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 facedSkepticism 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 uptakepatient 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 evidenceSystemic reviewRCTsNon randomized controlled trialsCohort studiesCase control studiesObservational studies

DesignThree-arm cluster randomised controlled trial.Setting: Fifty GP practices in the north of, EnglandParticipants: 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 armMMR decision aid plus usual practiceParents 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.uk50 parents

Second armMMR 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 armUsual 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 practicesInterested parents are contacted and demographics data are taken downBaseline questionnaires given Parents are then randomized to three armsAfter assignment to each arm, researchers and participants are no longer blinded Follow up questionnaires given 2 weeks after intervention

Baseline characteristicsThere 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 employmentchildren were 89 months old at recruitment.

Decision aid

LeafletHealth Scotland leaflet MMR your questions answered Unable to find

Primary outcomesDecisional 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. I know which options are available to me. 2. I know the benefits of each option. 3. I know the risks and side effects of each option. 4. I 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 resultsparents in all three arms reported levels of decisional conflict associated with difficulties in making an informed decisionPost-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 outcomeMMR vaccination uptake data for 203 children (93%) were collected from GP practices. 48 in the decision aid arm 85 in the leaflet arm70 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 115%, 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 blindedDifferent gp practise consistencyPopulation of study do not reflect local populationAt 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 decisionsBut the Challenge is to provide the informationDecision aids is one way to doing thisLocal application may see future benefits