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Salads and First Courses
Catering + Menu Design
Beverages + Bar
Entertainment + Music
Lighting + Production
Corporate Event Gallery
Community + Philanthropy
What makes Jane Hammond Events unique is our genuine love for what we do and the working relationships we develop. We pride ourselves in treating our clients, as well as our venue contacts, vendors and staff with personal attention and respect. Many of our dedicated employees have worked with us for over 10 years, demonstrating their long term commitment and loyalty. As most of our chefs and service staff have worked with us for such a long time, we have created a close knit and cooperative dynamic that adds to the professional and friendly feel of your event. Additionally, we have built partnerships with many well loved and trusted Bay Area vendors to complement our event planning services.
Jane Hammond, Owner and Planner Extraordinaire
Jane grew up in England and has a background in the sciences. She went on to train at the Cordon Bleu in London, and started her catering career in England before moving to America in 1975. Jane taught cooking in the U.S. for several years, and then began her professional catering career. Jane Hammond Events has been growing ever since and under her kind and careful direction has expanded into the highly respected full service company it is today.
Amy Trapp, Senior Event Manager
Amy has worked for JHE for over 20 years and is involved in every aspect of running the company. Prior to joining JHE, she graduated from St. Lawrence University, traveled extensively and worked in the political arena. Amy began working in our kitchen and serving at events and has evolved into our senior events coordinator and manager. Amy brings incredible attention to detail and personal warmth to all our events and clients.
Naomi Ages, Senior Event Manager
Naomi is a graduate of UC Berkeley, and has lived abroad in Central America and Chile. She loves speaking Spanish, volunteering as a doula, and hiking the East Bay hills. She joined the JHE team in 2005, initially as the staffing manager, and soon made herself indispensible to every aspect of the business. Naomi considers JHE to be like her family; she is proud to be part of a team that provides warm and personalized attention to each client. She currently serves as an Event Planner and Manager.
Ceanna Stephens, Senior Event Manager
Ceanna joined the JHE team in 2006. She graduated from the University of Oregon with a degree in International Studies. Ceanna spent many years working in the non-profit educational field and traveled extensively internationally. It was her love of trying foods around the world and taking many cooking courses along the way that led her to the catering industry. Ceanna manages many of our corporate events and weddings.
Olivia Rick, Event Manager
Olivia grew up cooking with her mother but fell in love with food while studying sustainable food ideologies and movements in Italy. After receiving her B.A in International Relations from the University of Minnesota, she decided to get hands on culinary training, which included Gather Restaurant, in Berkeley. She first joined the JHE team in 2010. In her free time, she volunteers teaching cooking and nutrition classes to children and families.
James Timpanaro, Staffing Manager and Event Designer
James originally hails from the East Coast, but has been a San Francisco denizen for the last 13 years. He joined the JHE team in 2016 and brought in fresh energy to our event design, as well as taking over the role of staffing manager. James is known for his incredible attention to detail and eye for creative design. Outside of work he is a dog enthusiast and world traveler.
Jason Echols, Executive Chef
Jason has been professionally cooking for 20 years, both in restaurants and the catering industry. Outside work he enjoys live music and spending time with his son Milo.
Kent K.
Kent graduated on the Dean's list from both the California Culinary Academy ('95) and Johnson and Wales University ('00.) His experience is in fine dining, including the Cypress Club, Carnelian Room and the St. Regis Hotel. Kent has competed in and received several awards from various culinary competitions. His love for food brought his travels to over 15 countries, which helped to shape his palate and cuisine.
Yolanda and Beatriz
Yolanda and her daughter Beatriz have been a part of the JHE team for over 20 years, keeping our kitchen organized and sparkling for every event
Dan Rosenbach
Dan Rosenbach is our in-house DJ, lighting designer and electronics guru. Dan also serves as the Emcee for many of our events, and additionally runs our photobooth operation. He has worked with JHE since 2011. Dan graduated from Rutgers University in 2000 with a BS in Management.
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redpajama_set_name: RedPajamaCommonCrawl


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Acting CEO of Serbia's power utility EPS quits after several major outages
Acting director of Elektroprivreda Srbije (EPS) Milorad Grčić resigned from his post following five outages and fires in Serbia's coal power industry in the past month. The thermal power plant collapse on December 11 even threatened the stability of the European grid. Grčić has held the position since 2016 in breach of rules on the management of state-owned enterprises.
An excavator that deposits mine tailings in the Kolubara coal mining basin caught fire on January 10. According to Deputy Prime Minister and Minister of Mining and Energy of Serbia Zorana Mihajlović, it may take up to one year to repair the machine, bought in 2018 for almost EUR 19 million. Acting director of state-owned coal and electricity producer Elektroprivreda Srbije Milorad Grčić submitted his resignation, but he also accused Mihajlović of trying to destroy the company.
