Verteporfin photodynamic therapy for neovascular age-related ...

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20 Key changes to the protocolThese amendments did not alter the overall study design, the setting, the eligible studypopulation or the outcomes.Changes to study procedures relating to participating sitesAs the study progressed, more hospitals were designated to provide VPDT. At the start of thestudy, because of the novel and complex nature of the treatment, there was professional concernto restrict the provision of VPDT to designated centres in which specified doctors and otherpersonnel had been accredited by attending appropriate training, provided by the Royal Collegeof Ophthalmologists. As time passed, this policy became more difficult to sustain because ofthe inconvenience to patients in sparsely populated geographic areas. Some hospitals, togetherwith their commissioning PCTs which wanted the hospitals to provide VPDT, were unwilling toparticipate in the study. Unfortunately, despite the fact that policy-makers provided a lot of theimpetus to carry out the study, there was no NHS directive requiring centres to participate. It alsobecame clear at quite an early stage that participating sites were not complying with the follow-upschedule; this required the principal investigators to adapt the planned statistical analyses.Collection of additional predictors of visual functionThe data set being collected for the study was reviewed after 12 months. Because of evidenceabout the influence of other factors on BCVA, the Steering Committee accepted therecommendation of the principal investigators to ask centres to collect information on additionalpotential confounding factors:■■smoking status 46–48■■use of statins 49■■family history of nAMD 50■■visual status of fellow eye. 51These factors were likely not to vary over time for a participant, and we asked centres to collectthe data at the next visit for participants who had already been recruited. At the time of thischange to the data set, there was only a small minority of existing participants who had alreadybeen discharged from treatment or lost to follow-up.Smoking status was classified as current smoker, ex-smoker or never smoked. The visual statusof the fellow eye (worse or better BCVA) was assigned based on BCVA data collected across theduration of the study. If the better-seeing eye varied across visits, that is both eyes had similarBCVA, the fellow eye status was classified as uncertain.Network of Ophthalmic Reading Centres in the UKImages from the VPDT cohort study were graded from 2004 to 2008 by NetwORC UK. Regulartraining and concordance exercises within the three designated reading centres ensured thereproducibility and reliability of grading outputs. During this period, improvements occurredin image acquisition systems which led to an expansion in the knowledge of the differentphenotypes of nAMD. The expanded phenotypic spectrum was incorporated into the gradingvocabulary, and the grading protocols were also appropriately amended.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 621Data collection and managementChanges in the data collection strategySeveral factors were responsible for the study recruiting substantially fewer people thananticipated. However, one was the failure of the original data collection strategy to function in themanner intended. The strategy failed for four main reasons:■■■■■■■■The database supplied by the third party could not be adapted in a satisfactory way to theneeds of the study.One particular aspect of the inadequacy of the database was the perceived lack of securityof electronic data submission. The study coincided with considerable investment in ITmodernisation in the NHS and greater awareness among IT managers of national guidanceabout the confidentiality of patient data held in electronic form. 52Some sites refused to install the local database on their local computer networks.Despite the investment in modernising IT in the NHS, many participating sites did not havereliable local computer networks to support data collection at the multiple points of careinvolved in the management of patients being treated with VPDT. Also, some sites providedVPDT in clinics that were remote from the main ophthalmology department.There were two main consequences of the failure of the strategy. Data collection at most siteswas carried out on paper forms, using forms developed and recommended by the co-ordinatingcentre (Figure 3) or custom forms developed by a site. Using paper forms often representedduplication of the recording of most of the clinical data and required an unexpected timecommitment locally for entry of data into the database. There was also a general reluctance to usethe adapted database and difficulties in submitting data at some sites.Concerns about the third-party database became sufficiently grave that, during the summerof 2005, the local database was completely rewritten by LSHTM staff, retaining only the tablestructure of the original so that data from old and new databases could be combined with relativeease. A new data transmission protocol was also developed by the LSHTM, in which data weretransmitted to a secure web address and were, therefore, powerfully encrypted by Secure SocketLayer technology. This revised data transmission protocol met with the requirements of theNHS Information Authority, which the original database could not do, allowing the sites thathad refused to submit data electronically to do so; it also persuaded some IT managers who hadpreviously been reluctant to do so to install the database on the local computer network. Therevised database and data transmission protocol also allowed implementation of submission ofthe anonymised minimum data set for patients who had treatment but from whom consent hadnot been obtained for participation in the cohort study (see Protocol amendments submitted to theResearch Ethics Committee).All centres were provided with the revised database. Clinics which had already collected datavia the original system were able to retain the original data tables and have the revised databaseadded as a new ‘front end’. Setting up the new databases required every site to receive a visit froma member of the LSHTM staff, during which the updated database was installed and staff weretrained. The first of these site visits took place in August 2005, with the majority of upgradestaking place during the 12 months from September 2005. The database upgrade also requiredadditional investment by the data management centre at the LSHTM, which had to recruit anextra full-time member of staff for 12 months.The fundamentally different design of the revised clinical database was welcomed by the vastmajority of clinics and overcame a lot of the reluctance to collect data. However, it could not© 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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84 References16. Stelmack J. Qualit
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88 References83. Margrain TH. Minim
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90 Appendix 1THE VERTEPORFIN PHOTOD
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92 Appendix 11. Overview of Manual
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94 Appendix 1And, if also collectin
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96 Appendix 1more patients in the v
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98 Appendix 12.4 Limitations of the
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100 Appendix 1Box 2 Key advantages
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102 Appendix 14. Study population4.
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104 Appendix 15. Recruitment to the
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108 Appendix 1Table 1: Schedule of
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110 Appendix 1The Verteporfin Photo
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116 Appendix 1level of benefit from
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128 Appendix 1Barnes RM, Gee L, Tay
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132 Appendix 1Liverpool re-treatmen
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176 Appendix 1ADVERSE REACTION AND
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FeedbackThe HTA programme and the a
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