FLOURESCENT LAMP
NAME PLATE
SPEAKER
STRIKE BUTTON
POWER SUPPLY SWITCH

#DEMGNETIZING SWITCH
SERVICE SOCKET
CASH BOX

COIN BOX KEY

#DEMGNETIZING SWITCH (Used only when correcting irregular colour when power switch is turned on.)

SPECIFICATION

POWER SUPPLY
AC100V - 240V (to be adjusted)

POWER CONSUMPTION
120W (AC100V)

GAME COST
ADJUSTABLE (REF. PAGE 3)

DIMENSIONS
W x D x H = 610 x 890 x 1700

CASH BOX CAPACITY
(2,200 coins of Yen ¥100.-)

CRT
20" Colour (monochro)

These specifications may be changed without notice.
As the CRT used is the same as that in home TVs care must be taken to avoid damage during transportation and installation.

As this set is for indoor use do not install outdoors.

Avoid places under direct sunlight and also avoid humid or dusty places.

Install on a solid level floor.

Leave a suitable space around the machine to avoid obstruction during play and maintenance.
BEFORE PLUGGING IN THE POWER CORD

USE THE DIP SWITCH TO SET YOUR MACHINE. IT IS LOCATED IN THE LOWER RIGHT AND ACCESSIBLE BY PULLING OUT PCB 1 AS SHOWN IN THE DIAGRAM.

EXAMPLE SET AT TIME OF SHIPMENT

SELECT YOUR COINAGE
SELECT REPLAY POINTS
REFER TO THE CHART FOR OTHER SETTINGS

PLUG IN THE POWER CORD (ARRANGE THE CORD SO THAT IT IS OUT OF THE CUSTOMERS WAY). TURN THE POWER SWITCH ON.

WHEN THE COLOUR IS IRREGULAR, PUSH THE DE MAGNETIZING SWITCH FOR 2 OR 3 SECONDS (SEE PAGES 1 & 9)

NO.
SET
FUNCTIONS

1

FOR ADJUSTMENT

2
ON
ON

3
ON
OFF

1500
3000

4
ON
ON

5
ON
OFF

3
4

BONUS POINTS

NUMBER OF HUNTERS

GAME CHARGE

NO.
SET
FUNCTIONS

6
ON
ON
OFF

7
ON
OFF
ON

1 coin
1 coin
2 coins

8
ON
PREVENT

OFF
TURNING

GAME SCREEN

| | | |

HOW TO PLAY

1. INSERT COIN

2. PUSH BUTTON ↓ FOR ONE PLAYER OR BUTTON ↓↓ FOR TWO PLAYERS AS DESIRED TO START.

3. ONE MOLE HUNTER WILL TRAVEL AUTOMATICALLY TO THE TOP CENTER OF THE SCREEN AND UPON HIS ARRIVAL THE MOLES WILL BURROW UNDERGROUND. THE GAME STARTS.

4. USE THE CONTROL LEVER TO MOVE THE HUNTER ACROSS, ALONG OR DIAGONALLY OVER THE SCREEN.

WHEN THE MOLES EMERGE TO EAT, STRIKE THEM.

THE HIGHEST SCORE ACHIEVED WHILE THE MACHINE IS ON WILL BE REGISTERED.

PARTNERS ↓↓ SCORE

SINGLE PLAYERS ↓ SCORE

PEANUT

DOTTED LIGHTS SHOWING WHERE THE MOLES ARE BURROWING

AFTER STRIKING A MOLE IT WILL RISE TO HEAVEN, LIKE THIS.

GRAND FATHER MOLE. HE IS ALWAYS WAITING FOR A CHANCE TO BITE THE HUNTER SO THE HUNTER SHOULD APPROACH HIM FROM BEHIND

NUMBER OF HUNTERS PER PLAY

HALF EATEN PEANUT

MOLE EATING A PEANUT

BABY MOLE EMERGING
5. IF THE HUNTER STRIKES THE
GRANDFATHER, HE WILL RECEIVE
50 POINTS BUT HE CANNOT KILL
THE GRANDFATHER UNTIL LAST
ONLY AFTER HE HAS DISPATCHED
ALL OF THE BABY MOLES.

6. THE BABY MOLES CANNOT HURT THE
HUNTER BUT THE GRANDFATHER
CAN. IF THE GRANDFATHER DOES
BITE THE HUNTER ANOTHER HUNTER
WILL MOVE ON SCREEN TO TAKE
HIS PLACE. HOWEVER IF THE
FOURTH HUNTER IS BITEN, TWO
CARRIERS WILL RUSH ON SCREEN
AND CARRY HIM OFF.

7. IF 2 PLAYERS ARE PLAYING AND THE
FIRST PLAYER LOSES ONE HUNTER THE
GAME WILL RETURN TO THE BEGINNING FOR
THE SECOND PLAYER TO COMMENCE.

8. IF THE HUNTER IS SUCCESSFUL IN
KILLING ALL OF THE BABY MOLES AND
FINALLY THE GRANDFATHER, HE WILL
RECEIVE 300 POINTS AND A FURTHER
100 POINTS FOR EACH PEANUT THAT
REMAINS.

9. THE HUNTER CANNOT GUESS WHERE THE
MOLES WILL EMERGE AND IF HE STRIKES
AT, AND MISSES ONE, THE GRANDFATHER
WILL LAUGH.

10. WHEN ALL OF THE HUNTERS HAVE BEEN
BITTEN AND THE LAST ONE CARRIED OFF
THE GAME IS OVER.

---

**SCORE**

GAME
POINTS

KILL BABY
30

STRIKE GRANDFATHER
50

KILL GRANDFATHER
300

REMAINING PEANUT
100

MORE HUNTER 2

IO and OPU boards same as

ASTRO FIGHTER - REFER TO
ASTRO FIGHTER TA-7 MANUAL,
電気図面です。図面の文脈や記号については不明です。
MOLE HUNTER

HOW TO PLAY

1. On the screen appear 16 baby moles and 16 peanuts. In the lower center lives Grandfather mole. In the top right hand corner, there are 4 mole hunters armed with hammers. (See Dia 1)

2. When you begin to play, one mole hunter will travel automatically to the center at the top of the screen. Upon his arrival, all the moles will disappear underground. The dotted lights showing where the moles are burrowing. (See Dia 2)
3. Soon, some baby moles will surface and begin to search for peanuts. However, they can only eat the peanuts if they can approach close enough to enter the dotted area around them. The hunter must try to kill the baby moles before all of the peanuts are eaten. (See Dia 3)

4. When the hunter kills a baby mole, they will go to heaven and points are awarded to the hunter. With the loss of each baby, the Grandfather cries. However, if the hunter strikes at and misses a baby, the Grandfather laughs. (See Dia 4)

5. If the Grandfather gets close to a peanut, he is able to eat it very quickly, but at this time, the hunter can strike him. When the hunter strikes the Grandfather, he will be awarded 150 or 300 mystery points, and will drive the Grandfather underground again. (See Dia 5)
6. However, the grandfather can hurt the hunter and is always waiting for a chance to attack


 more competitive in this market, and that is a good way to expand their business overseas.

\textsuperscript{6} CTS GAME STUDIES. Relatório de Investigação Preliminar: O Mercado Brasileiro de Jogos Eletrônicos.
3. POSSIBILITIES AND EXPECTATIONS

As we have discussed previously, the Brazilian gaming market is challenging for companies to establish operations, and for consumers who do not want (or cannot) pay high prices for games. But national companies are finding ways to contour difficulties and sustainably grow. If we observe some of the main products/services offered by national game companies we can find four main operations: 1) Mobile gaming; 2) Social media games and advergames; 3) Serious games and games for corporate training; 4) A small but emergent board/card games market. We will discuss each one in detail below:

1) Mobile gaming is a true emergent market for Brazilian developers. As mentioned before, the country has a wide base of mobile devices many of them included in the smartphone category with the feature of app downloading. Casual games deserve a highlight inside this context, and they can be defined, according to Trefay and Kaufmann (2010:1), as games that are quick to play, accessible and with simple mechanics. In this kind of game: the rules and goals must be clear; players need to be able to quickly reach proficiency; casual game play adapts to a player’s life and schedule; game concepts borrow familiar content and themes from life.

Lots of small publishers and studios are arising in the Brazilian mobile gaming scenario. Many mobile powerhouses are creating spaces for game developing inside their structures. As an example, we can bring the company named PontoMobi, that created in 2013 one game for a popular TV showman named Danilo Gentili; the game “The World Vs. Danilo Gentili7”. The game reached more than 100,000 download in few weeks and was offered to the users in a freemium model; Freemium (free + premium) is a business model by which a proprietary product or service (typically a digital offering such as software, media, games or web services) is provided free of charge, but money (premium) is charged for advanced features, functionality, or virtual goods (in that case, extra stages for the game).

Another example is the not-so-small company called Sioux, who has developed some mobile apps in partnership with “Grow”, a Brazilian company of toys and board games. One of their successes is the board game "Perfil" (which can be translated as Profile) where the player gets tips on famous people, places, things and years, and have to guess among some alternatives which is the right one – a classic Quiz Game. The mobile version made by Sioux

---

7 The game can be downloaded at https://itunes.apple.com/us/app/omvsdg-td/id473979611?mt=8
received 70,000 downloads in the first month, was among the top five in the AppStore Brazil and became one of the highlights in the Samsung Store.

2) Social media games and advergames are another way that Brazilian game designers found to make their games profit. The contemporary multiplatform environment, with so many connections between different devices, became a privileged ambient for the wide use of digital social networks and other technologies. In this context, all kinds of content can be consumed, shared and modified by the users, who also control their own modes of distribution.

Before we move on, it is important to explain that, in this context, we define social network sites in the words of Boyd and Ellison (2007), as web-based services that allow individuals to A) construct a public or semi-public profile within a bounded system, B) articulate a list of other users with whom they share a connection, and C) view and traverse their list of connections and those made by others within the system. The nature and nomenclature of these connections may vary from site to site.

