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Journal club

Andrew Wakefield

In 1998, Wakefield and colleagues published an


article in The Lancet claiming that the measles
vaccine virus in MMR caused inflammatory bowel
disease and autism
The validity of this finding was later called into
question when it could not be reproduced by
other researchers.
In addition, the findings were further discredited
when an investigation found that Wakefield did
not disclose he was being funded for his research
by lawyers seeking evidence to use against
vaccine manufacturers.
Wakefield was permanently barred from
practicing medicine in the United Kingdom

Problems faced
Skepticism leading to emergence and
out- breaks of diseases in children
due to refusal of vaccination

Decision aids a solution?


Typical government information
empahsises the risks of not havingthe
vaccine with the aim of increasing uptake
patient decision aidsare a different type of
information resource that provide
detailedinformation on the probable risks
and benefits of having and nothaving the
MMR vaccination, encouraging people to
deliberate abouttheir MMR beliefs may
affect their motivation to vaccinate

New Zealand, a childhood immunisation


paperbased decision aid reduced parents
anxiety about making the decision and
encouraged promptness in vaccination.
An Australian MMR vaccination web based
decision aid resulted in parents having
more positive views towards MMR, feeling
more informed.
This decision aid was subsequently
adapted for UK parents

A cluster randomised controlled trial


of a web based decision aid to
support parents decisions about
their childs Measles Mumps and
Rubella (MMR) vaccination
S. Shouriea,1, C. Jacksona,, F.M.
Cheatera,2, H.L. Bekkerb, R. Edlinb,3, S.
Tubeufb, W. Harrisonc, E. McAleesed, M.
Schweigerd, B. Bleasbye, L. Hammondf

Published in journal
-Vaccine 2013
edition by Elsevier

Objective: To evaluate the


effectiveness of a web based
decision aid versus a leaflet versus
usual GP practice in reducing parents
decisional conflict for the first dose
MMR vaccination decision. The,
impact on MMR vaccine uptake was
also explored.

Study design appropriate


Level of quantitative evidence
Systemic review
RCTs
Non randomized controlled trials
Cohort studies
Case control studies
Observational studies

Design
Three-arm cluster randomised controlled trial.
Setting: Fifty GP practices in the north of,
England
Participants: 220 first time parents making a
first dose MMR decision.
Interventions: Web, based MMR decision aid
plus usual practice, MMR leaflet plus usual
practice versus usual practice only, (control).
Main outcome measures: Decisional conflict was
the primary outcome and used as the, measure
of parents levels of informed decision-making.
MMR uptake was a secondary outcome.

First arm
MMR decision aid plus usual practice
Parents were posted the web link for the
MMR decision aid and to reduce
contamination risk were provided with a
personal login to access it.
They continued to receive usual practice
from their GP practice.
It can be accessed at www.leedsmmr.co.uk
50 parents

Second arm
MMR leaflet plus usual practice
Parents were sent the Health Scotland
leaflet MMR your questions answered
and received usual practice.
Prior evidence in increasing MMR uptake
but does not fulfill requirement to be a
decision aid.
93 parents

Control arm
Usual practice only (control) Parents
received the usual service provided by
their GP practice.
Included an appointment for the first
dose MMR vaccination, a leaflet
(usually MMR the Facts ), and the
offer of a consultation if the parent had
concerns.
77 parents

Recriutment
Parents identified via GP practices
Interested parents are contacted and
demographics data are taken down
Baseline questionnaires given
Parents are then randomized to three arms
After assignment to each arm, researchers
and participants are no longer blinded
Follow up questionnaires given 2 weeks
after intervention

Baseline characteristics
There were no statistically significant
differences in parental or child
characteristics across the three trial arms (all
p > 0.1).
Most parents were white British mothers, in
their early 30s, married or co-habiting.
Approximately half were educated beyond
18 years and in full-time employment
children were 89 months old at recruitment.

Decision aid

Leaflet
Health Scotland leaflet MMR your
questions answered
Unable to find

Primary outcomes
Decisional conflict scale assesses
psychometric properties in decision
makin
This 16-item (questions) validated
scale and five sub-sections:
Informed informed about decision
values clarity personal values, risk and
benefit
Support supported in decision making
Uncertainty certain about decision
effective decision good or bad decision

Traditional Decisional
Conflict Scale (DCS)
1.
2.
3.
4.

