case study analysis workshop

How To Facilitate A Case Study Workshop Session

A case study can be used as part of a training workshop to facilitate a learning point or as part of an assessment programme to gauge candidate’s response and analysis of situations. Case studies can be great for sharing experiences and reaffirming knowledge and understanding.

Here are some reasons to give a case study a try:

• increases awareness of a problem and helps teams formulate possible solutions.
• exchanges ideas and helps team members share past experiences.
• helps to analyse a problem and reach a decision as a team.
• facilitates and reaffirms key learning points.

Pre-printed scenario cards (optional)

Space Required:

Small. Classroom or training room

Group Size:

6 to 16 people

Total Time:

• 5 minutes to introduction and setup
• 10 minutes per case study for analysis and discussion (based on 4 case studies)
• 5 minutes for final review and case study debrief

Case Study Setup

Select the topic or theme that you were like to focus on during the training exercise. Prepare some possible scenarios or research articles related to the subject.

Case studies should be descriptions of events that really happened or fictional but based on reality. When leading the exercise, you can present the case study yourself, provide it in written form or even use videos or audio clips.

When I lead case studies sessions, I normally print the question on a piece of A4 paper and laminate them ready for workshop.

Case Study Instructions

From experience, I have found that a case studies session can be delivered two different ways.

The first way is to simply provide the group with a scenario and let them discuss it together as one big group.

The alternative is to split the group into smaller sub-groups and provide each group with the scenario. Once all groups have an opportunity to analyse and discuss the scenario, ask each group to present their findings back. This is a good way to get participants that are less likely to open up in bigger groups involved.

Look at your group and think about what will work best and give you the results you need.

When leading the case studies session, actively listen to discussion and provide necessary assistance to facilitate (guide) the analysis and discussion in the proper direction. Make sure you lead the discussion towards the learning objectives of the training workshop.

If you have people that conflicting views, then let them argue their points. If the discussion becomes too heated, stop them and summarise the discussion points and move on.

If everyone in the group agrees on something, or the discussion becomes stagnant then try playing devil’s advocate to get participants to look at the scenario from a different point of view.

When introducing the scenario, ask the group to think about the following 5 questions:

• What’s the problem?
• What’s the cause of the problem?
• How could the problem have been avoided?
• What are the solutions to the problem?
• What can you learn from this scenario?

Try to be flexible with your timings. If you need to stop a scenario early because the group become too heated or the group have explored the subject completely, stop them and summarise before moving on. If the scenario leads to valuable learning and you’re running out of time, allow an extra five minutes and skip another scenario.

Tips and Guidance

A good way to lead up to a case study is to present the scenario to the group at the end of the day and ask them to read up on the material and prepare in the evening. The first part of the following days’ workshop should then be the case study.

I like to lead a case study session by simply handed over the question cards and letting the group begin the discussion on their own. At the end of the discussion, I’ll summarise the key points – help them identify why the case study was important to the learning and move on to the next one.

If you’re discussing any sensitive subjects such as child protection etc then it is important to tell the group at the beginning of the case study. Explain that anything discussed exercise must not be mentioned again and if anyone needs to leave for a couple of minutes then they are more than welcome to.

Further Reading

10 Tips for Better Facilitation 

How To Facilitate Group Discussions: The “Gallery” Exercise

Questions? Comments?  Let us know in the comments below!

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Thanks! This article helped me a lot!

Glad it was helpful!

Thanks – Helped! Have you any thoughts around case studies which are not based around a problem?

Gigi, I am glad this helped.

Can you elaborate on what you mean about the case studies not being based on a problem?

A big part of the value of this type of exercise is that you can ideally take emotions out of play and analyze an undesired situation or problem neutrally helping your team to better deal with these types of scenarios in real life when emotions could potentially flare up. If the person can realize the bigger picture and be equipped with productive ways to handle the situation then hopefully the outcome with be better in real life.

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Case workshop programme

Participate in a case teaching or writing workshop to dramatically enhance your skills and enjoyment as a case teacher or author.

Our open programme includes workshops held online and worldwide in-person throughout the year on a variety of case method topics. You'll benefit from a world-leading case expert as your tutor, and the opportunity to develop your case skills with fellow participants from business schools and universities around the globe.

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Learning with cases can be a challenging experience.

Our interactive study guide takes students through the process, providing practical tips, tricks and tools.

Root Cause Analysis 3-Day Refresher Workshop

Introduction to the Course: Introduction of the participants and instructor(s).

Introduction to the workshop: concepts, methods, exercises, outcomes, and expectations.

Review of Key Definitions and Concepts: Introduction of key definitions and concepts. Presentation of criteria and features of conducting a state-of-the-art root cause analysis.

Conducting Investigations: Discussion of framing the investigation, developing a team charter, and allocating resources. Events and Causal Factors (E&CF) Analysis: Presentation on guidelines, symbols, and directions for sequencing an accident on an events and causal factors chart.

Fault Tree Analysis: Presentation of analytic trees, including uses, principles of construction, symbols, and examples.

Change Analysis: Discussion on the role of change in accidents and presentation of a model for identifying elements of change.

Hazard-Barrier-Target (H-B-T) Analysis: Presentation on using H-B-T to describe and analyze systems for causes.

Day 1 Workshop Activities:

• Review case study and preliminary causal analysis documentation
• Develop a root cause analysis charter for the case study
• Begin constructing an E&CF chart for the case study
• Begin constructing a fault tree to depict one aspect of the case study
• Perform a change analysis related to the case study
• Perform an H-B-T analysis related to the case study

Introduction to MORT: Presentation of the Management Oversight and Risk Tree, its history, development, and applications.

Preliminary Ideas: Discussion of ideas to enhance the understanding of MORT: risk, tree structure, oversight vs. risk, conventions, time universal application, and data administration needed for source referencing the analysis.

MORT Analysis: Specific Control Factors: Discussion, application, and exercises on amelioration; H-B-T (accident); technical information; facility functional operability, maintenance; inspection; supervision; human error; and higher supervision services.

Day 2 Workshop Activities:

• Update E&CF chart, fault tree analysis, change analysis, and H-B-T analysis
• Begin performing MORT analysis

MORT Analysis: Management System Factors: Discussion, application, and exercises on policy, implementation of policy; risk assessment system; concepts and requirements; design and development plan; human factors review; and program review.

MORT Analysis: Safety Culture: Discussion of evaluating impacts of Safety Culture using the MORT traits and attributes.

Determining Causes: Discussion of how to integrate various types of information into the investigation report (e.g., physical evidence, expert testimony, interviews, and analytical results). Identifying facts and formulating causal statements and causes.

Corrective Actions: Discussion on developing, writing, and evaluating corrective actions. Applying criteria and analytical techniques to corrective actions.

Day 3 Workshop Activities:

• Complete MORT Analysis
• Assemble all materials including all analyses, lists of facts, conclusions, recommendations, and other work materials
• Prepare for and deliver oral briefing of analysis results
• Case study review

Teaching Approach

Training materials.

Training Course materials will be provided to each participant. These materials include the training course manual, case study and supporting documents. The training materials will also include Conger & Elsea’s Mishap Analysis & Prevention System (MAPS)® Software which includes digital tools to facilitate the performance and documentation of causal analysis including Events and Causal Factors, Change Analysis, Hazard-Barrier-Target Analysis, Fault Tree Analysis, Management Oversight and Risk Tree (MORT) Analysis, and Failure Modes and Effects Analysis. All training materials are proprietary and the property of Conger & Elsea.

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11 th Case Method Workshop - Online : Writing Effective Cases and Teaching Notes on August 2024

Indian Institute of Management Calcutta Case Research Centre (IIMCCRC) at IIM Calcutta and Ivey Publishing are collaborating to co-host an extensive online Workshop on Writing Effective Cases and Teaching Notes. The workshop will span across four days on August 3rd, 5th, 7th and 9th of 2024 and the sessions will be held in the evenings (GMT + 5:30, Indian Standard Time).

DATES OF WORKSHOP: 3rd (Saturday), 5th (Monday), 7th (Wednesday) and 9th (Friday) August 2024. MODE OF DELIVERY: Online (over zoom platform) LAST DATE FOR REGISTRATION: 27th July 2024 (Saturday) Read More

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2-Day TapRooT® Advanced Case Study Workshop

In the 2-Day TapRooT® Advanced Case Study Workshop, attendees will study unique cases and learn advanced TapRooT® RCA skills to improve their investigation process. The advanced skills learned in the course can be applied to all types of unique TapRooT® investigations.

The objectives of this 2-day training workshop are to deepen the attendee’s understanding of TapRooT® RCA, teach new ways of applying TapRooT® RCA to their investigations, learn advanced root cause analysis skills, go beyond basic safety examples, and discover new TapRooT® software features. Some of the advanced techniques attendees will learn in this class are SnapCharT® grouping skills, Casual Factor identification, in-depth Root Cause Tree® information, developing Corrective Actions, and Grading your investigation.

This course workshop is best suited for certified TapRooT® Trainers, people who have at least attended a 2-Day TapRooT® training course and would like to refresh their knowledge, and TapRooT® Users looking for advanced information about the TapRooT® Root Cause Analysis method.

• Class Introductions and Ice Breaker
• Building a SnapCharT® Diagram
• Group Work (Finding New Evidence)
• Identify Causal Factors
• Taking through the Root Cause Tree® Diagram
• Take through the Root Cause Tree® Diagram
• Identify Generic Causes
• Develop Corrective Actions

Upon completion of the course, attendees will receive a certificate of completion.

Course Guarantee for 2-Day TapRooT® Advance Case Study Workshop

Attend this course, go back to work, and use what you have learned to analyze accidents, incidents, near-misses, equipment failures, operating issues, or quality problems. If you don’t find root causes that you previously would have overlooked and if you and your management don’t agree that the corrective actions that you recommend are much more effective, just return your course materials and we will refund the entire course fee.

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Methods and Case Studies Workshop

November 2-3, 2017

Harvard University (Longwood Campus) Boston, MA

**Please click here to view the most recent versions of the methods papers.**

At this workshop, we discussed the draft methods papers and case studies and their initial recommendations, as well as next steps. The workshop program, which includes speaker biographies as well as the agenda, can be downloaded here . The papers build on our scoping report and will be used to develop  guidance on conducting benefit-cost analysis. Please use the links below to download the workshop papers and slides and to view the workshop video.

The revised versions of the methods papers and case studies, which reflect the comments received during this workshop, will be posted here as they are completed.

We were very pleased to welcome special guests  Lawrence H. Summers , who joined us for a conversation with Dean Jamison ( video ), and  Sue J. Goldie .

Agenda, Papers, and Slides

8:00-8:30:  Registration and Breakfast

8:30-9:00:  Welcome and Introduction ( video )

• David Wilson (Bill and Melinda Gates Foundation) ( slides )
• Lisa A. Robinson (Harvard University, Center for Health Decision Science) ( slides )

9:00-10:00:  Valuing Mortality Risk Reductions ( draft paper ) ( video ) (Chair: Lynn Karoly, RAND)

• Lead Authors: Lisa A. Robinson and James K. Hammitt* (Harvard University) ( slides )
• Discussants: Anna Alberini (University of Maryland) ( slides ), Maureen Cropper (University of Maryland) ( slides )

10:00-10:15:  Break

10:15-11:15:  Valuing Nonfatal Health Risk Reductions ( draft paper ) ( video ) (Chair: Peter Neumann, Tufts Medical Center)

• Lead Authors: Lisa A. Robinson* and James K. Hammitt (Harvard University) ( slides )
• Discussants: Mark Dickie (University of Central Florida) ( slides ), Montarat Thavorncharoensap (Mahidol University) ( slides )

11:15-12:15:  Assessing Economy‐wide Effects  ( draft paper ) ( video ) (Chair: David de Ferranti, Results for Development)

• Lead Authors: Kenneth Strzepek* (MIT), Collins Amanya* (Ugandan Ministry of Water and Environment) and James E. Neumann (Industrial Economics, Incorporated) ( slides )
• Discussants: Channing Arndt (International Food Policy Research Institute) ( slides ), Anil Deolalikar (University of California – Riverside) ( slides )

12:15-1:30:  Lunch

1:30-2:30:  Assessing the Distribution of Impacts ( draft paper ) ( video ) (chair: Stéphane Verguet, Harvard T.H. Chan School)

• Lead Authors: Lisa A. Robinson and James K. Hammitt* (Harvard University) with supplement by Matthew Adler (Duke University) ( slides )
• Discussants: Neal Fann (U.S. Environmental Protection Agency) ( slides ), Sam Harper (McGill University) ( slides )

2:30-3:30:  Discounting Future Impacts ( draft paper ) ( video ) (chair: Maureen Cropper, University of Maryland)

• Lead Author: Karl Claxton* (University of York) ( slides )
• Discussants: Miqdad Asaria (Independent Consultant, Delhi) ( slides ), Gernot Wagner (Harvard University) ( slides )

3:30-3:45:  Break

3:45-5:15:  Case Studies ( video )   (chair: Frederico Guanais, Inter-American Development Bank)

• Education ( draft paper ) (Elina Pradhan and Dean Jamison*) ( slides )
• Stunting ( draft paper ) (Brad Wong* and Peter F. Orazem) ( slides )
• Discussants: Anil Deolalikar (University of California – Riverside) ( slides ), Lynn Karoly (RAND) ( slides ), Roger Perman (University of Strathclyde) ( slides ), George Psacharopoulos (Georgetown University) ( slides )

5:15-5:30:  Wrap-up

5:30-7:00:  Reception with remarks from Sue Goldie

8:30-9:00:  Welcome and Recap

9:00-10:00:  A Conversation with Dean Jamison and Lawrence H. Summers ( video )

10:15-11:15:  Valuing Changes in Time Use ( draft paper ) ( video ) (chair: Brad Wong, Copenhagen Consensus Center)

• Lead Authors: Dale Whittington* (University of North Carolina) and Joseph Cook (Washington State University) ( slides )
• Discussants: Abusaleh Shariff (US-India Policy Institute) ( slides ), James E. Neumann (Industrial Economics, Incorporated) ( slides )

11:15-12:15: Valuing Protection against Health-Related Financial Risks ( draft paper ) ( video ) (chair: Michele Cecchini, OECD)

• Lead Authors: Dean Jamison (University of California – San Francisco) and Jonathan Skinner* (Dartmouth College) ( slides )
• Discussants: Kalipso Chalkidou (Centre for Global Development, Imperial College London) ( slides ), Mark Shepard (Harvard University) ( slides )

12:15-12:30:  Wrap-up and Adjourn

*indicates paper presenter.

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Cause Mapping™ Root Cause Analysis Workshops – for Facilitation Leads and Participants

These are our core workshops for becoming better at analyzing, documenting, communicating and solving problems. People attend these workshops to improve their skills in problem solving, incident investigation, root cause analysis and risk mitigation. The following root cause investigation training options are delivered by a ThinkReliability instructor at the client’s site, but can also be presented effectively, over the web, to meet a client’s specific needs.

Cause Mapping Root Cause Analysis Fundamentals: From 5-Why to a Complete RCA 1-Day - - - - - - - - - -

For Investigators, Contributors, Participants, and Team Members Geared towards managers and supervisors across all business functions, this one-day workshop covers the concepts, lessons and steps of the Cause Mapping method, including a focus on 5-Why Cause Mapping, while building in some case studies, examples and exercises. Participants will establish a foundation for analyzing and preventing problems using cause-and-effect thinking. Attendees will learn how to drive a prevention-focused (vs blame) investigation, how to avoid problem miscommunications and will discover how a thorough problem explanation reveals better solution options to reduce risk, increase reliability and improve work processes.

Cause Mapping Root Cause Analysis for Facilitators (Most Popular Workshop) 2-days - - - - - - - - - -

For Facilitation Leads and Root Cause Analysis Specialists This workshop covers the foundation of the Fundamentals workshop, and includes facilitation skills to lead a group through a comprehensive problem investigation from start to finish. Attendees work through multiple exercises and case studies to apply the lessons they’ve learned. Every attendee learns how to start a quick analysis that can expand into a detailed explanation of exactly what happened. The course also covers important insights for documenting and presenting a complete investigation.

Cause Mapping Root Cause Analysis for Facilitators + Documentation 3-days - - - - - - - - - -

For Facilitation Leads and Root Cause Analysis Specialists – Includes Documentation Skills This is the Facilitator Workshop with an additional day of documentation skills. Attendees will learn all the tips, tricks and shortcuts for documenting an entire incident within Microsoft Excel®. The workshop covers each element of the Cause Mapping Template including how to add and edit diagrams, drawings and photos for a clearer investigation. Examples for how investigations should be presented to management are also provided. Each attendee will need to bring their laptop for the 3rd day.

Cause Mapping Root Cause Analysis Online Workshop 4 Modules - - - - - - - - - -

For Facilitation Leads and Root Cause Analysis Specialists – Includes Documentation Skills This is the online version of our Cause Mapping for Facilitators + Documentation Workshop, presented in a series of 3-hour modules online. Attendees will learn in addition to the fundamentals of Cause Mapping and facilitating an investigation, all the tips, tricks and shortcuts for documenting an entire incident within Microsoft Excel®.

5-WHY CAUSE MAPPING ® WORKSHOPS – FOR FRONTLINE PROFESSIONALS

Troubleshooting and Problem Solving These workshops provide the people on the frontline with a quick and simple way to start analyzing any problem. The frontline frequently sees problems at their earliest stage, before they blow up into something major. Frontline people are an essential part of a risk mitigation strategy. Including them changes the problem-solving capability of an organization.

5-Why Cause Mapping for Frontline Half-day - - - - - - - - - -

For Frontline Problem Solvers, Technicians, Troubleshooters, Operations, Maintenance, Craft The 5-Why Cause Mapping Workshop explains root cause analysis, and dives into 5-Why Cause Mapping benefits and concepts. Using examples and case studies, attendees learn the DOs and DON’Ts of 5-Whys, the three steps to Cause Mapping, the important role of evidence, the basics of critical thinking and how to develop useful troubleshooting guides. Skills from this workshop give the frontline a better resource in larger problem investigations and improves the way they explain an issue to management.

5-Why Cause Mapping for Frontline + Application 1-day - - - - - - - - - -

For Frontline Problem Solvers, Technicians, Troubleshooters, Operations, Maintenance, Craft – Includes Application Practice This course covers the material in the 5-Why Cause Mapping for Frontline in the morning then allows time in the afternoon for attendees to apply what they’ve learned. In order for participants to apply what they have learned to company-specific problems, situations, incidents and issues, client case studies can be organized in advance of the workshop with input from supervision and management or they can be identified during the morning session. Working these examples during the training provides the group with a head start on their current problems. This class develops problem lookouts within the company.

Leadership Overview – for Management & Executives

High reliability leadership 1-3 hours - - - - - - - - - -.

This workshop provides leaders with a clear understanding of how cause-and-effect thinking improves an organization’s ability to analyze, document, communicate and prevent problems. An overview is provided of the concepts, lessons and steps of Cause Mapping and how it aligns with the scientific method for a consistent approach to all problems. Leaders need to know what expectations should be for people who attended the Cause Mapping and 5-Why Cause Mapping workshops. This session also provides several Human Performance & Work Process Reliability examples to explain how errors occur and what some organizations do to make them significantly lower. The relationship between problems and work processes is an important take-away for leadership to understand what Highly Reliable Organizations do and how the approach can be applied within their groups.

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What happened in the Kolkata rape case that triggered doctors’ protests?

Activists and doctors in India demand better safeguarding of women and medical professionals after a trainee medic was raped and murdered in Kolkata.

Activists and doctors across India continued to protest on Wednesday to demand justice for a female doctor, who was raped and murdered while on duty in a hospital in the eastern city of Kolkata.

Feminist groups rallied on the streets in protests titled “Reclaim the Night” in Kolkata overnight on Wednesday – on the eve of India’s independence day – in solidarity with the victim, demanding the principal of RG Kar Medical College resign. Some feminist protesters also marched well beyond Kolkata, including in the capital Delhi.

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While the protests were largely peaceful, a small mob of men stormed the medical college and vandalised property. This group was dispersed by the police.

This comes after two days of nationwide protests by doctors following the incident at RG Kar Medical College in West Bengal’s capital city. “Sit-in demonstrations and agitation in the hospital campus will continue,” one of the protesting doctors, identified as Dr Mridul, told Al Jazeera.

Services in some medical centres were halted indefinitely, and marches and vigils shed light on issues of sexual violence, as well as doctors’ safety in the world’s most populous nation.

What happened to the doctor in Kolkata?

A 31-year-old trainee doctor’s dead body, bearing multiple injuries, was found on August 9 in a government teaching hospital in Kolkata.

The parents of the victim were initially told “by hospital authorities that their daughter had committed suicide,” lawyer and women’s rights activist Vrinda Grover told Al Jazeera. But an autopsy confirmed that the victim was raped and killed.

Grover has appeared for victims in sexual violence cases in India in the past, including Bilkis Bano , a Muslim woman who was gang-raped during the 2002 Gujarat riots, and Soni Sori, a tribal activist based in Chhattisgarh state.

Thousands of doctors marched in Kolkata on Monday, demanding better security measures and justice for the victim.

On Tuesday, the Kolkata High Court transferred the case to the Central Bureau of Investigation (CBI).

The Federation of Resident Doctors Association (FORDA) called for a nationwide halting of elective services in hospitals starting on Monday. Elective services are medical treatments that can be deferred or are not deemed medically necessary.

On Tuesday, FORDA announced on its X account that it is calling off the strike after Health Minister Jagat Prakash Nadda accepted protest demands.

One of these demands was solidifying the Central Protection Act, intended to be a central law to protect medical professionals from violence, which was proposed in the parliament’s lower house in 2022, but has not yet been enacted.

FORDA said that the ministry would begin working on the Act within 15 days of the news release, and that a written statement from the ministry was expected to be released soon.

Press release regarding call off of strike. In our fight for the sad incident at R G Kar, the demands raised by us have been met in full by the @OfficeofJPNadda , with concrete steps in place, and not just verbal assurances. Central Healthcare Protection Act ratification… pic.twitter.com/OXdSZgM1Jc — FORDA INDIA (@FordaIndia) August 13, 2024

Why are some Indian doctors continuing to protest?

However, other doctors’ federations and hospitals have said they will not back down on the strike until a concrete solution is found, including a central law to curb attacks on doctors.

Those continuing to strike included the Federation of All India Medical Associations (FAIMA), Delhi-based All India Institute Of Medical Sciences (AIIMS) and Indira Gandhi Hospital, local media reported.

Ragunandan Dixit, the general secretary of the AIIMS Resident Doctors’ Association, said that the indefinite strike will continue until their demands are met, including a written guarantee of the implementation of the Central Protection Act.

Medical professionals in India want a central law that makes violence against doctors a non-bailable, punishable offence, in hopes that it deters such violent crimes against doctors in the future.

Those continuing to protest also call for the dismissal of the principal of the college, who was transferred. “We’re demanding his termination, not just transfer,” Dr Abdul Waqim Khan, a protesting doctor told ANI news agency. “We’re also demanding a death penalty for the criminal,” he added.

“Calling off the strike now would mean that female resident doctors might never receive justice,” Dr Dhruv Chauhan, member of the National Council of the Indian Medical Association’s Junior Doctors’ Network told local news agency Press Trust of India (PTI).

Which states in India saw doctors’ protests?

While the protests started in West Bengal’s Kolkata on Monday, they spread across the country on Tuesday.

The capital New Delhi, union territory Chandigarh, Uttar Pradesh capital Lucknow and city Prayagraj, Bihar capital Patna and southern state Goa also saw doctors’ protests.

Who is the suspect in the Kolkata rape case?

Local media reported that the police arrested suspect Sanjoy Roy, a civic volunteer who would visit the hospital often. He has unrestricted access to the ward and the police found compelling evidence against him.

The parents of the victim told the court that they suspect that it was a case of gang rape, local media reported.

Why is sexual violence on the rise in India?

Sexual violence is rampant in India, where 90 rapes were reported on average every day in 2022.

Laws against sexual violence were made stricter following a rape case in 2012, when a 22-year-old physiotherapy intern was brutally gang-raped and murdered on a bus in Delhi. Four men were hanged for the gang rape, which had triggered a nationwide protests.

But despite new laws in place, “the graph of sexual violence in India continues to spiral unabated,” said Grover.

She added that in her experience at most workplaces, scant attention is paid to diligent and rigorous enforcement of the laws.

“It is regrettable that government and institutions respond only after the woman has already suffered sexual assault and often succumbed to death in the incident,” she added, saying preventive measures are not taken.

In many rape cases in India, perpetrators have not been held accountable. In 2002, Bano was raped by 11 men, who were sentenced to life imprisonment. In 2022, the government of Prime Minister Narendra Modi authorised the release of the men, who were greeted with applause and garlands upon their release.

However, their remission was overruled and the Supreme Court sent the rapists back to jail after public outcry.

Grover believes that the death penalty will not deter rapists until India addresses the deeply entrenched problem of sexual violence. “For any change, India as a society will have to confront and challenge, patriarchy, discrimination and inequality that is embedded in our homes, families, cultural practices, social norms and religious traditions”.

What makes this case particularly prominent is that it happened in Kolkata, Sandip Roy, a freelance contributor to NPR, told Al Jazeera. “Kolkata actually prided itself for a long time on being really low in the case of violence against women and being relatively safe for women.”

A National Crime Records Bureau (NCRB) report said that Kolkata had the lowest number of rape cases in 2021 among 19 metropolitan cities, with 11 cases in the whole year. In comparison, New Delhi was reported to have recorded 1, 226 cases that year.

Prime Minister Modi’s governing Bharatiya Janata Party (BJP) has called for dismissing the government in West Bengal, where Kolkata is located, led by Mamata Banerjee of All India Trinamool Congress (AITC). Banerjee’s party is part of the opposition alliance.

Rahul Gandhi, the leader of the opposition in parliament, also called for justice for the victim.

“The attempt to save the accused instead of providing justice to the victim raises serious questions on the hospital and the local administration,” he posted on X on Wednesday.

Roy spoke about the politicisation of the case since an opposition party governs West Bengal. “The local government’s opposition will try to make this an issue of women’s safety in the state,” he said.

Have doctors in India protested before?

Roy explained to Al Jazeera that this case is an overlap of two kinds of violence, the violence against a woman, as well as violence against “an overworked medical professional”.

Doctors in India do not have sufficient workplace security, and attacks on doctors have started protests in India before.

In 2019, two junior doctors were physically assaulted in Kolkata’s Nil Ratan Sircar Medical College and Hospital (NRSMCH) by a mob of people after a 75-year-old patient passed away in the hospital.

Those attacks set off doctors’ protests in Kolkata, and senior doctors in West Bengal offered to resign from their positions to express solidarity with the junior doctors who were attacked.

More than 75 percent of Indian doctors have faced some form of violence, according to a survey by the Indian Medical Association in 2015.

What happens next?

The case will now be handled by the CBI, which sent a team to the hospital premises to inspect the crime scene on Wednesday morning, local media reported.

According to Indian law, the investigation into a case of rape or gang rape is to be completed within two months from the date of lodging of the First Information Report (police complaint), according to Grover, the lawyer.

The highest court in West Bengal, which transferred the case from the local police to the CBI on Tuesday, has directed the central investigating agency to file periodic status reports regarding the progress of the investigation.

The FIR was filed on August 9, which means the investigation is expected to be completed by October 9.

Bengal women will create history with a night long protest in various major locations in the state for at 11.55pm on 14th of August’24,the night that’ll mark our 78th year as an independent country. The campaign, 'Women, Reclaim the Night: The Night is Ours', is aimed at seeking… pic.twitter.com/Si9fd6YGNb — purpleready (@epicnephrin_e) August 13, 2024

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ISB’s Case Writing and Teaching Workshop

May 2023, indian school of business, hyderabad.

Participative and collaborative learning has proven to be an exciting alternative to traditional management pedagogy. Today’s students demand an active role in their own learning. Teaching with case studies in the classroom provides a means for abstract and conceptual ideas to be applied to practical, real-world business scenarios. Cases place students in real-life situations, forcing them to identify with the protagonist and come up with solutions to a plausible problem. As such, they turn students into active learners rather than passive receivers, helping them develop problem-solving and decision-making skills.

The Centre for Learning and Management Practice (CLMP) at the Indian School of Business (ISB), in its endeavour to promote effective learning and teaching with cases, offers Case Writing and Teaching Workshops through the year.

The intent of these workshops is to train high-potential faculty and case writers in the case writing and case teaching process, and to develop a case writing and case teaching culture in Indian management schools.

Conducted by experienced faculty, experts in the case method, each intensive workshop covers the fundamentals of both case writing and case teaching.

The workshop will start with outlining the importance of case study methodology as a pedagogical approach for active learning. Participants will learn the theory behind developing a good case study and the guiding principles to write case studies. By the end of the workshop, participants would have built a strong foundation for developing their own cases. This is thus a great opportunity to develop valuable writing skills. By inspiring you to write and use your own cases, this workshop will also assist in improving your teaching. The workshop would also include tips on how to teach a case effectively.

Programme Calendar

Target Audience

The participants at the workshop would include faculty, case writers, doctoral students and research staff from the academic community across management disciplines as well as representatives from business and the Government, such as heads of training departments, consultants and individuals teaching as visiting faculty at academic institutions. Interested participants would be requested to come to the workshop with an idea that they would like to develop into their own case study.

Training Objectives

At this very interactive and practical workshop, participants will learn about the case study—the history behind it, and its benefits and limitations. They will then be taught as to what makes a ‘good’ case. Instruction would be provided on how to design a case study – ensuring that the key areas of

the introduction, body, conclusion and exhibits - are covered systematically. The workshop would also include tips on how to teach a case.

For the participants, we expect that developing in-house case studies would provide the following key benefits for their students/audience: 

• To demonstrate stronger critical thinking skills
• Make connections across multiple content areas
• Develop a deeper understanding of concepts
• Be better able to view an issue from multiple perspectives
• Take a more active part in class
• Become more engaged
• Develop positive peer to peer relationships

Pre-Workshop Requirements

• Participants are required to come to the workshop with a definite idea and learning objectives for a business case. They need to identify a company, the case protagonist, and preferably (not mandatory) obtain permission from the company to write the case.
• Participants are requested to share their case idea and learning objectives with us by two weeks prior to the workshop dates.

Post-Workshop Activities:

• By the end of the workshop, each participant will have successfully drafted a 2-3 page Case Plan. The Case Plan includes the opening paragraph, the outline of the finished case by subtitles, list of data requirements, and a time plan. This plan is the basis of each case study.
• Participants will receive feedback on the Case Plan from the workshop trainers within a few weeks of the completion of the workshop.

Dr. Saumya Sindhwani

Saumya Sindhwani is an Assistant Professor (Practice) in the Strategy & OB group. Her research interests are at the intersection of strategy, leadership and society. She actively looks into the challenges faced by organisations while designing and implementing strategy, given the highly volatile, uncertain and complex business environment we live in today. She also has keen interest in the role of women as economic change agents, including their leadership styles. She has published two books, one on leadership and the other on the role of creativity in business. An expert on case teaching, she has authored and published several case studies. Bringing new formats to the classroom to complement case studies, she has developed and used multimedia simulations with great success in her courses. Prior to entering academia she has spent many years as a consultant with Aon Hewitt and also worked with British Broadcasting Corporation. She regularly publishes in applied journals and presents at various academic conferences and corporate events. She is an award-winning teacher.

Geetika Shah

Geetika Shah is Senior Associate Director at the Centre for Learning, and Management Practice at ISB.

Geetika manages content development and publishing at the Centre. Leading and managing the Centre’s team of writers and editors, she helps in case development and preparing teaching materials that support the pedagogical and knowledge-creation objectives of the school.

Working closely with faculty across disciplines at ISB, she has co-authored and published more than 30 cases which are available on Harvard Publishing, The Case Centre and Ivey Publishing. Two of her cases were winners at international competitions - European Foundation for Management Development (EFMD) Case Writing Competition 2015 and Oikos Case Writing Competition 2016. She has reviewed more than 300 cases and provided mentoring support and detailed feedback for improvement to numerous case authors.

As a facilitator, she has delivered several training workshops and webinars on case writing and teaching for faculty audiences from around the world.

An MBA from IIM Bangalore, she joined the Centre at ISB in its early years and helped build expertise at the Centre in developing, reviewing and publishing high-quality case studies that engage students in the business classroom. More recently, she also oversees the design, content and publication of the school's flagship quarterly magazine,  ISB Management ReThink , a forward-looking platform that strives to connect academia with industry through its take on management research and thinking. 

Accommodation

Workshop Venue

Indian School of Business, Hyderabad Campus, Gachibowli, Hyderabad - 500111

Accommodation (Hotels near the workshop venue) 

Participants are expected to cover their own transportation and other living cost. If you are looking for stay options close to the workshop venue, you may explore the following.

Registration

For any queries, write to Arun Khan, Senior Manager, Centre for Learning and Management Practice, Indian School of Business.

Workshop Fee

30,000 (inclusive of taxes)

040-23187399.

For group discounts of 3 or more participants, e-mail to

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Annual Giving Workshop 2024

Learning objectives.

• Highlight key fundamentals in annual giving. 
• Discuss proven and emerging practices to maximize results in direct mail, phone, and online giving programs. 
• Enhance your interpersonal skills to build strong professional relationships. 
• Analyze data and research regarding current and future trends in annual giving. 
• Strategize how to collaborate with internal and external stakeholders about the value of annual giving. 
• Identify the effectiveness of appeals and apply lessons for more powerful solicitations. 

Who Should Attend 

• Long-time development professionals with new responsibilities in annual giving who would benefit from fresh ideas and the opportunity to network with others in the field. 
• Newcomers and intermediate-level professionals in annual giving. 

Meet Your Chairs

Colin Hennessy

Colin Hennessy brings over 15 years of professional fundraising and management experience with expertise in annual giving, alumni engagement, segmentation strategy, data analysis, and more. He is recognized as an industry leader with a proven track record of developing philanthropic pipelines through thoughtful interventions informed by behavioral economics, data science, stewardship, and engagement.

As Vice President for Alumni and Donor Engagement, Colin leads a team dedicated to supporting the University of Iowa through thoughtful and innovative engagement and programming—overseeing alumni engagement, communication and marketing, events, and stewardship efforts.

Before joining the UI Center for Advancement in 2022, Colin held leadership positions at the University of Pennsylvania and the University of Chicago. In addition, he was a senior vice president and practice area leader at the fundraising management consulting firm Grenzebach Glier and Associates. Colin earned his bachelor’s degree in communication and media studies from the University of Iowa, a master’s degree in adult and distance education from the University of Phoenix, a master’s in public policy and administration from Iowa State University, and a doctorate in higher education management from the University of Pennsylvania. He is the 2019 Diane Thompson Award Winner for Excellence in Annual Giving from the Northeast Annual Giving Conference Association. In addition, Colin is a CASE Crystal Apple Award-winning speaker and teacher, in addition to the numerous CASE Circle of Excellence Awards presented to teams under his leadership.

Megan Rajski

Megan joined Fairfield University, a private Jesuit Catholic University, in Fairfield, CT during the summer of 2021 as the Director of Annual Giving. In her role she oversees and collaborates on a robust portfolio responsible for contributing $3.3 million to the Fairfield Fund and leads strategy on alumni participation efforts. She directly oversees the Reunions, Leadership Annual Giving, Senior Class Gift, Young Alumni, & Telefund teams. Additionally Megan spearheads Giving Day efforts and all direct marketing strategy and execution. 

Prior to joining Fairfield, Megan was Senior Associate Director, Donor Participation and Annual Giving for the University of Chicago, where she oversaw strategic initiatives supporting annual giving and donor participation goals. Present for the planning and execution of the creation of Giving Day, Megan’s responsibility and ownership of the program grew in the 6+ Giving Days and under Megan’s leadership UChicago saw its most successful day raising an institution record ($10 million raised in the 2021). She credits her success in exceeding goals and driving revenue and alumni participation at UChicago by ensuring the use of multi-channel solicitation strategies, data analytics, wide segmentation integration and diverse and mission focused messaging. In 2019 Megan received the UChicago Gates Award, voted on by her colleagues for outstanding contributions to fundraising.  

Before joining University of Chicago, Megan spent four years with the Alzheimer’s Association, one of the top 50 non-profits in the US, where she was project manager for direct marketing efforts in acquisition, renewal and upgrades to 10 million+ donors. Prior to her work in Annual Giving, Megan spent seven years in university admissions, at Illinois Institute of Art and Westwood College, both in Chicago.

Megan received a Bachelor of Arts in Communications and Theatre/Television Arts from Valparaiso University in Valparaiso, IN, and an MBA from University of Phoenix(before it was cool to be online. She is ever present in the AG space as a presenter and organizer for annual giving conferences, and spent 10 years involved with the Board of Directors of New Leash on Life, an animal rescue nonprofit.   

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Case Studies and Discourse Analysis in Qualitative Geoscience Education Research

The goal of this workshop is to identify the types of research problems/questions that can be answered within qualitative education research frameworks. The primary focus will be on evaluating how decisions are made to identify a qualitative research design. We will specifically learn about the two major qualitative case study designs (single and multiple case), their differences, and the use of critical discourse analysis in these designs. The hope is that the workshop will be a time for us to share our work with one another and receive advice and feedback on our projects.

Case study remains one of the most effective methodological approach but also the most challenging in qualitative research. When, why, and how to use case study to explore a phenomenon or a topic can be a daunting task for researchers, especially students and early career professionals. This workshop aims to provide participants with a comprehensive understanding of qualitative case study research and equip them with the necessary knowledge and skills to conduct and analyze case studies effectively. We will also introduce an innovative analytical approach, discourse analysis in case study designs, and ways to enhance validity and reliability in qualitative case studies.

The workshop aims to foster a collaborative learning environment where participants can engage with experts and colleagues, exchange ideas, and gain practical insights into this powerful research methodology. Join us in this workshop and unlock the potential of qualitative case studies in your research endeavors.

Workshop Program »

Target Audience

Whether you are a researcher, a student, or a professional in various fields, this workshop will help you unlock the potential of qualitative case study research in generating rich and in-depth insights.

Participants will have a solid foundation in qualitative case study research and will be equipped with the necessary skills to design, conduct, analyze and report their own qualitative case studies. The specific goals for the workshop are:

• Familiarization with qualitative case study research designs and methods.
• Familiarization with qualitative discourse analysis approaches.
• Assist participants in developing the aim, design, methods, tools and analysis plans for qualitative case studies and discourse analysis.

Learning Outcomes

By the end of this workshop, participants will be able to

• Explain when to use case studies and identify the research questions, rationale for doing a case study, and deciding to use the case study method. Explain the two case study designs (single case and multiple case).
• Select and use appropriate case study designs based on the unit of analysis and case selection and understanding their strengths and limitations.
• Use appropriate case study data collection and analytical techniques
• Explain discourse analysis   
• Select and apply discourse analysis using an appropriate unit of analysis.
• Analyze the affordances and limitations of discourse analysis.

The workshop will be structured in a way that combines theoretical knowledge with practical exercises and interactive discussions. Each session will focus on specific aspects of qualitative case study research and will provide ample opportunities for participants to engage in hands-on activities and exchange ideas with fellow participants and the facilitators.

See the the workshop program for a detailed schedule of daily events.

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Home » Infographics » Case Study: SWOT Analysis of a Waste Management Company

Case Study: SWOT Analysis of a Waste Management Company

• Posted on August 20, 2024
• / Under Infographics , Strategy
• / With 0 Comments

Introduction

In this case study, we will explore a SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis for a waste management company. The SWOT analysis is a strategic planning tool used to identify the internal and external factors that can impact an organization’s performance. The image provided offers a clear visual representation of these factors.

