Hi base on the number of the explanation could u please justify why…

Hi base on the number of the explanation could u please justify why this study of RCT way of doing is better from evidence base practice. example t randomization study is better due to whyyy and compare with other ebp rct methods. for all questions. thank u

 

 

1. True randomization was used for assignment of participants to treatment groups because there were 

709 in-hospital patients at risk for pressure ulcers from 25 medical, surgical, and intensive care units of 12 Italian hospitals and they selected the randomly and assigned clinical trial participants to treatment groups such that each participation has a known (usually equal) chance of being assigned to any of the groups. Patients were recruited from 25 medical, surgical and intensive care units of 12 hospitals in North and Central Italy, including three Research Institutes, three large-size teaching hospitals and six small-size to large-size public general hospitals. The ordering of patients within each block was also randomly assigned using a computerized research randomizer (www. randomization.com). The randomization list was generated by the principal investigator at the research center outside the hospitals.

2.The allocation sequence was concealed from the research nurse enrolling and evaluating participants in sequentially numbered opaque, sealed, and stapled envelopes. 

3. Yes, beacuse the investigator is more confident and observed differences in outcomes between the groups that are related to the intervention rather than confounding factors.

4.The participants and the healthcare professionals were not blinded due to the nature of the intervention. Moreover, the skin imprint after the foam removal made impossible to blind the outcome assessor.

5. Treatment groups were treated identically. Standard PUs preventive care – All included patients received standard PU prevention according to hospital protocols, based on contextualization and adaptation of International guidelines.

6. The sample-size calculation was based on the results of a previous single center randomized clinical trial (27) with an incidence of PUs of any grade of 4.5% in the experimental group and of 15.4% in the control group. Assuming similar results in the populations included in this study, 228 patients had to be randomized to ensure a power of 80% to detect the expected difference with a two-sided alpha error of 5%. To evaluate the effectiveness of using polyurethane foams in each subgroup defined by hospital areas (medical, surgical, intensive care), the same sample size had to be guaranteed in each group. Considering a possible 10% follow-up loss and assuming a 10% withdrawal proportion, the planned sample size was 280 patients per area for a total of 840 patients (420 per arm).

 

 

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