Verteporfin photodynamic therapy for neovascular age-related ...

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176 Appendix 1ADVERSE REACTION AND EVENT FORMCentre Code______ Surname_________________ Date of Birth__/__/__/Part 1: Adverse reaction during or just after treatment(Tick and add details if necessary)Date of Treatment__/__/__/□ Back pain during infusion □ mild □ moderate □ severetime of onset _________________ (minutes since infusion start)further details_____________________________________________□ Pain at the injection site further details_____________________________________________□ Extravasations at injection site further details_____________________________________________□ Other events detailsfurther details_____________________________________________Date of onset I___I___I / I___I___I / I___I___IDate of resolution I___I___I / I___I___I / I___I___IReaction attributable toVisudyne treatment?□ definitely; □ probably; □ possibly; □ no (tick one only)Part 2: Adverse event since last visit(Tick and add details if necessary)Date of last treatment__/__/__/□ Transient visual lossDate of onset I___I___I / I___I___I / I___I___IDate of resolution I___I___I / I___I___I / I___I___I□ Loss of ≥ 20 letters Onset within 7 days of treatment / last visit? Y / NWas deterioration?Sudden / Gradualfurtherdetails____________________________________________□ RPE tearfurther details____________________________________________□ Haemorrhagefurtherdetails____________________________________________□ PhotosensitivityDate of onset I___I___I / I___I___I / I___I___IDate of resolution I___I___I / I___I___I / I___I___I□ Otherfurtherdetails____________________________________________Date of onset I___I___I / I___I___I / I___I___IDate of resolution I___I___I / I___I___I / I___I___IEvent attributable to Visudynetreatment?□ definitely; □ probably; □ possibly; □ no (tick one only)Ophthalmologist _________________________ Signature __________________________
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6177NOTES FOR MAIN DATA COLLECTION SHEETNumber Data item Notes1 Patient details1a Name Self-explanatory1b Date of Birth Self-explanatory1c Gender Self-explanatory1d Hospital Number Self-explanatory1e NHS number CHI (Community Health Index) number should be used forScottish patients.We recognise that this number can be difficult forclinicians to obtain, but it should be readily available in theTrust, for example to clerical staff. This number is veryimportant for linking data for patients to the national ONSpopulation register.1f PCT Again, we recognise that this can be difficult for cliniciansto obtain, but it should be readily available in the Trust, forexample to clerical staff. This information is veryimportant for understanding patterns of referral and forreporting to commissioners.1g Phone number This is optional. It may be useful for clinicians and otherNHS staff to have a record of the patient’s phone numberon the database for reference.1h Address Please pay particular attention to the postcode.2 Referral details Only complete for new patients2a Primary CareReferral DateThis should be the date when the patient was referred (orfirst presented) to a primary care health professional(optometrist or GP) with symptoms. The date will notnecessarily be documented in correspondence associatedwith a new referral, especially if a patient has beenreferred to a designated provider from an ophthalmicdepartment in another acute Trust. If it is notdocumented, it is very important to ask the patient.The ‘approximate’ box should be used if the patientcannot remember the exact date. Where the patient selfpresents to a hospital eye service A&E/casualty2b2cOphthalmologistReferral DateReferring Hospital;First PDT Centredepartment enter this date.This should be the date when the patient was referred tothe designated provider from an ophthalmic department inanother acute Trust, or from another clinic in thedesignated provider Trust. If a patient has been referreddirectly to the designated provider from primary care,enter the same date as for 2a. This date should bedocumented in correspondence associated with a newreferral. If it is not documented, it is very important toask the patient. The ‘approximate’ box should be used ifthe patient cannot remember the exact date.Write ‘Not applicable’ for:• patients who have not been referred from anophthalmic department in another acute Trust;• patients who have not had PDT before eitherprivately or in an ophthalmic department in another© 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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xExecutive summaryretreat on criter
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xiiExecutive summaryof data, with i
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2 Introductionon-going or new clini
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20 Key changes to the protocolThese
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24 Key changes to the protocolADVER
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26 Key changes to the protocolPlan
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28 Key changes to the protocolClass
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30 Key changes to the protocolFor i
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32 Key changes to the protocolIn ad
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34 Key changes to the protocolsites
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38 Results (1) - study cohortTABLE
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46 Results (2) - objectives A, B, C
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66 Discussion of resultsStrengths a
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68 Discussion of resultsThe VPDT st
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70 Discussion of resultsOur analyse
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72 Discussion of resultsA further c
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74 Discussion of resultsVPDT. It is
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84 References16. Stelmack J. Qualit
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86 References49. Guymer RH, Chiu AW
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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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106 Appendix 16. Background data co
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108 Appendix 1Table 1: Schedule of
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110 Appendix 1The Verteporfin Photo
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112 Appendix 1• Additional clinic
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114 Appendix 18. Recording adverse
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116 Appendix 1level of benefit from
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118 Appendix 1• comparison of num
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120 Appendix 110.6 Sub-group analys
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122 Appendix 112. Data issues12.1 D
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124 Appendix 113. Organisation13.1
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