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Events group Hyve to sell Ukrainian business in management buy-out

Events group Hyve to sell Ukrainian business in management buy-out

July 19 (Reuters) – British exhibitions group Hyve (HYVE.L) said on Tuesday it is selling its Ukrainian unit to a group led by Anatoly Sushon, the Ukrainian business’ managing director, as events in the country continue to be on hold following Russia’s invasion.

Hyve said it would receive up to 3 million pounds ($3.59 million) from the sale, which will be paid annually until September 2027 based on the Ukrainian operations’ profitability.

($1 = 0.8354 pounds)

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Reporting by Muhammed Husain in Bengaluru; editing by Uttaresh.V

Our Standards: The Thomson Reuters Trust Principles.

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Event Management Platform Market Worth $60Bn by 2028 at 11.5% CAGR Led by Cloud-based Deployment (74.6% Market Share in 2021), Global Analysis (18+ Countries, 5 Key Regions, 50+ Companies) by The Insight Partners

Event Management Platform Market Worth $60Bn by 2028 at 11.5% CAGR Led by Cloud-based Deployment (74.6% Market Share in 2021), Global Analysis (18+ Countries, 5 Key Regions, 50+ Companies) by The Insight Partners

New York, July 06, 2022 (GLOBE NEWSWIRE) — The Insight Partners published latest research study on “Event Management Platform Market Forecast to 2028 – COVID-19 Impact and Global Analysis By Component [Hardware (Physical and Hybrid Check-in), Software, and Services (Professional Services, Managed Services)], Deployment (On Premise and Cloud-based), Application (Event Planning, Event Registration and Ticketing, Event Marketing, Content Management, Networking Management, Analytics and Reporting, Audience Management and Communication, Visitor Management, Venue Management, Virtual Lobby Management, and Others  ), End User (Trade Show Organizers, Event Management Agencies, Corporates, Academics, Organizations, Associations/Non-profitable Trusts/Government Bodies, and Others)”, based on component, the market is segmented into hardware, software, and services. The software segment led the market with the largest market share in 2021.

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Event Management Platform Market Report Scope & Strategic Insights:

Report Coverage Details
Market Size Value in US$ 31.23 Billion in 2022
Market Size Value by US$ 60.01 Billion by 2028
Growth rate CAGR of 11.5% from 2022 to 2028
Forecast Period 2022-2028
Base Year 2022
No. of Pages 174
No. Tables 153
No. of Charts & Figures 104
Historical data available Yes
Segments covered Component, Deployment, Application, and End User
Regional scope North America; Europe; Asia Pacific; Latin America; MEA
Country scope US, UK, Canada, Germany, France, Italy, Australia, Russia, China, Japan, South Korea, Saudi Arabia, Brazil, Argentina
Report coverage Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Event Management Platform Market: Competitive Landscape and Key Developments
ACTIVE Network, LLC; BigMarker; Aventri, Inc.; Bizzabo; Swapcard; Goldcast; WebEx Events; PheedLoop Inc.; Zuddl; and Airmeet are among the key players profiled during the study of the global event management platform market. In addition, several other essential market players were studied and analyzed to get a holistic view of the event management platform market and its ecosystem.

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In May 2022, ACTIVE Network and accesso entered into a strategic partnership to extend the reach of the company’s solutions to the ski industry. This partnership would allow ACTIVE Network to access the e-commerce ticketing suite of accesso, and the clients of accesso would get an option for real-time transport protocol (RTP).

In January 2022, Aventri merged with MeetingPlay, an innovative solution provider for in-person, virtual, and hybrid events. The new event software powerhouse would combine the strengths of both companies to offer a complete full-service solution for meetings and events.

The major stakeholders in the global event management platform market ecosystem include event management platform hardware/software/service providers, system integrators, and end users. With the rising demand for event management platform solutions for event planning, event registration and ticketing, event marketing, content management, networking management, analytics and reporting, audience engagement and communication, visitor management, venue management, virtual lobby management across the globe, the event management platform providers are also experiencing sustainable growth opportunities.

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The major end users of the event management platform market include trade show organizers, event management agencies, corporates, academic, organizations, associations/non-profitable trusts/government bodies, and others. Among end users, the event management agencies segment to have the highest share. Event management agencies help organizations develop and plan events for their clients. The events include creating effective invitations, managing registrations, organizing housing and travel preferences, collecting online payments, and viewing reports in actual time.

Event Management Platform Market: Application Segment Overview
Based on application, the market is segmented into event planning, event registration and ticketing, event marketing, content management, networking management, analytics and reporting, audience engagement and communication, visitor management, venue management, virtual lobby management, and others. The event planning segment led the event management platform market with the largest market share in 2021.

Companies are incorporating videos to create more digital experiences as audiences’ preference for on-demand viewing is growing. Virtually every marketer considers webinars a crucial component of their strategy and the most effective medium for generating quality sales leads. With webinars, companies from all industries are fast turning to digital-first interaction. According to the ON24 Webinar Benchmarks Report 2021, companies are rapidly transitioning to digital-first engagement with webinars. The findings are based on over ~2,000 businesses providing over ~100,000 digital experiences with ~100 participants utilizing ON24 in one of the most comprehensive data investigations of digital events in 2020.

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As per the data, the use of webinars climbed 162%, with attendance nearly quadrupling to over ~60 million people. Over ~61 million hours of material were consumed by audiences, representing ~300% growth. As the shift to digital platforms rises, webinars are becoming increasingly necessary in marketing and sales. In a follow-up poll to the benchmarks report, 99% of marketers think webinars are essential to their strategies, with 72% stating they directly influence pipeline and revenue. The benefits of webinars, such as audience analytics, engagement data, and buying signals, allow marketers to claim that 66% of sales teams prioritize webinar leads, making webinars the top digital channel for generating qualified leads and sales leads for 89% of respondents.

Using modern technologies, such as webinars, in the healthcare industry helps to continuously optimize the execution of care and streamline processes that support and enable efficient care delivery. Webinars can also help break down collaborative boundaries, allowing faster clinical discovery. Similarly, educational webinars and web conferencing technologies have recently received more attention. Students do not need to spend money on transportation or lodging to receive an education. Similarly, the educational institution does not need to make significant space or class size investments to accommodate new pupils. Thus, the growing use of webinars is driving the event management platform market growth.

Impact of COVID-19 Pandemic on North America Event Management Platform Market:
The dramatic shift to virtual events created new challenges for event planners, such as rethinking plans and designs, managing remote speakers to deal with new technologies, and finding interesting ways of keeping people engaged. Moreover, the declining gross domestic product (GDP) of the region hampered the event management platform market growth. The COVID-19 crisis has drastically forced event planners to switch from in-person meetings to virtual meetings.

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The COVID-19 outbreak has slightly affected the event platform providers for conducting virtual events. However, the event management platform market is expected to foresee significant growth opportunities in the coming years owing to the rising demand for digital content and live streaming. Thus, the overall impact of the COVID-19 pandemic on the North American event management platform market is moderate.

Browse Adjoining Reports:
Events Market Forecast to 2028 – COVID-19 Impact and Global Analysis By Event Type (Virtual, Hybrid, and Physical), Revenue Source (Ticket Sale, Sponsorship, and Others), Type (Music Concert, Festivals, Sports, Exhibitions and Conferences, Corporate Events and Seminars, and Others), Organizer (Corporate, Sports, Education, Entertainment, Association, and Others), Application (B2B and B2C), and Enterprise Size (Small and Medium Enterprises and Large Enterprises)

Event Management Software Market to 2027 – Global Analysis and Forecasts by Solution Type (Software, and Services); Application (Event Planning, Event Marketing, Venue and Ticket Management, Analytics and Reporting, and Others); End-User (Corporate, Government, Education, Media and Entertainment, and Others)

Virtual Event Software Market Forecast to 2028 – COVID-19 Impact and Global Analysis By Solution (Software and Services), Enterprise Size (SMEs, Large Enterprises), and End User (Trade Show Organizers, Event Management Agencies, Corporates, Academic Organizations, Others)

Security Information and Event Management Market to 2027 – Global Analysis and Forecasts by Solution (Patch Management, Log & Event Management, Firewall Security Management, and Others); Service (Integration, Consulting, and Support); and End User (Healthcare, Energy & Utility, BFSI, Government, Retail, and Others)

SIEM Software Market Forecast to 2028 – COVID-19 Impact and Global Analysis By Deployment Type (Cloud, On-Premise); Solution Type (Log and Event Management, Patch Management, Firewall Security Management, Others); Vertical (BFSI, IT and Telecommunication, Hospitality, Educational Institutes, Government Offices, Energy and Utility, Retail, Others) and Geography

Crowd Management and Event Security Market Forecast to 2028 – COVID-19 Impact and Global Analysis by Component (Solution, Services); Deployment Type (Cloud, On-premises); Enterprise Size (Small and Medium-Size Enterprises, Large Enterprises); End-user (Transportation, Retail, Hospitality and Tourism, Others) and Geography

Audience Intelligence Platform Market Forecast to 2028 – COVID-19 Impact and Global Analysis by Deployment Type (On-Premises, Cloud); Application (Government, Retail and eCommerce, Healthcare and Life Sciences, BFSI, Transportation and Logistics, Telecom and IT, Manufacturing, Other) and Geography

Audience Analytics Market Forecast to 2028 – Covid-19 Impact and Global Analysis – Component (Solutions and Services); Application (Sales & Marketing, Customer Experience, and Competitive Analysis); End-user (BFSI, IT & Telecommunication, Retail, Healthcare, Media & Entertainment, Hospitality, and Government) and Geography

About Us:
The Insight Partners is a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We specialize in industries such as Semiconductor and Electronics, Aerospace and Defense, Automotive and Transportation, Biotechnology, Healthcare IT, Manufacturing and Construction, Medical Device, Technology, Media and Telecommunications, Chemicals and Materials.

