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SASUOG Newsletter: January 2019

Dear Member

Hope all of you had a restful and peaceful festive season and that you are ready to start 2019 with bustling energy and enthusiasm.I thought I would use this newsletter as an opportunity to introduce to all members the formation of the Expert Opinion Panel, an affiliate of SASOG, which I chair, a body tasked with dealing with the extraordinary challenges facing Obstetrics and Gynaecology today from a medico-legal perspective.

The main objective of the EOP is to serve the discipline from a medico-legal point of view in dispute resolution.
  • EOP is a strictly independent, neutral body which renders scientific evidence based, up-to-date, unbiased and accurate opinions
  • The distinguished academic nature of the members of the EOP will ensure this, with strict procedural protocol and checks and balances in place with up to 3 experts potentially involved in each review
  • It was originally mandated by SASOG and was developed due to the spiraling cost of indemnity and unrealistic manner of litigation and inappropriate judgments
  • It is a service to SASOG members as well as to other third parties in medico-legal disputes with the best evidence out there
  • It fantails into the BetterObs program and mediation as a whole to resolve medico-legal conflicts.
The aim is to eliminate so-called “serial” experts or “hired guns” and sometimes retired clinicians supplementing income with a bias who may represent clients in cases across different fields of O&G, giving smoking gun assessments without necessary data. Generally, these “isolated” experts advising either defendants or plaintiffs suit and “serve” the case they are involved in often for monetary gain. The “traditional expert opinion system” does not equate to an unbiased and equitable legal remedy. It is not acceptable that cases are often pronounced on singular diverse and maverick opinions/interpretation of experts where the unsuspecting generalist is at the mercy of an unchecked opinion of the expert. This is a “lamb to the slaughter” or “russian roulette” scenario which is dependent on the expert.

The present medico-legal path we are on is unsustainable and if there are no changes, it will surely lead to the demise of Obstetrics in the private sector. Another major goal of the EOP is to create a paradigm shift or mindset change in that there is an alternative to costly and unsustainable litigation.In fact, the EOP is strongly promoting alternate dispute resolution or mediation as the primary path to deal with complaints. To this end, the EOP has concluded a memorandum of understanding (MOU) with both MPS and Constantia, the 2 main indemnifiers in South Africa– that alternate dispute resolution or mediation will be first port of call for any complaint. All members need to be aware of this.

If a SASOG member requires help or advice, he or she should contact the EOP secretariatto register the case with the approved Case Management System, after which it will then be referred to the Chair of the EOP. The EOP secretary is Mrs Alison Shaw (contact details) : alison@royalh.co.za.

Enough with medicolegal matters. I thought I would also give some feedback of the last FMF World Fetal Medicine Congress held in Athens, Greece mid- last year. As usual it was a wonderful occasion in fantastic surroundings and ambiance. The annual FMF World Congresses, where leading experts in the field of fetal medicine meet up, often feels like a pilgrimage to yearly attendees like myself. It is wonderful to see many fellow South Africans also attending. The hospitality and warmth shown by Prof Kypros Nicolaides at these conferences is a feature in itself.

The research and data presented in a packed 5 day programme was immense, as usual, and is unlike any other conference and you really need to have massive energy to stay the full course (often up to 12 hours per day). The research which caught my eye from the proceedings of the conference includes the following,which I will propose as 3 questions, which I will briefly answer from the data presented.
  • Can we predict 3rdtrimester stillbirths?
  • Is pre-eclampsia a preventable disease?
  • Should we give aspirin to all?
In terms of question 1 we had really interesting data from the FMF and 2university centres in Spain. The bottom line is unfortunately there is no silver bullet in predicting 3rdtrimester stillbirths. The cerebroplacental ratio in particular, which showed great initial promise,was not predictive of stillbirths in the FMF study whilst although predictive in the Spanish studies its performance as a screening test was poor. The general conclusion I got was that every patient should have an individualised risk model, a sort of “an intrapatient risk model assessment” that should include history, screening risks, biometry, Dopplers (fetal and materno-placental), CPR, biophysical parameters including AFI and placenta, biophysical profile, presence or absence of combined placental mediated disease phenotypes, bio-monitoring and bioelectronic monitoring. Using these multiple components an individualised intrapatient risk assessment model needs to be formulated for every patient that will help in establishing timing of delivery. There are no short-cuts and the hard yards have to be put in in every patient.

In terms of question 2 the results of the ASPRE trial, which was published in the NEJM in 2017 and aspects were presented at the conference,makes it possible to ask the question: Is pre-eclampsia a preventable disease?. The headline-findings of the publication were the following: if 150mg aspirin was used < 16 weeks gestation in high risk screened patients, it would result in an 89% reduction of pre-eclampsia < 32 weeks gestation, 84% < 34 weeks, 62% 37 weeks. These results would obviously need to be reproduced in different countries and different settings (where it is suggested a more aggressive type of pre-eclampsia may exist like in Africa) before the question can be fully answered. However based on the ASPRE trial it seems we are definitely heading in a direction where prevention of pre-eclampsia can even be contemplated.

In terms of question 3, if aspirin is so successful in preventing pre-eclampsia (an inexpensive medication) whilst screening for pre-eclampsia is a complex and expensive exercise why not just give aspirin to all? This question was proposed by Prof John Hyatt from Australia. The conclusion was that it is a probably a bad idea to give aspirin to all for the following reason: safety of aspirin in routine use is not established. In fact to the contrary, the International Journal of Epidemiology published a paper in 2017 looking at the association of aspirin in pregnancy and cerebral palsy in the child and found that aspirin increased the risk of cerebral palsy with an odds ratio of 2.4 (1.1-5.3). However if aspirin is used only in high risk patients (which will amount to 10% of the population) it would actually decrease the CP rate due to the fact that premature deliveries will significantly decrease.

