Verteporfin photodynamic therapy for neovascular age-related ...

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168 Appendix 1Option 2 – units intending to use paper-based data captureThis is the alternative training format, to be implemented where live clinic data capture willnot be used.In this instance, paper based records will be entered under supervision at the end of thebasic training session.The observations will again ensure that:• Paper-based record keeping is accurate and well-organised• Routine software manipulations are carried out correctly (as under Stage 1 above)• Data capture is accurate – compared to the paper record• Errors/potential errors of manipulation are caught and correctedIn each case, live transmission of data will be carried out at the end of the session.It is anticipated that Stage 2 of training will involve a further half day for each DP on-site.Follow upA member of the local unit will be nominated as the key point of contact for following up thetraining session (the ‘Data Manager’). The hot-line telephone number will be provided to thisperson in case of immediate need. This individual will be contacted by the training teamwithin 10 days of training (or at least one data transmission after training) to ensure that anyresidual issues are cleared up.Additionally a member of the local IT department will be identified as the key contact (ITLead) for support issues. This person to be present at the time of software installation.ImplementationIt is envisaged that the study will be implemented in established DPs from March to end April2004. DPs include the following: Belfast, Bristol, Birmingham, Cardiff, Hillingdon, Leeds,Liverpool, Manchester, Moorfields, Newcastle, Sheffield, Southampton, Torbay,Wolverhampton. Invitations will be issued to all established DPs registered on the existingsurveillance programme and via the RCOphth website.This schedule ensures that there will be good early geographical coverage as well asbringing the existing pilot centres on line with the new software as soon as practicable. Rollout will continue throughout the year with the aim of bringing at least 25 sites on board byAugust 2004 and 40 by December 2004.Template for Site VisitPre visit planningInvitation Questionnaire completedProject Planning Team establishedEmail correspondence to confirm hardware and software capacityDay 1Day 2The details above refer to initial site implementation and training for the Strategen database.For most DPs, the revised database (see 12.3) will not appear dissimilar and trainingrequirements will be identified at time of installation
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6169Appendix 10: Instructions for completing and administeringquality of life and resource use questionnairesThe NEIVFQ(25), the SF-36 and the questionnaire with additional items about livingcircumstances are designed to be self-completed. Some patients will have normal felloweyes or adequate binocular vision to read the large print questionnaires that have beenprepared and will be able to complete their responses themselves. Other patients will beunable to complete the questionnaires themselves. For these patients, an accompanyingperson can read out the questions and fill in the questionnaires, but they must be told thatthey should attempt to answer the question on behalf of the patient. Alternatively, a memberof staff can administer the questionnaires.NEIVFQ(25):Please see instructions at the beginning of the questionnaire.SF-36:The following is an extract from the Manual for the SF-36 Health SurveyIntroducing the SF-36 Health Survey• The questionnaire can be introduced with these words: “We are conducting a studyto assess the benefits of a new treatment for macular degeneration, calledphotodynamic therapy. We would like to better understand how you and otherpersons in this study feel, how well you are able to do your usual activities, and howyou rate your own health. To help us better understand these things about you andother persons, please complete this questionnaire about your general health”.• The patient should also be told: “Be sure to read the instructions on the top of the firstpage. This is not a test and there are no right or wrong answers. Choose theresponse that best represent the way you feel”.• Respondents must be informed that they should answer these questions bythemselves. Spouses, or other family members, or visitors, should not assist them incompleting the questionnaire*.Closing• When the respondents returns the SF-36, check the questionnaire for completeness.If it is not complete, ask the respondent whether he/she had any difficulty completingit and record the reasons for non-completion.*These instructions relate to people with normal vision completing the SF-36. Spouses,other family members or friends should not answer the questions for the personcompleting the form, but may read out the questions and help to record the responses.© 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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86 References49. Guymer RH, Chiu AW
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90 Appendix 1THE VERTEPORFIN PHOTOD
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92 Appendix 11. Overview of Manual
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