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If you have any queries about this report or if you would like further information, please contact us:

Contact Person: Sameer Joshi
Phone: +1-646-491-9876
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Event Management Software Industry Worth $14+ Billion by 2026 | Global Market Research Report, 2022 | Gamification of Events to Engage a Larger Audience –

Event Management Software Industry Worth $14+ Billion by 2026 | Global Market Research Report, 2022 | Gamification of Events to Engage a Larger Audience -

DUBLIN–()–The “Event Management Software Market with COVID-19 Impact, by Component (Software (Event Registration and Ticketing, Content Management) and Services), Deployment Mode, Organization Size, End User and Region – Global Forecast to 2026” report has been added to’s offering.

The Global Event Management Software Market is forecast to grow from USD 7 billion in 2021 to USD 14.1 billion by 2026, at a Compound Annual Growth Rate (CAGR) of 14.9% during the forecast period.

Event management software helps organizations keep track of all of their event’s moving parts to help their event run more smoothly. It also facilitates organizations to automate various processes, including sourcing, coordination, event planning, venue management, expense tracking, marketing, and data analysis, throughout the life cycle of their events. This helps enterprises manage these processes from a centralized platform, enabling them to improve their operational processes and increase their marketing leads from events.

By Component, the Services segment to grow at the higher CAGR during the forecast period

By Component, the Services segment is expected to grow at a higher growth rate during the forecast period. Services are necessary for easy deployment, integration, and proper functioning of the software. The services segment has been further segmented into professional services and managed services. Rising pressure on event management service providers to stay competitive in the market leads to improved quality of service being provided to the customers.

By Services, the Professional Services segment to hold the larger market size

The Professional Services segment is expected to hold a larger market size. These services include deployment and integration, consulting, and support and maintenance services. The professional services provide an expert level of deployment, integration, consulting, and support and maintenance services for the proper installation of a specific software either on-premises or over the cloud.

By Deployment Mode, Cloud segment to grow at the highest CAGR during the forecast period

The Cloud segment is projected to grow at the highest CAGR during the forecast period. Cloud-based solutions are provided directly through cloud-deployed network connectivity. These solutions help reduce the overall costs while providing highly flexible and scalable access to event management solutions through the IT infrastructure hosted by cloud service providers.

Research Coverage

The Event Management Software Market is segmented by Component, Deployment Mode, Organization Size, End-user, and Region. A detailed analysis of the key industry players has been undertaken to provide insights into their business overviews; solutions and services; key strategies; new product launches and product enhancements; partnerships, acquisitions, and mergers; agreements and business expansions; and competitive landscape associated within the Event Management Software Market.

The following key vendors are profiled in the report:

  • Cvent (US)
  • Aventri (US)
  • Eventbrite (US)
  • Ungerboeck (US)
  • Hopin (UK)
  • XING Events (Germany)
  • Bizzabo (US)
  • Certain (US)
  • RainFocus (US)
  • ACTIVE Network (US)
  • Eventzilla (US)
  • Meeting Evolution (US)
  • EventMobi (Canada)
  • Zoho (India)
  • Regpack (US)
  • EventBooking (US)
  • Bitrix24 (US)
  • Arlo (UK)
  • webMOBI (US)
  • Tripleseat (US)
  • Hubilo (US)
  • Circa (US)
  • Hubb (US)
  • Accelevents (US)
  • Glue Up (US)
  • idloom (Belgium)
  • Eventdex (US)
  • Event Temple (Canada)
  • Whova (US)
  • Airmeet (US)

Market Dynamics

  • Drivers

    • COVID-19: A Catalyst to Accelerate the Adoption of Virtual Events
    • Rise in Demand to Manage Large Volumes of Data and Automate Event Management Tasks
    • Compelling Need to Save Time and Money with Real-Time Data Analysis
    • Increase in Demand to Capture Actionable Business Insights from Events
    • Growth in the Use of Social Media for Event Marketing
  • Restraints

    • Difficulty in Integrating Event Management Software with Business Systems
    • High Initial Cost Associated with Event Management Software
  • Opportunities

    • Gamification of Events to Engage a Larger Audience
    • Growth in Inclination Toward Adoption of AI and ML in Event Management
  • Challenges

    • Wide Gap Between Organizers’ Offerings and Attendees’ Needs
    • Lack of Awareness of Event Management Software

Case Study Analysis

  • NEC Corporation Showcasing Proven SaaS Solutions to Customers Through Virtual Events on the Cvent Platform
  • HLB Designed a Virtual Event with Aventri Virtual Event Platform
  • Glassdoor Used Hopin for Its First Fully Virtual Sales Kickoff
  • Acronis Scales Their Hybrid Event Strategy with Bizzabo

Premium Insights

  • Growing Demand for Event Management Software Solutions Would Tackle High Demand from Event Organizers and Planners
  • Software to Account for a Larger Market Share During the Forecast Period
  • The Support and Maintenance Segment to be the Largest Market During the Forecast Period
  • On-Premises Deployment to Account for a Larger Market Share During the Forecast Period
  • Large Enterprise Segment to Account for a Larger Market Share During the Forecast Period
  • Event Organizers and Planners Segment to Account for the Largest Market Share During the Forecast Period
  • Asia-Pacific to Emerge as the Best Market for Investments in the Next Five Years

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Ungerboeck’s Latest Acquisition Enables Launch of Risk Management Tool for Venues and Events

Ungerboeck's Latest Acquisition Enables Launch of Risk Management Tool for Venues and Events

ST. LOUIS, May 24, 2022 (GLOBE NEWSWIRE) — Ungerboeck, the global leader in event management software, announced today that it has acquired the products developed by risk management agency Reliance Risk and will be debuting an industry-first application for mitigating risk to events and venues.

Risk management is an essential part of venue management and event planning. As the industry continues to be impacted by major shocks like the COVID-19 pandemic, terrorism, accidents, and severe weather incidents, Ungerboeck is committed to helping its customers better manage risks of all kinds.

The acquisition of both Reliance Risk products, RiskSense101 and VRM360, gives Ungerboeck the power to offer a valuable new solution: Risk Manager by Ungerboeck. The new application is specifically designed to give venue and event organizers a better understanding of threats and help them be proactive instead of reactive in the face of potential issues. 

“The unique nature of events dictates the need for a customized, simple, but powerful technology solution to help mitigate and monitor risk,” said Wayne Middleton, founder of Risk Sense Technologies and co-developer of the new application. “We have built this into Risk Manager by Ungerboeck and are grateful for the shared vision, passion, and global reach that Ungerboeck brings to help our industry manage risk.”

Steve Mackenzie, Executive Vice President of Ungerboeck, said the new application fills a void in the market. 

“Over the past few years, several events have become major headlines for all the wrong reasons,” he said. “Think of the Manchester Arena bombing, the shooting in Las Vegas, or the Astroworld crowd incident. By offering this tool, we are ensuring venue and event operators are equipped to identify potential risks and produce the necessary tasks and reports to back up the process.” 

Before joining the Ungerboeck family, Middleton’s risk management software was already used in venues across the Asia Pacific Region. Now thanks to Ungerboeck’s global reach, thousands of additional organizations will benefit. 

“Qudos Bank Arena, along with the larger ASM Global operated venues throughout Australia, have held a license to the software for over seven years. It has been an important tool in helping us understand the risks that our venues encounter and ensure that we have taken appropriate measures to mitigate them,” said Steve Hevern CVE, General Manager of Qudos Band Arena. “We congratulate Wayne and Ungerboeck on this global partnership and look forward to more innovative technology that will help us continue to host safe and successful events.” 

Middleton will continue in his role as Managing Director of Reliance Risk, and as a risk management consultant, setting the benchmark for best practices across the industry.

“We’ll build on the unique system that Wayne, a world-renowned risk management expert, has developed over the past decade,” Mackenzie said. “This is incredibly exciting for the market to finally have access to a dedicated risk management software.” 

About Ungerboeck

Ungerboeck provides industry-leading event and venue management software to over 50,000 users in more than 50 countries, empowering the people that bring people together. Its comprehensive platform offers event professionals powerful Software as a Service (SaaS) technology that provides a 360-view of their business, allowing them to cut costs, save time, and increase revenue. Founded in 1985, Ungerboeck is headquartered in the United States, with regional presence in Germany, France, Mexico, England, Australia, Mainland China, Hong Kong, and Singapore.

About Reliance Risk

Reliance Risk is a risk management consultancy established to provide quality risk management and safety support. We offer services across the risk spectrum with expertise in health and safety, business risk, business continuity and resilience, security, and emergency management. Many of our consultants have international risk management experience working across a range of industry sectors and we draw upon our network of technical experts to provide the right solution for client needs.

