Lessons Learned from a Cancelled Urban Transport Project in a Developing Country: The Importance of the Front-end Planning Phase

Background: The US Food and Drug Administration’s Sentinel Initiative is well positioned to support pragmatic clinical trials. FDA-Catalyst combines direct contact with health plan members and/or providers with data in the Sentinel infrastructure. Here, we describe the rationale, feasibility analyses, and lessons learned from the planning phase of the first large pragmatic trial conducted using the Sentinel Initiative’s delivery system capabilities—IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (the IMPACT-AFib trial). Methods: During the planning phase, we convened representatives from five commercial health plans, FDA, study coordinating centers, and a patient representative for protocol development, institutional review board preparation, and other activities. Administrative claims data from the plans were included in a retrospective cohort analysis to assess sample size for the trial. Members ≥30 years old with ≥365 days of medical/pharmacy coverage, ≥2 diagnosis codes for atrial fibrillation, a guideline-based indication for oral anticoagulant use for stroke prevention, and no evidence of oral anticoagulant use in the 365 days prior to the index atrial fibrillation diagnosis in 2013 were included. Exclusions for the analysis included other conditions requiring anticoagulation, history of intracranial hemorrhage, and gastrointestinal bleed. We calculated rates of oral anticoagulant use, transient ischemic attack or stroke, and bleeding in the 365 days following the index atrial fibrillation diagnosis. Results: A total of 44,786 members with atrial fibrillation with no evidence of recent oral anticoagulant use were identified. In total, 87% (n = 38,759) were classified as having a guideline-based indication for oral anticoagulants. Of those, 33% (n = 12,867) had a new oral anticoagulant dispensed during the following year, 15% (n = 5917) were hospitalized for stroke or transient ischemic attack, and 9% (n = 3469) for bleeding events. This information was used to develop the trial protocol including sample size, power calculations, and level of randomization. Conclusion: Sentinel infrastructure generated preliminary data that supported planning and implementation of a large pragmatic trial embedded in health plans. This planning identified unanticipated challenges that must be addressed in similar trials.

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Determinants of ICT Innovations: Lessons Learned from Sweden and Sri Lanka

Administrative Sciences ◽

10.3390/admsci11040135 ◽

2021 ◽

Vol 11 (4) ◽

pp. 135

Author(s):

Chaminda Wijesinghe ◽

Henrik Hansson ◽

Love Ekenberg

Keyword(s):

Technology Transfer ◽

Sri Lanka ◽

Developing Country ◽

Risk Taking ◽

Lessons Learned ◽

Living Standards ◽

Innovation Activities ◽

Doing Business ◽

Technology Transfer Offices ◽

Essential Services

Innovation is critical for enterprises and the country’s economy, and it has resulted in an improvement in living standards. There may be appropriate lessons to learn from other countries, but their adoption must be assessed due to education and living standards variations. This paper aims to build an in-depth understanding of the stimulating factors for ICT innovations from Sweden, and examines their adoption in the context of a developing country, Sri Lanka. ICT innovations significantly impact development in other sectors, as they can ease doing business and other essential services. This study is based on seven interviews, including key people leading innovation activities in Sweden. Then, it critically analyses and presents the application of stimulating factors in Sweden to the context of a developing country, namely Sri Lanka. The results indicate that education and mindset, a risk-taking environment, embracing failures, digitalisation and collaboration are the critical determinants of ICT innovations in Sweden. This research is vital for educational policymakers in universities, technology transfer offices, and governmental policymakers.

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The Development of a Community-Based, Pharmacist-Provided Falls Prevention MTM Intervention for Older Adults: Relationship Building, Methods, and Rationale

INNOVATIONS in pharmacy ◽

10.24926/iip.v5i1.322 ◽

2014 ◽

Vol 5 (1) ◽

Cited By ~ 8

Author(s):

David A. Mott ◽

Beth Martin ◽

Robert Breslow ◽

Barb Michaels ◽

Jeff Kirchner ◽

...

