1. RCT Critical appraisal 高雄長庚醫院外科加護護理長 長庚科技大學護理系講師 Cochrane Bone, Joint, Muscle Trauma Group

2. Basic information about the trial First author Olson DM Publication year2009 Title Effect of mechanical chest percussion on intracranial pressure: a pilot study CountryUS Funding source National Institute for Nursing Research (T32 NR07091 Interventions to Prevent and Manage Chronic Illness)

4. Levels of evidence pyramid (for therapy/prevention, aetiology/harm) Cochrane reviews Non-Cochrane systematic reviews Randomised controlled trials Cohort studies Case-control studies Case series/report Expert opinions without explicit critical appraisal, theory based on physiology or plausibility, bench studies, animal studies Ib

5. Are the results of the trial valid? Item 1 AppraisalComments Was the assignment of patients to interventions randomised? ■ Yes Unclear □ Unclear No □ No 所有患者依 隨機分為兩 組 If the trial is not a RCT, we should put it aside unless there are no RCTs. If the trial is not a RCT, we should put it aside unless there are no RCTs.

6. Are the results of the trial valid? Item 2 AppraisalComments Was the allocation concealed? Yes □ Yes ■ Unclear No □ No No description

7. Are the results of the trial valid? Item 3 AppraisalComments Were the groups similar at the start of the trial? ■ Yes Unclear □ Unclear No □ No 在 mean age, gender, race, post injury day, diagnosis 等方面，兩 組無明顯差異

8. Are the results of the trial valid? Item 4 AppraisalComments Was follow-up of patients sufficiently long and complete? ■ Yes Unclear □ Unclear No □ No 11:50 AM to 12:20 PM Assuming the effect of chest percussion on ICP is instant and only transient Assuming the effect of chest percussion on ICP is instant and only transient

9. Are the results of the trial valid? Item 5 AppraisalComments Were all patients analysed in the groups to which they were randomised? (Intention-to-treat analysis) ■ Yes Unclear □ Unclear No □ No

10. Are the results of the trial valid? Item 6 AppraisalComments Were measures objective or were the patients and clinicians kept “blind” to which intervention was being received? ■ Yes Unclear □ Unclear No □ No ICP monitor was used.

11. Are the results of the trial valid? Item 7 AppraisalComments Were groups treated equally, apart from the experimental therapy? ■ Yes Unclear □ Unclear No □ No

12. Are the results of the trial valid? Yes Randomisation Allocation concealment Comparability of the groups Follow up Intention-to-treat analysis Blinding/objective measures Equal care Yes (low risk of bias) Unclear No (high risk of bias)

13. If the results of the trial are valid, how important are they? Item 1 ResultsComments What is the magnitude of the intervention effect?

14. Results Hypothesis testing was done by using 2-way analysis of variance for median and mean values to explore within- and between-subject models. Mean and medial values were determined for the 10-minute epoch before chest percussion was performed on the intervention group (11:50 AM- noon), during chest percussion (noon-12:10 PM), and after chest percussion was performed on the intervention group (12:10-12:20 PM).

15. Between-patient model: no differences in ICP between the patients or among the 3 time epochs The between-patients models were insufficient to reject the null hypothesis for the omnibus test of difference in mean ICP (F = 0.19, P = 0.83) or median ICP (F = 0.14, P = 0.87). Similarly, the data were insufficient to reject the null hypothesis of a difference in mean or median for any of the 3 time epochs (Table 2).

16. With-subject model: no differences among the 3 time epochs The within-subject differences in mean ICP across the 3 time epochs also were not significant (P = 0.96). The data (Table 3) were explored for comparison of slopes by using the general linear model. No evidence of unequal slopes was apparent across all 3 time periods combined (F = 0.55, P = 0.46) or for the 10 minutes during which the intervention group received chest percussion (F=0.10, P = 0.76).

17. If the results of the trial are valid, how important are they? Item 1 ResultsComments What is the magnitude of the intervention effect? No differences in ICP between the patients or among the 3 time epochs. No differences in ICP between the patients or among the 3 time epochs. No differences in ICP before, during, and after chest percussion. No differences in ICP before, during, and after chest percussion. Complicated multiple comparisons did not show differences in ICP after chest percussion.

18. If the results of the trial are valid, how important are they? Item 2 ResultsComments How precise is the estimate of the intervention effect? Low precision 13 vs. 15 participants

19. Are the results of the trial clinically relevant? Yes

20. Can we apply the results of the trial to our patients? Item 1 AppraisalComments Is our patient so different from those in the trial that its results cannot apply? Yes □ Yes ■ No Unclear □ Unclear 我們有同樣的 病人與情境

21. Can we apply the results of the trial to our patients? Item 2 AppraisalComments Is the intervention feasible in our setting? ■ Yes No □ No Unclear □ Unclear 我們有相同的 設備與介入措 施

22. Can we apply the results of the trial to our patients? Item 3 Appraisal What are our patient’s potential benefits and harms from the therapy? Benefits: potential benefits in preventing aspiration pneumonia. Harms: No significant potential harms.

23. Can we apply the results of the trial to our patients? Item 4 Appraisal (Optional) What are our patient’s values and expectations for both the outcome we are trying to prevent and the intervention we are offering? ( 手邊的病人 ) Patient’s values: 頭部外傷病人需預防肺 炎與感染合併症縮短住 院天數。 Patient’s expectation: 希望有療效，且不傷身。

24. Can we apply the results of the trial to our patients? Yes

25. 感謝聆聽，敬請指教