UK Cystic Fibrosis Database
| Role of National Team | Strengths of the Database
We have been commended for the level and quality of support we provide for data managers and Centres throughout the UK. This falls into the following areas:
- Customised training in Dundee for data managers and clinic personnel who are new to the Database
- Customised training in Dundee for data managers and clinic personnel who are familiar with Microsoft Access97 and wish to use their Database to design and perform their own tailor-made interrogations on the data.
- Training days for groups of clinic staff
- Telephone support for clinics experiencing difficulties with the Database
- Software support
- Verification of data returns and notifying clinics of errors for correction in order to maintain the quality of their data
Dr Anil Mehta Director 01382 633958 Mrs Margaret Fraser Data Quality Manager 01382 633919 Mrs Sheila Krawczyk Database Administrator 01382 633958 Mrs Gita Mehta Project Manager / Coordinator 01382 632596 Dr Erika Sims Research Fellow 01382 633958 Dr Jonathan McCormick Clinincal Lecturer 01382 633958
UK CF Database
Maternal & Child Health Sciences
University of Dundee
Ninewells Hospital & Medical School
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Technical manuals and guides
- Growth & Lung Function Equations
- Database manual Version 1
- Database manual Version 2
- Analysis Tools Volume 1
- Analysis Tools Volume 2
- How to complete Database forms
- Correcting Errors on UKCF Database
- Form Filling - General Hints
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A typical clinic implementation
It can been argued that the success of the national CF Database depends to a significant extent on the efficient implementation of each and every participating clinic. This can be divided logically into two stages. Firstly, getting the clinic software ready for issue, and secondly, training and on-going verification procedures to ensure data remains of a high standard.
The national team liaises closely with clinic staff before the clinic software can be dispatched, with all the patient data being double-checked, the software licence signed and a dedicated computer of a standard specification issued to the larger centres. The rate limiting step is the availability of sufficient ring fenced resource within a given clinic to perform this initial task. The figure below summarises the various stages in the process and the key activities performed by each group.
Clinic Tasks Steps to a Successful Implementation National Tasks Complete Clinic Registration Form Register Clinic Register clinic and allocate clinic code Complete a Registration and Biography Form for each patient in clinic Register Patients Generate patient numbers & ‘sticky labels’ and send to clinic Confirm patient lists are correct Quality Check Double-check data accuracy Sign software license Licensing Issue software license for signature Set up computer – stand alone and dedicated to Database use Hardware Order PC of standard specification for clinic Install Database on PC Software Configure Database software for clinic Commence training phase - enter clinical data in batches of 20 patients and submit for verification User Training Verify data from clinic and provide training and software support
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Once the software is successfully installed on a clinic computer, it is the responsibility of clinic staff to maintain an up-to-date list of patients and their clinical details. At regular intervals, ideally in batches of about 30 patients, electronic data is transferred to the national team, along with a copy of the paper form, for verification and subsequent merging with the national Database.
The national verification procedure is comprehensive and rigorous. As it is helpful for clinics to receive feedback on data quality as rapidly as possible, every effort is made to return the verification error log within a week, and at most within two weeks, of receipt of the data by the national team.
- The paper forms are counted and checked against the number of new records entered in the Database to ensure that all new data has corresponding forms and can be verified
- The verification and error log generated from the previous transfer is checked to ensure those errors have been actioned by the clinic
- For all the new data submitted, every field on every form is checked for consistency between the paper form and the electronic record. All discrepancies are logged by patient ID number and visit date.
- Several exception reports (also available to clinics) are run. These list
- Height, weight and BMI outside 3 standard deviations of the norm
- Lung functions outside the range 5% predicted - 135% predicted
- Forced Expiratory Volume (FEV1) greater than Forced Vital Capacity (FVC), which implies an inaccurate reading
- FEV1 equal to FVC, which implies poor technique or severe disease
- Patients with incomplete clinical data such as missing Annual Reviews or Snapshots
- All records highlighted are notified to the clinic for correction or confirmation of accuracy in the event of a particular patient being genuinely outside the normal range
- An error rate is calculated for the number of patients with inaccurate data as a percentage of the number submitted for verification for both Annual Reviews and Snapshots
- A verification summary sheet, listing the error rate and any recurring errors (e.g. misinterpretation of forms), is returned to the clinic along with the detailed annual review error log and snapshot error log for them to action as necessary and return with their next data return. Occasionally, this is followed up with a telephone call to clarify a particular aspect of the Database or the data entry process.
Experience has shown that the initial data return for a clinic has a very high error rate, typically 75% or higher. This drops to about 20% within three data returns. Once clinic personnel are fully trained in the use of the Database, the error rate stabilises at approximately 5% - 7%. The most common source of error lies in badly completed paper forms and the importance of getting this correct is emphasised from the very outset. A list of common errors is circulated to all clinics, with those occurring most frequently in their own data identified separately. In addition, errors or omissions on the paper forms are highlighted and returned with a short explanatory “post-it” note affixed next to each one. While this level of error checking and training is onerous and time consuming at the beginning, it has proved to be a very thorough and ultimately cost-effective method of training clinic personnel to complete the data to a consistently high standard.
