Elucidation of qualitative patient-reported outcome (PRO) data using latent dirichlet allocation (LDA) in patients (pts) undergoing radical cystectomy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18245-e18245
Author(s):  
Thomas Michael Atkinson ◽  
Bruce D. Rapkin ◽  
Elizabeth Schofield ◽  
Bernard H. Bochner ◽  
Yuelin Li

e18245 Background: As PROs become commonplace in clinical trials and routine care, we must identify efficient analytic methods to better understand and ultimately integrate this information into clinical decision-making. While PROs are often captured via qualitative methods to provide context and pt voice to traditional objective and/or quantitative assessments, the current analytic standard is resource intensive and impractical for timely delivery of this information to clinicians and trialists. To address this problem, we propose the use of LDA, a natural language processing technique that automates the distillation of vast amounts of free-text data into underlying topics. Methods: As part of a prospective longitudinal trial of pts ( N = 200; M age = 63.8; 20% female; 46%) undergoing radical cystectomy (52% stage T2-T4) and urinary diversion (49% continent) for bladder cancer (ClinicalTrials.gov identifier NCT00745355), pts completed 30 minute interviews at baseline and 6-months post-surgery where they were asked to characterize their quality of life with respect to goals or milestones they would like to reach, problems they would like to solve, situations they would like to prevent, things they would like to remain the same, and commitments they would be willing to let go. LDA was used to extract latent topics and themes, stratified by time. Results: LDA extracted 7 latent topics and showed shifting patient priorities. At baseline, pt primary concerns were related to surgery and recovery. Six months post-surgery, pt goals transitioned toward themes related to concerns about cancer recurrence, regaining a sense of normalcy, return to work, enjoyment of life and increased appreciation of friends and family. Conclusions: LDA was used as an automated tool to illustrate a shift in pt goals and concerns as they transition into survivorship. This novel data analytic technique offers the possibility of significantly reducing the resources required to summarize qualitative PRO data. As such, this information may now be more readily available for immediate inclusion in the decision-making process as part of routine care and clinical trials. Clinical trial information: NCT00745355.

Author(s):  
Rikke Torenholt ◽  
Henriette Langstrup

In both popular and academic discussions of the use of algorithms in clinical practice, narratives often draw on the decisive potentialities of algorithms and come with the belief that algorithms will substantially transform healthcare. We suggest that this approach is associated with a logic of disruption. However, we argue that in clinical practice alongside this logic, another and less recognised logic exists, namely that of continuation: here the use of algorithms constitutes part of an established practice. Applying these logics as our analytical framing, we set out to explore how algorithms for clinical decision-making are enacted by political stakeholders, healthcare professionals, and patients, and in doing so, study how the legitimacy of delegating to an algorithm is negotiated and obtained. Empirically we draw on ethnographic fieldwork carried out in relation to attempts in Denmark to develop and implement Patient Reported Outcomes (PRO) tools – involving algorithmic sorting – in clinical practice. We follow the work within two disease areas: heart rehabilitation and breast cancer follow-up care. We show how at the political level, algorithms constitute tools for disrupting inefficient work and unsystematic patient involvement, whereas closer to the clinical practice, algorithms constitute a continuation of standardised and evidence-based diagnostic procedures and a continuation of the physicians’ expertise and authority. We argue that the co-existence of the two logics have implications as both provide a push towards the use of algorithms and how a logic of continuation may divert attention away from new issues introduced with automated digital decision-support systems.


Medicina ◽  
2021 ◽  
Vol 57 (11) ◽  
pp. 1237
Author(s):  
Alexandra Vinagre ◽  
Catarina Castanheira ◽  
Ana Messias ◽  
Paulo J. Palma ◽  
João C. Ramos

Background and Objectives: This systematic review aimed to assess the literature focusing on the clinical management of traumatized teeth with Pulp Canal Obliteration (PCO) and propose an updated clinical decision-making algorithm. The present review follows the PRISMA guidelines and was registered on PROSPERO database (CRD42020200656). Materials and Methods: An electronic search strategy was performed in Pubmed, EBSCOhost and LILACS from inception to March 2021. Only anterior permanent teeth with PCO due to dental trauma were included. Regarding clinical approaches, only teeth managed with a “watchful waiting” approach, tooth bleaching or root canal treatment (RCT) were included. Quality assessment was performed using the JBI Critical Appraisal Tool for Case Reports. Results: Twenty case reports were selected, resulting in a total of 27 patients. The number of traumatized teeth diagnosed with PCO was 33. The “watchful waiting” approach was the most implemented clinical strategy. Discolored non-symptomatic PCO teeth were mostly managed with external bleaching. The prevalence of pulp necrosis (PN) was 36.4%. For teeth diagnosed with PN, non-surgical RCT was performed in 10 teeth and surgical RCT in one tooth. Guided endodontic technique was performed in six of those teeth. Conclusions: For discolored non-symptomatic PCO teeth, external bleaching is advocated and the RCT approach should not be implemented as a preventive intervention strategy. Symptomatic PCO teeth should follow regular endodontic treatment pathways. Clinical approach of teeth with PCO should follow a decision-making algorithm incorporating clinical and radiographic signs and patient-reported symptoms.


