All COVID-19 vaccines under development, the technology behind them and their current state of progress in trials

Many media sources have reported that when taken at bedtime, blood pressure pills work better, reducing the risk of heart attack and early death.

It follows a large trial conducted through northern Spain general practices. It included about 20,000 people with high blood pressure (age 60 on average).

Half the people were told at bedtime to take their blood pressure tablets, and the other half at waking. These were followed up for an average of 6 years, during which time about one in ten suffered a heart attack, heart failure or stroke, or died from cardiovascular disease.

The study found that people who take their blood pressure tablets at bedtime the night blood pressure was significantly lower and 45% less likely to have one of these results.

The trial lend support past studies with similar findings. However, the trial just analysed Spaniards from white ethnic backgrounds. It also does not look at the effects of time on a certain blood pressure tablets. Therefore, as the researchers say, more studies are needed before we see whether the advice on how to take blood pressure medication should be changed.

Unless you are taking diuretics (water tablets), which may mean you have to get up a lot at night to urinate, there should be no negative effects from taking them at night. But it might be worth talking to the GP before making changes in how you take your medications, especially if you take several different medications.

What is the story’s origin?

This study was conducted by researchers from the University of Vigo and several other institutions in Spain. This project received financial support from the Spanish government and several other organizations.

The study was published in the peer-reviewed open European Heart Journal and is available for online access.

British media coverage of this study was widely accurate.

What kind of research was this?

This was a randomized controlled trial aimed to see whether it is better to take blood pressure tablets at bedtime or in the morning. A randomized trial is the best way to see the effectiveness of treatment for randomization have to balance differences in patient characteristics, such as health and lifestyle, which could affect the outcome.

One slight limitation is that the open-label trial (not blind) means patients and researchers are aware when they are taking their tablets.

An ideal design may have provided all the patients tablet morning and night, one set into the other drug and matching placebo (dummy tablets). However, the length of this trial will be extremely difficult. There could also be the risk of error (for example, patients taking placebo tablets 2 sets of the day and there is no cure them).

What did the research involve?

The trial was conducted between 2008 and 2018 in 40 general practices in northern Spain. This includes adults diagnosed with high blood pressure (hypertension) in accordance with the standards and criteria prescribed one or more blood pressure medications.

They recruited a total of 19 084 patients (mean 60 years, 56% male) who were told to take their medication at bedtime or in the morning. About a quarter of all patients recruited had type 2 diabetes, 43% were obese, 15% were smokers and 10% already have a past cardiovascular events such as heart attack. Patients wear different types of blood pressure medications.

Patients were followed up with clinical assessment at least once a year, which included blood tests and wore blood pressure monitors for 48 hours (ambulatory blood pressure monitoring). The main outcome of interest is the patients who experienced one or more:

• heart attack
• stroke
• a procedure to open the heart arteries (like stent insertion)
• heart failure
• death from cardiovascular disease

They adjusted their analysis for the patient’s age, sex, cholesterol, initial blood pressure, smoking, diabetes and kidney disease.

What is the basis of the results?

During an average follow-up of 6 years, in 1752 adults (9%) had a major cardiovascular outcomes.

Patients who take their blood pressure tablets at bedtime had a 45% lower risk of any of these events (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.50 to .61). The researchers also found a decreased risk when they see each of the individual outcomes, such as heart attack or stroke.

Results of 48-hour blood pressure monitoring showed that patients taking their tablets at bedtime had lower blood pressure at night. There was no difference in daytime blood pressure between the two groups.

There was no difference between the groups in any of the side effects of treatment. There was also no difference in how many patients do not take their tablets should be, or when they should.

How did the researchers interpret the results?

The researchers concluded that drug-taking blood pressure on sleep results in improved control of blood pressure “and, most importantly, markedly reduced the occurrence of major cardiovascular disease events”.

Conclusion

It is a worthwhile experiment to investigate the best time to take blood pressure medication. It has certain powers of a very large sample size and long duration of follow-up, which is quite rare for a randomized trial.

They found that taking the medication at bedtime lowers blood pressure at night and reduce the risk of heart attacks and other cardiovascular events. They found these differences not only when looking at all the combined event, but each individual. This suggests that when you take the drugs makes a real difference. This lends support to previous trials that have had similar findings.

