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.

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.

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.

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 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

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.

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/

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

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.