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Monday, 25 September 2017
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Lightning Process 'could help children with chronic fatigue syndrome', study claims - 21 Sep 2017

"Controversial Lightning Process 'helps children with chronic fatigue syndrome'," reports The Guardian.

The story is based on a UK study investigating whether a treatment called the Lightning Process helped teenagers being treated for chronic fatigue syndrome (CFS), also known as ME (myalgic encephalomyelitis).

The study randomly split 100 young participants into two groups: those who received standard CFS/ME treatment and those who received the standard treatment plus the Lightning Process (LP).

LP treatment involved an intensive three-day group-therapy course aiming to teach participants how to use their brain to improve their body's health.

Researchers found those who received the LP were more active, less tired and less anxious after six months. At 12 months, they also had improved depression scores and school attendance.

However, this therapy is not recommended by the NHS, which currently suggests behavioural and exercise therapy for people with CFS/ME.

There are an estimated 250,000 people affected by chronic fatigue syndrome in Britain, according to the ME Association charity.

It's not known what causes CFS/ME, but there are a number of theories, such as it being triggered by an infection.

Living with the condition can be difficult, with extreme tiredness and other symptoms making everyday activities challenging.

As well as support from family and friends, it might also be useful for people with CFS/ME to talk to others with the condition and perhaps find a local support group.

Where did the story come from?

The study was carried out by researchers from the University of Bristol and the University of Nottingham in the UK. It was funded by the National Institute for Health Research and two charitable trusts: The Linbury Trust and The Ashden Trust.

The study was published in the peer-reviewed medical journal Archives of Disease in Childhood, part of BMJ Journals, and is free to read online.

The media reporting of this study was generally accurate, but the Daily Telegraph's suggestion that the therapy helps children get back to school cannot be certain – there are a range of possible explanations for why children in the LP therapy group had better school attendance.

What kind of research was this?

This was a randomised controlled trial involving teenagers who had been diagnosed with CFS/ME. They were randomised to receive either usual care, or usual care plus the LP.

The LP is a therapy developed from osteopathy, life coaching and neurolinguistic programming (a behavioural psychotherapy that "retrains the brain"), and is used for a variety of conditions.

CFS/ME is a long-term illness with a wide range of symptoms, the most common being extreme tiredness.

It can also cause sleep problems, concentration problems, muscle or joint pain, headaches, a sore throat, flu-like symptoms, feeling dizzy or sick, or a fast or irregular heartbeat.

Current accepted treatments in the UK health service include cognitive behavioural therapy (CBT); a structured exercise programme called graded exercise therapy; and medication to control pain, nausea and sleep problems.

What did the research involve?

The researchers randomised 100 children aged 12 to 18 with diagnosed CFS/ME to receive either specialist medical care (SMC) or SMC plus the LP, and followed them up at 3, 6 and 12 months.

There were 51 participants in the SMC-only group. The SMC focused on improving sleep, and using activity management to establish a baseline level of activity (including school attendance, exercise and social activity) that was then gradually increased.

Sessions were delivered by professionals such as doctors, psychologists and physiotherapists. The number and timing of sessions were agreed with the teenager and their family.

There were 49 participants in the SMC-plus-LP group. In addition to the same SMC, they attended an LP course consisting of three different sessions, lasting four hours each, on consecutive days. They attended in groups of two to five.

The first was a theory session looking at:

  • stress response
  • how the mind and body interact
  • how thought processes can be positive or negative

This was followed by a group session in which participants were asked to think about what they could take responsibility for and change.

The third was a practical session in which participants were asked to choose a goal they wished to achieve, such as being able to stand for a longer period of time. They were given different thinking strategies to perform before and during attempting to achieve the goal. They also chose a further goal, to be attempted at home.

Each participant was offered two follow-up phone calls.

Outcomes assessed were:

  • physical function, measured using the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS)
  • quality of life using quality-adjusted life years (QALYs), measured using the EQ-5D-Y standardised instrument
  • fatigue, using the Chalder Fatigue Scale
  • pain, using the Visual Analogue Scale (VAS)
  • anxiety and depression, using the Hospital Anxiety and Depression Scale (HADS)
  • school attendance (days per week)
  • child's use of health services, educational services or health-related travel, and other family costs, using a questionnaire

What were the basic results?

