scholarly journals Stakeholder Perspectives on Navigating Evidentiary and Decision Uncertainty in Precision Oncology

2022 ◽  
Vol 12 (1) ◽  
pp. 22
Author(s):  
Samantha Pollard ◽  
Jessica Dunne ◽  
Sarah Costa ◽  
Dean A. Regier

(1) Background: Precision oncology has the potential to improve patient health and wellbeing through targeted prevention and treatment. Owing to uncertain clinical and economic outcomes, reimbursement has been limited. The objective of this pan-Canadian qualitative study was to investigate barriers to precision oncology implementation from the perspectives of health system stakeholders. (2) Methods: We conducted 32 semi-structured interviews with health technology decision makers (n = 14) and clinicians (n = 18) experienced with precision oncology. Participants were recruited using a purposive sampling technique. Interviews were analyzed using thematic analysis. Recruitment continued until two qualitative analysts reached agreement that thematic saturation was reached. (3) Results: While cautiously optimistic about the potential for enhanced therapeutic alignment, participants identified multiple decisional challenges under conditions of evidentiary uncertainty. Decision makers voiced concern over resource requirements alongside small benefitting patient populations and limited evidence supporting patient and health system impacts. Clinicians were comparatively tolerant of evidentiary uncertainty guiding clinical decision-making practices. Clinicians applied a broader definition of patient benefit, focusing on the ability to assist patients making informed clinical decisions. (4) Conclusions: Sustainable precision oncology must balance demand with evidence demonstrating benefit. We show that clinicians and decision makers vary in their tolerance for evolving knowledge, suggesting a need to establish evidentiary standards supporting precision oncology reimbursement decisions.

2019 ◽  
Vol 17 (3.5) ◽  
pp. BPI19-021
Author(s):  
Vishal Vashistha ◽  
Pradeep J. Poonnen ◽  
Vimla L. Patel ◽  
Halcyon G. Skinner ◽  
Jane L. Snowdon ◽  
...  

Background: Genomic sequencing of tumor samples is often considered for patients diagnosed with metastatic malignancies. In July 2016, the Veterans Health Administration (VHA) created the VA National Precision Oncology Program (NPOP) to offer next generation sequencing (NGS) multigene panels for veterans with advanced solid tumors. We sought to assess the perceptions of NPOP among medical oncologists across VHA. Methods: Semi-structured interviews were designed to evaluate the following concepts: expectations for NGS testing, required workflow to conduct testing, applicability of testing results, and summative views of genomic sequencing. VHA medical oncologists who had previously sent at least one sample for testing through NPOP were solicited to participate for an in-person or telephonic conversation. Interviews were analyzed by an inductive narrative approach to code responses, which was then followed by thematic analysis for key findings that emerged. Results: 17 medical oncologists were interviewed from 16 different VA medical centers (VAMCs) in 12 states. 16 (94.1%) oncologists reported sending at least 5 samples for NGS testing; 4 (23.5%) oncologists practiced at VAMCs that sent over 100 samples. Clinicians collectively expected that testing would determine all clinically relevant genomic alterations in a reasonable time. Testing was expedited for oncologists who maintained a collaborative relationship with their local pathologists and proceduralists. 8 (47.1%) oncologists felt that testing reports should provide greater insight into the clinical significance of uncommon gene variants. 6 (35.3%) respondents expressed that educational efforts are warranted to describe optimal sample processing, indications for testing, and/or relevance of rare mutations. Twelve (70.6%) respondents felt strongly that NGS testing would improve outcomes for their patients, while 3 (17.6%) oncologists were wary that the current number of actionable mutations is too limited to offer widespread benefit. Conclusions: VHA medical oncologists opined that NGS testing through VA NPOP improved outcomes. The testing process is expedited with multidisciplinary involvement. Designed approaches to semi-algorithmically report testing results may improve efficiency of clinical decision-making. More education is warranted to detail the procedural requirements to conduct testing, indications for test ordering, and interpretation of results.


2021 ◽  
Author(s):  
Fen-Fang Chung ◽  
Shu-Chuan Lin ◽  
Yu-Hsia Lee ◽  
Pao-Yu Wang ◽  
Hon-Yen Wu ◽  
...  