SWOT Analysis Breakdown

• Low labor cost:  The company benefits from lower operational costs due to affordable labor.
• Strong specialization in electrical services:  Expertise in electrical services sets the company apart from competitors.
• Well-recognized national brand name:  A strong brand presence enhances customer trust and loyalty.
• Good relationship with major investors:  Strong investor relations ensure financial stability and support for growth initiatives.

Weaknesses:

• Lack of expertise in renewable energy:  The company needs to develop skills in renewable energy to stay competitive.
• Lack of industrial partners in capital creation:  Limited partnerships hinder the company’s ability to raise capital.
• Low international market share:  The company has a minimal presence in international markets.
• Policy standards capability:  The company struggles to meet policy standards, affecting its operational efficiency.

Opportunities:

• 2-year government subsidies:  Government support provides financial incentives for growth.
• Fast-growing sector:  The waste management industry is expanding rapidly, offering new business opportunities.
• High social acceptance:  Increasing public awareness and acceptance of waste management practices.
• Well-established legal framework:  A robust legal framework supports the storage, manufacturing, and transportation of commodities.
• Potentially high R&D expenses:  Research and development for new waste management technologies can be costly.
• High waste management fees:  Rising fees can impact profitability.
• The “Not In My Backyard” philosophy:  Public opposition to waste management facilities can create operational challenges.
• Large competitors:  Dominant players in the market can capture a significant market share.

Additional Examples of SWOT Analysis

• Strengths:  Dominant retail presence, efficient logistics, strong bargaining power.
• Weaknesses:  Dependence on the U.S. market, low-profit margins.
• Opportunities:  Expansion into emerging markets, e-commerce growth.
• Threats:  Intense competition, regulatory challenges 1 .
• Strengths:  Strong brand recognition, innovative products, extensive distribution network.
• Weaknesses:  High production costs, reliance on third-party manufacturers.
• Opportunities:  Growth in emerging markets, increasing demand for athleisure.
• Threats:  Counterfeit products, changing consumer preferences 2 .

Recommendation: Visual Paradigm Online

For creating detailed and professional SWOT analysis infographics like the one shown in the image, I recommend using  Visual Paradigm Online . This tool offers a comprehensive suite of diagramming tools that make it easy to create, customize, and share high-quality SWOT analysis diagrams. Its user-friendly interface and extensive template library can help you visualize your strategic planning effectively.

Would you like to know more about how to use Visual Paradigm Online for your projects?

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Hackathon Data Collections

Dr. John Heine from the Moffitt Cancer Research Center has provided three comprehensive EDRN data collections from the protocol Automated Quantitative Measures of Breast Density for our hackathon. These datasets are publicly accessible and stored in the Cancer Biomarker Data Commons ("LabCAS").

In order to make the best use of the time available for the hackathon, all of this data is available for downloading using IBM Aspera .

About the Collections and Links to LabCAS

The following information describes the three collections and contains links into the EDRN biomarker data commons, LabCAS:

Collection 1: Automated System For Breast Cancer Biomarker Analysis

Instrument: General Electric (GE) Senographe 2000D full field digital mammography (FFDM), 2D units

Data Description: 180 case-control pairs; 2D mammograms in both for presentation and for processing image data representations; demographical-clinical; and pathological data from women, 18 years and older.

Grant Number: R01CA114491 breast density and breast cancer risk study (2006-2011).

Collection 2: Automated Quantitative Measures of Breast Density Data

Instrument: Hologic Selenia FFDM 2D units and Dimensions digital breast tomosynthesis (DBT) units operating in the 2D mode

Data Description: 319 case-control pairs; 2D mammographic images in for presentation and for processing image data representations; demographical-clinical; and pathological data, from women 18 years and older.

Grant Number: R01CA166269 breast density and breast cancer study (2013-2017).

Collection 3: Moffitt's Hologic Dimensions 3D Case-Control Mammography Study

Instrument: Hologic Dimensions digital breast tomosynthesis (DBT) mammography units

Description: 348 case-control pairs; mammographic images: (2D) for presentation and for processing image data representations; DBT volumetric (2D slices) and C-View synthetic 2D mammograms; demographical-clinical; and pathological data from women 18 years and older.

Grant Number: U01CA200464 breast density and breast cancer risk study (2016-2022).

Metadata Explorer

We have setup the following GitHub to explore the metadata for all three datasets. That will provide insights to members wanting to formulate problems to be attacked during and after the hackathon.

Smaller Subset

A smaller subset of the data (in the form of a GZIP-compressed TAR archive) is also available. This subset contains selected datasets for ease of downloading, use, and analysis. This subset, as well as the above three collections, are available to download using Aspera .

Results and Conclusions Summary

Select findings from studies using these collections are briefly described, as the investigations spanned roughly 19 years. Concise findings and detailed descriptions of the algorithms and methods can be found from the respective citations.

From Collection 1, a calibration system was established to adjust for processing mammograms to a common normalized effective x-ray attenuation coefficient scale [1]. This system included a serial quality assurance (QA) monitoring system based on the cumulative sum (CUSUM) technique. This QA approach was used to check the serial accuracy of baseline calibration data so it could be updated if calibration accuracy moved beyond a given tolerance [2]. This technique was able to detect signs of impending x-ray tube failure long before the actual failure. Calibration also required an accurate estimate of the compressed breast thickness during the acquisition. Compression paddle force on the breast caused deviations in the compressed breast tissue thickness spatial distribution; a method was developed to compensate for the compression paddle contortion [3]. Using calibrated data, the mean, variation, BI-RADS ordinal breast composition measures, and a PD-type measure produced significant ORs [4-6]. The variation from both for presentation and for processing mammograms produced significant ORs, and that BI-RADS descriptors could be developed without calibration.

From Collection 2, the same calibration system was extended from the Collection 1 study [7], and the QA monitoring approach was advanced. Here we showed how to monitor a given acquisition’s baseline calibration data with a 50/50 percent adipose/glandular phantom and correct a given curve when it drifted out of a present calibration tolerance with the same phantom 50/50 phantom measurement [8]; this system also required a compressed breast thickness correction technique to compensate for the paddle deflection due to the compression force [9]. The calibrated variation measure produced significant ORs [10]. An automated PD measure developed earlier [11, 12], modified to operate on for presentation and for processing images (i.e., non-calibrated data) also produced significant ORs [13] unrelated to the calibration study.

From collections 1 and 2, Fourier ring measurements (texture analyzed in the Fourier domain) produced significant findings across the power spectrum with calibrated, for processing, and for presentation data representations[14]; illustrations were provided showing how these measures translate to image texture and relevant spatial scales. In particular, a low frequency measurement produced significant ORs that was in agreement with earlier work performed with digitized film mammograms [15] and subsequently validated with two large disparate populations with FFDM data [16]. A summarized local spatial correlation measures produced significant ORs related also related to specific spatial scales [17].

From Collection 3, several PD type measures produced significant ORs [18]. PD as a volumetric quantity, PD averaged over the DBT slices (area quantity) and determined from 2D synthetic images. ORs were about the same across these measures. Theoretical derivations predicted the volumetric and average slice measures are the same agreeing with these findings. PD was modeled as a function compressed breast thickness (CBT). Maximum PD location was approximately 0.41×CBT and similar across case-controls. PD determined from the slice where it was a maximum value produced significant ORs very similar to the other PD methods. Both the average pixel values from the DBT volume and from the 2D synthetic images produced significant ORs. Unlike the analysis of 2D FFDM images, variation measured in multiple ways did not produce significant findings.

Method Details

Approach : all collections were developed to make breast density measurements using a matched (1:1) case-control design. Mammograms in the craniocaudal view were used in all studies. Breast density is a generalized term used in our context to imply an arbitrary measurement from a mammogram. For the most part, citations were reserved for the results section unless prior work was required for replicating the algorithms or to put investigations in context. Image definitions and descriptions are provided in the Data collection protocol Section. Collection 1 used two-dimensional (2D) mammograms acquired with full field digital mammography (FFDM). This collection’s main study purpose was to standardize ( for processing ) mammograms using a calibration phantom imaging approach to account for acquisition technique influences (i.e., target-filter combination, mAs, and compressed breast thickness). This approach was founded on making effective x-ray coefficient measurements from breast tissue equivalent phantoms [19] and developing a serial quality control method using the cumulative sum approach [20]. Images were mapped to a standardized scale (0 – 100) representing total adipose to total glandular tissue respectively, prior to making image measurements. The mapping required developing baseline calibration curves at time-zero (about 160 phantom acquisitions). Differential evolution optimization [21] was used to develop a four-state ordinal measurement system that paralleled the BI-RADS [22] breast composition descriptors using both calibrated and non-calibrated data. The implementation of this DE approach is also described in detail in this work [23]. For risk modeling in all related studies, conditional logistic regression was used to estimate odds ratios (ORs) for given image measurement in a standard deviation increment with confidence intervals (CIs). ORs are the primary risk metric for the matched design with our intent to isolate a given image measurement. For most modeling outputs, ROC curve areas were provided as well with CIs. Both body mass index and ethnicity were controlled for in the modeling with a given image measurement. In all studies discussed here, breast density measurements were made from the non-affected breast for a case and same-side breast for the matched control. Calibrated measures were compared with breast density measured with the user-assisted Cumulus PD method [24-26] (binary labeling of breast density based on thresholding with the dense area normalized by the total breast area). This PD measure is often used as the standard for comparison. Automated measures were based on eroding the breast area first by 25% unless noted. Here we assumed the breast was an approximate half semi-circle and eroded the breast area inward radially by 25%. Erosion was used to approximate the breast area that was in contact with the compression paddle surface during the acquisition. Collection 2 was designed with the same intent as Collection 1 to evaluate if the same calibration approach was applicable to a different type of mammography technology. In both collections, various measures were made both for processing and for presentation images without calibration within the eroded area. Measures included the mean, standard deviation, Fourier based on dividing the power spectrum into concentric rings and summing the power within a given ring [27] (texture analysis in the Fourier domain), local correlation, and automated PD (without erosion). The same image processing techniques and risk modeling used for Collection 1 were applied to Collection 2. When making Fourier measures, the largest rectangle that would fit within the breast area was used as the measurement-region. This rectangle algorithm is described in detail in this work [14]. Collection 3 was designed to make breast density measurements from DBT data and the related 2D synthetic images. Here, an automated PD type measurement was applied to the volume slices producing (1) a volumetric measure, and (2) an average PD measurement taken over the DBT slice measures. The same PD approach was applied to the synthetic 2D images. The same modeling design was used as with the other collections, where a given breast density measurement was modeled with conditional logistic regression; analyzing DBT data did not require breast area erosion.

Data Collection Protocol

All datasets were developed with the same IRB-approved protocol. Cases (unilateral breast disease) were either: (1) women attending the breast clinics at Moffitt Cancer Center (MCC) diagnosed with breast cancer (type-1) or (2) attendees of surrounding area clinics sent to MCC for breast cancer treatment or diagnostic purposes and found to have breast cancer (type-2). Cases have pathology verified unilateral (first time) breast cancer. Controls were attendees of MCC with no history of breast cancer. Controls were individually matched to cases on age (± 2 years), hormone replacement therapy (HRT) usage and current duration, screening history, and mammography unit. The HRT match was based on status of current users or non-users. Nonusers included women that have not taken HRT for at least two years. If a case was a current HRT user, the control was matched on this duration (± 2 years). Controls were matched by screening history using a three-category classification. Group 1 included women with prior screening history by any means; the duration between the last screening and the study image date must be no more than 30 months. Group 2 included women with a screening history that does not fit within in Group 1 or Group 3. Group 3 included women with no screening history. We used mammograms in craniocaudal (CC) views as study images. The unaffected breast was used as the study image for cases (image acquired before treatment) and the matching lateral breast for controls. Women that had breast implants were excluded from this study. Cases were selected retrospectively (type-1) via electronic medical records search or recruited (type-2). Controls were selected retrospectively via electronic medical records search. Multiple suitable controls were matched to a given case and one control was selected randomly for the study.

The collections represent mammograms from different technology designs and manufactures. For conventional 2D images acquired with full field digital mammography (FFDM), there are two sets of related images available at the acquisition time termed for processing and for presentation ; for processing mammograms can be considered as raw data and are not used clinically. Manufacturer specific algorithms are applied to these images to produce enhanced for presentation images that are used clinically. Both types of images can be used for experimental measurement investigations. FFDM images from Collection 1 have 100µm pitch and mammograms (FFDM) from collection 2 have 70µm pitch. Digital breast tomosynthesis data includes volumetric images that are 2D slices of the breast about 1mm thick (or about 10 slices per cm of compressed breast thickness) and 2D synthetic images referred to as C-View images for the technology associated with Collection 3. We will refer to these as 2D synthetic images. Pixel spacing in DBT acquired images is about 100µm but varies across women from roughly 80µm to 110µm in these datasets (but is the same for a given woman’s DBT dataset). DBT units can take both 2D FFDM and DBT acquisitions in tandem without patient repositioning; due the way the images from Collection 2 and 3 were acquired, a larger DBT dataset can be constructed by combining elements from both collections (see citation in Collection 3 results). There is an accompanying data dictionary with these collections. Of importance for automated processing, an intricate image file naming convention was developed to tell the user many study and image characteristics such as study number, case-control status, mammographic view, eligible study image, and image type. The file name string convention can be searched automatically to find a given image type relatively easily and to ensure cases and matching controls can be assembled.