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Adverse Events with IO-TKI Combination Regimens for Advanced RCC and Their Management

Adverse Events with IO-TKI Combination Regimens for Advanced RCC and Their Management

Arnab Basu, MD: Dr Anakwah, can you please talk about the dosing for lenvatinib and pembrolizumab in your practice? What is a typical starting dose, and how does it compare to the CLEAR trial?

Shawnta Anakwah, MD: I haven’t had a lot of experience, but the patients I’ve tried it on, typically my patients are more frail, have a lot more comorbid conditions. One particular patient I had was on dialysis but she had a very high disease burden, so I started her lenvatinib dose at 10 mg instead of 20 mg as per the CLEAR trial. She tolerated it very well. I tend to start lower and then try to titrate up in my patient population.

Arnab Basu, MD: That’s a great strategy.

Shawnta Anakwah, MD: Exactly.What are the commonly observed adverse effects with IO/TKI [immunotherapy/tyrosine kinase inhibitor] combinations, and how do you manage them in your clinical practice?

Arnab Basu, MD: Good question. The adverse effects of combination therapy would be from the VEGF inhibitor or from the systemic immunotherapy. Speaking of VEGF adverse effects, hypertension is very common, and I try to see if the patient can tolerate a calcium channel blocker. This appears to be the mechanism of choice for VEGF-mediated hypertension. We do a nitric oxide release. I use that as a first-line agent. As a second line, I try to use an ACE [angiotensin-converting enzyme] inhibitor based on patient comorbidities, if possible. Other than hypertension, fatigue is unfortunately a difficult problem, and there’s no good way to address that other than through dose reductions or sometimes through some regimens that are friendlier to the patient, like taking a few days off of therapy, for example.

For stomatitis, which our patient here had, I typically use a dexamethasone mouthwash, 0.5 mg twice a day. The data for this come from some of the mTOR inhibitor trials, although there are some data in VEGF inhibitors as well. It is important not to swallow, as this can impair the TKI absorption. And you must be careful in prescribing, especially in patients with a likelihood of future fungal infections or viral infections. If you don’t want to use dexamethasone, you could certainly use magic mouthwash, or viscous lidocaine in these patients for mild symptoms. Another VEGF adverse effect is hand-foot syndrome. I suggest using moisturizers for mild symptoms. For moderate symptoms, I do some dose reductions or interruptions as necessary. And for GI [gastrointestinal] effects like diarrhea, Imodium is usually the first one, then Lomotil.

In regard to immunotherapy adverse effects, as you know, these are varied and unpredictable, but recognizing these early and intervening with steroids is associated with the best outcomes, in my experience. Dr Anakwah, when do you dose reduce some of these TKIs such as lenvatinib?

Shawnta Anakwah, MD: I try to reserve it for patients who have severe adverse effects, to the point where it’s affecting their quality of life. I agree with the management of the stomatitis. With patients, typically I’ll interrupt the dose, treat them with the supportive care, and then once their symptoms resolve or improve, I typically would try to start them at a lower dose.

Arnab Basu, MD: Do you ever revert their dose to their starting dose?

Shawnta Anakwah, MD: Typically, I don’t. From my understanding, in clinical trials, when patients have adverse effects and must be dosed reduced, typically they don’t dose escalate back up in the trials. It’s not allowed.

Arnab Basu, MD: Absolutely, this is why there’s no grade 1 evidence in this field. This is always an important question because we do think that the dose density of the TKI would be important in clinical outcomes. But once someone has demonstrated they’re not tolerating that dose, perhaps keeping going on that would essentially lead to the same problem down the line again. That’s a great point.

Transcript edited for clarity.

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Halton sets two virtual events for public input on growth management strategy

Halton sets two virtual events for public input on growth management strategy

Halton Region has announced two virtual events to both inform the public and gain input on the region’s growth management strategy. Both events will review and discuss Halton’s proposed amendment to the Regional Official Plan: “ROPA 49: An Amendment to Implement the Integrated Growth Management Strategy.”

The purpose of proposed Regional Official Plan Amendment 49 (ROPA 49), according to regional staff, “is to help define where and how Halton will grow.” This newly proposed ROPA 49 applies to all lands in the Regional Municipality of Halton, including the town of Oakville.

One of the events will be an “open house” to ask questions and review the amendment. The second event will be a statutory public meeting, which is more formal and allows residents to give direct comments to Halton Regional Council about the amendment. Both scheduled events are virtual.

The virtual events are scheduled as follows:

  • The Open House will take place on Wednesday April 6, 2022 at 7 p.m.
  • The Statutory Public Meeting will be one week later on Wednesday April 13, 2022 at 9:30 a.m.

Both events will be held over Zoom. Meeting IDs and passcodes have been released publicly and are available at the bottom of this story.

“Halton Region,” they begin in a public notice, “is holding a Public Open House and a Statutory Public Meeting in connection with Draft Regional Official Plan Amendment No. 49 (ROPA 49). ROPA 49 is proposed as a component of Halton’s Regional Official Plan Review and municipal comprehensive review process pursuant to the Provincial Growth Plan for the Greater Golden Horseshoe and Section 26 of the Planning Act, as amended.”

This is the second Amendment to be considered by Regional Council as part of the Regional Official Plan Review (ROPR) and Halton says it “builds on the Regional Urban Structure defined by ROPA 48.”

“It proposes,” they continue, “to implement the results of the Integrated Growth Management Strategy and Regional Council’s direction to accommodate population and employment growth within Halton’s existing Regional Urban Boundary to 2041 and to develop a framework for planning for growth from 2041 to 2051.”

ROPA 49 also proposes changes that support Halton’s growth strategy, including updates to:

  • Policies and mapping related to Settlement Area boundaries
  • The Regional Urban Structure
  • Strategic Growth Areas and Employment Areas
  • Forecasts and targets for population and employment growth, intensification, density and phasing


Questions can be submitted in advance for the open house by emailing [email protected] or calling 311. Attendees are asked to “please check closer to the meeting to download a copy of the presentation and follow along.”

Advance registration is being “strongly encouraged” for those who wish to make a verbal presentation during the statutory meeting. Halton says that, to preserve the integrity of the meeting, “anonymous or offensive Zoom account names will not be allowed to speak.”

Halton Region says they are “not responsible for unstable internet connections that may impact your ability to provide your comments. Participants who are disruptive or who speak on a subject other than the stated purpose of the meeting may be removed from the meeting without warning.”

To join or attend either event, there are two ways to do so:

  • Online: On the date of the event, visit
  • By phone: Call 1-855-703-8985 (toll-free) or 1-647-374-4685 and use the Meeting ID and Passcode above. 

For the statutory public meeting on April 13, the Meeting ID is: 999 8275 2781. The Passcode is: 624381 (if requested.)

If you wish to be notified of the decision of Halton Region on the proposed Amendment, you must make a written request to the Regional Clerk.

For more information about this event, you can read the full details in Halton’s public notice online.

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Management of Adverse Events After Combination Lenvatinib/Pembrolizumab

Management of Adverse Events After Combination Lenvatinib/Pembrolizumab


Ramez Eskander, MD: I do think it’s important to realize that the more common treatment-related adverse events [AE] were ones that we manage commonly with other treatment regimens, and are not necessarily AEs that we don’t think we should be competent or comfortable addressing for patients on lenvatinib and pembrolizumab. On the trial, the more frequent grade 3 or greater adverse events were hypertension, hypothyroidism, also diarrhea, [and] decrease in appetite. I like to categorize these and I compartmentalize them so I can think about them when I’m speaking to patients. But each of these adverse events are manageable as long as you’re proactive, you educate your patient, and you also communicate and have a team you’re collaborating with.

I do want to take a moment, you and [David M.] O’Malley, [MD,] had a great publication in The Oncologist that talks about the regimen and how to manage treatment-related adverse effects. In that publication there is a figure that beautifully illustrates when might I expect to see these adverse effects for patients I’m treating on this regimen. When I think about hypertension, well, a good proportion of patients are going to experience it early in treatment, within 2 weeks of start of therapy. So I have to be proactive, educate my patient, and make sure they have a prescription. I like to give them a prescription from the beginning of therapy because this is not hypertension where I can say call your primary care physician. The primary care doctor, they’re incredibly busy and can’t get them in for 4 weeks, so now they’re sitting with uncontrolled hypertension. I give them a prescription for whatever it may be. Amlodipine, I tend to use as a calcium channel blocker, it works well for my patients. I also talk to them about proteinuria. They are not symptomatic from that, but I will tell them, we’re looking for that in your laboratory work, and we may identify that, usually about 3 weeks in on treatment. What about fatigue? Similar cadence, [it appears] about 3 weeks into treatment. But over time there is improvement and acclimation.

