Dr Alice Byram

Featured

Telemonitoring

Listen to this as a podcast courtesy of the IFMiL or Catalan Institute of Medical Education and Leadership.

What is it?

Telemonitoring has been defined as “the distance monitoring of components of a patient’s health as part of a larger chronic care model” as recently as 2016 (1). It is clear, however, that real-time telemonitoring is now opening up the possibility to manage acute illness too.

Types of devices.

Many telemonitoring devices are available. From weight to oxygen saturation, to heart rate and rhythm, it is important to choose the parameters which will affect your management. In an acute setting, this may be the parameters of a NEWS or early warning score such as blood pressure, oxygen saturation and heart rate among others. For more chronic patients, it may be recording weight variations a way of evaluating fluid balance.

Patients own

A recent article in the BMJ noted that “it may be possible to get the patient to take readings from instruments they have at home—for example, temperature, pulse, blood pressure, blood glucose, peak expiratory flow rate, and oxygen saturation”(2). Many patients also have wearables, such as Fitbits and Apple watches. These wearables can measure biomarkers such as heart rate and, in the case of the apple watch, heart rhythm. Although the FDA approval for heart rhythm came out to great fanfare, there was also a backlash from cardiologists against the identification of asymptomatic atrial fibrillation for example. And the worried well using and wanting consultations about the information from their home monitoring can be a challenge in a stretched health care system.

Official

Some home monitoring has been FDA approved for information transfer and sharing with health care professionals. CGMs or continuous glucose monitoring is increasingly available to people with diabetes, enabling them to alter carbohydrate intake, lifestyle and medications in real-time. Not having CGM has been likened to a block of cheese with holes. Even if you do eight pinprick blood glucose checks a day, you will still have only a very limited picture as to what is going on. CGM not only provides a continuous blood glucose measurement, but it also gives tendencies. Knowing you have a BM of 100 stable or 100 going down fast will lead to very different decisions as to how much insulin to inject. Commercial CGM sensors all have FDA approval.

#wearenotwaiting

Sometimes the FDA approved technology is not enough. This is the case in people with type 1 diabetes who can have significant and dangerously low blood sugar levels, especially at night. The need to be able to share this information with other family members who can act if the person with diabetes does not react in time led to the #wearenotwaiting and nightscout movement. Using opensource technology, people with diabetes can upload their CGM readings to the cloud. They can set up alerts and share their blood glucose in a way which was not initially offered by the manufacturers and is still not available for all the CGMs on the market. As this is opensource, it does require a level of commitment that is not needed with out of the box commercial solutions. There is also a disclaimer that the movement is not liable for any safety issues. However, users say it is safe, much more so than the commercial solutions for enabling parents to keep an eye on their children at a distance and for adults to live independently alone.

Pros

Like any technology or therapeutic intervention, there are pros and cons. Advantages include the fact that patients using telemonitoring can be in their own home. This is especially relevant when hospitals are at capacity. Cost is generally, but not always, agreed to be decreased with telemonitoring. The devices themselves have an initial and maintenance cost which has to be absorbed. Depending on the value placed on health care professional time, telemonitoring may be more or less cost-effective. In the case of less expensive monitoring such as BP measurement for hypertension management, telemonitoring and self-monitoring are more cost-effective than clinic care(3). Telemonitoring information can easily be shared across several professionals enabling real multidisciplinary decisions. Another advantage is that patients are empowered by having real-time information and acting reactively or proactively. They can work with their HCP on medication but also lifestyle changes. Studies have shown that telemonitoring of patients with diabetes leads to better blood glucose control, a positive impact on comorbidities and better treatment and hygiene-dietary adherence(4). Elderly or frail patients in whom transfer to a health care centre can be challenging can particularly benefit from telemonitoring. A Swedish team showed that in elderly patients with advanced HF and COPD, telemonitoring decreased the need for hospitalisation without increasing the overall health costs(5).

Cons

However, telemonitoring does have some negatives. The transfer of monitoring to a home context has been shown to place a high burden on patients. The patient has to be able to carry out these measurements correctly. There is also evidence, perhaps surprisingly, of an increase in clinician and nurse workloads as telemonitoring services expanded(1). Another consideration is the inability to calibrate home apparatus. Several authors recommend specifying in the medical notes if the values reported by the patient are not consistent with the HCP’s wider assessment(2). Hacking and security breaches can also happen. The consequences can be lethal, especially if that information is used to change treatment without human input, as in the case of insulin pumps.

Case Studies

Heart failure.

Heart failure is one of the pathologies which has had the most interest when it comes to home monitoring(6). Telemonitoring has existed for a long time in this domain, as far back as 1966 in the form of phone calls(7). Now it includes smart scales and BP monitoring which is transferred directly via the patient’s smartphone. There seems to be a reduction in all-cause mortality and HF-related hospitalisations, especially in the case of recently discharged patients(6). A Cochrane review and a more recent Basque review also noted that participants in the heart failure studies reported improvements in quality of life and self-care behaviours(8)(9).

