Current Portfolio

Current Portfolio

Arthritis and Quality of Life

The arthritis and quality of life study has recruited over 600 patients who were admitted to Ninewells hospital for lower limb arthroplasty surgery. Each participant completed a postal questionnaire prior to surgery and a follow-up questionnaire annually thereafter. The study commenced in 2003 and follow-up is still ongoing.

Thirteen osteoarthritis health outcome measures are used:

(1) American Knee Score (2) Arthritis Impact Measurement Scale Disease Repercussion Profile (3) EuroQol (4) Functional Limitation Profile (5) Harris Hip score (6) Health Assessment Questionnaire (7) Lequesne Hip and Knee Indices (8) London Handicap Scale (9) Oxford Hip Score (10) Oxford Knee Score (11) RAND 36 Item Short Form Health Survey (12) Western Ontario and MacMaster Universities Osteoarthritis Index (13) World Health Organisation Quality of Life Assessment-Brief

This study was conceived and designed as a result of a collaboration between Professor Marie Johnston and Dr Beth Pollard (University of Aberdeen), Dr Dianne Dixon (University of Stirling) and Professor Dieppe (University of Bristol).

What has been our role?

  • Design of a questionnaire to incorporate all of the outcome measures
  • Database and user interface design and programming
  • Data entry, validation and transformation

Recent publication:

Asthma and Allergy

The Asthma and Allergy Research Group, based at Ninewells Hospital, conduct studies to improve the lives of those who suffer breathing problems. Results of patient screening tests are recorded and used to select suitable volunteers for new studies based upon a combination of pre-determined qualifying criteria. A previous outsourced attempt to create an electronic data store and data retrieval application had failed to satisfy the user requirements of the unit and we were approached to salvage the existing data and develop a web application to meet the client’s specification.

What services have we provided?

  • Comprehensive requirements analysis
  • SQL Server database design, build and administration
  • Data transformation and import
  • Design and programming of a web based Crystal Reports user interactive patient search and reporting tool
  • Design and programming of a patient data management website
  • User support documentation
  • Data input and validation

Knee Arthroplasty Trial (KAT)

The Knee Arthroplasty Trial is a pragmatic multicentre study involving 116 surgeons in 34 United Kingdom centers. The 2356 participants were randomly allocated to metal backing or not (409); patellar resurfacing or not (1718); mobile bearing or not (540). Primary outcome measures are the Oxford Knee Score (OKS), SF-12 and EQ-5D. The trial addresses three developments in knee replacement surgery:

  • Metal back tibial component versus non metal back
  • Patella resurfacing versus not resurfacing
  • Mobile bearing versus fixed bearing knee design

Annual follow-up is in place and will continue for at least ten years. The main comparisons at follow-up are between the generic variants of total knee replacement. Data from the KAT study will be used to estimate the costs of each intervention and hence relative cost-effectiveness within each randomised comparison.

The Knee Arthroplasty Trial is funded by the United Kingdom Department of Health via its Health Technology Assessment Research and Development Programme. Additional funding for research support in clinical centres was provided by Howmedica Osteonics, Zimmer, J & J DePuy, Corin Medical, Smith & Nephew Healthcare Ltd. and Biomet Merck Ltd. The Health Services Research Unit is core funded by the Scottish Executive Health Department.

What services have we provided?

  • Recruitment of surgeons and centres on to the trial
  • Interviewing and training research nurses in participating centres
  • Local recruitment of patients
  • Visiting centres to provide support for surgeons and research nurses
  • Clinical coordination of all centres north of Manchester
  • Additional writing team for publications

Smoking Cessation

A Minimum Dataset has been developed to evaluate the Scottish NHS Board (Health Board) Smoking Cessation Services. The client questionnaire incorporates the mandatory core data required for anonymous national reporting of smokers who access the service. Information Services Division (ISD) is responsible for coordinating and reporting on all Scottish data. Tayside has two systems in place to meet this objective:

  • Direct web based data entry into the ISD database

The Clinical Audit Unit is responsible for the data processing and management of the Tayside Smoking Cessation project. Over 400 new clients are enrolled into the programme every month.

What services do we provide?

