Dendrite Clinical Systems

Two distinguished members join Dendrite’s Scientific Advisory Board

OHaskins — Fri, 13 Sep 2024 09:44:35 +0000

Two distinguished members join Dendrite’s Scientific Advisory Board

OHaskins Fri, 13/09/2024 - 10:44

Dendrite Clinical Systems has announced the appointment of two members to the company’s newly established Scientific Advisory Board - Sir Bruce Keogh (KBE FMedSci FRCS FRCP) and Professor Anthony Goldstone (CBE MA (Oxon) FRCP FRCPE FRCPath). The Scientific Advisory Board has been created to provide unique advice and guidance to Dendrite’s management team by taking an objective look at our activities and sharing with us their experience and knowledge. This includes evaluating the scientific merit of projects, assessing progress and offering strategic input on the company’s priorities.

“We are delighted to welcome two illustrious members to our new Scientific Advisory Board, both of whom have unparallelled experience in the international healthcare sector,” said Dr Peter Walton, Dendrite’s managing Director. “Their expertise and knowledge will provide us with valuable insights into how we can enhance and improve our expanding software portfolio, as well as increase awareness of our company globally.”

Sir Bruce has had a distinguished international career as a cardiac surgeon. He developed a longstanding interest in clinical outcomes from working closely with Dendrite to establish a national database for adult cardiac surgery early in his surgical career.

Sir Bruce Keogh

He subsequently became chair of Cardiac Surgery at University College London and Director of Surgery at the Heart Hospital, before being appointed Medical Director of the National Health Service and Director General in the Department of Health (DoH), a role that later transferred to NHS England. During this period (2007-18) as the most senior doctor in the NHS he was had particular responsibility for the development and implementation clinical policy and strategy across the health service in England.

In the DoH, he was the Government sponsor for NICE, the Healthcare Commission and the National Patient Safety Agency. He has served on several boards including NHS England. He is currently Chair of the Birmingham Women’s and Children’s NHS Foundation Trust, he was knighted for Services to Medicine in 2003.

Professor Goldstone is a senior haematology specialist with over 35 years’ experience of working in the NHS. He was appointed as a Consultant at University College Hospital (UCH) in 1976 and initiated the first stages of what became the biggest Adult Haematology unit in the UK. Professor Goldstone is a former Medical Director of University College London Hospital, former President of the British Society of Haematology and former Chair of the European Society for Blood and Marrow Transplantation Lymphoma Group.

Professor Anthony Goldstone

He specialises in adult haematology and haematological malignancy, adult leukaemia, lymphoma (Hodgkin's and Non-Hodgkin's Lymphoma) and myeloma and other non-malignant haematological conditions. The founder of the stem cell transplant unit at UCH, Professor Goldstone is a renowned pioneer in haematological stem cell transplantation. A Principal Investigator on many leukaemia trials in the UK and internationally, he is strong advocate of evidence-based medicine and believes registries now stand alongside randomised clinical trials as real-world evidence.

Professor Goldstone, a former Director of the North London Cancer Network, has published over 360 peer-reviewed papers in haematology and has authored three books. He was awarded a CBE June 2008 for Services to Medicine.

UzAMBS and Dendrite Clinical Systems to establish National Registry of Bariatric and Metabolic Surgery of Uzbekistan

OHaskins — Sat, 06 Jul 2024 15:20:59 +0000

UzAMBS and Dendrite Clinical Systems to establish National Registry of Bariatric and Metabolic Surgery of Uzbekistan

OHaskins Sat, 06/07/2024 - 16:20

The Association of Bariatric and Metabolic Surgeons of Uzbekistan (UzAMBS) and Dendrite Clinical Systems will establish a National Registry of Bariatric and Metabolic Surgery of Uzbekistan. The purpose of the Registry is to collect information on patients and bariatric procedures in the country so researchers can use the data to improve outcomes in patients.

“The creation of a national bariatric registry will allow us to evaluate the technical characteristics of bariatric interventions performed in different centers, the geographical characteristics of the distribution of bariatric patients, track strategies for choosing types of surgical treatment, systematize data on the characteristics of management and clinical tactics, and evaluate long-term results,” explained President of UzAMBS, Professor Oktyabr Teshaev (Head of the Department of Surgery of the Tashkent Medical Academy, Tashkent, Uzbekistan).