Vicky Makker, MD: The few things that I would want to highlight from what you said, and you’ve said all this very eloquently, is that across the lenvatinib/pembrolizumab experience in endometrial cancers, the adverse events, the toxicities, that are spoken about repeatedly and appropriately are all consistent with what we see with immune checkpoint inhibitors across the board and other TKIs [tyrosine kinase inhibitors] across the board. And there are many other TKIs that are now in development. It’s important to remember that on all of the trials no new safety signals were identified, and that the toxicity profile of this combination, exactly as you said, is indeed manageable with aggressive supportive care, dose modifications, interruptions of lenvatinib when needed after you’ve employed maximum supportive care. I also want to highlight that among the responding patients, on the whole lenvatinib/pembrolizumab experience in endometrial cancers, it’s important to know that reductions in tumor size occurred over time despite lenvatinib dose reductions. But most of the responses were seen at the 20-mg dose. This does suggest that clinicians should start at the recommended starting dose of lenvatinib for this malignancy, which is 20 mg, and then dose reduce as needed. There are data from differentiated thyroid cancer and renal cell carcinoma that show that starting at lower doses may lead to inferior efficacy, though not necessarily less toxicity. And this has been published upon, so I think there are some important lessons here.

But my approach is exactly the same as yours, inform the patient about the mechanism of action, common toxicities, and then discuss the management plan so that they’re aware. Exactly as you do, we prescribe antihypertensives, we ensure that they have a BP [blood pressure] cuff and know how to use it. They need to know that they need to check their blood pressure every day, and for us, that point of escalation to the doctor call is greater than 140/90 [mm Hg] in terms of blood pressure. Even one time, because as you said it goes up and it goes up quickly, and it goes up steeply, so you can’t just sit on it, you really need to act quickly. We also prescribe an antihypertensive that they have at home. I like the ARBs [angiotensin receptor blockers], losartan is my go-to medicine, but there are many choices. And you’re right that The Oncologist publication gives practical advice on how to manage the common toxicities. They have antiemetics, they have an antidiarrheal, they have the antihypertensive, so they’re armed with a strategy of management. And they know that they must call often and they must call early. Additionally, as you said, the toxicities really do come on in those first couple of cycles, the first 2 or 3 cycles. So we see the patient back weekly, and we’ll check labs more frequently if necessary. We also really espouse the philosophy of prehabilitating the patients at every step possible to make sure blood pressure, nausea, any cachexia, things like that, are optimally controlled.

I think this has to be a situation where there is a culture of shared responsibility. Where you’re training not only your colleagues, but also the PAs [physician assistants], the NPs [nurse practitioners], the nurses who are on the front lines and do such a great job in helping to manage the common toxicities. Then the last thing I’ll say is I think that we shouldn’t shy away from getting consultants involved early in the course of therapy when toxicities come on. Those are the strategies that we employ, and then of course, the fact that attention to patient care really can’t wane at any point.

Ramez Eskander, MD: I can’t agree more. I think some people, they go to the publication or the presentation, and they say, well, the median dose intensity of lenvatinib was 13.8 mg, which means I can just start at 14 mg because it’s the same thing. But just like you eloquently stated, it is not identical. Starting at 14 mg is not the same as a median dose intensity of 13.8 mg. I do also, exactly as mentioned, be proactive about treatment-related adverse events, support your patients through this. One of the questions I get frequently is about the diarrhea. They’re on pembrolizumab that can cause a colitis, and lenvatinib. “What do I do if my patient calls me and has diarrhea?” I espouse the fact that pembrolizumab-related diarrhea, colitis from IO [immuno-oncology therapy] and checkpoint [inhibitor therapy], is not necessarily the same as lenvatinib-associated diarrhea. They present a bit differently. So I like to say, prioritize assessment of the patient. Do they have bloody diarrhea? Are they having fevers? Are they having severe abdominal pain associated with their diarrhea? If they are, my concern for IO-related colitis rises, and of course, we don’t want to wait on that because delaying intervention and supportive care can lead to compromised outcomes.

Conversely, if they say, “Ramez, listen, the frequency of my bowel movements is up. They’re more watery. I’m worried. It’s not my norm,” and they’re on the lenvatinib portion, and thankfully, pembrolizumab is once every 3 weeks and lenvatinib is daily. So the cadence helps us mitigate that. I’ll commonly just say, hold your lenvatinib, initiate your antidiarrheal agents as we discussed, and they have a prescription for them, and then re-evaluate. Is that in line with how you manage this?

Vicky Makker, MD: It is indeed. There are certainly some overlapping toxicities, the diarrhea being one of them, but also the hypothyroidism and the insults that can occur to the liver. So yes, I think you’re right. Sometimes it’s the quality of the AE, the volume, whether there’s bleeding or pain associated with it, such as with the diarrhea, and also the timing of it. Was it midcycle; was it at the beginning of the cycle? Sometimes those things can offer clues as well. But sometimes, it’s safer to bring the patient in, check their electrolytes, make sure they’re OK, and then make decisions as you said because there is the potential for toxicity, and you really need to be mindful and always keep patient safety at the forefront. But I do agree that the 2 can differentiate based on timing of onset of some of these toxicities.

Transcript edited for clarity.

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Adverse events and risk management in residential aged care | RMHP

Angiotensinogen and Risk of Stroke Events in Patients with Type 2 Diab | DMSO


Regarding urbanization and industrialization, population aging is one of the most urgent problems globally, specifically for developing countries with limited resources for old-age care.1 China has the highest number of older adults; it is also one of the countries with the fastest aging population.2 The proportion of adults over 65 years has increased from 13.3% in 2010 to 18.7% in 2020.3 Residential aged care facilities (RACFs), a thriving way of old-age care, have become increasingly important in China, because of the “one-child” policy, increase in life expectancy, and weakening role of family care.4 Currently, less than 200,000 nurses provide nursing care for about 2.146 million older adults in 42,300 RACFs.5 Due to the decline of physical strength and physiological functions of older adults, their chances of suffering from chronic physical diseases, mental disorders, and disabilities have increased.6 Along with the shortage of nursing staff, insufficient professional skills, and other problems,7 older adults living in RACFs are at a high risk of suffering from care accidents and nursing adverse events (eg falls, burns, choking, aspiration, wandering away, and pressure sores),8 which negatively impact their physical and mental wellbeing and can cause disputes, economic and property losses, among others. The role of risk management in effectively reducing nursing adverse events and maintaining older adults’ safety has been widely documented.9,10 Given various risks faced by RACFs, managers urgently need to actively adopt risk management and early warning strategies to reduce the potential mistakes in care delivery for older adults.


Risk management is a complicated process of implementing and maintaining countermeasures to reduce risk impact to an acceptable level.11 In the past decade, governments, researchers, and RACFs have been devoted to exploring nursing risk indicators, establishing nursing risk early warning systems, and formulating nursing risk prevention strategies. For example, the UK and the US have applied a standardized assessment tool, namely the Minimum Data Set (MDS), to systematically assess and review nursing practices, identify nursing home residents at risk of deterioration, and protect residents’ integrity and autonomy.12,13 Australia developed nursing risk assessment indicators for older adults, which involve pressure sores, falls or fractures, use of physical restraints, and psychological and behavioral symptoms.14 Several risk analysis methods such as Failure Mode and Effects Analysis (FMEA),15 Fine–Kinney method,16 SHEL model (software, hardware, environment, and liveware),17 Swiss cheese model,18 are widely applied to identify potential human mistakes in practice. With the wide application of information technology (IT) in healthcare, risk management information systems (RMIS) are often applied for data collection, information analysis, and statistical reports to identify and monitor preventable incidents. In the UK, through the National Early Warning Score (NEWS) system19 as well as the National Reporting and Learning System, a supportive environment for actively reporting and sharing errors is created, and related experiences and lessons are widely disseminated.

Chinese scholars and healthcare professionals tried to conduct preliminary studies of risk management in RACFs. For example, Li et al20 used FMEA to analyze various internal risks regarding infectious diseases, injuries, falling, and accidents in RACFs. Zhou21 tried to establish risk prevention and management systems for RACFs including external, internal, and economic risks. Based on the prevention, preparedness, response, and recovery (PPRR) risk management model, Zhang22 established an emergency practical path for public health emergencies in RACFs. China’s government departments such as the China National Committee on Aging, Ministry of Civil Affairs, China Academy of Social Management have tried to improve RACFs care quality and have promulgated relevant policies and regulations. China’s Ministry of Civil Affairs created requirements for the room environment and older adults’ sanitation as well as safety measures in RACFs, such as barrier-free design and smooth and non-slip floors. The establishment of such facilities should pass the evaluation by local authorities regarding construction, fire protection, sanitation, and epidemic prevention. Additionally, the national mandatory standard-basic specification of service safety for senior care organizations requires each RACF to reduce risks of choking, pressure ulcer, scald, fall, and so on through standardized operation procures and risk management.23

Effective risk management activities usually include the following stages: identification, analysis, evaluation and treatment, and communication and consultation.24 Evaluation and feedback are essential to accumulate long-term evidence and guarantee the care outcomes and older adults’ safety regarding risk management and early warning in RACFs. However, existing studies fail to provide a clear picture of the prevalence status, risk management, and risk early warning of nursing adverse events in RACFs. Thus, this study aims to (1) investigate the prevalence of nursing adverse events, risk management, and risk early warning status and (2) explore the factors associated with risk management in RACFs in China.

Materials and Methods


This study used a cross-sectional design and employed an online questionnaire to investigate RACFs in Hunan Province.


A convenience sample (a type of non-probability sampling method where the sample is drawn from a group of people easy to contact and obtain their participation)25 of 272 RACFs were recruited in Hunan Province. RACFs’ managers were invited to respond to the survey. The inclusion criteria were 1) license for establishment and registration in the local civil affairs department; 2) operation duration of at least one year; 3) equipped with ten or more beds; 4) consent to participate in the study.