COVID-19

Doctivi

The COVID-19 pandemic has accelerated the adaptation of telemedicine but also that of telemonitoring as a way of keeping patients out of hospitals which are already at capacity. In Barcelona, a recently implemented telemonitoring project for chronic patients, Doctivi, was quickly adapted to include stable COVID-19 patients under the Hospital del Mar. Integrated technology provided by the hospital means that parameters such as blood pressure, oxygen saturation, heart rate and even steps can be monitored at a distance. Alerts are set up if out of range values are picked up. As this technology includes video calls, this can lead to a medical consultation and review of the management plan.

Conclusion.

Telemonitoring is already with us, and costs will continue to come down. Patients themselves can sometimes be ahead of the health care professionals, and in these cases, you can learn a lot from your patients about the digital health solutions available. Every patient and pathology will need different parameters to be monitored. The ability to filter the parameters of interest and get rid of the excess information noise in order will be paramount. This is where the practice of the health care professional will be augmented, and the patient empowered.

1. Bashshur RL, Howell JD, Krupinski EA, Harms KM, Bashshur N, Doarn CR. The Empirical Foundations of Telemedicine Interventions in Primary Care. Telemed e-Health. 2016;

2. Greenhalgh Trisha, Koh Gerald Choon Huat CJC-19: a remote assessment in primary care B 2020; 368 :m1182. Covid-19: a remote assessment in primary care. BMJ. 2020;368:m1182.

3. Monahan M, Jowett S, Nickless A, Franssen M, Grant S, Greenfield S, et al. Cost-Effectiveness of Telemonitoring and Self-Monitoring of Blood Pressure for Antihypertensive Titration in Primary Care (TASMINH4). Hypertens (Dallas, Tex 1979). 2019;

4. Andrès E, Meyer L, Zulfiqar AA, Hajjam M, Talha S, Bahougne T, et al. Telemonitoring in diabetes: evolution of concepts and technologies, with a focus on results of the more recent studies. Journal of medicine and life. 2019.

5. Lyth J, Lind L, Persson HL, Wiréhn AB. Can a telemonitoring system lead to decreased hospitalisation in elderly patients? J Telemed Telecare. 2019;

6. Kitsiou S, Paré G, Jaana M. Effects of home telemonitoring interventions on patients with chronic heart failure: An overview of systematic reviews. Journal of Medical Internet Research. 2015.

7. Louis AA, Turner T, Gretton M, Baksh A, Cleland JGF. A systematic review of telemonitoring for the management of heart failure. European Journal of Heart Failure. 2003.

8. Inglis SC, Clark RA, Dierckx R, Prieto-Merino D, Cleland JGF. Structured telephone support or non-invasive telemonitoring for patients with heart failure. Cochrane Database of Systematic Reviews. 2015.

9. Güemes Careaga I. Telemonitorización en pacientes con insuficiencia cardiaca o enfermedad obstructiva crónica. Revisión sistemática de la literatura. Inf Evaluación Tecnol Sanit. 2012;

Certifying a death in times of COVID-19

Certifying a death in Spain and, more specifically, Catalonia, can be confusing. Changes across Europe in times of COVID-19 vary both in time and location.

The paperwork – literally.

Before 2009, certifying a death involved completing two separate documents, one the certificate itself and another the form for the national bureau of statistics. As of 2009, this is one single document, which is the same in the whole of Spain. In certain very specific cases, such as if the body is to be transported, embalmed or incinerated, there may be a need for two certificates. The Mortuary Police Regulations or Reglamento de la Policía Sanitaria Mortuoria should be your reference for these cases. The death certificate must be presented within 24h to the Registry Office or registro of the Municipality where the death occurred.

The whole job.

As we all know, signing a death certificate is just one of the tasks a doctor undertakes. A death is an emotional time, and although we may no longer know the family and friends set-up of the person who has died, we have an ethical duty to those left behind. Our help may be practical, having the details of the local funeral homes or religious or community leaders. It is worth having the contact details of local funeral directors and religious leaders with your certification paperwork.

In times of COVID.

Certifying a death in times of COVID, especially at times when tests have not always been available, led to the Barcelona College of Physicians to provide specific guidance.(1) In the case of a laboratory-confirmed COVID diagnosis, which is deemed to be the cause of death, then the fundamental cause of death should be recorded as “COVID-19”. If there is no laboratory confirmation, and after having reviewed the symptoms and medical history of the patient, the fundamental cause of death should be recorded as “COVID-19 not confirmed” or “COVID-19 no confirmat”. Or as “Suspected infection of coronavirus” or “Sospita d’infecció per coronavirus.”

In England and Wales, the Coronavirus Act 2020 has been brought into place to cover the fact that it may not be the doctor who attended the patient during their last illness.(2) The part “last seen by me” should be deleted, and if any other doctor has seen them during the last 28 days, then that doctor’s name should be inserted there. For the purposes of describing looking after a patient, video consultations but not phone consultations are now valid.(3) Guidance has been updated to help non-medical practitioners verify a death, including remote assistance for the process.(4) COVID-19 is an acceptable direct or underlying cause of death and, although a notifiable disease, does not need to be communicated to the coroner in England and Wales.

Communicating the cause of death and epidemiological details is always important for public health reasons, but even more so in a pandemic. Sometimes accessing the information can be the limiting factor. In France, the lack of use of the electronic online system for certifying deaths, especially in prehospital contexts, made epidemiological work more complicated at the beginning of the pandemic.

In Germany the Koch institute recommends at least level 3 PPE for any health professional certifying a death in a COVID infected corpse.(5) Special attention to aerosols and droplets is to be made when pressing on a corpse’s thorax. Cremations in certain German Länder or regions require a second examination of the corpse. In times of COVID, the Koch Institute recommends that a risk-benefit analysis be undertaken before these are carried out.

Now that social distancing is required, whether COVID was the cause of death or not, breaking bad news in PPE or personal protective equipment of any level can be challenging. Although much information and research have become available as the pandemic has progressed as how to best break bad news in telemedicine, there is very little about face to face conversations. A paediatric oncologist in Marseille has written of how he has struggled with not using non-verbal ways of communication, including hugging or holding hands.(6) One of his patients says he thinks he can read his eyes above his mask. Other publications about prehospital breaking bad news in the time of COVID tend to concentrate on making sure people have time to say good bye to loved ones as they will typically not be seeing them in hospital whatever the outcome and also the burden on healthcare workers who are having to communicate this information.

Traditionally, the SPIKES model has been used to break bad news.(7) Although by the time you get to the patient to certify a death, the family and friends will usually be aware that the person has died, this may not always be the case. Even when the death is clear, it helps to have a structured procedure to take a level of distress away from the medical professional. SPIKES is an acronym and stands for:

S- Setting: Set up the interview in a space which is appropriate and away from interruptions. With the people who need to be there.

P – Perception: Work out what the family and friends have understood about the situation with open-ended questions. Questions about the inevitability of the death at this point might come out.

I – Invitation: This involves finding out just how much detail the family want about what has happened. Some people may want to know how much the person knew or if they were in pain. Others prefer less information.

K – Knowledge: Give knowledge and information to the family and friends according to what they have told you in the perception and invitation stages. Use clear language and avoid medical jargon and ambiguous terms. Especially in a hospital setting where the relatives may not have seen the dead body or see a lot of machinery, make sure you use the words death.

E – Empathy: Identify and recognise the emotions that are being felt. “I can imagine you are very sad but also worried about what will happen now in a pandemic”.

S – Strategy and summary: This is the time to explain what will be happening now, what steps the relatives need to take, and in what time frame. It is also a good moment to give them any contact details.

Finally, certifying a death, is mentioned previously a highly emotive time for all involved and as such the healthcare professional may also need some help. In Barcelona, for the past 20 years, the PAIMM service has been helping doctors deal with their own health issues. Similar services are provided by other professional medical institutions and this a theme we will be returning to later on in the series. Don’t forget to subscribe to the podcast to automatically receive new episodes as they become available.

1. COMB – Col·legi Oficial de Metges de Barcelona. Consideracions sobre les Certificacions Mèdiques de Defunció en la pandèmia COVID-19 [Internet]. 2020 [cited 2020 Dec 5]. Available from: https://www.comb.cat/cat/actualitat/noticies/noticies_fitxa.aspx?Id=IIc5UXfbSVCnnsJjAnJ4Vw%3D%3D

2. UK Publication General Acts. Coronavirus Act 2020 [Internet]. Available from: https://www.legislation.gov.uk/ukpga/2020/7/contents/enacted

3. Medical Defense Union. Certifying deaths during COVID-19 outbreak – The MDU [Internet]. [cited 2020 Dec 5]. Available from: https://www.themdu.com/guidance-and-advice/latest-updates-and-advice/certifying-deaths-during-covid-19-outbreak

4. Department of Health & Social Care. Coronavirus (COVID-19): verifying death in times of emergency – GOV.UK [Internet]. 2020 [cited 2020 Dec 5]. Available from: https://www.gov.uk/government/publications/coronavirus-covid-19-verification-of-death-in-times-of-emergency/coronavirus-covid-19-verifying-death-in-times-of-emergency#annex-1

5. Robert Koch Insitute. RKI – Coronavirus SARS-CoV-2 – Empfehlungen zum Umgang mit SARS-CoV-2-infizierten Verstorbenen [Internet]. [cited 2020 Dec 5]. Available from: https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Verstorbene.html

6. André N. Covid-19: Breaking bad news with social distancing in pediatric oncology. Pediatr Blood Cancer [Internet]. 2020 Sep 1;67(9):e28524. Available from: https://doi.org/10.1002/pbc.28524

7. Baile WF, Buckman R, Lenzi R, Glober G, Beale EA, Kudelka AP. SPIKES—A Six‐Step Protocol for Delivering Bad News: Application to the Patient with Cancer. Oncologist [Internet]. 2000 Aug [cited 2020 Dec 5];5(4):302–11. Available from: https://pubmed.ncbi.nlm.nih.gov/10964998/

Menopause and menstruation myths.

Why do we have myths?

Myths are an integral part of our life, both as children and adults. For children, we equate them with traditional stories, but myths are more than stories. There are many definitions as to what a myth is according to the discipline from which you are studying them. For Edward Burnett Tylor, considered by many to be the founding father of anthropology, myths belong especially to “primitive” and static cultures. Myth only exist until they are replaced by science.(1) However, as we will see later, myths are present in all our cultures and not many people like to think of their own culture as primitive. Tylor does pick up on the fact that myths often concern important and emotional life events.(2) Jung and Freud, also leaned on myths, especially the classical Greek ones, to explain human experience and psychology such as the Oedipal complex.(3) These life events are often taboo or at least not always dinner table conversation. And if you have any doubts, just ask yourself when you had the last conversation about the menopause or menstruation in an open forum?

Menstruation.

Why is it important? Because as long as we don’t discuss menstruation outside of an obs& gynae setting, we are limiting society’s access to new resources and research. Just think about how prostate or breast cancer have become mainstream. 10 years ago no-one was talking about testicular cancer or male suicide yet thanks to Movember, a movement in which facial hair is grown during November, more people are testing and treating previously taboo diseases.

Myths and superstitions about menstruation are varied and often contradictory, even within the same country. Fairly commonly, they lead to recommendations not to have a bath, from Europe to America to Africa. Some are more country specific, such as in Japan some people believe you shouldn’t eat sushsi if you have your period because you have altered taste. My own favourite, as an Agatha Christie fan, is the myth that having sex whilst menstruating can kill your partner. Although it seems to come from Poland I have been unable to verify either that fact or find any (solved) cases of this type of murder. Or would it be homicide? Other myths lead to life-altering customs such as having to live separate from their family. Chaupaudi, as it is know, is not happening just in Nepal, but there it has been outlawed in response to a number of deaths of girls being left in huts whilst menstruating. It is based on a belief that women are untouchables and as such are expected to live separate from the the rest of the community during the time that they are menstruating.

The products used for periods are also shrouded in mystery. And here is my full disclosure, until I was asked to do some writing for a buy one, gift one menstrual cup, I had not really thought about them. I certainly had no idea how medical safety questions such as to how long menstrual cups could be left in – it turns out that although the Lancet have published a review stating that menstrual cups are safe, there is a lack of well structured research on how long they can be left in.(4) The Australian Therapeutic Goods Administration recommend no longer than 8h based on research into tampons whilst other regulatory authorities have not set any time recommendations at all. Many manufacturers say they can be left in place for up to 12h.(5) At a time of period poverty, over a lifetime menstrual cups are more cost effective than traditional tampons or pads. Depending on the facilities available, including running water, and also confidence about different products, menstrual cups can be a good option in developing countries. Here in Europe, the more you know about the options available, the more you can help your patients and also yourself and the people around you find period solutions which work.

Period poverty is a concept which has come to the attention to the public only recently, and a concept which some people refuse to believe exists in more affluent countries such as Spain and the UK. Yet in 2017, 1 in 10 girls in the UK reported not being able to afford sanitary products for their menstruation, leading to 1 in 7 girls having to ask friends for sanitary products.(6) And excluded from these types of reports are often people who have periods but may not identify as women or girls. Worldwide many people with periods miss out on schooling whilst menstruating. To combat this UNESCO has a program where schools are the place to educate and provide resources for those with periods.(7) And in a glass half full world, Scotland has just become the first country to provide free menstrual products.(8) Since January 2020 English schools can order free period products for those pupils receiving free school dinners.(9)

The madness of the menopause.

At the other end of the reproductive years, is the menopause. Our knowledge about it is as old as the texts we have to record health events. The menopause was reported as early as 6^th Century Byzantium, when the physician Aeitius reported that “The menses do not cease before the thirty-fifth year nor appear after the fiftieth year”. Aeitius also noted that “those who are fat cease early”.(10) In Classical times, Aristotle spoke of “the menses ceas[ing] in most women around the fortieth year.(11)

Mental health and cognitive abilities around the menopause are widely studied but you might be surprised to hear that the story of menopause and madness is not an old one. In fact in the Anglo-Saxon world it only dates back to the 18^th Century when Victorian values of sexual purity led to the medicalisation of libido in women who were past their child-bearing years. Stories of hysterectomies and cliteroidectomy in a time of no or little anaesthesia are chilling. Many women did not survive the treatment of their supposedly pathological symptoms, including sexual desire, enhanced emotions and hot flushes, periods of intense heat and sweating. Isaac Baker Brown was a surgeon in Victorian England who became famous and later infamous for his clitoridectomies as treatments for hysteria, epilepsy and insanity, as according to his book published in 1866.(12) Although he was criticised by the BMJ, there is an argument that this was more to do with colleagues wishing to save their own prestige and reputation rather than disagreeing or even stopping the procedure themselves.(13)

Less extreme, the “brain fog” many women experience around the menopause is now also becoming a more accepted subject of conversation. Especially as more women become leaders and senior figures in their 40s, 50s and 60s. A longitudinal study published in Neurology concluded that a decrease in cognitive performance was transitional coinciding with the perimenopausal period with post-menopause recuperation.(14) It also concluded that

“Hormone initiation prior to the final menstrual period had a beneficial effect whereas initiation after the final menstrual period had a detrimental effect on cognitive performance.”(14) Obviously, this is the conclusion from one study and not a recommendation.

As with menstrual products, the more conversation, the more research but also, the more society will be able to accommodate symptoms of the menopause. Often it is not an unwillingness to help but a lack of knowledge. And this may also apply to doctors. It is not only a case of treating our patients but also looking at our employees, colleagues and maybe even ourselves. The Faculty of Occupational Medicine and Royal College of Physicians has provided guidance for employers which include ventilation, staggered or flexible work times if sleep is an issue. It promotes an open general discussion but private individual chats, potentially with occupational health if the worker prefers that option. If you are interested in finding out about how to help with the menopause in healthcare workers, Sherwood Forest Hospital have a case study as to how to go about it. At a time of increased strain on healthcare workers, this may make the difference between losing and keeping experienced senior workers. A lot of positive feedback came early on in their project when the discussion was started and the taboo about the menopause was broken. Being heard was a positive help in itself. Of note, is that it doesn’t always need to be a big organisational shift, but rather an individual champion in your department. It could be you. And it’s not just for women. Gender equality in the workplace is a legal requirement, and if you identify as a man you can be proud to join the #heforshe movement promoted by the United Nations.

If you would like more information and resources, and to record your CPD associated with this podcast, please visit the IFMiL website. You will also find links to all the projects and articles mentioned in this podcast.

1. LARSEN T. E.B. Tylor, religion and anthropology. Br J Hist Sci [Internet]. 2013 Dec 1;46(3):467–85. Available from: http://www.jstor.org/stable/43820407

2. Tylor EB. Primitive culture: Researches into the development of mythology, philosophy, religion, art, and custom. Primitive Culture: Researches into the Development of Mythology, Philosophy, Religion, Art, and Custom. 2010.

3. Freud S. The Interpretation of Dreams (Second Part). The Standard Edition of the Complete Psychological Works of Sigmund Freud, Volume V (1900-1901): The Interpretation of Dreams (Second Part) and On Dreams. 1900.

4. van Eijk AM, Zulaika G, Lenchner M, Mason L, Sivakami M, Nyothach E, et al. Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis. Lancet Public Heal. 2019 Aug;4(8):e376–93.

5. Therapeutic Goods (Standard for Menstrual Cups) Order 2018 [Internet]. [cited 2020 Dec 1]. Available from: https://www.legislation.gov.au/Details/F2018L01546

6. Plan International UK. Plan International UK*s Preserach on Period Poverty and Stigma [Internet]. 2017 [cited 2020 Dec 1]. Available from: https://plan-uk.org/media-centre/plan-international-uks-research-on-period-poverty-and-stigma

7. United Nations Educational la science et la culture Organización de las Naciones Unidas para la Educación, la Ciencia y la Cultura Организация Объединенных Наций по вопросам образования, науки и культуры منظمة الأمم المتحدة للتربية والعلم والثقافة 联合国教育、 S and COO des NU pour l’éducation, UNESCO, ЮНЕСКО, اليونسكو, 联合国教科文组织, United Nations Educational S and CO, et al. Puberty education & menstrual hygiene management. UNESCO;

8. Scotland becomes first nation to provide free period products for all | Scotland | The Guardian [Internet]. [cited 2020 Dec 1]. Available from: https://www.theguardian.com/uk-news/2020/nov/24/scotland-becomes-first-nation-to-provide-free-period-products-for-all

9. Department for Education. Period product scheme for schools and colleges in England [Internet]. 2020 [cited 2020 Dec 1]. Available from: https://www.gov.uk/government/publications/period-products-in-schools-and-colleges/period-product-scheme-for-schools-and-colleges-in-england

10. Amundsen DW, Diers CJ. The Age of Menopause in Medieval Europe. Hum Biol [Internet]. 1973;45(4):605–12. Available from: http://www.jstor.org/stable/41459908

11. AMUNDSEN DW, DIERS CJ. THE AGE OF MENOPAUSE IN CLASSICAL GREECE AND ROME. Hum Biol [Internet]. 1970;42(1):79–86. Available from: http://www.jstor.org/stable/41449006

12. Brown IB. On the curability of certain forms of insanity, epilepsy, catalepsy, and hysteria in females. Robert Hardwicke, editor. 1866.

13. Sheehan E. Victorian clitoridectomy: Isaac Baker Brown and his harmless operative procedure. Med Anthropol Newsl [Internet]. 1981 [cited 2020 Dec 4];12(4):9–15. Available from: https://pubmed.ncbi.nlm.nih.gov/12263443/

14. Greendale GA, Huang MH, Wight RG, Seeman T, Luetters C, Avis NE, et al. Effects of the menopause transition and hormone use on cognitive performance in midlife women. Neurology [Internet]. 2009 May 26 [cited 2020 Dec 4];72(21):1850–7. Available from: https://pubmed.ncbi.nlm.nih.gov/19470968/

Working with the pharmaceutical industry.Friend or foe?

Just the words “pharmaceutical industry” are likely to elicit some sort of reaction from you whether it is positive or negative. But what is behind this reaction and how and in what ways do our interactions influence us?

A story as old as the industry itself.

Back in the 1950s Senator Kefauver, as chairman of the united states senate’s anti-trust and monopoly subcommittee started to question the practices of the pharmaceutical industry.(1) He charged the industry with excessive margins and prices, these same costs being increased due to expensive marketing. He also claimed that most of the industry’s new products were no more effective than established drugs on the market.(2) Fast forward to 1973 and the US Senate were hearing from Senator Kennedy that “the irrational prescribing of drugs is a serious and increasing problem in this country, a problem that is being paid for by thousands of Americans with their health and sometimes with their lives”.(3) Antibiotic resistance was already on the table and so much of this hearing, including the methods used to influence prescribers could have been written yesterday.

There ain’t no such thing as a free lunch … or pen.

Ex-employees of Pfizer and Merck among others testified to the use of pens to get access to the doctors they wanted to influence. It wasn’t all free fridge freezers, which has since fallen out of favour. They talk of the unique aspect of selling a medication, you have to sell it and unsell it. That is, to sell it you also have to speak of the product’s disadvantages, or side-effects as we physicians would speak of it.(3) Of course, if you hear of a product’s disadvantages, on one level it gives a level of credibility to the advantages…

These ex-employees also spoke of the ubiquity of their role. A bit like the Beatles’ love ballard, the drug reps are here, there and everywhere. For the physician is the final step in a ladder which starts with the receptionist who opens the door. A receptionist who can be engaged in conversation about a busy physician’s tastes and timetable. The ladder involves stepping over the nurse who knows the prescribing habit of the physician they work with. You as the physician are not the only person writing with a free pen.

It’s not all bad.

Of course, not all pharmaceutical interaction is negative and many physicians are able to attend conferences thanks to a drugs rep. And when it comes to generic medication, the recommendation to prescribe any generic. Although you might question the alphabetical laboratory listing in your EHR or electronic health record. Are you really going to scroll down to pick the one from the company starting with Z? There is also an argument that without the pharmaceutical industry there would be no research and development. There have been claims that for every dollar spent on R&D, 2 dollars are spent on marketing. These allegations made the headlines but the industry themselves have defended themselves time and time again, most recently in September 2020 saying that this is not the true vision.(4) You can watch their statements for yourself on YouTube.

When Ben Goldacre’s book “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients” came out in 2013, it topped the best seller charts and changed practise.(5) If you haven’t read it, do. It covers many topics including the non-publication of trials with what could be seen as negative results. The alltrials project pushes for all trials to be registered and published with a full report of their methods and summary results.

Speaking of which, how do you keep up to date? Is it through, maybe only partially, studies and reports which your local drug reps present you? It is incredible hard to keep on top of all the research being published. Indeed, IBM Watson Health have an entire AI program based on this, where the computer scans all the research publications which appear every day and gives you a summary based on your professional interests. However, it is unlikely that the local drug rep will be offering you the most unbiased view, even with the selling and unselling mentioned before. Subscribing to library updates such as the KnowledgeShare service means you will be alerted to the latest research in your area of interest and you can then look at it critically yourself. Later in the series we will be looking at easy methods for critically appraising research to make it less of a task at the end of a busy day.

“Clean CPD”.

Another space you may have thought of as “clean” is CPD or continuing professional development. Yet, if it is free to access you should be looking at who is providing the access and why. Even when accessing the CPD of established institutions you should look carefully at conflict of interests of those writing the CPD module. You might be surprised not only at who the author has been financed by, but also the extent to which they rely on their own research. As an audit of your own practise you can look at how you would have to answer a competing interests policy, such as that of the BMJ. As my own competing interest declaration I should mention that I also work freelance for the British Medical Journal as digital copy editor and also quality audit the Spanish Best Practise translations.

Being aware of who is providing funding is also relevant to online resources for rare conditions. Often these resources for patients and clinicians are financed by companies offering therapeutics of all types, not just pharmacological, in that area. Expert patients offer valuable insight into helping them manage their conditions but in order to make informed decisions everyone has to be aware of who the information is coming from, especially if their SEO or search engine optimisation means that they are coming out top in a google search.

Danone have come under particular fire for their recommendations about safe distances during COVID which makes breastfeeding impossible and goes against WHO recommendations. This was on their affiliated website.

It’s not all work.

Finally, as members of society and consumers ourselves, we may find ourselves consuming products and information which affects our practise. If you have children, you may be exposed to marketing of baby milk products or foods in your home, for example on social media despite this breaking the international codes of conduct about breastfeeding. Nestle is the most well known to have a long-time boycott against its products, it was started in 1977, but Danone again has been flagged for invading our Facebook feeds even if it is not us who signed up to their information sites.

Over to you.

So how do you know if are being influenced in your prescribing? And if you think that you’re not, then, according to the drug reps themselves, you are the most interesting candidates to work on.

The first and easy option is to look around you and on you. What are you writing with, and on? Is it a free writing pad? It doesn’t really matter if it was given to you directly or you picked it up in a conference bag, or even if the pen has been recycled to your children’s pencil case, it’s still present in your mind. You can use this realisation as a prompt to think why you prescribe this medication. It’s not a critique but rather a stimulus to get you thinking about if your practise is still up to date. Do you have the phone number of any drug reps in your contacts?

On the IFMiL website where this podcast is hosted, you will find a couple of exercises to work through in order to get your CPD, but this is a quick one you can do here and now. Off the top of your head, that is without careful thought, write down the first ten medications which come to mind. Now ask yourself why do I use them? Have I checked recent trust or hospital guidelines to make sure I am still current. Then have a chat with a colleague working in a similar environment and see what they use. If it’s different (and even if it’s the same) are you able to say why? Working in different countries and different hospitals has opened my eyes and made me question certain prescriptions. But I never did review my practise in a routine way.

Going forward.

If you’d like to know more about this subject, IFMiL runs an online course on working with the pharmaceutical industry which goes in to more detail about how your interaction as a clinician is regulated both in Catalonia and further afield.

1. Greene JA, Podolsky SH. Reform, Regulation, and Pharmaceuticals — The Kefauver–Harris Amendments at 50. N Engl J Med [Internet]. 2012 Oct 18 [cited 2020 Nov 27];367(16):1481–3. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4101807/

2. Kefauver E. In a Few Hands: Monopoly Power in America. Pelican; 1966.

3. Committee on Labor and Public Welfare, United States Senate, Ninety-third Congress F and SS. Examination of the Pharmaceutical Industry, 1973-74: Hearings Before the … – United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health – Google Books [Internet]. United States. Congress. Senate. Committee on Labor and Public Welfare; 1974 [cited 2020 Nov 26]. Available from: https://books.google.es/books?id=jBzQY0IuGhoC&num=100

4. U.S. House of Representatives Oversight and Reform Committee. Pharma executives testify at House hearing on drug pricing — 9/30/2020 – YouTube [Internet]. CNBC Television. 2020 [cited 2020 Nov 27]. Available from: https://www.youtube.com/watch?v=FkI4_xHGkAQ

5. Goldacre B. Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. In 2013.

Digital transformation

Listen to this as a podcast courtesy of the IFMiL or Catalan Institute of Medical Education and Leadership.

Ever since the industrial revolution, there has been a fear of machines taking over our work and medicine is no different. There can be a feeling among digital health enthusiasts that doctors are anti-innovation and that they will have to reinvent themselves or be left behind. Nothing further from the truth in a profession where life-long learning is part of the course and having to think on your feet with every patient is the norm. What is true is that clinicians need to see a validated use for digital health solutions, and that may not be the use that the developers initially had in mind. Another aspect is that there is the mantra “first do no harm” is never far from any clinicians” mind and that reticence to adopt new technology is often coupled to a very real and not theoretical realisation that it is people’s life and health which are at risk if they don’t work. Every medication prescribed has been through a stringent, ongoing safety process and even then, as we sign digitally or with a pen, we do it knowing that is always a risk-benefit balance to our decision. It is not a dinosaur mentality which prevents clinicians unthinkingly adopting every new shiny digital health solution we are presented with. Instead, it is our primary function of being the patient’s advocate and therefore making sure the risk-benefit is in their favour.

Digital health technology, including lifestyle apps, don’t require clinical evidence to be released, and the need for them to be regulated, is discussed in episode 1 of this third series. Digital medicine software or hardware that intervenes and measures human health do need clinical evidence. Furthermore, when it comes to digital therapeutics, in which the technology delivers an intervention, that evidence needs to be not only clinical but also based on real-world outcomes.

Getting the clinicians onboard.

