The Signature Program: Bringing the Protocol to the Patient.
Ontology highlight
ABSTRACT:
SUBMITTER: Kang BP
PROVIDER: S-EPMC4676287 | biostudies-other | 2015 Aug
REPOSITORIES: biostudies-other
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Project description:The implementation of induced pluripotent stem cells (iPSCs) in biomedical research more than a decade ago, resulted in a huge leap forward in the highly promising area of personalized medicine. Nowadays, we are even closer to the patient than ever. To date, there are multiple examples of iPSCs applications in clinical trials and drug screening. However, there are still many obstacles to overcome. In this review, we will focus our attention on the advantages of implementing induced pluripotent stem cells technology into the clinics but also commenting on all the current drawbacks that could hinder this promising path towards the patient.
| S-EPMC6940848 | biostudies-literature
Project description:Canada must become proactive in addressing type 2 diabetes. With the second highest rate of diabetes prevalence in the developed world, the number of Canadians living with diabetes will soon reach epidemic levels. Against international comparisons, Canada also performs poorly with respect to diabetes-related hospitalizations, mortality rates, and access to medications. Diabetes and its comorbidities pose a significant burden on people with diabetes (PWD) and their families, through out-of-pocket expenses for medications, devices, supplies, and the support needed to manage their illness. Rising direct and indirect costs of diabetes will become a drain on Canada's economy and undermine the financial stability of our health care system. Canada's approach to diabetes medication assessment and funding has created a patchwork of medication access across provinces. Access to treatments for those who rely on public programs is highly restricted compared to Canadians with private drug plans, as well in contrast with public payers in other countries. Each person living with diabetes has different needs, so a "patient-centric" approach ensures treatment focused on individual circumstances. Such tailoring is difficult to achieve, with the linear approach required by public payers. We may be undermining optimal care for PWD because of access policies that are not aligned with individualized approaches - and increasing overall health care costs in the process. The scope of Canada's diabetes challenge demands holistic and proactive solutions. Canada needs to get out from "behind the eight ball" and get "ahead of the curve" when it comes to diabetes care. Improving access to medications is one of the tools for getting there. Canada's "call to action" for diabetes starts with effective implementation of existing best practices. A personalized approach to medication access, to meet individual needs and optimize outcomes, is also a key enabler. PWD and prescribers need reimbursement approaches that allow them to use existing tools (ie, medications and supplies) to manage diabetes in a timely manner and to avoid and/or delay major downstream complications.
| S-EPMC5074731 | biostudies-other
Project description:Background:The purpose of this 6-week intervention was to test the feasibility and acceptability of implementing a telehealth-adapted Diabetes Prevention Program (DPP) at a senior center. Methods:Older adults (n?=?16) attended weekly interactive webinars. At each measurement time point, participants completed questionnaires covering lifestyle, physical activity, quality of life, and food records and wore physical activity trackers. Qualitative data were gathered from 2 focus groups inviting all 16 participants with 13 and 10 participants attending, respectively. Results:Over 2000 senior center members were contacted, approximately 2% (n?=?39) responded to the recruitment email, and 16 were recruited into the study. Retention was 75%, and attendance rates averaged 80% across the six intervention sessions. The focus group participants provided positive opinions for most program components, especially the webinar group interaction and using physical activity trackers. Suggestions for improvement included a greater focus on specific needs of older adults (i.e., adapting activities) and placing a greater emphasis on dietary strategies to prevent diabetes. Mean weight loss was 2.9% (2.7?kg [95% CI 1.6, 3.7]; p value?=?0.001). Conclusion:The feasibility of providing DPP via webinar appears to be high based on the retention and attendance rates. Similar to other behavioral interventions engaging older adults, recruitment rates were low. Acceptability was evidenced by high attendance at the intervention sessions and feedback from participants during focus group sessions. The intervention efficacy should be evaluated based on CDC criteria for program recognition in a larger scale randomized trial. Trial registration:NCT03524404. Registered 14 May 2018-retrospectively registered. Trial protocol will be provided by the corresponding author upon request.