Survey Tools

The self-administered questionnaire used had four sections: prevalence of nursing adverse events, risk management, risk early warning, and general information survey scales.

Prevalence of Nursing Adverse Events

This section is used to inquire about the prevalence of nursing adverse events in RACFs in the past year (2019), including 14 fill-in-the-blank questions. Respondents were required to provide an accurate figure in each blank. The type of adverse events in this study included falls,26 falling out of beds (or chairs), fractures,27 food poisoning,28 burns or scalds,29 choking,30 aspiration or swallowing of foreign bodies,31 wandering away,32 accidental death, pressure sores,33 medication errors,34 adverse events caused by physical restraints,35 and accidental catheter removal (ie cannula, endotracheal tube, nasogastric tube, and urinary catheter).36

Risk Management Scale

The risk management scale was self-developed from our previous research37 to evaluate the status of RACFs. It includes 28 items and four management dimensions: environment (4 items), personnel (4 items), service (10 items), and safety (10 items). Each item is scored on a five-point Likert scale ranging from 1 (completely inappropriate) to 5 (completely appropriate). The scale is scored by summing the numerical ratings for each item and dividing the result by the total number of items. Possible scores ranged from 1 to 5. The higher the score, the better risk management. The overall Cronbach’s α coefficient of this scale was 0.974, and its split-half reliability (used to measure the internal consistency reliability of survey instruments and assessed by splitting the items of survey instrument in half, and then calculating the correlation of the scores for each half)38 was 0.951. Cronbach’s α coefficients for the environment personnel, service, and safety management dimensions were 0.842, 0.905, 0.924, and 0.943, respectively.

Risk Early Warning Scale

The risk early warning scale was self-designed from our previous study39 to evaluate the early warning status of RACFs. The scale comprises four dimensions with 26 items: nursing staff training (six items), a contingency plan for public security incidents (eight items), a contingency plan for age-related safety incidents (seven items), and emergency management (five items). Participants respond “Yes” or “No” to each item (1 = Yes; 0 = No). The total score ranges from 0 to 26, and a higher score signifies better risk early warning. In this study, the Cronbach’s α coefficient of the entire scale was 0.874 and the split-half reliability was 0.786. Cronbach’s α coefficients for the nursing staff training, a contingency plan for public security incidents, contingency plan for age-related safety incidents and emergency management dimensions were 0.720, 0.813, 0.724, and 0.682, respectively.

General Information

This section captured RACFs’ demographic characteristics, such as the ownership and location of the facility, whether it has the Practice Certificate of Social Welfare Facilities, operation duration (year), bed-size, number of residents, number of nursing staff, whether it requires nursing staff to work with certificates, and payment for nursing staff (RMB/month).

Data Collection

From February 1 and March 1, 2020, the primary researchers sent the recruitment invitation and informed consent form to the RACF managers in Hunan Province through email and obtained a copy of the written informed consent from 401 eligible RACFs. Then, we recruited sophomore nursing students as investigators, who were not allowed to return to School because of the isolation policy due to COVID-19. From March 5 to May 10, 2020, potential student investigators received curriculum and instructions on the questionnaire survey guidelines, quantitative research design, and data collection methods. The primary researcher distributed the questionnaire link to WeChat groups (the most popular social media application in China) and ensured all student investigators had the survey link. Finally, 114 students participated in the data collection of RACFs in their county administrative areas (one investigator per county-level administrative region). From May 13 to June 1, 2020, student investigators collected data from nearby RACFs and invited the managers to respond to the survey. In the field survey, the investigators did not conduct the questionnaire survey until they obtained the participants’ oral consent. While interviewing the RACF managers according to the survey scale, the investigators recorded the answers into the online questionnaire ( on their mobile phones.

Ethical Considerations

Before collecting data, the investigators explained the purpose, process, as well as potential benefits and risks to the RACF managers. The collected data did not contain the identifiable information of the RACFs or managers. This study conforms to the provisions and ethical principles of the 1995 Declaration of Helsinki (revised in Edinburgh in 2000). The Institutional Review Board of the Affiliated Hospital of Xiangnan University approved this study (registration number: KY–201508001).

Data Analysis

We excluded questionnaires with more than 20% data missing, which could not be supplemented by other means. The questionnaires were sorted by the principal researchers, and the data were analyzed using SPSS 25.0 statistical software. The Kolmogorov–Smirnov normality test was performed on continuous data. The normality tests showed that all continuous variables had a non-normal distribution. In this study, continuous variables were described by median (interquartile range, IQR), and categorical variables were described as frequency and percentage and presented in bar charts. The statistical analysis was conducted using the Mann–Whitney U-test and Kruskal–Wallis H-test, and Spearman correlation was used to analyze the association with the main independent variables. The significance level was set as 0.05.


General Characteristics of the Sample

In total, 328 questionnaires were collected; after excluding 56 questionnaires, 272 valid questionnaires were obtained. Figure 1 shows the distribution of the sample RACFs.

Figure 1 Distribution of the research residential aged care facilities in the Hunan Province.

Finally, this study analyzed 152 (55.88%) public and 120 (44.12%) private RACFs. Most were in rural areas (n = 150; 55.15%), obtained the Practice Certificate of Social Welfare Facilities (n = 234; 86.03%), and required nursing staff to work with certificates (n = 239; 87.87%). The operation duration of RACFs was 1 to 62 (11; IQR: 12) years. The number of beds in RACFs ranged from 10 to 10,000 (70; IQR: 97), among which 81 (29.78%) had 10 to 49 beds, 86 (31.62%) had 50 to 99 beds, 60 (22.06%) had 100 to 199 beds, and 45 (16.54%) had 200 or more beds. During the survey period, the number of older adult residents was between four and 7216 (40, IQR: 54), the number of nursing staff was between one and 4000 (7, IQR: 14), and the nursing hours per resident day (HPRD) ranged between 0.16 and 16.84 (1.48, IQR: 1.64; calculated according to nursing staff working 8h per day; Table 1, Figure 2).

Table 1 Demographic Characteristics of the Research RACFs (n=272)

Figure 2 General characteristics of the sample (median, n=272).

Prevalence of Nursing Adverse Events, Risk Management, and Risk Early Warning in RACFs

We found that an average of five (15) adverse events occurred in RACFs in 2019, with falls (2, IQR: 5) and pressure sores (0, IQR: 1.75) at the highest level, and accidental death (0, IQR: 0) and food poisoning (0, IQR: 0) at the lowest level (Figure 3).

Figure 3 The prevalence of nursing adverse events in 2019.

This study revealed that the facility’s risk management score was at an acceptable and relatively desirable level. The total average score of risk management in RACFs was 4.72 (0.98) out of 5. The score of environment management and personnel management dimensions was the highest at 4.75 (1), followed by safety management at 4.70 (1), while the score of service management dimension was the lowest at 4.60 (1; See Table 2).

Table 2 Risk Management in Residential Aged Care Facilities (n=272)

Regarding the nursing staff training of RACFs, as shown in Graph A of Figure 4, more than 90% had trained their nurses on nursing knowledge and rehabilitation skills, but only 72.79% on relevant ethical and legal considerations. In terms of contingency planning for public safety incidents, most RACFs had made contingency plans for fire (96.31%) and food poisoning (92.28%), but only 66.91% and 56.99% had formulated contingency plans for gas poisoning and drowning, respectively, as shown in Graph B of Figure 4. Regarding contingency planning for age-related safety incidents, Graph C of Figure 4 shows that 95.96% and 90.81% of RACFs had made contingency plans for falls and sudden changes of diseases, respectively. However, only 73.53% reported suicide contingency plans. More than 90% regularly organized nursing staff to conduct emergency drills (92.28%), had set up emergency teams (91.91%), established a safety emergency monitoring system (92.65%), and quickly coordinated and distributed emergency materials and equipment according to critical situations (94.12%). However, only 84.56% provided pre-hospital first aid for older adults, as shown in Graph D of Figure 4.

Figure 4 Risk early warning status in residential aged care facilities.

Associated Factors of Risk Management in RACFs

The Mann–Whitney U-test or the Kruskal–Wallis H-test showed that the following factors of RACFs favor risk management: in urban areas, obtaining the Practice Certificate of Social Welfare Facilities, with more than 50 beds, providing higher HRPD, requiring nursing staff to work with certificates, and paying higher salary (all p < 0.05; Table 3).

Table 3 Differences in Risk Management Scores with Participants’ Demographic Characteristics (Score, n = 272)

Relationships Between Risk Management Scores, Frequency of Nursing Adverse Events, and Risk Early Warning Scores

In this study, frequency of adverse events was weakly negatively correlated with the risk management scores (rs = −0.208, p < 0.01), as well as environment (rs =−0.151, p < 0.05), personnel (rs = −0.212, p < 0.01), service (rs = −0. 205, p < 0.01), and safety management (rs = −0.204, p < 0.01). Moreover, risk early warning scores was moderately positively correlated with the risk management scores (rs =0.516, p < 0.01), as well as environment (rs =0.434, p < 0.01), personnel (rs =0.461, p < 0.01), service (rs = 0.497, p < 0.01), safety management (rs =0.511, p < 0.01) scores, as shown in Table 4.