Limitations : sampling of cases and controls was not population-based, but rather a mixture of cases ascertained at an NCI-designated comprehensive cancer center inclusive of referrals from the community. There is no evidence from our studies that the cases are not representative, but findings should be replicated in a population-based study. The data fields allow for selection of the population-based cases (discounting the referrals) but will reduce the case-control numbers. Image data from the General Electric Senographe 2000D full field digital mammography units do not include women with large breasts due to the x-ray detector design limitations. Images may contain artifacts such as nipple markers, mole markers, biopsy clips, and scar markers. These artifacts are documented in the data fields. All images were visually inspected and approved for automated processing. Here, a judgement was made to exclude a sample with too many markers or to include the sample because artifacts were deemed negligent.

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[2] J. J. Heine, K. Cao, and C. Beam, "Cumulative sum quality control for calibrated breast density measurements," Med Phys, vol. 36, no. 12, pp. 5380-90, Dec 2009, doi: 10.1118/1.3250842.

[3] J. J. Heine, K. Cao, and J. A. Thomas, "Effective radiation attenuation calibration for breast density: compression thickness influences and correction " BioMedical Engineering OnLine vol. 9, p. 73, 2010.

[4] E. E. Fowler, T. A. Sellers, B. Lu, and J. J. Heine, "Breast Imaging Reporting and Data System (BI-RADS) breast composition descriptors: automated measurement development for full field digital mammography," Med Phys, vol. 40, no. 11, p. 113502, Nov 2013, doi: 10.1118/1.4824319.

[5] J. J. Heine, K. Cao, D. E. Rollison, G. Tiffenberg, and J. A. Thomas, "A Quantitative Description of the Percentage of Breast Density Measurement Using Full-field Digital Mammography," (in eng), Acad Radiol, vol. 18, no. 5, pp. 556-64, May 2011, doi: 10.1016/j.acra.2010.12.015.

[6] J. J. Heine, E. E. E. Fowler, and C. I. Flowers, "Full field digital mammography and breast density: comparison of calibrated and noncalibrated measurements," (in English), Acad Radiol, vol. 18, no. 11, pp. 1430-6, 2011, doi: 10.1186/1475-925X-12-114.

[7] E. E. Fowler, B. Lu, and J. J. Heine, "A comparison of calibration data from full field digital mammography units for breast density measurements," Biomedical engineering online, vol. 12, p. 114, 2013, doi: 10.1186/1475-925X-12-114.

[8] B. Lu, A. M. Smallwood, T. A. Sellers, J. S. Drukteinis, J. J. Heine, and E. E. Fowler, "Calibrated breast density methods for full field digital mammography: a system for serial quality control and inter-system generalization," Med Phys, vol. 42, no. 2, pp. 623-36, Feb 2015, doi: 10.1118/1.4903299.

[9] E. E. E. Fowler, A. M. Smallwood, N. Z. Khan, K. Kilpatrick, T. A. Sellers, and J. Heine, "Technical challenges in generalizing calibration techniques for breast density measurements," Med Phys, vol. 46, no. 2, pp. 679-688, Feb 2019, doi: 10.1002/mp.13325.

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Basics of a Case Study Analysis Workshop

This article looks at some of the basics for a case study analysis workshop that is conducted by companies and the results from the workshop. The basic objectives of the workshop are to examine existing solutions, and create new solutions based on the study.

The case study analysis workshop may involve questions about the scope of the event, what it will focus on, what skills the participants should bring and the benefits of the event for the company. A discussion of the purpose of the event, who will be attending and when it will be held is very important. It will help people determine their purpose and expectations during the event.

Collaboration is essential when analyzing case studies. Participants need to understand the tools and procedures required to identify the most appropriate way to evaluate the business. During the meeting, a facilitator should explain that individuals have the responsibility to create a database of knowledge. After the participants learn how to use the database effectively, they can create and implement the best decision-making process for the overall business.

Key concepts that should be considered for the workshop include a strong case and weaker cases. There is a continuum of case studies for success. Employees need to understand the decision tree, such as should be done first, how much time should be spent, which action steps should be taken and where the problem should be located.

It is very difficult to analyze issues that are not focused on for most organizations. This means that it is very important to know where the problem lies and how to solve it. The case study analysis workshop helps people understand the importance of analyzing problems early, so that they can take action.

A meeting can be used to discuss the strategy of internal auditing. There is no set process for internal auditing. Organizations need to develop their own policies and train their employees on their use.

While analyzing a problem, it is important to take the perspective of the team and break down the problems into their smallest parts so that the team can find the root cause of the problem and work towards fixing it. The individuals who work on the problem also need to understand the differences between problems that are isolated and those that are systemic.

People learn new solutions or change the design of existing systems. In the case study analysis workshop, people gain an understanding of how these changes can improve the organization. Communication strategies are designed to manage the work flow to find the information needed to get the changes done.

People need to gain knowledge and develop assessment skills for a successful event. There are lots of tools available that can help individuals create reports. After the participants learn how to use these tools, they can run reports themselves and get feedback on their accuracy.

During a case study analysis workshop, attendees will come up with suggestions for future improvement projects. They will brainstorm ideas to come up with a good solution. This can be a great learning experience.

These are some of the basics of a case study analysis workshop. It can be a valuable learning experience for all participants.

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Back to Journals » International Journal of General Medicine » Volume 17

Association Between Periodontal Diseases and Hypothyroidism: A Case–Control Study

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Authors AlAhmari FM   , Albahouth HS , Almalky HA   , Almutairi ES , Alatyan MH , Alotaibi LA  

Received 19 June 2024

Accepted for publication 13 August 2024

Published 20 August 2024 Volume 2024:17 Pages 3613—3619

DOI https://doi.org/10.2147/IJGM.S476430

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Dr Jacopo Manso

Fatemah Mohammed AlAhmari, 1 Hind Saleh Albahouth, 2 Hadeel Ali Almalky, 2 Ebtihal Saad Almutairi, 2 Muzun Hamoud Alatyan, 2 Lama Ali Alotaibi 2 1 Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh, Saudi Arabia; 2 College of Dentistry, King Saud University, Riyadh, Saudi Arabia Correspondence: Fatemah Mohammed AlAhmari, King Saud University, Riyadh, Saudi Arabia, Email [email protected] Objective: Periodontal diseases are chronic inflammatory disorders influenced by systemic health of the individual. This study aimed to investigate the association between hypothyroidism and periodontal disease in a cohort of adult Saudi population. Methods: This case–control study included 201 adults with hypothyroidism on hormone replacement therapy and 188 healthy controls. The medical files of patients were reviewed to check thyroid stimulation hormone (TSH) and free thyroxine (FT4) levels. Participants completed a questionnaire on demographic and health information, followed by a comprehensive periodontal examination. Pearson chi-square and binary logistic regression analyses determined associations, with a significance set at p ≤ 0.05. Results: Gingivitis was found in 20.9% of cases and 58% of controls. Periodontitis stages I, II, III and IV were in general higher in cases compared to controls (23.4%, 27.9%, 21.9%, 6% in cases versus 13.8%, 17%, 9.6%, 1.6% in controls, respectively). Mean PPD and CAL values were higher in cases (5.54 ± 2.5 and 3.88 ± 3.1) than in controls (4.03 ± 1.6 and 1.72 ± 2.4). Significant associations between periodontal status and hypothyroidism were found (p Conclusion: The findings of the current study showed that, in a cohort of adult Saudi subjects, patients with hypothyroidism have higher prevalence and more severe periodontal disease symptoms compared to controls, suggesting significant association. Keywords: hypothyroidism, periodontal diseases, hormone replacement therapy, association, case–control study

Introduction

Periodontitis is one of the most common infectious diseases in humans. It is a chronic bacterial infection characterised by persistent inflammation, connective tissue breakdown and alveolar bone destruction. The chronic inflammation associated with the disease is attributed to the subgingival bacteria-induced immune response dysregulation. Severe periodontitis affects 7.4% of the world’s population, making it a serious global public health challenge. 1 , 2 Clinically, the disease can cause impaired function and aesthetics, adversely affects the overall quality of life of affected individuals, and if not properly treated, it will irreversibly progress and result in tooth loss. There is a growing body of evidence that indicates that periodontitis is independently associated with several systemic conditions, including cardiovascular disease, type 2 diabetes, respiratory diseases, premature birth, osteoporosis, Alzheimer’s disease, rheumatoid arthritis, and other autoimmune diseases. 2 , 3

Hypothyroidism is a common endocrine disorder identified as failure of the thyroid gland to produce adequate thyroid hormone to meet the metabolic demands of the body. If left untreated, it can lead to other significant comorbidities, such as hypertension, dyslipidemia, infertility, cognitive impairment, and neuromuscular dysfunction. 4 The most common cause of hypothyroidism is primary gland failure, either due to congenital causes, autoimmune thyroiditis, or infiltrative diseases. The disease can also occur due to insufficient thyroid gland stimulation by the hypothalamus or pituitary gland. Iodine deficiency, surgical thyroidectomy, and some medications can also induce hypothyroidism in some patients. Autoimmune thyroid disease is the most common aetiology of hypothyroidism in the United States. In some other countries, iodine deficiency is highly prevalent, causing hypothyroidism affecting children and infants too. 5 , 6

Periodontitis shares risk factors with other chronic noncommunicable diseases and has bidirectional associations with general health and other systemic diseases. There is a growing global consensus that improving oral and periodontal health positively impact the systemic health and well-being. Previous investigations had suggested a reciprocal relationship between endocrine disorders, including hypothyroidism, and periodontal diseases and that this relationship is mediated through the immune system. Hypothyroidism may be associated with an increased risk of periodontal disease. 7–9 There is debate whether their concomitance reflects a causal link is coincidence, or the result of one unmasking the other and the data from the Saudi Arabian population are limited. The aim of the current study was to investigate the relationship between hypothyroidism and periodontal status in a cohort of Saudi Arabian adult population.

Materials and Methods

The test group consisted of 201 cases selected according to predefined criteria of being adults (age ≥ 18 years), diagnosed with primary hypothyroidism and treated with hormone replacement therapy. Cases were excluded if their medical records indicated previous diagnosis of other chronic diseases such as diabetes mellitus or other systemic conditions such as cardiovascular diseases, renal diseases, cancer, and hepatic disorders; received other pharmaceutical agents such as antibiotics, steroids, anti-inflammatory medications and/or bisphosphonates within the past 60 days; and/or received any periodontal treatment in the past 60 days. Female patients were excluded if they were pregnant and/or nursing. The control group consisted of 188 healthy age and gender matching adults. All participants responded to a pre-examination questionnaire to collect information about the age, sex, education level, smoking habits, medical history, oral hygiene behaviours, brushing frequency, duration since hypothyroidism was first diagnosed, and the dose of medication used. The periodontal status of all participants was then assessed via comprehensive full oral exam recording the probing pocket depth (PPD; distance between the marginal gingiva and the bottom of the periodontal pocket, in millimeters), plaque index (PI; The presence or absence of dental plaque at four points mesial, buccal, lingual, and distal on each tooth, determined after the application of a disclosing agent), bleeding on probing (BOP; the occurrence of bleeding within 15 seconds after probing, indicating a positive result) and clinical attachment loss (CAL; distance between the cemento-enamel junction and the bottom of the pocket, in millimeters). A Williams’ periodontal probe (Hu-Friedy ® PW6) was utilized for measuring the clinical parameters including PPD and CAL. Six sites per tooth were assessed, and a diagnosis of periodontitis was established when subjects had at least two sites with a PPD ≥ 4 mm and a CAL ≥ 1 mm (one on each tooth). A case with 30% or more of teeth involved was classified as generalized periodontitis. Individuals with mean PPD <3mm and less than 10% bleeding sites with absence of clinically detectable signs of inflammation were categorized as having a healthy periodontium. Classification of periodontitis was determined based on the criteria proposed by the 2017 World Workshop on the Classifications of Periodontal and Peri-implant Diseases and Conditions. 3 , 10

Statistical Analysis

Data were analyzed using IBM SPSS Statistical software for Windows version 26.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics (mean, standard deviation, frequencies, and percentages) were used to describe the quantitative and categorical variables. Pearson chi-square test and odds ratios were used to assess and measure the association between categorical variables and outcome (cases and controls). Student’s t -test for independent samples was used to compare the mean values of quantitative variables between cases and controls. The binary logistic regression was used to identify the independent variables associated with hypothyroidism diagnosis. A p-value of ≤0.05 and 95% confidence intervals were used to report the statistical significance and precision of results.

The sample was classified into 201 hypothyroidism patient (Cases, mean age 40.55 ± 9.7 years, 48.3% males) and 188 healthy subjects (Control, mean age 39.37 ± 11 years, 45.2% males). The characteristics of the two groups are presented in Table 1 . A brushing frequency of one time a day was reported for 34.8% and 56.9% and two times a day for 38.3 and 30.9% of the cases and control groups, respectively. The distribution of periodontal disease was generalized in 91.9% of cases and 76.1% among controls. The periodontal status was classified as gingivitis in 20.9% of cases and 58% of controls. Periodontitis classification of stages I, II, III and IV was in general higher in cases compared to controls (23.4%, 27.9%, 21.9%, 6% in cases versus 13.8%, 17%, 9.6%, 1.6% in controls, respectively). The mean values of PI and BOP in cases were 49.22 ± 19.6 and 56.06 ± 22.2 versus 47.85 ± 23.3 and 57.79 ± 26.6 among controls, respectively. The mean values of PPD and CAL in cases were 5.54 ± 2.5 and 3.88 ± 3.1 versus 4.03 ± 1.6 and 1.72 ± 2.4 among controls, respectively ( Table 1 ).