| S-EPMC6849183 | biostudies-literature
Project description: Not available
| S-EPMC2483553 | biostudies-literature
Project description:BackgroundStrengthening the coordination, continuity and intersectoral cooperation for cancer patients' during cancer treatment is being underlined by international guidelines and research. General practitioners have assumed a growing role in the cancer patient disease trajectory because of their roles as coordinators and the consistent health provider. However, general practitioners are challenged in providing support for cancer patients both during treatment and in the survivorship phase. General practitioners reported barriers are lack of timely and relevant communication from the oncologist and limited knowledge to guidelines, as well as lack of trust from patients. Therefore, the current study will examine whether a shared video-based consultation between the cancer patient, general practitioner and oncologist can ease general' challenges and thereby enhance the patient-centeredness for the cancer patients and their perception of intersectoral cooperation and continuity.MethodsThe study is designed as a pragmatic randomised controlled trial for patients starting chemotherapy at the Department of Oncology, Lillebaelt Hospital, Denmark who are listed with a general practitioner in the Region of Southern Denmark. We intend to include 278 adults diagnosed with colorectal, breast, lung, gynecologic or prostate cancer. The intervention group will receive the "Partnership intervention" which consists of one or more video-consultations between the cancer patient, general practitioner and oncologist. The consultations are estimated to last between 10 and 20 min. The specific aims of the consultation are, summary of the patient trajectory, sharing of knowledge regarding comorbidity, psychosocial resources and needs, physical well-being, medicine, anxiety and depression symptoms, spouses, workability and late complication and side-effects to the cancer treatment.DiscussionVideo-based consultation that brings the cancer patient, the general practitioner and the oncologist together in the early phase of treatment may facilitate a sense of partnership that is powerful enough to improve the patient's perception of intersectoral cooperation, continuity of cancer care and health-related quality of life.Trial registrationClincialTrials.gov Identifier: NCT02716168 . Date of registration: 03.03.2016.
| S-EPMC6593592 | biostudies-literature
Project description:Background:Exposure to patient or user suicide (PUS) is identified as a challenging occupational hazard for mental health and social work professionals. Professionals exposed to PUS may encounter several ranges of emotional, traumatic or professional impacts in the aftermath. A high proportion of exposed professionals reports a lack of support in the aftermath of PUS. SUPPORT is a postvention program designed to provide a comprehensive, adaptative and effective support to professionals impacted by PUS. The aims of the SUPPORT-S study are to (1) improve the design of the SUPPORT program, (2) evaluate the effectiveness of the program to buffer the emotional, traumatic and professional impacts and to improve the perceived social support for professionals exposed to PUS, and (3) provide more insights into the consequences of PUS on both professionals and organizations. Method:The SUPPORT-S study is a mixed method collaborative and participatory action research. The simultaneous and complementary collection and analysis of qualitative and quantitative data will offer an in-depth evaluation of the implementation and the effectiveness of the program. The qualitative evaluation includes: (a) an ethnographic observation; (b) 25 semi-directed interviews with randomized participants; (c) an activity analysis with providers of the program; and (d) collaborative sharing of the results with providers and participants. The quantitative evaluation includes pre- and post-measures in participants of: (a) emotional impact (Differential Emotions Scale IV); (b) traumatic impact (Impact of Event Scale-Revised); (c) professional impact (non-validated questionnaire); and (d) perceived social support (Perceived Social Support Scale for Professionals). The action research design will rely on: (a) the cycling process of implementation/evaluation/data sharing/adjustment and (b) the participatory approach through data sharing with providers and participants. Triangulation, saturation, randomization, and participatory design will also reduce the risk of biases and will improve the generalizability of conclusions. Expected Results:We expect the SUPPORT-S study to evaluate and improve the design of the SUPPORT program to effectively help professionals to cope with PUS. Conclusion:The results of the study will allow us to disseminate an effective and adaptive postvention program for professionals and institutions encountering PUS.
| S-EPMC7217323 | biostudies-literature
Project description:BACKGROUND:Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. OBJECTIVE:The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. METHODS:The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ?7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. RESULTS:Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. CONCLUSIONS:The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16799.