The National Register of Bariatric Surgery of Uzbekistan will be financed by the members of UzAMBS and mainly collect the following data:

data on all types of bariatric surgeries
patient data before and after surgery
general clinical and biochemical blood tests
data from instrumental studies of ultrasound, X-Ray, MSCT, EGDFS, ECG, etc.
selection of bariatric surgery method
postoperative management
postoperative observation with repeat examinations one, three, six, 12 and 24 months
analysis of remote results of surgeries performed
complications and quality of life after bariatrics
data on bariatric surgeons
performance indicators of surgical centres, as well as statistical processing of the obtained data and creation of reports

“Systemisation and unification of the results of bariatric interventions will allow us to audit and certify clinics, which will obviously improve the quality of bariatric care in the country. We analysed the activities of several companies in the field of programming and creating registers, but having studied the activities of Dendrite Clinical Systems and learned the structure of the IFSO Registry, we came to the conclusion that it would be right to entrust the creation of the National Register of Bariatric Surgeons of Uzbekistan to Dendrite,” he added.

About Dendrite

Dendrite Clinical Systems is a UK-headquartered international company with over a 30-year track record as a specialist provider of secure clinical registries, analysis software and consultancy services for the international healthcare sector, specifically for clinical research, multi-centre real-world studies, observational registries, international, national and hospital clinical databases.

Dendrite has been recognised as a leading provider of clinical registries across various specialties with a unique track record of implementing over 200 major clinical registry systems globally including systems for major research projects for medical device companies, CROs and pharmaceutical companies.

Dendrite and LumiThera initiate EUROLIGHT Registry Study to Evaluate Long-term Benefits of Photobiomodulation (PBM) Treatment using the Valeda® Light Delivery System in Patients with Dry Age-Related Macular Degeneration

OHaskins — Thu, 04 Jan 2024 15:34:34 +0000

Dendrite and LumiThera initiate EUROLIGHT Registry Study to Evaluate Long-term Benefits of Photobiomodulation (PBM) Treatment using the Valeda® Light Delivery System in Patients with Dry Age-Related Macular Degeneration

Dendrite and LumiThera initiate EUROLIGHT Registry Study to Evaluate Long-term Benefits of Photobiomodulation (PBM) Treatment using the Valeda® Light Delivery System in Patients with Dry Age-Related Macular Degeneration

OHaskins Thu, 04/01/2024 - 15:34

Dendrite Clinical Systems and LumiThera have initiated the largest photobiomodulation (PBM) study ever conducted. The multi-center clinical registry, EUROLIGHT (European Union Registry Study) will enroll 500 to 1000 patients treated with with PBM using the LumiThera Valeda Light Delivery System in the EU over the past three years. The study will initially include up to 20 European centres and could be expanded in other countries outside the Europe Union (EU) where Valeda is approved.

Utilising Dendrite’s intuitive and robust ‘Intellect-Web Registry’ software, EUROLIGHT will collect safety and clinical efficacy outcomes such as best corrected visual acuity (BCVA) and Optical Coherence Tomography (OCT) imaging data from multiple centres that have been treating dry Age-Related Macular Degeneration (AMD) subjects in their practice. This large registry will collect data retrospectively with centres providing existing data from subjects who underwent PBM treatment every 4-6 months for up to three years. Patients will continue to be followed prospectively. The data will be used to support reimbursement in multiple countries and provide important clinical information on real world use of Valeda. The study has targeted select European centers with extensive expertise in the use of Valeda.

“We are delighted that the EUROLIGHT Registry has been launched across multiple centres throughout Europe. EUROLIGHT is a highly-complex registry in terms of its capacity to track multiple treatments, whilst simultaneously collecting and recording both procedural and outcomes data at differing time sets from multiple centres,” said Dr Peter Walton, Managing Director of Dendrite Clinical Systems. “This bespoke registry design has been developed over several months and I would like to thank everyone involved in the process, and we look forward to seeing the outcomes in due course.”

Dendrite’s Intellect-Web Registry software enables users (clinicians, hospitals, societies and associations, healthcare companies etc) to collect, analyse, track and report procedural, treatment and outcomes data for clinical audit and benchmarking, research, clinical trials and Real World Evidence studies. The flexible system can be tailored for any clinical scenario and is designed to support multiple specialties and at multiple locations. Data can be entered safely and securely on smart-phones, tablets or computers anywhere in the world via the internet, with the data automatically updated to the registry. The system’s unique ‘Visual Dashboard’ facilitates real-time data analysis reflecting the required analysis/reporting needs, and the recently launched innovative e-PROMS module allows contacts to receive and answer questionnaires remotely.

“We are thrilled to be part of the Eurolight study,” said Dr Oygunn Uthiem, MD, PhD, Norwegian Dry Eye Clinic / Øyehelseklinikken, Department of Medical Biochemistry/Department of Ophthalmology, Oslo University Hospital, Oslo, Norway. “We have treated over 350 patients in the last four years and have seen the real world benefits of the Valeda treatments for our patients. We have started to upload data into the registry database and have obtained over 70 informed consents from patients that want to be part of the study. Our patients have strictly followed the clinical trial protocols and been tested every 4-6 months, some for up to four years.”

The current registry collection will examine patients from early through late stage AMD disease and provide evidence of safety, clinical efficacy and biomarkers from imaging data. An estimated 16,000 patients in Europe and Latin America have been treated to date and represents a valuable dataset to garner further information about PBM treatment and AMD disease progression.

“We have seen recent publications from the real-world setting that mirror our RCT trial results and we have several years of experience with Valeda treatments in the EU and LATAM,” stated Clark Tedford, Ph.D., President and CEO, LumiThera. “The ability to collect additional safety and efficacy data from our global experiences will help us continue to study the safety and effectiveness of PBM in early to late-stage disease treatment of dry AMD and its effect on the progression of disease and GA lesion growth rates.”

About AMD

AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, read, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).

About Dendrite

About LumiThera

LumiThera, Inc. is a medical device company focused on diagnosing, treating, and monitoring ocular disease and damage including dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 65.

LumiThera’s flagship product, the Valeda® Light Delivery System, uses multiwavelength photobiomodulation to treat dry AMD patients. Valeda is CE Marked in the EU and is available in Europe and in countries in Latin America. Valeda is not yet approved by the Food & Drug Administration (FDA).

AdaptDx Pro® dark adaptation functional testing technology enables eye care professionals to detect and monitor AMD three years before clinical presentation. AdaptDx Pro is listed on the FDA’s Establishment Registration & Device Listing.

Diopsys ERG and VEP systems help eye care professionals analyze the entire pathway for visual and neuro-visual disorders. VEP is FDA-cleared. ERG and VEP are available in select countries outside of the USA.

LumiThera’s AMD Excellence Program® provides customer implementation, training, best practices, and ongoing support across all brands.

For more information about the EUROLIGHT (European Union Registry Study) Registry, please visit: https://demo.e-dendrite.com/lumithera/

SBMSK and Dendrite Clinical Systems to establish National Registry of Bariatric and Metabolic Surgery of Kazakhstan

OHaskins — Sat, 25 Nov 2023 17:25:26 +0000

SBMSK and Dendrite Clinical Systems to establish National Registry of Bariatric and Metabolic Surgery of Kazakhstan

OHaskins Sat, 25/11/2023 - 17:25

The Society of Bariatric and Metabolic Surgeons of Kazakhstan (SBMSK) and Dendrite Clinical Systems will establish a National Registry of Bariatric and Metabolic Surgery of Kazakhstan. The purpose of the Registry is to collect information on patients and bariatric procedures in the country so researchers can use the data to improve outcomes in patients.

Oral Ospanov

“Bariatric surgery in Kazakhstan is a relatively new branch of medicine. Therefore, I really wanted this part of the surgery to go the right way from the very beginning. We wanted to understand and see the overall picture of bariatric surgery in our country. What procedures are performed and in what quantity? what quality and result?,” explained President of SBMSK, Professor Oral Ospanov, Professor of Medicine and Surgery, Head of Department of Laparoscopic & Bariatric Surgery at Astana Medical University, in the Republic of Kazakhstan. “And in order to have an objective picture of what is happening, we created a bariatric register, looking at the experience of other countries. It was important to understand where we stand and to determine the population's need for bariatric surgery.”

The registry uses Dendrite’s intuitive Intellect-Web registry software that facilitates the collection, recording and analysis of patient and procedural data from all bariatric procedures performed at the hospital including baseline demographic data, procedure type (including OAGB/MGB), all complications that might occur and also notes the severity of post-op complications (using the Clavien-Dindo classification). The system also takes into account the use of gastric balloons so that a subsequent first surgical procedure becomes a Primary Procedure and does not appear as a revision.

"The benefits we can get from launching the register are enormous. The quality and safety of various types of operations will be assessed. The data will be used for analysis and research, as well as improving the quality of care provided,” Professor Ospanov added. “The data we receive will be reported to the Ministry of Health and the Health Insurance Fund to make appropriate decisions. Ultimately to show the medical community and the public that this is a very safe surgery that can treat many diseases, as well as overcome the stigma regarding the treatment of obesity and related diseases, which could have formed in our country.”

About Dendrite

State of Kuwait Ministry of Health publishes 3rd National Bariatric Registry Report

OHaskins — Mon, 23 Oct 2023 08:01:04 +0000

State of Kuwait Ministry of Health publishes 3rd National Bariatric Registry Report

State of Kuwait Ministry of Health publishes 3rd National Bariatric Registry Report>id/>

OHaskins Mon, 23/10/2023 - 09:01

The State of Kuwait Ministry of Health and Dendrite are delighted to announce the publication of the 3rd Kuwait National Bariatric Registry Report 2023. This latest report, which includes 6,484 bariatric surgery cases, contains data on baseline obesity-related disease, operation types, operative outcomes and disease status after bariatric surgery in Kuwait.

“With the establishment of the National Bariatric Surgery Database, we anticipate that this report will guide policymaking, highlight expenditure, and aid in future planning with a vision to improve the quality of care. We aim to tackle the burden of obesity and its related comorbidities like dyslipidemia, hypertension, diabetes, sleep apnea, among others, and emphasize the benefits of bariatric surgery,” said Salman Al-Sabah, former Chairman of Surgery, Jaber Al-Ahmad Al-Sabah Hospital and Associate Professor of Surgery, Kuwait University, Kuwait. “A future aim remains to assimilate data from all surgeons and hospitals into a national registry. Meanwhile, we need to motivate participants to provide more comprehensive patient details. A pressing need for standardization in reporting various comorbidities is evident, which will be crucial to achieve accurate reporting and thus gather maximum information regarding the effectiveness of our surgical procedures.”

The Kuwait National Bariatric Registry is a collaboration between the State of Kuwait Ministry of Health and Dendrite. The registry uses Dendrite’s intuitive Intellect-Web registry software that facilitates the collection, recording and analysis of patient and procedural data from all bariatric procedures performed at the hospital including baseline demographic data, procedure type (including OAGB/MGB), all complications that might occur and also notes the severity of post-op complications (using the Clavien-Dindo classification). The system also takes into account the use of gastric balloons so that a subsequent first surgical procedure becomes a Primary Procedure and does not appear as a revision.

The Kuwait National Bariatric Registry currently comprises data being submitted from seven public hospitals (Al Adan Hospital, Al Amiri Hospital, Farwaniya Hospital, Jahra Hospital, Mubarak Al-Kabeer Hospital, Al Sabah Hospital and Jaber Hospital) by 102 surgeons. Of the 6,484 cases - 5,270 were primary procedures (81.3%), 874 were subsequent or revision operations (13.5%) and 340 were balloon insertions (5.2%).

Data collection was once again of a high quality; approximately 90% of entries for patients having their primary operation had either no missing data or one missing data item among a list of 10 obesity-related diseases assessed pre-operatively (including type 2 diabetes, back or leg pain, depression, impaired functional status, gastro-oesophageal reflux, raised blood pressure, dyslipidaemia, liver disease, sleep apnoea and increased risk of deep vein thrombosis or pulmonary embolism).

Key patient outcomes from the report showed:

At the time of primary surgery, 72.0% of all patients are female.
In Kuwait the patients have surgery at a younger age than most other countries; on average male Kuwaiti patients are 32.3 years old and female patients 32.9 years old at the time of their operation.
Patients in Kuwait have a slightly higher BMI than the average reported from the IFSO Global Registry; the average BMI for a male Kuwaiti patient was 45.7 and for the average female patients it was 43.2.
The bulk of the patient population (93.5% of males and 95.0% of females) presents with one to five obesity-related conditions.
Over 93% of patients had impaired functional status pre-operatively.
29.0% of men and 25.1% of women have leg or back pain related to their weight.
There were a large number of patients with type 2 diabetes (16.6% of the men and 12.5% of the women), which is a significant burden for the country’s healthcare system.

Key surgical outcomes from the report included:

Most operations in Kuwait were sleeve gastrectomy procedures (94.3% of primary surgery), one anastomosis gastric bypass/mini gastric bypass was the next most commonly recorded operation (2.8%) and then Roux en Y gastric bypass (1.5%).
In line with current accepted practice, almost all primary surgery was performed laparoscopically; only four operations were reported as having been converted to an open procedure.
7.2% of patients had an additional procedure concurrently with their bariatric surgery (3.6% cholecystectomy; 2.9% hernia repair; 0.1% liver biopsy; 0.8% another kind of minor procedure).
Operative complication rates were low: 1.06% of patients had a related bleed and 0.06% had a staple line leak.
Post-operative complications were also rare, considering the patients’ rates of obesity-related disease pre-operatively: 3.5% has a cardio-vascular complication and 5.2% had another complication.

The reported post-operative, in-hospital mortality was a very low 0.02%.

“It is with great pleasure that I commend this 3rd Report of the National Bariatric Surgery Database made available by Dendrite Clinical Systems. The Kuwait National Bariatric Surgery Database clearly demonstrates the safety and effectiveness of bariatric and metabolic surgery for treating patients with obesity in Kuwait,” said Dr Peter Walton, Managing Director of Dendrite Clinical Systems. “Furthermore, this initiative is helping the bariatric community establish essential benchmark knowledge, as well as track national trends in surgery, patient outcomes and the burden of comorbidities over time. I would like to thank all the contributors for submitting their data.”

