Method After Approval Question & Answer Guide (With Explanation)

This question tests key academic concepts commonly covered in coursework.

What This Question Is About

This question relates to method after approval and requires a structured academic response.

How to Approach This Question

Start by identifying the main issue, then apply relevant academic frameworks.

Key Explanation

This topic involves method after approval. A strong answer should include explanation, application, and examples.

Original Question

Method After approval from Wonderful Children’s Hospital (WCH) Institutional Review Board for Human Research, the researchers submitted a request to the Clinical Data Warehouse to acquire the medical record numbers of all infants (defined as aged < 12 months) who had been on noninvasive respiratory support via high flow nasal cannula (flow rate of at least 2 liters per minute) or low flow nasal cannula (< 2 liters per minute) in any unit of WCH during the period of January 1, 2024 to January 1, 2025. A total of 300 patients met this criterion, and their electronic medical records were individually accessed to collect data. Of these patients, 80 were removed because they were on HFNC for < 24 hours. Of the remaining 220 patients, data were collected and recorded using de-identified alphanumeric labels (ex. P001). The sample was organized into two groups: the exposure group (those who were orally fed during HFNC use) and the control group, (those who were not orally fed during HFNC use). The primary outcome measures collected were hospital length of stay, time on HFNC or low flow nasal cannula (LFNC), and documented adverse events like coughing, escalation of care (i.e. - increased respiratory support levels), and new onest pulmonary diagnoses like aspiration pneumonia. Data were also collected on patient-level variables like age at admission, gestational age at birth, and admission diagnosis. Statistical analysis was conducted using SAS software (SAS Institute Inc., Cary, NC). 1. Recruitment a. What was the sampling method used to recruit the participants? b. Is it a probability/random method or non-probability method? (Explain). 2. Inclusion/Exclusion criteria a. What was the main inclusion criteria? b. Name one exclusion criteria. 3. Group assignment a. Were the participants randomly assigned to their intervention group? b. What are the advantages of randomization and what would be the consequences of not randomizing? 4. Variables and Variance a. What is the independent variable? b. What are the levels of the independent variable? c. What are the dependent variables? d. What strategy was used to reduce secondary variance? 5. Sample size a. Our sample size is N=220. Explain the ramifications of increasing and/or decreasing the sample size.

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