Acne Core
Outcomes Research
Network 2017:
Progress and
Problems
Diane Thiboutot, MD Penn State University USA
Jerry Tan, MD Windsor Clinical Research Canada
Anne Eady, PhD Harrogate UK
Alison Layton, MD Harrogate UK
ACORN membership
Stakeholder type
Number
Location
Health care
professionals
72
North America 42
Patients
6
Central &
7
South America
Industry
10
Europe
27
Non-clinical
researchers
2
Africa
2
Other
2
Asia/Far East
12
Australasia
2
TOTAL MEMBERS
92
Number
Projects to discuss
Systematic review of the impacts of
acne
Consensus exercise on developing
core set of outcome domains
PRISMA: Systematic review
of the impacts of acne
Impacts of acne review –
problems encountered 1
 Selection and piloting of search terms for
identifying relevant articles in databases
 10:1 ratio of “misses” to “hits”
 Sticking to the protocol
 Could not second guess what the searches would turn up
 Data summarised/reported in many different ways
 Many studies included no comparator group or
normative data so interpreting the meaning of
scores was very difficult
 Had to search literature for normative data by country of origin of
the study e.g. for SF-36
 In absence of control group, sought correlations with severity to link
some impacts to acne
Impact review – problems
encountered 2
Results of focus groups/interviews in QoL
development not reported
 The data we wanted existed but was not published!
Obtaining usable data from many QoL studies
 Often have only a mean total score for a multidimensional
instrument
 In some instruments, even single items address more than one
construct
 Forced to work at a higher level than we had hoped e.g. impact
on emotions in general and not on specific ones, OR exclude
these studies
Instruments to measure acne impacts
Instrument
No of studies in which
it was used
Key reference (if dermatology or
acne specific)
DLQI
54
Finlay et al 1994
CADI
36
Motley & Finlay 1992
Acne-QoL
28
Girman et al 1996
HADS
26
Skindex-29
22
SF-36
21
Skindex-16
12
Beck Depression Inventory
16
CDLQI
14
Rosenberg Self-esteem Scale
14
Spielberger State-Trait Anxiety
Inventory
9
GHQ-12
9
Chren et al 1997
Chren et al 2001
Lewis-Jones & Finlay 1995
Developing core set of
outcome domains–
participation in each round
Round
1
2
3
1In
No. of
patients
2991
52
34
No. of
professionals
3071
112
82
Total
number
500
164 (of 260)
116
this round, participants could select more than one option to identify their
status. Many professionals also identified themselves as current or past
patients. In the following rounds, they could only select one option.
Outcome domains– problems
encountered 1
How to define an item, outcome, domain, area
or construct on the list for voting.
 Chose items most easily understood by patients
 An item could be a domain (e.g. HRQOL), subdomain (e.g. mental
health) or a single construct (e.g. self-esteem, speed of
improvement)
 Deciding how many outcomes to include in the
core set (no target number)
 What to do when a commonly used outcome looks
like it will score too low to be included in the core
set
 This happened twice (once in round 1, once in the final round)
 Used the CSG Outcomes Identification Group as arbiters
Outcome domains– problems
encountered 2
 Stakeholder engagement and retention
 Shared ownership vital to universal adoption
 Conventional Delphi did not seem appropriate
given the number of stakeholder types and the
requirement for international representation
 Ended up with a hybrid approach
 Did some patient participants truly understand what was being
asked of them?
 Concern re: bias
 Had to abandon Delphi technique for final round
 Median score for all items in the previous round was 7 or 8 (on 19 scale)
 If data were fed back to respondents, most likely outcome was
that those with low scores would revise them upwards, the exact
opposite of what we wanted!
Outcomes included in the COS
1.
Satisfaction with appearance
2.
Long-term control of acne
3.
Extent of scars and dark marks1
4.
Signs and symptoms of (active) acne2
5.
Satisfaction with treatment received
6.
HRQOL3
7.
Global acne severity assessed by a healthcare professional 3, 4
1Added
after round 1 (suggested by participants), 2No agreement as
to who should assess these, 3Re-instated after round 1 (both ranked
outside the top 12), 4Strongly endorsed by professionals, disliked by
patients – included following arbitration.
ACORN seeks feedback on
developing core outcome
domains:
 Ensuring unbiased international stakeholder engagement and
retention in the overall process
 Sticking to pre-agreed protocols when findings were so
unpredictable for both the impact review and the ‘what to
measure’ exercise (for example, high scores for every item in the
first Delphi round).
 Identifying the best way forward when commonly used outcomes
look like they will fall out of the ‘what to measure’ exercise (e.g.
investigator IGA).
 Deciding the final number of outcomes in the core set when an
item on the list for voting/scoring could be a domain, sub-domain
or a single construct.
ACORN seeks feedback on
systematic review:
 How to deal with data from QoL questionnaires which are
invariably multidimensional and cannot be extracted at the
level of a single construct which would be much more useful to
inform what to include in any new instrument.
 Interpreting the meaning of scores on the wide range of
instruments used to assess impacts when study authors often did
not report this and many instruments are not freely available.
 THANK YOU!