Effectiveness of ASCO’s adverse event reporting decision aid: Results from an interventional study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3065-3065
Author(s):  
Kathryn Finch Mileham ◽  
Andrea D. Buchmeier ◽  
Meredith Kathleen Chuk ◽  
Courtney Davis ◽  
Anne Marie Forest ◽  
...  
Keyword(s):  
Adverse Event ◽  
Decision Aid ◽  
High Volume ◽  
Adverse Event Reporting ◽  
Investigational Drug ◽  
Interventional Study ◽  
Research Staff ◽  
To Receive ◽  
Safety Signals

3065 Background: Investigators often send adverse event (AE) reports to sponsors that are incorrectly categorized as serious or attributed to the investigational drug. Such errors contribute to a high volume of uninformative IND safety reports that sponsors submit to FDA and all participating investigators, straining stakeholder resources and impeding the detection of valid safety signals. To improve the quality of AE reporting, ASCO developed and tested a Decision Aid Tool (DAT). Methods: An interventional study with a cross-over design was conducted. Physician investigators and research staff were randomized to receive case studies. Cases were assessed for seriousness and attribution, first unassisted and then with the DAT. Participants completed a feedback survey. Effectiveness of reporting and attribution were assessed using logistic regression. Results are reported as odds ratios (OR) with 95% confidence intervals (CI). Results: Most of the 29 participants reported that the DAT was helpful (93%), improved their decision-making time (69%) and confidence in reporting (83%), and that they would use it in practice (83%). The DAT did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI: 0.31, 2.46) but it did significantly increase accuracy of attributing a serious AE to a drug (OR, 3.60; 95% CI: 1.15, 11.4). Conclusions: The DAT shows promise as a method to reduce errors in attribution of AEs, which may help to ensure the detection of valid safety signals. Many participants were experienced clinical trialists, and the DAT may show greater utility as an educational tool for novice investigators, research staff, and students.

scholarly journals Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors

2019 ◽  
Vol 15 (12) ◽  
pp. e1050-e1065 ◽  
Author(s):  
Kathryn F. Mileham ◽  
Caroline Schenkel ◽  
Meredith K. Chuk ◽  
Andrea Buchmeier ◽  
Raymond P. Perez ◽  
...  
Keyword(s):  
Adverse Event ◽  
Case Studies ◽  
Drug Safety ◽  
Decision Aid ◽  
Small Sample ◽  
Research Staff ◽  
Convenience Sample ◽  
New Drug ◽  
Safety Signals

PURPOSE: Investigators often send reports to sponsors that incorrectly categorize adverse event (AE)s as serious or attribute AEs to investigational drugs. Such errors can contribute to high volumes of uninformative investigational new drug safety reports that sponsors submit to the US Food and Drug Administration and participating investigators, which strain resources and impede the detection of valid safety signals. To improve the quality of serious AE (SAE) reporting by physician-investigators and research staff, ASCO developed and tested a Decision Aid. METHODS: A preliminary study with crossover design was conducted in a convenience sample. Physician-investigators and research staff were randomly assigned to receive case studies. Case studies were assessed for seriousness and attribution, first unassisted and then with the Decision Aid. Participants completed a feedback survey about the Decision Aid. Effectiveness of reporting and attribution are reported as odds ratios (ORs) with 95% CI. Power to detect associations was limited because of a small sample size. RESULTS: The Decision Aid did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI, 0.31 to 2.46), but it did significantly increase accuracy of attributing an SAE to a drug (OR, 3.60; 95% CI, 1.15 to 11.4). Most of the 29 participants reported that the Decision Aid was helpful (93%) and improved decision-making time (69%) and confidence in reporting (83%), and that they would use the Decision Aid in practice (83%). CONCLUSION: The Decision Aid shows promise as a method to improve the quality of SAE attribution, which may improve the detection of valid safety signals and reduce the administrative burden of uninformative investigational new drug safety reports. Study of the Decision Aid in a larger sample with analysis stratified by participant role and SAE reporting experience would further assess the tool’s impact.

scholarly journals Change Point Analysis for Detecting Vaccine Safety Signals

Vaccines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 206
Author(s):  
Seung-Hun You ◽  
Eun Jin Jang ◽  
Myo-Song Kim ◽  
Min-Taek Lee ◽  
Ye-Jin Kang ◽  
...  
Keyword(s):  
Adverse Event ◽  
Change Point ◽  
Predictive Value ◽  
Public Safety ◽  
Vaccine Safety ◽  
Adverse Event Reporting ◽  
Change Point Analysis ◽  
Event Reporting ◽  
Point Analysis ◽  
Safety Signals