It is also equally important to bring a definition of advergaming in this context. As we already discussed (BERIMBAU 2010: 61), there are many strategies in which brands can buy advertising space in the cyberspace of the game, like in-game advertising, dynamic in-game, game skinning, pre-game and post-game, static in-game and so on. More than to define the ever changing meaning of these practices, we need to understand that these communication strategies in videogames do not differ much from newspapers, TV programs, radio etc., in terms of media usage by ad makers. Here, brands too buy a place in a media that can (but not will) offer a content that is pertinent both to the media consumer and to the brand. Here, the relation of the brand with the game content looks more distant than the strategy of the advergame, that are, as defined by IAB, games created specifically for a brand, built from start to finish about a product or service. Here, the brand is not placed like an ad or a sponsor, somewhat dislocated from the experience generated through the game rules and aesthetics. In advergames, the fabric of meanings that constitute a brand are materialized within the dynamic and aesthetic of the game, producing experiences for the player that are uniquely relevant to that brand. Sports games, on the other hand, may seem as an exception, but they are not. It may seem that way because the sponsoring brands in racing cars or the ads on the edges of the soccer fields or tennis courts seem to give the player a better sense of reality,

---

8 This content is available at: [http://jcmc.indiana.edu/vol13/issue1/boyd.ellison.html](http://jcmc.indiana.edu/vol13/issue1/boyd.ellison.html) (last access: May, 2014)
trying to make the environment less fictitious to the player while simulating the experience of the consumption of the sport. In these cases, brands can be noted as “in the game”, and maybe even making it better somehow, but a game where Coke is present is not a game about Coke. The brand is not materializing its own semantic universe through the constituting elements of the game, but they are buying space (in this case, digital space) to be seen and remembered. In this sense, the game Doritos Crash Course looks more like a pertinent advergaming example as the constitutive elements of the game (rules and aesthetics) seek to give experiences to the player that promotes the symbolic consumption of the brand.

Digital environments are great places to simulate this type of advertising. Internet and videogames already have many games like that, and Mobile media (cellphones, iPads, iPhones) are increasingly being used by brands that choose this marketing strategy. Also, the evergrowing social networks like Facebook created a market for companies to develop games to social media and advergames. A company named Hive (www.hive.com.br) is one good example of an enterprise engaged in creating social games and advergames for global brands like Procter & Gamble and some local famous Brazilian brands, like the Skol beer.

3) Serious games and games for corporate training: following the thoughts of Nick Iuppa and Terry Borst (2007), this mode of game may be explained as games with a professional, educational or pedagogical use. Among electronic games, these serious games are the ones that most looks like advergames, in sense of its strategic use: in both, entertainment is the mean why the player is playing, but it is not why the game exists. There is the clear intention to communicate or teach something to the user. There are many companies like Games For Business (http://www.games4b.com.br/) that created many games for corporate training and ecological thinking. Some other are Aennova 360 (http://www.aennova.com/blog), E-Guru (http://www.e-guru.com.br/index.php/home) and OGG Corporate Simulations (http://www.ogg.com.br/index.php)

4) Board/card games market: This is still a fairly small market in Brazil, with some major players selling mostly traditional games. But since 2012 it is taking its first steps to new and creative products. Some of these big players are introducing European titles to the market and a still small company called “Galapagos jogos” is bringing some of the new successes of the United States and Europe board/ card game industry. Although we have not found any research on the subject, we can find some local evidence that this kind of gaming is showing signs of growing interest. Some of these evidences are the growth of local offer of new products, appearance of communities in social networks to arrange gamedays, promote trades and meetings; opening of board/ card games theme pubs etc. This kind of hobby is slowly
getting a wider base of fans. Also, many of the companies listed on topic 3 also work with board and card games while using this format for training and education, and we can also see some small independent game designers using crowdfunding to put their ideas in the market.

Thus, we could observe movements of industrial development and consumption of games on the national scene, but there is still much in potential. The question that emerges from this situation is: what does it take to make that potential become a fact? As noted in a Brazilian news site named [http://convergecom.com.br/](http://convergecom.com.br/), based on a recent research made by BNDES10 (National Bank for Economic and Social Development), gaming industry in the country needs more business experience. Brazil has lots of talents for programming, 3D design, game writing and sound design, but still has a


insight from this project would be a better understanding of how coordination and collaboration in highly competitive gaming worlds can build players’ motivations and confidence to engage in self-improvement and a number of social activities. These findings will lead to future research on designing digital games that better combines competitive and collaborative dynamics for effective social learning.
How, if at all, Can Students Benefit from Structured Competitive Play?

James Kozachuk, B.S.
University of Central Florida

There is a strong link between participation in structured after-school activities and increased academic achievement among high school students, while engagement in solo activities such as Television Watching has been found to decrease performance in school (Cooper, Valentine, Nye, & Lindsay, 1999). However, much of this research was conducted on sports teams and other structured groups (e.g. church groups) leaving a critical gap of assessing the impact of team-based competition separate from traditional sports. With video-games as such a mainstream source of entertainment for youth, playing these games at a competitive level with friends has begun to follow a similar trend. Electronic sports, or “esports,” refers to competitive video-game play, often played in organized teams. The aim of this research was to better understand what role, if any, organized competitive video-game play has on school performance and to perform an assessment of their suitability as a beneficial after-school activity. Previously, competitive video games have been criticized for increasing feelings of aggression and decreased academic achievement (Gentile, Lynch, Linder, & Walsh, 2004). While much of this research has been criticized (Ferguson, 2007) and esports are becoming an increasingly popular activity for young adults (Hollist, 2015), a dearth of studies are left in their place indicating assessing this research questions is a critical need in both the game and teamwork fields. The current research sought to assess this critical issue by measuring factors that influence team cohesion and academic performance among high school esports teams who play competitive video-games games in a varsity circuit and how this play impacted individuals’ team cohesion at the time of play and the specific factors that influence academic performance of esports team members. Five-hundred (500) students participating in an online varsity video-game league, upon completion of a 12-week competition, were surveyed about their high school team experiences. A structural equation model was built to determine the factors that influence team cohesion, motivation to play, and academic achievement within the esports players. As hypothesized, the amount of structure of the esports club was a moderate predictor of ($\beta = .14, p<.05$) academic performance (GPA, Number and percentage of honors classes taken) and the cohesiveness of the team ($\beta = .16, p<.05$). Additionally, self-reports of team performance were also associated with increased cohesiveness ($\beta = .32, p<.01$), but not motivation to play or academic performance. Amount of video-game play was associated with decreased academic performance ($\beta = .15, p<.05$), indicating that it is participation in the esports team not video game play that drives increased cohesion and academic performance. Additionally, we found another indirect effect of team cohesion on academic performance as teams that were more cohesive had members who were more intrinsically motivated to play ($\beta = .56, p <.001$) which lead to further increased academic achievement ($\beta = .11, p<.05$). The practical implications of this finding could be generalized to the realm of education. Providing a suitable outlet for students to socialize and interact with a community of peers similar to themselves would allow positive academic and social benefits to students. An example of this would be the inception of an esports team at Robert Morris University in Chicago, Illinois. With university investment, Robert Morris University created a high quality team experience for their students, resulting in large performance benefits: reaching high placements in numerous collegiate varsity tournaments in 2014 and 2015. High school such as Guilford High School in Rockford, Illinois, have also adopted similar programs that have been well received by administration, students, and parents. Industry involvement has begun to grow: a good example of this is acquisition of collegiate community organizer, “Tespa,” by Blizzard Entertainment in 2013. This new partnership brings structured community environments to students. Through our research, we hypothesize this kind of environment is bound to produce similar academic benefits demonstrated by the high school students without our sample. Through dissemination of this research to teachers, educators, and school-board members we have better informed potential relevant stakeholders to this positive academic experience, who in turn have begun to take action to help reduce the archaic resistance to allowing these clubs on their campuses. This leaves an opportunity for companies to help further advance the structure of these clubs through other supporting partnerships, such as easing the monetary cost of these high quality experiences through product sponsorships, interactivity with these students, or other quality program-building processes. One might ask why industry has been reluctant to invest in these teams: a misconception about the gaming community may be the answer. There is the common stereotype that avid video game players are seen as addicted which leads to further perpetuating the negative connotation that video game players are “low-class, proto-violent addicted and dangerous kids” (Beavis, 1998). This is due to the idea that game playing is addictive, which thus produces a particular form of gamer (Cover, 2006). This has many implications on industry and development in the gaming world. This also leads to the question of the legitimacy of gamers and their authenticity as members of a broad community. There are opportunities to take this research even further: within the literature there are additional benefits which have not been addressed in the present sample. These potential benefits include an increase in prosocial behavior (Kataoka & Vandell, 2013). Further research is currently being conducted within this domain, and we hope to better understand the importance of these high quality socialization experiences and their benefits to students. Through dissemination of this research to teachers, educators, and school-board members we have better informed potential relevant stakeholders to this positive academic experience, who in turn have begun to take action to help reduce the archaic resistance to allowing these clubs on their campuses.