It was the fifth major incident in EPS since December 12, when the two biggest thermal power plants shut down as the lignite was laden with mud. The outage forced the country to turn to emergency imports.
The collapse at Serbia's biggest coal-fired power plants a month ago resulted in emergency imports of electricity at high prices
ENTSO-E – the European Network of Transmission System Operators, later said it registered frequency deviations since the same date due to a drop in production in the southeast and urged for the issues to be resolved. They were exacerbated by December outages in coal-fired plants in Kosovo*.
President Aleksandar Vučić recently said Grčić needs to go, after the TENT B plant broke down again because of a fire and a damaged coal mill.
The acting director was appointed in 2016 and his term expired after one year, but he was left at the helm of the dominant power producer until now in breach of law. Program Director of Transparency Serbia Nemanja Nenadić has noted that Grčić actually didn't qualify to become the head of EPS in the first place. He explained the chief executives of state-owned enterprises must have at least five years of relevant experience but that Grčić got a university diploma only four years before he was appointed.
Chief executives of state-owned enterprises must have at least five years of relevant experience but Grčić got a university diploma only four years before he was appointed
The domestic media and EPS union chief Milan Đorđević learned that Executive Director for Electricity Generation Technical Affairs Miroslav Tomašević is the most likely successor.
The combined costs of emergency power imports and repairs of the damages suffered in the past month are estimated at several hundred million euros. The consequences of the latest fire on electricity production are yet to be seen.
* This designation is without prejudice to positions on status and is in line with UNSCR 1244/99 and the ICJ Opinion on the Kosovo declaration of independence.
Tags: electricity, Elektroprivreda Srbije, EPS, Milorad Grčić
Home » News » Electricity » Acting CEO of Serbia's power utility EPS quits after several major outages


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NBA Star Danny Green Talks NBA-Level Training, Working With Puma, and Why Core Strength Is Important for Basketball Players
by Matthew Jussim
NBA guard Danny Green is thriving with the Toronto Raptors. After spending the previous eight seasons with the San Antonio Spurs and establishing himself as one of the top 3-point shooters in the league while winning the 2014 NBA championship, Green was traded to the Raptors alongside All-Star Kawhi Leonard. (Update: Green is now with the Lakers.)
Basketball Is Back: The Minimally Informed Man's Guide to the 2018-19 NBA Season
While the trade was a major change for Green, the guard has been playing as well as he ever has on the court. Through 25 games since going North of the border, Green is putting up career-high numbers in numerous categories, including field goal percentage, 3-point shooting percentage, offensive rebounds, and 3-pointers made per game.
Green's play—along with Leonard's strong play—has the Raptors off to a franchise best start and thinking about making a run to the NBA Finals. Green's been relishing his time with the Raptors, and has been enjoying his experience with the fans in the city.
"It definitely helps to adjust easier when you're winning," Green says. "The organization of people, teammates they've done a great job helping me feel at home, myself and Kawhi, it's been great. City has been amazing, always loved this city even before I became a Raptor. Fans have been awesome embracing me, and making me feel like I've been there for years. Winning makes it comfortable, but it's been great so far."
Green has also started working with PUMA, partnering with the brand earlier this season on a multi-year deal. The company announced the deal with a pretty awesome video featuring Green and, yes, some actual pumas.
#Repost @pumahoops with @get_repost ・・・ IT'S OFFICIAL. We here at @thetorontozoo introducing @greenranger14 to the extended family. WELCOME to the #pumafam 🌊🌊🌊 #bigcats
A post shared by Danny Green (@greenranger14) on Oct 9, 2018 at 3:55pm PDT
Green is excited to get to work and is looking forward to the collaboration and partnership going forward: "It's been amazing, I've had a great time getting started with Puma, they've done a great job of giving me everything I need," Green says. "They're very stylish and new. The shoes are very comfortable and they've been great for me. They help a lot with everything I'm doing on and off the court. I'm excited to partner with them and working with them for years to come."
Green spoke with Men's Journal about his training routine, how he prepares for the NBA season, his excitement about working with PUMA, and what it's like playing in Toronto.
What's your workout routine like in the offseason?
In the summer we do a lot more heavy loads and workouts. I'll do two-a-day training sessions, lifting and on the court work, for more hours than I usually will during the season. When the season is going on, it's not as much heavy stuff, it's more correctives and stuff to maintain strength and make sure no injuries happen. Preseason is about conditioning and getting into basketball shape, because there's no real way to prepare for that except for playing. During the year it's taking care of your body, treatment, shooting, a lot of corrective work and activation of your muscles, and making sure you're staying on top of your health and staying on top of your body.
