The coronavirus pandemic has brought medical procedures, like COVID-19 testing and COVID-19 vaccinations, into our day-to-day lives like never before. These experiences aren’t easy for everyone, especially for children.
But even outside a pandemic, medical procedures such as vaccinations and blood draws are common throughout childhood. When asked, children reliably say that their biggest concerns about medical procedures are needles and pain. They are also worried that their comfort won’t be taken into account. And evidence says they’re right.
Research is also clear that when children’s pain and fear aren’t well managed during medical procedures, there are both short- and long-term consequences. Procedures can take longer and have an increased risk of adverse events (such as fainting or being physically restrained), and children are likely to need more medications for pain and to develop negative or traumatic memories.
These fears can lead to delays or avoidance of necessary health care, even when children become adults.
We have prepared tips to make COVID testing and needles comfortable, and those recommendations are really important. But here’s the thing: what helps for pain and low-to-moderate fear isn’t enough when children are very afraid.
If children’s pain and fear aren’t well managed every time, medical procedures can get harder and harder until children begin to refuse. Sometimes people interpret a child’s refusal as misbehaviour. Nothing could be further from the truth.
With repeated negative experiences, a child’s distress and fear can become so high that it can produce a true adrenaline fight-or-flight response, similar to if they were face-to-face with a lion. Traumatic stress from medical procedures is in the eye of the beholder: a child’s own experience of the procedure, and fear response to it, are more important than the “objective” severity or how painful or scary it may seem to others.
Coping with fear and distress
We have heard from parents that they want to know more about what to do when their child is refusing a procedure because of high levels of fear, often resulting from a previous negative or traumatic experience. Sometimes when children become highly distressed, adults will restrain them in an effort to “just get the procedure over with.”
We want to be clear: Holding a highly distressed child down for a routine medical procedure is never OK, isn’t patient-centred care and has the potential to make things exponentially worse in the long term.
A child’s fear must be taken seriously and addressed before they can benefit from efforts to manage pain and low-to-moderate fear. If your child is very afraid of a medical procedure (for example, COVID testing, vaccinations, blood draws, dental treatment), the following science-backed steps are needed.
In exposure-based therapy, someone gradually faces their fear head on, starting with easier situations and working their way up to more difficult ones. In this case, it involves educating your child about what is going to happen and why, and enabling them to practise gradually facing each step of the medical procedure before the actual procedure itself.
Make space for their feelings and have a conversation.
- Validate your child’s concern: acknowledge their feelings and why they make sense (even if you don’t agree or can’t relate).
Figure out what is worrying them about the situation.
Take an open, non-judgmental and curious approach to understand what scares them about the medical procedure.
Don’t assume. Ask. Make sure your child understands what they are being asked to do as part of the medical procedure, why they are being asked to do it, what will happen, what it will feel like, how long it will last and who will be there. Answer any questions that they have and correct any misperceptions. You might need to get some information from a health-care professional so that you have all the answers.
What is the focus of their fear? Older children and youth can often tell you what they are worried about regarding the procedure. For younger children, you may have to offer suggestions or alternatives and make your best guess.
Practise facing the fear
For fears that are out of proportion to the danger posed, children will need to practise facing their fear head on. You need to generate a list of fear-inducing situations related to the procedure, such as:
talking about the procedure;
seeing pictures or videos of it (tip: make sure these are positive videos where minimal or no distress is shown);
playing with related toys/equipment;
driving past the health centre or site where the procedure will take place; and
the micro-steps leading up to the procedure itself (such as sitting in a chair, having a tourniquet applied or their arm cleaned with an alcohol swab, etc.).
Order the situations from easiest to hardest by getting a fear rating for each one. This becomes their “fear ladder.”
Tip: for children ages five to seven, you can use the Children’s Fear Scale; for seven-year-olds and older, a zero-to-10 scale ranging from no fear at all to most fear possible; for younger children, you could order the situations by asking them to make choices in head to head comparisons in which the child picks which one is easier out of two, or if all else fails, your best guess.