Periodontitis is the most common form of periodontal diseases, which includes a group of inflammatory diseases that affect the periodontal supporting tissues of the teeth. It is commonly regarded a “silent disease” since patients present with no or few symptoms until the disease progresses to destroy the periodontal soft tissues and alveolar bone. 11 Periodontitis is considered the main cause of tooth loss after the third decade of life. Current evidence indicates that periodontitis is a complex disease with multiple potential contributing factors including genetics and epigenetics, environmental, and behavioural factors. Low socioeconomic status, poor oral hygiene, psychological stress, advanced age, use of certain medications, and some systemic conditions are well-recognised risk factors that contribute to the initiation and progression of periodontal diseases. 11 , 12

Hypothyroidism is one of the most common hormone deficiency disorders. According to the time of onset, it could be classified as congenital or acquired. Symptoms of hypothyroidism include fatigue, weight gain, alteration in cognition, infertility, menstrual abnormalities, irregular heart rate, and depression. Monotherapy with levothyroxine at doses to normalize the serum thyroid-stimulating hormone (TSH) is the standard of care for treating hypothyroidism. 13 , 14 Studies had previously suggested that hypothyroidism may be associated with an increased risk of periodontal diseases. The present study was conducted to investigate the association between hypothyroidism and periodontal status in a cohort of Saudi Arabian adult population.

We have demonstrated a significantly increased prevalence and severity of periodontitis in subjects with treated hypothyroidism compared to controls. This increase seen in adult Saudi patients diagnosed with hyperthyroidism was similar to reports on other ethnic populations. 15–18 In the current study, subjects with hypothyroidism had significantly higher PPD and CAL when compared with matched controls. Attard and Zarb, 19 in their study, demonstrated an association between hypothyroidism and peri-implant radiographic bone loss, compared with normal controls. 19 Rahangdale and Galgali 20 reported statistically significant higher PPD and CAL in hypothyroidism patients in comparison to the controls. They concluded that, since all other variables that might affect the periodontal status of the patients were controlled, the history of hypothyroidism and replacement therapy probably had the main effect on PPD and CAL, the most reliable measure of periodontitis. Our data, together with previous observations, support the generally accepted view that chronic inflammatory periodontal diseases are associated with endocrinal morbidity.

In adults, the integrity of the skeletal structures, including the alveolar bone, is maintained by bone remodelling, a process controlled by thyroid hormones and TSH. 21 Animal models of hypothyroidism have demonstrated alterations in bone metabolism, through a mechanism by which thyroid hormone has direct or indirect effects on bone cells. 22–24 Feitosa et al 22 used an experimental periodontitis model in rats to evaluate, histologically, the influence of thyroid hormones on the rate of periodontal disease progression. The results indicated that hypothyroidism significantly increased the bone loss resulting from ligature-induced periodontitis and the number of TRAP-positive cells on the linear surface of bone crest. They concluded that decreased serum levels of thyroid hormones may enhance periodontitis-related bone loss, as a function of an increased number of resorbing cells. It is possible to speculate that the significant association between higher distribution and severity of periodontal disease in hypothyroidism cases in the current study was related to the negative effect of hypothyroidism on bone remodelling sequence.

The present study is the first to indicate that the periodontal status of the hypothyroidism cases was significantly associated with the hormone replacement therapy dose and duration. Patients on higher doses of medication and for longer duration suffered more severe periodontal tissue destruction. This might imply that the duration of the disease onset and the degree of hormonal deficiency are critical in determining the periodontal tissue response. It has been proposed that the cytokines produced due to thyroid dysfunction might act as initiators for an amplified inflammatory cascade systemically. 25 This, in combination with the existing inflammatory reaction in the periodontium due to the endotoxins produced by microbial plaque, might lead to higher local inflammatory mediator concentration in the periodontal tissues, including matrix metalloproteinases, leading to excessive periodontal tissue breakdown. Furthermore, it has been reported that in patients with hypothyroidism using a large dose of thyroxine replacement therapy, the risk of bone fracture increased compared to small doses, which could be attributed to lower bone density and poor bone quality reported with high-versus-low-dose thyroxine replacement. 26 , 27

In summary, we have shown that, in a cohort of adult Saudi subjects, patients with hypothyroidism have higher prevalence and more severe periodontal disease compared to controls, suggesting association. However, it is important to interpret the data carefully, since case–control study is not the best approach to show a cause-and-effect relationship. Furthermore, the result of the current study was based on data collected from a single hospital, and its conclusions might not be entirely generalizable. Despite the limitations, this study offers guidance for future research and presents evidence of correlation from a group that has not been previously explored. The results of this study thus support routine periodontal evaluation for patients with hypothyroidism. Further studies are required to investigate the pathophysiology of periodontal tissue diseases and its relationship to the underlying endocrinal disorder.

The findings of the current study showed that, in a cohort of adult Saudi subjects, patients with hypothyroidism have higher prevalence and more severe periodontal disease symptoms compared to controls, suggesting significant association. However, the study was not sufficiently powered to estimate the association in the general population. Further studies are required to investigate the pathophysiology of the periodontal tissue reaction and its relationship to the underlying endocrinal disorder.

The authors report no conflicts of interest in this work.

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15. Zahid TM, Wang BY, Cohen RE. The effects of thyroid hormone abnormalities on periodontal disease status. J Int Acad Periodontol . 2011;13:80–85.

16. Kothiwale S, Panjwani V. Impact of thyroid hormone dysfunction on periodontal disease. J Sci Soc . 2016;43:34–37.

17. Bhankhar RR, Hungund S, Kambalyal P, Singh V, Jain K. Effect of nonsurgical periodontal therapy on thyroid stimulating hormone in hypothyroid patients with periodontal diseases. Ind J Dent Res . 2017;28(1):16–21. doi:10.4103/ijdr.IJDR_174_16

18. Aldulaijan HA, Cohen RE, Stellrecht EM, Levine MJ, Yerke LM. Relationship between hypothyroidism and periodontitis: a scoping review. Clin Exp Dent Res . 2020;6:147–157. doi:10.1002/cre2.247

19. Attard NJ, Zarb GA. A study of dental implants in medically treated hypothyroid patients. Clin Imp Dent Res . 2002;4(4):220–231. doi:10.1111/j.1708-8208.2002.tb00174.x

20. Rahangdale SI, Galgali SR. Periodontal status of hypothyroid patients on thyroxine replacement therapy: a comparative cross-sectional study. J Indian Soc Periodontol . 2018;22:535–540. doi:10.4103/jisp.jisp_316_18

21. Akalin A, Colak O, Alatas O, Efe B. Bone remodelling markers and serum cytokines in patients with hyperthyroidism. Clin Endocrin . 2002;57(1):125–129. doi:10.1046/j.1365-2265.2002.01578.x

22. Feitosa DS, Marques MR, Casati MZ, Sallum EA, Nociti FH, De toledo S. The influence of thyroid hormones on periodontitis-related bone loss and tooth-supporting alveolar bone: a histological study in rats. J Periodontal Res . 2009;44(4):472–478. doi:10.1111/j.1600-0765.2008.01144.x

23. Bassett JH, Williams GR. Role of thyroid hormones in skeletal development and bone maintenance. Endocr Rev . 2016;37(2):135–187. doi:10.1210/er.2015-1106

24. Williams GR, Bassett JHD. Thyroid diseases and bone health. J Endocrinol Invest . 2018;41(1):99–109. doi:10.1007/s40618-017-0753-4

25. Monea A, Elod N, Sitaru A, Stoica A, Monea M. Can thyroid dysfunction induce periodontal disease. Eur Sci J . 2014;10(15):74–83.

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27. Karimifar M, Esmaili F, Salari A, Kachuei A, Faragzadegan Z, Karimifar M. Effects of Levothyroxine and thyroid stimulating hormone on bone loss in patients with primary hypothyroidism. J Res Pharm Pract . 2014;3(3):83–87. doi:10.4103/2279-042X.141099

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Case study method is an important method of teaching for MBA students. In view of this comprehensive case study workshopsare conducted at the institute, every year, for students of MBA Semester-III and Semester-I. Numerous cases are analysed at different levels, in three phases. The benefits accrued to students are that they’re able to develop an analytical mind and are able to search various elements of the case, the issues and problems involved, elements causing issues, their inter-relationships, alternate solutions and the best possible solution to solve the case.

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• Introduction
• Conclusions
• Article Information

The reports to the Vaccine Adverse Event Reporting System met the case definition of myocarditis (reported cases). Among individuals older than 40 years of age, there were no more than 8 reports of myocarditis for any individual age after receiving either vaccine. For the BNT162b2 vaccine, there were 114 246 837 first vaccination doses and 95 532 396 second vaccination doses; and for the mRNA-1273 vaccine, there were 78 158 611 and 66 163 001, respectively. The y-axis range differs between panels A and B.

The reports to the Vaccine Adverse Event Reporting System met the case definition of myocarditis (reported cases). Among recipients of either vaccine, there were only 13 reports or less of myocarditis beyond 10 days for any individual time from vaccination to symptom onset. The y-axis range differs between panels A and B.

A, For the BNT162b2 vaccine, there were 138 reported cases of myocarditis with known date for symptom onset and dose after 114 246 837 first vaccination doses and 888 reported cases after 95 532 396 second vaccination doses.

B, For the mRNA-1273 vaccine, there were 116 reported cases of myocarditis with known date for symptom onset and dose after 78 158 611 first vaccination doses and 311 reported cases after 66 163 001 second vaccination doses.

eMethods. Medical Dictionary for Regulatory Activities Preferred Terms, Definitions of Myocarditis and Pericarditis, Myocarditis medical review form

eFigure. Flow diagram of cases of myocarditis and pericarditis reported to Vaccine Adverse Event Reporting System (VAERS) after receiving mRNA-based COVID-19 vaccine, United States, December 14, 2020-August 31, 2021.

eTable 1. Characteristics of all myocarditis cases reported to Vaccine Adverse Event Reporting System (VAERS) after mRNA-based COVID-19 vaccination, United States, December 14, 2020–August 31, 2021.

eTable 2. Characteristics of all pericarditis cases reported to Vaccine Adverse Event Reporting System (VAERS) after mRNA-based COVID-19 vaccination, United States, December 14, 2020–August 31, 2021.

eTable 3. Characteristics of myocarditis cases reported to Vaccine Adverse Event Reporting System after mRNA-based COVID-19 vaccination by case definition status.

• Myocarditis and Pericarditis After Vaccination for COVID-19 JAMA Research Letter September 28, 2021 This study investigates the incidence of myocarditis and pericarditis emergency department or inpatient hospital encounters before COVID-19 vaccine availability (January 2019–January 2021) and during a COVID-19 vaccination period (February-May 2021) in a large US health care system. George A. Diaz, MD; Guilford T. Parsons, MD, MS; Sara K. Gering, BS, BSN; Audrey R. Meier, MPH; Ian V. Hutchinson, PhD, DSc; Ari Robicsek, MD
• Myocarditis Following a Third BNT162b2 Vaccination Dose in Military Recruits in Israel JAMA Research Letter April 26, 2022 This study assessed whether a third vaccine dose was associated with the risk of myocarditis among military personnel in Israel. Limor Friedensohn, MD; Dan Levin, MD; Maggie Fadlon-Derai, MHA; Liron Gershovitz, MD; Noam Fink, MD; Elon Glassberg, MD; Barak Gordon, MD
• Myocarditis Cases After mRNA-Based COVID-19 Vaccination in the US—Reply JAMA Comment & Response May 24, 2022 Matthew E. Oster, MD, MPH; David K. Shay, MD, MPH; Tom T. Shimabukuro, MD, MPH, MBA
• Myocarditis Cases After mRNA-Based COVID-19 Vaccination in the US JAMA Comment & Response May 24, 2022 Sheila R. Weiss, PhD
• JAMA Network Articles of the Year 2022 JAMA Medical News & Perspectives December 27, 2022 This Medical News article is our annual roundup of the top-viewed articles from all JAMA Network journals. Melissa Suran, PhD, MSJ
• Diagnosis and Treatment of Acute Myocarditis—A Review JAMA Review April 4, 2023 This Review summarizes current evidence regarding the diagnosis and treatment of acute myocarditis. Enrico Ammirati, MD, PhD; Javid J. Moslehi, MD
• Patient Information: Acute Myocarditis JAMA JAMA Patient Page August 8, 2023 This JAMA Patient Page describes acute myocarditis and its symptoms, causes, diagnosis, and treatment. Kristin Walter, MD, MS
• Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military JAMA Cardiology Brief Report October 1, 2021 This case series describes myocarditis presenting after COVID-19 vaccination within the Military Health System. Jay Montgomery, MD; Margaret Ryan, MD, MPH; Renata Engler, MD; Donna Hoffman, MSN; Bruce McClenathan, MD; Limone Collins, MD; David Loran, DNP; David Hrncir, MD; Kelsie Herring, MD; Michael Platzer, MD; Nehkonti Adams, MD; Aliye Sanou, MD; Leslie T. Cooper Jr, MD
• Patients With Acute Myocarditis Following mRNA COVID-19 Vaccination JAMA Cardiology Brief Report October 1, 2021 This study describes 4 patients who presented with acute myocarditis after mRNA COVID-19 vaccination. Han W. Kim, MD; Elizabeth R. Jenista, PhD; David C. Wendell, PhD; Clerio F. Azevedo, MD; Michael J. Campbell, MD; Stephen N. Darty, BS; Michele A. Parker, MS; Raymond J. Kim, MD
• Association of Myocarditis With BNT162b2 Vaccination in Children JAMA Cardiology Brief Report December 1, 2021 This case series reviews comprehensive cardiac imaging in children with myocarditis after COVID-19 vaccine. Audrey Dionne, MD; Francesca Sperotto, MD; Stephanie Chamberlain; Annette L. Baker, MSN, CPNP; Andrew J. Powell, MD; Ashwin Prakash, MD; Daniel A. Castellanos, MD; Susan F. Saleeb, MD; Sarah D. de Ferranti, MD, MPH; Jane W. Newburger, MD, MPH; Kevin G. Friedman, MD

