Speaker ：R1吳師豪 Supervisor：VS吳孟書 2008-08-27 Journal reading Speaker ：R1吳師豪 Supervisor：VS吳孟書 2008-08-27

Randomized controlled trial of asthma education after discharge from an emergency department MSR Khan, et al. J. Paediatr. Child Health (2004)40, 674–677 Sydney Children’s Hospital at Randwick, Sydney, New South Wales, Australia

Meta-analysis Forest plot The Evidence Pyramid Animal research In vitro (test tube) research Case series/ Reports Ideas, Editorials, Opinions Case Control Studies Cohort studies Randomized Controlled Studies Randomized Controlled Double Blind Studies Meta - analysis Meta-analysis Forest plot Hierarchy of evidence that arranges study designs by their susceptibility to bias.

Grade of Recommendation Level of Evidence Therapy Systemic review of RCTs 1b Single RCT 1c ‘All-or-none’ [B] 2a Systemic review of cohort studies 2b Cohort study or poor RCT 2c ‘Outcomes’ research 3a Systemic review of case-control studies 3b Case-control study [C] 4 Case series [D] 5 Expert opinion, physiology, bench research Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed. David L. Sackett, Sharon E. Straus, W. Scott Richardson, William Rosenberg, R. Brian Haynes. Churchill Levingstone. 2000, p173-177

Background (1) The importance of patient education and recommend the use of written asthma action plans during exacerbations. Lack of parental knowledge and lack of use of a written asthma action plan during an emergency has been associated with increased admissions and ED visits.

Background (2) However, the Cochrane review by Haby and her colleagues of children who had attended the ED with asthma found that education to their parents or to them neither reduced subsequent ED visits, hospital admissions nor unscheduled doctor visits.

Background (3) The aim of this study was to determine whether education provided by telephone soon after discharge from the ED with asthma improves asthma management and control.

Methods (1) Design and setting Time frame and Participants This was a randomized, single blinded, controlled trial. At the Emergency Department of Sydney Children’s Hospital Time frame and Participants 16 October 2000 ~ 28 February 2002.

Methods (2) Inclusion Criteria: Exclusion criteria Those who were discharged from the Emergency Department of Sydney Children’s Hospital with asthma Exclusion criteria Parents whose English was inadequate to complete the questionnaires and conduct the telephone consultation in English.

Methods (3) Information were collected at baseline and 6 months later symptoms, parental asthma knowledge, parental quality of life and use of asthma action plans and preventer therapy.

Methods (4) The primary outcome measure was number of days of wheezing in the last 3 months. Intermediate outcomes were possession and use of a written asthma action plan during a crisis, use of preventer medication, increased asthma knowledge scores and parental quality of life scores.

Methods (5) Other secondary measures were number of visits to GP/paediatricians, Number of attendances at ED and admissions to hospital with asthma in the previous 6 months.

Methods (6) Comparisons were made using as appropriate. χ2 Mann–Whitney U, Wilcoxon-signed rank, or McNemar’s tests

Result (1) Baseline data: 50.3% of controls, 56.1% of intervention group with infrequent episodic asthma or a first attack. 54.2% in control and 57.4% in intervention had a written asthma action plan The control group children were more likely to use preventers than the intervention group (55.5% vs 43.9%).

Results (2)

Result (3)

Results (4)

Results (5)

Conclusions Reinforcement by telephone consultation did not improve the primary outcome of wheeze in the last 3 months. However, it increased the possession and regular use of written asthma action plans in the intervention group.

Discussion Was the intervention ineffective? It is possible that the large improvement in both groups represented a seasonal effect and that this might have swamped any possible positive effects.

Critical Appraisal Skills VIP Valid: 研究方法的探討 Important: 結論的分析 Practice: 如何運用來照顧病人 RCT / Cohort study / Case-control study

Critically Appraising the Evidence-1 Validity (closeness to the truth) Was the assignment of patients to treatment randomized? Yes Was follow-up of patients sufficiently long and complete (follow-up > 80%) ? Yes Were all patients analyzed in the groups to which they were randomized? Yes

Critically Appraising the Evidence-2 Were patients and clinicians kept blind to treatment? No, only single blind Were groups treated equally, apart from the experimental therapy? Yes Were the groups similar at the start of the trial? Yes

Critically Appraising the Evidence-3 Validity: Selection bias: No Information bias: No Confounding: Inter-observer bias: No Reliability of measurement: Intra-observer: Yes internal consistency Yes

Critically Appraising the Evidence-4 Impact (size of the effect, clinical importance NNT (number needed to treat) = 1/ARR (absolute risk reduction) NNH (number needed to harm) = 1/ARI (absolute risk increase) Applicability (usefulness in our clinical practice) Integrating the evidence with our clinical expertise and patients’ values and preferences.

範例說明

Written asthma action plan between intervention and control patients Control Event Rate ( CER) = 72.3% Experimental Event Rate ( EER) = 87.5% Relative Risk = 87.5%/72.3% = 1.21 Relative Risk Reduction = |1 – RR| = 0.21 Absolute Risk Reduction ( ARR)= |72.3% - 87.5%| = 15.2% Number Need to Treat( NNT) = 1/ARR = 1/1% = 6.58 Written asthma action plan Present Absent Intervention group 119 17 Control group 94 36

Conclusion: Integrate with our clinical practice Is reinforcement by telephone consultation efficacy for increased the possession and regular use of written asthma action plans in the intervention group ? NNT: 6.58 (efficacy of written asthma action plan between intervention and control patients)

The primary outcome of wheeze in the last 3 months between intervention and control patients Control Event Rate ( CER) = 2.31% Experimental Event Rate ( EER) = 1.47% Relative Risk = 1.47%/2.31% = 0.6364 Relative Risk Reduction = |1 – RR| = 0.3636 Absolute Risk Reduction ( ARR)= |2.31% - 1.47%| = 0.84% Number Need to Harm( NNH) = 1/ARR = 1/0.84% = 119.05 outcome of wheeze Present Absent Intervention group 2 134 Control group 3 127

Conclusion: Integrate with our clinical practice Is reinforcement by telephone consultation efficacy to improve the primary outcome of wheeze in the last 3 months in the intervention group ? NNH: 119.05 (negative) (The primary outcome of wheeze in the last 3 months between intervention and control patients)

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