Verteporfin photodynamic therapy for neovascular age-related ...

DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 619Chapter 4Key changes to the protocolThe scope and duration of the VPDT cohort study were atypical. In particular, its longitudinalnature with visits at regular intervals at which retreatment decisions were made, and the factthat many participating sites had to establish VPDT provision, distinguished it from many earliertreatment registries or comparative outcome studies. 43–45 Its set-up also involved negotiationsbetween many stakeholders, namely ophthalmologists at participating sites, the Royal Collegeof Ophthalmologists, SCGs, PCTs and the Department of Health. Consequently, amendmentsto the protocol and the study procedures were required during the course of the study. Theseincluded the submission to the Ethics Committee for a protocol amendment, addition of studysites, revision of the data set and the methods of data collection, and changes to the imagegrading procedures.Protocol amendments submitted to the Research Ethics CommitteeOne formal protocol amendment was approved by the Research Ethics Committee during thecourse of the study.An amendment was submitted for approval in September 2005 requesting approval forfive changes:1. to obtain an anonymised minimum data set for all patients considered for VPDT2. to include presenting binocular visual acuity as part of the data set3. to adopt a modified patient information sheet (PIS)4. to allow nested RCTs as a secondary objective5. to approve one such trial (comparing combined triamcinolone and VPDT vs VPDT only),for which a detailed protocol was submitted.The request for an amendment was rejected because of the amendments describing nested RCTs.The amendment was resubmitted without items 4 and 5 in December 2005 and was finallyapproved in February 2006.The reasons for seeking these amendments were as follows. Patients receiving VPDT in theNHS had to give informed consent for their data to be included. We wanted to describe thecharacteristics of all patients considered for VPDT, by eligibility for treatment and by willingnessto take part in the study, so that we could comment on the representativeness of the studypopulation. We wanted to collect presenting binocular visual acuity (i.e. binocular visual acuitywith a patient’s habitual spectacle correction, rather than BCVA) because we reasoned that thiswas likely to be the visual function parameter most strongly associated with a patient’s selfreportedvision-specific HRQoL. We requested approval to adopt a much simpler PIS becausepatients reported to us that the PIS initially approved (which included possible side effectsof having VPDT) was too complex and discouraged participation. The proposed simpler PISdistinguished procedural consent for treatment (independent of the study) from research consentto use the data collected in the course of treatment.© 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.