Quantitative Study on a Pediatric Population

¶ … protection human participants, data collection, data analysis, problem statement, interpretation findings. Each study analysis 750-1,000 words submitted document.

CRITICAL APPRAISAL: QUANTITATIVE STUDY

Protection of Human Participants

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

The subjects of the quantitative study were children who had undergone hematopoietic stem cell transplantation, "an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects" (Chamorro-Vina 2012: 1). The participants had already elected to go through the procedure before the study began.

• Was informed consent obtained from the subjects or participants?

Consent was obtained from the legal guardians; the children were not cognitively impaired and the children had to give their verbal agreement to participate (Chamorro-Vina 2012: 4).

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

Yes, given they voluntarily submitted to an exercise program and both their and their parents' consent was obtained.

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

The Alberta Hospital's approval was given (where the study was conducted).

Data Collection

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

The independent variable was participation in an exercise program for the transplant recipients; the dependent variable was improvement on health-related fitness assessments.

• How were data collected in this study?

Data was collected via physicians and participants through established questionnaires to determine patient health along with objective physical fitness tests of factors such as muscular fatigue.

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

This was to allow for more holistic data input and also for objective evidence of program success.

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

The exercise program was instituted in the hospital for two weeks, followed by a 10-week program after discharge in an outpatient setting.

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

First, data was accumulated on the patient regarding their health status from the physician and the participants themselves. Fitness was assessed at baseline followed by a comprehensive assessment after the exercise regime in the experimental group. "Once consent has been obtained, the research nurse will be responsible for instructing participants (parents and pediatric patient) (1) on the use of the accelerometers and log book, (2) on how to perform the food record, and (3) on the QOL [Quality of Life] assessment" (Chamorro-Vina 2012:6).

Data Management and Analysis

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

Data was accumulated via physicians and healthcare providers in the hospital setting and by participants, after being instructed, during the outpatient setting.

• 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?

According to the researcher regarding the research (which is still ongoing): "these data will provide a detailed and complete understanding of the effect of an EX-program in pediatric cancer patients undergoing autologous SCT. From our knowledge, this study will be one of the most comprehensive studies in this population, and will provide an initial database along with the impetus to promote a multisite study" (Chamorro-Vina 2012:9).

• 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?

The dual use of different sources of information (providers and patients) is used to minimize biases. A mid-term assessment was used to ensure that data was being tracked accurately and to ensure that baseline and final health data was reflective of reality.

Findings / Interpretation of Findings

• What is the researcher's interpretation of findings?

The conclusion of the researcher was that the exercise regime will likely significantly improve patient outcomes in terms of fatigue, quality of life, and fitness once the study is terminated

• Are the findings valid or an accurate reflection of reality? Do you have confidence in the findings?

The findings seem to be logical, despite the limits of the study and the study, although small, had a randomized control design, considered the gold standard of medical research.