Clients

Italian clinical audit - Centro Cardiologico Monzino di Milano

The Centro Cardiologico Monzino of Milano, Italy, has published its tenth consecutive annual clinical audit on surgical activity. The report included data on over 16,500 patients over a 12-year period (1997-2008) who underwent cardiac and vascular surgery at the Centre. The report concluded that the Centre had developed and maintained a high level of clinical audit and that its outcomes were in line with (and often better than) those of the most recent, regarded and reliable cardiac surgery databases and surveys, such as the STS Cardiac National Database (USA) and the National Adult Cardiac Surgical Database Report from the Society of Cardiothoracic Surgeons of Great Britain and Ireland.

 However, historically, the Centre was not always able to produce rigorous clinical audit to such high standards. From 1997 to 2004, the Centre utilised a 'homemade' database based at first on Microsoft Superbase, then on Microsoft Access. According to Dr Stefano Salis, Consultant Cardiac Anaesthetist, and Clinical Audit Lead at the Centro Cardiologico Monzino, the statistical analyses the 'homemade' systems could perform were limited to mean ±standard deviation (or median). Although the homemade system could report single patient volume and outcomes, the hospital required a system that could provide: 

Centro Cardiologico Monzino di Milano

Centro Cardiologico Monzino

  • More advanced data analysis and reporting
  • Outcome tracking and risk modelling
  • Inbuilt risk stratification algorithms
  • Logistic regression models


The overall aim of clinical audit is to improve patient outcomes by improving professional practice and the general quality of services delivered. The Centro Cardiologico Monzino tried to achieve this by reviewing patient care against agreed standards. Unfortunately, the homemade system utilised by the Centre restricted its ability to do so as the current system did not have a mechanism to perform advanced statistical analyses or implement a robust method for risk adjustment. The institution was eager to identify software that could be easily implemented into the Centre and which would allow a systematic and critical analysis of the quality of surgical activity provided.

The solution

Dr Salis, who had previously worked with Dendrite in 1999, when he worked as a cardiac anaesthetist at Bristol Royal Infirmary, UK, identified the company database as the preferred solution. The company had developed sophisticated software that had inbuilt risk stratification algorithms including Bayes and logistic regression models, allowing individual clinicians or institutions to benchmark their results against regional, national or international standards, adjusted for severity of illness using well-established statistical methods.

Implementation

For the Centro Cardiologico Monzino, it was not only Dendrite's highly flexible software that supported multi-specialty applications that was appealing, it was also the company's expertise and extensive experience in planning and executing complex clinical database configurations for hospitals across Europe. Moreover, the company provided the hospital with several visits from their dedicated trainers for all those involved with inputting data, however simple or complex the level of data input required. In addition to site visits, the hospital was also provided with the necessary literature that outlined the different operational aspects of the Dendrite solution. Although there were some minor initial difficulties, these problems were easily solved through further cooperation between the company's technical team and the hospital's IT department.

Outcomes

The installation at the Centro Cardiologico Monzino di Milano, has dramatically improved the hospital's ability to perform a comprehensive clinical audit for cardiac and vascular surgery. According to Dr Salis, such audits are being considered more and more important at the hospital, and in the summer of 2008 the centre received accreditation by the European Cardiovascular and Thoracic Surgery Institute of Accreditation (ECTSIA).

The comprehensive, 100-page, 2008 report will document that the total peri-operative in-hospital mortality in 2008 was 2.85% for cardiac surgery and 1.1% for vascular surgery (cumulative cardiac and vascular 2.18%). Using the Logistic Euroscore as a risk-adjustment method the observed mortality was very much lower than the expected mortality in all risk classes. Furthermore, this latest report noted that the medium Logistic Euroscore for 2008 was 6.33, the highest in the last four years. The main post-operative complications were not cardiac related and were composed of renal insufficiency, respiratory insufficiency, neurological complications, intestinal ischaemia and necrosis. Interestingly, prior to the installation of the Dendrite system at the Hospital, data collection was only performed by anaesthetists.

Dr Stefano Salis Dr Stefano Salis However, since its installation surgeons, perfusionists and anaesthetists input data onto the hospital's system - allowing data collection from the hospital's cardiac and vascular departments. This not only demonstrates the inherent flexibility of a system that can be utilised across different surgical departments, but also the system's ability to create an environment in which the analysis and reporting of data becomes easier and clinically meaningful, whatever the specialty.

"The software has significantly improved our ability to perform a comprehensive clinical audit for cardiac and vascular surgery. I think the software is a relatively complex one, and requires a considerable amount of time and commitment to fully use its potential," added Dr Salis. "However, the in-built capability of performing even complex analysis is a great help. Without this software I do not think we would be able to perform clinical audit in such a rigorous manner."

A copy of the 2008 report into surgical activity at the Centro Cardiologico Monzino di Milano, Italy is available at www.cardiologicomonzino.it 

 

British Bifurcation Coronary Study - Old, New and Evolving Strategies (BBC ONE)


Dendrite Clinical Systems helped to design and develop the British Bifurcation Coronary Study - Old, New and Evolving Strategies (BBC ONE), the first web-based interventional cardiology clinical trial in the United Kingdom.

The company constructed a web-based system that incorporated the clinical trial dataset. Although the dataset was quite complex, due to the design of the trial, which compared two procedures, the system was easy to use whether cardiologists or nurses entered data.

Features of the web-based system include:

  • Secure access to the system - recruitment centres are sent a unique login and password, ensuring patient confidentiality.
  • Automatic patient randomisation - once the inclusion and exclusion criteria are completed, a random number generator automatically randomises the patient to a treatment group.
  • Web-based system - once the data is saved, unlike a paper system, it is secure and instantly retrievable.


Dr Hiddick"The web-based system means we could 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," said Dr Hildick-Smith, co-Principal Investigator of the trail (Brighton, UK). "This system allowed us to keep a track on patient randomisation and importantly, ensure centres were adhering to protocol etc."

BBC ONE is a randomised, open label, uncontrolled safety and efficacy Phase III clinical trial, designed to investigate whether a simple (provisional T stenting) or a complex strategy (crush or culotte stenting) is best for the treatment of coronary bifurcation stenoses. Inclusion criteria for the trial included patients aged >18 years who presented with a coronary bifurcation lesion requiring treatment. The exclusion criteria included cardiogenic shock, acute myocardial infarction (MI), additional type C lesion for Rx, platelets Each time a patient was enrolled the PI received an email and could access the record's and check the dataset has been completed. The trial, which started in January 2005, successfully enrolled the last of 500 patients on target in December 2007.

"Compared to the paper system, the web-based system was much more efficient, easy-to-use, simplifies the process and allows instant access to the trial database no matter what your location. If I was asked to run a trial and it was not web-based I would not do it - I would not work with a paper-based system again," added Dr Hildick-Smith.

The BBC ONE investigators announced the results at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2008.

20th March 2008

Dendrite announces the release of the Second National Audit Report of the BAETS

The British Association of Endocrine and Thyroid Surgeons (BAETS, previously the British Association of Endocrine Surgeons) is pleased to announce a new joint publication of the Second National Endocrine Surgery Audit Report, with Dendrite Clinical Systems. This latest publication documents the current status of endocrine surgery in the UK and provides valuable insights into the outcomes and workload of endocrine surgery and it is hoped this will assist in the planning and structure of training programmes for future endocrine surgeons.

"The aim of the Audit is to build a national picture of the practice of various pathologies. By recording the outcomes of investigations, operations and in particular complications, it allows members to compare their outcomes with National data," commented Mr David Scott-Coombes, Director of the BAETS Audit and Consultant in Endocrine Surgery at the University Hospital of Wales, Cardiff, UK. "In addition, by establishing individual workloads, the Audit provides information that we hope will encourage national debates, such as who should be a national training unit and how many centres are needed to undertake surgery for rare illnesses. The audit records the amount of surgical training that individual members provide. This latest report will show that the BAETS is a truly professional body demonstrating its commitment to audit."

Since the launch of BAETS' web-based data entry system in August 2005, some 11,000 endocrine operations have been submitted by BAETS members on surgery to the thyroid, parathyroid, adrenal and pancreas. Prior to the BAETS involvement with Dendrite the audit did not exist. A paper pilot was undertaken, designed by the members of the Executive committee (of the BAETS) that specified the data that the Association wished to be gathered. The BAETS engaged Dendrite to produce the first national audit report from paper-based data collection.