What are some of your favorite moves to use in your training?
I enjoy lifting, whether it's squats, benching, all that stuff. The feeling of being sore isn't the greatest thing, but it makes you feel the way you're supposed to be. And once you get used to it and take care of that soreness, you get into a good flow of training. This summer I did a lot of stuff with the CoreX, Alex McKechnie [The Raptors' Director of Sports Science] invented it, and it did a great job for me helping my core.
What types of workouts do you enjoy doing most?
I like doing game situation-type workouts and game simulated workouts, where you're not just running in place on a treadmill, but you're out there on the court or in the gym, going through the same moves you'd do on the court. Coming off screens, running around cones and changing directions, moves to the basket. I try and get a lot of repetition on those moves, it's the better route to getting in shape than running on a track or running on treadmill because you're putting your body through the same movements you'll be doing on the court during the season. You have an end result in mind. I'll do a lot of shooting on the move, running and shooting, because that's a big part of my game. It puts you in situations that are game-like.
You've joined up with PUMA. What's the partnership been like so far?
It's great to be part of the team. I'm excited about working with Puma. They have a great group of people at Puma, and the guys with them on their roster from the league are great as well. I'm excited to be part of that and excited to see the new shoes and gear they put together as we move forward. It's been great to start, and I'm ready for even more moving forward.
IT'S OFFICIAL. We here at @thetorontozoo introducing @greenranger14 to the extended family. WELCOME to the #pumafam 🌊🌊🌊 #bigcats
A post shared by PUMA Basketball (@pumahoops) on Oct 9, 2018 at 3:48pm PDT
If you could use only one type of workout to train for basketball what would it be?
For me, I'm a shooter. The game has changed so much, and everyone needs to be able to shoot beyond the perimeter, even the bigger guys who play power forward or center. Working on your ball handling is important, but I think those game-situation drills, perfecting your shot, your form, and your touch with the ball are really important for players. You don't have to be the tallest guy, if you can shoot it well, you can get very far in the game of basketball.
What's your recovery routine like?
After games I definitely have to ice, I do a foot bath for my calves, Achilles, and feet, and an ice bath or an ice tub. I do some stretching, I have a NormaTec I use as well. That helps me recover. I'll get some treatment and massage to help my body and muscles recover. It takes me a couple hours, if you're taking things seriously with your body and recovery, you have to stay on top of it and put in the time. It should take you at least an hour or two hours if you're putting the right focus on it.
What other workouts have you used in your training?
During my time in San Antonio we did some boxing workouts, we did some yoga, pool workouts, we did pilates as well. I think all those things are great. Especially in the summertime and preseason I'll do a lot of that. During the year I don't do that as much, but I'll try and do some yoga. Yoga and Pilates translate to the court to me by keeping my body loose, and they both help with injury prevention. That's key for us, you need to feel right game in and game out, and the only way to do that is to do your recovery and keep yourself loose. It also helps make me feel stable.
What are some of the things you enjoy doing most off the court?
I love watching movies and TV series, I watch all types of genres. I'm trying to branch out and learn off the court and learn what I want to do when my career is over. Broadcasting is something I'm interested in. I love to hang with the dog, chill with the family too. I watch a lot of different sports, different games, a little bit of everything. I like bowling, and enjoying the sites of the city wherever I'm at, whether it's a new restaurant or something new to do.
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Panthers sweep SDSU at Frost
spkoob
UNI showed the Jacks what a mid-major power can do on the courts.
SDSU's 3-0 loss to UNI at Frost Arena on Nov.7 featured a program at the top of their game and another searching for answers to a lost season.
The 12th-ranked Panthers jumped out to a 3-0 lead in set one and never really looked back, sweeping the Jacks by scores of 25-22, 25-20 and 25-18.
SDSU didn't have an answer for UNI setter Bre Payton, who posted 32 assists along with 11 kills in only 14 attempts. Blocking UNI's Krista DeGeest was also a problem for the Jacks. DeGeest recorded a .571 attack percentage and finished the night with a match high of 13 kills.
Phil McDaniel, SDSU head coach, had the scouting edge for the match, having coached at Drake against UNI in the Missouri Valley Conference the previous three seasons. That edge didn't seem to factor much into the final decision, though.
"Obviously UNI's a very good team," McDaniel said. "I've known that group for four years now, coming from the Valley, and they're well coached and very athletic and move the ball around very well."
Battling from behind the whole first set, the Jacks pulled within one point but couldn't get past the fast-paced UNI offense.
Set two was close to the same story. Instead of playing from behind from the get-go, the Jacks held a slim lead during the first half of the set, but UNI wouldn't go away and ended the match with four straight kills. The Panthers picked up right where they left off in set three, and the Jacks really didn't have much of a chance for a comeback.
