Danish Fracture Database – DFDB.DK

Danish Fracture Database – DFDB.DK
Herlev Sygehus
04.03.2015
Kirill Gromov, MD, PhD, - e-mail: [email protected]
Purpose of DFDB
”Web-based prospective quality monitoring of fracture related surgery”
Evaluation:
Rates of reoperation
Operative parameters
2
Assessment of Quality
Why assessment of quality is relevant:
Life time prevalence of getting a fracture is 38.2 %
20,000 fracture related surgeries are estimated to be carried out annually in DK
No prospective data for assessing the quality of fracture related surgery in general has
previously been collected
3
Need for registry based research
• Observational data
• Treatment guidelines
• Implant monitoring
History of DFDB
6 years ago:
Paper and pen-based database tested at
Aabenraa Hospital
2 years ago:
Web-based database initiated at Hvidovre and
Odense Hospitals, Dept. of Orthopaedics
Now:
21 departments in total
Administration and statistics
» Steering group with
annual meetings
Michael Brix
Anders Troelsen
5
Participating departments
Hvidovre
Kolding
Odense
Aabenraa
Rigshospitalet
Herlev
Slagelse
Bispebjerg
Køge
Esbjerg
Nykøbing F.
Holbæk
Hillerød
Viborg
Århus
Horsens
Vejle
Aalborg & Farsø
Gentofte
Randers
21 departments n ≈
35,000 operations
6
Completeness and validity
Early data completeness and validity
COMPLETENESS
Primary surgeries
Reoperations
DATA VALIDITY
Hvidovre
Odense
Both Departments
90% (145/161)
86%(102/118)
88% (247/279)
84% (27/32)
71% (22/31)
77% (49/63)
App. 90-100 %
Gromov et al., DMJ, oktober 2013
7
DFDB
History of data entries
> 8000 entries /
6 months
8
Structure
• DFDB.dk online registration, developed by PROCORDO®
• 2 min per registration
• Filled out by the surgeon immediately after surgery
• Patient, trauma and surgery related factors are registered
• Reoperations are linked with primary operations
9
Data
• Departments own their own data
• Department can use data for quality monitoring, research etc.
• Departments can veto use of data in projects by other departments
• Departments deliver data for annual report at the DOS congress
• All rules followed, all is reported to The Danish Data Protection Agency
• Alle departments have a person responsible for data who is also member of
the steering group
10
User featers
• Status messages
• Surgical log
Status messages
Kirill Gromov, læge, PhD, - e-mail: [email protected]
Fremtid
• Landsdækkende database (ansøgning til SSI indsendt)
• Flere forskningsprojekter
• Implantat sporing
13
Forskningsprojekter
• 4 artikler i Pubmed
• 1 accepteret til JBJS – surgical delay.
– Danish Fracture Database Collaboration ordning.
• Flere på vej ???
Surgical Delay
3517 primary surgeries for low energy, non-pathological AO31A and AO31B
fractures on patients age > 50 were identified from DFDB.
Median age:
82.0 (range 51-107)
AO31A (trochanteric)
1729 (49%)
Female
2458 (70%)
Primary Endpoint : 30-day and 90-day mortality (Civil Registrational system).
Modifiable Risk Factors:
Surgical delay = From diagnostics (x-ray) to onset of surgery.
Educational level of surgeon
AA = Attending or above
BA = Below attending
Nyholm et al. JBJS. Accepted
15
Surgical Delay
Mortality
Surgical delay
16
Logistical regression*
*Adjusted for age, gender, ASA score, fracture type, treatment, educationale level of surgeon/surgical delay
Surgical
delay
30-day
mortality
risk (OR)
90-day
mortalit
y risk
(OR)
Surgical
delay
30-day
mortality
risk (OR)
90-day
mortalit
y risk
(OR)
<12 h
1
1
≥12 vs <12h
1.45*
1.10
12-24 h
1.33
1.02
≥24 vs <24h
1.34*
1.23*
24-36 h
1.60*
1.22
≥36 vs <36h
1.32
1.21*
36-48 h
1.37
1.08
≥48 vs <48h
1.56*
1.36
48-72 h
2.61*
1.83*
≥72 vs <72h
1.23
1.09
≥72 h
1.67
1.18
Educatilnal level of
surgeon
30-day mortality risk 90-day mortality risk
(OR)
(OR)
AA
1
1
BA
1.28*
1.26*
Conclusions
Short surgical delay (<12h) reduces risk of 30-day mortality.
