Interpreting Nonrandomized Evidence for Clinical Decision Making in Cardio-Oncology.
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ABSTRACT:
SUBMITTER: Chatur S
PROVIDER: S-EPMC10308051 | biostudies-literature | 2023 Jun
REPOSITORIES: biostudies-literature
Publications
Interpreting Nonrandomized Evidence for Clinical Decision Making in Cardio-Oncology.
Chatur Safia S Fu Edouard E Vaduganathan Muthiah M
JACC. CardioOncology 20230620 3
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Project description:IntroductionClinical decision-making in oncology is a complex process, with the primary goal of identifying the most effective treatment tailored to individual cancer patients. Many factors influence the treatment decision: disease- and patient-specific criteria, the increasingly complex treatment landscape, market authorization and drug availability, financial aspects, and personal treatment expertise. In the domain of genitourinary cancers, particularly prostate cancer, decision-making is challenging. Despite the prevalence of this malignancy, there are few in-depth explorations of these factors within real-world scenarios. Understanding and refining this intricate decision-making process is essential for future successful clinical decisions and the integration of computerized decision support into clinicians' workflows.AimThe objective of this study is to improve the current knowledge base and evidence of the factors that influence treatment decision-making for patients with genitourinary cancers.MethodsAssessment of how routine treatment decisions are made for genitourinary cancers was performed by a mixed-methods study, encompassing field observations and focus group discussions.ResultsIn total, we identified 59 factors that influence clinical decision-making in oncology, specifically for genitourinary and prostate cancer. Of these, 23 criteria can be classified as decision-maker-related criteria encompassing personal, cognitive, and emotional attributes and factors of both, healthcare professionals and patients. Moreover, 20 decision-specific criteria have been identified that refer to clinical and disease-related factors, followed by 16 contextual decision factors that describe the relevant criteria introduced by the specific circumstances and environment in which the treatment decision is made.ConclusionBy presenting an exhaustive set of decision factors and providing specific examples for genitourinary cancers, this observational study establishes a possible framework for a better understanding of decision-making. Moreover, we specify and expand the set of decision factors, while emphasizing the importance of cognitive, emotional, and human factors, as well as the quality and accessibility of decision-relevant information.
| S-EPMC11494402 | biostudies-literature
Project description:Drug development can be associated with slow timelines, particularly for rare or difficult-to-treat solid tumors such as glioblastoma. The use of external data in the design and analysis of trials has attracted significant interest because it has the potential to improve the efficiency and precision of drug development. A recurring challenge in the use of external data for clinical trials, however, is the difficulty in accessing high-quality patient-level data. Academic research groups generally do not have access to suitable datasets to effectively leverage external data for planning and analyses of new clinical trials. Given the need for resources to enable investigators to benefit from existing data assets, we have developed the Glioblastoma External (GBM-X) Data Platform which will allow investigators in neuro-oncology to leverage our data collection and obtain analyses. GBM-X strives to provide an uncomplicated process to use external data, contextualize single-arm trials, and improve inference on treatment effects early in drug development. The platform is designed to welcome interested collaborators and integrate new data into the platform, with the expectation that the data collection can continue to grow and remain updated. With such features, GBM-X is designed to help to accelerate evaluation of therapies, to grow with collaborations, and to serve as a model to improve drug discovery for rare and difficult-to-treat tumors in oncology.
| S-EPMC10681026 | biostudies-literature
Project description:BackgroundDespite recent advances in research, there are still critical lacunae in our basic understanding of the cause, pathogenesis, and natural history of many cancers, especially heterogeneity in patient response to drugs and mediators in the transition from malignant to invasive phenotypes. The explication of the pathogenesis of cancer has been constrained by limited access to patient samples, tumor heterogeneity and lack of reliable biological models. Amelioration in cancer treatment depends on further understanding of the etiologic, genetic, biological, and clinical heterogeneity of tumor microenvironment. Patient-derived organoids recapitulate the basic features of primary tumors, including histological complexity and genetic heterogeneity, which is instrumental in predicting patient response to drugs.MethodsHuman iPSCs from healthy donors, breast and ovarian cancer patients were successfully differentiated towards isogenic hepatic, cardiac, neural and endothelial lineages. Multicellular organoids were established using Primary cells isolated from tumor tissues, histologically normal tissues adjacent to the tumors (NATs) and adipose tissues (source of Mesenchymal Stem Cells) from ovarian and breast cancer patients. Further these organoids were propagated and used for drug resistance/sensitivity studies.ResultsOvarian and breast cancer patients' organoids showed heterogeneity in drug resistance and sensitivity. iPSCs-derived cardiomyocytes, hepatocytes and neurons showed donor-to-donor variability of chemotherapeutic drug sensitivity in ovarian cancer patients, breast cancer patients and healthy donors.ConclusionWe report development of a novel integrated platform to facilitate clinical decision-making using the patient's primary cells, iPSCs and derivatives, to clinically relevant models for oncology research.