Help your child practise facing their fear by experiencing these situations. They have to stay in the situation long enough so that their fear will come down, and/or that they learn whatever they’re worried about isn’t going to happen or if it does, they can survive it. Remember, this is for fears that are worse than the actual danger of the situation.
This is hard work! So, for each exposure or practice, your child should earn a reward. You can set up a reward program to go with each step of the fear ladder. Rewards should be small, something you are OK to withhold if they don’t earn them, and don’t have to cost money (for example, playing a special board game or giving a five-minute massage, rather than a new toy).
Your child has to stay in the situation long enough. If they escape the situation before their fears have subsided to a manageable level, it will just maintain their fear. Taking some deep breaths and encouragement from you can help!
If a step is way more difficult than the previous one (too big a gap in the ladder), try to break down the situation by varying factors like who is there as a support, or start with imagining it first before trying that step in real life. Each step might have to be practised multiple times before the fear reduces.
Don’t rush through — there are no points for speed! It’s best to make sure your child is ready to make it as positive an experience as possible, and to make things easier in the future. Once your child has made it to the top of their ladder, the next step is the procedure itself.
The science-backed principles outlined in this article can help children and their parents to feel confident about medical procedures. As parents and clinicians, we have an opportunity to practise too: preparing and empowering children to take an active role in their health, confident that they are the focus of patient-centred care.
This story is part of a series produced by SKIP (Solutions for Kids in Pain), a national knowledge mobilization network whose mission is to improve children’s pain management by mobilizing evidence-based solutions through co-ordination and collaboration.
Meghan McMurtry has received funding from the Canadian Institutes of Health Research and the Public Health Agency of Canada for research related to needle pain and fear as well as laboratory infrastructure support from the Canadian Foundation for Innovation and the Ministry of Research and Innovation.
Kathryn Birnie is Associate Scientific Director of Solutions for Kids in Pain (SKIP).treatment testing therapy pandemic coronavirus covid-19 canada
Joined up thinking needed for joined up data plans
Joined up data could transform the pharmaceutical industry and help create a healthier Europe for decades to come
The post Joined up thinking needed for…
Joined up data could transform the pharmaceutical industry and help create a healthier Europe for decades to come – but the route to change is far from smooth sailing.
Without careful consideration and full stakeholder input, the EU’s plans for a connected data system could end up being counterproductive.
That’s the view of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which has published a list of recommendations aimed at helping the sector get the most of out of the data it holds.
“If the European Health Data Space (EHDS) and the rules surrounding access to the data are not carefully thought through, with the involvement of all stakeholders, there could be unintended consequences that limit the utility of the data for developing innovative medicines,” said the organisation.
The EFPIA Recommendations on a Connected Data System in Europe, published at the end of April, welcomes the proposals, which are part of the European Strategy for Data, to create common data spaces.
Said the authors: “A connected health data ecosystem has the potential to empower more effective and efficient research and development of new treatments and diagnostics. It would also ensure better planning and delivery of patient-centred care through personalised medicine.
“This, combined with value-based healthcare, can result in better allocation of resources and more sustainable healthcare systems.”
The value of this approach, which places real-world data in the hands of the right people at the right time, was demonstrated in abundance over the last few years, they went on.
It was, they explained, stakeholders from across the healthcare ecosystem coming together to share insights, whether from clinic, research, or genomics, that changed the course of the COVID-19 pandemic.
Applying the same ethos to healthcare in general, then, could give the drug development sector all the information it needs to contribute to a fitter, healthier Europe.
“For the research-based industry, access to data is critical at every step. From accelerating drug discovery to understanding patients’ behaviours and the outcome of treatment, the availability of data is essential to testing hypotheses, identifying trends and assessing proposed treatments,” they said, adding that improved access to, and transmission of, health data could “transform the pharmaceutical industry”.
While EHDS is a lofty ambition, bringing it to fruition will not be without its challenges, both practical and regulatory.
As the EFPIA paper points out, health data is currently held in a wide range of repositories, from clinical notes and electronic health records to insurance claims, patient registries, patient-reported outcomes records, and continuous patient monitoring data from apps and wearables.
