Verteporfin photodynamic therapy for neovascular age-related ...

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12 MethodsTABLE 3 Schedule of visits and tests for the VPDT cohort studyActivityScreeningvisitMonth0Month3Month6Month9Month12Month15Month18Month21Month24Minimum data setInformed consent üClinical historyüRefraction a ü ü ü ü üBDVA in the study eye ü ü ü ü ü* ü ü* ü ü* ü üBinocular distance visual ü ü ü ü ü* ü ü* ü ü* ü üacuity with habitualcorrectionOphthalmic exam üStereo colour photographyand angiography c,d ü ü ü ü ü* ü* ü* ü* ü* ü* ü*Month36Extended data setContrast sensitivity test(Pelli–Robson)Quality of life and resourceuse questionnairesü ü ü ü ü üü ü ü ü ü üBDVA, binocular distance visual acuity.a Protocol refraction was encouraged at every visit, but had to be done at the screening visit, the first treatment visit (month 0) and yearly.b Presenting BDVA and BCVA measurements were recorded at every clinic visit; MDVA had to be recorded using forms showing the number ofletters read on each line and copies returned to the co-ordinating centre.c Stereo colour photography and angiography had to be performed at month 0 and at every visit until the treated eye was considered to befree of leakage on two occasions or until treatment has been stopped for clinical reasons. Photography and angiography were mandatory attreatment-related visits.d In years 2 and 3, stereo colour photography and angiography were required on at least one visit, but timing was not critical if the angiographywas not treatment related.The screening/baseline visit and ‘month 0’ were sometimes the same visit if a patient was treated at the screening visit. Three-monthly clinicalvisits, with distance visual acuity (BDVA and MDVA) checks, were mandatory up to 6 months after the first PDT treatment in all treated patients.Three-monthly visits were also required in all patients continuing to receive treatment. For patients who did not continue to receive treatment,6-monthly assessments were required, for example at months 12, 18 and 24 if no treatment was given after month 6. Given that the schedulingof visits after 6 months depended on whether or not a patient was treated, some later visits (with asterisks) could not be specified definitively.The study aimed to collect data for all patients who were referred to a participating VPDTclinic and who gave consent for their data to be collected. This population included those whowere subsequently found to be ineligible for VPDT treatment, so that an accurate estimatecould be made of the proportion of all referrals who were subsequently found to be eligible fortreatment. This proportion, and the way in which it changed over time, was of interest because ofuncertainty about the ability of referring practitioners to diagnose CNV lesions that were eligiblefor treatment. With experience and training, we expected the proportion of referrals found to beeligible for treatment to increase.At each patient visit, data had to be collected on BCVA, any VPDT treatment given, ARsresulting from VPDT treatment given at the current visit and any AE possibly resulting fromVPDT treatment given at the previous visit. Demographic and referral data were also collected atthe patient’s first clinic visit.Imaging of the fundus of the eye was carried out at each clinic visit, yielding colour images andFAs. Grading of these images was co-ordinated by CARF (see Network of Ophthalmic ReadingCentres in the UK) and the resulting data then had to be transmitted electronically to the LondonSchool of Hygiene and Tropical Medicine (LSHTM) and linked with all other data.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 613EdinburghManchesterBirminghamLondonFIGURE 2 Map of the UK showing sites which participated in the VPDT cohort study. Sites shown as open circles wereselected to collect the extended data set, including contrast sensitivity, HRQoL and resource use.Based on a previous postmarketing surveillance study sponsored by the manufacturer ofverteporfin (Novartis), the cohort study adopted a strategy of requiring ophthalmologists,optometrists, nurses and administrative staff to collect and enter data in the course of providingtreatment at each PDT clinic. It was felt that this approach would maximise data quality, reducethe burden of data collection upon a small number of individuals and avoid the need foradditional staff to be appointed.The information technology (IT) strategy for data collection required a robust, networkedmethod of electronic data entry at each site. When the strategy was planned in 2003, web-basedmethods of longitudinal data collection were not easily available at a reasonable cost and this,combined with the complexity of the clinical data being recorded, meant that a database installedon the local network within each hospital was the preferred solution to allow data entry atmultiple points of care. Participating sites were provided with a copy of a uniform MicrosoftAccess (Microsoft Corporation, Redmond, WA, USA) database developed by a third party. Thisdatabase was a modification of the database used for the previous postmarketing surveillancestudy. Where possible, the database was installed on the hospital network. A minority of theinitial 30 DHs had taken part in this study and were familiar with the database.© 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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90 Appendix 1THE VERTEPORFIN PHOTOD
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FeedbackThe HTA programme and the a
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