At six months after randomisation, data from 81 participants showed that those in the SMC-plus-LP group were:

More active

They had better physical function compared with the SMC-only group according to the SF-36-PFS scale of 0 to 100, where lower scores indicate worse physical function. The SMC-plus-LP group's average increased from a baseline of 53 to 81.7, and the SMC-only group's increased from 56 to 70.2 (adjusted difference in means 12.5, 95% confidence interval [CI] 4.5 to 20.5).

Less fatigued

They had less fatigue, scoring 14.4 compared with 19.8 in the SMC-only group on a scale of 0 to 33, where higher scores indicate more fatigue (adjusted difference in means 4.7, 95% CI 7.9 to 1.6).

Less anxious

They had greater improvement in anxiety symptoms as measured by the HADS (scored from 0 to 21, with higher scores indicating worse symptoms) than the SMC-only group. The SMC-plus-LP average score was 6.1, compared with 9.0 for the SMC-only group (adjusted difference in means 3.3, 95% CI 5.6 to 1).

At 12 months after randomisation, data from 79 participants showed that the SMC-plus-LP-group were:

More active, less fatigued and less anxious

They still had better physical function, less fatigue and improved anxiety symptoms compared with the SMC-only group.

Feeling better

The SMC-plus-LP group also had greater improvement in depression symptoms on the HADS – scored from 0 to 21, with higher scores indicating more-severe symptoms (adjusted difference in means -1.7, 95% CI -3.3 to -0.2).

Attending school more often

School attendance, as measured by attendance in the previous week, was better for the SMC-plus-LP group, at 4.1 days on average, than the SMC-only group's 3.1 days (adjusted difference in means 0.9, 95% CI 0.2 to 1.6).

How did the researchers interpret the results?

The researchers concluded: "This is the first randomised trial investigating the effectiveness of the LP for any condition. It is the first trial that has demonstrated the effectiveness of an intervention other than CBT for paediatric CFS/ME.

"The addition of the LP to SMC improved physical function at 6 and 12 months in adolescents with CFS/ME and this difference increased at 12 months."

Conclusion

The results from this very small randomised controlled trial showed that people having LP therapy in addition to usual CFS/ME care had improved physical function, fatigue and anxiety symptoms at six months, and improved school attendance and depressive symptoms at 12 months.

However, there are a number of limitations to this research that need to be considered:

  • Participants in both groups improved, so both treatments were effective to some extent.
  • This was a very small trial, and the results analysis involved fewer than the 100 people recruited. It would need to be repeated in a much larger group to demonstrate more robust findings.
  • A number of outcomes were looked at, so it was very likely that some of them would return positive findings by chance – the improvements might not have been due to the LP therapy.
  • Participants were not blinded – they were aware of the group they were in; therefore, their self-reported outcomes might have been biased. They may have been more likely to report positive outcomes because they knew they were getting additional therapy in the LP group.
  • Of all those eligible to participate in the trial, fewer than 30% agreed to take part. The reason why the majority didn't want to is unknown.

As the LP therapy was given in addition to the usual CFS/ME care, it certainly cannot be suggested as a replacement for the current usual care.

There's no single way of managing CFS/ME that works for everyone and, if you have the condition, you should be offered a treatment plan based on your symptoms. Your doctor should discuss all options with you and make you aware of any benefits and risks.

Links To The Headlines

Chronic fatigue therapy 'could help teenagers', study says. BBC News, September 21 2017

Controversial 'light' treatment for young ME patients - endorsed by celebrities - DOES work despite being labelled as 'quack medicine'. Mail Online, September 21 2017

Controversial Lightning Process 'helps children with chronic fatigue syndrome'. The Guardian, September 20 2017

M.E. 'Lightning Process' trains the brain to ward off tired thoughts. The Daily Telegraph, September 20 2017

Links To Science

Crawley EM, Gaunt DM, Garfield K, et al. Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial. Archives of Disease in Childhood. Published online September 20 2017

 

Many teenagers reporting symptoms of depression - 20 Sep 2017

Summary

"One in four British girls hit by depression at 14 as experts blame increase in cyber bullying and academic pressure," says the Sun after a large study found 24% of 14-year-old girls in the UK report symptoms of depression.

