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Pilot analysis notes.pdf
PSA UsedIf pre-biopsy not present, use presenting PSA38% had presenting PSA on GP letterPre-biopsy always Hosp 1Presenting PSA mixture of Hosp 1 and GPDo we need Hosp no for pre-biopsy PSA?Should presenting PSA be Hosp OR GP?Is this data useful?Recommendation: PSA value to be on study db as numeric value to ease analysis.
Co-morbiditiesList attached. Can these be further categorised?
Diagnosis and StagingIs it necessary to have Result? Mets on next section, some cannot have MRI becauseof metal implants – could have box to say “Unable to have MRI – Y/N” Rest blank.
KE – also need Cystoscopy and Biopsy.
Evidence of MetsYes/No only – or do we need to know which test detected them?
GleasonRecommendation: Gleason to be on study db as single numeric value to ease analysis.
Clinical Stage (TNM)Recommendation: single box only and combine with pathological stage (postresection) as only 1 or 2 entries for each item out of 87.
Dates Used for analysisIf date is not fully found, e.g. Jan 1999, enter mid-month, e.g. 15/1/99.
GPREFER = on reg db (56% complete), supplemented with study db (70% complete).
HOSP1 = reg dbTREAT DATE = reg db’s first treatment date, as study db’s treatment dates not allrecorded (e.g. no hormone date) and treatment decision date (item 7) is very patchyand sometimes is after actual treatment date, so could be unreliable.
Treatment GroupsThe sample of 87 were divided for analysis purposes into 5 treatment groupsaccording to the data collected for the study (Surgery, External XRT, Brachytherapy,Hormone and None).
It can be seen from data below that there were some discrepancies between the datacollected for the study (study db) and data collected by the registry (reg db).
Recommendations for main study follow descriptions.
SurgeryReg db has 7/9 of study db as radical surgery (other 2 out of reg treatment dateperiod?)
Need to record date of surgery on study db.
Reg db records TURPs as Type of Surgery, whereas study db records TURPs as typeof investigation.
Recommendation: study to record Type of Surgery and Date of Surgeryindependently of reg db.
RadiotherapyReg db has 23/26 of external beam xrt recorded.
Reg db has 6/7 of brachytherapy recorded.
Recommendation: study to record Ext Beam XRT + Date Started + DoseAnd Brachytherapy XRT + Date Started + No. Seeds
HormoneSole – reg db 19/26 recorded.
XRT – 19/26 had hormone, 2 sole, 6 adjuvant, 11 neo-adjuvant. All recorded on regdb. Are sole incorrect? Would it be more reliable to use hormone date startedcompared with XRT date started to work out sole/adjuvant/neo-adjuvant?Surgery – 3/8 had hormone, 1 sole, 2 neo-adjuvant. 1/3 of these were recorded on regdb.
Brachytherapy – 5/7 had hormone, 4 neo-adjuvant, 1 adjuvant. All recorded on regdb.
Recommendation: study to record Hormone Treatment and Date Started.
No TreatmentAll study db match reg db (except TURPs as surgery).
Watchful Waiting25 recorded, 8 of whom are also recorded as having some treatment (2 Surgery, 1Brachytherapy, 5 Hormone).
17/23 of No Treatment group had watchful waiting.
Recommendation: emphasise on proforma that need only look for watchful waitingevidence and date if no treatments found.
Side-effects/OutcomesPositive/clear margins – only 1 recorded “pathologist said it may be a positivemargin”Secondary treatment – 9 true – cyprrterone (2), zoladex, bilateral subcapsularorchidectomy, hormone, suprabubic catheter, casodex, TURP.
Post-op mortality, post-rt mortality – all No.
Can secondary treatment be categorised?Do these items give a true picture of outcomes?
CommentsNeed comments box on proforma.
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2 -- Suplemento -- Registro Oficial Nº 959 -- Miércoles 22 de mayo del 2013 No. NAC-DGERCGC13-00237 estableciendo la presentación del Anexo Transaccional Simplificado (ATS) de manera obligatoria para los sujetos EL DIRECTOR GENERAL pasivos señalados en dicho acto normativo; DEL SERVICIO DE RENTAS INTERNAS Que el artículo 4 de la referida Resolución No. NAC- Considerando: