Verteporfin photodynamic therapy for neovascular age-related ...

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104 Appendix 15. Recruitment to the cohort study5.1 Multicentre Research Ethics Committee approvalAn application for ethical approval was submitted to the London MetropolitanMulticentre Research Ethics Committee (MREC), which was considered in Nov 2003.The MREC Committee approved the study in principle on 28 Nov 2003 but required(a) clarification of some details and (b) modifications to the patient information sheetand consent form. Responses to these queries were submitted in Dec 2003, butfurther modifications to the patient information sheet were requested. These weresubmitted in Jan 2004 and the MREC Chair gave final approval in Feb 2004. Thereference number for the study is MREC/03/11/103. Copies of the MREC letter ofapproval and other documents are distributed to DPs when they register for the study.5.2 Recruitment of centres nominated as ‘designated providers’Local Specialist Commissioning Groups (LSCGs) and Primary Care Trusts (PCTs)are responsible for identifying their local ‘designated provider’ (DP), with whomcontracts to provide PDT will be placed. The identities of the DPs are communicatedto the study investigators and the Data Management Centre, and the DataManagement Centre sends invitations to the DPs to register with the study. (Duringthe early stages of implementation, in order to avoid delays, some invitations werealso sent to centres that were considered very likely to be DPs, e.g. because theywere already providing PDT, but which had not yet been confirmed as designatedproviders by LSCGs/PCTs.) Registration requires the lead clinician at a DP to sendback a short questionnaire to the Data Management Centre (see Appendix 3).5.3 Local Research Ethics Committee approvalThe ‘local principal investigator’ in each DP must obtain ethical approval from theLocal Research Ethics Committee (LREC). This approval is in addition to the MRECapproval. LRECs may require minor revisions to the patient information and consentforms, or request modifications owing to special local circumstances, but may notover-rule the approval already given by the MREC.The local principal investigator in each DP must also register the study with theResearch Office / R and D Office of the local Trust.The Data Management Centre will prepare as much of the paperwork as possible fora DP to submit for LREC and local R&D approval. Much of the information requestedin the registration questionnaire is used for this purpose.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 61055.4 ConsentParticipation in the cohort study is not optional for patients in the reference populationbeing assessed for treatment on the NHS. The minimum dataset and angiogramsmust be submitted to the Data Management Centre and to the Central AngiographicResource Facility (CARF) at Belfast for all such patients.Some DPs will be nominated by their local commissioners to collect the extendeddataset, which requires patients to complete quality of life and resource usequestionnaires. Patients may withhold consent from taking part in the extended datacollection but still consent to submission of their clinical data.The consent form for the study that has been approved by the MREC therefore hastwo levels of consent. Consenting at the first level (“partial consent”) indicates that apatient consents to information required for the minimum dataset to be forwarded tothe Data Management Centre and for angiograms to be sent to the CARF. Theminimum dataset only includes information required for treating and managing apatient; patients consenting at this first level are not required to undergo anyadditional tests or provide any biological samples other than those that may berequired for their treatment. Consenting at the second level (“full level”) indicates thata patient consents to completing the quality of life and resource use questionnairesand for this information also to be forwarded to the Data Management Centre.The MREC approved patient information sheet and consent form are included inAppendix 4. DPs will need to reproduce these documents on local headed paperand obtain local LREC approval before use.5.5 Overview of data collectionThe cohort study requires different kinds of information to be collected, i.e.demographic, clinical, angiographic, quality of life and resource use data (see Figure1). The demographic data, most clinical data and the angiograms constitute theminimum dataset. The minimum dataset, contrast sensitivity, the quality of life andresource use data constitute the extended dataset. All DPs must collect all of theitems that make up the minimum dataset; it is not sufficient to assume that theinformation required will be documented in the medical notes. A representativesample of DPs, nominated by the commissioners, will collect the extended dataset;their contracts will include extra funding to cover additional resources required tocollect the additional data. The schedule of visits and the information to be collectedon each visit are shown in Table 1.© 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
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FeedbackThe HTA programme and the a
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