurrent themes" (emerging in two or more focus areas) and compared them across groups to identify "unique themes" (emerging from a maximum of two stakeholder groups). "Unique thematic emphases" (unique themes that would not have emerged if a stakeholder group was not interviewed) are described. KEY RESULTS:Patients and their families emphasized preceptors' ultimate authority. Allied healthcare providers described preceptors as engaged collaborators involved in discharge planning and requiring a sense of humor. Bedside nurses highlighted the need for role standardization. Nurse managers stressed preceptors' need for humanism. Medical students highlighted preceptors' emotional labor and their influence on learners' emotional well-being. Residents emphasized preceptors' responsibilities to multiple stakeholders. Preceptors described lifelong learning and exercising control over one's environment. CONCLUSIONS:Various stakeholder groups hold unique and nuanced views of the attending physician preceptor role. These views could broaden formal role guidance for medical education and patient care. This study generated real-world, practical examples of what stakeholders feel are important preceptor skills. These skills should be practiced, taught, and role modeled in this clinical setting.

Project description:BackgroundFew studies describe system-level challenges or facilitators to implementing population-based colorectal cancer (CRC) screening outreach programs. Our qualitative study explored viewpoints of multilevel stakeholders before, during, and after implementation of a centralized outreach program. Program implementation was part of a broader quality-improvement initiative.MethodsDuring 2008-2010, we conducted semi-structured, open-ended individual interviews and focus groups at Kaiser Permanente Northwest (KPNW), a not-for-profit group model health maintenance organization using the practical robust implementation and sustainability model to explore external and internal barriers to CRC screening. We interviewed 55 stakeholders: 8 health plan leaders, 20 primary care providers, 4 program managers, and 23 endoscopy specialists (15 gastroenterologists, 8 general surgeons), and analyzed interview transcripts to identify common as well as divergent opinions expressed by stakeholders.ResultsThe majority of stakeholders at various levels consistently reported that an automated telephone-reminder system to contact patients and coordinate mailing fecal tests alleviated organizational constraints on staff's time and resources. Changing to a single-sample fecal immunochemical test (FIT) lessened patient and provider concerns about feasibility and accuracy of fecal testing. The centralized telephonic outreach program did, however, result in some screening duplication and overuse. Higher rates of FIT completion and a higher proportion of positive results with FIT required more colonoscopies.ConclusionsAddressing barriers at multiple levels of a health system by changing the delivery system design to add a centralized outreach program, switching to a more accurate and easier-to-use fecal test, and providing educational and electronic support had both benefits and problematic consequences. Other health care organizations can use our results to understand the complexities of implementing centralized screening programs.

Project description:BackgroundConventional clinical trials are essential for generating high-quality evidence by measuring the efficacy of interventions in rigorously controlled clinical environments. However, their execution can be expensive and time-consuming. In addition, clinical trials face several logistical challenges regarding the identification, recruitment, and retention of participants; consistent data collection during trials; and adequate patient follow-up. This might lead to inefficient resource utilization. In order to partially address the current problems with conventional clinical trials, there exists the need for innovations. One such innovation is the virtual clinical trial (VCT). VCTs allow for the collection and integration of diverse data from multiple information sources, such as electronic health records, clinical and demographic data, patient-reported outcomes, anthropometric and activity measurements, and data collected by digital biomarkers or (small) samples that participants can collect themselves. Although VCTs have the potential to provide substantial value to clinical research and patients because they can lower clinical trial costs, increase the volume of data collected from patients' daily environment, and reduce the burden of patient participation, so far VCT adoption is not commonplace.ObjectiveThis paper aims to better understand the barriers and facilitators to VCT adoption by determining the factors that influence individuals' considerations regarding VCTs from the perspective of various stakeholders.MethodsBased on online semistructured interviews, a qualitative study was conducted with pharmaceutical companies, food and health organizations, and an applied research organization in Europe. Data were thematically analyzed using Rogers' diffusion of innovation theory.ResultsA total of 16 individuals with interest and experience in VCTs were interviewed, including persons from pharmaceutical companies (n=6), food and health organizations (n=4), and a research organization (n=6). Key barriers included a potentially low degree of acceptance by regulatory authorities, technical issues (standardization, validation, and data storage), compliance and adherence, and lack of knowledge or comprehension regarding the opportunities VCTs have to offer. Involvement of regulators in development processes, stakeholder exposure to the results of pilot studies, and clear and simple instructions and assistance for patients were considered key facilitators.ConclusionsCollaboration among all stakeholders in VCT development is crucial to increase knowledge and awareness. Organizations should invest in accurate data collection technologies, and compliance of patients in VCTs needs to be ensured. Multicriteria decision analysis can help determine if a VCT is a preferred option by stakeholders. The findings of this study can be a good starting point to accelerate the development and widespread implementation of VCTs.

Dataset Information

Stakeholder perspectives on addressing adverse events from adjuvant cancer therapy: A qualitative study.

Background

Methods

Results

Conclusions

Publications

Stakeholder perspectives on addressing adverse events from adjuvant cancer therapy: A qualitative study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets