GLOBAL NEUROLOGY REPORT: A CRITIQUE OF ELECTRONIC FETAL MONITORING

 

The Surgery Journal recently published a peer reviewed critique of electronic fetal monitoring (EFM) by neurologist James C. Johnston, MD, JD and leading healthcare attorney Thomas P. Sartwelle.

These authors, Thomas P. Sartwelle and Dr. James C. Johnston, along with pre-eminent medical ethicist Professor Dr. Berna Arda, have repeatedly advised that continuous EFM should not be performed in routine labour due to a 99.8% false positive rate, and the fact it does not predict or prevent cerebral palsy or any other neonatal neurological injury.

EFM does increase the caesarean section rate, with an increase in maternal and newborn deaths and birth complications as well as devastating long term complications. In fact, these very concerns have led Australia, New Zealand and the UK to advise returning to intermittent auscultation (IA) instead of EFM, and in 2017 the American College of Obstetrics and Gynecology finally provided a long overdue recommendation that women be given an informed choice between IA and EFM.

Unfortunately, there are EFM apologists continuing to defend the procedure, and journal editors suppressing scientific debate on the topic. This most recent Surgery Journal article exposes one example of these harmful practices, and should raise serious questions about those EFM proponents recommending a procedure that causes more harm than good to mothers and babies alike. But perhaps the more disturbing aspect is a medical journal editor determined to stifle scholarly debate.

This open access article is available through the following link:

https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0038-1632404

The authors have also published their concerns in the Journal of Child Neurology, Maternal Fetal and Neonatal Medicine, British Medical Journal, Neurologic Clinics, Journal of Pediatric Care, Maternal Health Neonatology and Perinatology, Medical Law International, Surgery Journal and several other journals and books. These articles are available at James C. Johnston’s ResearchGate.net site:

https://www.researchgate.net/profile/James_Johnston6/contributions

Electronic Fetal Monitoring and CP

MLI.image

Dr. James C. Johnston is the founding partner of Global Neurology and Director of the non-profit organization Global NeuroCare. As a board-certified neurologist with thirty years of experience, Dr. James C. Johnston has authored over one hundred peer reviewed journal articles, papers and book chapters on various topics related to neurology and global health including cerebral palsy (CP).

The high rate of CP in developing nations has led many of these regions to seek electronic fetal monitoring (EFM) as a means of reducing perinatal mortality and morbidity. However, EFM is an ineffective modality with a 99% false positive rate, and does not predict cerebral palsy, acidemia, neonatal neurological injury, stillbirths or neonatal encephalopathy. It does increase the C-section rate and is a significant source of harm to mothers and babies.

Despite 50 years of continuous use of EFM, the cerebral palsy rate and rate of other neurological birth related maladies remains unchanged. Continuous EFM should not be used in normal pregnancies, especially in developing regions where it will waste money that is so desperately needed for prenatal and post-partum care for mothers and babies, and add another layer of undesirable morbidity and mortality to an already critical situation.

Dr. James C. Johnston and his colleagues have published a number of peer reviewed articles concerning EFM and CP. They have discussed CP litigation in the Journal of Child Neurology; ethical concerns related to EFM in Maternal Health, Neonatology and Perinatology; review of the Task Force failure to address this problem in J Maternal Fetal and Neonatal Medicine; the history of EFM and medical training for EFM in separate articles in the Surgery Journal; and some of the legal and ethical concerns in Medical Law International.

J of Child Neurology: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4431995/

Maternal Health, Neonatology and Perinatology: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5697350/

J Maternal, Fetal and Neonatal Medicine: https://www.ncbi.nlm.nih.gov/pubmed/26067269

Surgery Journal: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5530627/

Surgery Journal: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5553489/

Medical Law International: http://journals.sagepub.com/doi/abs/10.1177/0968533217704883

These and related articles are also available through Researchgate.net at https://www.researchgate.net/profile/James_Johnston6.