REFERENCES<|endoftext|>The sequence of events in a novel leading to the climax

"Bakers make a lot of __" is an example of a pun

Personification gives __ characteristics to an inanimate object

"It is raining cats and dogs" is an example of an __

Logos is the use of __ in an argument

How a story is narrated is called the __ of view

Words used in everyday language or as a passing fad

"In Idaho, potatoes grow" is a __ order sentence

__ is the use of an emotional appeal in an argument

Making fun of human weakness or flaws is called __ in literature

A comparison using "like" or "as"

An object or person that stands for more than just itself

Standard English __ does not identify the writer's class or region

Ethos is the use of __ appeal in an argument

In synesthetic __, one sense represents another; "it smelled yellow"

A __ tells a story with human characters and lesson or moral

__ uses bitter or cutting remarks that often understate

The __ includes the time, place and mood of the story

__ sentences do not express a complete thought until the end

The __ is the introduction at the beginning of a story

An inner __ is a way of showing the stream of consciousness

A metaphor where a part represents the whole and vice versa

__ shows that two ideas are equal within a sentence

__ adds in extra words to extend the message that is being given

Smog is a well-known __ of smoke and fog

__ diction uses overly complex language to sound smarter

Buzz, huff, quack, moo, splash, beep, tick-tock

"It was only a little temblor" to describe an 8.6 earthquake

Enter unused letters from puzzle, in order:

___ __ __ __ __ __ __ __ __ __

___ __ __ __ __ __ __ __ __ __

___ __ __ __ __ __ __ __ __ __

Copy boxed letters to form your hidden message:

___________________________

Solve Hundreds of Clue Search Puzzles
Covering All Kinds of Topics for FREE!
No Membership or Email Required!
Visit us at www.ClueSearchPuzzles.com<|endoftext|>WE THANK YOU FOR PURCHASING OUR MOLE HUNTER.
WE ARE HOPEING THAT YOUR CUSTOMERS WILL ENJOY
THIS COLOURFUL HUNTING GAME. WE PRESENT THIS
MANUAL SO THAT YOU MAY HAVE MAXIMUM LIFE AND
ENJOYMENT FROM YOUR MACHINE.

INTRODUCTION FOR "MOLE HUNTER"
==================================

CONTENTS
Page.

1. Specifications
1

2. Installation
2

3. How to play
4

4. Maintenance
6

5. Maintenance chart
9

SPECIFICATIONS

SCREEN
HUNTERS MOVEMENT LEVER
HUNTER MAY BE MOVED ACROSS, ALONG OR DIAGONALLY OVER THE SCREEN.

NUMBER OF PLAYERS SELECTION BUTTONS (Plays available for single or double players)

COIN SLOT

COIN RETURN LEVER

COIN RETURN CUP

MAINTENANCE KEY.


 and high school students, and Dr. Guo Freeman has a robust background in studying social dynamics in multiplayer online games, and is using that knowledge to inform electronic sports research. This discussion panel will consist of ten-minute introductions by each of the panelists regarding their current relevant research and professional backgrounds, and will conclude the remainder with an open discussion panel. This panel hopes to explore questions such as:

• With the large reach of these competitive games for both players and spectators, why are there few psychological studies directly looking into the phenomenon of electronic sports?
• How can researchers recruit individuals for studies on electronic sports? What are the barriers to this research?
• In what ways can electronic sports-related research be conducted in the field of human factors psychology?
• How can research benefit the experience of esports players and spectators?
• What is the role of the spectator in esports? How can human factors better serve this demographic?
• What can we learn about other disciplines, such as traditional sports, through electronic sports research?
• Are the similarities between electronic sports and traditional sports similar enough to warrant future studies?

PANELISTS

How, if at all, does Playing Video Games Affect Attention and Cognition?
Cyrus K. Foroughi, M.A.
George Mason University

The rise in competitive esports and more generally in the amount of time that individuals spend playing video games has led researchers to begin to explore the above question. As human factors practitioners, we should investigate how humans interact with these technologies (i.e., video games), and whether those interactions affect attention and cognition.

Previous Research (Video Game Play). The seminal work by Green and Bavelier (2003) in Nature showed that individuals who self-report as playing video games have heightened attentional abilities. In studies 1-4, they showed that video game players (VGP) had better performance compared to non-video game players (nVGP) on a battery of tasks including the flanker, enumeration, useful-field-of-view, and attentional-blink tasks. These studies were supported by a 5th training study that showed that nVGP who played action video games had increased visual selective attention compared to controls, supporting a casual mechanism. Since then, many cross-sectional and training studies have supported their work (e.g., Cain, Landau, & Shimamura, 2012; Castel et al., 2004; Green & Bavelier, 2006; Green & Bavelier, 2007). However, many studies have failed to replicate these findings. Specifically, Boot and colleagues (2008) failed to replicate the findings of Green and Bavelier (2003) with a similar training study, and many studies have not replicated the cross-sectional findings (e.g., Irons, Remington, & McLean, 2001; Murphy & Spencer, 2009). Further, Boot, Blakely, & Simons (2011) pointed out methodological flaws in many previous studies and other possible explanations that could explain the previous findings. In sum, there is mixed evidence to support the claim that playing video games enhances attentional abilities.

Esports. Although researcher have begun to explore how playing video games may affect attention and cognition, little research exists that has examined how playing esports affects attention and cognition. Arguably, there are many similarities, but some differences are likely to exist. Most individuals who play/compete in esports likely represent the extreme end of individuals who play video games in terms of the amount of time played and the level of skill in the game. Thus, the obvious question is a classic “chicken or egg” question: how does one become an elite esport player? Taking Ericsson’s (Ericsson, Krampe, & Tesch-Römer, 1993) approach, does it requires countless hours of deliberate practice to become elite? Or do innate abilities such as a predisposition of improved reaction time come into play? Or, and this is the most likely scenario, what combination of both is required?
Assessing Esports Players. One important consideration is the feasibility of measuring the attentional and cognitive abilities of the elite esports players, in this case, professional video game players. This would provide a ceiling for which other data can be compared across video game domains. It is not easy recruiting professional gamers for research. These players travel often and dedicate large portions of their day to practicing. Contacting them can be difficult and attempting to find a time when they can complete an on-site experiment is nearly impossible. Fortunately, as a former professional gamer, I was able to reach out to a few of my friends, and gain access to some current professional action video game players for experiments. Thus, combining my former experience in gaming with my formal training in experimental research, I have started to bridge a gap in this area of research. Further, being someone that these players can relate with made our interactions very positive. Unsurprisingly, early data from our lab indicates that elite esports players (i.e., professional video game players) have attentional abilities that are “off the charts” with very low reaction times and excellent performance on many attentional tasks (e.g., flanker, SART). However, as this data is not final and as correlational does not mean causation, we caution our findings for the time being.

How, if at all, does Esports Shape Players’ Online and Offline Social/Interpersonal Relationships?

Guo Freeman, Ph.D.
University of Cincinnati

In the field of CSCW (Computer-Supported Cooperative Work) and HCI (Human-Computer Interaction), digital games have been considered an effective way to incorporate “warmth, playfulness, and poeticism” (Strong & Gaver, 1996) as powerful complements to design and develop any collaborative systems (Freeman, Bardzell, & Bardzell, 2016). There is already a large body of CSCW and HCI literature on social dynamics in gameplay (e.g., Brown & Bell, 2004; Ducheneaut, Moore, & Nickell, 2007; Ducheneaut & Moore, 2004; Freeman et al., 2015; McEwan et al., 2012). However, esports, as a new form of social gameplay intertwined with sports, collaboration, competition, cohesion, comradeship, blurred boundaries between online and offline social interactions, as well as game culture itself, has received relatively little research attention. The juxtaposition of the social meanings of competitive sports with the implementation of teamwork and collaboration as a game mechanic raises interesting questions about how studying social dynamics in esports can contribute to better designing games for social support and social learning. There is a growing body of scientific research on esports. For example, using interviews and ethnography, Taylor (2012) thoroughly investigates the connection between esports and sports, the path from amateur gaming to professional gaming, the structure and culture of esports, as well as gender issues in the traditionally male-dominated gaming world. By definition, esports is playing competitive games according to generally accepted rules of leagues and tournaments on the Internet (Weiss, 2008). On the one hand, esports are sophisticated Internet applications. Games such as FIFA video game series, Counterstrike (CS), Dota 2, and League of Legends (LoL) rely on advanced networking technologies to facilitate real-time inter-player interaction and competition. On the other hand, esports are highly complex sociotechnical systems. Players usually form small teams (e.g., “clubs”) to compete with other teams. In order to win in such highly competitive virtual environments, esports players extremely emphasize the sense of community, belongingness, cohesion, and comradeship among them. In contrast to regular multiplayer games in which players are physically distant and rarely meet one another offline, esports involve simultaneous watching gameplay on streaming websites (e.g., Twitch) and meeting others regularly at offline tournaments hosted by providers such as the League of Legends Tournament, the Electronic Sports League (ESL), and the National Gaming League. In all of these ways, esports in fact require and foster high level social skills (e.g., interaction, communication, cooperation, negotiation, and management) rather than undermining such skills. Then, the question becomes: How, if at all, do esports shape players’ social lives and interpersonal relationships, both online and offline? To explore this question, this research brings different perspectives and research methods to this topic. Specifically, this research has two contributions: First, it focuses on esports players’ social experiences and interpersonal relationships. This includes a scientific investigation of collaborative/competitive dynamics within the esports community and sheds light on the explicit and/or implicit impacts of esports on players’ collaborative learning and sociability. Second, by exploring when and how esports players feel enjoyment and emotional satisfaction in the interplay between game-mediated competition and collaboration, it endeavors to design and develop games for online social support. This points to future directions for designing value-sensitive and socially oriented games (Flanagan et al., 2005; Friedman, 1996) in contrast to the stereotype of revenue-oriented digital gaming industry. Both online and offline data will be collected for this research. The first type of data will be esports players’ self-reported data (i.e., posts and threads) of their gameplay and social experiences collected from popular online public forums for esports and public Facebook pages for esports teams. The second type of data source will be interview data. Esports players or people who engage in the esports community will be recruited to participate in semi-structured interviews. An in-depth qualitative analysis will be used to code and interpret the data, in order to explore participants’ unique and subjective personal experiences of esports and the rich sociocultural context surrounding their gameplay activities. At last, players’ in-game behaviors and go to public events/social gatherings/offline tournaments for esports will be observed to investigate their social interactions both online and offline. One


 and bite him. In order to defend himself, the hunter should attack the Grandfather smartly in the beginning. (See Dia 6)

7. If the Grandfather does bite the hunter, a new hunter will take his place. If the fourth and last hunter is bitten, however, two carriers will rush on screen and carry the wounded hunter off. (See Dia 7)

8. If the hunter is successful in killing all of the baby moles, he can then kill the Grandfather. When the hunter succeeds in striking the Grandfather, he will send the Grandfather slowly to heaven and be awarded 300 points plus a further 100 points for each peanut that remains. (see Dia 8)

This concludes play and the player will be returned to the start again. However your next play may prove more difficult as the moles movement will be faster.<|endoftext|>ABSTRACT

In this paper we seek to observe the Brazilian gaming market with special emphasis on its potential and peculiar characteristics. Videogames are leading and intertwining landmarks of contemporary culture and, in Brazil, they develop a special role inside the entertainment industry. The Brazilian gaming scenario has a great number of obstacles and difficulties in production and development and is characterized by its high taxes and the absence of big players in gaming industry producing games locally. This results in expensive games that can be bought mostly by the richer classes, which leads, in turn, to high levels of piracy. Despite these challenges, the Brazilian market promises enormous potential for exploring games in many different areas, mostly through digital informational/educational games. We intend to discuss this scenario observing some data and researches, establishing some directions for broader discussions about this promising and complicated communicational ecosystem.