| S-EPMC7210498 | biostudies-literature
Project description:Investigating targeted therapies can be challenging due to diverse tumor mutations and slow patient accrual for clinical studies. The Signature Program is a series of 8 phase 2, agent-specific basket protocols using a rapid study start-up approach involving no predetermined study sites. Each protocol evaluated 1 agent (buparlisib, dovitinib, binimetinib, encorafenib, sonidegib, BGJ398, ceritinib, or ribociclib) in patients with solid or hematologic malignancies and an actionable mutation. The primary endpoint of each study was the clinical benefit rate (ie, complete or partial response, or stable disease) at 16 weeks. A total of 192 individual sites were opened in the United States, with a median start-up time of 3.6 weeks. The most common tumor types among the 595 treated patients were colorectal (9.2%), non-small cell lung adenocarcinoma (9.1%), and ovarian (8.4%). Frequent genetic alterations were in PIK3CA, RAS, p16, and PTEN. Overall, 30 partial or complete responses were observed with 6 compounds in 16 tumor types. The Signature Program presents a unique and successful approach for rapid signal finding across multiple tumors and allowed various agents to be evaluated in patients with rare alterations. Incorporating these program features in conventional studies could lead to improved trial efficiencies and patient outcomes.
| S-EPMC5940401 | biostudies-literature
Project description:BackgroundSurgical site infections (SSI) represent a significant public health problem as the most common nosocomial infection and a leading cause of unplanned hospital readmissions among surgical patients. Many develop following hospital discharge and often go unrecognized by patients. Telemedicine offers the opportunity to leverage the mobile technology to remotely monitor wound recovery in the transitional period between hospital discharge and routine clinic follow-up. However, many existing telemedicine platforms are episodic, replacing routine follow-up, rather than equipped for continued monitoring; they include only low-risk patient populations and those who already have access to and comfort with the necessary technology; and transmit no visual information.ObjectiveDrawing upon the Coleman model for care transitions and the Proctor model for implementation, we propose a protocol of postoperative wound monitoring using smartphone digital images. In this study, we will establish the feasibility of such a program, both for patients and for the clinical care team.MethodsWe will recruit 40 patients or patient/caregiver pairs from our inpatient vascular surgery service. Eligible patients will be English-speaking, 18 years of age or older, and have an incision at least 3 cm in length. Participants will receive a training session, during which they will learn to use the device and the wound monitoring smartphone app. Following hospital discharge, they will submit digital images of their wound and responses to a survey about their recovery for 14 days. Experienced health care providers on the vascular surgery inpatient service will review transmitted data daily and contact patients for any concerning findings.ResultsPrimary outcomes will include participant adherence to the protocol, time required for providers to review submissions, time from submission to provider review, and participant satisfaction. Secondary outcomes will include SSI detection and hospital readmission.ConclusionsHealth systems are increasingly dedicating efforts to transitional care improvement programs. This feasibility trial will confirm whether patients and their caregivers can learn to use a postdischarge wound monitoring smartphone app and will assess patient and provider satisfaction. This protocol will provide preliminary evidence for a shift in the delivery of postdischarge care in a patient-centered and cost-effective manner.Trial registrationClinicaltrials.gov NCT02735525; https://clinicaltrials.gov/ct2/show/NCT02735525 (Archived by WebCite at http://www.webcitation.org/6oIvN4Mab).
| S-EPMC5343214 | biostudies-literature
Project description:Early treatment with rt-PA is critical for favorable outcome of acute stroke. However, only a very small proportion of stroke patients receive this treatment, as most arrive at hospital too late to be eligible for rt-PA therapy.We developed a "Mobile Stroke Unit", consisting of an ambulance equipped with computed tomography, a point-of-care laboratory system for complete stroke laboratory work-up, and telemedicine capabilities for contact with hospital experts, to achieve delivery of etiology-specific and guideline-adherent stroke treatment at the site of the emergency, well before arrival at the hospital. In a departure from current practice, stroke patients could be differentially treated according to their ischemic or hemorrhagic etiology even in the prehospital phase of stroke management. Immediate diagnosis of cerebral ischemia and exclusion of thrombolysis contraindications enabled us to perform prehospital rt-PA thrombolysis as bridging to later intra-arterial recanalization in one patient. In a complementary patient with cerebral hemorrhage, prehospital diagnosis allowed immediate initiation of hemorrhage-specific blood pressure management and telemedicine consultation regarding surgery. Call-to-therapy-decision times were 35 minutes.This preliminary study proves the feasibility of guideline-adherent, etiology-specific and causal treatment of acute stroke directly at the emergency site.
| S-EPMC2966432 | biostudies-literature