Dendrite proposed the implementation of their web-based registry system and this was commissioned two years ago "The very good news is that Members have taken to the web-based data entry system like ducks to water," he revealed. "It has been so successful that there are very few questions generated to the support staff."

This latest report covers the period from January 1st 2005 to December 31st 2006 and covers the four key surgical areas of endocrine disease; thyroid, parathyroid, adrenal and pancreatic surgery. The 144-page document examines existing surgical practice and reports on current clinical quality, which can be compared with standards set by national guidelines. The ability to record pathology also allows an examination of current surgical practice in benign and malignant disease, as well as participation in modern multidisciplinary management for thyroid cancer.

Key results from the Audit

Included in the publication are the outcomes from 3,804 thyroid operations (approximately one-fifth of the total number performed each year in the UK) submitted by over 70 BAETS members and the report highlights that there is a wide range of workload for thyroid disease. According to the Audit, some 22.5% of surgeons perform five or less thyroid operations per year. Another finding is that thyroid surgery is consultant-led in the main. In relation to clinical data and outcomes, the report records that thyroid malignancy accounted for 20% of all thyroid operations. No fewer than 80% of patients with thyroid cancer underwent pre-operative fine needle aspiration biopsy. Areas for improvement include the fact that only 79% cases of thyroid cancer were discussed at a multidisciplinary team meeting and that the rate of pre-operative vocal cord check for redo thyroid surgery was only 79%.

The analysis for parathyroid surgery includes data from 1,896 procedures submitted from over 50 BAETS members. Again, the reports notes that there was a wide range in workload, with 41% of surgeons performing less than ten cases each year. Like thyroid surgery, parathyroid surgery is consultant-led with evidence of supervised training in one-fifth of operations. The latest analysis has confirmed that BAETS members have embraced localisation studies; although the report highlights that there is some confusion about its role with regard to undertaking a targeted approach for those pathologies, which are themselves an indication for bilateral neck exploration. Overall, a third of operations were targeted. The overall success rate (normocalcaemia) was an impressive 95%. The data indicates that intraoperative qPTH assay and pre-operative localisation improved outcomes. The report also shows that the failure rate for multiple endocrine neoplasia was 20%. The overall mortality was 0.2%.

A total of 27 members submitted data from 317 adrenal operations, with 70% of cases undertaken by eight members and ten member performing two cases or less over a two-year period. Phaeochromocytoma, Cushing's and Conn's accounted for 72% of the pathology, with laparoscopic surgery reported as the most favoured approach, unless the tumour was malignant. The mortality was rate was reported as 0.7%.

In regard to pancreatic surgery insulinoma was found to be the most common pathology, with 70% of operations involving a laparotomy. Unfortunately, there was insufficient data to draw conclusions as only 24 cases were submitted by nine members. It is hoped that an increase in the data will provide more meaningful conclusions over time.

"We have had a fantastic response in terms of numbers of cases being submitted. I think this success in numbers we have is because the data we are collecting is not overcomplicated, but the huge numbers that we are accumulating make the data powerful. The report clearly shows that there is a wide variance in individual workload of members, particularly in the practice of surgery for thyroid cancer," added Mr Scott-Coombes. "The Audit also reveals that there are probably too many surgeons operating on rare diseases. The complication rates are higher than were expected, however this demonstrates honest data collection. Overall, there were good outcomes for parathyroid disease and the evidence clearly shows good training within thyroid and parathyroid surgery. Currently, the data for adrenal and pancreas surgery is still too small to draw many conclusions."

Future goals

It is expected that in the future the dataset can be expanded to create greater clarity on additional issues. For example, distinguishing the primary thyroid pathology from any secondary diagnosis, establishing the indication for thyroid surgery and whether re-do thyroid pathology is performed on the same side as the previous operation. The web-based data entry system will allow a subtle increase in the complexity of the data collected.