The effect is less pronounced at 90-day mortality.
Junior surgeons should be supervised.
IMPLANTATSPORING
Hvidovre Hospital
Intelligent implantat sporing
&
klassifikation
Kirill Gromov, læge, PhD, - e-mail: [email protected]
19
Implantat sporing
Behov
”Det anvendte implantat skal kunne identificeres
entydigt og specifikt ved angivelse af implantatets
navn og model, størrelse af implantatet,
fabrikantens navn, serienummer eller LOT
efterfulgt af batchkode”
1) Hvad har vi opereret patienten med?
• Reoperationer
• Recalls
2) Hvordan går det med det nye implantat?
• Kontinuerlig kvalitets monitorering
Kirill Gromov, læge, PhD, - e-mail: [email protected]
20
Implantat sporing
idag
1) Hvad har vi opereret patienten med?
• Reoperationer
• Recalls
Kirill Gromov, læge, PhD, - e-mail: [email protected]
21
Implantat sporing
idag
2) Hvordan går det med det nye implantat?
• Kontinuerlig kvalitets monitorering
Kirill Gromov, læge, PhD, - e-mail: [email protected]
22
Implantat sporing i fremtiden
•
•
•
Nem tilgængelig og med landsdækkende
potentiale
Løbende monitorering med ”early warnings”
Intelligent implantat sporing med
klassifikation
Kirill Gromov, læge, PhD, - e-mail: [email protected]
23
Hvorfor klassificere?
Er det ikke nok at kende firmaet og lot nummeret
nummeret?
Kirill Gromov, læge, PhD, - e-mail: [email protected]
24
1978
Ford Pinto – ”Barbecue that seats four”
Kirill Gromov, læge, PhD, - e-mail: [email protected]
25
Defekt produktion, design eller noget
helt tredje?
Kirill Gromov, læge, PhD, - e-mail: [email protected]
26
2010
27
Defekt produktion, design eller noget
helt tredje?
Kirill Gromov, læge, PhD, - e-mail: [email protected]
28
Indføring af cladestik
Kirill Gromov, læge, PhD, - e-mail: [email protected]
29
Implantatklassifikation giver større viden
• Sammenligning på tværs af
producenter
• Mulighed for at kigge på flere faktorer
samtidigt
• Identificering af fejl i designet
• Mulige farlige ”kombinationer”
Kirill Gromov, læge, PhD, - e-mail: [email protected]
30
Cladestik ved implantatregistrering
•
•
•
•
Klassificeres første gang af kirurgen
En implantat skal kun klassificeres en gang
Alle implantater klassificeres
Valideres af superbruger
Kirill Gromov, læge, PhD, - e-mail: [email protected]
31
Overlevelses kurver
32
Overlevelses kurver
33
Aktuel status på Marvsøm
• Hvad er evidensen for brug af forskellige implantater til
proximal femur frakturer?
Begrænsninger:
– Engelsksproget
– publiceret 1990 eller senere.
– Trochantær eller collum fem (dvs. ikke pipkin eller distalt for troc.
minor)
– Primære hoftefracture
– Ikke patologisk
– Angive failure of implant
– Min.follow-up 1 år
– Klart angive implantat
Søm
Implant
N
N (patients) N (patients) N (patients)
total
(studies) Prospective Retrospective
Gamma3
12
759
259
1018
IMHS
7
210
352
562
InterTan
5
585
10
595
PFN
13
785
183
968
PFNA
20
PTN
0
887
0
686
0
1573
0
• HUSK AT REGISTRERE I DFDB