I
I
I
I

know which options are available to me.


know the benefits of each option.
know the risks and side effects of each option.
am clear about which benefits matter most to
me.
5. I am clear about which risks and side effects
matter most.
6. I am clear about which is more important to me
(the benefits or the risks and side effects).
7. I have enough support from others to make a
choice.
8. I am choosing without pressure from others.
9. I have enough advice to make a choice.
10. I am clear about the best choice for me.
11. I feel sure about what to choose.
12. This decision is easy for me to make.
13. I feel I have made an informed choice.
14. My decision shows what is important to me.
15. I expect to stick with my decision.
16. Iamsatisfiedwithmydecision.
Decisional Conflict Scale AM OConnor, 1993,
revised 2005

Strongly Agree
[0]
Agree
[1]
Neither Agree Or
Disagree [2]
Disagree
[3]
Strongly Disagree
[4]

Scoring and interpretation

TOTAL SCORE
16 items [items 1-16 inclusive] are: a) summed; b) divided by 16; and c)
multiplied by 25. Scores range from 0 [no decisional conflict] to 100 [extremely
high decisional conflict].
UNCERTAINTY SUBSCORE
3 items [ 10, 11, 12 ] are: a) summed; b) divided by 3; and c) multiplied by 25.
Scores range from 0 [feels extremely certain about best choice] to 100 [feels
extremely uncertain about best choice].
INFORMED SUBSCORE
3 items [ 1, 2, 3 ] are: a) summed; b) divided by 3; and c) multiplied by 25.
Scores range from 0 [feels extremely informed] to 100 [feels extremely
uninformed].
VALUES CLARITY SUBSCORE
3 items [ 4, 5, 6 ] are: a) summed; b) divided by 3; and c) multiplied by 25.
Scores range from 0 [feels extremely clear about personal values for benefits &
risks/side effects] to 100 [feels extremely unclear about personal values]
SUPPORT SUBSCORE
3 items [ 7, 8, 9 ] are: a) summed; b) divided by 3; and c) multiplied by 25.
Scores range from 0 [feels extremely supported in decision making] to 100 [feels
extremely unsupported in decision making].
EFFECTIVE DECISION SUBSCORE
4 items [ 13, 14, 15, 16 ] are: a) summed; b) divided by 4; and c) multiplied by
25. Scores range from 0 [good decision] to 100 [bad decision].

Primary out come results


parents in all three arms reported levels of
decisional conflict associated with
difficulties in making an informed decision
Post-intervention, mean decisional conflict
had decreased for parents in both
intervention arms
The greatest reduction in decisional
conflict occurredfor parents in the
decision aid arm, and this was evident for
all fivesubscales (all p < 0.001

Secondary outcome
MMR vaccination uptake data for 203 children (93%)
were collected from GP practices.
48 in the decision aid arm
85 in the leaflet arm
70 in the control arm

Vaccination uptake was 100%, 91% and 99%


respectively
Statistical significant difference in uptake between
the leaflet and 311 control arms (8%, 95% CI 1
15%, p = 0.04), and between the decision aid and
leaflet arms (9%, 95% CI 316%, p = 0.05), but not
between 313 the decision aid and control arms (1%,
95% CI 1 to 4%, p = 0.99)
Did not explain statistical signicance of leaflet arms.

Comclusion
Parents decisional conflict was
reduced in both, the decision aid and
leaflet arms. The decision aid also
prompted parents to act upon that
decision and, vaccinate their child.
Achieving both outcomes is
fundamental to the integration of
immunisation, decision aids within
routine practice

Limitation
Not double blinded
Different gp practise consistency
Population of study do not reflect local
population
At baseline there was a statistically significant
difference in decisional conflict across the three
arms F(2,192) = 3.42, p = 0.04)
Despite statistical significantly lower decisional
conflict of leftlet arm compared to control in the
primary outcome, uptake of MMRvaccine in the
secondary outcome is statistically lower

Conclusion
Well informed patients make well
informed decisions
But the Challenge is to provide the
information
Decision aids is one way to doing this
Local application may see future
benefits