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Oster ME , Shay DK , Su JR, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022;327(4):331–340. doi:10.1001/jama.2021.24110

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Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021

• 1 US Centers for Disease Control and Prevention, Atlanta, Georgia
• 2 School of Medicine, Emory University, Atlanta, Georgia
• 3 Children’s Healthcare of Atlanta, Atlanta, Georgia
• 4 Vanderbilt University Medical Center, Nashville, Tennessee
• 5 Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio
• 6 Boston Medical Center, Boston, Massachusetts
• 7 Duke University, Durham, North Carolina
• 8 US Food and Drug Administration, Silver Spring, Maryland
• Research Letter Myocarditis and Pericarditis After Vaccination for COVID-19 George A. Diaz, MD; Guilford T. Parsons, MD, MS; Sara K. Gering, BS, BSN; Audrey R. Meier, MPH; Ian V. Hutchinson, PhD, DSc; Ari Robicsek, MD JAMA
• Research Letter Myocarditis Following a Third BNT162b2 Vaccination Dose in Military Recruits in Israel Limor Friedensohn, MD; Dan Levin, MD; Maggie Fadlon-Derai, MHA; Liron Gershovitz, MD; Noam Fink, MD; Elon Glassberg, MD; Barak Gordon, MD JAMA
• Comment & Response Myocarditis Cases After mRNA-Based COVID-19 Vaccination in the US—Reply Matthew E. Oster, MD, MPH; David K. Shay, MD, MPH; Tom T. Shimabukuro, MD, MPH, MBA JAMA
• Comment & Response Myocarditis Cases After mRNA-Based COVID-19 Vaccination in the US Sheila R. Weiss, PhD JAMA
• Medical News & Perspectives JAMA Network Articles of the Year 2022 Melissa Suran, PhD, MSJ JAMA
• Review Diagnosis and Treatment of Acute Myocarditis—A Review Enrico Ammirati, MD, PhD; Javid J. Moslehi, MD JAMA
• JAMA Patient Page Patient Information: Acute Myocarditis Kristin Walter, MD, MS JAMA
• Brief Report Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military Jay Montgomery, MD; Margaret Ryan, MD, MPH; Renata Engler, MD; Donna Hoffman, MSN; Bruce McClenathan, MD; Limone Collins, MD; David Loran, DNP; David Hrncir, MD; Kelsie Herring, MD; Michael Platzer, MD; Nehkonti Adams, MD; Aliye Sanou, MD; Leslie T. Cooper Jr, MD JAMA Cardiology
• Brief Report Patients With Acute Myocarditis Following mRNA COVID-19 Vaccination Han W. Kim, MD; Elizabeth R. Jenista, PhD; David C. Wendell, PhD; Clerio F. Azevedo, MD; Michael J. Campbell, MD; Stephen N. Darty, BS; Michele A. Parker, MS; Raymond J. Kim, MD JAMA Cardiology
• Brief Report Association of Myocarditis With BNT162b2 Vaccination in Children Audrey Dionne, MD; Francesca Sperotto, MD; Stephanie Chamberlain; Annette L. Baker, MSN, CPNP; Andrew J. Powell, MD; Ashwin Prakash, MD; Daniel A. Castellanos, MD; Susan F. Saleeb, MD; Sarah D. de Ferranti, MD, MPH; Jane W. Newburger, MD, MPH; Kevin G. Friedman, MD JAMA Cardiology

Question   What is the risk of myocarditis after mRNA-based COVID-19 vaccination in the US?

Findings   In this descriptive study of 1626 cases of myocarditis in a national passive reporting system, the crude reporting rates within 7 days after vaccination exceeded the expected rates across multiple age and sex strata. The rates of myocarditis cases were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively).

Meaning   Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men.

Importance   Vaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are unclear.

Objective   To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US.

Design, Setting, and Participants   Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021.

Exposures   Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna).

Main Outcomes and Measures   Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes.

Results   Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%).

Conclusions and Relevance   Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.

Myocarditis is an inflammatory condition of the heart muscle that has a bimodal peak incidence during infancy and adolescence or young adulthood. 1 - 4 The clinical presentation and course of myocarditis is variable, with some patients not requiring treatment and others experiencing severe heart failure that requires subsequent heart transplantation or leads to death. 5 Onset of myocarditis typically follows an inciting process, often a viral illness; however, no antecedent cause is identified in many cases. 6 It has been hypothesized that vaccination can serve as a trigger for myocarditis; however, only the smallpox vaccine has previously been causally associated with myocarditis based on reports among US military personnel, with cases typically occurring 7 to 12 days after vaccination. 7

With the implementation of a large-scale, national COVID-19 vaccination program starting in December 2020, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration began monitoring for a number of adverse events of special interest, including myocarditis and pericarditis, in the Vaccine Adverse Event Reporting System (VAERS), a long-standing national spontaneous reporting (passive surveillance) system. 8 As the reports of myocarditis after COVID-19 vaccination were reported to VAERS, the Clinical Immunization Safety Assessment Project, 9 a collaboration between the CDC and medical research centers, which includes physicians treating infectious diseases and other specialists (eg, cardiologists), consulted on several of the cases. In addition, reports from several countries raised concerns that mRNA-based COVID-19 vaccines may be associated with acute myocarditis. 10 - 15

Given this concern, the aims were to describe reports and confirmed cases of myocarditis initially reported to VAERS after mRNA-based COVID-19 vaccination and to provide estimates of the risk of myocarditis after mRNA-based COVID-19 vaccination based on age, sex, and vaccine type.

VAERS is a US spontaneous reporting (passive surveillance) system that functions as an early warning system for potential vaccine adverse events. 8 Co-administered by the CDC and the US Food and Drug Administration, VAERS accepts reports of all adverse events after vaccination from patients, parents, clinicians, vaccine manufacturers, and others regardless of whether the events could plausibly be associated with receipt of the vaccine. Reports to VAERS include information about the vaccinated person, the vaccine or vaccines administered, and the adverse events experienced by the vaccinated person. The reports to VAERS are then reviewed by third-party professional coders who have been trained in the assignment of Medical Dictionary for Regulatory Activities preferred terms. 16 The coders then assign appropriate terms based on the information available in the reports.

This activity was reviewed by the CDC and was conducted to be consistent with applicable federal law and CDC policy. The activities herein were confirmed to be nonresearch under the Common Rule in accordance with institutional procedures and therefore were not subject to institutional review board requirements. Informed consent was not obtained for this secondary use of existing information; see 45 CFR part 46.102(l)(2), 21 CFR part 56, 42 USC §241(d), 5 USC §552a, and 44 USC §3501 et seq.

The exposure of concern was vaccination with one of the mRNA-based COVID-19 vaccines: the BNT162b2 vaccine (Pfizer-BioNTech) or the mRNA-1273 vaccine (Moderna). During the analytic period, persons aged 12 years or older were eligible for the BNT162b2 vaccine and persons aged 18 years or older were eligible for the mRNA-1273 vaccine. The number of COVID-19 vaccine doses administered during the analytic period was obtained through the CDC’s COVID-19 Data Tracker. 17

The primary outcome was the occurrence of myocarditis and the secondary outcome was pericarditis. Reports to VAERS with these outcomes were initially characterized using the Medical Dictionary for Regulatory Activities preferred terms of myocarditis or pericarditis (specific terms are listed in the eMethods in the Supplement ). After initial review of reports of myocarditis to VAERS and review of the patient’s medical records (when available), the reports were further reviewed by CDC physicians and public health professionals to verify that they met the CDC’s case definition for probable or confirmed myocarditis (descriptions previously published and included in the eMethods in the Supplement ). 18 The CDC’s case definition of probable myocarditis requires the presence of new concerning symptoms, abnormal cardiac test results, and no other identifiable cause of the symptoms and findings. Confirmed cases of myocarditis further require histopathological confirmation of myocarditis or cardiac magnetic resonance imaging (MRI) findings consistent with myocarditis.

Deaths were included only if the individual had met the case definition for confirmed myocarditis and there was no other identifiable cause of death. Individual cases not involving death were included only if the person had met the case definition for probable myocarditis or confirmed myocarditis.

We characterized reports of myocarditis or pericarditis after COVID-19 vaccination that met the CDC’s case definition and were received by VAERS between December 14, 2020 (when COVID-19 vaccines were first publicly available in the US), and August 31, 2021, by age, sex, race, ethnicity, and vaccine type; data were processed by VAERS as of September 30, 2021. Race and ethnicity were optional fixed categories available by self-identification at the time of vaccination or by the individual filing a VAERS report. Race and ethnicity were included to provide the most complete baseline description possible for individual reports; however, further analyses were not stratified by race and ethnicity due to the high percentage of missing data. Reports of pericarditis with evidence of potential myocardial involvement were included in the review of reports of myocarditis. The eFigure in the Supplement outlines the categorization of the reports of myocarditis and pericarditis reviewed.

Further analyses were conducted only for myocarditis because of the preponderance of those reports to VAERS, in Clinical Immunization Safety Assessment Project consultations, and in published articles. 10 - 12 , 19 - 21 Crude reporting rates for myocarditis during a 7-day risk interval were calculated using the number of reports of myocarditis to VAERS per million doses of COVID-19 vaccine administered during the analytic period and stratified by age, sex, vaccination dose (first, second, or unknown), and vaccine type. Expected rates of myocarditis by age and sex were calculated using 2017-2019 data from the IBM MarketScan Commercial Research Database. This database contains individual-level, deidentified, inpatient and outpatient medical and prescription drug claims, and enrollment information submitted to IBM Watson Health by large employers and health plans. The data were accessed using version 4.0 of the IBM MarketScan Treatment Pathways analytic platform. Age- and sex-specific rates were calculated by determining the number of individuals with myocarditis ( International Statistical Classification of Diseases and Related Health Problems, Tenth Revision [ICD-10] codes B33.20, B33.22, B33.24, I40.0, I40.1, I40.8, I40.9, or I51.4) 22 identified during an inpatient encounter in 2017-2019 relative to the number of individuals of similar age and sex who were continually enrolled during the year in which the myocarditis-related hospitalization occurred; individuals with any diagnosis of myocarditis prior to that year were excluded. Given the limitations of the IBM MarketScan Commercial Research Database to capture enrollees aged 65 years or older, an expected rate for myocarditis was not calculated for this population. A 95% CI was calculated using Poisson distribution in SAS version 9.4 (SAS Institute Inc) for each expected rate of myocarditis and for each observed rate in a strata with at least 1 case.

In cases of probable or confirmed myocarditis among those younger than 30 years of age, their clinical course was then summarized to the extent possible based on medical review and clinician interviews. This clinical course included presenting symptoms, diagnostic test results, treatment, and early outcomes (abstraction form appears in the eMethods in the Supplement ). 23

When applicable, missing data were delineated in the results or the numbers with complete data were listed. No assumptions or imputations were made regarding missing data. Any percentages that were calculated included only those cases of myocarditis with adequate data to calculate the percentages.

Between December 14, 2020, and August 31, 2021, 192 405 448 individuals older than 12 years of age received a total of 354 100 845 mRNA-based COVID-19 vaccines. VAERS received 1991 reports of myocarditis (391 of which also included pericarditis) after receipt of at least 1 dose of mRNA-based COVID-19 vaccine (eTable 1 in the Supplement ) and 684 reports of pericarditis without the presence of myocarditis (eTable 2 in the Supplement ).

Of the 1991 reports of myocarditis, 1626 met the CDC’s case definition for probable or confirmed myocarditis ( Table 1 ). There were 208 reports that did not meet the CDC’s case definition for myocarditis and 157 reports that required more information to perform adjudication (eTable 3 in the Supplement ). Of the 1626 reports that met the CDC’s case definition for myocarditis, 1195 (73%) were younger than 30 years of age, 543 (33%) were younger than 18 years of age, and the median age was 21 years (IQR, 16-31 years) ( Figure 1 ). Of the reports of myocarditis with dose information, 82% (1265/1538) occurred after the second vaccination dose. Of those with a reported dose and time to symptom onset, the median time from vaccination to symptom onset was 3 days (IQR, 1-8 days) after the first vaccination dose and 74% (187/254) of myocarditis events occurred within 7 days. After the second vaccination dose, the median time to symptom onset was 2 days (IQR, 1-3 days) and 90% (1081/1199) of myocarditis events occurred within 7 days ( Figure 2 ).