Global Neurology Report: Neurological Disorders are the Largest Cause of Disability

The Lancet: Life Expectancy

The Lancet: Life Expectancy

Neurological diseases are the main cause of disability worldwide according to a recent analysis of the Global Burden of Disease (GBD) Study. (Global, regional and national burden of neurological disorders during 1990-2015: A systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurology 2017).

The significant increase in the burden from 1990-2015 occurred despite remarkable advances in the prevention and treatment of neurological disorders, and is partially attributable to population growth and aging. Additionally, the World Health Organization recently re-classified stroke as a neurological disease instead of a cardiovascular disorder which provided a more realistic view of the true neurological burden.

Cerebrovascular disease accounts for the largest proportion of disability adjusted life years, and in fact was the leading cause of disability in 18 of the 21 Global Burden of Disease regions including sub-Saharan Africa (SSA). And the study may underestimate the extent of stroke related disease and disability due to the paucity of data in many developing regions. More research is necessary to define the true extent of stroke and formulate effective prevention and treatment protocols that comport with the available resources in specific areas.

The most serious concern is in SSA which harbours the highest burden of disease, with the least resources, and has a population of one billion people that is expected to double in the next generation.

There are serious impediments to neurological care including stroke management in SSA – a dearth of specialists, limited imaging facilities, lack of medications, adherence to traditional beliefs and seemingly insurmountable infrastructural challenges, all superimposed on abject poverty with food and water insecurity. In addition to the high morbidity of stroke related complications, there are limited if any secondary stroke interventions, and an absence of neurorehabilitation. It is not surprising that the rates of stroke mortality and disability are ten-fold higher in SSA than in developed regions.

As a Director of Global NeuroCare, a non-profit organization dedicated to advancing neurological care in SSA and particularly Ethiopia, Dr. Johnston strongly recommends capacity building through sustainable, comprehensive, multimodality programs to address stroke prevention, treatment and rehabilitation, focusing on realistic goals that are commensurate to local resources. But, stroke prevention is of upmost importance, and funding should be allocated accordingly.

The most effective means of advancing neurological care is to form collaborative partnerships between developed countries and the least developed regions, with clearly defined goals, focusing on the needs of the South to establish self-sustaining programs that incorporate physician training, patient care and medical research, provide triangular cooperation and encourage South-South cooperation.

This is the approach Global NeuroCare has adopted with the Addis Ababa University Department of Neurology, which has an expanding, autonomous neurology residency program that has graduated 30 neurologists over the past decade. The program is now training physicians from other African nations and developing South-South ties that will serve to more effectively combat the neurological burden of disease.

GLOBAL NEUROLOGY REPORT: NEUROIMAGING IN THE PATIENT WITH HEADACHE

The most common diagnostic error in neurology over the past three decades is the misdiagnosis of headache, often the failure to diagnose brain tumor or other intracranial structural disease.  This recurring error is partially attributable to the guidelines set forth by the American Academy of Neurology and six other professional societies under the United States Headache Consortium (USHC), which state that neuroimaging is not warranted in patients with migraine and a normal examination.

These guidelines were based on a meta-analysis of 11 small retrospective studies with serious flaws, all antedating 1985 and almost half using first generation CT scans.  This outdated data suggested a very low incidence of intracranial abnormalities in patients with headache (0.2%), and led to the improper conclusion that a normal examination excludes any brain tumor or other intracranial disease.  Both of these presumptions are flatly wrong.

Patient with headache and a normal examination

For example, proper imaging demonstrates intracranial abnormalities in 6-8% of people, far higher than the outdated figure of 0.2%.  Some of these abnormalities are incidental, but many warrant monitoring (aneurysm), further investigation (stroke) or treatment (arachnoid cyst).  Additionally, over 10% of patients with brain tumors present with isolated headache and a normal examination, so following the guidelines would deny imaging to 3-7% of patients with brain tumor.  Earlier imaging reduces the cost of headache care in patients that rank high on anxiety or depression scales.

Unfortunately, these outdated guidelines were parroted by the American Headache Society and the American College of Radiology which bluntly stated “Don’t do imaging for uncomplicated headache.”

This type of intransigent adherence to flawed, outdated guidelines falls below an acceptable standard of care.  Additionally, the failure to discuss the likelihood of finding an abnormality on imaging, and giving the patient an option of having an MRI, eviscerates any meaningful informed consent.

Dr. James C. Johnston discussed these concerns in several recent articles including Neurologic Clinics 2016; 34:747-773, and recommended deleting the guidelines until further research properly correlates intracranial abnormalities with individual patient data, headache patterns, underlying disease, imaging protocols, associated conditions and a host of other factors to provide rational evidence based guidelines. (https://www.researchgate.net/publication/305409777_Neurological_Fallacies_Leading_to_Malpractice_A_Case_Studies_Approach).

In the meantime, he advised it is prudent to consider imaging all patients presenting with a new headache, or a headache increasing in frequency or pattern, or with any other warning sign.

Dr. Johnston presented these findings at the 2017 World Association for Medical Law conference, and the concerns were discussed by Dr. Mehila Zebenigus of Addis Ababa, Ethiopia who noted that in her clinic most patients with headache are referred for a baseline imaging study.  Attendees from other countries echoed her recommendation.  And, yet, in the United States about 12% of patients with headache have an MRI, and some neurologists are calling for more restrictions, even stating that limiting MRI should be a “major national priority.”  It is past time for the USHC and Choosing Wisely societies to review the evidence and move forward.

GLOBAL NEUROLOGY REPORT: TRIANGULAR COOPERATION

Dr. James C Johnston

Triangular Cooperation | Dr. James C Johnston

Global NeuroCare is a non-profit organization dedicated to advancing neurological care in developing regions, especially sub-Saharan Africa and particularly Ethiopia.  It is one of the few non-government organizations to hold Special Consultative Status with the United Nations ECOSOC, which allows Director and Neurologist Dr. James C. Johnston to actively participate with the UN intergovernmental bodies, decision makers and related organizations.  Additionally, Global NeuroCare is accredited by the World Health Organization, and affiliated with the Office of the Special Adviser on Africa.

On behalf of Global NeuroCare, Dr. Johnston presented several statements over the past few years to the UN High Level Political Forum, the Commission for Social Development and the Integration Segment.  Four of these statements have been adopted and published, focusing on advancing collaborative partnerships between the North and South in an effort to improve healthcare in Africa.

Dr. Johnston emphasized the importance of ensuring that relationships between the North or developed countries and the South are based on sustainable, collaborative, ethically congruent partnerships that truly benefit the South, as opposed to the short term medical missions that are so harmful to developing regions.  Successful partnerships will allow sub-Saharan African nations to develop functional capacity building, thereby becoming self-sustainable, further advancing patient care, physician training and medical research.

These types of North-South partnerships can be even more effective by encouraging South-South and triangular cooperation.  South-South cooperation is the process whereby two or more developing countries pursue individual or shared objectives through exchanges of knowledge, skills and resources.  This is not a substitute for, but rather a complement to North-South partnerships.  In triangular cooperation, partnerships between two or more developing nations are supported by a developed country or even multinational organizations.

For example, Global NeuroCare focuses on advancing neurology in Ethiopia where Dr. Johnston serves as an Honorary Professor of Neurology in the Addis Ababa University Department of Neurology Residency Training Program.  This program has graduated 32 board certified neurologists over the past decade.  However, there are no local opportunities for advanced neurophysiology training, so Dr. Johnston arranges for the resident physicians to attend the University of Siena, Italy for 6 month fellowships.  This requires separate funding which has been provided through scholarships sponsored by a Canadian based neurophysiology society.  Thus Global NeuroCare coordinates Ethiopian training through Italy with financial support from Canada and, in turn, as an example of South-South cooperation, the Ethiopian physicians return to train their colleagues as well as physicians from other African nations.

Global NeuroCare plays a crucial role in coordinating this type of triangular coordination, which is the most effective means of ensuring sustainable capacity building leading to self-sufficiency that will truly advance healthcare in sub-Saharan Africa.