The research design of open-labelled, comparative, and randomised prospective study is appropriate in answering research question, which seeks to find if early enteral feeding has beneficial effects of improving the hormonal profile of patients with traumatic brain injury when compared with delayed enteral feeding. Comparative aspect of the research design enabled comparison of early enteral feeding and delayed enteral feeding.
Randomisation aspect of the research design is very important because it assigned the patients randomly into two groups, namely, one that received early enteral feeding and the other that received delayed enteral feeding. The prospective aspect of the study allowed measurements of hormonal levels during admission, after six days, and after 12 days. Alternative ways that could have enhanced validity of the findings are the use of single blind design and double blind design to reduce placebo effects and related biases of researchers (Karanicolas, Farrokhyar, & Bhandari, 2010).
The qualitative research design, which applies vignettes and semi-structured interviews, is appropriate in describing factors that influence the decisions of nurses when weaning critically ill patients from the mechanical ventilation.
Since the research question aims at describing factors that influence the decisions of nurses, qualitative research design is appropriate. The use of semi-structured interviews guided the researchers to ask standard questions and enabled participants to provide accurate and relevant answers (Russell & Gregory, 2008). Moreover, the use of vignettes provided standard scenario that could effectively assess the factors, which influence the decisions that nurses make when weaning patients with critical conditions from the mechanical ventilation. The alternative ways that the research could have used are open-ended interviews and open-ended questionnaires so that nurses could provide information freely without any restrictions.
Randomised-controlled trial is a research design that is appropriate in establishing if the protocol-directed management of sedation is more effective when compared to the non-protocol directed management of sedation. In this case, randomisation is appropriate to prevent biased assignment of the patients to protocol group and non-protocol group (Suresh, 2011). The control aspect of the design is appropriate because it allowed researchers to control confounding variables and assess the impact of sedation management on the prognosis of patients. Evidently, the findings show that protocol-directed sedation does not have a significant impact on the duration of mechanical ventilation relative to non-protocol sedation. The research could have employed standard dosages and similar route of administrations to alleviate the impact of confounding variables and enhance the validity of the findings.
Qualitative, descriptive, and exploratory aspects of research design are appropriate in establishing the nature of beliefs and practices of end-of-life care among intensive care nurses. Since the beliefs and practices exist in qualitative form, the application of the qualitative approach is appropriate. Russell and Gregory (2008) state that the exploration and description of certain themes require the qualitative approach as it aids in their elucidation.
The findings indicated that intensive care nurses play a central role in supporting patients and their respective families to cope with end-of-life trauma and derive a positive experience of life. As the study used semi-structured interview in collecting information from the patients, the use of semi-structured and structured questionnaires could have been appropriate as alternative ways of performing similar research.
Randomisation
Randomisation is the process of allocating participants to different groups for purposes of study. During randomisation, researchers do not consider any special features of participants because it would amount to biases and influence the outcome of the research findings (Smith & Pell, 2003). In the study, 316 patients met inclusion the criteria and the researchers randomised them to protocol sedation group and non-protocol sedation group. Out 316 patients, the study randomly selected 161 patients for the non-protocol sedation group and 155 patients for the protocol sedation group. The randomisation process ensured that both the protocol sedation group and non-protocol sedation group have an almost similar number of patients for the comparison to be valid.
Allocation concealment
The study applied allocation concealment during the process of randomisation to prevent the occurrence of selection bias and introduction of confounders. Usually, selection bias and related confounders emanate from the selection process, where researchers and participants understand the course of research prior to its commencement. In the study, allocation concealment occurred via the selection of the serialised names of the patients in opaque envelop in which the senior nurse was unable to influence the process of randomisation. Hence, the study secured and ensured that the process of randomisation was free from any form of bias, which has a detrimental effect on the validity of the research findings.
Blinding
The study did not apply any form of blinding in the treatment of the groups, protocol sedation group and non-protocol sedation group. The nurses knew about the treatment groups, while the patients understood the nature of treatment group the randomisation placed them. Normally, blinding reduces biases that researchers may have in the treatment of participants and assessment of the research outcomes (Karanicolas et al., 2010). Hence, the absence of blinding means that the research findings are prone to treatment and assessment biases, which have significant influence on the research outcome. In this case, the absence of blinding may make researchers to provide different sedation management to the protocol group and non-protocol group.
Patient follow-up
The study conducted patient follow-up to ascertain their progress following the administration of respective treatments. Stanley (2007) asserts that the function of the researchers in sampling is to make sure that the selected participants are able to adhere to the treatment regimens lest they withdraw and dilute the findings of the study. In the study, there was a deliberate follow-up of the study sample for purposes of analysing the research outcomes. In the follow-up, the study revealed that 41 patients died during mechanical ventilation, while 23 died after managing to undergo successful weaning from mechanical ventilation. Overall, 238 patients managed to survive, but 74 patients died in the process, which is a significant number to influence research outcomes.
