Prezentacja Prof. Leszka Pączka 930,2 KB PDF File pobierz plik

Prof. Leszek Pączek
Rada Naukowa
Ministra Zdrowia
24 marca 2015 roku
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Warszawski Uniwersytet Medyczny
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Warszawski Uniwersytet Medyczny
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Warszawski Uniwersytet Medyczny
Improving the Drug Development Processmore not less randomised trials.
JAMA, Jan.22 2014, 355,

..an evaluation of registered protocols first received by
ClinicalTrials.gov between August 1,2013 and August
14,2013, shows that 53 of 105 phase 1 trials ( 50% )
and 42 of 113 phase 2 trailas ( 37% ) were
nonrandomised…

One specific dose ( or dose range ) has been selected
for a new tratment , it makes little sense to collects
uncontrolled observational data, instead of comparing
this dose or doses against the best standard of care…
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Warszawski Uniwersytet Medyczny
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Warszawski Uniwersytet Medyczny
Implementation of guidelines for management of possible
multidrug-resistant pneumonia in intensive care: an
observational, multicentre cohort study
Prof Daniel H Kett MD a , Ennie Cano PharmD a, Andrew A Quartin MD a, Prof Julie
E Mangino MD b, Prof Marcus J Zervos MD c, Paula Peyrani MD d, Cynthia M Cely
MD a, Kimbal D Ford PharmD e, Ernesto G Scerpella MD e, Prof Julio A Ramirez
MD d, the Improving Medicine through Pathway Assessment of Critical Therapy of
Hospital-Acquired Pneumonia (IMPACT-HAP) Investigators‡
_______________________________________________________________________
Published online January 20,2011 DOI:10.1016/S1473-3099(10)70314-5
Warszawski Uniwersytet Medyczny
Guideline – compliant empirical treatment outcomes for 28-day
mortality, grouped by pathogen and adjusted for treatmentindependent risk
Warszawski Uniwersytet Medyczny
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Warszawski Uniwersytet Medyczny
GRYPA

www. Narodowy Instytut Zdrowia Publicznego PZH
2012,12,16:
1-7 XII 2012 zarejestrowano 58 130 zachorowań, zgonów
z powodu grypy nie odnotowano .


INFLUENZA :… substantial mortality. 36 000 deaths in
USA / year ( 2002 ) 1,5 % zgonów
W Polsce ( 2002) zmarło 20 z powodu grypy,
0.005% zgonów
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Warszawski Uniwersytet Medyczny
Volume 383, Issue 9931, 24–30 May 2014, Pages 1824–1830
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Warszawski Uniwersytet Medyczny
Modelling suicide and unemployment: a longitudinal
analysis covering 63 countries, 2000–11
Dr Carlos Nordt PhD, Ingeborg Warnke PhD, Prof Erich
Seifritz, MD PD, Wolfram Kawohl, MD
Findings
Despite differences in the four world regions, the overall model, adjusted for the
unemployment rate, showed that the annual relative risk of suicide decreased by 1·1%
(95% CI 0·8–1·4) per year between 2000 and 2011. The best and most stable final
model indicated that a higher suicide rate preceded a rise in unemployment (lagged by
6 months) and that the effect was non-linear with higher effects for lower baseline
unemployment rates. In all world regions, the relative risk of suicide associated with
unemployment was elevated by about 20–30% during the study period. Overall, 41 148
(95% CI 39 552–42 744) suicides were associated with unemployment in 2007 and
46 131 (44 292–47 970) in 2009, indicating 4983 excess suicides since the
economic crisis in 2008.
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Warszawski Uniwersytet Medyczny
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Warszawski Uniwersytet Medyczny
Common non-synonymous SNPs associated with breast cancer
susceptibility: findings from the Breast Cancer Association Consortium
.
Milne RL1, Burwinkel B2, Michailidou K3, Arias-Perez JI4, Zamora MP5, Menéndez-Rodríguez P4, Hardisson D6, Mendiola M7, González-Neira A8, Pita G8,
Alonso MR8, Dennis J3, Wang Q3, Bolla MK3, Swerdlow A9, Ashworth A10, Orr N10, Schoemaker M11, Ko YD12, Brauch H13, Hamann U14; GENICA Network,
Andrulis IL15, Knight JA16, Glendon G17, Tchatchou S18; kConFab Investigators; Australian Ovarian Cancer Study Group, Matsuo K19, Ito H20, Iwata H21, Tajima
K22, Li J23, Brand JS24, Brenner H25, Dieffenbach AK25, Arndt V26, Stegmaier C27, Lambrechts D28, Peuteman G28, Christiaens MR29, Smeets A29, Jakubowska
A30, Lubinski J30, Jaworska-Bieniek K30, Durda K30, Hartman M31, Hui M32, Yen Lim W 32, Wan Chan C33, Marme F34, Yang R34, Bugert P35, Lindblom A36,
Margolin S37, García-Closas M38, Chanock SJ39, Lissowska J40, Figueroa JD39, Bojesen SE41, Nordestgaard BG41, Flyger H42, Hooning MJ43, Kriege M43, van
den Ouweland AM44, Koppert LB45, Fletcher O46, Johnson N46, dos-Santos-Silva I47, Peto J47, Zheng W 48, Deming-Halverson S48, Shrubsole MJ48, Long J48,
Chang-Claude J49, Rudolph A49, Seibold P49, Flesch-Janys D50, Winqvist R51, Pylkäs K51, Jukkola-Vuorinen A52, Grip M53, Cox A54, Cross SS55, Reed MW 54,
Schmidt MK56, Broeks A56, Cornelissen S56, Braaf L56, Kang D57, Choi JY58, Park SK57, Noh DY59, Simard J60, Dumont M60, Goldberg MS61, Labrèche F62,
Fasching PA63, Hein A64, Ekici AB65, Beckmann MW 64, Radice P66, Peterlongo P67, Azzollini J68, Barile M69, Sawyer E70, Tomlinson I71, Kerin M72, Miller N72,
Hopper JL73, Schmidt DF73, Makalic E73, Southey MC74, Hwang Teo S75, Har Yip C76, Sivanandan K77, Tay WT78, Shen CY79, Hsiung CN80, Yu JC81, Hou MF82,
Guénel P83, Truong T83, Sanchez M83, Mulot C84, Blot W 85, Cai Q85, Nevanlinna H86, Muranen TA86, Aittomäki K87, Blomqvist C88, Wu AH89, Tseng CC89, Van
Den Berg D89, Stram DO89, Bogdanova N90, Dörk T91, Muir K92, Lophatananon A93, Stewart-Brown S93, Siriwanarangsan P94, Mannermaa A95, Kataja V96,
Kosma VM95, Hartikainen JM95, Shu XO48, Lu W 97, Gao YT98, Zhang B48, Couch FJ99, Toland AE100; TNBCC, Yannoukakos D101, Sangrajrang S102, McKay J103,
Wang X104, Olson JE105, Vachon C105, Purrington K105, Severi G106, Baglietto L106, Haiman CA89, Henderson BE89, Schumacher F89, Le Marchand L107, Devilee
P108, Tollenaar RA109, Seynaeve C43, Czene K24, Eriksson M24, Humphreys K24, Darabi H24, Ahmed S110, Shah M110, Pharoah PD111, Hall P24, Giles GG106,
Benítez J112, Dunning AM110, Chenevix-Trench G113, Easton DF111.
Abstract
Candidate variant association studies have been largely unsuccessful in identifying common breast cancer
susceptibility variants, although most studies have been underpowered to detect associations of a realistic
magnitude. We assessed 41 common non-synonymous single-nucleotide polymorphisms (nsSNPs) for which
evidence of association with breast cancer risk had been previously reported. Case-control data were combined
from 38 studies of white European women (46 450 cases and 42 600 controls) and analyzed using unconditional
logistic regression. Strong evidence of association was observed for three nsSNPs: ATXN7-K264R at 3p21
[rs1053338, per allele OR = 1.07, 95% confidence interval (CI) = 1.04-1.10, P = 2.9 × 10(-6)], AKAP9-M463I at
7q21 (rs6964587, OR = 1.05, 95% CI = 1.03-1.07, P = 1.7 × 10(-6)) and NEK10-L513S at 3p24 (rs10510592, OR
Hum Mol Genet. 2014 Nov 15;23(22):6096-111. doi: 10.1093/hmg/ddu311. Epub 2014 Jun 18.
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Warszawski Uniwersytet Medyczny
Seasonal Variation of Overall and Cardiovascular Mortality: A Study
in 19 Countries from Different Geographic Locations
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Warszawski Uniwersytet Medyczny
?

– spis chorych – liczba chorych

Czy

- REJESTR : liczba chorych

wyniki leczenia

podział na regiony/szpitale

REJESTR pozwala na prowadzenie polityki zdowotnej
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Warszawski Uniwersytet Medyczny
FIRMA FARMACEUTYCZNA
Minister Zdrowia
Towarzystwo
Konsultant
Naukowe
Krajowy
Rejestr
Zalecenia
Baza Chorych
Stowarzyszenia Chorych
KOSZTY,
EFEKTY LECZENIA
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Warszawski Uniwersytet Medyczny
TRWAŁOŚĆ REJESTRU
Dane
człowiek !
w XXI wieku
czyny społeczne
są mało popularne
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(BAZA)
- serwer
Analiza
- publikacja
- administrator
- dostępność web
- (informatyk, program)
Warszawski Uniwersytet Medyczny
System Rejestrów
czy
każdy rejestr inny ?
(onkologiczny / kardiologiczny / udarowy / transplantacyjny)
1. Może wspólna konstrukcja informatyczna ?
(koszt ulega multiplikacji, gdy wiele baz)
2. Może „kompatibilność” z bazami, Unia Europejska/ inne ?
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Warszawski Uniwersytet Medyczny
10 letnie przeżycie pacjenta i przeszczepionej nerki
Przeżycie
pacjenta
[%]
Przeżycie Źródło
przeszczepu
[%]
USA
54
46
OPTN SRTR
EUROPA
75
56
CTS
POLSKA
81
57
Poltransplant
Instytut Transplantologii,
WUM
89
79
Analizy własne
Warszawski Uniwersytet Medyczny