Unlocking their value, then, requires a high level of interoperability between different IT systems, providers, data sources, and software, all based in different countries with different levels of infrastructure maturity.
“Healthcare system information must be better connected. This will allow stakeholders to use this data for optimising and improving health outcomes,” said the paper, adding that interoperability was a “critical enabler of the digital transformation of healthcare in Europe”.
Conflicting national laws could be another important barrier to data access and use. Varying interpretations of the General Data Protection Regulation (GDPR), for example, present challenges for clinical development of innovative medicines, said the authors.
“Conflicting interpretations of Article 9 of the GDPR, and the additional limitations on processing of health and genomic data that member states have enacted under this article, cause significant delays in study start-up and patient enrolment.
“Some member states take the position that the only lawful basis for processing health data is when individuals have given their consent for its collection and use. Others… take the position that processing this health data, when necessary for scientific research, is lawful.”
EU Data Protection Supervisors, the paper recommends, must reach a common understanding of key GDPR terms if citizens are to enjoy the same rights across the EU.
The EFPIA paper makes a number of recommendations on how the EU could embrace the full potential of the proposed EHDS.
First, it says that developing a shared understanding of the relevant requirements in digital health is essential, and calls for an EU-wide approach to how data is accessed, pooled, compared and used, while also protecting privacy.
In terms of possible solutions, it points to the use of Federated Data Networks (FDN), in which separate networks share mutual RWD resources.
“In an FDN, data is not moved from its host source, though hybrid models can exist with local and central data hosting. The research question or query moves to where the data is originally hosted, with results aggregated centrally or delivered to the researcher,” said the authors.
This, they went on, could unlock the power of data in primary or secondary care settings, in clinical care decision-making, and in research, whilst preserving the privacy of the RWD at a local level.
Common data models (CDM), which standardise the logical infrastructure of software systems to enable interoperability, are also required.
“CDM is essentially a construct, a means to an end to help organise RWD into a common structure, formats, and terminologies across diverse, heterogeneous, and multiple source datasets,” said the paper.
“It addresses a central need to be able to curate data for analysis on a contemporaneous and continuous basis (not on a per study basis) or for largescale, geographically diverse, network studies of multiple data sources.”
Joined up approach to joined up data
Ultimately, building a usable EU-wide health data system requires input from all stakeholders, and decisions on FDNs and CDMs should be taken internationally, as a sector.
Because, as the EFPIA says, we all have one goal: using the power of data to improve the health of the citizens of Europe.
- Read the full recommendations paper here
About the author
Amanda Barrell is a freelance health and medical education journalist, editor, and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, HCPs and the public.
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Weekly investment update – The soft underbelly of hard inflation data
Warnings by the US and Chinese authorities have underscored the dilemma of conflicting inflation and growth data, with energy and tight labour markets…
Warnings by the US and Chinese authorities have underscored the dilemma of conflicting inflation and growth data, with energy and tight labour markets pushing up producer and consumer prices amid creeping signs of softening growth. This has put global monetary policy, and markets in risky assets, in a bind.
The Dow Jones Industrial Average fell for the seventh consecutive week last week, while the benchmark US Treasury 10-year yield hovered around 3.0% (almost double the 1.6% of a year ago). Commodity prices came under selling pressure as risk aversion among investors mounted. Safe-haven flows pushed up the US dollar, driving its trade-weighted index to near two-decade highs (see Exhibit 1).
China fanned market worries early last week, with Premier Li Keqiang warning that the domestic jobs situation was getting ‘complicated and grave’. The country’s zero-Covid policy is taking a heavy toll on the local economy with negative spillover effects globally. While Shanghai’s lockdown may be wound down soon, other major cities (including Beijing) are facing renewed restrictions.
US Federal Reserve Chair Jerome Powell issued a warning mid-week: The Fed could not guarantee a ‘soft landing’ as it looked to get runaway inflation back to its 2% target amid a tight US labour market. The US Senate nonetheless overwhelmingly confirmed Powell for a second term, signalling monetary policy continuity.
