UK Cystic Fibrosis Database

Background

History | Data Protection | Data Entry Software | Analysis Tools | Sample Database Forms

Cystic Fibrosis (CF) is an inherited disease that induces long term morbidity leading to multiple medical consultations. CF patients, in common with those with suffering from any other chronic disease, are widely dispersed throughout the United Kingdom. 5% of the population are carriers of the affected CF gene and there are over 1000 mutations producing clinical disease. The result is that the current 7500 or so patients in the UK present with a range of symptoms and degrees of severity of their condition, requiring therapies tailored to their specific needs. For any individual Regional CF Centre, the absolute numbers of patients seen remains relatively small. A medium sized Centre typically treats 50 to 75 patients a year, with a small number of ‘tertiary’ CF Centres seeing 200 patients or more. In terms of accumulating sufficient information to audit and research the disease and its natural history, it became rapidly evident that some means of recording, collating and analysing data from all the CF Centres was required. The UK CF Database was developed to meet this need. With over 7000 patients registered, it is now operational in all Regional CF Centres in the country, recording clinical data on an ongoing, annual basis.

 

History

• Started in 1992 as a project to audit the health of CF patients in Scotland
• In 1999, it was extended across the UK, with customised software running on computers in Specialist CF Centres and peripheral hospitals
• Funded in 1992-1994 by the Clinical Resource and Audit Group, and since then by the National Services Division of NHS (Scotland), to report on Scottish CF patients
• Funded since 1995 by the CF Trust

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Data Protection

• Patient anonymity is a key feature of the UK CF Database. For each patient, the software generates a secure, non-reversible ID number from time-invariant details such as name at birth, day and month of birth etc. Only those with a “need-to-know” are aware of the identity of individuals. Clinic staff who are in this category are thus able to use their local Database to assist in the treatment of their patients, whom they are able to identify by name. The national team receives only data tagged by the anonymous ID number that enables audit and research while at the same time guarding the identity of the individual
• Comprehensive information about the Database, including all uses of the aggregated and anonymised data is provided to patients. Informed consent, or indeed refusal of consent, is requested and stored in the patient’s clinic. Over 99% of patients give their consent for their information to be included in the Database.
• The Database was commended as an example of “excellent practice” by the Data protection Compliance Manager (Health) at the Data Protection Commissioner’s Offices.

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Data Entry Software

The software of the UK CF Database can be broadly divided into two categories: data entry and the Analysis Tools. In addition, users familiar with Microsoft Access are able to define their own interrogations and queries for their data.

The major modules within the data entry software are the following:

• Patient Registration. This is the first of two stages for registering a new patient with the Database. Its purpose is to generate the unique identifier. Time-invariant patient information (e.g. day and month of birth, legal family name at birth etc) is entered into the program and a unique patient ID number is generated. The number is carefully constructed so that it will always be unique for a patient, irrespective of where or how often it is requested. This ensures that the same unique number always remains with the patient even if he subsequently moves to, and is registered in, a different clinic, or multiple clinics. Another important feature of the number is that due to the algorithm employed, it is not easy to reverse-engineer the patient details from the number. Hence, outside the patient’s own clinic, his identity remains anonymous. A sheet of ‘sticky labels’ is produced containing the number and henceforth only these labels are used for identifying the patient on all subsequent paper forms and for updating the Database.
• Patient Biography. This form completes registration. Details enabling statistical analyses (e.g. year of birth, sex, genotype etc) are entered for the patient’s allocated ID number. Only when these details are complete can clinical data can be entered against his number.
• Annual Reviews. Details of annual reviews are entered by clinic staff. A three-page form is completed prior to data entry. Approximately two-thirds of the form can be completed from the notes prior to seeing the patient in clinic and many clinics choose to do this as it takes about 25 minutes and provides an up-to-date history of the patient over the previous twelve months. The remainder of the form is completed in clinic and should take a further 5 minutes. The software mirrors the paper form exactly thus speeding up the data entry process, which takes no more than two minutes after training.
• Clinic Visits / Snapshots. This offers a choice to clinics with respect to the frequency of on-going data collection. Details of clinic visits are entered by clinic staff. A one-page form is completed, again prior to data entry. Completion of the form in clinic should take 5 to 10 minutes per patient, with a further half a minute to enter it into the software. While a minimum requirement of the Database is that at least one clinic visit form is completed per patient per annum, many clinics choose to complete one every time the patient is seen (on average 4 times a year). This has the advantage of permitting the clinical team to monitor key outcomes such as lung function, growth, short term and long term drugs, bacteriology and hospital admissions. An especially adapted clinic visit form permits its use as a clinic record as well as a Database form, thus simplifying the record keeping process.
• Amend patient status. The software maintains a list of “Active” patients by updating details for those who have been transferred, died or had their diagnosis of CF reversed.
• Reports. Several reports are available showing clinic and patient summaries. Data checking reports are also available highlighting possible errors for clinics to confirm.
• Data transfer. The data transfer feature copies a subset of the patients’ data (Biography, Annual review and Clinic Visit), tagged only by the anonymous patient number to a specially encrypted and password-protected file on zip disk. This disk is then posted to the national team.
• Data Backup. This copies the entire Database, encrypted and password-protected if requested, to a zip disk. This is used by clinics to keep backup copies of their data in the event of a hardware or software problem.
• System functions. Several system functions are available such as setting and deleting passwords, amending user permissions and authorising code-driven access to data tables for use by the central team when required to provide software support over the telephone.

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Analysis Tools

The Analysis Tools are tailor-made for cystic fibrosis in general, and the UKCF Database in particular, and allow the user to produce reports and graphical summaries about many aspects of cystic fibrosis such as clinic audit reports and graphs to monitor treatment and care of individual patients.

• Audit reports. A menu-driven, user-friendly interface permits the creation of audit reports for the most clinically relevant data in the Database. The first stage identifies which graph is required e.g. percent predicted lung function, Body Mass Index etc., and whether it should be restricted to children, adults or all patients. Output is available showing either total numbers of patients or percentages. The second stage permits further refinement of the data presented e.g. whether it is required to be split further by one of several options (age groups, infection etc), which year is required for analysis, whether percentiles or standard deviations (Z-scores) should be used for height/weight/BMI graphs and so on. Once all the selection criteria have been specified, a graph is displayed with the facility to change its display characteristics (e.g. histogram/line graph, changing the colours used etc) and save either the graph or the underlying table of data to a Word document, PowerPoint presentation, Excel spreadsheet or bitmap file.
  
  

• Patient tracking. This module permits the progress of individual patients to be tracked with respect to bacteriology, short term and long term drugs, hospital admissions and graphs for growth and lung function. A simple print facility allows the output to be printed for filing in the patient’s notes.
• Another facility provided is the ability to analyse the completeness of the data in the Database. E.g. the user may check which of their patients have not visited the clinic sufficiently often during the year. Another option shows if the visit record is being filled in correctly – e.g. if the patients height/weight is being recorded. This is done via the 'Unknowns' Analysis.
• These tools run on the local clinic machines, providing all clinics with the facility to audit their clinic and monitor the progress of their patients. Comparisons with national data are facilitated as all clinics are therefore able to generate their own data to compare against the national report.

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Sample Database Forms

There are 4 forms used to collect the data. Samples of these can be downloaded below.

• Patient Registration
• Patient Biography
• Clinic Visit Form
• Annual Review Form :
  • Page 1 of 3
  • Page 2 of 3
  • Page 3 of 3

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