There are currently a variety of blood pressure medications do not have a strict prescription information at the time of the day they need to be taken, with the exception that diuretics (water tablets) are often taken in the morning to avoid the need to urinate frequently at night.

Despite the positive findings, there are some limitations to the trial. These include that the researchers were not able to analyze the effect of time for individual anti hypertensives. Also the study was held in mainly Spanish, exclusively white ethnic populations that may not be representative of other populations.

The researchers themselves acknowledge that their test results now need to be validated in other study populations. More conclusive findings might in the future lead to a change in the way anti hypertensives are prescribed.

The research

Hermida RC, Crespo JJ, Domínguez-Sardiña M, et al.

Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial

European Heart Journal. Published online October 22 2019

1.  Don’t procrastinate and get advice early on about your pending appraisal.
2.  Ask someone for help about what is on your mind. Usually this might be advice about what you are thinking of  submitting.
3.  Look at some examples of submitted examples of appraisals.
4.  Breaking down big goals into small goals. Starting to enter data into GP Tools , contacting your appraiser, etc.
5. Avoid unnecessary work. It is not really necessary to scan and upload large amounts of evidence, unless particularly asked for. You only need to show notes if you have not written them into the toolkit. If you are submitting more than 15 documents per year you are wasting your time and effort in this process.
6.  Avoid duplication of effort and avoid repeating yourself. Concentrate on being focussed.
7.  4 domains of Good Medical Practice, sometimes can cause confusion. A great document for this is a GMC pdf discussing the four domains and their relevance to appraisal and revalidation.  Click here to download the PDF document
8.  Quantifiying the amount of time you are spending on entering the data. SEAs/ QIAs shouldn’t take more than 15-20 minutes.
9.  CPD log captures your CPD for the year. Should contain the date, number of hours, learning points. Having 1-2 learning points for each topic is enough. There is no need to scan everything on and it shouldn’t take more than 1 to 1.5 hours to convert all your notes into CPD data.
10. Using a validated and accepted toolkit such as GP Tools to help you document your data. Use the mobile apps to collect your CPD data on the go.
11. For MSF 360 feedback and patient surveys, remember to start early and allow a month for collection of your data and about a week for processing and collation of the responses into a report. Both types of feedback are free with GP Tools.

For more on this topic, watch a great video by Dr. Paula Wright:

QRISK has been used in the general practice setting since 2007. It has been upgraded to QRISK 2. It is a 10 year cardiovascular risk tool. There is a proposal to upgrade to a newer version of the algorithm called QRISK 3. This has been outlined in a recent paper published by Julia Hippisley-Cox, professor of clinical epidemiology and general practice1,Carol Coupland, professor of medical statistics in primary care and Peter Brindle, evaluation and implementation theme lead, NIHR CLAHRC West. The paper was published in the 23rd May 2017 issue of the BMJ. BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2099

Currently QRISK 2 includes the ages of 25 to 84 and includes

• Ethnicity
• Deprivation (the Townsend score)
• Systolic blood pressure
• BMI
• Total cholesterol/HDL ratio
• Smoking
• Family history of coronary artery disease in a first-degree relative aged less than 60
• Type I diabetes
• Type II diabetes
• Treated hypertension
• Rheumatoid arthritis
• Atrial fibrillation
• Chronic kidney disease (stage 4 or 5)

QRISK 3 will include the following additional factors:

• Chronic kidney disease (stage 3, 4, or 5)
• Systolic blood pressure variabilit
• Migraine
• Corticosteroid use
• Systemic lupus erythematosus
• Atypical psychotics
• Severe mental illness,
• Erectile dysfunction in men
• HIV/AIDS.

Overall the calculator performed as the previous version. The new added risk factors were found to increase risk by about 10%, the only exception being HIV/AIDS.

You can use the new risk calculator here:  https://qrisk.org/three/

The new 2017/18 Qof with the frailty index does away with the bureaucratic unplanned admissions direct enhanced service and replaces it with indentifying and managing the over 65s with moderate to severe frailty.

What is the electronic frailty index (eFI)?

The electronic Frailty Index (eFI), which has been developed by the  University of Leeds, TPP (System One), Bradford Teaching Hospitals NHS Foundation Trust, Bradford University and Birmingham University, is an evidence based criteria for identifying frail patients.

