Medical information, communication, and archiving system (MICAS): Phase II integration and acceptance testing

1999 ◽  
Author(s):  
Edward M. Smith ◽  
John Wandtke ◽  
Arvin E. Robinson
Keyword(s):  
Phase Ii ◽  
Medical Information ◽  
Acceptance Testing ◽  
Information Communication

scholarly journals Informing Clients through Information Communication Technology in Health Care Systems

10.28945/3367 ◽  
2009 ◽  
Author(s):  
Vangari Vishwa Mohan ◽  
Vahideh Zarea Gavgani
Keyword(s):  
Communication Technology ◽  
Science Communication ◽  
Information Needs ◽  
Medical Information ◽  
Information Communication Technology ◽  
Structured Interview ◽  
Sources Of Information ◽  
Information Communication ◽  
Critical Information ◽  
Care Givers

Information Communication Technology (ICT) has revolutionized the world communication order. People can be informed in more effective, efficient and convenient ways. Access to media has percolated to the grassroots. In spite of all such remarkable developments, whether ICT facilitates Science communication is a billion dollar question. Though information is freely and widely available by virtue of ICT, yet, there are areas where Science communication through ICT still needs to be developed to deliver critical information to the needy. Objectives: The objectives of the study are to find out: whether patients and care givers have perception of their information needs? What sources of information they usually consult? What type of channels/media they possess to access the information? What sources the patients and care givers prefer to consult? Whether in the opinion of the patients and their care givers, the ICTs are effective in delivering the critical information. Methodology: An exploratory survey was conducted. A semi-structured interview was employed to collect data from a group of 188 patients and care givers in the hospitals and clinics in Hyderabad (India). Results and conclusion: The study determined the patients’ and care givers’ preferences for technologies in keeping informed. It also brought to light the limitations and usefulness of ICTs in Science communication in general and medical information in particular.

scholarly journals Co-Design of a Consultation Audio-Recording Mobile App for People With Cancer: The SecondEars App (Preprint)

2018 ◽  
Author(s):  
Ruby Lipson-Smith ◽  
Fiona White ◽  
Alan White ◽  
Lesley Serong ◽  
Guy Cooper ◽  
...  
Keyword(s):  
Stakeholder Engagement ◽  
Medical Records ◽  
Interface Design ◽  
Medical Information ◽  
Legal Protection ◽  
User Acceptance ◽  
Mobile App ◽  
Acceptance Testing ◽  
Audio Recording ◽  
Minimal Impact

BACKGROUND Many patients choose to audio-record their medical consultations so that they can relisten to them at home and share them with family. Consultation audio-recordings can improve patients’ recall and understanding of medical information and increase their involvement in decision making. A hospital-endorsed consultation audio-recording mobile app would provide patients with the permission and means to audio-record their consultations. The Theory of Planned Behavior provides a framework for understanding how patients can be encouraged to appropriately audio-record consultations. OBJECTIVE The aim of this study was to use a co-design process to develop a consultation audio-recording mobile app called SecondEars. METHODS App development began with stakeholder engagement, followed by a series of 6 co-design workshops and then user acceptance testing. Stakeholder engagement included advice from legal, information technology (IT), clinical and allied health leads; digital strategy; and medical records. he co-design workshops were attended by: patient consumers, members of the research team, IT staff, the app designers, clinicians, and staff from medical records. During workshops 1 to 4, the purpose and scope of the app were refined, possible pitfalls were addressed, and design features were discussed. The app designers then incorporated the results from these workshops to produce a wireframe mock-up of the proposed SecondEars app, which was presented for feedback at workshops 5 and 6. RESULTS The stakeholders identified 6 requirements for the app, including that it be patient driven, secure, clear in terms of legal responsibilities, linked to the patient’s medical record, and that it should require minimal upfront and ongoing resources. These requirements informed the scope of the co-design workshops. The workshops were attended by between 4 and 13 people. The workshop attendees developed a list of required features and suggestions for user interface design. The app developers used these requirements and recommendations to develop a prototype of the SecondEars app in iOS, which was then refined through user acceptance testing. CONCLUSIONS The SecondEars app allows patients to have control and autonomy over audio-recording and sharing their consultations while maintaining privacy and safety for medical information and legal protection for clinicians. The app has been designed to have low upkeep and minimal impact on clinical processes. The SecondEars prototype is currently being tested with patients in a clinical setting.