It is important to detect signals of abrupt changes in adverse event reporting in order to notice public safety concerns and take prompt action, especially for vaccines under national immunization programs. In this study, we assessed the applicability of change point analysis (CPA) for signal detection in vaccine safety surveillance. The performances of three CPA methods, namely Bayesian change point analysis, Taylor’s change point analysis (Taylor-CPA), and environmental time series change point detection (EnvCpt), were assessed via simulated data with assumptions for the baseline number of events and degrees of change. The analysis was validated using the Korea Adverse Event Reporting System (KAERS) database. In the simulation study, the Taylor-CPA method exhibited better results for the detection of a change point (accuracy of 96% to 100%, sensitivity of 7% to 100%, specificity of 98% to 100%, positive predictive value of 25% to 85%, negative predictive value of 96% to 100%, and balanced accuracy of 53% to 100%) than the other two CPA methods. When the CPA methods were applied to reports of syncope or dizziness following human papillomavirus (HPV) immunization in the KAERS database, Taylor-CPA and EnvCpt detected a change point (Q2/2013), which was consistent with actual public safety concerns. CPA can be applied as an efficient tool for the early detection of vaccine safety signals.

When the goal is not cure: A randomized trial of a patient decision aid in advanced colorectal cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6509-6509 ◽  
Author(s):  
N. B. Leighl ◽  
H. Shepherd ◽  
P. Butow ◽  
S. J. Clarke ◽  
M. McJannett ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Decision Making ◽  
Advanced Cancer ◽  
Decision Aid ◽  
Advanced Colorectal Cancer ◽  
Treatment Options ◽  
Decisional Conflict ◽  
Patient Understanding ◽  
To Receive

6509 Background: With improvements in treatment and supportive care, decisions in advanced cancer are increasingly complex. To facilitate decision-making, we developed a decision aid (DA) for patients considering first-line chemotherapy for incurable colorectal cancer, reviewing treatment options, prognostic information and toxicities. We examined its impact on patient understanding, consultation and decision- making satisfaction, anxiety, decisional conflict, quality of life, information preferences, and treatment decisions made. Methods: 207 newly diagnosed advanced colorectal cancer patients at 5 cancer centers in Australia and Canada were randomized to receive either a standard medical oncology consultation, or the same plus the DA, (take-home booklet with audio-recording, selected review by oncologist). Results: 100 were randomized to the control arm, 107 to receive the DA. Sample characteristics: median age 62 years, 58% male, 89% PS 0/1, 36% prior adjuvant chemotherapy. Patients in the DA arm demonstrated a greater increase in understanding of prognosis, options, benefits and toxicities (+19% vs +5.6%, p 0.001), with higher overall understanding (72% vs 60%, p<0.0001). Decision and consultation satisfaction, decisional conflict and quality of life were similar between groups. Anxiety, measured serially over 4–6 weeks, was similar and decreased over time. Most arrived at a decision during the first consultation; 80% chose chemotherapy, 7.5% supportive care alone, 10.5% a wait and watch strategy, with no differences between arms. 87% wanted as much information as possible, 82% wished to share decision-making with the physician, and only 15% felt the doctor alone should make the decision. More patients who received the decision aid felt they received all possible details about therapy, (72% vs 63%). 90% felt the decision was shared in part between physician and patient. Conclusion: This first randomized trial of a decision aid in advanced cancer patients shows that its use in advanced colorectal cancer improved patient understanding of prognosis, treatment options, risks and benefits without increasing anxiety. Decision aids can improve informed consent and decision-making, and can be tested through randomized trials even in the setting of advanced cancer. No significant financial relationships to disclose.

scholarly journals Assessment of the Potential Adverse Events Related to Ribavirin-Interferon Combination for Novel Coronavirus Therapy

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Wenya Shan ◽  
Dongsheng Hong ◽  
Jieqiang Zhu ◽  
Qingwei Zhao
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Event ◽  
Reporting Odds Ratio ◽  
Serious Adverse Events ◽  
Bayesian Confidence Interval ◽  
Novel Coronavirus ◽  
Safety Signals