It is based upon 36 deficits comprising 2000 Read codes . The score is strongly predictive of adverse outcomes and has been validated in large international studies.

The eFI score is out of 36. For example if 9 deficits are present then the socre will be (9/36) or 0.25. In this way the following frailty categories can be defined:

How to get the eFI score and the list of moderately and severely frail patients?

What your practice needs to do:

Wikipedia defines Upselling as a sales technique whereby a seller induces the customer to purchase more expensive items, upgrades or other add-ons in an attempt to make a more profitable sale.

We believe that the whole revalidation industry that has sprouted out of nowhere is at its core built on upselling. If it were up us at GP Tools, we would provide this toolkit completely free to our users. Unfortunately, in the post-truth world that we live in, offering something for free implies a catch somewhere down the road or some other negative connotation.

Which is why we are not surprised when we receive emails from Doctors’ who have been somehow manaevred into buying unnecessary add-ons from other toolkit providers.

Our company ethos at it’s most basic level prevents us from engaging in predatory business practices such as upselling. Nowhere on the site will you ever be bombarded with messages forcing you to take out a learning module subscription, nor will we ever email you anything similar.

Due to guidance from the GMC and the revalidation survey carried out this year which is finally coming to a conclusion, the vast majority of Royal College’s have updated the requirements for revalidation. Because of the underlying tone of revalidation being seen as an onerous activity detracting from patient care, the criteria have been relaxed. It seems that most UK doctors are unaware of these updated points and in fact talking to appraiser’s regularly it seems that they are as well.

For GPs, the RCGP has published a very useful document called RCGP Revalidation Mythbusters , in which the following key changes are worth mentioning. It should be pointed out that the revalidation requirements have been considerably downgraded after feedback from the GMC and RCGP revalidation survey.

Current revalidation myths, in order of importance (these are all FALSE).

• I have to use a portfolio defined by my responsible officer to revalidate.

The RO has no mandate to force upon doctors any particular toolkit. If your RO or local appraisal team is bullying or coercing you into using a particular legacy commercial toolkit then you are within your rights to make a formal complaint about the RO to the national revalidaiton support team at:

[email protected]

• I can’t claim credits for impact now.

You can now claim as many credits for subsequent hours of work that you think have made an impact. e.g. if doing a search and implementing protocols took you 3 hours then 3 credits can be claimed regardless of how much time the initial learning activity took.

• I have to include two significant events every year.

No longer a requirement. Events that caused no harm to patients should be documented under an alternatvie category.

• I have to do at least one clinical audit in the five year cycle.

Transformed into QIAs, case reviews, patient journeys, reflection on how to improve patient care, and how you are providing patient care.

• My appraisal portfolio is entirely confidential.

Unfortunately this is not the case, and a recent court case demonstrated that your appraisal reflections can be used against you if a complaint has been taken to court.  Trainee’s portfolio ‘used as evidence against them’ in legal case.

• I need to scan certificates to provide supporting information about my CPD. This is not a GMC requirement, but you know how GP Tools makes it easy for you if you want to.

• I have to write a separate reflective note for every hour of CPD I do.  One reflective note for each activity even if it lasts all day.