Males comprised 82% (1334/1625) of the cases of myocarditis for whom sex was reported. The largest proportions of cases of myocarditis were among White persons (non-Hispanic or ethnicity not reported; 69% [914/1330]) and Hispanic persons (of all races; 17% [228/1330]). Among persons younger than 30 years of age, there were no confirmed cases of myocarditis in those who died after mRNA-based COVID-19 vaccination without another identifiable cause and there was 1 probable case of myocarditis but there was insufficient information available for a thorough investigation. At the time of data review, there were 2 reports of death in persons younger than 30 years of age with potential myocarditis that remain under investigation and are not included in the case counts.

Symptom onset of myocarditis was within 7 days after vaccination for 947 reports of individuals who received the BNT162b2 vaccine and for 382 reports of individuals who received the mRNA-1273 vaccine. The rates of myocarditis varied by vaccine type, sex, age, and first or second vaccination dose ( Table 2 ). The reporting rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.73 [95% CI, 61.68-81.11] per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.86 [95% CI, 91.65-122.27] per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.43 [95% CI, 45.56-60.33] per million doses of the BNT162b2 vaccine and 56.31 [95% CI, 47.08-67.34] per million doses of the mRNA-1273 vaccine). The lower estimate of the 95% CI for reporting rates of myocarditis in adolescent males and young men exceeded the upper bound of the expected rates after the first vaccination dose with the BNT162b2 vaccine in those aged 12 to 24 years, after the second vaccination dose with the BNT162b2 vaccine in those aged 12 to 49 years, after the first vaccination dose with the mRNA-1273 vaccine in those aged 18 to 39 years, and after the second vaccination dose with the mRNA-1273 vaccine in those aged 18 to 49 years.

The reporting rates of myocarditis in females were lower than those in males across all age strata younger than 50 years of age. The reporting rates of myocarditis were highest after the second vaccination dose in adolescent females aged 12 to 15 years (6.35 [95% CI, 4.05-9.96] per million doses of the BNT162b2 vaccine), in adolescent females aged 16 to 17 years (10.98 [95% CI, 7.16-16.84] per million doses of the BNT162b2 vaccine), in young women aged 18 to 24 years (6.87 [95% CI, 4.27-11.05] per million doses of the mRNA-1273 vaccine), and in women aged 25 to 29 years (8.22 [95% CI, 5.03-13.41] per million doses of the mRNA-1273 vaccine). The lower estimate of the 95% CI for reporting rates of myocarditis in females exceeded the upper bound of the expected rates after the second vaccination dose with the BNT162b2 vaccine in those aged 12 to 29 years and after the second vaccination dose with the mRNA-1273 vaccine in those aged 18 to 29 years.

Among the 1372 reports of myocarditis in persons younger than 30 years of age, 1305 were able to be adjudicated, with 92% (1195/1305) meeting the CDC’s case definition. Of these, chart abstractions or medical interviews were completed for 69% (826/1195) ( Table 3 ). The symptoms commonly reported in the verified cases of myocarditis in persons younger than 30 years of age included chest pain, pressure, or discomfort (727/817; 89%) and dyspnea or shortness of breath (242/817; 30%). Troponin levels were elevated in 98% (792/809) of the cases of myocarditis. The electrocardiogram result was abnormal in 72% (569/794) of cases of myocarditis. Of the patients who had received a cardiac MRI, 72% (223/312) had abnormal findings consistent with myocarditis. The echocardiogram results were available for 721 cases of myocarditis; of these, 84 (12%) demonstrated a notable decreased left ventricular ejection fraction (<50%). Among the 676 cases for whom treatment data were available, 589 (87%) received nonsteroidal anti-inflammatory drugs. Intravenous immunoglobulin and glucocorticoids were each used in 12% of the cases of myocarditis (78/676 and 81/676, respectively). Intensive therapies such as vasoactive medications (12 cases of myocarditis) and intubation or mechanical ventilation (2 cases) were rare. There were no verified cases of myocarditis requiring a heart transplant, extracorporeal membrane oxygenation, or a ventricular assist device. Of the 96% (784/813) of cases of myocarditis who were hospitalized, 98% (747/762) were discharged from the hospital at time of review. In 87% (577/661) of discharged cases of myocarditis, there was resolution of the presenting symptoms by hospital discharge.

In this review of reports to VAERS between December 2020 and August 2021, myocarditis was identified as a rare but serious adverse event that can occur after mRNA-based COVID-19 vaccination, particularly in adolescent males and young men. However, this increased risk must be weighed against the benefits of COVID-19 vaccination. 18

Compared with cases of non–vaccine-associated myocarditis, the reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination were similar in demographic characteristics but different in their acute clinical course. First, the greater frequency noted among vaccine recipients aged 12 to 29 years vs those aged 30 years or older was similar to the age distribution seen in typical cases of myocarditis. 2 , 4 This pattern may explain why cases of myocarditis were not discovered until months after initial Emergency Use Authorization of the vaccines in the US (ie, until the vaccines were widely available to younger persons). Second, the sex distribution in cases of myocarditis after COVID-19 vaccination was similar to that seen in typical cases of myocarditis; there is a strong male predominance for both conditions. 2 , 4

However, the onset of myocarditis symptoms after exposure to a potential immunological trigger was shorter for COVID-19 vaccine–associated cases of myocarditis than is typical for myocarditis cases diagnosed after a viral illness. 24 - 26 Cases of myocarditis reported after COVID-19 vaccination were typically diagnosed within days of vaccination, whereas cases of typical viral myocarditis can often have indolent courses with symptoms sometimes present for weeks to months after a trigger if the cause is ever identified. 1 The major presenting symptoms appeared to resolve faster in cases of myocarditis after COVID-19 vaccination than in typical viral cases of myocarditis. Even though almost all individuals with cases of myocarditis were hospitalized and clinically monitored, they typically experienced symptomatic recovery after receiving only pain management. In contrast, typical viral cases of myocarditis can have a more variable clinical course. For example, up to 6% of typical viral myocarditis cases in adolescents require a heart transplant or result in mortality. 27

In the current study, the initial evaluation and treatment of COVID-19 vaccine–associated myocarditis cases was similar to that of typical myocarditis cases. 28 - 31 Initial evaluation usually included measurement of troponin level, electrocardiography, and echocardiography. 1 Cardiac MRI was often used for diagnostic purposes and also for possible prognostic purposes. 32 , 33 Supportive care was a mainstay of treatment, with specific cardiac or intensive care therapies as indicated by the patient’s clinical status.

Long-term outcome data are not yet available for COVID-19 vaccine–associated myocarditis cases. The CDC has started active follow-up surveillance in adolescents and young adults to assess the health and functional status and cardiac outcomes at 3 to 6 months in probable and confirmed cases of myocarditis reported to VAERS after COVID-19 vaccination. 34 For patients with myocarditis, the American Heart Association and the American College of Cardiology guidelines advise that patients should be instructed to refrain from competitive sports for 3 to 6 months, and that documentation of a normal electrocardiogram result, ambulatory rhythm monitoring, and an exercise test should be obtained prior to resumption of sports. 35 The use of cardiac MRI is unclear, but it may be useful in evaluating the progression or resolution of myocarditis in those with abnormalities on the baseline cardiac MRI. 36 Further doses of mRNA-based COVID-19 vaccines should be deferred, but may be considered in select circumstances. 37

This study has several limitations. First, although clinicians are required to report serious adverse events after COVID-19 vaccination, including all events leading to hospitalization, VAERS is a passive reporting system. As such, the reports of myocarditis to VAERS may be incomplete, and the quality of the information reported is variable. Missing data for sex, vaccination dose number, and race and ethnicity were not uncommon in the reports received; history of prior SARS-CoV-2 infection also was not known. Furthermore, as a passive system, VAERS data are subject to reporting biases in that both underreporting and overreporting are possible. 38 Given the high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination, underreporting is more likely. Therefore, the actual rates of myocarditis per million doses of vaccine are likely higher than estimated.

Second, efforts by CDC investigators to obtain medical records or interview physicians were not always successful despite the special allowance for sharing information with the CDC under the Health Insurance Portability and Accountability Act of 1996. 39 This challenge limited the ability to perform case adjudication and complete investigations for some reports of myocarditis, although efforts are still ongoing when feasible.

Third, the data from vaccination administration were limited to what is reported to the CDC and thus may be incomplete, particularly with regard to demographics.

Fourth, calculation of expected rates from the IBM MarketScan Commercial Research Database relied on administrative data via the use of ICD-10 codes and there was no opportunity for clinical review. Furthermore, these data had limited information regarding the Medicare population; thus expected rates for those older than 65 years of age were not calculated. However, it is expected that the rates in those older than 65 years of age would not be higher than the rates in those aged 50 to 64 years. 4

Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.

Corresponding Author: Matthew E. Oster, MD, MPH, US Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333 ( [email protected] ).

Correction: This article was corrected March 21, 2022, to change “pericarditis” to “myocarditis” in the first row, first column of eTable 1 in the Supplement.

Accepted for Publication: December 16, 2021.

Author Contributions: Drs Oster and Su had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Oster, Shay, Su, Creech, Edwards, Dendy, Schlaudecker, Woo, Shimabukuro.

Acquisition, analysis, or interpretation of data: Oster, Shay, Su, Gee, Creech, Broder, Edwards, Soslow, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, Lopes, Sperling, Baumblatt, Thompson, Marquez, Strid, Woo, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro.

Drafting of the manuscript: Oster, Shay, Su, Gee, Creech, Marquez, Strid, Woo, Shimabukuro.

Critical revision of the manuscript for important intellectual content: Oster, Shay, Su, Creech, Broder, Edwards, Soslow, Dendy, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, Lopes, Sperling, Baumblatt, Thompson, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro.

Statistical analysis: Oster, Su, Marquez, Strid, Woo, Shimabukuro.

Obtained funding: Edwards, DeStefano.

Administrative, technical, or material support: Oster, Gee, Creech, Broder, Edwards, Soslow, Schlaudecker, Smith, Baumblatt, Thompson, Reagan-Steiner, DeStefano.

Supervision: Su, Edwards, Soslow, Dendy, Schlaudecker, Campbell, Sperling, DeStefano, Shimabukuro.

Conflict of Interest Disclosures: Dr Creech reported receiving grants from the National Institutes of Health for the Moderna and Janssen clinical trials and receiving personal fees from Astellas and Horizon. Dr Edwards reported receiving grants from the National Institutes of Health; receiving personal fees from BioNet, IBM, X-4 Pharma, Seqirus, Roche, Pfizer, Merck, Moderna, and Sanofi; and receiving compensation for being the associate editor of Clinical Infectious Diseases . Dr Soslow reported receiving personal fees from Esperare. Dr Schlaudecker reported receiving grants from Pfizer and receiving personal fees from Sanofi Pasteur. Drs Barnett, Ruberg, and Smith reported receiving grants from Pfizer. Dr Lopes reported receiving personal fees from Bayer, Boehringer Ingleheim, Bristol Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, Portola, and Sanofi and receiving grants from Bristol Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi. No other disclosures were reported.

Funding/Support: This work was supported by contracts 200-2012-53709 (Boston Medical Center), 200-2012-53661 (Cincinnati Children’s Hospital Medical Center), 200-2012-53663 (Duke University), and 200-2012-50430 (Vanderbilt University Medical Center) with the US Centers for Disease Control and Prevention (CDC) Clinical Immunization Safety Assessment Project.

Role of the Funder/Sponsor: The CDC provided funding via the Clinical Immunization Safety Assessment Project to Drs Creech, Edwards, Soslow, Dendy, Schlaudecker, Lang, Barnett, Ruberg, Smith, Campbell, and Lopes. The authors affiliated with the CDC along with the other coauthors conducted the investigations; performed collection, management, analysis, and interpretation of the data; were involved in the preparation, review, and approval of the manuscript; and made the decision to submit the manuscript for publication.

Disclaimer: The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the CDC or the US Food and Drug Administration. Mention of a product or company name is for identification purposes only and does not constitute endorsement by the CDC or the US Food and Drug Administration.

Additional Contributions: We thank the following CDC staff who contributed to this article without compensation outside their normal salaries (in alphabetical order and contribution specified in parenthesis at end of each list of names): Nickolas Agathis, MD, MPH, Stephen R. Benoit, MD, MPH, Beau B. Bruce, MD, PhD, Abigail L. Carlson, MD, MPH, Meredith G. Dixon, MD, Jonathan Duffy, MD, MPH, Charles Duke, MD, MPH, Charles Edge, MSN, MS, Robyn Neblett Fanfair, MD, MPH, Nathan W. Furukawa, MD, MPH, Gavin Grant, MD, MPH, Grace Marx, MD, MPH, Maureen J. Miller, MD, MPH, Pedro Moro, MD, MPH, Meredith Oakley, DVM, MPH, Kia Padgett, MPH, BSN, RN, Janice Perez-Padilla, MPH, BSN, RN, Robert Perry, MD, MPH, Nimia Reyes, MD, MPH, Ernest E. Smith, MD, MPH&TM, David Sniadack, MD, MPH, Pamela Tucker, MD, Edward C. Weiss, MD, MPH, Erin Whitehouse, PhD, MPH, RN, Pascale M. Wortley, MD, MPH, and Rachael Zacks, MD (for clinical investigations and interviews); Amelia Jazwa, MSPH, Tara Johnson, MPH, MS, and Jamila Shields, MPH (for project coordination); Charles Licata, PhD, and Bicheng Zhang, MS (for data acquisition and organization); Charles E. Rose, PhD (for statistical consultation); and Scott D. Grosse, PhD (for calculation of expected rates of myocarditis). We also thank the clinical staff who cared for these patients and reported the adverse events to the Vaccine Adverse Event Reporting System.

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