Keywords: communication; Brazil; consumption; games; videogames; media;
1. A WORD ABOUT BRAZIL

As an emergent country, Brazil is a land of contrasts. The country is the fifth largest in the world, it has the sixth largest population and it ranks seventh in terms of Internet usage. Brazilians are heavy Internet users, spending the largest average number of hours online\(^1\), mainly in social network websites like Facebook, Instagram and Twitter.

It may sound curious, but it is a fact: the number of mobile phones in Brazil nowadays is larger than the size of its population. In the beginning of 2014, more than 270 million phone lines were in activity in the country and more than 30 million of smartphones are expected to be working\(^2\). This is an important point to highlight because in the last five years mobile Internet access has become the dominant in Brazil. A recent study from Nielsen has found that Brazilian mobile users mainly download games, social network and video applications\(^3\).

Acknowledging the prominence of digital culture in today's mediapolis (SILVERSTONE 2007), the large amount of videogames and digital platforms can be considered a privileged space for communication and marketing researchers of all kinds.

This kind of information helps us understand some features of the potential for a gaming market. Although we have no extensive research about the subject, there are some research efforts to better understand the Brazilian gaming market. One research presented in an important Brazilian videogame fair named "GameWorld" revealed that 60 million people have at least one videogame console at home. It is almost 33% of Brazil's population. The research revealed another curious fact: 48% of the players buy illegal games and only 17% of the sales occur at game shops\(^4\).

With this brief overview of the Brazilian gaming ecosystem, we will show deeper impressions, numbers and perceptions that we hope to help us broaden the discussion of this subject.

---

\(^1\) 23 hours a week, according to the latest available figures.

\(^2\) Source: [http://teleco.com.br/](http://teleco.com.br/) (last access: May, 2014)

\(^4\) Source: [http://jogos.uol.com.br/ultimas-noticias/2012/03/31/segundo-ibope-mais-de-60-milhoes-de-brasileiros-possuem-videogame-em-casa.htm](http://jogos.uol.com.br/ultimas-noticias/2012/03/31/segundo-ibope-mais-de-60-milhoes-de-brasileiros-possuem-videogame-em-casa.htm) (last access: May, 2014)
2. BRAZILIAN GAMING MARKET: FROM ORIGINS UNTIL TODAY

Videogames are a reality in Brazil since the late 1970s. At that time we had very few Brazilian programmers making games, but we had a lot of small industries copying games, but they could be regarded as "legally pirated" games. This began with a government practice in 1977 - and became an actual law in 1984, with the Federal Law 7.232/84 according to Chiado (2011:13) - in which government prohibits all computer hardware and software importation, as well as the establishment of foreign computer companies in the country – and that included videogames as well. With time, this law eventually opened a gap in the legal system which allowed domestic companies to copy the original hardware and software “adjusting” them to the Brazilian market, which basically consists in keeping the software intact and changing their titles, and making some minor changes in hardware (mostly aesthetic, but sometimes they were simpler versions of their original North American counterparts), and then releasing them without paying anything in royalties or copyright. This allowed many games to be released in the Brazilian market.

This situation may look a lot like the recent strategies of many Chinese industries, but with one major difference: the price of videogames for consumers in Brazil were very high - something between US$600.00 and US$1,000.00 for one videogame console. At that time, videogames were a product for the Brazilian richest – just a few could pay this much for electronic entertainment. This “legal piracy” kept going for some time, and only in 1983 Brazilian people saw the first official videogame in the country: The Atari 2600, known locally only as “Atari” and distributed by a Brazilian company called Polyvox, officially representing the American company in country.

In the late 1980s and 1990s this “legal piracy” was slowly losing its power and, at the same time, other brands officially arrived in Brazil: Nintendo and Sega first, and XBOX (Microsoft) and Sony later. However, games prices were kept very expensive - both consoles and software. Even when we observe the PC’s market, hardware and software appear as expensive goods. In the 2000s, PC games cost about US$ 70.00, and videogames about US$110.00. If we consider that the Brazilian family income per person of the 20% richest is, today, approximately US$ 1200.00, it is possible to realize that games have always been an entertainment for few people.

5 Source:
<http://www.ibge.gov.br/home/estatistica/populacao/condicaodevida/indicadoresminimos/sinteseindicessociais2013/default_tab.xls.shtm> (last access: May, 2014)
Despite being a very expensive product, a common practice in Brazil is the special financing offer of dividing the payment of the product among months, adding interest. It may be too difficult for an average Brazilian to pay US$1,000.00 for an XBOX ONE, but when one divides its payment equally into twelve months with one’s credit card, it gets a lot easier. This financial practice helped games became more and more a common practice among Brazilians, especially children and teenagers, which received these so desired expensive machines of entertainment mostly on commemorative days such as birthdays or Christmas gifts from their parents.

But what helped gaming culture spread through Brazilian media repertoire was piracy. Many people, until today, buy pirated goods or download it from the Internet. A researcher from MIT GAMBIT GameLab\textsuperscript{6} made it clear:

"Piracy begins when the system reaches an extreme point where it is more convenient and cheaper (than the correct, legal system). If ‘games’ are sold at a fair price and if they are accessible; if the distribution model is efficient and cheap and well done, no one will have a reason to go Pirate. Give people fair prices for products and make them more accessible – that is one way to combat piracy. If it’s accessible and the price is not abusive... What matters is convenience, and it has to surpass piracy. Then, it is not a problem anymore”.

In Brazil, piracy is quite high, but this looks like a consequence of the characteristics of the domestic market, which suffers mainly from high taxes, concentration of wealth, and lack of infrastructure. Certainly, that is something to be understood and dealt with, if any gaming company thinks of beginning operations locally.

More recently the gaming culture has emerged in other social classes. That happens due to the high market penetration of smartphones in the middle class (as we saw in the previous topic). Because of that, mobile gaming is increasingly becoming more present among the entertainment habits of Brazilian people. The mobile gaming market is a kind of “escape route” for game developers in Brazil, which have the possibility to create games and – effectively – make them available for download to the entire world. That is why many national companies are making games for tablets and smartphones, knowing that they can be


lack of professionals to consistently and sustainably develop the field. Still, it’s a seemingly ordinary idea in the national industry that most of the newly graduated game designers dream of making their own God of War game, or work in the next Call of Duty project – and that is something that he will not find here. As we have seen the local industry demands for people who THINK games, they are quick in solving production issues with simple and straightforward ideas and know how to use them as a means of communication, if necessary. It may not be a job that will offer all the glamour of having your name in the credits of a super-production, but by no means is it less challenging, demanding and interesting.

These main operation types of Brazilian companies and freelancers should be understood as illustrations of the national producer/consumer scenery. In no way we seek to include all the strategies of Brazilian gaming companies or exhaust the possibilities of activities on national or international gaming markets. We wish here to point to some characteristics of the national scene looking to shed light on the common sense that the "game industry" refers only to videogame consoles or mainstream PC games. This perception is something that specialized media seems to emphasize, because that seems to be the preference of games heavy users - although, as seen through research, the casual gamer plays more games and for longer than the hardcore gamer, as Juul (2010) says. For local producers, perhaps Steam, Apple Store, Google Play and gaming portals are more suitable as distribution channels, while research and development focused on training/education games seem to be a more fertile market.

---

10 Source: http://goo.gl/00Wi1X (last access: May, 2014)
4. IN SHORT

By discussing this overview about the Brazilian gaming market, we hope to demonstrate the different strategies that some companies utilize to explore the market and excel in this contemporary digital ecosystem.

The delicate relationship between consumers and brands/companies in a digital environment requires special care on both sides. Marketing and technology are no longer separate worlds and we can see it clearly in the videogames universe.

We welcome the opportunity to present this relevant discussion as a means of contributing to the ongoing efforts in exploring the Brazilian gaming market in contemporary media and consumption culture. We hope this brief paper inspires other researches and new ways to find answers in this prosperous and complicated entertainment market.
REFERENCES

TREFAY, Gregory; KAUFMANN, Morgan. *Casual Game Design*. Burlington: Morgan Kaufmann, 2010<|endoftext|>WE THANK YOU FOR PURCHASING OUR MOLE HUNTER.
WE ARE HOPEING THAT YOUR CUSTOMERS WILL ENJOY
THIS COLOURFUL HUNTING GAME. WE PRESENT THIS
MANUAL SO THAT YOU MAY HAVE MAXIMUM LIFE AND
ENJOYMENT FROM YOUR MACHINE.

INTRODUCTION FOR "MOLE HUNTER"
==================================

CONTENTS
Page.

1. Specifications
1

2. Installation
2

3. How to play
4

4. Maintenance
6

5. Maintenance chart
9

SPECIFICATIONS

SCREEN
HUNTERS MOVEMENT LEVER
HUNTER MAY BE MOVED ACROSS, ALONG OR DIAGONALLY OVER THE SCREEN.