Abstract Background Shared decision making (SDM) is a patient-centred nursing concept that emphasises the autonomy of the patient. It is a co-operative process of exchanging information, communication and response, and treatment decisions made between medical staff and patients. In this study, we explored the experience of clinical nursing staff participating in SDM. Methods We adopted a qualitative research method. Semi-structured interviews were conducted with 21 nurses at a medical centre in northern Taiwan. The data obtained from interview recordings were transferred to verbatim manuscripts. Content analysis was used to analyse and summarise the data. Results Clinical nursing staff should have basic professional skills, communication and response skills, respect and cultural sensitivity, the ability to form a co-operative team, the ability to search for and integrate empirical data, and the basic ability to edit media to participate in SDM. Conclusions The results of this study describe the experiences of clinical nursing staff participating in SDM, which can be used as a reference for nursing education and nursing administrative supervisors to plan and enhance professional nursing SDM in nursing education.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11035-11035
Author(s):  
Kristen Marrone ◽  
Jessica Tao ◽  
Jenna VanLiere Canzoniero ◽  
Paola Ghanem ◽  
Emily Nizialek ◽  
...  

11035 Background: The accelerated impact of next generation sequencing (NGS) in clinical decision making requires the integration of cancer genomics and precision oncology focused training into medical oncology education. The Johns Hopkins Molecular Tumor Board (JH MTB) is a multi-disciplinary effort focused on integration of NGS findings with critical evidence interpretation to generate personalized recommendations tailored to the genetic footprint of individual patients. Methods: The JH MTB and the Medical Oncology Fellowship Program have developed a 3-month precision oncology elective for fellows in their research years. Commencing fall of 2020, the goals of this elective are to enhance the understanding of NGS platforms and findings, advance the interpretation and characterization of molecular assay outputs by use of mutation annotators and knowledgebases and ultimately master the art of matching NGS findings with available therapies. Fellow integration into the MTB focuses on mentored case-based learning in mutation characterization and ranking by levels of evidence for actionability, with culmination in form of verbal presentations and written summary reports of final MTB recommendations. A mixed methods questionnaire was administered to evaluate progress since elective initiation. Results: Three learners who have participated as of February 2021 were included. Of the two who had completed the MTB elective, each have presented at least 10 cases, with at least 1 scholarly publication planned. All indicated strong agreement that MTB elective had increased their comfort with interpreting clinical NGS reports as well as the use of knowledgebases and variant annotators. Exposure to experts in the field of molecular precision oncology, identification of resources necessary to interpret clinical NGS reports, development of ability to critically assess various NGS platforms, and gained familiarity with computational analyses relevant to clinical decision making were noted as strengths of the MTB elective. Areas of improvement included ongoing initiatives that involve streamlining variant annotation and transcription of information for written reports. Conclusions: A longitudinal elective in the JHU MTB has been found to be preliminarily effective in promoting knowledge mastery and creating academic opportunities related to the clinical application of precision medicine. Future directions will include leveraging of the MTB infrastructure for research projects, learner integration into computational laboratory meetings, and expansion of the MTB curriculum to include different levels of learners from multiple medical education programs. Continued elective participation will be key to understanding how best to facilitate adaptive expertise in assigning clinical relevance to genomic findings, ultimately improving precision medicine delivery in patient care and trial development.


2019 ◽  
Vol 16 (6) ◽  
pp. 574-579 ◽  
Author(s):  
Kevin P Weinfurt ◽  
Li Lin ◽  
Jeremy Sugarman

Background The need for more and better evidence to inform clinical decision making among all stakeholders has fueled calls for creating learning healthcare systems. The successful realization of a learning healthcare system seems to assume that various parties have a responsibility to participate in learning activities, including research. The objective of this study was to determine whether members of the general public perceive an ethical responsibility to participate in pragmatic clinical research that would be inherent to a learning health system. Methods A total of 2994 English-speaking adults completed a nationally representative online survey. Results About two-thirds of respondents were relatively neutral regarding a responsibility for themselves and others to participate in research; the remainder felt that they and others did not have a responsibility to participate in research. Conclusions Efforts to justify and develop a robust learning health system in an ethically acceptable fashion need to take these findings into account.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 1568-1568
Author(s):  
Navdeep Dehar ◽  
Tasnima Abedin ◽  
Patricia A. Tang ◽  
D. Gwyn Bebb ◽  
Winson Y. Cheung