This leads to the question; how can we get valid digital medicine solutions into our daily practice? This is something at which Dr Cesar Morcillo at the Sanitas hospital in Barcelona has been looking. He argues that this is our opportunity to make the change to patient-centred care, and also to expand it to health workers who, as we are seeing in the current pandemic, can quickly become patients in themselves. The power of these digital solutions, whether on the ward in the hospital or at home after they have been discharged, is the ability to relay the information 24h not just the snapshot of time the doctor and nurse are at the bedside. Digital solutions have to be agile and responsive to patient needs. Aim for a good enough attitude to the first version, which is perfected in response to feedback from real patients and clinicians. This feedback needs to be complemented with data and evidence-based. The ability to harvest patient data and work with it in this way directly benefits the patients to whom the data belongs. Medicine is not a solitary practise and working in a transversal manner with other teams leads to better integration of digital health solutions. It also leads to improvement as they too will feedback on what works and what can be done better based on their expertise.

If the mindset is that of “improving a service rather than implementing a technology”, the introduction of new digital solutions is more likely to be successful.

Real-world examples.

Often successful innovation comes from HCP themselves. Being best placed to see the problem first-hand, they can then suggest solutions which work for their population within the framework of the services they already offer. One example of this is the fracture clinic at the Royal Sussex County Hospital in Brighton, England. A physiotherapist and an orthopaedic surgeon have saved the NHS over half a million pounds by enabling fracture and soft tissue injuries to be followed up virtually. As an EM doctor, I would see patients in the ED, x-ray if necessary, treat and discharge and then the patient would previously have had to come back to a fracture clinic at a hospital with terrible parking and access. Even more complicated for patients with injuries which decrease their mobility. Now, their details would be entered into the virtual fracture clinic referral with all contact details, physical examination and management plan from the ED. All of these patients get reviewed within 24h and receive a video message from the consultant or phone call. Further follow-up can also be virtual. Only patients really needing face to face contact have to come in. An example of innovation from within, this system has been extended to other hospitals. Although this is a model that existed in other parts of the world, the fact that it was introduced by colleagues and not externally, giving a real solution to a real problem meant that the uptake was smoother. All hospitals, whether in Spain or the NHS, have an innovation team. They are tasked with helping clinicians to transform their clinical solutions into reality. They have the experience and team to support clinicians who may otherwise be reticent to take on the non-clinical aspects of digital transformation. If you have an idea, it is worth contacting them even if you don’t want to take on the project yourself. As a practising clinician, you are best placed to see what problems and frustrations affect your day to day practise and offer suggestions for solutions from within.

Conclusion.

COVID-19 has accelerated the acceptance of digital health technologies, as has been mentioned in previous episodes. Telemonitoring and video consults are becoming the new norm, and there will be no turning back. As Eric Topol says, “Machines won’t replace physicians, but physicians using AI will soon replace those not using it.”

The digital doctor’s bag.

Listen to this as a podcast courtesy of the IFMiL or Catalan Institute of Medical Education and Leadership.

When you think of the traditional image of a doctor outside of the hospital or the consulting room, he or she always carries a bag. Much like Mary Poppin’s carpet bag, it is full of magical instruments. Apart from a stethoscope, this could also have included a sphingometer to measure the blood pressure and maybe a couple of syringes to administer an all curing medication. Times have changed, and today we have different instruments, but their objective remains the same: to be a diagnostic aid at the bedside. This is especially true in rural and remote areas where a transfer to a local hospital may be complicated and time-consuming. However, it is also true for patients with decreased mobility in an urban setting. These are the patients who already receive the home visits instead of coming in to see their GP at the surgery.

The concept of the digital doctor’s bag describes a combination of digital medicine devices linked to a smartphone or tablet. It also includes decision aid apps and even the EHR or electronic health record. The EHR means that the HCP has access to all the patient’s notes and results on the go, even those of other specialists.

Emergency visits, whether by a GP or a prehospital service, also benefit from having a digital doctor’s bag. This may mean the difference between transferring a patient to a hospital or keeping them at home. The obvious example is an ECG being recorded and being sent straight through to the cath lab and cardiologist on call. If the patient doesn’t fulfil cath lab criteria, they may well be transferred to their local hospital instead of being sent further afield. But some of the devices are used by the HCP in situ. The portability and decrease in the cost of hand-held ultrasound machines have made them very much more accessible. Ultrasound does remain operator dependant and rule in not rule out. Traditional stethoscopes are replaced by digital stethoscopes which record and analyse heart sounds to provide a visual representation. Listening then becomes optional. Portable spirometers as an add on to a smartphone which then adds the information to the patient’s own records can reduce clinic visits for chronic patients. They can also empower patients to identify and manage their exacerbations in combination with their HCP at a distance.

Digital dermatoscopes are another welcome addition to the doctor’s bag. Working with high quality augmented images, you can diagnose yourself, send to dermatologist colleague for a second opinion or even let the AI do it for you. In 2018 Haenssle et al. concluded that deep learning convolutional neural networks outperformed even dermatologists when it came to melanoma identification(1) and that all HCP no matter what their level could benefit from this technology.