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Quantitative Research Critique and Ethical Considerations
Introduction
The research question that is the focus of this paper is that; in patients suffering from obesity, does exercise and lifestyle changes, compared with only medical therapy, improve health status and reduce weight in a period of one year? The paper will involve a critique of a quantitative study to support the efficacy of exercise and lifestyle modification programs over medical therapy in weight loss among obese patients.
Background of Study
Quantitative research by Burguera et al. (2015) identifies morbid obesity as a clinical problem that requires more efficacious non-surgical interventions than conventional obesity therapy (COT). While previous RCTs associate behavioral and/or pharmacological methods with significant weight loss and maintenance, they did not include morbidly obese subjects nonsurgical candidates. The significance of the study is established by providing statistics related to prevalence of morbid obesity (MO) in America (8%), associated complications/effects low quality of life and social stigma. The authors also indicate that a 10% weight loss by MO patients is recommended to avert cardiovascular comorbidities (Burguera et al., 2015).
The purpose of the study is clear from its aims and objectives. The authors sought to compare the efficacy of intensive lifestyle intervention (ILI) with either COT or Bariatric surgical intervention in weight loss in MO patients after a six-month follow-up (Burguera et al., 2015). The study involved a 24-month trial. The research questions are explicitly stated. However, from the study background, two research questions can be inferred: (1) what are the beneficial effects of ILI on MO patients, compared to COT-surgery combination therapy? And (2) how is weight loss maintained after six months following a 24-month ILI intervention? The studys purpose and the inferred questions are closely related to the research problem.
Methods of Study
The stated benefits of participation included specialist help with lifestyle changes Mediterranean diet and daily aerobic exercises and weight loss medicines (Orlistat) for the ILI group. In contrast, the MO patients in the COT group and the Surgical Obesity Group (SOG) received standard care and monitoring at no cost. The risks of participation are not stated. However, according to Polit and Beck (2012), the potential risks of participating in clinical trials include unknown side effects and the possible treatment failure or minimal response. Informed consent was obtained from all the subjects. Additionally, the Bariatric Surgery Program group gave written informed consent before the surgery.
It seems that subject participation was voluntary. The participants received no cash payments or inducements that could be considered coercive. However, as expected in any a controlled clinical trial, they did not pay for medical care or medicines. The researchers obtained IRB approval before commencing the study.
All the major variables of the study are well defined. The independent variables are the COT, ILI, and SOG interventions, while the dependent (outcome) variable is weight loss (BMI decrease) during the 24-month study period. Data collection involved obtaining the body weight and BMI (Kg/m2) measurements of the subjects at baseline and during clinic visits. Also, quarterly measurements of four secondary outcomes were measured fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), blood pressure (BP), and fasting lipid level (Burguera et al., 2015, p. 3).
The author does not provide a rationale for using this data collection approach. However, since the study involves a comparison of the health impact of three obesity interventions, collecting subject body weight and BMI data of subjects in each group seems appropriate for the study. The data collection period was 24 months plus a six-month follow-up.
Data collection events for a participant started with obtaining baseline data body weight, height, BMI, and clinical data. Subject height/weight measurements were taken simultaneously in light clothing, without shoes, and with the Frankfurt, plane posture using a digital beam scale containing an affixed height measure/tape (Burguera et al., 2015).
BMI was computed by obtaining the ratio between weight (Kg) and height (m). The subsequent weight and height measurement timelines depended on the intervention group. It was done weekly for the ILI group, quarterly for the COT subjects, and during routine checkups for the SOG group. Secondary clinical outcomes were measured quarterly for all the participants. Blood tests FPG, HbA1c, and BP were performed on a fasting blood sample (40mL) collected from each subject in a seated position on a quarterly basis after intervention initiation (Burguera et al., 2015). The secondary data were used in the analysis.
The studys data management and analysis methods included analysis of variance (ANOVA) and Fishers test for between-group comparisons. Variable demographic and clinical traits comparisons at baseline involved chi-square tests (Burguera et al., 2015). Bonferroni pairwise analysis was used to perform comparisons of intervention significance.
The rigor of the research process was assured through effective sample size determination and inclusion criteria. Sample size (120) determination involved considerations of Type I error (5%), expected statistical power (80%), baseline BMI, and attrition rates (Burguera et al., 2015). The R-project version 2.12.0 was used to ensure the accuracy of the analysis. The effects of researcher bias were minimized by not providing cash payments to induce participation.
Results of Study
The researchers found that following a 24-month intervention, subjects in the ILI group achieved a significant percentage BMI decrease compared to those in the COT group (-11.3% vs. -1.6%). Their interpretation of these findings is that ILI is an effective non-surgical intervention for MO patients. The findings seem valid due to the scientific rigor involved in sampling, quantitative data collection, and analysis. I have adequate confidence in the findings.
The researchers enumerate several limitations inherent in their study. These include lack of randomization of the SOG subjects, limited sample size (120), high dropout rate, and withdrawal of sibutramine therapy two months after initiation. The presentation of the findings has a coherent logic and integrates past evidence on the topic. The study has significant implications for nursing practice, specifically for obesity therapy for MO patients. The inclusion of ILI therapy in nursing interventions can help achieve the recommended weight loss in adult patients with morbid obesity. The suggestion made for further studies is that programs should randomize into surgical intervention only patients unresponsive to lifestyle modification therapy.
Ethical Considerations
The author received an Institutional Review Boards approval prior to conducting the study. The Balearic Islands Human Ethics Committee provided the IRB approval. In this study, the protection of patient privacy involved maintaining the anonymity of the subjects during the clinic visits and in the article. One key ethical consideration of this study includes written informed consent from all the subjects prior to participation and/or before undergoing Bariatric surgery. According to Gupta (2013), obtaining informed consent minimizes harm to the participants because it enhances their understanding of the study design, outcomes, benefits, and risks. The other ethical considerations evident in this study include patient confidentiality and the avoidance of coercive inducements (cash payments).
Conclusion
The critique corroborates the papers thesis that exercise plus lifestyle modification is more efficacious than medical therapy alone as a weight loss intervention in obese patients. The appraisal gives level I evidence (RCT) in support of an intensive lifestyle program as an alternative intervention, especially for MO patients that are prone to comorbid conditions. In nursing practice, exercise/lifestyle modification programs, as opposed to medication therapy, can be used with MO patients to achieve significant weight loss.
References
Burguera, B., Tur, J. J., Escudero, A. J., Alos, M., Pagán, A., Cortés, B.,&Soriano, J. B.
(2015). An intensive lifestyle intervention is an effective treatment of morbid obesity: The TRAMOMTANA studyA two-year randomized controlled clinical trial. International Journal of Endocrinology, 1, 1-12.
Gupta, U. C. (2013). Informed consent in clinical research: Revisiting few concepts and areas. Perspectives in Clinical Research, 4(1), 26-32. doi:10.4103/2229-3485.106373
Polit, D. F., & Beck, C. T. (2012). Nursing research: Generating and assessing evidence for nursing practice (9th ed.). Philadelphia: Lippincott Williams & Wilkins.
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