1568 Background: With the increasing number and frequency of biomarker and genetic tests that are offered to patients with cancer, it is important to ensure that they fully understand the implications of these tests. In this survey study, we aimed to compare the attitudes and expectations of patients and cancer physicians about the role of biomarker and genetic testing in clinical decision-making. Methods: Two separate, complimentary, self-administered questionnaires for cancer patients and their physicians, respectively, were collected in Calgary, Alberta, Canada. Survey responses from patients were subsequently matched with those of their corresponding oncologists to form patient–oncologist dyads. We determined the concordance rates between responses of patients and those of their oncologists. Results: A total of 113 patients and 15 physicians participated in the study from July to September 2019. Patients demonstrated good understanding of general cancer biology (79%) and diagnostic processes (91%) associated with precision oncology. About 70% patients were willing to undergo minor procedures, and participate in research involving biomarker or genetic testing; however, this was over-estimated by their physicians in 82% of cases. Many patients felt that their tumor should be tested to guide treatment (70%) and were not bothered by potential delays in treatment due to testing (23%). These views from patients were largely shared by their oncologists (concordance 64%). While only 28% patients thought that they had enough knowledge to make informed decisions, majority (68%) said that they needed more information. Importantly, knowledge and expectations regarding the applications of biomarker or genetic test results on actual diagnosis and prognosis were grossly discrepant between patients and their oncologists (concordance 26% and 36%, respectively). Conclusions: Patients and cancer physicians tend to be aware of the advances in precision oncology and are willing to participate in biomarker and genetic testing and research. However, they do not consistently agree about the roles and applications of these tests, which may result in misplaced expectations. Strategies to improve education and communication are needed to align these expectations and improve the quality of clinical decision-making.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Saeideh Daryazadeh ◽  
Payman Adibi

Background: Morning reports are important training programs (especially for residents) as they enhance clinical decision-making skills, social interactions, and participatory learning. Given the need to eliminate the educational gap and provide optimal conditions, educational interventions regarding morning reports are often implemented in the form of evidence-based morning reports with an interactive and consultative approach. Objectives: The present study aimed to evaluate the quality of evidence-based morning reports using an interactive and consultative approach. Methods: This qualitative study was conducted with an inductive approach in 2019 in Iran. Changes were made to develop an evidence-based morning report and create a friendly educational environment between faculty members and residents, as well as interactive learning among the residents. The intervention was assessed through explaining the experiences of 16 participants via individual semi-structured interviews. Purposive sampling continued until data saturation. Data analysis was performed in the MAXQDA10 software. Results: In total, 153 codes, two main categories (education and dimensions of change), six categories (educational deficiencies, influential factors in the quality of education, requirements, barriers, benefits, and response to change), and 20 subcategories were extracted. Conclusions: According to the results, the residents were satisfied with the changes, while the faculty members needed more justification and motivation. The strengths and weaknesses identified in the intervention could lay the groundwork for broader changes in the same clinical fields.


2021 ◽  
Author(s):  
V. Sah

The amount of druggable tumor-specific molecular aberrations has increased significantly over the last decade, with biomarker-matched therapies demonstrating a major survival advantage in many cancer forms. Therefore, molecular pathology has been critical not just for tumor detection and prognosis, but also for clinical decision-making in everyday practice. The advent of next-generation sequencing technology and the proliferation of large-scale tumor molecular profiling services through universities worldwide have transformed the area of precision oncology. When systematic genomic studies become more accessible in clinical and laboratory environments, healthcare professionals face the difficult challenge of outcome analysis and translation. This study summarizes existing and future methods to implementing precision cancer medicine, outlining the obstacles and possible strategies for facilitating the understanding and maximization of molecular profiling findings. Beyond tumor DNA sequencing, we discuss innovative molecular characterization techniques such as transcriptomics, immunophenotyping, epigenetic profiling, and single-cell analysis. Additionally, we discuss present and future uses of liquid biopsies for evaluating blood-based biomarkers such as circulating tumor cells and nucleic acids. Finally, the shortcomings of genotype-based treatments give insight into opportunities to extend personalized medicine beyond genomics.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S140-S140
Author(s):  
Kimberly Dukes ◽  
Julia Walhof ◽  
Madisen Brown ◽  
Kalpana Gupta ◽  
Judith Strymish ◽  
...  

