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Appropriatezza Chirurgica Definizione degli Standard
URO-ONCOLOGIA
Tommaso Prayer Galetti - Clinica Urologica Azienda Ospedaliera Università Padova
Giario Conti – Azienda Ospedaliera S. Anna, Como.
IEZZONI ALGEBRA OF EFFECTIVENESS
The American Journal of Surgery (2009)
198 (Suppl to November 2009), S19–S27
� Indicazioni al trattamento – “Guidelines”
� Complicanze peri e post operatorie –”Incident Reporting”
� Costi – “DRG”
� Durata degenza – “SDO”
� Aspetti tecnici
� Risultati� Sopravvivenza
� Qualità della vita post-intervento
� Continenza
� Potenza erettile
� Informazione
OUTCOMES MISURABILI in UROLOGIA
GUIDELINES in UROLOGIA
ES: «La Sorveglianza Attiva nel Carcinoma Prostatico»
Maria Laura Chiozza
SC Qualità e Accreditamento Azienda Ospedaliera di Padova
Incident reporting > eventi sentinella
Segnalazioni reazioni avverse da farmaci – incidenza pre-programmata !
FONTE dei DATI per la Valutazione della Qualità
prolonged length of stay (> 11 days) thromboembolic events
90-day readmission 90-day mortality
Patients with mean level of all covariates (PSA, Gleason score,EPE, SVI, LNI, year of surgery)
5-year predicted probability of freedom from recurrence by surgeon.
Treated by surgeons with a minimum of 40 prior cases.
J Urol. 2010 March ; 183(3): 977–982
Conclusions
MARGINI CHIRURGICI POSITIVI
MARGINE CHIRURGICO POSITIVO
MARGINE CHIRURGICO
IATROGENO
MARGINI CHIRURGICI POSITIVI
Forest plot of 5-year predicted probability of freedom from recurrence by surgeon.
Treated by surgeons with a minimum of 40 prior cases & Surgical Margins (SM+).
“Significant heterogeneity in BCR rates (P = 0.001) suggests that differences in outcome between surgeons
go over and above removing all tissue positive for cancer by gross pathology.”
J Urol. 2010 March ; 183(3): 977–982
Adjusted multivariate analysis
assessing for predictors for
Clavien grade IV or V complication
among urologic procedures
Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of
surgery with examples of utility in holecystectomy. Surgery 1992;111:518-26.
Clavien Classification
Data set: 119 articles reporting outcomes in 22,530 patients
(42 RCTs and 77 retrospective series)
NO articles met all criteria of the 10 short-term surgical outcomes,
“The inconsistency of reporting and the lack of accepted principles of
accrual, display, and analysis of complication data argue strongly for the
creation and generalized use of standards for reporting this information”
Rate of complications reported with radical prostatectomy
AUA Prostate Cancer Guidelines rev. 2012
BJU Int 2013:1-8. doi:10.1111/bju.12407
Urinary continence at 1 year after RP stratified by treatment era
89-100% for patients treated with RALP
80-97% for patients treated with open- RP
NOTE:
1. The major limitations of the included studies were the frequent
retrospective study design and the use of different assessment tools
preventing a proper comparison between techniques and series.
2. Wide surgeon dependent variation
eau guidelines 2015 : “Patients should be informed that functional outcome after
Sex Med and open prostatectomy will be similar”
Eur Urol 2012 Sep;62(3):418-30.
Mean Urinary Continence Rates at 12 months
Surgeons in 3 groups by erectile strength outcome.
total of 207 patients of 4 surgeons with bestoutcomes.
total of 290 patients of surgeons with intermediate outcomes.
total of 270 patients of 5 surgeons with worst outcomes
Vol. 189, 1295-1301, April 2013
METHODOLOGY in REPORTING OUTCOMES AFTER RP
Trifecta
Continence, potency and cancer control
Pentafecta
“Trifecta” + peri-operative complications &
positive surgical margins rates
Bianco FJ Jr, Scardino PT, Eastham JA. Radical prostatectomy: long-term cancer control and recovery of sexual
and urinary function (“Trifecta”). Urology 2005 Nov;66(5 Suppl):83-94.
Patel VR, Sivaraman A, Coelho RF, et al. Pentafecta: a new concept for reporting outcomes of robotassisted
laparoscopic radical prostatectomy. Eur Urol 2011 May;59(5):702-7.
TRENDS in Urology about
Chirurgia: Indicatori di Esito “Ministeriali”
ParametroTipologia
Atto Medico ValoreIndicatore di
% pazienti che necessitano di
un ulteriore ricovero entro
30 giorni dall’intervento
Chirurgia < 5 % Qualità dell’intervento
Secondo le linee guida NICE, dovrebbero essere eseguite almeno 150 procedure
robotiche all’anno affinché tale investimento risulti costo-efficace
Published number of cases recommended to achieve
competency for robotic-assisted radical prostatectomy
Evidence-based data are limited but suggest an
increased prevalence of adverse patient safety
events for robotic prostatectomy early in the
national diffusion period.
Learning curves for robotic urologic surgery are
subjectiveand based on non-validated metrics.
“ The urological community should develop
rigorous, evidence-based processes by which
future technological innovations may diffuse in
an organized and safe manner”
Il contesto futuro
LEAN MANAGEMENTseeks to eliminate any waste of time, effort or
money by identifying each step in a business
process and then revising or cutting out steps
that do not create value. The philosophy has
its roots in manufacturing.
ORGANIZZAZIONE per INTENSITA’ di CURADirigenza Medica 20.3.2015
Can Urol Assoc J 2011;5(5): 342-8;DOI:10.5489/cuaj.11002
Recommendations for the primary assessment of NMIBC Recommendations for the primary assessment of NMIBC Recommendations for the primary assessment of NMIBC
Recommendations for the primary assessment of NMIBC
Performance of individual steps:
Perform TURB systematically
in individual steps !
Special situations
Pathological Report
PDTA – Percorsi Diagnostico Terapeutici Assistenziali
Strumento finalizzato all’ introduzione delle
Linee Guida (LG) nel contesto locale (CL)
Ricadute:
� Organizzative
� Assistenziali
� Medico - legali
� Economiche
Di fatto definiscono Standard di Qualità.
Slow medicine
� Implicazioni cliniche�creazione di un “linguaggio comune",
�documentazione dell’attività svolta,
�verifica dei risultati clinici ottenuti,
�miglioramento dei risultati ottenuti
.
� Implicazioni amministrativi�gestione del rischio clinico
�allocazione delle risorse
�superamento di una logica solo economica
�compartecipazione alla gestione strategica
STANDARD DI QUALITÀ in UROLOGIA
� Adeguata Informazione