Earlier in the week, former Fed Chair Ben Bernanke warned about the risk of stagflation in an interview with The New York Times.
Aggravated by hard inflation data…
US consumer price inflation was 8.3% YoY in April, down slightly from 8.5% in March. However, core inflation (which excludes food and energy prices), rose on the month from 0.3% to 0.6%, a level still too high for the Fed’s comfort.
Services inflation was particularly strong, rising by 0.7% MoM in April, marking the biggest monthly gain since August 1990. Underscoring continued robust consumer demand, retail sales rose by 0.9% vs the prior month, though this marks the third month in a row that the growth rate has decelerated.
The prospects for inflation to fall back to the Fed’s 2% target anytime soon may not be good: High wage growth – hourly earnings rose at around 5% YoY – could continue to fuel inflation in the near term. We note that services inflation tends to be much stickier than other index components.
From the Fed’s perspective, these price pressures could in turn drive inflation expectations higher.
The market perceives the latest inflation report as sealing a 50bp rate rise at the June and July meetings of Fed policymakers. It also boosts the chances of the Fed persisting in its aggressive tightening stance at later meetings. A key question is the extent to which – and when – higher interest rates will hit real incomes and crimp demand growth, slowing the economy overall.
The high services inflation data also suggests labour market tightness would have to ease significantly to bring wage growth back to levels that are acceptable to the Fed. We believe something will have to give. If not, the Fed may have to tap harder on the brakes down the line.
The ECB continues to move closer towards a hawkish policy, with the market now expecting its asset purchasing programme (APP) to end in July, to be followed by a 25bp rate rise soon after. Underpinning the ECB’s policy tightening stance is strong inflation, which rose by 7.4% YoY in April (same as in March), and falling unemployment (the jobless rate hit a record low of 6.8% in March).
The war in Ukraine has added to the upside risks to inflation via food and energy price increases and supply bottlenecks. In addition to higher inflation, the ECB also appears to be concerned about the spillover effects from wage increases. An increasing number of policymakers has spoken out recently in favour of an initial rate rise as soon as July.
And creeping signs of slower growth
Indications of weakening growth momentum have appeared, most noticeably in the UK where GDP growth contracted unexpectedly by 0.1% MoM in March.
In the eurozone, industrial production shrank by 1.8% MoM in March and manufacturing output was down by 1.6%. The main culprit was disruption caused by the war in Ukraine. The weakness was concentrated in Germany, whose supply chains are more integrated with eastern Europe. Its car sector is missing components produced in Ukraine.
Even in the US, recent data showed signs of slowing growth. Jobless claims filings showed an increase in initial claims; the May Senior Loan Officer Opinion survey recorded a drop in demand for mortgages; the University of Michigan consumer sentiment May index hit its lowest level since the start of the pandemic; and the May Empire State Manufacturing survey plunged.
China also released weak data, with industrial output, fixed-asset investment and retail sales all showing year-on-year declines. The property market’s woes deepened, with new home sales and starts falling precipitously.
Mr. Bernanke’s warning of stagflation underscores the dilemma facing policymakers and financial markets: Inflation and growth data are sending conflicting signals. Parts of the US yield curve are inverted, pointing to some risk of an economic recession.
The slowdown concerns are linked to inflation forcing the Fed to tighten policy into restrictive territory and turning weaker growth into a contraction.
The situation is similar in the eurozone: inflation is at its highest ever and could lead the ECB to take stronger measures, exacerbating headwinds from weak Chinese activity and a Russia-induced energy supply shock.
Against the backdrop of the continuing Ukrainian conflict and prolonged supply-chain disruptions, we do not favour sovereign bonds and European equities at this point. We prefer commodities, Japanese and emerging market equities, including Chinese stocks.
Please note that articles may contain technical language. For this reason, they may not be suitable for readers without professional investment experience.
Any views expressed here are those of the author as of the date of publication, are based on available information, and are subject to change without notice. Individual portfolio management teams may hold different views and may take different investment decisions for different clients. The views expressed in this podcast do not in any way constitute investment advice.