The Jacks have suffered from mental mistakes and inconsistent play all season long and last Monday wasn't any different.
"I don't think we did terrible," Kelli Fiegen said. "We could've done better, kind of sloppy and we just weren't engaged the whole time."
Fiegen nailed a team high of 10 kills, followed by Kelly Herrmann and Kaitlin Klingemann with nine and eight kills, respectively. The Jacks finished the night with a .164 attack percentage for an offense that looked out of sync most of the match.
What's the biggest difference between the two programs that battled in Frost Arena on Nov. 7?
"They've got the complete group there and I'd say we're missing a couple pieces," McDaniel said.
UNI extended its winning streak to 17 games while the Jacks fell to 13-18 overall. The match showed what tradition can do for a program and what SDSU needs to work on.
"The [tradition] is passed down from year to year with new freshmen coming in knowing that they have to work hard," Fiegen said. "I think we could do a better job of taking a little bit more pride in our game and playing for South Dakota State."
Issue: The Metaverse is Meta-stupid


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C3D1 girls soccer championship: Cape Central vs. North County
Jacob Wiegand
The Cape Central Tigers defeated North County High School 2-0 to win the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau.
Cape Central's Payton Alexander (4), holding plaque, celebrates with Emma Winkler (11), right, and other teammates following the Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
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Cape Central's Emma Huff (1) goes up for the ball during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Payton Alexander (4) goes to kick the ball next to North County's Jillian Wruck (26) during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
North County's Erin Gantz (11), Emily Veach (2), Kayleigh Winch (40) and Ashlyn Moore (1) form a wall for a kick during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. Cape Central earned a point as a result of the kick. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Payton Alexander (4) and Emma Winkler (11) celebrate a goal during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Emma Winkler (11), center facing forward, and Bradyn Pittman (7), right facing forward, celebrate a Tiger goal with Abigail Clippard (14), center, Emma Huff (1), left, and other teammates during the Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Emma Winkler (11) goes up for the ball during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Emily Spinner (15) kicks the ball during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Anna Mattison (23) goes after the ball near North County's Ashlyn Moore (1) during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
North County's Erin Gantz (11) and Cape Central's Abigail Clippard (14) go up for the ball during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Emily Spinner (15) and North County's Gabriella Gant (19) go after the ball during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Abigail Clippard (14) goes up for the ball near North County's Gabriella Gant (19) during the Cape Central Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Payton Alexander (4) accepts the championship plaque near Mattie Huff (2), Emma Winkler (11) and other teammates following the Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Payton Alexander (4) holds up the championship plaque near Emma Winkler (11) and other teammates during the Tigers' 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Tigers have their picture taken following Cape Central's 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
Cape Central's Payton Alexander (4) and Mattie Huff (2) hold up three fingers with other teammates following the Cape Central's 2-0 win over North County High School in the Class 3 District 1 championship Thursday, May 16, 2019, at Cape Central High School in Cape Girardeau. (Jacob Wiegand ~ Southeast Missourian)
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Meta-analysis of cardiovascular superiority trials published in the New England Journal of Medicine to elucidate the concept of superiority margin
Nanda Gamad,
Nusrat Shafiq,
http://orcid.org/0000-0002-6049-1628Samir Malhotra
Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
Correspondence to Professor Samir Malhotra, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India; smal.pgi{at}gmail.com
Objective To show that overpowered trials claim statistical significance detouring clinical relevance and warrant the need of superiority margin to avoid such misinterpretation.
Design Selective review of articles published in the New England Journal of Medicine between 1 January 2015 and 31 December 2018 and meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist.
Eligibility criteria for selecting studies and methods Published superiority trials evaluating cardiovascular diseases and diabetes mellitus with positive efficacy outcome were eligible. Fixed effects meta-analysis was performed using RevMan V.5.3 to calculate overall effect estimate, pooled HR and it was compared with mean clinically significant difference.
Results Thirteen eligible trials with 164 721 participants provided the quantitative data for this review. Largely, the primary efficacy endpoint in these trials was the composite of cardiovascular death, non-fatal myocardial infarction, unstable angina requiring rehospitalisation, coronary revascularisation and fatal or non-fatal stroke. The pooled HR was 0.86 (95% CI 0.84 to 0.89, I2=45%) which was lower than the mean clinically significant difference of 0.196 (19.6%, range: 0.09375–0.35) of these studies. There was a wide 95% CI in these studies from 0.56 to 0.99. The upper margin of CI in most of the studies was close to the line of no difference. Absolute risk reduction was small (1.19% to 2.3%) translating to a high median number needed to treat of 63 (range: 43 to 84) over a follow-up duration of 2.95 years.