The Millenium Cohort Study followed more than 19,000 children born in the UK in 2000 to 2001. Parents completed surveys when the children were aged 3, 5, 7, 11 and 14 about any emotional difficulties they were having. At age 14, the children also completed a short questionnaire about their mental health.

Levels of anxiety and depressive symptoms were similar for girls and boys up to the age of 11. At age 14, parents reported 12% of boys and 18% of girls had emotional problems. But when the 14-year-olds themselves were asked about their mental health, 9% of boys and 24% of girls reported depressive symptoms.

Though the statistics are worrying, it is important to note that these were responses to questionnaires and not formal diagnoses of depression so the real figures are likely to be lower. However, it is still of concern that so many children are struggling with emotional problems.

If you have concerns about yourself or a child, see your GP as there are many effective treatments available including talking therapies.

Find more information and advice for young people on mental health problems.

Where did the story come from?

The study was carried out by researchers from University College London, and was funded by the Economic and Social Research Council and the Government.

It was published by the Centre for Longitudinal Studies, an Economic and Social Research Council resource centre based at University College London and is free to read online (PDF, 554kb).

In general, the media reported the research accurately, although few explained that the children had not been formally diagnosed with depression and had only reported some symptoms in a questionnaire.

What kind of research was this?

This was a cohort study in which children born in the millennium were followed up over 14 years through questionnaires given to both parents and the children themselves.

This type of observational study is good for looking at patterns of illness in the population. However, it relies on people agreeing to take part so can be subject to selection bias whereby only people with an interest in the topic complete the survey.

What did the research involve?

The Millenium Cohort Study recruited the parents of 19,517 children born in 2000 to 2001 from England, Scotland, Wales and Northern Ireland.

When the children were aged 9 months, 3, 5, 7, 11 and 14 years, the parents answered questionnaires about their physical, emotional, social, cognitive and behavioural development. They also provided details about their family relationships, economic status and family life.

When the children were aged 3 and above, the questionnaires included the Strengths and Difficulties Questionnaire which includes parental concerns about behaviour problems, hyperactivity and bullying, and gives a score out of 10, with higher scores indicating greater problems.

When the children were aged 14, they completed the Short Mood and Feelings Questionnaire. This consists of 13 statements. Children are asked if they felt the statements were true, sometimes true or not true reflections of how they felt in the previous two weeks:

  • I felt miserable or unhappy.
  • I didn't enjoy anything at all.
  • I felt so tired I just sat around and did nothing.
  • I was very restless.
  • I felt I was no good anymore.
  • I cried a lot.
  • I found it hard to think properly or concentrate.
  • I hated myself.
  • I was a bad person.
  • I felt lonely.
  • I thought nobody really loved me.
  • I thought I could never be as good as other kids.
  • I did everything wrong.

What were the basic results?

Average scores on the Strengths and Difficulties Questionnaire (0 to 10) completed by parents were low overall (a lower score indicating lesser problems):

  • Behaviour problems were more likely at the age of 3, with a score of just below 3, which then reduced and stayed around 1.
  • Emotional symptoms gradually increased from 1 to just over 2 by the age of 14.
  • Hyperactivity was the biggest problem, scoring around 3 at all ages.
  • Peer problems scored between 1 and 2 at all ages.