Abstract Background In 2019, the IDSA Clinical Practice guidelines on asymptomatic bacteriuria (ASB) recommended that clinicians no longer screen or treat patients for ASB before non-urological surgeries. However, it remains to be seen whether these guideline recommendations alone will produce changes in practice. Understanding clinical decision-making about preoperative urine screening and treatment can help design effective interventions to facilitate guideline concordance and support antibiotic stewardship. Our project objective was to qualitatively assess barriers and facilitators to reducing preoperative urine testing and treatment. Methods We conducted semi-structured interviews with 24 participants (surgeons, advance practice providers, pharmacists, infectious disease physicians, epidemiologists) at 4 Veterans Administration hospitals. We solicited feedback on 4 proposed interventions (substitution, lab restrictions, audit and feedback, interactive workshop), and invited suggestions on other interventions. Three researchers separately coded 20% of interview notes to sort responses to each intervention into acceptable, possibly acceptable, and not acceptable. The team then compared coding, resolved differences by consensus, and refined the code dictionary to ensure intercoder agreement; then each member coded one third of remaining notes. Results Participants expressed concerns about de-implementing routine urine testing and treatment for specific procedures and specialties (e.g., cardiothoracic). Some actively sought to identify and treat ASB. Participants found audit and feedback and substitution of different infection-control practices most acceptable. Participants suggested changes to make interventions more acceptable or feasible (e.g., tailoring to procedure, educational tailoring). Participants also identified new potential interventions (e.g. order set changes, collaborative decision making, education on potential harms, identification of testing costs). Table 1. Acceptability of Proposed Interventions by Percentage of Participants. Percentages Do Not Add up to 100% Because Some Interviewees Did Not Answer Every Question. Conclusion Interventions to optimize urine screening and treatment for patients undergoing surgeries may require tailoring for surgical specialties, and should address clinical concerns about intervention feasibility. Disclosures Kalpana Gupta, MD, MPH, Abbott (Shareholder)DBC Pri-Med (Consultant)Glaxo Smith Kline (Consultant)Moderna (Shareholder)Nabriva Therapeutics (Consultant)Pfizer (Other Financial or Material Support, Grant to the institution)Qiagen (Consultant)Rebiotix (Consultant)Spero Therapeutics (Consultant)Utility Therapeutics (Consultant) Daniel Suh, MS MPH, General Electric (Shareholder)Merck (Shareholder)Moderna (Shareholder)Smile Direct Club (Shareholder) Bruce Alexander, PharmD, Bruce Alexander Consulting (Independent Contractor) Marin Schweizer, PhD, 3M (Grant/Research Support)PDI (Grant/Research Support)


Author(s):  
Janet E. Squires ◽  
Alison M. Hutchinson ◽  
Mary Coughlin ◽  
Kainat Bashir ◽  
Janet Curran ◽  
...  

Background: Context is recognized as important to successful knowledge translation (KT) in health settings. What is meant by context, however, is poorly understood. The purpose of the current study was to elicit tacit knowledge about what is perceived to constitute context by conducting interviews with a variety of health system stakeholders internationally so as to compile a comprehensive list of contextual attributes and their features relevant to KT in healthcare. Methods: A descriptive qualitative study design was used. Semi-structured interviews were conducted with health system stakeholders (change agents/KT specialists and KT researchers) in four countries: Australia, Canada, the United Kingdom, and the United States. Interview transcripts were analyzed using inductive thematic content analysis in four steps: (1) selection of utterances describing context, (2) coding of features of context, (3) categorizing of features into attributes of context, (4) comparison of attributes and features by: country, KT experience, and role. Results: A total of 39 interviews were conducted. We identified 66 unique features of context, categorized into 16 attributes. One attribute, Facility Characteristics, was not represented in previously published KT frameworks. We found instances of all 16 attributes in the interviews irrespective of country, level of experience with KT, and primary role (change agent/KT specialist vs. KT researcher), revealing robustness and transferability of the attributes identified. We also identified 30 new context features (across 13 of the 16 attributes). Conclusion: The findings from this study represent an important advancement in the KT field; we provide much needed conceptual clarity in context, which is essential to the development of common assessment tools to measure context to determine which context attributes and features are more or less important in different contexts for improving KT success.


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