Table 4 Correlations Between Risk Management Scores, Frequency of Adverse Events, and Risk Early Warning Scores (Rs, N = 272)


We found RACFs experienced an average of five (15) adverse events in 2019, which is significantly higher than that in Italian nursing homes.40 This may be related to the differences in survey methods (field survey vs online survey), the healthcare environment, and the time period (one year vs six weeks). However, these numbers may be significantly lower than actual incidents. Generally, most RACFs try to underreport any adverse events, which might affect their quality ratings and reputation in the community.41,42 Kapoor43 reported that the prevalence of adverse events in patients transitioning from hospitals to long-term care facilities was 37.3%. According to a study by Health and Human Services Inspector General Office, about 22% of older adults experienced at least one adverse event during their stay in the nursing home, and the total cost leading to rehospitalization was about USD 208 million.44 The trend of adverse events is similar to those in other countries;43,45,46 for instance, falls, pressure sores, psychological adverse events, falling out of bed (or chair), choking, and aspiration or swallowing foreign bodies were common adverse events in RACF settings. These may have potentially negative impacts on residents’ health outcomes, quality of life, and mental health. Thus, RACFs and healthcare professionals need to make effective resident-safety interventions to reduce adverse events.

Although the facility’s risk management score is at an acceptable and relatively desirable level, it might be reasonable to increase it to a more optimal level, specifically in the safety management and service management domains. In RACFs, numerous quality and safety issues, such as minor mistakes, missing and rushed care, and disruptions in care, can negatively impact the physical and mental health of older people over time.47,48 A significant amount of previous research49,50 has shown that RACFs need to establish a safety culture and encourage active and unpunished error reporting of nursing adverse events to reduce potential harm. In China, the safety management and service quality provided by RACFs are highly variable due to weak quality regulation, insufficient inspections, and poor enforcement of rules.51 To ensure quality care in supporting independence, autonomy, dignity, and safety of the older adults, it is imperative to establish an effective long-term care regulatory framework and quality assurance system.

Regarding staff training in RACFs, only about 70% had trained nursing staff regarding relevant ethical and legal considerations. Legal knowledge is often neglected in the training and education of nursing staff.52 Typically, geriatric care training conducted by RACFs focuses on the daily-life care of older individuals and basic nursing knowledge, such as diet care, oral cleaning, pressure ulcer prevention, and use of crutches and wheelchairs. However, nursing staff in RACFs shoulder complex ethical responsibilities, take ethical care actions, and balance moral dilemmas and legal issues related to health and safety.53 Thus, it is important to emphasize nursing staff’s understanding of the legal and ethical framework for geriatric care to provide the better care.

Regarding contingency plans, this survey showed that 30% to 40% of the facilities did not have contingency plans for suicide, electric shock, gas poisoning, and drowning, although China’s Ministry of Civil Affairs issued the Administrative Measures for Residential Aged Care Facilities, which requires RACFs to formulate contingency plans for natural disasters, accidents, public health incidents, and social security incidents.54 Fisher et al55 stated that contingency planning is a continuous process, which demonstrates personnel responsibilities, response time, corresponding strategies as well as resource preparation before, during, and after the emergency. Moreover, evidence has shown that emergency preparedness and disaster response plan is important in the emergency system and guide timely and effective emergency rescue.56,57 Our findings demonstrate the need for administrative authorities (eg the Ministry of Civil Affairs and the Central Politics and Law Commission) to strengthen the monitoring of RACFs’ emergency system to effectively address emergencies and minimize losses.

Regarding emergency management, only 84.56% of RACFs utilized pre-hospital first aid for older adults. In China, to minimize daily operating costs, some small RACFs choose the sharing mode to cooperate with nearby community health service centers and hospitals to address residents’ healthcare treatment.58 However, due to the shortage of qualified employees and equipment, these facilities may experience potential hazards such as missing the prime time for first aid and causing serious life-threatening consequences. Hence, we recommend RACFs make an extensive and sustained effort to develop manpower (eg in-service training, simulation of incident scenes, and operational training)59 and equipment (eg alarm device, upgraded technologies, necessary emergency rescue equipment, and ambulances)60 to ensure residents’ safety and meet the needs of first aid and high-quality medical services.61

The findings revealed that urban RACFs scored significantly higher than those in rural areas. The common assumption is that those in rural areas with higher poverty rates, limited support staff, and lower availability of health promotion and disease projects62–65 experience more difficulty in creating a physical environment suitable for the older adults, recruiting and training nursing staff with sufficient competences, and establishing effective risk management programs. Moreover, RACFs that have obtained the Practice Certificate of Social Welfare Facilities are better at risk management. In China, they can successfully obtain it only when they meet the basic standards of civil affairs departments for living places, and outdoor activity venues, start-up funds, regulations and personnel, as well as the national fire safety, sanitation, and epidemic prevention standards. Such policy promotes managers to address the risk and safety issues in the application process of the certificate and further improves the scores in all dimensions. Similarly, in the US, the Centers for Medicare and Medicaid Services and health authorities in various states have issued a series of policies (eg Five-Star Quality Rating System) to supervise and inspect nursing homes, to ensure that care delivery meets the necessary legal, quality, and safety standards.66 We identified lower risk management scores in small-scale RACFs with 10 to 49 beds than those with more than 50 beds, consistent with the previous study by Liu,67 which found the vast majority of small RACFs are equipped with little emergency medical equipment and tend to recruit rural women with poor professional knowledge and limited emergency nursing skills as nursing aids. Notably, adequate and qualified nurses are important for risk management in RACFs along with nursing HPRD (staffing) and qualified care workers’ recruitment. Typically, nursing staff are crucial human resources in reducing pressure sores, falls, use of immobilization devices, and pain and furthering residents’ better outcomes.68,69 However, the results showed that the average nursing HPRD in RACFs in China was 1.48 (1.64), significantly lower than the international standard.68,70 According to payroll-based journal data, in 2019, nursing homes reported 3.89 nursing HPRD on average (0.68 registered nurse HPRD, 0.88 licensed vocational nurse/licensed practical nurse HPRD, and 2.33 certified nursing assistant HPRD, including all administrative nurses).71 It is well known that RACFs should recruit sufficient qualified nursing staff with appropriate competencies; however, in this study, although 85.45% of the facilities required nursing staff to work with certificates, many did not recruit on-site registered nurses. Given the low nursing HPRD and limited registered nurses in Chinese RACFs, further efforts are needed to attract nursing staff to geriatric care and retain them, thereby addressing the nursing shortage. Interestingly, the risk management score of RACFs is related to nursing staff’s salary. This can be explained as RACFs offering higher salaries for a greater likelihood of better financial resources and higher employee retention. Furthermore, it is well documented that nurses with relatively low incomes are more likely to report higher job burnout,72 lower prestige, less professional autonomy,73 and lower work creativity, which may lead to less empathic care delivery, and missing or rushed care. A national survey of 239,312 employees in China RACF settings also revealed that the labor (taking care of six to seven disabled or semi-disabled older adults on average every day) and payment (<3000 RMB) for nursing staff were significantly unbalanced, which leads to a continual decline in their efforts and attitudes toward nursing development and career retention.74 Recommendations include strengthening national route inspections and enforcement provisions, improving care workers’ performance, establishing a reward and punishment mechanism to help risk management of RACFs, specifically for those in a rural area with limited healthcare resources.

As expected, the lower frequency of adverse events was correlated with better risk management, consistent with the results of Lawati et al75 and Smith et al,76 which suggest that successful risk management programs could facilitate creating and maintaining safe systems of care, improving human performance, and reducing adverse events. However, the correlation was not as high as expected,77,78 with the figure of −0.208 indicating only a weak correlation between adverse event frequency and risk management. It is unclear whether this is related to confounding factors’ effect such as RACF characteristics and the validity of the measurement tool. More evidence is needed linking risk management to the incidence of adverse events. Additionally, RACFs’ risk early warning favors risk management, which is supported by previous studies.79,80 Catalyst11 believed that education and training, contingency plans, response, and mitigation are essential components for all healthcare risk management programs. Prevention beats remediation, with an emphasis on “early warning, risk reduction and managing uncertainties around older residents.”81 With the continuous development of artificial intelligence (AI), applying AI algorithms such as machine learning, and back propagation neural networks in constructing nursing risk early warning models can overcome the shortcomings of traditional integrated prediction methods and provide managers with decision-making information.82 RACFs could consider integrating innovative IT across risk early warning and management to address the quality and safety concerns of stakeholder groups.

The risk management and risk early warning of adverse events affect the interactions, attitudes, and practice of leaders, employees, and residents of RACFs, and can help leaders initiate quality improvement interventions. This study contributes to the existing literature on risk management and related factors. It also provides evidence for policymakers and RACF managers and staff to develop strategies to optimize care delivery in these settings.