The proportion of children reported to have emotional problems by their parents increased with age:

  • at the age of 3, it was 8%
  • by 11, this had risen to 12%
  • at 14, it was still 12% for boys but had increased to 18% for girls

The proportion of children reported to have behaviour problems varied with age:

  • at the age of 3, 20% of boys and 17% of girls
  • at 5, 11% of boys and 7% of girls – at 14, 15% of boys and 11% of girls

According to the Short Mood and Feelings Questionnaire completed by 14-year-old children:

  • 24% of girls reported high levels of depressive symptoms
  • 9% of boys reported high levels of depressive symptoms

Ethnicity and household income results indicate that children from all backgrounds and socioeconomic status can suffer from symptoms of depression:

  • Prevalence for girls ranged from 9% of Black African and 15% of Bangladeshi background to 25% of white and 27% of mixed race.
  • Mixed-race boys were also more likely to have symptoms of depression, at 13% compared to 3% of those of Indian ethnicity.
  • 18% of girls from the highest income bracket, 23% from the lowest and up to 27% of those from the second lowest bracket had symptoms of depression.
  • 12% of boys in the second lowest bracket going down to 6% in the highest bracket had depression symptoms.

How did the researchers interpret the results?

The researchers concluded that "children's perspectives about their mental health may be different from their parents". They say this "highlights the importance of obtaining young people's own perspective of their mental ill-health, alongside other perspectives".

Conclusion

This large cohort study highlights high levels of depressive symptoms in children and adolescents.

It is however important to note that these are symptoms – we don't know how many of the children would be diagnosed with depression.

When parents complete the Short Mood and Feelings Questionnaire, it is estimated that it will accurately identify 75% of children with depression and 73% of children without depression. But it is less accurate when children complete it. Recent research suggests that it can identify 60% of children with depression and 61% of children without depression.

Despite these limitations, the fact that so many children report symptoms is of concern. Various experts in the media have suggested reasons, ranging from greater awareness of mental health issues and therefore increased reporting, to greater pressure from social media. Further research is needed to identify the causes.

It is important to seek help early for children with emotional problems and your GP is the best place to start. You can also contact the charity Young Minds that offers information and help to both young people and their parents or carers.

Links To The Headlines

Quarter of 14-year-old girls 'have signs of depression' BBC News, September 20 2017

How a quarter of girls are hit by depression: Shocking figures show teenagers are struggling to cope with school, stress and pressures of social media Mail Online, September 20 2017

Teenage Blues One in four British girls hit by depression at 14 as experts blame increase in cyber bullying and academic pressure The Sun, September 20 2017

One in four teenage girls are depressed, by their own accounts The Daily Telegraph, September 20 2017

One in four girls have depression by the time they hit 14, study reveals The Guardian, September 20 2017

A quarter of all 14-year-old girls are depressed, research shows The Independent, September 20 2017

Quarter of girls are depressed at 14 in mental health crisis The Times, September 20 2017

Links To Science

Patalay P, Fitzsimons E. Mental ill-health among children of the new century (PDF, 554kb) Briefing paper from Centre for Longitudinal Studies, UCL Institute of Education. Published online September 20 2017.

Single-injection vaccine device still a long way off - 18 Sep 2017

"Scientists invent injection that could deliver every childhood vaccine in one go," reports The Independent. Various media sources have run stories on a new injection they claim could allow multiple childhood vaccines to be delivered in a single jab.

This follows the development in the US of a method of making a tiny, multilayered biodegradable device, or microstructure, that can be given via injection. The device has several compartments that can be filled with solutions to be released at different points in time.

For the study, mice were given a single injection of the microstructure, which had been loaded with two fluorescently labelled sugar solutions. The researchers showed that the device could release the solutions at different times and that the delivery seemed to be better than in mice who received the solutions via two separate injections.

This device could have great medical potential, but it's important to realise that this is very early research.

More stages of testing in mice would be needed before we could think about human trials. There may be many as-yet-unknown obstacles in terms of safety and effectiveness when considering using the device for human immunisation.

Where did the story come from?

The study was carried out by researchers from the Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology (MIT) in the US and was funded by the Bill & Melinda Gates Foundation. Individual researchers received various additional funding grants.

The study was published in the peer-reviewed journal Science and is free to read online.

The media reporting was generally representative of the study and discussed the potential applications of such a device, as well as some of the hurdles that still remain.

What sort of research was this?