• I can choose my designated body / where to have my appraisal.
• Appraisal is the main way to identify concerns about doctors.
• Appraisal is a pass/fail event.
• My appraiser will decide about my revalidation recommendation.
• I need to undertake a minimum number of GP sessions to revalidate as a GP
• I have to document all my learning activities. Put down the highest quality one’s to get to 50 hrs of learning.
• It is reasonable to spend a long time getting the supporting information together for my appraisal. You should not spend more than 3.5 to 4 hours gathering this information. In fairness, this should not take any time if you have been using GP Tools regularly.
• I only need to provide all six types of GMC supporting information about my clinical role.
• All my supporting information has to apply to work in the NHS.
• Supporting information from work overseas cannot be included in my appraisal portfolio.
• Documented reflection has to be longwinded. It should be brief and to the point.
• Reflection is difficult. How they describe reflection now as thinking critically about what we do does make it seem easier.
• Only courses and conferences count as CPD. GP Tools has made it clear that this is not the case.
• I have to do an equal amount of CPD every year despite different circumstances.
• As a part-time GP, I only need to do part-time CPD.
• My CPD for each part of my scope of work has to be different.
• My supporting information from part of my scope of work already discussed elsewhere has to be presented again at my medical appraisal for revalidation.
• The GMC requires GPs to complete Basic Life Support and Safeguarding Level 3 training annually in order to revalidate successfully.
• I cannot claim any credits for a learning activity if I do not learn anything new.
• My appraiser will be impressed by my hundreds of credit. Some of them are born not be impressed!
• I have to do 50 credits of CPD every year. Well, to keep the RO of your back, probably best to comply with this on an average of 50/year.
• I need 50 credits of clinical CPD every year. Across your whole scope of work.
• I have to demonstrate 50 credits each year even if I have not been able to practise for much of the time. Exceptional circumstatnces may be invoked.
• I can stop learning and reflecting once I have reached 50 credits of CPD.
• Time spent on Quality Improvement Activities (QIA) is not CPD. Again,  GP Tools has always made it clear that this is not the case.
• I have to do all of my Quality Improvement Activity (QIA) myself.
• There are specific types of Quality Improvement Activities (QIA) that I must include. You do not have to include any specific type of quality improvement activity but you must reflect on the quality of your practice and how you meet the requirements of Good Medical Practice (GMP).
• GMC Significant Events are the same as GP significant events. Events that do not cause harm to the patient are not the same as GMC SEAs.
• I have to use the GMC questionnaire for my patient and colleague feedback.  The main patient survey from your clinical work and the main colleague survey from your  clinical work, normally undertaken once every five years,  should be fully GMC compliant, but other feedback need not be.
• All my patient and colleague feedback has to meet the GMC requirements.
• I have to do a patient survey every year.
• I have to find other ways to get feedback from patients every year.
• My Personal Development Plan (PDP) must include…
• My Personal Development Plan (PDP) cannot include…
• I have to have 3/4/5 Personal Development Plan (PDP) goals (or I have to have 3/4/5 clinical PDP goals).

The RCGP recommends that your portfolio of supporting information should include all the core elements required by the GMC in a format that is professionally presented, typed so that it is legible, and capable of being transmitted electronically.

NHS England clearly says that, while they require appraisals to be submitted electronically and not on paper, the individual GP should have a choice about which toolkit to use (medical-appraisal-policy-0415,  page 15).

The following is a communication from the Londonwide LMCs to all London based GPs regarding freedom of appraisal toolkit choice (27 January 2016 – emphasis added).

Dear Colleague.

As you will know, NHSE funding for the use of the Clarity appraisal toolkit has ceased. Although many of you will pay for and continue to use Clarity, we have been asked to remind you that, should you wish, there are alternative toolkits as well as the free downloadable MAG form.

There is no requirement in the regulations to use any particular vehicle for your appraisal, although it may remain convenient to you to use a toolkit with which you, your appraiser and the responsible officers are familiar.

We recommend that GPs intending to use an alternative inform their appraisers well before their next appraisal date, and check with any alternative supplier the mechanism for transferring previous appraisal data from Clarity.

Yours sincerely

Michelle

Dr Michelle Drage FRCGP
Chief Executive
Londonwide LMCs

Dear Colleagues,

With the recent changes in NHS funding for appraisal toolkits. It is now the respoonsibility of the individual doctor to pay for thier online appraisal and revalidation toolkit.

Common sense dictates that as doctors are going to be paying for their toolkit they should be able to choose whichever appraisal vehicle / toolkit they like – as long as it fulfils all the requirements.

This very helpful NHS guidance:

NHS England guidance on appraisal toolkit choice

clearly states :

‘Whichever vehicle you decide to use, you will be responsible for ensuring that your appraiser has access to your system and understands its functionality. You must also ensure that your appraisal information complies with the Medical Appraisal Guide and is available in a format that permits it to be uploaded to the RMS. In terms of this latter point, if your appraisal can be downloaded as a pdf or Word document, this will be acceptable.’

So you are free to use whatever appraisal toolkit you like. With a range of innovative features we feel that GP Tools should be your first choice. Our ‘easy as email’ approach and ability to fulfil all NHS England requirements make us the ‘go to’ vehicle for medical appraisals.