This study has the following limitations. First, the cross-sectional design and potential selection bias limit the results’ generalizability. Future longitudinal study can include facilities from other provinces. Second, some facilities might choose to underreport adverse events and increase effective preventive measures to protect their reputation, although we required investigators to check the relevant documents and records of the organizations to minimize data biases. Third, the psychometric properties of the questionnaires and participants’ subjective ideas need to be further explored, although the entire scales have good reliability and validity with the Cronbach’s α coefficients between 0.874–0.974 and the split-half reliabilities between 0.786–0.951. Fourth, student investigators may lack an in-depth understanding of the questionnaire items, leading to missing important information and inability to guarantee the data accuracy. Moreover, given their low prestige, respondents could skip the question or choose the best answer provided, resulting in some biases on answers. Finally, this study failed to record some types of adverse events (eg suicide, hospital admissions) and did not consider some potential variables (eg star rating, occupancy ratio of disabled older adults, the proportion of residents aged over 80 years, and profit and loss status). Multi-center and cross-sector research is needed to evaluate other factors that may be related to risk management and early warning.


Adverse events in RACFs are the leading causes of morbidity and mortality among residents; facilities should conduct appropriate risk management and risk early warning. The results of our study showed that the staffing level of nursing staff in RACFs in Hunan, China was low, but the frequency of nursing adverse events (eg falls, pressure sore, psychological adverse events, falling out of bed [or chair] and choking) was high. Overall, the risk management level of the surveyed RACFs was at an acceptable and relatively desirable level. Regarding risk early warning, care workers’ ethical and legal training and some important contingency plans (eg suicide, electric shock, gas poisoning, and drowning) were often overlooked. Besides, large-scale urban RACFs that obtain the Practice Certificate of Social Welfare Facilities, are equipped with adequate and qualified care workers, pay a higher salary to their employees, and gain higher risk management scores. We observed that the lower the frequency of adverse events, the better the risk management, and the better the risk early warning, the higher is the risk management score. RACFs need to adopt multi-dimensional methods and strategies to address the high prevalence of nursing adverse events and advance risk management and risk early warning, to deliver safe and high-quality care for older adults. The results could inform an empirical study of risk management in RACF settings in China to develop a blueprint for the improvement of care outcomes in the context of global rapid aging.

Ethical Approval

The Ethics Review Committee of the Affiliated Hospital of Xiangnan University approved this study (reg. no. KY–201508001).


We would like to thank all the investigators and respondents who participated in this study for their contributions and the Affiliated Hospital of Xiangnan University for its approval and support. We are grateful to Hunan Social Science Achievement Evaluation Committee for their financial and material support.


This study was supported by the Hunan Social Science Achievement Evaluation Committee (grant no. XSP20YBC164), 2018 key scientific research projects of Hunan Provincial Department of Education [grant no. 18A459], the General Project of Hunan Provincial Department of Education [grant no. 21C0723], the General Project of Hunan Philosophy and Social Science Fund [grant no. 17Y3A361], Hunan Clinical Medical Technology Demonstration Base[grant no. 2021sk4046].


The authors report no conflicts of interest in this work.


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Checkpoint Inhibitors Present Unique Adverse Events, Require Careful Management Strategies in Breast Cancer

Checkpoint Inhibitors Present Unique Adverse Events, Require Careful Management Strategies in Breast Cancer

Most, but not all, immunotherapy-related adverse events (irAE) occur throughout the first 12 weeks of treatment, and can affect any organ, according to La-Urshala Brock, FNP-BC, CNM, RNF, a clinical instructor specializing in breast and gynecologic cancers at the Nell Hodgson Woodruff School of Nursing with Emory University.1

Brock recently presented during the 39th Annual Miami Breast Cancer Conference® about immunotherapy-related adverse event management, in a lecture titled, “Immunotherapy Adverse Effects,” which focused specifically on toxicities associated with pembrolizumab (Keytruda).

In July 2021, the PD-L1 inhibitor pembrolizumab was approved by the FDA to treat patients with triple-negative breast cancer (TNBC) in the neoadjuvant meeting in conjunction with chemotherapy, to be continued as an adjuvant monotherapy after surgery.2

The approval for pembrolizumab was supported by findings from the randomized, multicenter, double-blind, placebo-controlled KEYNOTE-522 trial (NCT03036488).3 Results demonstrated a 37% reduction in the risk of disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause (HR, 0.63; 95% CI, 0.48-0.82; P = .00031).The recommended dose for intravenous pembrolizumab is 200 mg every 3 weeks.2

Notably, this approval also marked the first immunotherapy to treat patients with high-risk early-stage TNBC. However, the introduction of the agent also opens the door for more toxicity management education for nurses who care for patient with breast cancer.

“Immunotherapies present with a novel spectrum of AEs that differ in important ways from those associated with chemotherapy and targeted agents,” said Brock. “When you’re using immunotherapy, truly any organ can be affected. The median onset is 4 to 5 weeks [after beginning treatment], but adverse events can happen as early as when you start the treatment.”

Atezolizumab (Tecentriq), a PD-L1 inhibitor, was granted accelerated approval for TNBC to be given every 3 weeks with weekly nab-paclitaxel (Abraxane) in 2019, but this agent was withdrawn from market, since it was not shown to improve survival in patients with locally unresectable metastatic, PD-L1–positive disease.4

In her discussion, Brock highlighted a wide range of toxicities that are associated with immune checkpoint inhibitiors (ICI)—particularly for patients with TNBC receiving pembrolizumab. Toxicities of interest include dermatitis, endocrine effects, adrenal insufficiencies, lung effects, colitis, hepatotoxicity, and ocular side effects, in addition to a couple rarer immune-related AEs (irAEs).


ICIs may induce low-grade rashes in many patients. This can include reticular erythema, papules, and plaques. In more rare cases, Stevens-Johnson syndrome or toxic epidermal necrolysis, palmar–planta dysesthesia may also occur.

Effective management of skin-related toxicities involve frequent photo documentation of the toxicity and follow-up photos to track potential changes, as well as consulting a dermatologist to obtain a biopsy. For low-grade toxicities, symptomatic treatment with antihistamines typically prove to be effective. However, for high-grade toxicities, treatment with topical or oral steroids may be appropriate. In addition, if symptoms progress to grade 3, treatment should be withheld, and if symptoms worsen to grade 4, treatment should be discontinued.5,6,7,8

“We hold at this point,” said Brock. “You could think about using rituximab [Rituxan] for treatment. You want to continue steroids until the blisters have resolved completely and then [once] the blisters have resolved, you want to slowly taper the steroids.”

Endocrine Toxicities

Endocrine toxicities occur in approximately 10% of patients receiving pembrolizumab. Nurses should watch for vision changes, weight gain or weight loss, dizziness, constant chilliness or feeling cold, constipation, and hair loss. Other signs of endocrine toxicities include increased headaches or changes in headache patterns, increased heartbeat, increased urination, increased tiredness, increased thirst or appetite, changes in mood, and increased sweating.8

Patients suspected to be experiencing these toxicities should have their thyroid-stimulating hormone (TSH) and free thyroxine (FT4) checked every 4 to 6 weeks with complete blood count (CBC) and comprehensive metabolic panel (CMP).

Adrenal Insufficiency

Adrenal insufficiency, or Addison’s disease, means that the adrenal glands produce insufficient amounts of the hormone cortisol, Brock explained. Signs and symptoms include extreme fatigue, darkening skin or hyperpigmentation, low blood pressure or fainting, abdominal pain, muscle or joint pain, salt craving, weight loss, depression or behavioral changes, and nausea, vomiting, or diarrhea.

For primary adrenal insufficiency, the workup should include assessing morning cortisone and adrenocorticotropic hormone (ACTH) levels, as well as CMP to assess sodium, glucose, potassium, and carbon dioxide.

If a patient has elevated TSH levels but normal or low FT4, then hypothyroidism is the cause. So long as the toxicity remains a grade 1 (TSH < 10 ml U/L or asymptomatic), they may continue receiving the checkpoint inhibitor with continued TSH and FT4 monitoring.

For hypophysitis, or inflammation of pituitary gland, the workup should include assessing morning cortisone as well as ACTH, TSH, FT4, testosterone in men, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrogen in premenopausal women, and an MRI of the brain with or without contrast with pituitary cuts.

If the hypothyroidism progresses to a grade 2 (TSH > 10 mIU/L or symptomatic), the ICI should be withheld, an endocrinologist should be consulted, and a thyroid hormone supplementation should be implemented. The patients will continue to require TSH and FT4 checks every 6 weeks, but if the severity reduces to a grade 1 event, they may continue treatment.

In the event of grade 3/4 hypothyroidism, the ICI should be withheld until symptoms resolve to baseline with thyroid supplementation.

If a patient has low TSH and high, normal, or elevated FT4 levels, then this person is experiencing hyperthyroidism. As long as the toxicity remains at grade 1, they may continue receiving the ICI with continued TSH and FT4 checks every 2 to 3 weeks.

If the hyperthyroidism progresses to a grade 2, the ICI should be withheld until symptoms return to baseline and an endocrinologist should be consulted. A beta blocker might also be considered.

For grade 3/4 hyperthyroidism, the ICI will need to be withheld until symptoms resolve to baseline with thyroid supplementation. In addition, at this grade, hospitalization may be required if thyroid storm occurs. Prednisone should be considered at a dosage of 1 to 2 mg/kg daily and then put on a tapering schedule.

“With hyperthyroidism, what I want to mention here is that if someone is experiencing symptoms, we can use a beta blocker, but we also still want to be consulting endocrinology,” Brock highlighted. “One of the risk factors here when we get to grade 4 is the risk for thyroid storm. That is why it is important to have endocrinology involved.”