Keyword(s):

Older Adults ◽

Community Engagement ◽

Planning Process ◽

Lessons Learned ◽

Relationship Building ◽

Falls Prevention ◽

Original Research ◽

Community Partners ◽

Planning Phase ◽

Engagement Process

The objectives of this article are to discuss the process of community engagement experienced to plan and implement a pilot study of a pharmacist-provided MTM intervention focused on reducing the use of medications associated with falling, and to present the research methods that emerged from the community engagement process to evaluate the feasibility, acceptance, and preliminary impact of the intervention. Key lessons learned from the community engagement process also are presented and discussed. The relationship building and planning process took twelve months. The RE-AIM framework broadly guided the planning process since an overarching goal for the community partners was developing a program that could be implemented and sustained in the future. The planning phase focused on identifying research questions that were of most interest to the community partners, the population to study, the capacity of partners to perform activities, and process evaluation. Much of the planning phase was accomplished with face-to-face meetings. After all study processes, study materials, and data collection tools were developed, a focus group of older adults who represented the likely targets of the MTM intervention provided feedback related to the concept and process of the intervention. Nine key lessons were identified from the community engagement process. One key to successful community engagement is partners taking the time to educate each other about experiences, processes, and successes and failures. Additionally, partners must actively listen to each other to better understand barriers and facilitators that likely will impact the planning and implementation processes. Successful community engagement will be important to develop both formative and summative evaluation processes that will help to produce valid evidence about the effectiveness of pharmacists in modifying drug therapy and preventing falls as well as to promote the adoption and implementation of the intervention in other communities. Type: Original Research

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Il costo dell'Alta Velocitŕ ferroviaria in Italia

ECONOMIA PUBBLICA ◽

10.3280/ep2008-001007 ◽

2009 ◽

pp. 203-251

Author(s):

Claudio Virno

Keyword(s):

Risk Assessment ◽

Conceptual Design ◽

Cost Estimation ◽

High Speed ◽

Cost Effective ◽

Lessons Learned ◽

High Speed Rail ◽

Cost Overruns ◽

Front End ◽

Complex Projects

- Cost overruns are common in large and complex projects, especially in high speed rail ones. Budgeting for cost escalation is a major issue in the planning phase of these projects. This paper describes lessons learned on high speed rail in Italy and focuses on problems such as initial poor design, tactical budgeting, inadequate cost estimation and risk assessment, etc. The paper discusses possible means to avoid major flaws in the initial conceptual design of mega-projects. There is a growing understanding of the need to focus on the front-end phase in order to achieve more successful and cost-effective projects.

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Asset Integrity Management - Implementation Plan During Front End Loading Phases

10.2118/207756-ms ◽

2021 ◽

Author(s):

Giorgio Ferrario ◽

Salvatore Grimaldi

Keyword(s):

Asset Management ◽

Operations Management ◽

Joint Venture ◽

Lessons Learned ◽

Predictive Maintenance ◽

Digital Implementation ◽

Front End ◽

Integrity Management ◽

Advanced Analytics ◽

Set Up

Abstract Capitalization of lessons learned on Asset Integrity Management during Front End Loading phases of a green field Project Development, by defining plan for implementation of a diagnostic digital tool for reducing downtime and introduce predictive maintenance during Operation. Eni developed a platform of Digital applications for enhanced Operations management by implementing an Integrated Asset Management (IAM) system. Advanced Analytics tool is part of it and is designed for monitoring, foreseeing and preventing production upsets and anomalies; the tool is set up by verification of areas of interest and criticalities, with identification of main equipment data sets and by the implementation and validation of predictive models. Starting from historical data, data scientists supported by experts develop algorithms capable of finding interdependencies between a set of input variables and an output variable (phenomenon to be predicted/monitored), thus detecting anomalies and criticalities. Main areas of benefit are envisaged on Production continuity, capable of predicting problems on static and rotating equipment and giving information on the most impacting variables on the incipient problems. The tool will support technicians to help them preventing failures and out-of-specs events which may cause loss of production or asset integrity issues, with the activation of predictive maintenance and the aim to strive a continuous monitoring and improvement of plant operational performances. An Energy Efficiency predictive model will also be set up, capable of forecasting the future energy performances of the asset through the prediction of the Stationary Combustion of Carbon Dioxide (CO2) emission index (t CO2/kbbl) and providing the list of the main influencing equipment and variables. The plan for implementation of the tool from the Early phases of development help the organization on prioritizing the implementation of Digital tools as part of the execution and realization of the Asset to be delivered to the Operational personnel, by easing the transition and avoiding subsequent retrofitting carrying brownfield works and additional costs. The implementation of Advanced Analytics tool has been embedded in a new green field initiative of a Development Project since Front End Loading phases, thus fostering digital implementation and minimizing deployment costs by including those as part of the Investment Proposal presented to Joint Venture Partners and Authorities.

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