Conclusions The results of this meta-analysis indicate that overpowered trials give statistically significant results undermining clinical relevance. To avoid such misuse of current statistical tools, there is a need to derive superiority margin. We hope to generate debate on considering clinically significant difference, used to calculate sample size, as superiority margin.
overpowered trials
http://dx.doi.org/10.1136/postgradmedj-2019-136569
Superiority trials test if one drug is better than the other. This information is mostly used by busy clinicians who want quick information and are in search of new treatment for the unmet needs of their patients.1 The design of such trials facilitates determination of the smallest difference in the primary endpoint between the study arms. Traditional null hypothesis statistical testing is used to decide the statistical significance of two-sided tests using p value and CI. Progress towards such informative trial design and analysis has been slow and this method of testing carries a high chance of misinterpretation and misuse.1–3 The smallest difference to be detected is usually made a priori and used to calculate sample size. Currently, there is no consensus or scientific formulae to choose the smallest difference that is clinically meaningful and important for public health decisions.4 Over the years smallest difference is taken for granted for a realistic difference that can be identified with the available sample size,5 which raises two issues: smaller than an ideal sample size increases type II error while larger than required sample size increases the power of the study ('overpowered trials') and decreases the magnitude of the smallest difference required to produce statistical significance.
Criticisms have been raised by us3 6 7 and other authors2 4 8 regarding the conduct and interpretation of superiority trials. We have raised our concerns on the results of trials such as EMPA-REG3 and CANTOS7 the HRs of which are 0.86 and 0.85, respectively. Its 95% CIs are 0.74 to 0.99 and 0.74 to 0.98 and the clinically meaningful differences used to calculate its sample size are 0.77 and 0.80 (20% risk difference translates to HR of 0.80), respectively. Since the upper limits of 95% CI of these studies is close to line of no difference, there is a small improvement over the control arms. Had the authors considered clinically meaningful difference while analysing their study results, both the studies would give statistically non-significant results. Such interpretation of results has the potential of misuse of data as the drugs may not be sufficiently beneficial to obtain regulatory approval. Few methodologies have been put forth to evaluate the statistical significance such as lowering p value to 0.005,9 Cohen's rule of thumb10 and number needed to treat (NNT),11 but none of them work as well as non-inferiority (NI) margin for NI trials in justifying both statistical and clinical significance.
In this meta-analysis, we consolidate our suggestion about superiority margin for superiority trials akin to NI margin for NI trials, with some evidence. We have analysed superiority trials with significant outcomes and have assessed the clinical relevance of their results. The analysis made in this study may impact on the considerations to be taken while conducting and also while interpreting the results of superiority trials.
This is a selective review and meta-analysis of all the superiority trials published in the New England Journal of Medicine (NEJM) between 1 January 2015 and 31 December, 2018.
We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses consensus statement for the design, implementation and reporting of this study.12 All trials published in NEJM between 2015 and 2018 were hand-searched for the type of study design. Articles were selected based on our inclusion criteria.
Study selection, inclusion and exclusion criteria
We included all blinded or open-label superiority trials with pharmacological intervention conducted in adults that had positive primary outcome with a continuous or categorical variable. We set a 4 year search limit of studies published in NEJM because we thought this was sufficient to show the trend of conducting and reporting of superiority trials practiced worldwide by eminent researchers. We chose to include studies conducted in populations with cardiovascular diseases and diabetes mellitus because these disease conditions encompass large sample size trials, owing to high prevalence and chronicity, and also because several drugs in this section receive Food and Drug Administration (FDA) approval every year claiming superiority over the existing drugs. Studies conducted in paediatric population, or in populations with venous thromboembolism, bleeding, cardiomyopathy and shock, were excluded. We also excluded trials involving any non-pharmacological intervention such as (but not limited to) lifestyle modification, percutaneous coronary intervention, coronary artery bypass grafting and pacemaker implantation. Studies which expressed their primary endpoint in mean difference,13–23 OR24 and risk ratio25 26 and also studies which had non-significant primary efficacy outcome were excluded. This eligibility criteria largely yielded an uniform primary outcome, that is, the composite of cardiovascular death, non-fatal myocardial infarction (MI), unstable angina requiring rehospitalisation, coronary revascularisation, fatal or non-fatal stroke,24–39 except for one study40 which had safety endpoint as its primary outcome. So although it met our eligibility criteria, we excluded this study to maintain uniformity and generalisability of our results.
Individual journal volumes and issues were hand-searched for superiority trials. All the selected articles and their supplementary materials were searched for clinically meaningful difference or effect size used to calculate the sample size.