About Dendrite

Leading UK clinic to launch Dendrite's comprehensive obesity workflow system

OHaskins — Tue, 06 Jun 2023 16:00:19 +0000

Leading UK clinic to launch Dendrite's comprehensive obesity workflow system

OHaskins Tue, 06/06/2023 - 17:00

The multi-disciplinary team (MDT) at Luton and Dunstable Hospital's Obesity Clinic, working in conjunction with Dendrite Clinical Systems, have developed a single database that tracks at every stage the patient’s entire treatment pathway. The new system records and collects data from the initial patient referral and pre-clinical assessments to each element of their MDT experience, obesity treatment/s, as well as follow-up appointments. We spoke with Dr Anjali Zalin, a Consultant Physician at the hospital who has helped to develop the database, and she outlined how the new database could transform the delivery of care by healthcare professionals and the experience of patients seeking treatment/s for their obesity.

Prior to using the Dendrite system, the team at Luton and Dunstable Hospital's Obesity Clinic used a variety of databases and systems to record and report patient and procedural data however, these methods were rigid, did not provide the quality of data with the granularity that was required and presented a challenge when uploading the centre’s data to the UK’s National Bariatric Surgery Registry (NBSR). They also had separate systems for pathology, discharge letters, medications, follow-up appointments etc. So, there was an urgent requirement to integrate these different systems into a single database.

Dr Anjali Zalin

“Due to the different services and treatments we offer at our Obesity Clinic, we really needed a comprehensive system that would be able to capture and record all our patient data at every stage of their journey,” explained Dr Zalin. “Working with Dendrite, and in parallel to our pathway re-design, we have developed a highly personalised pathway that is unique to each patient’s individual preferences, background, comorbidities and treatments. This obesity workflow system has allowed us to capture the patient’s data at each appointment or referral with each member of our MDT.”

She explained that the process of designing and building the database involved the cooperation of the entire MDT, as well as the IT department at the hospital to ensure smooth integration. The system is currently at the demonstration stage and the team at Luton are hoping the system will go ‘live’ in the coming weeks.

“Our database mirrors each and every stage and assessment within our tier 3 programme - from the point of referral to our clinic and initial assessments to every stage of their journey from follow-up and treatments to add-on assessments via each member of the multi-disciplinary team (MDT) and so on. So at every stage, whether that is their blood work or imaging results, their data is collected and recorded with in one single comprehensive database. Crucially, this database is linked to our local hospital system so our MDT has access to, and are aware of, their patient’s past and current status as well as future appointments and assessments.”

As soon as a patient is accepted onto the clinic’s obesity pathway programme and before they have attended the clinic, they are sent (via their smart phone) a series of health-related electronic questionnaires and their responses are uploaded to the database and populated into their individual patient record within the database. The benefits are twofold: firstly, the patient is engaged early in their journey, this not only enables the patient to become involved early in the process, but secondly, also saves the clinicians’ valuable time without having to spend time entering rudimentary data. In essence, the MDT at Luton as two databases rolled into one – a database for tier 3 (non-surgical) and tier 4 (surgical) pathways, but the intuitive design on the database negates the need to repeat time-consuming and repetitive data entry.

“So far, I have been particularly impressed with the functionality of system, the self-populating fields and patient reporting features are working really well. The clarity around the interface means the systems in very intuitive and easy for the end user. In addition, our Tier IV NBSR data will be able to be seamlessly and electronically uploaded to NBSR.”

The database will be one of the first in the UK to collect data and will report outcomes on the weight loss drug Wegovy (semaglutide), approved for use by UK’s NICE regulatory body, in February 2023. This section of the database incorporates the inclusion criteria, screening, group delivery and outcomes, both in terms of weight loss and side-effects.

“Due to the patient numbers coming through tiers 3 and 4, and the need for them to have peer-support, we came to the conclusion that group delivery was an effective way to treat patients who are embarking on Wegovy treatment. Within the database, we have built options for group sessions, this does not record specific data on the sessions, but rather who attended the sessions. This could prove valuable when it comes to examining the timing of their referral, individual outcomes and whether attending these sessions impacted their outcomes. Crucially, the system allows a clinician to see how long a patient has been in tier 3 and, if necessary, the clinician can then activate the next stage of their treatment.”

Dr Zalin stressed that obesity is a multi-factorial disease and to treat such a chronic disease necessitates an MDT approach. Therefore, the way in which data is collected is a key part of care delivery. By engaging the MDT in the early developmental stages of the new database and designing and creating the data fields they require to do their job, means each member of the team is whole-heartedly involved and empowered in the project.

“In our tier 3 programme alone in the last 12 months we have approximately 1,400 referrals. Therefore, effectively managing the data using a single database, I think, will transform the way we deliver patient care and, I hope, improve the experience for our patients.”