  • Questionnaire design
  • Online data entry
  • Bespoke database and data entry interface for the pharmacy project
  • Coordination of follow up questionnaires as per the protocol
  • Provide local analysis and reporting, as requested

Surveillance of Hospital Acquired Bacteraemia

The Surveillance of Hospital Acquired Bacteraemia pilot started in October 2000. The pilot targets all patients admitted for total hip arthroplasty surgery, knee arthroplasty and hip fracture. The objectives of the surveillance are to:

  • Provide hospitals with definitions and surveillance methods for monitoring hospital acquired bacteraemia
  • Estimate the incidence of hospital acquired bacteraemia
  • Provide data on hospital acquired bacteraemia suitable for comparison within the hospital and within aggregated anonymised data from other institutions
  • Enable participating hospitals to identify areas where hospital acquired bacteraemia could be reduced by appropriate infection control methods
  • Identify trends in bacteraemia rates, causative organisms and other antibiotic resistance patterns
  • Enable participating hospitals to detect clusters or outbreaks which may require further investigation

The feedback of results will be confidential and in a format which is useful to participating hospitals. This information will allow each hospital to compare their results over time with anonymised aggregated data from similar hospitals that have participated in the same surveillance.

Tayside Arthroplasty Audit Group (TAAG)

TAAG provides a mechanism for monitoring the outcome of arthroplasty surgery in Tayside. All patients admitted for primary total hip arthroplasty, primary total knee arthroplasty, hip resurfacing, uni-compartmental knee replacement, revision hip and revision knee surgery are encouraged to participate. Baseline information is collected by independent practitioners (trained physiotherapist or nurse) in each participating centre in Tayside (Stracathro, Scottish Regional Treatment Centre, Ninewells, Fernbrae and Perth Royal Infirmary). Patients are then followed up for the lifetime of their prosthesis according to the study protocol.

The Harris Hip Score and Knee Society Score are used as standard outcome measures. Short and long-term complications are recorded as well as patient satisfaction. Any highlighted problems are fast tracked back to the operating consultant. Local performance benchmarks have been agreed by the TAAG steering group. The TAAG steering group consists of the Clinical Director of the Tayside orthopaedic unit, the Clinical Governance Chairperson and the Clinical Audit Services Manager.

What services do we provide?

  • Protocol design
  • Training all centres to collect data as per the study protocol
  • Designing and provision of case report forms
  • Database and user interface design and programming
  • Date entry and validation
  • Data selection, extraction and analysis
  • Provision of annual reports to each participating surgeon detailing individual versus group results
  • Identifying trends and outliers (those surgeons that have not met local benchmarks) and highlighting these to theTAAG Steering Group

Previous Global Outcome Studies

The Clinical Audit Unit has coordinated post-market surveillance for two medical device companies, Zimmer Ltd. and Smith and Nephew. Independent collection and analysis of data is critical to the credibility of the product appraisal process. The performance of specific medical devices were monitored and these included total hip replacement and total knee replacement systems. Each participating centre employed trained independent practitioners to collect the data according to one protocol. The data was then sent to the Clinical Audit Unit for data input, validation, analysis and outcomes reporting.

Zimmer Ltd

The first medical device to be monitored was the IBII knee system in 1990. Studies went on to incorporate the NexGen and Mobile Bearing Knee systems, the Collarless Tapered Hip and the VerSys and ZMR hip systems.

Pre-operative baseline information, operation details and acute stay complications data was collected. All patients were subsequently invited to attend review clinics where outcome measure information was recorded. Centres from 40 + countries participated, enrolling over 30,000 knee patients and more than 7,000 hip patients. Data was collected pre-operatively and at 1, 3, 5, 7 and 10 years post-operatively.

Smith and Nephew

This was a post-market surveillance outcome study of the Profix knee system with nine participating UK centres. Again, as this study was co-ordinated by the Clinical Audit Unit, the data could be independently collated, input and analysed. 1500 knees were included and up to 5 year follow up data was available for analysis.

Which services did we provide?

  • Multi-site coordination
  • Case report form design and supply
  • Bespoke database and user interface design and programming for each study
  • Manual data entry and validation
  • Local web based data entry for participating centres
  • Production and distribution of annual reports
  • Online reporting system
  • Presentation of results at international conferences