If either clinic staff or the national team feel it would be beneficial, clinic personnel are invited to a training day at the national centre. As clinic teams encompass a wide range of skills and computer-literacy, training on such occasions is customised for the needs of the individuals attending. In addition, more general training days for groups of clinics are held on an ad hoc basis when it is considered helpful to introduce or explain some aspect of the Database.
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The role of the national team
The most important role of the national team is to maintain the UK Database and take the necessary steps to ensure its accuracy and completeness. To this end, it undertakes the following activities:
Maintaining the quality of data in the national Database
- Verification of all data returned from clinics, as described above. Only data that passes the stringent quality checks is merged into the national UK Database. Data for a complete calendar year is merged in March of the following year.
- Maintaining the integrity of data within the UK Database. Once all the data is merged, it is the task of the national team to ensure the UK data is robust, complete and accurate. There are several aspects to this quality control:
- Patients registered in different clinics are cross-checked for consistency of information
- Patients registered with slightly different details in two clinics are identified and the respective clinics notified
- Clinical details are collated for shared care patients to ensure a patient is not “seen” twice for Annual Review in a year
- Patients who have been “missed” are identified as are patients with incomplete details and their clinics notified
- Completeness of each clinic’s data is calculated to ensure that all their patients are being reported
- Numerous checks are done on data quality across the Database in conjunction with the individual clinics where possible errors are identified
- Duplicate records as a result of merging clinics are identified and stripped out
- Patients who have transferred or died are checked to see that they are identified as such
- Patients who have requested that their information be excluded from the Database have all records relating to their ID number deleted
Assisting with data entry for clinics
It rapidly became apparent that almost all clinics experience resource difficulties at some time due to staff turnover thereby accumulating a backlog of paper forms. They are unable to maintain their Database for themselves and this leads to a degradation of data. In such cases, the central team, by prior arrangement, maintains the Database for them until such time as they are able to resume this function. A copy of the entire Database is returned to the central team and all completed paper forms are forwarded to them for entry. Depending on individual clinic circumstances, data entry centrally has continued for between 2 and 18 months. This one-off service has proved to be of great help to clinic staff by allowing them to “catch up” and has invariably led to data continuing to be of a high standard as clinic personnel have concentrated their efforts on the gathering of good data on paper forms.
Certain other clinics, while willing to participate in the Database, have not the resource to allocate to data entry. Such cases are few and far between, as most clinics perceive a benefit to themselves in having their patients’ data available to them locally. In such cases, the clinic’s Database is maintained entirely by the central team. However, the clinic is able to request their Database to run on their own computers at any stage if they feel it would be helpful to them.
Software development and support
Accurate data is contingent upon user-friendly computer software for both data entry and analysis. Feedback is encouraged from all clinics using the Database regarding further enhancements to the software. User requests were recently incorporated into an upgraded version 2 of the programs and this has been implemented in all clinics. As requests for newer features continue to be made, these are collated for inclusion into a subsequent version 3. Furthermore, if clinic staff are familiar with using Microsoft Access, assistance is provided with building customised queries which may not be available in the standard issue of the software.
Support is also provided to all clinics if they experience difficulties with the existing software or hardware. As all clinics have been issued with computers of the identical specification with only the Database software installed, it is relatively straightforward to identify and rectify faults with telephone support alone. In the rare cases where this is not possible, the entire Database is returned to the central team, the errors fixed and the Database returned to the clinic for reinstating on their own computer.
All computers were issued with the manufacturer’s 3-year on-site warranty in the event of hardware failure.
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Strengths of the UK CF Database
Strengths of the UK CF Database Clinically useful As clinics find the Database useful to them, they maintain accurate information for their own patient monitoring and audit requirements Operational flexibility The Database model is adaptable for several modes of clinic operation, e.g. Regional Centres, peripheral clinics and clinics that only complete paper forms Comprehensive training Customised and on-going training via the data verification process ensures that data quality is maintained to a high standard, irrespective of staff turnover Central data entry facility The facility to request temporary help with data entry ensures clinics are able to handle most short term contingencies without impacting on quality Readily accessible support As software support is readily available at the end of a telephone, clinics seldom experience great delays in their work as all problems are swiftly resolved Dedicated ring-fenced staffing The funding of the Database at a clinic level ensures that trained staff are responsible for the Database with consequent improvement in quality Rapid verification of clinic data Rapid tun-around times for verified data help local clinics to correct errors and omissions while the information is still readily available (e.g. via patients’ notes) Comprehensive UK-wide information All participants are agreed that a key strength of the system is the amalgamation of country-wide data that is available for audit and research
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Page Last Updated: 2 April 2010