| S-EPMC10362580 | biostudies-literature
Project description: Not available
| S-EPMC8820069 | biostudies-literature
Project description:Biologic factors limiting responsiveness to matched targeted therapies include genomic heterogeneity and complexity. Advanced tumors with unique molecular profiles can be studied by comprehensive genomic profiling (CGP) and enhance patient outcomes using principles of precision medicine. The clinical utility of CGP across all cancer types and different therapeutic interventions using overall survival (OS) and progression-free survival (PFS) data was studied in this systematic literature review. Randomized controlled, nonrandomized, and observational studies conducted in adult patients with advanced cancer, dated up to September 2022, were searched from PubMed and EMBASE databases following PRISMA guidelines. Of 14 CGP studies, 7 (50%) and 9 (64%) reported OS and PFS as an outcome, respectively. Improved OS and PFS were reported when CGP guided treatment decisions, but its clinical utility varied among cancer types. Treatments were assigned based on matching scores and with the involvement of molecular tumor board (MTB) enhanced OS and PFS. Patients following MTB recommendations had superior treatment outcomes compared with those on physician's choice regimens. CGP clinically benefited patients with genomically matched therapies and yielded better clinical outcomes regardless of cancer type. Further, uniform clinical value-based ranking of actionable mutations can encourage oncologists to use CGP tests for patients.
| S-EPMC11728381 | biostudies-literature
Project description:RATIONALE:Limited pharmacological data are available to guide methadone treatment during pregnancy and postpartum. OBJECTIVES:Study goals were to (1) characterize changes in methadone dose across childbearing, (2) determine enantiomer-specific methadone withdrawal kinetics from steady state during late pregnancy, (3) assess enantiomer-specific changes in methadone level/dose (L/D) ratios across childbearing, and (4) explore relationships between CYP2B6, CYP2C19, and CYP3A4 single-nucleotide polymorphisms and maternal dose, plasma concentration, and L/D. METHODS:Methadone dose changes and timed plasma samples were obtained for women on methadone (n?=?25) followed prospectively from third trimester of pregnancy to 3 months postpartum. RESULTS:Participants were primarily white, Medicaid insured, and multiparous. All women increased their dose from first to end of second trimester (mean peak increase?=?23 mg/day); 71 % of women increased from second trimester to delivery (mean peak increase?=?19 mg/day). Half took a higher dose 3 months postpartum than at delivery despite significantly larger clearance during late pregnancy. Third trimester enantiomer-specific methadone half-lives (range R-methadone 14.7-24.9 h; S-methadone, 8.02-18.9 h) were about half of those reported in non-pregnant populations. In three women with weekly 24-h methadone levels after delivery, L/D increased within 1-2 weeks after delivery. Women with the CYP2B6 Q172 variant GT genotype have consistently higher L/D values for S-methadone across both pregnancy and postpartum. CONCLUSIONS:Most women require increases in methadone dose across pregnancy. Given the shorter half-life and larger clearances during pregnancy, many pregnant women may benefit from split methadone dosing. L/D increases quickly after delivery and doses should be lowered rapidly after delivery.
| S-EPMC3537905 | biostudies-literature
Project description:Despite copious research and clear policies in many healthcare systems, evidence based practice has yet to be widely adopted. Part of the problem is insufficient consideration of the patient-clinician consultation, which lies at the heart of clinical practice and is where most decisions are made. Shared decision making (SDM)-the interactive process in which patients and clinicians decide on healthcare together-capitalises on the consultation to better translate the best evidence into clinical decisions while taking the patient's values and preferences into account. This paper takes stock of interventions that seek to embed SDM in clinical practice, such as patient decision aids that target both patients and clinicians. It also presents challenges that remain: among others, the paucity of evidence on effective implementation strategies and the lack of consideration of how SDM works when care is delivered by interprofessional teams. The paper then reviews current initiatives to improve and disseminate SDM across the healthcare continuum, and discusses why SDM should be encouraged as a means to leverage evidence based practice. The evidence suggests that finding ways to overcome the challenges and promote SDM will accelerate the uptake of evidence in gastroenterology and hepatology clinical practice.
| S-EPMC5517219 | biostudies-other
Project description:Plasmatic microRNA sequencing was conducted in specific matched subgroups of subjects (n = 53) with and without OSA using HTG EdgeSeq miRNA WTA Assay technology.