Intention-to-treat analysis
Intention to undertake comprehensive analysis of the findings is an integral aspect of randomised-controlled trials. The analysis of both the protocol sedation group and non-protocol sedation group indicates the intention-to-treat analysis. According to Gupta (2011), the concept of intention-to-treat analysis holds that the number of participants randomised must be analysed irrespective of their withdrawal from the study or non-adherence to treatment regimen.
In this study, the analysis of findings considers the number of participants as 312 in the analysis although 41 patients died during mechanical ventilation and 23 patients died after undergoing successful weaning from mechanical ventilation. Therefore, the application of the concept of intention-to-treat analysis in the study does reflect the reality of clinical practice, as noncompliance and non-adherence are common.
The article has a clear statement that indicates the aim of the research, which is to describe factors that influence the decision of critical care nurses when deciding when to withdraw patients from mechanical ventilators. Russell and Gregory (2008) hold that an aim of a study should be clear, concise, and achievable. In this case, the aim is quite appropriate and relevant. In the review of the methodology, the qualitative methodology was appropriate in describing factors that influence the decisions of nurses in weaning patients from mechanical ventilators in a critical care environment. Since the nurses provided their views and opinions about how they could wean patients from mechanical ventilators, the qualitative study was appropriate because it aimed at describing these views and opinions.
Evidently, the research design was appropriate in addressing the aims of the study because it employed semi-structured interviews and vignettes. Semi-structured interviews guided nurses to provide uniform and accurate answers basing on their competencies. Moreover, the study justified that vignettes offer an economical manner of deriving information and efficient way of focusing on complex issues.
Hence, the study explained why semi-structured interviews and vignettes were appropriate in collecting qualitative data. In the aspect of sampling, the recruitment strategy was appropriate because the study stratified 57 nurses, according to their years of experience and selected 25 nurses randomly, who took part in the research. The randomisation aspect of selecting the nurses is important because it reduces accidental and selection biases, which are likely to occur (Suresh, 2011). Hence, the study selected nurses basing on their professional experiences in terms of years.
The review of data collection indicates that the study collected data in the manner that addressed the research issue of weaning patients from mechanical ventilators. Semi-structured interviews and vignettes were instruments that enabled the researchers to collect relevant data, which describe factors that influence the practice of weaning patients from ventilators. Although the relationship between researchers and participants is very important in research, the study did not consider adequately the relationship between them; however, it indicated that they knew each other. Fundamentally, the study only focused on the participants without indicating demographic variables of the researchers or their roles in the intensive care unit.
The study is an ethical research because it considered the ethical issues before and during the course of the study by complying with appropriate ethical requirements. Firstly, researchers sought ethical approval from the human ethics committees of the hospital before commencing the study. Secondly, the researchers informed the participants about the nature of the study and let them to sign the consent form, and thus, meeting the ethical requirement of informed consent. Thirdly, the researchers maintained privacy of the participants by assigning numbers to their names.
Regarding data analysis, the procedure was sufficiently rigorous because the researchers performed a thematic analysis of the views and opinions of nurses comprehensively. The thematic analysis indicated that clinical assessment, physiological influence, professional competence, ventilation state, protocols, and intensive care environment are some of the factors that influence decisions of nurses when weaning patients from mechanical ventilators.
Moreover, the article presents a clear statement of findings because it summarised the findings into one statement. Specifically, the article reports that clinical assessment, physiological influence, professional competence, ventilation state, protocols, and intensive care environment are the six factors that influence decisions of nurses in weaning patients from mechanical ventilators. Overall, the research is very valuable because it contributes to the body of knowledge of weaning protocols in the critical care environment. Since weaning of patients from mechanical ventilators remains to be a contentious issue in the critical care environment, the study highlighted pertinent factors that complicate this issue. In this view, the research recommends the study of the roles of patients in the weaning process.
References
Gupta, S. (2011). Intention-to-treat concept: A review. Perspectives in Clinical Research, 2(3), 109-112.
Karanicolas, P., Farrokhyar, F., & Bhandari, M. (2010). Blinding: Who, what, when, why, how? Canadian Journal of Surgery, 53(5), 345-348.
Russell, C.K., & Gregory, D. M. (2008). Evaluation of qualitative research studies. In N. Cullum, D. Ciliska, B. Haynes, & S. Marks (eds.). Evidence-based Nursing: An introduction (p.204). Oxford: Blackwell Publishing.
Smith, G., & Pell, J. (2003). Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. British Medical Journal, 327(7429), 1459-1461.
Stanley, K. (2007). Design of randomised controlled trials. Circulation, 115(9), 1164-1169.
Suresh, K. (2011). An overview of randomisation techniques: An unbiased assessment of outcome in clinical research. Journal of Human Reproductive Sciences, 4(1), 8-11.