*With thanks to Dendrite team, especially Jonathon Blount and Luton colleagues - Mr Douglas Whitelaw, Tom Smith, David Cox, Bindhu Jophy and Mr Chanpreet Arhi.

About Dendrite

Outcomes from the Out-of-Hospital Cardiac Arrest Registry is transforming patient care

OHaskins — Tue, 21 Mar 2023 11:40:29 +0000

Outcomes from the Out-of-Hospital Cardiac Arrest Registry is transforming patient care

OHaskins Tue, 21/03/2023 - 11:40

The initial results from the British Cardiovascular Intervention Society's Out-of-Hospital Cardiac Arrest Pilot Registry, which records information from the time of cardiac arrest, right through hospital stay and extended follow-up of patients, has had a positive impact on the referral patterns and outcomes for cardiac arrest patients.

The registry’s research team, based at Essex Cardiothoracic Centre, have used the registry to record information from a pilot of a new pre-hospital conveyance algorithm - designed to offer guidance to ambulance staff on which centres to take a patient to if they recover a pulse after an out of hospital cardiac arrest. This pathway diverts patients with a potential higher chance of having a cardiac cause for their arrest and needing acute cardiac care to a cardiac arrest centre where they can receive appropriate care. The registry, which only includes patients who have had a cardiac arrest from a suspected cardiac aetiology, began collecting data in October 2022 and now had over 770 cases.

“We know cardiac arrest is a huge problem in the UK and around the world, and the survival rates between 8-10% in the UK are behind our European neighbours and North America. One of the main problems is that it is difficult to affect change in cardiac arrest that is going to improve mortality,” explained Dr Rupert Simpson (Mid and South Essex NHS Foundation Trust). “Understanding the extent of the problem, particularly on a local level is a challenge, as there is a lack of data on inpatient stay, local practices and patient follow-up are not being documented.”

Currently, there are no guidelines concerning patient referrals after a cardiac arrest and patients are usually taken to the nearest suitable centre for treatment. The team from Essex adopted a more nuanced approach that considers the initial heart rhythm patients present with. Dr Simpson stated that there is evidence suggesting that if a patient has a particular rhythm, one that can be defibrillated (a so-called ‘shockable rhythm’), the patient may have a higher likelihood of having a cardiac aetiology for their arrest. If the patient is then brought to a cardiac arrest centre, the patient may then receive treatment that could result in more positive outcomes.

“Ambulance teams already collect really useful information and researchers at Warwick University have done some excellent work with that data. The next step was to gather the follow-up data, with particular focus on longer term functional, neurological and psychological outcomes,” added registry lead, Dr Thomas Keeble (Consultant Cardiologist, Essex Cardiothoracic Centre, UK). “Essentially, what this dataset does is build upon the pre-hospital ambulance data, add in the in-patient hospital data and includes the follow-up data. We now have a holistic registry - complete data from the time of the cardiac arrest to follow-up. A lot of the data we are collecting is already collected within the NHS, but it is in lots of different databases and has not been amalgamated. This is the first time all the data has been collected in a single registry.”

“One of the key advantages of using the Dendrite system was their unique electronic patient-reported outcome measures (ePROMs) facility, that gave the us the ability to assess a patient's health status (QoL) at a particular points in their follow-up,” explained Dr Simpson. “This is crucial in assessing whether our interventions are improving outcomes in the longer term.”

Since they launched the algorithm across Essex, they have managed to increase the proportion of patients coming to their centre with a cardiac arrest secondary to an initial shockable rhythm. Prior to the registry, the proportion of these patients across Essex coming to the Essex Cardiothoracic Centre was about 44% and since the launch of the new algorithm that number has increased to about 60%.

“We are not aware of any guidelines for pre-hospital teams regarding the referral of cardiac arrest patients and we are the first centre to be running this pilot algorithm, on behalf of the British Cardiovascular Intervention Society. So, depending on the outcomes of this pilot, it has the potential to really transform patient care on a country wide basis,” Dr Keeble highlighted.

Moreover, for the research team the project fully underpins the principles of ‘Getting It Right First Time (GIRFT)’ report for cardiology, which emphasised the need for better data collection, reducing clinical variation and supporting cardiology services to work more flexibly through clinical networks.

“We know that about the same number of patients arrive at our centre also arrive at the five non-cardiac centres (Harlow, Colchester, Southend, Basildon and Chelmsford),” Dr Keeble added. “Now, it is not feasible for our centre to take all those patients, but we can take those patients who we think ae most likely to be presenting with a cardiac aetiology and give them the most effective treatments to hopefully improve their outcomes. Ultimately, it is about getting the right patient, at the right time to the right centre to give them the right care. Of course, getting the patient to the right centre also benefits ambulance teams as they are avoiding unnecessary secondary transfers with intensive care teams.”