NG did the search and independently screened the titles and abstracts yielded by the search against the inclusion criteria. Full reports for all titles and abstracts that appeared to meet the inclusion criteria or where there was any uncertainty were obtained. NG and SM then screened the full-text reports and decided whether these met the inclusion criteria. We resolved disagreements through discussion with our third author NS. Reasons for excluding trials were recorded. The review authors extracted the data on study characteristics such as (1) trial design, population and sample size; (2) intervention details; (3) duration of treatment and median follow-up; (4) outcome measures; and (5) study results for the primary efficacy outcome.
Data abstracted included endpoints for decision-making, that is, HR in the primary efficacy endpoint along with their CI, p value and NI margin or clinically significant difference, if present.
Risk of bias within and across studies
Two authors (NG and SM) independently assessed the risk of bias of each included trial. If risk of bias was not clear from the main manuscript, we obtained records from the articles' supplementary materials. Cochrane's risk of bias tool was used to assess risk of bias among included studies. We assessed overall risk based on the description of randomisation methods, allocation concealment, blinding of participants, investigators and statistician and attrition and reporting biases. As per tool input, biases were recorded as low risk, high risk or unclear (either lack of information or uncertainty over the potential for bias). Any disagreements in the risk of bias were discussed and resolved by consensus of all the authors.
Results for all primary efficacy outcomes are expressed as HR with 95% CIs, calculated from end of treatment values. For data expressed in person years, we calculated incident rate for the total duration of the study. Overall effect estimate of the meta-analysis was calculated using RevMan V.5.3 with fixed effects model of heterogeneity and Observed-Expected (O–E) and variance statistic as per Cochrane Handbook for Systematic Reviews of Interventions41 and Tierney et al.42 Two studies34 35 had two coprimary efficacy outcomes. In the fixed effects model, HR of only the first coprimary outcome is used, as HR and its CI for second coprimary outcome were almost the same. For the same reason, we used only the single-dose analysis values from the study by Bonaca et al,39 for the final assessment. Sensitivity analysis including these values did not differ significantly from the reported result. Further, descriptive statistics were used to describe sample size, duration of the studies and overall clinically significant difference. Absolute risk reduction (ARR) and NNT were also calculated from the end of treatment values.
During the search limit period, a total of 840 original articles were published in NEJM. The selection process of the articles is outlined in figure 1. Studies reporting results of subgroup analysis or combined analysis were excluded as duplicates. Filtering the articles based on disease-specific criteria yielded 171 potentially relevant articles. Further, 113 studies were excluded as they were either not a superiority trial or involved any non-pharmacological intervention. Full text of the remaining studies were retrieved and assessed. In total, 16 superiority trials were eligible for the final analysis. Out of these, three trials26–28 had to be excluded as they reported results as OR or risk ratio (RR). Since OR and RR evade time-dependent factor, in contrast to HR, it was considered inappropriate to club trials reporting OR/RR with HR. However, sensitivity analysis including these three trials was conducted, it yielded similar pooled estimate but with increased heterogeneity (result not shown).
PRISMA flow diagram for selecting studies.PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
Study characteristics
Overall, 164 721 participants were included in the 13 trials that provided the quantitative data for this review (for individual study details, see table 1). Largely, the primary efficacy endpoint in these trials was composite of cardiovascular death, non-fatal MI, unstable angina requiring rehospitalisation, coronary revascularisation and fatal or non-fatal stroke. Two studies had two coprimary outcomes: composite of death from cardiovascular causes, non-fatal MI or non-fatal stroke (first coprimary outcome) and the composite of these events plus resuscitated cardiac arrest, heart failure or revascularisation (second coprimary outcome). HRs for each coprimary outcomes were similar and hence for pooled analysis, HR and CI of first coprimary outcome were used. Sensitivity analysis including both the primary outcomes did not vary the final effect estimate considerably.
Summary of study characteristics and calculation of ARR and NNT
Out of 13, only 9 (69.2%) studies mentioned the clinically significant difference used to calculate their sample size. The range of these clinically significant differences was between 9.375 and 35 with an average value of 19.6. Studies which used annual rate of primary event or NI margin to calculate their sample size were excluded from calculating average of differences. Further, the primary hypothesis of four studies was to test NI with the use of NI margin and conclude superiority when the upper boundary of 95% CI was <1.0.30 32 33 36 Overall, lower boundary of 95% CI of the included studies ranged from 0.56 to 0.89, while upper boundary of 95% CI ranged from 0.86 to 0.99. Incidence of the primary event was described as HR in all the 13 studies.
Synthesis of results
The overall effect estimate (pooled HR) was 0.86 with 95% CI of 0.84 to 0.89, p<0.00001. The test for heterogeneity, I2 in our meta-analysis was 45%, which indicates that there was moderate heterogeneity or inconsistency in the studies included, which conflicts with the fixed effect assumption. According to fixed effects model assumption, each study included in the meta-analysis is trying to estimate the same quantity of intervention effect41 (figure 2).
