The science of Sad: understanding the causes of ‘winter depression’

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.
In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

Nobel prizes 2017: everything you need to know about circadian rhythms

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

Read More: http://snip.ly/25gi4#https://www.theguardian.com/lifeandstyle/2017/oct/30/sad-winter-depression-seasonal-affective-disorder
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Heart surgery survival chances ‘better in the afternoon’

Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.
The research, published in the Lancet, suggests the heart is stronger and better able to withstand surgery in the afternoon than the morning.
And it says the difference is not down to surgeons being tired in the morning.
Doctors need to stop the heart to perform operations including heart valve replacements. This puts the organ under stress as the flow of oxygen to the heart tissue is reduced.
The doctors and researchers looked for complications including heart attacks, heart failure or death after surgery. They found:

• 54 out of 298 morning patients had adverse events
• 28 out of 298 afternoon patients had adverse events
• Afternoon patients had around half the risk of complications
• One major event would be avoided for every 11 patients operated on in the afternoon

One of those involved in the research, Prof Bart Staels, from the Institut Pasteur de Lille, told the BBC News website: “We don’t want to frighten people from having surgery – it’s life saving.”
He also said it would be impossible for hospitals to conduct surgery only after lunch.
But Prof Staels added: “If we can identify patients at highest risk, they will definitely benefit from being pushed into the afternoon and that would be reasonable.”
Obesity and type 2 diabetes have been shown to increase the risk of complications after surgery.
Heart health is already known to fluctuate over the course of a day.
The risk of a heart attack or stroke is highest first thing in the morning, while the heart and lungs work at their peak in the afternoon.

 

Dr John O’Neill, from the UK Medical Research Council’s Laboratory of Molecular Biology, said: “Scientifically it is not hugely surprising, because just like every other cell in the body, heart cells have circadian rhythms that orchestrate their activity.
“Our cardiovascular system has the greatest output around mid/late-afternoon, which explains why professional athletes usually record their best performances around this time.”

• BBC Body Clock: What makes you tick?
• Body clock scientists win Nobel Prize
• Weekend camping resets body clock

Other possible explanations for the findings included surgeons being tired in the morning or their own body clock affecting their surgical skill, particularly if they are not “morning people”.
Read More: http://snip.ly/lr9h9#http://www.bbc.com/news/health-41763958

Software as a Service, SaaS, is a way by which applications are delivered over the Net. It provides Software as a Service using just the Internet, and hence the name. SaaS applications are known by varied names. On-demand software, hosted software, and web-based software are some of these.
Where SaaS differs as a method of delivering applications is that there is no need to install and maintain software at or from the client’s location. All that is needed to access all these is an Internet connection. The provider can run SaaS applications on his own servers. With the provider taking over the responsibility of managing all aspects of the application, such as making it available and secure, and also for its performance; the client is spared the hassle of having to manage unfamiliar and often complex software and hardware.
Given this novelty and ease of its application; SaaS has grown into a huge market. Its US market was estimated at just over $ 10 billion in 2011. In the next couple of years, the global SaaS market is set to grow to around $ 120 billion. Experts put its speculated CAGR at between 18 and 24 percent and expect SaaS to make up more than one fifth of all software services by 2019.
Now, the difficult part of SaaS

All these bright spots about SaaS notwithstanding; it comes with a few hiccups. Given its nature, most SaaS providers outsource their resources to cut costs. This makes them very vulnerable, since most regulations, such as 21 CFR Part 11, apply only to the provider, and give little by way of safeguards to the vendor. With very less vigilance and scrutiny on the vendor; the onus of ensuring compliance for both infrastructure qualification and Computer System Validation lies with the regulated company, for it is they who have to show compliance with the regulations and prevent issues relating to availability, performance and protection of data.  In other words, while the actual work of SaaS is carried on by the vendor; it is the client who has to ensure compliance with regulations arising out of 21 CFR Part 11.
Since on paper it is the regulated provider to whom all the regulations apply; it becomes the target of FDA inspections on software validation. They have to show compliance with these regulations set out in 21 CFR Part 11 and other regulations such as Annex 11 if they have to avoid FDA actions such as Warning Letters and 483’s. There is thus a major need for regulated companies, software vendors and SaaS/cloud providers to show compliance with 21 CFR Part 11. This is the only way to avoid legal and other issues associated with noncompliance.
The ways of staying compliant

