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Graphic of red blood cells in blood vessel. © Image by allinonemovie from Pixabay

Researchers at the Centre for Evidence Based Medicine have been leading a programme of work to optimise the use of anticoagulants. The work includes a suite of systematic reviews, several of which have influenced national and international health policy, clinical guidelines, and pharmaceutical companies.

August 2006

Underpinning research published

Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006;367:404–11.

November 2008

Underpinning research published

Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, Bankhead C, Xu Y. 
Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review.
Circulation: Cardiovascular Quality and Outcomes. 2008 Nov;1(2):84-91.

April 2010

Underpinning research published

Garcia‐Alamino JM, Ward AM, Alonso‐Coello P, Perera R, Bankhead C, Fitzmaurice D, Heneghan CJ. 
Self‐monitoring and self‐management of oral anticoagulation
Cochrane Database of Systematic Reviews. 2010(4).

December 2010

Impact

Liberating the NHS white paper
Department of Health’s white paper on “Equity and Excellence: Liberating the NHS” Cites 2010 Cochrane review as a strategy for involving more patients in their own care. 

Underpinning research published

Heneghan C, Tyndel S, Bankhead C, Wan Y, Keeling D, Perera R, Ward A.
Optimal loading dose for the initiation of warfarin: a systematic review.
BMC Cardiovascular Disorders. 2010 Dec;10(1):18.

June 2011

Impact

British Society of Haematology Guidelines on Anticoagulation (4th edition) cites 2010 systematic review on the optimal loading dose of warfarin, cite also 2010 review on self-monitoring. These guidelines remain current BSH guidance.

January 2012

Underpinning research published

Heneghan C, Ward A, Perera R, Bankhead C, Fuller A, Stevens R, Bradford K, Tyndel S, Alonso-Coello P, Ansell J, Beyth R. 
Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.
The Lancet. 2012 Jan 28;379(9813):322-34.

Funded by the National Institute of Health Research, included a meta-analysis of individual participant data involving over 30 international collaborators (“Self-Monitoring Triallist Collaboration”). The Individual patient data analysis, with 12,800 person-years of follow-up, showed that self-monitoring was effective in the long term and across a wide age range of participants.

February 2012

Impact

Evidence-Based Management of Anticoagulant Therapy Antithrombotic
Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines – cites 2006 self monitoring review, 2011 Lancet review and 2010 optimal loading dose review. These guidelines remain the current version.

April 2012

Underpinning research published

Mahtani KR, Heneghan CJ, Nunan D, Bankhead C, Keeling D, Ward AM, Harrison SE, Roberts NW, Hobbs FDR, Perera R.
Optimal loading dose of warfarin for the initiation of oral anticoagulation.
Cochrane Database of Systematic Reviews 2012 Issue 12. Art. No.: CD008685.
DOI: 10.1002/14651858.CD008685.pub2.

November 2012

Underpinning research published

Plüddemann A, Thompson M, Wolstenholme J, Price CP, Heneghan C.
Point-of-care INR coagulometers for self-management of oral anticoagulation: primary care diagnostic technology update.
Br J Gen Pract. 2012 Nov 1;62(604):e798-800.

April 2014

Underpinning research published:

Mahtani KR, Heneghan CJ, Nunan D, Roberts NW. 
Vitamin K for improved anticoagulation control in patients receiving warfarin.
Cochrane Database of Systematic Reviews. 2014(5).

July 2014

Impact:

Anti Coagulation Europe (ACE) (UK) is a charity dedicated to supporting patients who take anticoagulant and antiplatelet therapies. The charity partnered with three other UK charities to form the AntiCoagulation Self-Monitoring Alliance and submitted written evidence, citing the reviews, to the Parliamentary Health Select Committee’s inquiry into the Management of Long-Term Conditions (2014). They cite the 2006 and 2010 systematic reviews on self-monitoring.

Impact:

Anticoagulation services and patient access to INR self-monitoring in the NHS in England - A report by the AntiCoagulation Self-Monitoring Alliance (July 2014) cite the 2006 Lancet review. 

August 2014

Impact:

British Society of Haematology – Patient self‐testing and self‐management of oral anticoagulation with vitamin K antagonists: guidance from the British Committee for Standards in Haematology.

The guidance cites the 2012 Lancet review on self-monitoring. Heneghan invited as co-author of the guideline.

April 2015

Impact:

Royal College of Obstetricians and Gynaecologists – Thromboembolic Disease in Pregnancy and the Puerperium: Acute Management Green-top Guideline. The report cites the 2010 systematic review of the optimal loading dose of warfarin.

April 2016

Impact:

NHS Healthcall – An NHS collaboration driving improved care and technology innovation across the North East of England – produce patient information sheets citing 2012 Lancet review on self-monitoring.

May 2016

Impact:

Roche launches the CoaguChek® INRange system in countries accepting the CE Mark. Cite 2006 and 2012 systematic reviews on self-monitoring.

Roche also makes these related statements:

  • “CoaguChek meters have been offered in the U.S. for more than 20 years and there are more than one million CoaguChek XS devices in use around the world."
  • "Over 250,000 CoaguChek XS PT test strips are used globally per day."
  • "Nine of the top 10 U.S. integrated health networks (IHNs) choose CoaguChek technology."

July 2016

Underpinning research published:

Heneghan CJ, Garcia‐Alamino JM, Spencer EA, Ward AM, Perera R, Bankhead C, Alonso‐Coello P, Fitzmaurice D, Mahtani KR, Onakpoya IJ. 
Self‐monitoring and self‐management of oral anticoagulation.
Cochrane Database of Systematic Reviews 2016, Issue 7. Art. No.: CD003839. DOI: 10.1002/14651858.CD003839.pub3

The above review is press released. Lead author statement: “There are more than 1.2 million people in the UK on warfarin therapy, of whom fewer than 2 per cent self-monitor their INR levels despite mounting evidence that self-monitoring alone can cut the risk of death by nearly two fifths and more than half the risk of strokes.”

September 2016

BMJ Editorial:

Novel oral anticoagulants for atrial fibrillation 
Mahtani, K.R. and Heneghan, C.
BMJ (2016): i5187. 

May 2017

Impact:

Roche develop patient facing material to support self-monitoring of INR – “I know my value – Be an active part of your anticoagulation therapy with INR self-monitoring” – citing 2012 systematic review.

August 2017

Impact:

ESC/EACTS Guidelines for the management of valvular heart disease – Cite 2012 Lancet review on self-monitoring.

September 2017

Impact:

Inhealthcare launches an INR self-testing service for NHS patients in Manchester – citing 2012 Cochrane systematic review. “Inhealthcare is supplying the pioneering technology for the service, which is being delivered by staff from The Pennine Acute Hospitals NHS Trust, which runs North Manchester General Hospital.

It is available for up to 200 patients with Atrial Fibrillation in North Manchester. Their respective clinics will still be their first point of contact if they have any problems or concerns.”

November 2017

Impact:

NICE Clinical Knowledge summaries – What is the starting dose when warfarin therapy is initiated? – Recommendations from 2011 BSH guidance which cites 2006 and 2010 systematic review.

Impact:

NICE Clinical Knowledge Summaries (Anticoagulation) – Are self-testing and self-management as safe and effective as routine management?

Recommendations include:

  • For selected and successfully trained people, self-testing or self-management are as effective and safe as usual care for long-term oral anticoagulation therapy and can improve the quality of oral anticoagulation therapy in this group of people.
  • However, in the UK, self-testing is unlikely to be more cost-effective than usual care, because of the increased frequency of testing and subsequent cost of test strips.

The basis for the recommendation – heavily reference 2016 Cochrane systematic review on self-monitoring.

January 2018

Impact:

The self-testing point of care coagulation market is one of the largest sectors in the global point-of-care industry. In 2011, the market was valued at $1.0bn. By 2017, the global coagulation analyzer market was valued at $1.8bn.

Global Coagulation Analyzer Market to Surpass US$ 13.17 Billion by 2025”.

May 2018

Impact:

Department of Health and Social Care Reviews Facility – To support national policy development and implementation “The effective, safe and appropriate use of anticoagulation medicines.

A systematic overview of reviews” – cites 2016 Cochrane systematic review.

June 2018

Impact:

Roche introduces first self-testing device for Warfarin monitoring with built-in Bluetooth® technology.

“Patient self-testing with the Bluetooth-enabled CoaguChek Vantus system allows for a new level of patient monitoring. Patients can use their tablet or smartphone with a compatible app to send their results automatically via wireless connectivity which enables healthcare providers to receive patient INR results rapidly and accurately, while also reducing visits to the lab.” citing 2016 Cochrane systematic review on self-monitoring.

Blog:

NOACs: good for some perhaps, but not for all
Kamal R Mahtani
BMJ EBM

October 2018

 Impact:

Roche – “In vitro diagnostics: enabling better health decisions” cites Lancet 2012 review.

November 2018

 Impact:

American College of Chest Physicians – Antithrombotic Therapy for Atrial Fibrillation – CHEST Guideline and Expert Panel Report – cites 2016 Cochrane review on self-monitoring.

REACH – The website of CHEST states “CHEST is the global leader in prevention, diagnosis and treatment of chest diseases. Its mission is to champion advanced clinical practice, education communication and research in chest medicine. It serves as an essential connection to clinical knowledge and resources for its 19,000+ members from around the world who provide patient care in pulmonary, critical care and sleep medicine.”