In less than 1% of patients, ICI-mediated endocrinopathy type 1 diabetes mellitus may occur with rapid onset anytime following therapy initiation.

Management for this toxicity involves monitoring serum glucose at baseline and prior to each cycle of ICI. An endocrinologist should be consulted, and generally, lifelong insulin therapy will be required. Once blood sugar is well controlled, the ICI therapy can be restarted.

Lung Toxicity

Pneumonitis equates to inflammation of the lung parenchyma. This irAE occurs between 0% to 10% of patients, but the odds increase when patients receive combination therapy as opposed to monotherapy, as well as if there has been previous thoracic radiation.9-11 The onset time for lung toxicity can range from 2 to 24 months, however, the median onset time is 3 months.

Cough, fever, dyspnea, and chest pain should be evaluated when monitoring for lung toxicity. Patients who experience these symptoms will need a chest x-ray and CT scan. The threshold for obtaining a CT scan of the chest and a pulmonary consultation should be low, noting that CT findings typically lag patient symptoms.

Management includes routine pulse oximetry checks in addition to potential CT scans, as well as administration of high-dose steroids, starting at 1 to 2 mg/kg daily, and tapering across 45 to 60 days. If symptoms return, the steroids may require retapering.

If within 72 to 96 hours of steroid initiation there is no symptom relief, patients should receive infliximab-axxq (Avsola) at 5 mg/kg. In most cases, the addition of immunosuppressants will help to resolve the issue.Infectious workup should include a nasal swab for potential viral pathogens, including COVID-19.

Notably, lung toxicity has been associated with immune checkpoint inhibitors but is an uncommon AE; less than 5% of patients experience this irAE, and less than 1% report high-grade lung toxicity while receiving this type of immunotherapy. In comparison, lung toxicity tends to present more in patients receiving ipilimumab (Yervoy) plus nivolumab (Opdivo), explained Brock.


Colitis occurs in approximately 8% to 27% of patients receiving ICIs. Onset of GI toxicities typically appear about 5 to 10 weeks after treatment begins but can occur months after treatment with the ICI has stopped.

Initial workup for colitis should include CBC, CMP labs to assess TSH, c-reactive protein (CRP), HIV, hepatitis A and B; whereas interferon gamma release assay should be used to look for tuberculosis (TB). In addition, stool cultures to identify C. diff, CMB, ova, and parasites are recommended; lactoferrin should identify inflammation of digestive tracts and calprotectin can determine immune bowel disease (≤80 ug/g) vs inflammation (levels on 80 ≥ 1, 60 ug/g); and a CT scan.

At grade 1 severity, the ICI can either continue or be temporarily withheld. Providers should discuss dietary changes with their patients and review hydration strategies, and antdiarrheal administration may also be effective.

If the inflammation progresses to grade 2 level, the ICI should be withheld until symptoms return to grade 1 or less. A GI specialist should be consulted for an EGD/colonoscopy and prednisone should be administered at a dosage of 1 mg/kg daily. In addition, stools should be checked for inflammatory markers, such as lactoferrin and calprotectin. Once the symptom returns to grade 1, the steroids should be tapered across 4 to 6 weeks.

Grade 3 inflammation requires a hold on the ICI. Hospitalization may be required if there is electrolyte imbalance and dehydration. Providers should rule out CMV via colonoscopy and consult a GI specialist. Corticosteroids given at a dosage of 1 to 2 mg/kg day or infliximab at a dosage of 5 to 10 mg/kg daily should be administered.

“With colitis, there could be another rebound,” said Brock. “Someone could resolve back to a ready to a grade 1; if that occurs then, of course, we restart the steroids or increase the steroids and start again—slowly tapering once the symptoms improve.”

If the severity level reaches a grade 4, it is now life-threatening, and treatment should be discontinued permanently.

Hepatotoxicity/Immune-Mediated Hepatitis

Hepatotoxicity or immune-mediated hepatitis occurs in approximately 2% to 10% of patients receiving pembrolizumab and onset usually occurs between 6 to 12 weeks after treatment initiation. Symptoms include drowsiness, jaundice, right-sided abdominal pain, severe nausea or vomiting, increased bleeding, or bruising, decreased appetite, and abnormal liver blood tests (aspartate aminotransferase [AST], alanine transaminase [ALT], and bilirubin).

For grade 1 inflammation (AST or ASLT > upper limit of normal [ULN] to 3.0 and/or total bilirubin 1.0 ULN > 1.5 ULN), ICI treatment may continue but liver function should be monitored 1 to 2 times weekly. For grade 2 inflammation (ASR or ALT > 3.0 ULN to < 5.0 and/or total bilirubin 1.0 ULN to 3.0 ULN with symptoms), the ICI should be held until severity resolves to a grade 1.

In addition, the liver should be monitored every 3 days if the patient is symptomatic. If the symptom reaches statistical significance, after 3 to 5 days they can receive corticosteroids at a dosage of 0.5 to 1.0 mg/kg daily. This will require tapering over 1 month. Lastly, any hepatoxic medication should be halted.

For grade 3 inflammation (ASR or ALT 5 x 20 x ULN and/or total bilirubin >3-10 x ULN with symptoms such as biopsy-fibrosis or cirrhosis), the ICI should be discontinued permanently, and the patient should be monitored every 1 to 2 days. Corticosteroids should be administered at a dosage of 1 to 2 mg/kg/day, and the patient should be referred to a hepatologist.

If the symptom progresses to grade 4 (ASR or ALT >20 x ULN and/or total bilirubin > 10 x ULN, with symptoms such as ascites or encephalopathy), they will need to be hospitalized with daily lab monitoring and consultation from a hepatitis. They should receive methylprednisone at a dosage of 2 mg/kg daily.

Ocular Symptoms

Ocular symptoms typically occur in less than 1% of patient receiving PD-1/PD-L1 inhibitors alone or in combination. Symptoms include eyelid swelling, blurred vision, double vision, or color vision changes, photophobia, painful eye movement, scotomas, proptosis or bulging eyes, and visual field changes.

If a patient appears to be experiencing an ocular toxicity, they should be referred to an ophthalmologist and receive a slit-lamp exam.

Treatment management for uveitis or inflammation of the middle of the eye, and iritis, or inflammation of the iris, are similar. For grade 1 inflammation, ICI treatment should continue but a referral to an ophthalmologist should be made. For grade 2 inflammation (anterior uveisis), the ICI should be held until ophthalmology evaluation and topical or systematic corticosteroids can be administered. These can continue once the issue resolves or returns to grade 1 and the patient resumes ICI treatment.

If symptoms progress to grade 3 (posterior uveitis), the ICI should be discontinued permanently, and systematic and topical corticosteroids should be administered. Lastly, if symptoms become grade 4, not only should the ICI be discontinued permanently, but the patient may need emergency care.

Rare irAEs

In addition, rare irAEs that may present in patients receiving ICIs include myocarditis and pericarditis; nephritis; pancreatitis; musculoskeletal toxicities such as arthritis, arthralgia, myalgia, and myositis; and neurologic toxicities such as peripheral neuropathy, myasthenia gravis, and Guillain-Barré Syndrome.

General Principles of ICI Toxicity Management

In conclusion, for grade 1 toxicities (mild or asymptomatic toxicities), the patient can continue receiving the ICI without steroids or intervention. Patients with grade 1 toxicities may benefit from antihistamines.

For grade 2 toxicities (moderate toxicities), a specialist should be consulted, and steroids should be considered. The ICI should be withheld until the symptom returns to grade 1; if the grade 2 symptoms persist for more than 12 weeks, the ICI should be discontinued.

If symptoms progress to grade 3, the ICI should be held (or, in the case of pneumonitis, discontinued), and prednisone should be administered. A specialist should be consulted, and hospitalization may become necessary. If these symptoms remain consistent, the ICI should be discontinued.

Grade 4 toxicities are life-threatening. Unless the symptom is endocrine-related, grade 4 toxicities signify that the ICI should be immediately discontinued. The patient will need hospitalization, and to continue receiving prednisone. If the steroid does not yield symptom improvement, infliximab should also be considered.

Other important considerations include using a proton pump inhibitor or H2 blocker for gastritis, sulfamethoxazole/trimethoprim/fluconazole for opportunistic infections, and calcium and vitamin D for osteoporosis, Brock noted.

Furthermore, counseling patients and caregivers should involve setting evidence-based expectations for benefits. Patients may have heard of the drug and have misconceptions based on popular stories in the news. It should be clear that benefits taking longer to emerge with immunotherapy compared with treatments like chemotherapy and targeted therapy. Therefore, patients with significant tumor burden or rapidly progressing disease often cannot afford to elect these types of therapies.

For nurses caring for patients beginning immunotherapy, it is essential to emphasize the importance of monitoring and promptly reporting symptoms.

“Emphasize [the importance] of monitoring and promptly reporting symptoms,” Brock urged. “[Teach them to] contact the oncology care team if [they are] experiencing any new signs or symptoms [and to] report any visits to the emergency department and other healthcare providers.”

In addition, patients should also always always carry an immunotherapy wallet. Lastly, patients need adequate irAE management education.

“Discontinuing ICIs because of AEs does not worsen survival,”12 she noted. “Treating irAEs with steroids does not worsen response or survival.”13,14 


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