This is what a two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory industries, will offer. This seminar will explain in-depth how regulated companies, software vendors and SaaS or cloud providers can ensure compliance and safeguard and enhance their reputation as trustworthy providers
David Nettleton, who is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation, will be the Director of this seminar.
Please register for this webinar by visiting 21 CFR Part 11 compliance requirements for software validation and SaaS/Cloud. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
An explanation of proven techniques

Over the two days of learning at this seminar, David will demonstrate proven techniques for cutting costs associated with the implementation, usage, and maintenance of computer systems in regulated environments. In doing this, David will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and Computer System Validation.
With the FDA performing both GxP and Part 11 inspections; the EMA has released an updated Annex 11 regulation that expands Part 11 requirements. Companies must update their systems and processes to maintain compliance. This aspect will be explained at this seminar. The Director will offer participants an understanding of the specific requirements associated with local and SaaS/cloud hosting solutions.
Validation in several specialized areas
The regulatory agencies require almost every computerized system used in laboratory, clinical, manufacturing settings and in the quality process to be validated. David will show the ways by which they can do this while decreasing software implementation time and lowering costs using a 10-step risk-based approach to Computer System Validation. He will review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.
This seminar is of high value to anyone who uses computer systems to perform their job functions in the regulatory, clinical and IT areas of health care, clinical trial, biopharmaceutical, and medical device sectors. Software vendors, auditors and quality staff involved in GxP applications will also derive high value from this seminar.

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Understanding 21 CFR Part 11 compliance for software validation and SaaS/Cloud

Software as a Service, SaaS is a method of delivering applications over the Internet. This small definition just about summarizes the core of SaaS: It provides Software as a Service using just the Internet. SaaS applications go by different nomenclatures such as on-demand software, hosted software, or web-based software.
SaaS is a fundamentally different method of delivering applications, because when a client chooses SaaS; there is no need to install and maintain software. It can be accessed with just an Internet connection. SaaS applications can be run on the provider’s servers. Since it is the provider who takes over the responsibility of managing all aspects of the application, such as making it available and secure, and also for its performance; the client is spared the headache of having to manage unfamiliar and often complex software and hardware.
This sunny side of SaaS appeals to many clients, which is the primary reason for which SaaS is a huge market. From over $ 10 billion in 2011 in the US; the global SaaS market is set to grow to around $ 120 billion by 2019. Speculated to grow at a CAGR of anywhere between 18 and 24 percent; SaaS is estimated to make up more than one fifth of all software services by that year.
The difficult side of SaaS

This makes the prospects for the SaaS market very bright. However, there is a catch: Most SaaS providers outsource their resources to cut costs. This activity exposes them to the seamy side of this exploding market. Most regulations such as 21 CFR Part 11 are only for the provider, and very little of these are for the vendor. Since there is very less regulation that will offer safeguards to the user from the vendor; the onus of ensuring compliance for both infrastructure qualification and Computer System Validation lies with the regulated company, for it is they who have to show compliance with the regulations and prevent issues relating to availability, performance and protection of data.
Failure in doing so hurts their reputation, because it is they, and not the vendor, that is regulated. This regulated provider is the one that becomes the target of FDA inspections on software validation and should hence do everything it can to avoid FDA actions such as Warning Letters and 483’s. There is thus a major need for regulated companies, software vendors and SaaS/cloud providers to show compliance with 21 CFR Part 11 and other regulations such as Annex 11. This is the only way to avoid legal and other issues associated with noncompliance.
Learn the ways of staying compliant

How do regulated companies, software vendors and SaaS or cloud providers ensure compliance and safeguard and enhance their reputation as trustworthy providers? It is this critical issue that will be discussed threadbare at a very useful and educative two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory industries.
At this seminar, David Nettleton, who is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation, will be the Director.
Want to understand how David explains the way by which regulated companies can offer legally compliant SaaS and cloud solutions? Then please register for this seminar by logging on to Understanding 21 CFR Part 11 compliance for software validation and SaaS/Cloud. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Demonstrating proven techniques

The purpose of this seminar is to demonstrate proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Towards imparting this, David will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and Computer System Validation.
With the FDA performing both GxP and Part 11 inspections; the EMA has released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. David will discuss this. He will give participants an understanding of the specific requirements associated with local and SaaS/cloud hosting solutions.
Validation in a number of specialized areas
Since almost every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated; the ways by which they can decrease software implementation times and lower costs using a 10-step risk-based approach to Computer System Validation will be imparted. The Director will review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.
Anyone who uses computer systems to perform their job functions in the regulatory, clinical and IT areas of health care, clinical trial, biopharmaceutical, and medical device sectors will find this seminar highly useful. It is of high value for software vendors, auditors, and quality staff involved in GxP applications.