Verteporfin photodynamic therapy for neovascular age-related ...

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106 Appendix 16. Background data collection on the first, ‘screening’ visitAll background / baseline data form part of the minimum dataset. The precise way inwhich patients are screened for PDT treatment will vary in different DPs; Figure 2shows schematically the path that we expect patients to follow and illustrates variedreferral routes. Our intention is to capture these background data for all patientsconsidered for PDT treatment, i.e. including patients who have been referred for PDTbut who, on subsequent examination in the PDT clinic, are found to be ineligible. Insome DPs, the visit on which eligibility for treatment is determined may be the samevisit on which the first PDT treatment is given. The data include the patient’s:• Administrative and demographic information; the patient’s name, date of birth,address and postcode, consultant, hospital number.• Referral pathway; source and date when referred from primary care, consultationwith any ophthalmologist en route to the DP, and any delays in referral. (Referralpathways involving the private sector may be complicated. After an initial privateconsultation, patients may be referred from the private sector to an NHS DP, or toa private centre, for PDT treatment; patients may also transfer from private toNHS DPs as the latter become established. The study aims to collect theminimum dataset in the private sector as well as the NHS, but establishing datacollection in the NHS is being prioritised.) Note that these details may not bedocumented routinely in the medical notes or correspondence accompanying areferral; the ophthalmologist responsible for a patient will usually need to ask thepatient for this information.• Symptom history, ocular comorbidity, visual acuity and diagnosis at the time ofreferral, any previous treatments and details of important confounding factors, i.e.smoking history, family history of AMD, cardiovascular comorbidity, use of statins.• In DPs collecting the extended dataset, contrast sensitivity should be documentedand the quality of life and resource use questionnaires should be completed by /administered to patients at the screening visit whether subsequently treated,observed or ineligible. (NB. Questions 1 and 2 of the resource use questionnaireshould not be asked at the screening visit, see Appendix 10.)For additional details about background data collection, please see the database userguide and the database itself. Information about how to complete the database fieldsrequired for the minimum dataset will be provided during on-site training.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 61077. Clinical data collection on the first and subsequentvisitsThe following clinical data must be collected for all patients on all visits:• The patient’s presenting binocular visual acuity (BDVA) must be recorded first,prior to carrying out a refraction or testing the monocular distance visual acuity(MDVA) in each eye separately. The patient’s BDVA should be recorded usingchart R (see Appendix 5, section 7) with the patient wearing the distancespectacles that they usually wear. The number of letters read should be recordedin the relevant box on the duplicate form provided for recording BDVA (and in thedatabase). Recording of BDVA is very important for interpreting the QoL data.• Monocular distance visual acuity (MDVA); MDVA must be assessed usingETDRS logMAR visual acuity charts (see Appendix 5, section 1), with precisedetails of the letters seen/not seen on each line being recorded on the duplicatepaper form supplied by the Data Management Centre. The top copy of the formshould be retained and be placed in the patient’s notes. The duplicate copyshould be sent to the Data Management Centre. The protocol for MDVAassessment is described in Appendix 5. Note that it is essential to record thedate of assessment and the patient’s hospital number on the form. Details of thesupplier of ETDRS charts can be found in Appendix 5.• A full refraction protocol is encouraged at every clinic visit, but must be done atthe screening visit, the visit when a patient is first treated (0 months), and yearly(12, 24 and 36 months). On other visits, it is acceptable to record MDVA using thetrial lenses of the prescription most recently used for vision testing.• The DMC provides duplicate (no-carbon-required) paper forms for recording thenumber of letters read on each line when testing MDVA. The second, ‘flimsy’copies of the completed forms must be forwarded periodically to the DMC.© Queen’s Printer and Controller of HMSO 2012. This work was produced by Reeves et al. under the terms of a commissioning contract issued by theSecretary of State for Health.
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Page 98 and 99: 84 References16. Stelmack J. Qualit
Page 100 and 101: 86 References49. Guymer RH, Chiu AW
Page 102 and 103: 88 References83. Margrain TH. Minim
Page 104 and 105: 90 Appendix 1THE VERTEPORFIN PHOTOD
Page 106 and 107: 92 Appendix 11. Overview of Manual
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Page 110 and 111: 96 Appendix 1more patients in the v
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Page 124 and 125: 110 Appendix 1The Verteporfin Photo
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FeedbackThe HTA programme and the a
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