Transparency: Should CF-care centers ”open their books” and publish treatment outcomes? PRO by Erik Wendel, Danish Cystic Fibrosis Association Hamburg 2010 - Cystic Fibrosis Europe Symposium
Apr 01, 2015
Transparency: Should CF-care centers”open their books” and
publish treatment outcomes?
PRO
byErik Wendel, Danish Cystic Fibrosis Association
Hamburg 2010 - Cystic Fibrosis Europe Symposium
Ref. Jim Littlewood, CF Trust , UK
A tool for doctors:
• Obtain information to keep on record • Evaluate treatment result• Make new, or change present treatment methods/strategies• Pass information to others• Pass ways of good practice to other – avoid pitfalls• Setting treatment goals• Transparency• Stand up for what You do, and what You belive in
A tool for patients:
• Quality improvement• Access to information about other treatment strategies• Quicker access to new/other treatments
Why Data Collection and Publishing
Ref. Michael P. Boyle, NACFC 2007
http://www.cff.org/CCNP/CareCenterReporting/index.cfm?CCaction=PerformanceSummary&IDCC=84
http://www.cff.org/CCNP/CareCenterReporting/index.cfm?CCaction=PerformanceSummary&IDCC=6
Open data must come withopen CF Care Centertreatment standards
(What they do, how they do it )
• The US have opened the data door
• EU and US doctors have agreed on methods, data collection and what to publish
• Europe will have to follow with open data too
• Patient organisation can speed up this process
• We have passed the Point of No Return
Open data - Where are we
• 450 patients
• 2 CF Care Centers
Rigshospitalet (RH - East Denmark) established 1967 300 pts (100 children, 200 adults) Registration of patient data since 1967
Skejby (SKS - West Denmark) established 1990 App. 150 pts, (80 children, 70 adults) No official registration before 2000
• Year 2001: Danish Registry (RH + SKS)
• Year 2007: Published data - Country vs. Center
Why Open Data - The Danish Story
__________________________________________________________________________________________________
Year 2000-2006 Age ave. Age spread__________________________________________________________________________________________________
2006 (19 patients) 28,21 yrs 15 - 38 yrs2005 (9 patients) 26,44 ysr 11 - 42 yrs 2004 (4 patients) 18,50 yrs 09 - 18 yrs2003 (6 patients) 34,50 yrs 22 - 52 yrs2002 (9 patients) 24,33 yrs 11 - 35 yrs2001 (8 patients) 30,38 yrs 22 - 45 yrs2000 (9 patients) 23,44 yrs 10 - 34 yrs__________________________________________________________________________________________________
64 patientsAge at death with out transplantationAge at transplantation CFF 2007
Danish patients death/TX 2000-2006
2006 Sex Center Born TX † -TX Age ∆ SKS ∆ RH Notes
1 M SKS 1972 TX 34 2 M SKS 1973 TX 33 3 K SKS 1973 TX 33 4 M SKS 1978 TX 28 5 M SKS 1978 TX 28 6 K SKS 1979 † 27 7 K SKS 1981 TX 25 8 K SKS 1981 TX 25 9 K SKS 1983 † 23
10 K SKS 1985 TX 21 11 M SKS 1985 † 21 12 K SKS 1986 TX 20
13 K SKS 1991 † 15 25,61 13/150 = 8,67%
1 M RH 1968 TX 38 2 M RH 1971 TX 35 3 M RH 1972 TX 34 4 K RH 1972 TX 34 5 M RH 1974 † 32
6 M RH 1976 TX 30 33,83 6/300 = 2%7 M RH 1987 † 19 Car accident
2005 Sex Center Born TX † -TX Age ∆ SKS ∆ RH Notes
1 K SKS 1964 TX 41 2 K SKS 1973 † 32 3 K SKS 1980 † 25 4 M SKS 1983 TX 22 5 M SKS 1985 TX 20 6 K SKS 1994 † 11 25,17 6/150=4%
1 M RH 1963 TX 42 2 K RH 1979 TX 26 3 K RH 1986 TX 19 29,00 3/300=1%
Investigation of more detailed data needed
Why Open Data - The Danish Story
Copenhagen (east) vs Skejby (vest)Z-score BMI, children born after 01.01.1990, patients del508 homozygotes
Copenhagen (east) vs Skejby (vest)Lung function FEV1 of predicted, children born after 01.01.1990, patients del508 homozygotes
Data are not different
Data are different
DK Reactions to 2005 Data Outcomes
Stage 1: The data are wrong
Stage 2 The data are right, but it’s not a problem
Stage 3 The data are right; It is a problem; But it’s NOT my problem
Stage 4 I accept the burden of improvement
Typical reactions to Data Outcomes
What data to go for?
• Overall data on FEV1 and BMI, children and adults, is a good start.
• BUT most CF patients die from chronic lung infection with Pseudomonas, Burkholderia, Achromobacter etc.
• THEREFORE data on how our CF Care Centres handle and treat these infections, and the clinical output they get, IS IMPORTANT AND URGENT FOR PATIENTS
NACFConference 2008
NACFConference 2008
Christine Rønne Hansen, 2009
Christine Rønne Hansen, 2010
Christine Rønne Hansen, 2010
Factors which affect the outcome of CF
• CF mutations + ’modifier genes’.- all mutations demand treament when lung infection is present
• Lung infection (main cause of death in CF)- Infection type (pseudomonas, burkholderia, achromobacter etc.)- Treatment - Age when infection debut- Individuel reaction to infection (immunrespons)- Individuel reaction to treatment (allergy)- Not possible to predict individual treatment effect or output
• The individual approch – Living with CF - Acceptance - Understand CF as a disease and it’s development - Capabillty of action
• Social factors - country vs city (zip codes), education, family situation
PRO - Take Home Messages
• Most patients do not wish to change CF Care Center.
• Patients just want their doctors to give them access to the treatments with best clinical output.
• For patients, it’s not important by whom a treatment has been developed, as long as it works.
• Open data and open treatment standards bring the ’best treatments’ to patients faster.
• Open data and open treatment standards may expose the practice of some doctors. It may hurt doctors egos and personal feelings,
• BUT - The patients always come first.
• We pay the ultimate price for bad choices - with our lives.