“The main goal of the registry was the capture what we are doing locally in Essex and hopefully establish a blue-print for a UK-wide cardiac arrest registry. This unique web-based registry has now been adopted by the British Cardiovascular Intervention Society as a pilot registry and we are hoping the registry will be rolled out nationally,” said Dr Simpson. “When we complete this initial project in April 2023, it will be really interesting to compare the before and after group to see the impact the algorithm had had on patient outcomes.”

“As ever, to recognise the full potential of this project, there will need to be national roll-out that is sensitive to local healthcare systems, geographical variation, commissioning of services and the populations they serve. In the first instance, we have are expanding the registry to include selected other sites first to trial the usage and in time we hope to include all UK centres treating cardiac arrest patients,” Dr Keeble concluded.

The East of England Cardiac Network provided funding for this registry.

About Dendrite

SCTS Conference News 2022 newspaper now available online

OHaskins — Thu, 12 May 2022 09:36:37 +0000

SCTS Conference News 2022 newspaper now available online

OHaskins Thu, 12/05/2022 - 10:36

Dendrite Clinical Systems and the Society for Cardiothoracic Surgery in the UK are pleased to announce the SCTS Conference News 2022 newspaper is now available to view/download. The newspaper reports a multitude of presentations from the meeting including the latest and the best information on new technologies and techniques in cardio-thoracic surgery.

This year’s meeting in Belfast included presentations of the highest quality from surgical and masterclass presentations to the latest clinical updates and technical innovations. The newspaper will be of interest to surgeons, anaesthetists, nurses, surgical care practitioners, physiotherapists, child governance leads, database managers and allied health professionals.

Please click here to read SCTS Conference News 2022.

MiECS randomised controlled trial to assess MiECC vs. cCPB

OHaskins — Sun, 24 Apr 2022 08:09:22 +0000

MiECS randomised controlled trial to assess MiECC vs. cCPB

OHaskins Sun, 24/04/2022 - 09:09

Researchers led by the Clinical Research Unit at the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine, Greece, have initiated a randomised control trial (RCT) that will compare minimally invasive extracorporeal circulation (MiECC) with conventional cardiopulmonary bypass (cCPB).

According to the researchers, the ‘Minimally invasive extracorporeal circulation versus conventional cardiopulmonary bypass in patients undergoing cardiac surgery (MiECS)’ trial will be one of the largest multicentre RCTs on extracorporeal circulation. The study will be conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS).

“This study is ultimately designed to address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide,” explained Professor Polychronis Antonitsis, Associate Professor of Cardiac Surgery, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Greece, and co-investigator of the trial. “The primary hypothesis is that MiECC, as compared to cCPB, reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery.”

According to the researchers, the MiECS study will overcome most limitations of previous trials of MiECC as it will focus on specific perfusion-related clinical outcomes after cardiac surgery that could be potentially affected by MiECC, and should also target for higher-risk patients undergoing complex procedures that are more likely to develop complications and, thus, benefit from the advanced technology.

The study will be conducted in ten to 15 cardiac surgery centres worldwide (Germany, Greece, Italy, United Kingdom, Switzerland, Turkey and Canada) and any surgeon with an experience of more than 50 patients operated on MiECC is eligible to take part. Patients will be recruited if they are having coronary artery bypass surgery, aortic valve replacement or both. The research objectives will be addressed by randomising participants (1:1 ratio) to have surgery using MiECC system or cCPB.

The trial will be powered by Dendrite Clinical Systems’ Intellect Web software that will collect patient demographic, procedural, complication/s and outcomes data. In addition, the innovate software features automatic patient randomisation - once the inclusion and exclusion criteria are completed, a random number generator automatically randomises the patient to a treatment group.

"This intuitive system is incredibly easy to use whether it is a cardiac surgeon, perfusionist or nurse entering the data. In addition, investigators can monitor each patient record as the trial continues. With a paper-based system, one has no idea who is enrolling patients, who has put in incomplete data etc without directly monitoring them," explained Dr Peter Walton, Managing Director of Dendrite Clinical Systems. “Our system allows researchers to keep a track on patient randomisation and importantly, ensure centres are adhering to protocol etc. “A web-based platform for data collection offers unprecedented access by investigators across multiple sites, allowing real-time supervision of patient enrolment. Our web-based system can be adapted for national and international clinical registries and trials in any clinical setting.”

A total of 1,300 participants will be randomised in two arms over a period of 36 months. The composite primary outcome consists of death, myocardial infarction, stroke, acute kidney injury, reintubation, tracheostomy, mechanical ventilation for more than 48 hours, or reoperation up to 30 days after surgery.

“If MiECC is shown to be effective in such a trial, the technology is available and could be rapidly implemented in clinical practice providing a significant healthcare benefit,” Professor Antonitsis concluded.