Meta-analysis of primary efficacy endpoint of included trials using fixed effect model.
On an average, the sample size in each included study of our meta-analysis was 12 671 (range 3297–27 395). These participants experienced an ARR of 1.19% to 2.3% in the primary outcome which translated to a median NNT of 63 (range: 43–84) over a follow-up duration of 2.95 years. This follow-up duration was taken from the calculated median NNT (of 63) that corresponded to studies by Schwartz et al 25 and the Zinman et al,36 who had a median follow-up duration of 2.8 years and 3.1 years, respectively (table 1), yielding a median duration of 2.95 years (midpoint of above studies) for the said NNT.
Risk of bias
Full details of the risk of bias are outlined in figure 3. All the included studies described their randomisation methods and were considered as low risk. Information about allocation concealment was unclear for two trials, rest of them used either interactive voice response or web response or generated unique number to conceal allocation. All the included trials were double-blinded except for two, in which one was single-blinded30 and the other one was open label.37 Only in one trial39 even biostatisticians were blinded until analyses. Seven studies clearly mentioned that statisticians were not blinded, while it was unclear in rest of the studies. We did not look for incomplete outcome data and selective reporting as our study objective was to look for primary outcome of these studies.
Risk of bias summary.
The main objective of superiority trial is to determine the smallest difference in the primary outcome between the study arms.43 Therefore, they are designed in such a way that they have enough power to detect those differences. However, in this meta-analysis, we debate on assigning meaning to the smallest difference making it clinically significant and more specific. Currently, the clinically significant difference is used to calculate the sample size but it is not considered at the time of analysis of findings.
In this study, the effect estimate of the included studies is 0.86 with 95% CI 0.84 to 0.89. It means that there is ~14% decrease in risk of having the primary outcome, if the patient consumes experimental drug. This 14% may not be clinically significant as the estimated mean of clinically meaningful difference of these studies is 19.6%. Nine (69.2%) out of 13 included studies did not meet their own respective marks for clinical significance, despite obtaining statistical significance (clinically meaningful difference was not mentioned for other four studies). Either their pooled HR was beyond their own clinically meaningful difference25 29 31 34 35 38 39 or their 95% CI27 37 included this value, which means had the authors considered clinically meaningful difference during their analysis, the null hypothesis would be accepted and superiority of experimental drug would be rejected. This leads us to think whether a statistically significant result is clinically relevant. In one of the included trials,34 the investigators intended to evaluate 35% of lower risk with experimental drug.
Further, the effect estimate translates to a median NNT of 63 which means 63 patients need to be treated for a median duration of 2.95 years to prevent one extra outcome from happening. It is debatable whether such high NNT for the said time period is acceptable for a new, rather expensive medication with potential and unknown adverse effect profile, even more so because trial-based NNT often underestimates NNT in clinical practice.44
There are also critics highlighting that with the existing design of superiority trials, even the borderline effect will become statistically significant if we test with large sample size.45 In our study, the average sample size was ~12 600. In 11 of 13 included studies, the upper bound 95% CI crossed 0.90 and in two of 11 such studies, the upper bound 95% CI was 0.99,36 38 which is very close to line of no difference. We believe that the large sample size has given enough power to rule out null hypothesis in these studies. Such 'overpowered or oversized trials' have been criticised earlier by many researchers.2 46 47
It is a known fact that CIs offer predictive information about treatment effects that can be expected posttrial use. Narrow confidence intervals suggest little variability within the population and assure that even a wider interval, which we are bound to get once the drug is marketed, may provide similar difference in treatment effect in general population.48 Given the wide CIs and their close approximation to line of no difference in most of the included studies, there is an uncertainty regarding the effectiveness of such drugs after being marketed.
Nevertheless, as stated before, while analysing the results of the study, it is important to assess the relevance of difference between the means of two drugs. In NI trials, inclusion of NI margin addresses the issue of clinical relevance.49 We have earlier proposed the need for superiority margin for superiority trials similar to NI trials.3 6 With this study, we emphasise fixing the clinically meaningful difference for that particular outcome (suppose say '10%' for 'composite of death from coronary heart disease, non-fatal MI, fatal or non-fatal ischaemic stroke or unstable angina requiring hospitalisation') as a 'superiority margin'. It makes sure that only when 95% CI is beyond this margin, the experimental drug will be deemed superior. The proposed margin can be contemplated based on research question and entire active control effect, similar to NI margin.
