Identify the clinical problem and research problem that led to the study. What was not known about the clinical problem that if understood could be used to improve health care delivery or patient outcomes?

Background of Study:

·         How did the author establish the significance of the study? In other words, why should the reader care about this study? Look for statements about human suffering, costs of treatment, or the number of people affected by the clinical problem.

·         Identify the purpose of the study. An author may clearly state the purpose of the study or may describe the purpose as the study goals, objectives, or aims.

·         List research questions that the study was designed to answer. If the author does not explicitly provide the questions, attempt to infer the questions from the answers.

·         Were the purpose and research questions related to the problem?

 Methods of Study

·         Identify the benefits and risks of participation addressed by the authors. Were there benefits or risks the authors do not identify?

·         Was informed consent obtained from the subjects or participants?

·         Did it seem that the subjects participated voluntarily in the study?

·         Was institutional review board approval obtained from the agency in which the study was conducted?

·         Are the major variables (independent and dependent variables) identified and defined? What were these variables?

·         How were data collected in this study?

·         What rationale did the author provide for using this data collection method?

·         Identify the time period for data collection of the study.

·         Describe the sequence of data collection events for a participant.

·         Describe the data management and analysis methods used in the study.

·         Did the author discuss how the rigor of the process was assured? For example, does the author describe maintaining a paper trail of critical decisions that were made during the analysis of the data? Was statistical software used to ensure accuracy of the analysis?

·         What measures were used to minimize the effects of researcher bias (their experiences and perspectives)? For example, did two researchers independently analyze the data and compare their analyses?

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