Dendrite's cardiac dashboards facilitate on-line, real-time benchmarking at the touch of a button

OHaskins — Tue, 15 Mar 2022 15:55:54 +0000

Dendrite's cardiac dashboards facilitate on-line, real-time benchmarking at the touch of a button

OHaskins Tue, 15/03/2022 - 15:55

Dendrite Clinical Systems, working in close cooperation with the SCTS and several cardiac centres, has developed a series of ‘Dashboards’ that allow users to access to their unit’s surgical outcomes and compare them to national results in real-time. By uploading their data to the central Dendrite National Cardiac Surgical Registry, individual units or centres can instantly benchmark their results via an on-line database for internal consumption to assist units with their own clinical governance and for auditing purposes.

“There are several organisations in the United Kingdom that already examine surgical data and report a variety of clinical and organisational outcomes such as the National Cardiac Benchmarking Collaborative (NCBC). For several years the SCTS, working with the National Institute for Cardiovascular Outcomes Research (NICOR) as part of the National Cardiac Audit Programme, has been seeking to gather data on outcomes other than mortality,” explained Mr Uday Trivedi, Consultant Cardiothoracic Surgeon, from the Royal Sussex County Hospital, Brighton and Hove, and SCTS Adult Cardiac Surgery Audit Lead. “As the overall mortality from cardiac surgery is now so low, we really require data on additional outcomes such as complications like renal failure, stroke and bleeding, as well as length of hospital stay, patient surgical group demographics etc, to try and assess how we improve the quality of care for our patients. The Dashboards now give individual centres the ability to compare these complications at a national level. This is important data - not just for the multi-disciplinary surgical teams - but also for hospital managers and administrators.”

The Dashboards are exclusively for adult cardiac procedures and therefore excludes all congenital and thoracic procedures, as well as transplantation. During the development phase of the Dashboards, it was decided they would include the volume and type of procedures expected to be carried out by most surgeons or centres. As a result, the Dashboards report data on coronary surgery, aortic valve procedures and mitral valve procedures.

In addition to coronary and aortic and mitral valve procedures, a separate area for major aortic procedures is currently under development to try and ascertain how much major aortic work is performed in an emergency and/or elective setting. Specifically, this will help determine how many dissections are performed, by which units and reveal the outcomes from these procedures.

“One of the first things we had to decide was how to work around the information governance issues and GDPR requirements,” added Mr Trivedi. “Using only anonymised data, the process for data collection and analysis was mostly concerned with establishing suitable definitions, applying caveats to risk-modelling and risk-adjusted analyses.”

The desire for surgeons to benchmark themselves against national standards has always been a goal for the speciality. However, the ability to do this is dependent on several factors including how often data are submitted, it what form the data are submitted, how often and to what extent the data are analysed. By using the central Dendrite National Cardiac Surgical Registry, the ability to benchmark your data against national standards is realised with the push of a few buttons. Initially, the pilot Dashboards were rolled out to five centres and an additional 15 centres have expressed an interest in using them.

The Dashboards are not exclusive to units that only use Dendrite’s ‘Intellect Web’ software and are available for all units and centres across the develop nations. For example, units in Scotland can benchmark themselves against UK standards. Moreover, the intuitive Dashboards also allow users to take a more in-depth look at patients demographics and groups without the need for any additional coding or SQL queries on the part of users.

It is important to note that cardiac units can only look at their own data and benchmark their data to the national standard. The Dashboards cannot be used to compare one unit to another unit, and units cannot look at another unit’s data.

One key advantages of the Dashboards is the speed at which units can analyse their data, whether units unload their data monthly or quarterly, comparisons can be made in an instant. The data is presented in useful graphs and tables with the additional functionality of a data export facility to allow the data to be presented at governance and management meetings.

“We know that within centres, surgeons have different degrees of experience and seniority etc. This can lead to a skewed patient population for individuals. The SCTS has agreed with many national NHS bodies that the cardiac outcome data should be done on a unit level only and to move away from individual reporting. One of the tenets of this approach is for units to look for any negative variation in their outcomes on a quarterly basis. The Dashboards provide units with the tools to look for this variation,” Mr Uday concluded. “Clinical outcomes are the result of care provided by many clinical teams throughout the department or unit, not just one single surgeon or operation. By making the outcomes unit based, it provides both individual and collective responsibility for outcomes, creating awareness and therefore, driving quality improvement processes.”

“At the push of a single button and in just four or five seconds, surgeons can generate 37 comprehensive graphs and tables that illustrate surgical activity and outcomes at their hospital benchmarked against nationally collected data,” said Dr Peter Walton, Managing Director of Dendrite. “Dendrite is very pleased to be able to provide this added-value service to the UK community of adult cardiac surgeons.”