Whether there should be a guideline to the difference to be detected in a trial is debatable. Some authors argue that each research question is unique and deserves special consideration. They believe that guidelines encourage the same approach being used and enough attention may not be paid to individual differences towards all study designs.5 However, absence of guidelines may invite carelessness and engage investigators in playing with sample size, CI and p-value.
This study has a few limitations: First, we included articles published in NEJM only, hence, we cannot generalise the study conclusion for trials published in other journals. However, we believe that NEJM is sufficiently representative of leading medical journals and these results should be quite robust. Second, since a single journal was selected for review, only one author did the initial screen followed by all three authors. Third, we did not register our study protocol in PROSPERO which is typically recommended for systematic reviews and meta-analyses. Fourth, we did not include effect size of four studies to calculate average clinical meaningful difference as the effect size in these studies was not mentioned. They have used either annual rate of events or NI margin to calculate sample size. Owing to similar primary efficacy outcome in all the included studies, we presume that the authors would have considered similar effect sizes ranging from 9.375% to 35% to calculate sample size.
This study also raises some important questions such as, 'Is there a need of superiority margin for superiority trials? Which is the best parameter that can be used to derive superiority margin? and What are the pros and cons of choosing clinically significant difference as superiority margin? Or should it be modified?'
In the absence of a superiority margin, the current practice leads to a situation where overpowered superiority trials provide statistically significant results with effect size so small that they may be of little clinical relevance. This meta-analysis shows that this practice is widespread in cardiovascular diseases and diabetic trials published in NEJM. We hope to generate debate on such practice.
Main messages
Overpowered cardiovascular trials provide statistical significance but may have little clinical relevance.
Superiority margin must be taken into account while interpreting results of such trials in order to avoid scientific misinterpretation.
Clinically significant difference used to calculate sample size may be used as the superiority margin.
Current research questions
Is there a need of superiority margin for superiority trials?
Which is the best parameter that can be used to derive superiority margin?
What are the pros and cons of choosing clinically significant difference as superiority margin? Or should it be modified?
What is already known on the subject
Superiority trials use traditional null hypothesis statistical testing to decide the statistical significance between one or more experimental arms. Such analysis has the potential to misinterpretations and scientific misuse of superiority trials.
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Contributors NG and SM hand-searched the articles and independently reviewed the articles. Disagreements were discussed with NS. All three authors contributed in data analysis and manuscript preparation.
Patient consent for publication Not required.
Data availability statement There are no data in this work.


text:
'Ass Kicker' Coffee Exists, And It Will Do Just That If You Drink Too Much
by Hope Schreiber
Hey, buddy. How's your heart holding up lately?
Oh, no, I don't mean after your recent breakup -- those come too often for you ever to be repaired, you broken shell of a human.
I mean like physically. Because if your heart isn't strong, you should probably steer clear of "Ass Kicker" coffee at an Australian cafe called, fittingly, Vicious Coffee.
A cup of Ass Kicker iced coffee boast 80 times more caffeine than a shot of espresso and 50 times more than a regular cup o' joe.
Let's put this into perspective. That amount of caffeine is half the amount of a lethal dose.
It is recommended you take your time drinking a large, which should you should sip over four hours. Otherwise? RIP.
The "high" will last you 12-18 hours.
According to the USDA, a fluid ounce of espresso has 64 milligrams of caffeine and 95 milligrams in an 8-ounce cup of coffee. Ass Kicker, however, has 5 grams of the good stuff.
The drink was originally made for a nurse working a night shift in the emergency department. It took the nurse two days to finish the coffee and she remained awake for three days. The version at the cafe now is more toned down.
The owner of the cafe, Steve Benington, told Adelaide Now,
Some people love it and some are broken by it but it's all in the name of fun.
Bianca De Marchi
The brew is made by combining four shots of espresso, four 48-hour brewed cold drip ice cubes, 120 milliliters of 10-day brewed cold drip and wrapped up with four more 48-hour brewed cold drip ice cubes.
Just typing that gave me a caffeine headache.
People with heart or blood pressure issues should stay far away.
A general practitioner at Marion Domain Medical Centre in Oaklands Park and two southern area paramedics warned Benington after they all personally drank the Ass Kicker.
As you would suspect, teens take it as a challenge. Benington says,
I talk to them first, make sure they understand what they are doing, and people often think I'm trying to talk them out of it. It's pure coffee, it's good quality, and that's the only problem, it tastes so good that it's hard to make it last as long as it should.
Apparently it is possible to overdose on caffeine -- it is a drug after all. It would take nearly 70 cups of coffee to kill a person, but your stomach may not even be able to hold that much liquid.
You would start to experience mania and hallucinations before getting that much coffee down.
Citations: http://brobible.com/life/article/ass-kicker-coffee-caffeine-espresso/ (Bro Bible)
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