This was laboratory research describing the manufacture of a 3D microstructure that could be used for pulsed delivery of a drug or vaccine in a single injection.

The authors explained how 3D microdevices could be used for tissue engineering and drug delivery. Depending on size, shape and composition, the internal architecture of 3D microdevices offers greater potential than single-layer devices.

However, this research is still at the early experimental stage.

What did the research involve?

The researchers fully described the technique they used to create the microdevice. The methods are complex and only described in brief here.

The device was made of lactide-glycolide copolymers, the most widely used biodegradable polymers for human applications. The fabrication technique ("StampEd Assembly of polymer Layers" or SEAL) involves the technology used to produce computer chips.

The first layer of the microstructure is created using heated polymers in a silicone mould. This is then repeated, using microscopic alignment, to add layer upon layer to create structures smaller than 400 micrometres.

The process was tested by creating a number of different microstructures, including a 3D star, table and chair.

The researchers' main aim was to produce a microstructure that could be injected into the body and deliver timed pulses of different vaccines or drugs. They made a microstructure with hollow bases, filled these with a test solution and then carried out various experiments.

What were the basic results?

The researchers created a device that could give a controlled release of a substance. It delivered a fluorescently labelled test solution in a separate pulsed release, with no leakage prior to the set release time.

The sealed structures, filled with two labelled sugar solutions set to be delivered in separate pulsed releases, were then injected into a group of mice.

This group was then compared with mice that received the solutions via two separate injections timed to match the release from the microstructures. When tested after one week and then again after one month, levels of the test solutions were higher in the blood of the mice that received the single injection.

The microstructure and its pulse-release capacity were also stable under variations of temperature and acidity.

How did the researchers interpret the results?

The researchers said: "These experiments demonstrate that one injection of core-shell particles can induce a long-term antibody response, outperform multiple time-matched injections, and achieve twofold dose sparing."

Conclusion

Injection of a microstructure device that can give time-delayed release of a vaccine or drug could have great potential in medicine.

As the researchers noted, the structures are tiny and fully biodegradable, so they shouldn't cause a foreign-body reaction.

But they also mentioned the size – the lightweight device could only hold a small amount of solution. However, the researchers suggested that varying the wall thickness to create larger cores could greatly increase the device's capacity.

At this stage, the device has only been tested in a single experiment in mice. Further research in mice would be needed to see whether you could move on to testing it in humans. It's very difficult to stay at this stage which human vaccines the device could potentially be used for or what obstacles there could in terms of safety and effectiveness.

Various experts have given their response to the findings.

Dr Anita Milicic, senior scientist at the University of Oxford's Jenner Institute, said: "Single-dose vaccination has been a long-standing goal of the WHO [World Health Organization]: since the early 1990s researchers have been trying to create a vaccine formulation that is capable of delivering the equivalent of two or three prime-boost vaccinations with a single immunisation.

"Achieving this would circumvent many obstacles that immunisation coverage faces today: non-compliance, missed or delayed doses, logistical problems of vaccine storage and administration in hard to reach parts of the world, wastage of expired/unused doses, and so on."

Dr Kevin Pollock, honorary lecturer in infection, immunity and inflammation at the University of Glasgow, cautioned: "It may be as long as 15 to 20 years before such delivery systems could be used in vaccines.

"It is not yet well understood how the human immune system would respond as it is much more used to receiving a single dose, being allowed to recover and then being immunised again.

"This demonstrates the difficulty of going from in vitro or in vivo systems using mice to a vaccine ready to be rolled out in the NHS. This group are not even at this point. Therefore, there is much work to be done to consider the safety of these vaccines."

Find out more about the current childhood vaccination schedule in England.

Links To The Headlines

Scientists invent jab that could deliver every childhood vaccine in one go. The Independent, September 16 2017

New technology could allow multiple vaccines to be delivered in single jab. The Guardian, September 14 2017

Links To Science

McHugh KJ, Nguyen TD, Linehan AR, et al. Fabrication of fillable microparticles and other complex 3D microstructures Science. Published online September 15 2017

 
 
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