NUMBER OF PLAYERS SELECTION BUTTONS (Plays available for single or double players)

COIN SLOT

COIN RETURN LEVER

COIN RETURN CUP

MAINTENANCE KEY.

FLOURESCENT LAMP
NAME PLATE
SPEAKER
STRIKE BUTTON
POWER SUPPLY SWITCH

#DEMGNETIZING SWITCH
SERVICE SOCKET
CASH BOX

COIN BOX KEY

#DEMGNETIZING SWITCH (Used only when correcting irregular colour when power switch is turned on.)

SPECIFICATION

POWER SUPPLY
AC100V - 240V (to be adjusted)

POWER CONSUMPTION
120W (AC100V)

GAME COST
ADJUSTABLE (REF. PAGE 3)

DIMENSIONS
W x D x H = 610 x 890 x 1700

CASH BOX CAPACITY
(2,200 coins of Yen ¥100.-)

CRT
20" Colour (monochro)

These specifications may be changed without notice.
As the CRT used is the same as that in home TVs care must be taken to avoid damage during transportation and installation.

As this set is for indoor use do not install outdoors.

Avoid places under direct sunlight and also avoid humid or dusty places.

Install on a solid level floor.

Leave a suitable space around the machine to avoid obstruction during play and maintenance.
BEFORE PLUGGING IN THE POWER CORD

USE THE DIP SWITCH TO SET YOUR MACHINE. IT IS LOCATED IN THE LOWER RIGHT AND ACCESSIBLE BY PULLING OUT PCB 1 AS SHOWN IN THE DIAGRAM.

EXAMPLE SET AT TIME OF SHIPMENT

SELECT YOUR COINAGE
SELECT REPLAY POINTS
REFER TO THE CHART FOR OTHER SETTINGS

PLUG IN THE POWER CORD (ARRANGE THE CORD SO THAT IT IS OUT OF THE CUSTOMERS WAY). TURN THE POWER SWITCH ON.

WHEN THE COLOUR IS IRREGULAR, PUSH THE DE MAGNETIZING SWITCH FOR 2 OR 3 SECONDS (SEE PAGES 1 & 9)

NO.
SET
FUNCTIONS

1

FOR ADJUSTMENT

2
ON
ON

3
ON
OFF

1500
3000

4
ON
ON

5
ON
OFF

3
4

BONUS POINTS

NUMBER OF HUNTERS

GAME CHARGE

NO.
SET
FUNCTIONS

6
ON
ON
OFF

7
ON
OFF
ON

1 coin
1 coin
2 coins

8
ON
PREVENT

OFF
TURNING

GAME SCREEN

| | | |

HOW TO PLAY

1. INSERT COIN

2. PUSH BUTTON ↓ FOR ONE PLAYER OR BUTTON ↓↓ FOR TWO PLAYERS AS DESIRED TO START.

3. ONE MOLE HUNTER WILL TRAVEL AUTOMATICALLY TO THE TOP CENTER OF THE SCREEN AND UPON HIS ARRIVAL THE MOLES WILL BURROW UNDERGROUND. THE GAME STARTS.

4. USE THE CONTROL LEVER TO MOVE THE HUNTER ACROSS, ALONG OR DIAGONALLY OVER THE SCREEN.

WHEN THE MOLES EMERGE TO EAT, STRIKE THEM.

THE HIGHEST SCORE ACHIEVED WHILE THE MACHINE IS ON WILL BE REGISTERED.

PARTNERS ↓↓ SCORE

SINGLE PLAYERS ↓ SCORE

PEANUT

DOTTED LIGHTS SHOWING WHERE THE MOLES ARE BURROWING

AFTER STRIKING A MOLE IT WILL RISE TO HEAVEN, LIKE THIS.

GRAND FATHER MOLE. HE IS ALWAYS WAITING FOR A CHANCE TO BITE THE HUNTER SO THE HUNTER SHOULD APPROACH HIM FROM BEHIND

NUMBER OF HUNTERS PER PLAY

HALF EATEN PEANUT

MOLE EATING A PEANUT

BABY MOLE EMERGING
5. IF THE HUNTER STRIKES THE
GRANDFATHER, HE WILL RECEIVE
50 POINTS BUT HE CANNOT KILL
THE GRANDFATHER


 includes a scientific investigation of collaborative/competitive dynamics within the esports community and sheds light on the explicit and/or implicit impacts of esports on players’ collaborative learning and sociability. Second, by exploring when and how esports players feel enjoyment and emotional satisfaction in the interplay between game-mediated competition and collaboration, it endeavors to design and develop games for online social support. This points to future directions for designing value-sensitive and socially oriented games (Flanagan et al., 2005; Friedman, 1996) in contrast to the stereotype of revenue-oriented digital gaming industry. Both online and offline data will be collected for this research. The first type of data will be esports players’ self-reported data (i.e., posts and threads) of their gameplay and social experiences collected from popular online public forums for esports and public Facebook pages for esports teams. The second type of data source will be interview data. Esports players or people who engage in the esports community will be recruited to participate in semi-structured interviews. An in-depth qualitative analysis will be used to code and interpret the data, in order to explore participants’ unique and subjective personal experiences of esports and the rich sociocultural context surrounding their gameplay activities. At last, players’ in-game behaviors and go to public events/social gatherings/offline tournaments for esports will be observed to investigate their social interactions both online and offline. One insight from this project would be a better understanding of how coordination and collaboration in highly competitive gaming worlds can build players’ motivations and confidence to engage in self-improvement and a number of social activities. These findings will lead to future research on designing digital games that better combines competitive and collaborative dynamics for effective social learning.
How, if at all, Can Students Benefit from Structured Competitive Play?

James Kozachuk, B.S.
University of Central Florida

There is a strong link between participation in structured after-school activities and increased academic achievement among high school students, while engagement in solo activities such as Television Watching has been found to decrease performance in school (Cooper, Valentine, Nye, & Lindsay, 1999). However, much of this research was conducted on sports teams and other structured groups (e.g. church groups) leaving a critical gap of assessing the impact of team-based competition separate from traditional sports. With video-games as such a mainstream source of entertainment for youth, playing these games at a competitive level with friends has begun to follow a similar trend. Electronic sports, or “esports,” refers to competitive video-game play, often played in organized teams. The aim of this research was to better understand what role, if any, organized competitive video-game play has on school performance and to perform an assessment of their suitability as a beneficial after-school activity. Previously, competitive video games have been criticized for increasing feelings of aggression and decreased academic achievement (Gentile, Lynch, Linder, & Walsh, 2004). While much of this research has been criticized (Ferguson, 2007) and esports are becoming an increasingly popular activity for young adults (Hollist, 2015), a dearth of studies are left in their place indicating assessing this research questions is a critical need in both the game and teamwork fields. The current research sought to assess this critical issue by measuring factors that influence team cohesion and academic performance among high school esports teams who play competitive video-games games in a varsity circuit and how this play impacted individuals’ team cohesion at the time of play and the specific factors that influence academic performance of esports team members. Five-hundred (500) students participating in an online varsity video-game league, upon completion of a 12-week competition, were surveyed about their high school team experiences. A structural equation model was built to determine the factors that influence team cohesion, motivation to play, and academic achievement within the esports players. As hypothesized, the amount of structure of the esports club was a moderate predictor of ($\beta = .14, p<.05$) academic performance (GPA, Number and percentage of honors classes taken) and the cohesiveness of the team ($\beta = .16, p<.05$). Additionally, self-reports of team performance were also associated with increased cohesiveness ($\beta = .32, p<.01$), but not motivation to play or academic performance. Amount of video-game play was associated with decreased academic performance ($\beta = .15, p<.05$), indicating that it is participation in the esports team not video game play that drives increased cohesion and academic performance. Additionally, we found another indirect effect of team cohesion on academic performance as teams that were more cohesive had members who were more intrinsically motivated to play ($\beta = .56, p <.001$) which lead to further increased academic achievement ($\beta = .11, p<.05$). The practical implications of this finding could be generalized to the realm of education. Providing a suitable outlet for students to socialize and interact with a community of peers similar to themselves would allow positive academic and social benefits to students. An example of this would be the inception of an esports team at Robert Morris University in Chicago, Illinois. With university investment, Robert Morris University created a high quality team experience for their students, resulting in large performance benefits: reaching high placements in numerous collegiate varsity tournaments in 2014 and 2015. High school such as Guilford High School in Rockford, Illinois, have also adopted similar programs that have been well received by administration, students, and parents. Industry involvement has begun to grow: a good example of this is acquisition of collegiate community organizer, “Tespa,” by Blizzard Entertainment in 2013. This new partnership brings structured community environments to students. Through our research, we hypothesize this kind of environment is bound to produce similar academic benefits demonstrated by the high school students without our sample. Through dissemination of this research to teachers, educators, and school-board members we have better informed potential relevant stakeholders to this positive academic experience, who in turn have begun to take action to help reduce the archaic resistance to allowing these clubs on their campuses. This leaves an opportunity for companies to help further advance the structure of these clubs through other supporting partnerships, such as easing the monetary cost of these high quality experiences through product sponsorships, interactivity with these students, or other quality program-building processes. One might ask why industry has been reluctant to invest in these teams: a misconception about the gaming community may be the answer. There is the common stereotype that avid video game players are seen as addicted which leads to further perpetuating the negative connotation that video game players are “low-class, proto-violent addicted and dangerous kids” (Beavis, 1998). This is due to the idea that game playing is addictive, which thus produces a particular form of gamer (Cover, 2006). This has many implications on industry and development in the gaming world. This also leads to the question of the legitimacy of gamers and their authenticity as members of a broad community. There are opportunities to take this research even further: within the literature there are additional benefits which have not been addressed in the present sample. These potential benefits include an increase in prosocial behavior (Kataoka & Vandell, 2013). Further research is currently being conducted within this domain, and we hope to better understand the importance of these high quality socialization experiences and their benefits to students. Through dissemination of this research to teachers, educators, and school-board members we have better informed potential relevant stakeholders to this positive academic experience, who in turn have begun to take action to help reduce the archaic resistance to allowing these clubs on their campuses.