2024-04-01 | GSE229362 | GEO
Project description:ObjectivesThe worldwide interest of both dentists and patients in esthetic dentistry has affected decision-making in dental practice. The aim of this study was to investigate contemporary dental practice in restorative dentistry and the relationship between evidence-based dentistry in caries research and decision-making in clinical practice in restorative dentistry.MethodsThe study was conducted through a structured questionnaire distributed randomly at the Jordanian Dental Association registered dentists in Jordan. The questionnaire aimed to clarify the degree of knowledge and practice of evidence-based dentistry in caries research the dentists hold regarding clinical decision-making in restorative dentistry.ResultsThe majority of the surveyed dentists (77%) treat teeth with irreversible pulpitis with root canal treatment rather than vital pulp therapy. 13.8% routinely insert a post and 23% routinely crown the tooth after root canal treatment regardless of the remaining tooth structure. Badly damaged teeth are treated with full crowns in 72% of the cases. Regarding Hollywood smile or smile makeover, the majority of dentists choose conservative approaches, and implants were the first choice to replace missing teeth for 93.8% of the surveyed dentists.ConclusionA higher degree of implementation of evidence-based dentistry in clinical decision-making was found in Prosthetic Dentistry than in Endodontics. Yet, the gap between evidence-based data and clinical practice needs bridging. More emphasis on communicating these data to educators to integrate them into the dental curriculum is a must.
| S-EPMC8741395 | biostudies-literature
Project description:BackgroundTherapeutic decision-making in oncology is a complex process because physicians must consider many forms of medical data and protocols. Another challenge for physicians is to clearly communicate their decision-making process to patients to ensure informed consent. Computer-based decision tools have the potential to play a valuable role in supporting this process.ObjectiveThis systematic review aims to investigate the extent to which computer-based decision tools have been successfully adopted in oncology consultations to improve patient-physician joint therapeutic decision-making.MethodsThis review was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 checklist and guidelines. A literature search was conducted on February 4, 2021, across the Cochrane Database of Systematic Reviews (from 2005 to January 28, 2021), the Cochrane Central Register of Controlled Trials (December 2020), MEDLINE (from 1946 to February 4, 2021), Embase (from 1947 to February 4, 2021), Web of Science (from 1900 to 2021), Scopus (from 1969 to 2021), and PubMed (from 1991 to 2021). We used a snowball approach to identify additional studies by searching the reference lists of the studies included for full-text review. Additional supplementary searches of relevant journals and gray literature websites were conducted. The reviewers screened the articles eligible for review for quality and inclusion before data extraction.ResultsThere are relatively few studies looking at the use of computer-based decision tools in oncology consultations. Of the 4431 unique articles obtained from the searches, only 10 (0.22%) satisfied the selection criteria. From the 10 selected studies, 8 computer-based decision tools were identified. Of the 10 studies, 6 (60%) were conducted in the United States. Communication and information-sharing were improved between physicians and patients. However, physicians did not change their habits to take advantage of computer-assisted decision-making tools or the information they provide. On average, the use of these computer-based decision tools added approximately 5 minutes to the total length of consultations. In addition, some physicians felt that the technology increased patients' anxiety.ConclusionsOf the 10 selected studies, 6 (60%) demonstrated positive outcomes, 1 (10%) showed negative results, and 3 (30%) were neutral. Adoption of computer-based decision tools during oncology consultations continues to be low. This review shows that information-sharing and communication between physicians and patients can be improved with the assistance of technology. However, the lack of integration with electronic health records is a barrier. This review provides key requirements for enhancing the chance of success of future computer-based decision tools. However, it does not show the effects of health care policies, regulations, or business administration on physicians' propensity to adopt the technology. Nevertheless, it is important that future research address the influence of these higher-level factors as well.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42021226087; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021226087.
| S-EPMC8579220 | biostudies-literature