Purpose. We aimed to analyze and evaluate the safety signals of ribavirin-interferon combination through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS), so as to provide reference for the rationale use of these agents in the management of relevant toxicities emerging in patients with novel coronavirus pneumonia (COVID-19). Methods. Reports to the FAERS from 1 January 2004 to 8 March 2020 were analyzed. The proportion of report ratio (PRR), reporting odds ratio (ROR), and Bayesian confidence interval progressive neural network (BCPNN) method were used to detect the safety signals. Results. A total of 55 safety signals were detected from the top 250 adverse event reactions in 2200 reports, but 19 signals were not included in the drug labels. All the detected adverse event reactions were associated with 13 System Organ Classes (SOC), such as gastrointestinal, blood and lymph, hepatobiliary, endocrine, and various nervous systems. The most frequent adverse events were analyzed, and the results showed that females were more likely to suffer from anemia, vomiting, neutropenia, diarrhea, and insomnia. Conclusion. The ADE (adverse drug event) signal detection based on FAERS is helpful to clarify the potential adverse events related to ribavirin-interferon combination for novel coronavirus therapy; clinicians should pay attention to the adverse reactions of gastrointestinal and blood systems, closely monitor the fluctuations of the platelet count, and carry out necessary mental health interventions to avoid serious adverse events.

Lesson Study dan Implikasinya Terhadap Pembelajaran Berbasis Kurikulum Tingkat Satuan Pendidikan

2016 ◽  
Vol 1 ◽  
pp. 189-196
Author(s):  
Vian Harsution
Keyword(s):  
Learning Environment ◽  
Learning Process ◽  
Lesson Study ◽  
Learning Difficulties ◽  
Learning Needs ◽  
Democratic Leadership ◽  
Entrepreneurial Spirit ◽  
To Receive

Lesson study is a systematic, collaborative, and sustainable method of improving the quality of learning. Lesson study emphasizes the exploration of students’ learning needs; teacher openness towards learning difficulties encountered; the willingness of teachers to receive and provide advice and solutions to the difficulties encountered; and the consistency of the various parties to follow up the suggestions and solutions. Implementation of lesson study involving teachers, principals, and experts in the field of education. Kurikulum tingkat satuan pendidikan or abbreviated KTSP is operational curriculum formulated and implemented by each educational unit. KTSP has the characteristics, namely: giving broad autonomy to the educational unit, involving the community and parent participation, involving the democratic leadership of the principal, and require the support of a working team that is synergistic and transparent. KTSP based on the learning process, needs to be supported by a conducive learning environment and fun to be created by teachers.Teachers and principals in a professional, systematic and collaborative create an atmosphere that fosters independence, tenacity, entrepreneurial spirit, adaptive and proactive nature of the learning process. Thus, the learning needs of students who fulfilled optimally and professional ability of teacher who have increased on an ongoing basis, may usher in success – based learning KTSP. It means that the lesson study provides positive implications for the KTSP – based learning.

The Microbial Quality of a Wetland Reclamation Facility Used to Produce an Effluent for Unrestricted non-Potable Reuse

1999 ◽  
Vol 40 (4-5) ◽  
pp. 369-374 ◽  
Author(s):  
R. S. Fujioka ◽  
A. J. Bonilla ◽  
G. K. Rijal
Keyword(s):  
Fecal Coliform ◽  
Heterotrophic Bacteria ◽  
Fecal Indicator ◽  
Potable Reuse ◽  
Wetland Reclamation ◽  
Treated Sewage ◽  
Influent Water ◽  
Human Viruses ◽  
To Receive

An auxiliary Wetland Reclamation Facility (WRF) was constructed to receive stabilization pond treated sewage and further treat it with water hyacinth ponds, chemical flocculation, filtration and ultraviolet light disinfection. This was the first facility in Hawaii which was approved to produce the highest quality reclaimed water using alternative treatment schemes. We assessed the effectiveness of the WRF by monitoring water samples after each of the WRF treatment schemes for five genetically different groups of sewage borne microorganisms (fecal coliform, enterococci, C. perfringens, FRNA phage, total heterotrophic bacteria). The concentrations of all fecal indicator microoganisms, especially FRNA phase were low in the influent water to the WRF indicating that extended pond treatment may be especially effective in removing human viruses from sewage. The WRF treatment scheme was calculated to be able to reduce &gt;99.99% of fecal coliform and therefore was able to produce an effluent meeting the non-potable, unrestricted reuse standard of a geometric means of &lt;1 fecal coliform/100 ml.

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