This is the second such National Audit and although it has provided a wealth of data, according to Mr Scott-Coombes, there are still areas for improvements. "In order to get good compliance from our members the data that is collected has to be relatively uncomplicated. The feedback that we are giving to individual members is currently rather limited. We are working on a system that will give a more in-depth annual report for each member including comparisons with the National average. Although the Audit is currently anonymous, I think we may slowly lose the anonymity."

Moreover, the Audit currently collects data from members of the BAETS, despite much thyroid surgery being undertaken by non-members. "We have contacted other national organisations (ENT-UK [the British Association of Otorhinolaryngologists] and British Association of Head and Neck Oncologists [BAHNO]) to encourage those members who undertake thyroid surgery to contribute to the audit."

It is hoped that this latest report will be the catalyst for additional research projects as well and to stimulate debate among members that will result in improvements in service delivery, training and adherence to national guidelines. "The next Audit will report on 2006-2007 data. Much of this will be cumulative and will also include the data from the 2005-2006 audit. We will ask members to complete their data submission by April 2009 and hope to produce a report by September 2009. It is my hope that the large numbers of patients included will start to show trends with respect to workload and outcome," he added.

Mr Scott-Coombes also paid tribute to Dendrite: "I have enjoyed a close collaboration with Dendrite, a company that has a proven track-record in medical audit and who tailor the analyses in response to the clinical input. Not only has their support in writing the report has been magnificent, but their staff are both personable and knowledgeable in their field. I believe this type of audit will become more widespread amongst other specialties and I would have no hesitation in recommending Dendrite to other societies and associations."

Dr Peter Walton, Managing Director of Dendrite Clinical Systems, commented: "I would like to thank all the contributors for their efforts and in particular, Mr Scott-Coombes, for his unwavering enthusiasm and collaborative approach. This second national Audit clearly shows the value of national clinical audits. All healthcare systems have finite resources and such assessments can provide data on optimum provision of resources, especially in regard to current workloads and future training. We look forward to working to produce the third national audit with the BAETS in the future."

Press Contact: Owen Haskins
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20th March 2008

Landmark BBC ONE clinical trial completes enrolment.

Dendrite Clinical Systems is pleased to announce that the British Bifurcation Coronary Study - Old, New and Evolving Strategies (BBC ONE), the first web-based interventional cardiology clinical trial in the United Kingdom, has completed enrolment. The trial, which started in January 2005, successfully enrolled the last of 500 patients on target in December 2007.

BBC ONE is a randomised, open label, uncontrolled safety and efficacy Phase III clinical trial, designed to investigate whether a simple (provisional T stenting) or a complex strategy (crush or culotte stenting) is best for the treatment of coronary bifurcation stenoses. Inclusion criteria for the trial included patients aged >18 years who presented with a coronary bifurcation lesion requiring treatment. The exclusion criteria included cardiogenic shock, acute myocardial infarction (MI), additional type C lesion for Rx, platelets Each time a patient was enrolled the PI received an email and could access the record's and check the dataset has been completed.

"This web-based system means we 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," added Dr Hildick-Smith. "This system has allowed us to keep a track on patient randomisation and importantly, ensure centres were adhering to protocol etc."

The development of the web-based system was relatively straightforward. Once the dataset had been established, it was handed over to Dendrite Clinical Systems who constructed a web-based system that incorporated the dataset. Whilst acknowledging that there were some minor teething problems such as page design, establishing the correct definitions etc, Dr Hildick-Smith appreciates the unique set of challenges a web-based clinical trial presents. "This is the first time such a method of data collection had been undertaken and we anticipated there would be some issues along the way. However, once these teething problems were solved the system has performed as well as, if not better than we had hoped. I think the complexity (of the system) surprised me. Due to the design of the trial (comparing two procedures) the dataset was quite complex, with convoluted questions. Having said that, the system is incredibly easy to use whether it is cardiologists or nurses who are entering the data. Once people started using it, although unfamiliar with the concept, the vast majority of the feedback was very enthusiastic and many would use such a system again."

Features of the web-based system include:

  • Secure access to the system - recruitment centres are sent a unique login and password, ensuring patient confidentiality.
  • Automatic patient randomisation - once the inclusion and exclusion criteria are completed, a random number generator automatically randomises the patient to a treatment group.
  • Web-based system - once the data is saved, unlike a paper system, it is secure and instantly retrievable.


