Frequently Asked Questions
In response to queries received by the steering committee and lead investigators we have prepared these questions and answers which we hope will be helpful. They should provide you with the necessary information to make progress with service implementation. This FAQ has been also published in the first Issue of the VPDT Newsletter
Q: My PCT say they will not fund the data collection for the cohort study
A: The Department of Health (DH) has informed the cohort study team that all commissioners have signed up to the cohort study. The DH has also written to commissioners clearly stating that the cohort study is the vehicle through which patients will access PDT services in the NHS.
Q: What are the costs of data collection?
A: These costs were calculated using NHS reference costs for the appropriate staff grade. The costs of collecting the minimum data (best corrected acuity and standardised stereo angiography) and submitting the data to the DMC and the angiograms to the Central Angiographic Resource Facility (CARF) in Belfast are around £35 per patient visit. The costs of collecting the extended dataset (contrast sensitivity and completing the patient centred outcomes questionnaires) adds an extra £5 to £10 per visit. Thus cost of participation in the cohort study is of the order of £50 extra per visit per patient. Work out the activity of your centre and insist on staff appointments to allow you to collect the data.
Q: How do I know whether I am a preferred provider of PDT services?
A: All but a few PCTs have agreed who their PP will be on the basis of business cases that have been submitted by the ophthalmic units/Trusts. The team at the Data Management Centre (DMC) based in the London School of Hygiene have an up-to-date list of PP's that have been confirmed. If you think you are PP but have not already been contacted by this team please contact them immediately ( see page 4 for contact details).
Q: How can I get over the delays with the introduction of PDT?
A: It is important to realise that there are many steps in the process and managers at all levels can delay or obstruct progress. Key players are colleagues, Clinical Directors, directorate management, trust management, PCT managers and commissioners. We believe that all commissioners are on board and so that delays or inaction are occurring in the steps between the lead clinician and the local commissioner. Centres that have got going fastest have set up a project management team to include the lead clinician, service manager, Clinical Directors, director of finance and local IT lead. If you are having trouble getting clear information the best contact is with your local commissioner so that you are copied in or involved in all key decisions. We can provide support if needed via the National Commissioning Team lead by Julia Stallibrass.
Q: My Trust tells me that they won't appoint staff to allow me to deliver the service. How can I get round this?
A: You will need to agree with your trust a phased introduction. You shouldn't start until this is agreed. The Trust will be under pressure to provide a service as their PCTs will be funding it. This is your best lever and should not be given away lightly. As the service develops additional staff should be appointed including consultant sessions. Many colleagues have been pressured into fitting PDT into their existing activity and being "corporate" by helping the trust overspend. Again contact with the commissioners will help to deal with this obstructive tactic.
Q: I really can't be bothered with the cohort study. What are the advantages of the study?
A: We realise that there is much frustration with the delayed introduction of PDT. However it is worth remembering that the Department of Health has insisted on a monitored introduction of PDT. However there are several important benefits for ophthalmologists which make it worth committing to the funded development of PDT and AMD services: - patients get access to a quality assured service; - a large increase in funding for medical retina services in the UK; - a major advance in the standard of eye care across the UK; - the development of a network of investigating centres;
Q: What is the management structure of the cohort study
A: The cohort study is managed by the Steering Committee who operate under the aegis of the Royal College of Ophthalmologists. The Chairperson is Nick Astbury (President). In his absence the committee is chaired by David Wong (Chairman Scientific Committee, RCOphth). Usha Chakravarthy is the Chief Investigator and Simon Harding and Barney Reeves are co-investigators. The Data Management Centre (DMC) is located in the London School of Hygiene and Tropical Medicine (Barney Reeves is in charge). The Central Angiographic Resource Facility is located in the Queen's University of Belfast (Professor Chakravarthy is in charge). The sponsor of the study is the Royal Group of Hospitals at Belfast.
Q: What about ethics approval?
A: The cohort study has been approved by the Metropolitan MREC. Only one LREC approval is needed for hospitals within any one Strategic Health Authority (SHA) with one nominated clinical lead. All other investigators in one SHA should be listed by name in the LREC application. If you have any queries please contact the DMC (see Page 4).
Q: What about NHS R and D?
A: Part D of the NHS Research Ethics form must be completed and submitted to your hospital R and D Department. Provided your business case has been accepted by your PCT, your hospital should not raise any objections and should provide you with the completed documentation that you will need for full participation.
Q: What data should I collect?
A: Full details on the cohort study methods and data collection are to be found in the CD-R accompanying this newsletter. Some centres have been nominated to collect the extended dataset and these are listed in the newsletter. If your centre has been nominated, contact the PDT lead in your PCT to ensure that you will be appropriately recompensed for this data collection.
Q: How do I get the database up and running?
A: You should have the database installed by now. If not then contact Michele to arrange an installation date (see page 4 for contact details). There are still a few problems but the latest version number 2.04 seems to be working well. The database can seem unfamiliar but you will quickly become familiar with it. It is difficult to replicate on paper and is much more effective electronically.
Q: I can't use the database in my clinic. How can I collect data on paper?
A: We have prepared paper forms (see enclosed CD-R). However, if at all possible, please do try to use the database because the structure of the database (which requests different information depending on earlier responses) cannot be exactly reproduced on paper. The current paper forms cover the first two visits (like a CRF in a randomised controlled trial). Please print out a whole set (pp.8) and staple the pages together, then make sure that the booklet is kept with the patient's case notes. We need your views on the forms so that we can improve them. Once we have a version that people are satisfied with, we will print booklets and send them to you.