The value of investments and the income they generate may go down as well as up and it is possible that investors will not recover their initial outlay. Past performance is no guarantee for future returns.
Investing in emerging markets, or specialised or restricted sectors is likely to be subject to a higher-than-average volatility due to a high degree of concentration, greater uncertainty because less information is available, there is less liquidity or due to greater sensitivity to changes in market conditions (social, political and economic conditions). Some emerging markets offer less security than the majority of international developed markets. For this reason, services for portfolio transactions, liquidation and conservation on behalf of funds invested in emerging markets may carry greater risk.
Writen by Chi Lo. The post Weekly investment update – The soft underbelly of hard inflation data appeared first on Investors' Corner - The official blog of BNP Paribas Asset Management, the sustainable investor for a changing world.recession unemployment consumer sentiment pandemic bonds yield curve dow jones emerging markets equities stocks monetary policy fed federal reserve us treasury home sales us dollar senate lockdown gdp interest rates commodities european europe uk germany russia ukraine china
Moderna’s HIV vaccine prepped for trials in Africa
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV
The post Moderna’s HIV vaccine prepped for…
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt.
IAVI (the International AIDS Vaccine Initiative) has started screening subjects to be included in the study, called IAVI G003, at centres in Rwanda and South Africa, said the biotech.
Moderna’s vaccines deliver HIV-specific antigens discovered by researchers at IAVI and Scripps Research that have already been tested in a proof-of-concept study carried out last year using an adjuvant protein vaccine approach.
There are hopes that its mRNA approach, which proved so effective against COVID-19, could succeed where traditional vaccine technologies have failed in HIV.
One candidate – mRNA-1644 – has already shown its potential in an earlier phase 1 trial (IAVI G001) run in the US. It codes for an antigen called eOD-GT8 60mer and, in the study, stimulated a targeted B-cell immune response in 97% of vaccine recipients.
Moderna says that B-cell activation should lead to the induction of broadly neutralising antibodies (bnAbs), widely considered to be a goal of an efficacious HIV vaccine, but that immunising with eOD-GT8 60mer alone will almost certainly not be sufficient.
The biotech is looking at a combination regimen of vaccines targeting different HIV immunogens such as Core-g28v2 60mer to try to boost the immune response further against HIV and improve the protective efficacy.
Earlier this year, the first healthy volunteers were dosed with mRNA-1644 in a second phase 1 trial (IAVI G002), which is being funded in part by the Bill & Melinda Gates Foundation and is being carried out in US populations.
On HIV Vaccine Awareness Day, we want to acknowledge and thank the scientists, clinical trial participants, volunteers and so many others around the globe working together to advance the hope of a preventive #HIV #vaccine. #HVAD #HVAD2022 pic.twitter.com/KLrVRXtEAv
— Moderna (@moderna_tx) May 18, 2022
IAVI G003 will enrol 18 healthy HIV-negative adult volunteers who will receive two doses of the eOD-GT8 60mer mRNA shot. They will be followed for six months to gauge the safety and immunogenicity of the vaccine.
Moderna said the trial is a “first-in-Africa” study, evaluating an mRNA-delivered HIV immunogen in Africa with African researchers leading the project.
Despite more than 30 years of research, the tendency of the virus to mutate means that classical approaches to vaccine design have been ineffective, and at least four prior vaccine candidates have failed in clinical trials.
In February, one of the front-runner candidates in the decades-long quest to find an HIV vaccine – Johnson & Johnson – reported that its candidate failed a phase 2b trial.
The Ad26.Mos4.HIV vaccine – which uses the same adenoviral technology as J&J’s COVID-19 vaccine and targets four HIV antigens – showed that the shot was safe but unable to meet its target of reducing transmission of HIV by 50%.
And last year, the HVTN 702 study of two co-administered HIV candidate vaccines from Sanofi Pasteur and GlaxoSmithKline, combined with GSK’s adjuvant MF59, was also discontinued due to a lack of efficacy.
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