REFERENCES<|endoftext|>Squirt Bottle Game

Supplies:
Spray bottle set at the tight setting
Light weight balls
Broom/mop handles or other side rails
Flat table
Towel for drying between turns
Directions:
Arrange the broom handles, or other type of rails, along the long sides of the table. You can place a container at the receiving end to catch the balls. A water proof table cloth at this end is also a good idea to keep the area dry.
Have the child sit or stand at one end of the table with a ball in front of her/him. Give them the spray bottle and have them squirt the ball all the way down until it drops off the other end of the table. The child may need to use both hands and, if the child is very young or very weak, they may need hand-over-hand assistance.<|endoftext|>Exploring electronic sports: An interdisciplinary approach

James Kozachuk, B.S., University of Central Florida, Orlando, FL
Cyrus K. Foroughi, M.A., George Mason University, Fairfax, VA
Guo Freeman, Ph.D., University of Cincinnati, Cincinnati, OH

INTRODUCTION

Electronic Sports, or “esports,” refers to high-level play and spectating of digital video-games (Hamilton, 2012), and typically involves a team of players. These players perform at the peak level of performance in these games—making reflexive and precise hand-movements, taking in and responding to large amounts of information, and work effectively with their team. The large similarities that this form of competition has with traditional sport has lead the U.S. government to begin assigning P-1A athletic visas to competitors. This field has grown drastically over the last decade—more competitions and players are participating and events attract millions of worldwide online spectators. In this panel we will discuss current research involving these players in the fields of human-computer interaction, team dynamics, cognition, information processing, as well as the potential applications in other subfields. The panelists have both direct research and professional experience with electronic sports: Cyrus Foroughi will provide insight as a former professional-gamer, James Kozachuk has run multiple nationwide tournaments for college


Exploring electronic sports: An interdisciplinary approach

James Kozachuk, B.S., University of Central Florida, Orlando, FL
Cyrus K. Foroughi, M.A., George Mason University, Fairfax, VA
Guo Freeman, Ph.D., University of Cincinnati, Cincinnati, OH

INTRODUCTION

Electronic Sports, or “esports,” refers to high-level play and spectating of digital video-games (Hamilton, 2012), and typically involves a team of players. These players perform at the peak level of performance in these games—making reflexive and precise hand-movements, taking in and responding to large amounts of information, and work effectively with their team. The large similarities that this form of competition has with traditional sport has lead the U.S. government to begin assigning P-1A athletic visas to competitors. This field has grown drastically over the last decade—more competitions and players are participating and events attract millions of worldwide online spectators. In this panel we will discuss current research involving these players in the fields of human-computer interaction, team dynamics, cognition, information processing, as well as the potential applications in other subfields. The panelists have both direct research and professional experience with electronic sports: Cyrus Foroughi will provide insight as a former professional-gamer, James Kozachuk has run multiple nationwide tournaments for college and high school students, and Dr. Guo Freeman has a robust background in studying social dynamics in multiplayer online games, and is using that knowledge to inform electronic sports research. This discussion panel will consist of ten-minute introductions by each of the panelists regarding their current relevant research and professional backgrounds, and will conclude the remainder with an open discussion panel. This panel hopes to explore questions such as:

• With the large reach of these competitive games for both players and spectators, why are there few psychological studies directly looking into the phenomenon of electronic sports?
• How can researchers recruit individuals for studies on electronic sports? What are the barriers to this research?
• In what ways can electronic sports-related research be conducted in the field of human factors psychology?
• How can research benefit the experience of esports players and spectators?
• What is the role of the spectator in esports? How can human factors better serve this demographic?
• What can we learn about other disciplines, such as traditional sports, through electronic sports research?
• Are the similarities between electronic sports and traditional sports similar enough to warrant future studies?

PANELISTS

How, if at all, does Playing Video Games Affect Attention and Cognition?
Cyrus K. Foroughi, M.A.
George Mason University

The rise in competitive esports and more generally in the amount of time that individuals spend playing video games has led researchers to begin to explore the above question. As human factors practitioners, we should investigate how humans interact with these technologies (i.e., video games), and whether those interactions affect attention and cognition.

Previous Research (Video Game Play). The seminal work by Green and Bavelier (2003) in Nature showed that individuals who self-report as playing video games have heightened attentional abilities. In studies 1-4, they showed that video game players (VGP) had better performance compared to non-video game players (nVGP) on a battery of tasks including the flanker, enumeration, useful-field-of-view, and attentional-blink tasks. These studies were supported by a 5th training study that showed that nVGP who played action video games had increased visual selective attention compared to controls, supporting a casual mechanism. Since then, many cross-sectional and training studies have supported their work (e.g., Cain, Landau, & Shimamura, 2012; Castel et al., 2004; Green & Bavelier, 2006; Green & Bavelier, 2007). However, many studies have failed to replicate these findings. Specifically, Boot and colleagues (2008) failed to replicate the findings of Green and Bavelier (2003) with a similar training study, and many studies have not replicated the cross-sectional findings (e.g., Irons, Remington, & McLean, 2001; Murphy & Spencer, 2009). Further, Boot, Blakely, & Simons (2011) pointed out methodological flaws in many previous studies and other possible explanations that could explain the previous findings. In sum, there is mixed evidence to support the claim that playing video games enhances attentional abilities.

Esports. Although researcher have begun to explore how playing video games may affect attention and cognition, little research exists that has examined how playing esports affects attention and cognition. Arguably, there are many similarities, but some differences are likely to exist. Most individuals who play/compete in esports likely represent the extreme end of individuals who play video games in terms of the amount of time played and the level of skill in the game. Thus, the obvious question is a classic “chicken or egg” question: how does one become an elite esport player? Taking Ericsson’s (Ericsson, Krampe, & Tesch-Römer, 1993) approach, does it requires countless hours of deliberate practice to become elite? Or do innate abilities such as a predisposition of improved reaction time come into play? Or, and this is the most likely scenario, what combination of both is required?
Assessing Esports Players. One important consideration is the feasibility of measuring the attentional and cognitive abilities of the elite esports players, in this case, professional video game players. This would provide a ceiling for which other data can be compared across video game domains. It is not easy recruiting professional gamers for research. These players travel often and dedicate large portions of their day to practicing. Contacting them can be difficult and attempting to find a time when they can complete an on-site experiment is nearly impossible. Fortunately, as a former professional gamer, I was able to reach out to a few of my friends, and gain access to some current professional action video game players for experiments. Thus, combining my former experience in gaming with my formal training in experimental research, I have started to bridge a gap in this area of research. Further, being someone that these players can relate with made our interactions very positive. Unsurprisingly, early data from our lab indicates that elite esports players (i.e., professional video game players) have attentional abilities that are “off the charts” with very low reaction times and excellent performance on many attentional tasks (e.g., flanker, SART). However, as this data is not final and as correlational does not mean causation, we caution our findings for the time being.

How, if at all, does Esports Shape Players’ Online and Offline Social/Interpersonal Relationships?

Guo Freeman, Ph.D.
University of Cincinnati

In the field of CSCW (Computer-Supported Cooperative Work) and HCI (Human-Computer Interaction), digital games have been considered an effective way to incorporate “warmth, playfulness, and poeticism” (Strong & Gaver, 1996) as powerful complements to design and develop any collaborative systems (Freeman, Bardzell, & Bardzell, 2016). There is already a large body of CSCW and HCI literature on social dynamics in gameplay (e.g., Brown & Bell, 2004; Ducheneaut, Moore, & Nickell, 2007; Ducheneaut & Moore, 2004; Freeman et al., 2015; McEwan et al., 2012). However, esports, as a new form of social gameplay intertwined with sports, collaboration, competition, cohesion, comradeship, blurred boundaries between online and offline social interactions, as well as game culture itself, has received relatively little research attention. The juxtaposition of the social meanings of competitive sports with the implementation of teamwork and collaboration as a game mechanic raises interesting questions about how studying social dynamics in esports can contribute to better designing games for social support and social learning. There is a growing body of scientific research on esports. For example, using interviews and ethnography, Taylor (2012) thoroughly investigates the connection between esports and sports, the path from amateur gaming to professional gaming, the structure and culture of esports, as well as gender issues in the traditionally male-dominated gaming world. By definition, esports is playing competitive games according to generally accepted rules of leagues and tournaments on the Internet (Weiss, 2008). On the one hand, esports are sophisticated Internet applications. Games such as FIFA video game series, Counterstrike (CS), Dota 2, and League of Legends (LoL) rely on advanced networking technologies to facilitate real-time inter-player interaction and competition. On the other hand, esports are highly complex sociotechnical systems. Players usually form small teams (e.g., “clubs”) to compete with other teams. In order to win in such highly competitive virtual environments, esports players extremely emphasize the sense of community, belongingness, cohesion, and comradeship among them. In contrast to regular multiplayer games in which players are physically distant and rarely meet one another offline, esports involve simultaneous watching gameplay on streaming websites (e.g., Twitch) and meeting others regularly at offline tournaments hosted by providers such as the League of Legends Tournament, the Electronic Sports League (ESL), and the National Gaming League. In all of these ways, esports in fact require and foster high level social skills (e.g., interaction, communication, cooperation, negotiation, and management) rather than undermining such skills. Then, the question becomes: How, if at all, do esports shape players’ social lives and interpersonal relationships, both online and offline? To explore this question, this research brings different perspectives and research methods to this topic. Specifically, this research has two contributions: First, it focuses on esports players’ social experiences and interpersonal relationships. This


90 (as defined by the original treatment plan) with increasing VS accumulation leading to a sub-optimal coverage of the PTV_Eval. For 30 cc MLB catheter, V100 decreased by 1.4% and V90 decreased by 0.9% for every 1 cc of VS. For 45cc MLB catheter, V100 decreased by 1.3% and V90 decreased by 1.15% for every 1.0 cc accumulation of VS.