Final results of multicenter phase Ib/ II study of biweekly trifluridine/tipiracil with bevacizumab combination for patients with mCRC refractory to standard therapies (BiTS study).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 121-121
Author(s):  
Masato Nakamura ◽  
Hironaga Satake ◽  
Koji Oba ◽  
Masahito Kotaka ◽  
Yoshinori Kagawa ◽  
...  
Keyword(s):  
Phase Ii ◽  
Primary Endpoint ◽  
Statistical Power ◽  
Medical Information ◽  
Treatment Options ◽  
Dose Intensity ◽  
University Hospital ◽  
Phase Ib ◽  
Multicenter Phase

121 Background: We have conducted the multicenter, phase Ib/II study to assess the activity and safety of biweekly Trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) combination for pts with metastatic colorectal cancer (mCRC) who were refractory or intolerant to standard therapies, and the primary endpoint of investigator assessed progression-free survival rate at 16 weeks (16w-PFS) was met [Kotaka M, ASCO-GI 2018]. We show longer follow-up data from this prospective study. Methods: Patients with unresectable mCRC; refractory or intolerant to standard chemotherapies were enrolled. Phase Ib part is designed to determine the recommended phase II dose (RP2D), and the treatment was determined as biweekly FTD/TPI (70mg/m2/day on day 1-5, every 2 weeks) with BEV (5mg/kg, every 2 weeks). The primary endpoint in phase II part was a 16w-PFS with a hypothesis of 15% considered unacceptable and 38.7% deemed promising. Given a one-sided α of 0.025 and statistical power of 90%, a minimum of 40 pts were required for phase II part. This trial registered in University Hospital Medical Information Network, number UMIN000029198. Results: From October 2017 to January 2018, totally 46 pts were enrolled. Nine patients (20.5 %) received regorafenib before enrollment. Of the 44 eligible pts, 16w-PFS rate was 40.9 %. With a median follow up of 15.36 months (range, 2.79-16.93), median PFS was 4.29 months (95% CI: 2.54 to 5.83), median TTF was 4.16 months (95% CI: 2.39 to 5.82), and median OS was 10.86 months (95% CI:8.32 to 13.68), respectively. Disease control rate was 59.1 % (95%CI: 43.3 to 73.7 %). Patients received the study treatment for a median of 6.5 cycles (range, 1 to 24). The median relative dose intensity of FTD/TPI and BEV was 80.9% (range: 44.0 to 100%), 81.5% (range: 50.0 to 100%), respectively. Common grade 3 or higher adverse events were hypertension (40.9%), neutropenia (11.4 %) and leucopenia (11.4 %). Conclusions: An update analysis confirmed that biweekly FTD/TPI plus BEV showed promising anti-tumor effect with acceptable less toxicities, and might be one of the treatment options for patients with heavily treated mCRC. Clinical trial information: UMIN000029198.

The pretreatment lymphocyte-to-monocyte ratio (LMR) to predict treatment efficacy and prognosis in metastatic colorectal cancer treated with the combination of TAS-102 and bevacizumab (TAS-CC3 Study).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 224-224
Author(s):  
Akihisa Matsuda ◽  
Yoichiro Yoshida ◽  
Hirohiko Kamiyama ◽  
Chihiro Kosugi ◽  
Hiroshi Yoshida ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Combination Therapy ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Medical Information ◽  
Task Force ◽  
University Hospital ◽  
Current Phase ◽  
Combination Regimen ◽  
Line Therapy