Hematology ◽  
2015 ◽  
Vol 2015 (1) ◽  
pp. 496-500 ◽  
Author(s):  
Catherine Acquadro ◽  
Antoine Regnault

Abstract Patient-reported outcomes (PROs) are any outcome evaluated directly by the patient himself and based on the patient's perception of a disease and its treatment(s). PROs are direct outcome measures that can be used as clinical meaningful endpoints to characterize treatment benefit. They provide unique and important information about the effect of treatment from a patient's view. However, PROs will only be considered adequate if the assessment is well-defined and reliable. In 2009, the FDA has issued a guidance, which defines good measurement principles to consider for PRO measures intended to give evidence of treatment benefit in drug development. In hematologic clinical trials, when applied rigorously, they may be used to evaluate overall treatment effectiveness, treatment toxicity, and quality of patient's well-being at short-term and long-term after treatment from a patient's perspective. In situations in which multiple treatment options exist with similar survival outcome or if a new therapeutic strategy needs to be evaluated, the inclusion of PROs as an endpoint can provide additional data and help in clinical decision making. Given the diversity of the hematological field, the approach to measurement needs to be tailored for each specific situation. The importance of PROs in hematologic diseases has been highlighted in a number of international recommendations. In addition, new perspectives in the regulatory field will enhance the inclusion of PRO endpoints in clinical trials in hematology, allowing the voice of the patients with hematologic diseases to be taken into greater consideration in the development of new drugs.


2003 ◽  
Vol 21 (18) ◽  
pp. 3502-3511 ◽  
Author(s):  
Fabio Efficace ◽  
Andrew Bottomley ◽  
David Osoba ◽  
Carolyn Gotay ◽  
Henning Flechtner ◽  
...  

Purpose: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer. Materials and Methods: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making. Results: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions. Conclusion: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.


2018 ◽  
Vol 38 (6) ◽  
pp. 935-947 ◽  
Author(s):  
Bruno Fautrel ◽  
Rieke Alten ◽  
Bruce Kirkham ◽  
Inmaculada de la Torre ◽  
Frederick Durand ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031179
Author(s):  
Bróna Nic Giolla Easpaig ◽  
Gaston Arnolda ◽  
Yvonne Tran ◽  
Mia Bierbaum ◽  
Klay Lamprell ◽  
...  

IntroductionAn understanding of the real-world provision of oncology outpatient services can help maintain service quality in the face of escalating demand and tight budgets, by informing the design of interventions that improve the effectiveness or efficiency of provision. The aims of this study are threefold. First, to develop an understanding of cancer services in outpatient clinics by characterising the organisation and practice of multidisciplinary care (MDC). Second, to explore the key areas of: (a) clinical decision-making and (b) engagement with patients’ supportive needs. Third, to identify barriers to, and facilitators of, the delivery of quality care in these settings.Methods and analysisA suite of mixed-methods studies will be implemented at six hospitals providing cancer outpatient clinics, with a staged roll-out. In Stage One, we will examine policies, use unstructured observations and undertake interviews with key health professionals to characterise the organisation and delivery of MDC. In Stage Two, observations of practice will continue, to deepen our understanding, and to inform two focused studies. The first will explore decision-making practices and the second will examine how staff engage with patients’ needs; both studies involve interviews, to complement observation. As part of the study of supportive care, we will examine the implications of an introduction of patient-reported measures (PRMs) into care, adding surveys to interviews before and after PRMs roll-out. Data analysis will account for site-specific and cross-site issues using an adapted Qualitative Rapid Appraisal, Rigorous Analysis approach. Quantitative data from clinician surveys will be statistically analysed and triangulated with the related qualitative study findings.Ethics and disseminationEthical approval was granted by South Eastern Sydney Local Health District Human Research Ethics Committee (no. 18/207). Findings will be shared with participating hospitals and widely disseminated through publications and presentations.


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