Conclusions: Balloon catheter-tissue adherence ensures daily dose delivery to the planned PTV_Eval. Accumulation of seroma, hematoma or air between HDR fractions can significantly impact PTV_Eval dosimetry. Vacuum-port aspiration prior to delivery of each fraction, if available, should be considered to minimize the risk of geographic under dosing.

J Contemp Brachyther 2012; 4, 2: 101-105
DOI: 10.5114/jcb.2012.29366

Key words: seroma, dosimetry, breast brachytherapy, contura catheter.
Material and methods

This is a dosimetric re-planning study using two volumes (30 cc and 45 cc) in a Contura® MLB catheter model. The Contura® balloon catheter was used for this study, because it is the only FDA-approved balloon brachytherapy device currently on the market that contains a vacuum port specifically designed to aspirate seroma, hematoma and/or air collection. Proof of principle of aspiration of the accumulated seroma via the vacuum port is shown in Fig. 1.

Two customized optimal treatment plans (for balloon volumes of 30 and 45 cc) were first generated using a single patient scan. Uniform balloon expansion of 1 mm increments around the balloon surface was then performed to simulate a theoretical and symmetrical “virtual seroma” (VS) accumulation up to 9 mm (Fig. 2). The volume (in cc) of this expansion was calculated by the Eclipse Brachyvision™ (Varian Inc., Palo Alto, CA) software to estimate each VS. With the use of the multiple (up to 5) channels of the Contura® catheter, the plans were generated prescribing 3.4 Gy per fraction to a “PTV_Eval” (a 10 mm PTV with appropriate modifications for skin and chest wall per RTOG 0413 guidelines).

New individualized plans were then generated for each 1 mm increment, representing additional accumulating VS, resulting in 10 plans for each balloon volume. Each potential plan scenario and dose-volume histograms were individually generated to compare changes in dosimetric coverage of the initially defined PTV_Eval. PTV_Eval dosimetry was then analyzed independently for each plan to assess the effect of the VS on the percent volume of PTV_Eval covered by the 100% isodose line (IDL) (V100) and the percent volume of PTV_Eval covered by the 90% IDL (V90).

Results

A total of twenty individual and customized 3-dimensional brachytherapy plans were generated for this comparative dosimetric study (ten each for 30 cc and 45 cc balloon volumes), representing VS volumes of 6-60 cc. For each simulated plan, the accumulation of VS volume resulted in increased distance separating peri-cavity breast tissue target from the balloon surface. This separation produced a commensurate decrease in the V100 and the V90 of the PTV_Eval (as defined by the original treatment plan) with increasing VS accumulation. Table 1 shows the effect of increasing seroma accumulation on the plans generated for 30 cc and 45 cc balloon, respectively. Each increasing uniform expansion of the balloon catheter to simulate VS resulted in a symmetrical volumetric target separation. This translated into a corresponding decrease in V100 and V90. Tabular data is represented as a scatter plot for 30 cc and 45 cc balloon catheters in Figs. 3, 4 and 5, 6, respectively. The best-fit-line model for 30 cc balloon showed that V100 coverage of the PTV_EVAL decreased by 1.4% for every 1 cc accumulation of VS (Range = 7-10% for every 5-7 cc). A similar pattern was noted for the scatter plot analysis for 45 cc catheter, where V100 was shown to decrease by 1.3% for every 1 cc accumulation of VS (Range = 6-9% for every 5-7 cc). For V90, scatter plot analyses revealed a decreased coverage of 0.9% for every 1 cc of VS for 30 cc balloon plans and 1.15% for 45 cc balloon plans.
Table 1. Twenty plans based on 30 and 45 cc balloon catheters

Plan #
Increase in balloon to breast tissue distance (mm)
30 cc balloon catheter plans
45 cc balloon catheter plans

Seroma volume (cc)
Vol of PTV_Eval covered by 100% IDL (cc)
% of initial PTV_Eval covered by 90% IDL (V90)

1
0
65.6
100

2
1
6
59.6

3
2
10.3
55.3

4
3
15.7
49.9

5
4
21.8
43.8

6
5
28.2
37.4

7
6
34.9
30.7

8
7
41.8
23.8

9
8
49.3
16.3

10
9
59.2
9.9

Note: The table includes the effect of accumulating seroma causing an increase in balloon to breast tissue distance. This in turn affects the volume and percentage of the initial PTV_Eval covered by 100% (V100) and 90% (V90) IDL, leading to sub-optimal plans. IDL – isodose line.

Fig. 3. Scatter plot and best fit line of V100 for repeat plans with increasing seroma volumes for 30 cc balloon catheter

Fig. 4. Scatter plot and best fit line of V90 for repeat plans with increasing seroma volumes for 30 cc balloon catheter

Fig. 5. Scatter plot and best fit line of V100 for repeat plans with increasing seroma volumes for 45 cc balloon catheter

Fig. 6. Scatter plot and best fit line of V90 for repeat plans with increasing seroma volumes for 45 cc balloon catheter
Discussion

Seroma is formed by acute inflammatory exudates in response to surgical trauma and acute phase of wound healing. Although the pathophysiology of seroma is incompletely understood, the formation seems to be correlated with certain cytokine levels and body mass index [11,19]. With regards to breast brachytherapy, post-treatment seroma formation has been shown to be more likely to result from "open" (intra-operative) versus "closed" (post-operative) placement of the balloon brachytherapy catheter. Soran et al. [20] showed a 20% rate of persistent seroma (> 6 months) with open placement versus 0% for post-operative placement. Cosmetic outcomes were also noted to be worse in patients with seroma. Watkins et al. [21] showed that the only factor identified as statistically significant for the development of any seroma was catheter placement on a day of resection vs. ≥ 1 day later (59% vs. 33%). Numerous recent imaging studies have shown that the lumpectomy cavity volume changes significantly in time frames relevant to radiotherapy planning and delivery [16,17,22-27]. The range of average volume changes reported in these studies was 22.5-64% [16,27]. The change in volume of the seroma has been shown to affect the


of drugs, individual differences of drug responses, patient counseling, pharmaco-economic aspects, social aspects of drug use and misuse, correlation between clinical trials and clinical practice, formulations of better therapeutic guidelines, discovery of new indications, new drug discovery etc.
Hypertensive disorders are the most common medical complications of pregnancy with a reported incidence ranging from 6 to 10% [3]. The incidence varies among different hospitals, regions and countries. In addition, these disorders are a major cause of maternal and prenatal mortality world wide [4].

Hypertensive pregnant mothers have greater risks for premature deliver, intrauterine foetal death, growth retardation and abruption placenta, they also have an increased risk of vascular injury with thrombotic microangiopaty and co-agulopathy, cerebral haemorrhage, and multi organ injury especially of kidney and liver.

So as to avoid all such complications, it is better to start the treatment with antihypertensive after assessing correct stage and class of hypertension and always prescribe the safe drug to avoid adverse effects over the foetus and mother.

The goal of antihypertensive therapy is to protect the mother from the extremes of hypertension and potential morbidity, there by, allowing the pregnancy to continue and the foetus to grow and mature normally. Observations should be made on teratogenic risks, potential adverse effects on foetal cardiovascular of end organ function and a potential impact on foetal growth and uteroplacental haemodynamics and perfusion.

In contrast with drug utilization study, pharmacoepidemiological studies are the study of effects of the drugs in a large number of persons [5-7]. Recently the definition has been changed as “the study of distribution and determinants of drug related events in population and application of this for the safe and efficacious drug use with special emphases on the resulting medical, social and economic consequences” [8].

The first study in drug utilization can be traced back to the thalidomide tragedy when SPIERS made an extensive study of prescriptions in an area of Scotland called Stirling-shire to retrieve prescriptions written for thalidomide for majority of mothers[9].

The errors in prescriptions are not uncommon. This could be due to ignorance or inadequate knowledge about the disease and the pharmacology of the drugs prescribed. Erroruated prescriptions are recognized even in tertiary care hospital [10].

As prescribing habits differ from doctor to doctor and several factors influence drug prescription. It has been proposed that there are differences in prescribing due to differences in therapeutic approach among doctors in different countries [11].

MATERIALS & METHODOLOGY

Two teaching hospitals namely Govt. General Hospital and Sangmeshwar Teaching Hospital, Gulbarga attached to M. R. Medical College, Gulbarga were selected for our prospective study. Out of these, one is a Government Hospital and the other is a Private Hospital. This was done, keeping in view the patients of two economic classes (Higher / Lower). Both the hospitals have full fledged facilities of a tertiary care hospital.

The patients were selected from any of the units belonging to the department. Hence the teaching staff of the concerned units and postgraduate students was involved in the study. The plan of the study was discussed with them and information regarding the use of drugs in detail was sought. Some information was directly taken from the patients. The chief complaints, detailed history of the past and present, vital parameters, physical signs and investigations done were recorded. The total duration of the study was for a period of 2 years i.e., January 2003 to January 2005.

Core Indicators

i) Prescribing indicators :

a) Average number of drugs per encounter was calculated by dividing the total number of different drug products prescribed by the number of encounters surveyed.
b) Percentage of drugs prescribed by generic name was determined by dividing the number of drugs prescribed by generic name by the total number of drugs prescribed, multiplied by 100.

c) Percentage of drugs prescribed from essential drug list was determined by dividing the number of products prescribed from essential drug list of the hospital by the total number of drugs prescribed, multiplied by 100.

ii) Patient care indicators:

a) Average consultation time was determined by dividing the total time for a series of consultations, by the actual number of consultations.

b) Patients’ knowledge of correct dosage was found by dividing the number of patients who can adequately report the dosage schedule for all drugs, by the total number of patients interviewed, multiplied by 100.

iii) Facility Indicators:

a) Availability of copy of EDL by stating yes (or) no.

b) Availability of key drugs was calculated by dividing the number of specified products. Actually in stock by the total number of drugs on the check list of essential drugs multiplied by 100.