I hope the above questions and proposed answers gives everyone food for thought.

Regards and best wishes

Dr IE Bhorat
[MBChB(NTL), B.Sc, DA (SA), Dip Mid COG (SA), FCOG (SA), PhD, PhD SENIOR]




A warm welcome to the first newsletter from this SASUOG council!

We aim to publish four newsletters annually to keep members informed about what the Society does for you and new developments or issues you should know of.

It is important that all of you are aware of the fact that SASUOG is a daughter organisation of the SA Society of Obstetricians and Gynaecologists, and that we therefore share SASOG’s vision as presented in the latest newsletter from the SASOG President ( https://www.sasog.co.za/Content/Images/SASOG_PRESIDENTS_REPORT_DURBAN_2018.pdf). As a contribution to the SASOG 2030 vision, we formulated a SASUOG 2030s vision. Please check it out on our home page!

We want to share some exciting developments in the area of prenatal screening recently.
 
GOOD NEWS FLASH!! Bold move by Discovery Health Medical Schemes (DHMS) regarding prenatal screening.

We trust that all of you are aware of DHMS’s recent introduction of the Maternity Benefit for all its pregnant members. This benefit includes availability of NIPT according to set criteria and SASUOG helped DH to refine the criteria for prenatal screening. The current maternity benefit by DHMS includes:
  • Cost of NIPT for trisomy 21, 13 and 18 for all women with a risk of more than 1 in 1000 for any of these conditions. The risk is based on either first trimester serum screening (best at 9 weeks but possible up to 13 weeks), second trimester serum screening (best at 15-16 weeks but possible up to 20 weeks) or combined first trimester screening (serum + nuchal translucency scan by a professional whose name appears on the FMF-UK website) (https://fetalmedicine.org/lists/map/certified/NT). DHMS will also cover NIPT (without prior screening) for all women older than 40 and for those who had aneuploidy in a previous pregnancy.
  • Cost of formal genetic counselling for all women with a very high risk screening result (>1 in 10), a high risk (abnormal) NIPT result or failed/ambivalent NIPT result.
  • Cost of invasive testing (medical practitioner fee as well as genetic laboratory cost) for all women who have a positive (abnormal) NIPT result (as the diagnosis needs to be confirmed).
This is a massive step forward in making prenatal screening and diagnosis accessible to many women who previously could not afford this. We are extremely grateful for DHMS’s leadership and vision and secretly hope that other medical schemes will soon follow this example! Please make sure your patients are aware of this benefit and follow the guidelines closely to ensure they don’t miss out.
 
GOOD NEWS FLASH! Information leaflet and consent form regarding prenatal screening.

SASUOG has very actively contributed towards the development of the prenatal test leaflet, designed for use during the first antenatal visit to enhance the counselling about all available screening options and to assist parents-to-be in making important decisions. The leaflet has had a very wide input, including advice from the legal fraternity, and was designed to improve understanding by pregnant couples and hence ensure truly informed consent and reduce the risk of litigation. The updated version will also soon be loaded onto the SASOG website too ( https://www.sasog.co.za/Professional/Guidelines  ) and will soon become available in the other languages of our rainbow nation! It is best to make this leaflet available to pregnant clients (as hard copy, e-mail attachment or hyperlink) before their first visit so the couple comes prepared and (partially) informed. During the consultation, the leaflet is useful as a decision aid and it can ultimately function as a signed consent form. Any feedback is welcome!
 
TIP OF THE MONTH! A small change can reduce risk significantly!

We are all experiencing the threat of litigation, and missed diagnoses of trisomy 21 are a major source of the increase in indemnity fees. Claims occur because screening was not offered at all or not all options were offered (this may improve with the use of the prenatal tests leaflet), because the screening was of poor quality (this should improve with the use of NIPT for serum screening-based risk > 1:1000) or because parents claim they were falsely reassured by the practitioner. Often the latter results from the vocabulary used to describe the test result as “low risk”, “negative”, “reassuring” or “normal”. In the context of an extremely impactful decision (i.e. to proceed with more advanced testing or not) these terms are often seen as paternalistic as they tacitly insinuate a specific course of action. It is therefore strongly suggested never to use those terms when communicating screening test results but rather to
  1. quote the risk number (1 in xxx) and make sure the couple understands the number correctly (“out of xxx pregnancies 1 has the abnormality and yyy not”)
  2. put the number into perspective (“this compares to a population risk of 1 in 500 and to the age related risk of 1 in zzz”)
  3. compare the risk to the risk of the alternative i.e. NIPT (high cost and risk of a false positive result) or invasive testing (high cost with risk of pregnancy loss of ±1 in 200)
  4. ensure the parents understand that they basically have to make a choice between two competing risks, both of which could have a life changing impact being either the live birth of a child with special needs or the loss of the pregnancy
At the end of this discussion and without being pushed into any direction by the practitioner, the couple decides what route they want to take (and the medical scheme decides whether they will fund this or not). This could be documented in your records as “The risk was quoted as 1 in xxx and balanced against the cost and risk of further testing (NIPT or invasive testing or expert referral). After careful consideration the patient decided…..

I hope you enjoyed this first newsletter and welcome any feedback on topics you would like us to discuss or issues you would like SASUOG council to address. Have a great week!

Prof Lut Geerts, President: SASUOG