224 Background: The combination regimen of TAS-102 and bevacizumab as salvage-line therapy for metastatic colorectal cancer (mCRC) was established based on its high clinical effectiveness (C-TASK FORCE). Recently, our current phase II TAS-CC3 study demonstrated comparable median progression-free survival (PFS: 4.5m) and overall survival (OS: 9.2m) with exclusive inclusion of 3rd line therapy patients. However, practical predictors for its efficacy are lacking. This study evaluated inflammation-based scores as potential predictors for this combination therapy. Methods: This is a post hoc analysis of investigator-initiated, open-label, single-arm, multicentered phase II study (TAS-CC3) in Japan with 32 mCRC patients treated with the combination therapy. We investigated the predictive and prognostic values of pretreatment blood inflammation-based scores, including neutrophil-to-lymphocyte (NLR), platelet-to-lymphocyte (PLR), and lymphocyte-monocyte ratios (LMR), on disease-control (DC), PFS and OS. These were divided into two groups (high and low) using cut-off of each median values. This study was registered at the University Hospital Medical Information Network, as UMIN#000022438. Results: ROC curve analyses of 3 inflammation-based scores versus DC showed a best predictive performance in LMR, followed by NLR and PLR (AUC: 0.89, 0.85, and 0.68, respectively). The high LMR group had a significantly higher DC rate than the low group (87.5 vs. 43.8%, P= 0.023). Two patients showing partial responses were in the high group. The high LMR group showed significantly longer survivals compared with the low group (4.9 vs. 2.3m, respectively for median PFS, P= 0.014) (20.5 vs. 5.1m, respectively for median OS, P< 0.001). The values of LMR were significantly correlated with PFS and OS (r = 0.56: P< 0.001 and 0.62: P< 0.001, respectively). Conclusions: Pretreatment LMR is a valid predictive and prognostic biomarker for mCRC patients with TAS-102 and bevacizumab treatment and might be clinically useful for selecting patients of the responder. Clinical trial information: 000022438.

scholarly journals Harnessing Smartphone Technology to Improve Patient Engagement: Codesigning and Testing The SecondEars Consultation Audio Recording App for People With Cancer

2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 109s-109s
Author(s):  
R. Lipson-Smith ◽  
F. White ◽  
G. Cooper ◽  
L. Serong ◽  
A. White ◽  
...  
Keyword(s):  
Medical Information ◽  
Legal Protection ◽  
Mobile App ◽  
Acceptance Testing ◽  
Audio Recording ◽  
Legal Information ◽  
User Input ◽  
Health Technologies ◽  
Constructive Feedback ◽  
Smartphone Technology

Background: Oncology consultations can be overwhelming and information-dense. Consultation audio recordings are an effective method to promote patient participation, improve patients' recall and understanding of medical information, and can increase engagement and support through sharing with family and friends. Innovative m-health technologies such as the SecondEars consultation audio recording mobile app provide a patient-designed and controlled audio recording solution while ensuring security and legal protection for clinicians. To ensure the SecondEars app meets the needs of patients, family, clinicians and hospital administrators, the opinions of stakeholders and end users are integral to the concept and study creation, design, and testing processes. Aim: To use key elements of codesign methodology to develop and test SecondEars, a mobile app that allows patients to audio record their consultations within a clinical oncology setting. Methods: The SecondEars app concept began with consumer suggestions that consultation audio recording be used as standard practice of care using patient-driven (use is controlled/determined by patients) technologies. An app solution was conceived and the concept discussed through engagement of consumers as part of the project and research codesign team. Key health service stakeholders comprising representatives from: legal, information technology (IT), clinical service leads, digital strategy, and health information services (HIS), provided project oversight and core legal and data management requirements. The Scrum management framework was used to structure the codesign process during the development and testing phase. Six workshops were run to facilitate further user input with regard to specific app functionality and design. A wireframe version was developed and tested by the codesign team in the final workshop. Feedback was incorporated into a prototype which was circulated for acceptance testing. Results: Twenty people participated in the stakeholder engagement and workshops, comprising: oncology consumers, researchers, IT, HIS, app developers, and oncology health professionals. Key specifications necessitated that SecondEars be patient-driven, secure and confidential, have clear legal guidelines regarding audio recording sharing, be integrated with medical records, and require minimal upfront and ongoing resources. Seven people tested the prototype app during user acceptance testing and gave positive and constructive feedback. A final version of the app was then made available for clinical testing. Conclusion: The SecondEars consultation audio recording app has been successfully created by and for patients. This app gives patients permission and autonomy to audio record and share their consultations responsibly, while maintaining legal protection for clinicians. This app is currently being tested in a clinical setting prior to conducting an implementation study.

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