Complementary Indicators:
Total cost of the drugs was calculated by considering the cost for each 10 tab used in the study.

Definition of risk factors:
These definitions are those used by the United States food and Drug Administration (FDA).[12]

Category A:
Controlled studies in women fail to demonstrate a risk to the foetus in the 1st trimester (and there is no evidence of a risk in later trimesters), and the possibility of foetal harm remains remote.

Category B:
Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Category C:
Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women and animals are not available. Drugs should be given only if the potential benefits justify the potential risk to the foetus.

Category D:
There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g. if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Category X:
Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use drug in pregnant women clearly outweighs any possible benefits. The drug is contraindicated in women who are, or may become pregnant. The drugs used are shown in table- 1.

Antihypertensive used against Risk factors used by the United States Food and drug Administrator are categorized into A, B, C, D, X. Statistical analysis was done by simple sampling method.

Statistical Analysis:
Statistical analysis was done by simple sampling method.
RESULTS
A total of 200 prescriptions were collected. 21% were with essential hypertension, 25% were with Transient hypertension, 51% were with Pre eclampsia and 103% were with Eclampsia. The key drug indicators are given in table-2.

Names of Drugs
Sangameshwar Hospital
Govt. General Hospital
Category of drugs

Tab. Myogard (Nifedipine)
89
82
C

Tab. Ditide (Benzthiazide+Triamterence)
74
38
C

Inj. Lasix (Furosemide)
41
34
C

Tab. Stamlo (Amlodipine)
28
7
C

Tab. Depin (Nifedipine)
7
4
C

Tab. Methyl dopa (Methyldopa)
4
9
B

Tab. Nicardia Retard (Nifedipine)
1
--
C

Tab. Aten (Atenolo)
3
--
D

Tab. Amlong (Amlodipine)
2
3
C

Tab. Aldactone (Spironolactone)
2
--
C

Tab. Alphadopa (Methyldopa)
1
2
B

DISCUSSION
Eclampsia is considered to be a life threatening emerging for both mother & foetus. Magnesium Sulfate is found to be the drug of choice, a (anticonvulsant) as Magnesium Sulfate does not treat hypertension, antihypertensives have to be used which are beneficial to both mother & baby [13].

The incidence of hypertension in pregnancy was highest among primigravida our study correlates with the same as Cheeley in


medical
  concern from the review of a premarket submission and/or observed issues from the
  premarket data, a recall, medical device reports (MDRs), case studies, literature, or
  another source.
- Is the public health issue device-specific or device type-specific?
- For a device for which a condition of clearance or approval is being considered, can and
  should the public health question be addressed premarket rather than as part of a 522
  order?
- Is there any other source of data (e.g., MDR review, published literature, real-world
  data sources) or action (e.g., revised labeling, public health notice, recall), or a
  combination thereof, that may be used to address the public health question, instead of a
  522 order?
- Does another ongoing study (e.g., premarket approval application (PMA) post-approval
  study as described in 21 CFR 814.82(a)(2) and 21 CFR 814.82(a)(9)) address the public
  health question?
- What types of 522 postmarket surveillance design(s) should be recommended? Feasibility
  and timeliness of the different types of postmarket surveillance should be considered.
- What combination of efforts should be considered to address the public health question?
  In addition, when applicable, what changes, if any, are being made with regard to the
  premarket review?

D. Considerations Regarding Pediatric Population Provisions

As noted above, the statute authorizes postmarket surveillance for class II and III devices that
are “expected to have a significant use in pediatric populations” and also authorizes the
Agency to order postmarket surveillance as a condition of clearance or approval for devices
expected to have significant use in pediatric populations.4,5 These provisions are not limited to

4 Sections 522(a)(1)(A)(ii) and 522(a)(1)(B)
5 Since “pediatric populations” is not defined in section 522 of the FD&C Act, for the purposes of 522 orders, FDA
devices labeled for pediatric uses, and therefore specific consideration is given to devices with anticipated pediatric use.

Note that section 402(j)(1)(A)(ii) of the Public Health Service Act (PHS Act) (42 U.S.C. § 282(j)(1)(A)(ii)) also states that any “pediatric postmarket surveillance required under section 522” is considered to be an “applicable device clinical trial.” As such, the pediatric postmarket surveillance must be in compliance with the registration and results submission requirements of section 402(j) of the PHS Act (42 U.S.C. § 282(j)). Additional information on these requirements can be found at https://clinicaltrials.gov/.

FDA intends to work with the manufacturer to help FDA determine the appropriate timeframe for a pediatric 522 postmarket surveillance study.

E. Issuance of 522 Order

The 522 order will specify the device(s) subject to the surveillance order and the reason that we are requiring postmarket surveillance (i.e., the public health question(s)). The order will also typically include any general or specific guidance that is available to assist the manufacturer subject to the 522 order in preparing the postmarket surveillance plan. FDA intends to identify the premarket submission involved (i.e., premarket notification [510(k)], PMA, humanitarian device exemption (HDE) application, or De Novo request) in the 522 order. A 522 order could also include timelines for certain surveillance plan milestones such as subject enrollment, data accrual, and submission of the final report, depending on the plan and timing of the order. If a manufacturer disagrees with any order or condition requiring postmarket surveillance under section 522 of the FD&C Act, a manufacturer may request review under section 562 of the FD&C Act (see section 522(c) of the FD&C Act) and other options are further described in 21 CFR 822.7.

Section 522(a)(1)(A) of the FD&C Act specifies that the Agency may issue a postmarket surveillance order at the time of device approval or clearance or any time thereafter. When a 522 order is being considered for issuance at the time of market authorization, FDA may advise the manufacturer of the potential 522 order and the surveillance plan schedule. Pursuant to Section 522(b)(1) each manufacturer must develop and submit for FDA approval a postmarket surveillance plan within 30 days of receiving the order (see also 21 C.F.R. 822.9 and 822.10). Section 522(b)(1) of the FD&C Act provides that a manufacturer must commence postmarket surveillance not later than 15 months after the day the order is issued. FDA typically considers postmarket surveillance to have commenced when the first subject is enrolled as outlined in the approved surveillance plan. For plans that do not involve enrollment of subjects (e.g., non-clinical studies), FDA considers postmarket surveillance to

is defining pediatric populations to mean patients who are 21 years of age or younger at the time of diagnosis or treatment, that is, from birth through the twenty-first year of life, up to, but not including the patient’s twenty-second birthday. This definition is consistent with the definition of “pediatric patients” under section 520(m)(6)(E)(i) of the FD&C Act, which was added to the FD&C Act at the same time as the pediatric use criterion in section 522.

6 21 CFR 822.5.
7 Ibid
have commenced when data accrual has started as outlined in the approved surveillance plan.\(^8\) In FDA’s experience, surveillance plans that require enrolling subjects in a prospectively-targeted manner are more likely to achieve timely completion by following the recommended schedule below from the date of issuance of the 522 order.

- Study commenced within 15 months
- 20% of subjects enrolled within 18 months
- 50% of subjects enrolled within 21 months
- 100% of subjects enrolled within 24 months

### III. Postmarket Surveillance Plans

FDA will assign a postmarket surveillance (PS) order number (i.e., PS####) to each 522 order. Manufacturers should cite the assigned PS number when submitting a proposed postmarket surveillance plan. Surveillance plans are reviewed as supplements to the PS order number. If there are multiple postmarket surveillance questions in a 522 order that require different methodologies to address each question, then a separate postmarket surveillance plan should be submitted for each question, and it is tracked as an individual requirement under the PS order number. FDA will confirm receipt and identify each plan submission by a unique document number.\(^9\)

A manufacturer must submit a postmarket surveillance plan within 30 calendar days of receipt of the 522 order.\(^10\) Per Section 522(b)(1) of the FD&C Act and 21 CFR 822.17, FDA will review postmarket surveillance plans and respond within 60 calendar days of receipt. FDA intends to promptly review postmarket surveillance plans and work interactively with the manufacturer in order to issue a decision within 30 calendar days of receiving the plan. The manufacturer should prioritize resolution of any surveillance plan deficiencies identified by the Agency and work interactively with the FDA to facilitate that a full surveillance plan review can be achieved within 60 calendar days from the issuance of the 522 order date.

#### A. General Information

The general content and format of a postmarket surveillance submission is outlined in 21 CFR 822.9. See Appendix 1 for CDRH’s internal checklist for determining whether a submission is administratively complete in accordance with 21 CFR 822.9.

#### B. Elements to Include in a Postmarket Surveillance Plan

As outlined in 21 CFR 822.10, the following sections must be included in your postmarket surveillance plan:

---

\(^8\) For non-clinical surveillance/studies data, accrual milestone reports may be used to track progress.

\(^9\) See 21 CFR 822.8.

\(^10\) Section 522(b)(1) of the FD&C Act and 21 CFR 822.8
Contains Nonbinding Recommendations

Draft – Not for Implementation

- postmarket surveillance plan objectives addressing the surveillance question(s)\textsuperscript{11}
- postmarket surveillance approach (i.e., design) or methodology to be used\textsuperscript{12} (see Section III.E. of this guidance), we recommend including the hypothesis(es) and success criteria
- the subject of the study,\textsuperscript{13} e.g., the patient population (may include subject inclusion and exclusion criteria and definition and source of comparator group)
- the variables and endpoints for assessing the surveillance question(s),\textsuperscript{14} such as the primary and secondary endpoints; we recommend including definitions for endpoints, a list of expected adverse events/complications, an agreement to collect unexpected adverse events, and a plan to assess relatedness of endpoints with the device and/or the procedure
- sample size;\textsuperscript{15} we recommend including sample size calculation that is statistically justified and based on study hypothesis, where applicable
- description of the data source (e.g., hospital records