"Compared to the paper system, the web-based system is much more efficient, easy-to-use, simplifies the process and allows instant access to the trial database no matter what your location. If I was asked to run a trial and it was not web-based I would not do it - I would not work with a paper-based system again," concluded Dr Hildick-Smith.

"I would like to congratulate the investigators from the BBC ONE clinical trial in completing enrolment and in particular, Dr David Hildick-Smith, for his enthusiasm for this unique project,” said Dr Peter Walton, Managing Director of Dendrite Clinical Systems. “A web-based platform for data collection offers unprecedented access by PIs across multiple sites, allowing real-time supervision of patient enrolment. We hope this is the first of many web-based clinical trials that will utilise our innovative platform."

The BBC ONE investigators are hoping to announce the results at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2008.

21st July 2007

Inaugural cardiac surgery report demonstrates excellent outcomes for Prince of Wales Hospital, Hong Kong

A recent report published by the Division of Cardiac Surgery at The Chinese University of Hong Kong, which is based at the Prince of Wales Hospital, Shatin, New Territories, Hong Kong, has shown that the hospital's outcomes are better than predicted following analyses of all cardiac surgical activity. In addition, the report also states that the division's outcomes additional to mortality are 'excellent', having benchmarked postoperative morbidity against international standards.

"We believe that presentation of our outcomes in an open and 'risk-adjusted' manner has become a fundamental professional responsibility," said Professor Malcolm Underwood, Chief, Division of Cardiothoracic Surgery Department of Surgery, Prince of Wales Hospital. "We have implemented the Dendrite cardiac database system which has provided the necessary electronic record infrastructure to enable us to continuously monitor clinical outcomes. Being able to demonstrate the provision of high quality patient care will always have a high priority in our Department. The Dendrite database and analysis software is fully-integrated with our hospital clinical management system, which ensures flexibility and also opportunity to continually increase the scope of automated data collection and presentation of results."

According to the authors of this first annual report, the publication provides insights into the clinical activity in cardiac surgery, and charts progress in measuring and reporting risk-adjusted outcomes for the Division of Cardiac Surgery's patient population.

By presenting this information on an annual basis, the hospital hopes to ensure that important changes in the nature of disease treatment by cardiac surgery are observed in a timely manner, as well as assuring the community at large that its service quality and outcomes are being effectively monitored along international lines.

The 38-page report details all cardiac surgical activity between 1st November 2005 and October 31st 2006 and includes data analysis on 310 patients records. In order to ascertain how well the division was performing, the outcomes were compared and benchmarked against the National Cardiac Surgical Database report from the United Kingdom (UK).

The report was only possible to produce following the successful implementation of the Dendrite database package. This clinical management system enables the automatic uploading of patient demographic data into the cardiac database, therefore providing an audit trail, which in turn establishes the accuracy and validation of the data collected. Crucially, the clinical management system also incorporates risk stratification algorithms including Bayes and logistic regression models, which allowed clinicians at the hospital to benchmark their results against the UK's National Cardiac Surgical Database. As a result, the authors were able to verify the accuracy of the additive and logistic EuroSCORE in predicting outcomes for the patient population.

The publication shows: 

  • Risk scores suggest the hospital is operating on patients of similar risk to that of populations in the UK
  • In terms of overall activity the hospital performs fewer coronary artery bypass grafting operations and more valve operations than do comparative units in the UK
  • There are few re-operations within the hospitals cohort of patients, which is in keeping with the developing practice of a relatively new unit


Although the report acknowledges that the numbers contained within are small and low mortality mitigate against detailed risk and outcome analyses, the overall performance of the cardiac unit is stated as 'excellent' and the data collected will prove useful for future benchmarking and performance assessment, becoming yet more noteworthy as data accumulates over time.

"The first cardiac surgery report from the Division of Cardiac Surgery at the Prince of Wales Hospital clearly demonstrates the importance of clinical audit as a means of assessing surgical outcomes and ultimately, improving patient care," said Dr Peter Walton, Managing Director of Dendrite Clinical Systems. "I would like to congratulate the authors and contributors of this first report, which is a reflection of the tremendous hard work and team ethic at the hospital."

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