Background and Objectives

Discuss about the Introduction to Research in Health Care for Hyperglycaemia.

– 1a: Title of the article is “Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial”

– 1b: The research conducted to study the treatment protocols for QASC, swallowing dysfunction, hyperglycaemia, and fever

–           Background and Objectives

–           2a: QASC, swallowing dysfunction, hyperglycaemia, and fever have been causing a lot of problems to the people. Their management have to be improved to ensure that they are addressed. The study was therefore to provide further information to bridge the missing gap in knowledge regarding the management of these conditions (Middleton et al., 2011). 

–           2b: The objective of the research was to study the treatment protocols for QASC, swallowing dysfunction, hyperglycaemia, and fever

–           Trial design

–           3a: Multidisciplinary intervention applied to assess the participants used in the study.

–           3b: Random Controlled Trial used in the study to collect data from the participants. Single-blind cluster randomised controlled trial used

–           Participants

–           4a: A sample size of patients used to participate in the study to represent the entire target population

–           4b: Participants had to meet the criteria for the inclusion that had been set to ensure that they are suitable for the study

–           Interventions

–           5: Intervention for swallowing, sugar and fever done to the ASU clinicians whose selection was based on the Australia’s National Clinical Guidelines that helped in the development of the treatment protocol.

–           Outcomes

–           6a: The intervention group had less chances of being dependent or dead as compared to the control group that had higher chances of dying or becoming dependent (Middleton et al., 2011).

–           6b: There were improvements in the morality of the control group, but none at all in the intervention group

Sample Size

–           7a: The sample size was drawn from the ASUs. It was determined after considering the criteria that had been set for them to qualify for the study (Middleton et al., 2011)

–           7b: The selection of the sample was determined by the factors like on-site high dependency and access to CT.

Randomization Sequence

–           8a: The sequence was stratified into categories A and B. At the same time, absolute numbers were used in sequencing

–           8b: The research assistants and trial statisticians were masked

Allocation Concealment

–           9: The research assistants who were used to collect the data by reviewing the medical records and conducting telephone interviews were concealed from knowing the group allocation used (Middleton et al., 2011)

Trial Design

Implementation

–           10: Clinical Research Assistants

Blinding

–           11a: The participants were blinded

–           11b: Blinding done because there was a need not to interfere with the intervention process

Statistical Methods

–           12 a: Sas 9.2 software and intention-to-treat analysis done

–           12b: Descriptive statistics used to categorize the data

Results

–           13a: All the participants in the intervention group were subjected to equal treatment. The same applies to those in the control group (Middleton et al., 2011).

–           13b: 87% of the participants agreed to participate in the intervention while 13% refused to so.

Recruitment

–           14a: 90 days were given for the follow-up of the participants

–           14b: Trial stoped at the end upon completion as planned

Baseline Data

–           15: Intervention versus Control Group had different characteristics

–           -16:

Numbers analysed

–           17a: Results for the primary and secondary outcome properly analysed and illustrated in the trial

–           17b: The binary outcome for the study outlined as recommended

Ancillary Analyses

–           18: Adjusted and sub-group analyses done as required

Harms

–           19: The trial was harm-free because it had to comply with the ethical principle of safety

Discussion

Limitations

–           20: No limitations or biases identified because the trial was up to the expected standard

Generalisability

–           21: The research was reliable and valid. Its findings can be generalized into different clinical contexts.

Interpretation

–           22: The interpretation is accurate, correct, consistent, objective, and presents a clear reflection of the trial. 

Other Information

Registration:

–           23: DOI:10.1016/S0140-6736(11)61485-2

Protocol

–           24: The protocol can be accessed from Lancet

25:  The project was done courtesy of the support of National Health & Medical Research Council ID 353803, St Vincent’s Clinic Foundation, the Curran, Australian Catholic University, Australian Diabetes Society-Servier, and the College of Nursing (Middleton et al., 2011).

1. Did the trial address a clearly focused issue?

Yes. The trial succeeded in addressing the issue that was under study. The trial succeeded in finding out the implementation of the EBP treatment strategies for the QASC, hyperglycaemia, and fever. Everything in the trial was done as per the expected standards (Mackey & Gass, 2005),

The researchers were keen on conducting a randomized trial that would be relied upon to adequately respond to the research question and accomplish the research objectives. At the same time, deliberate measures were put to ensure that the findings generated were valid and reliable enough to be generalized to different contexts (Lewis, 2015). That is why the identification and selection of the sample size as well as the collection and analysis of the data was done as per the expected standards.  

1. Was the assignment of patients to treatment randomised?

Participants

Yes. The assignment of the patients was randomized because participants in the study were included after going through a well-defined randomization procedure. The study involved the use of different categories of participants: the intervention and control groups (Ledford & Gast, 2018). For one to be included in the study, one had to meet certain conditions that had been set by the researchers. The trial had to be done in compliance to a criterion that would make it possible to collect reliable data that could not be compromised in any way (Creswell & Clark, 2017). That is why it was necessary to randomize the participants because if it were not done this way, the entire trial would not be a success. 

1. Were all of the patients who entered the trail properly accounted for at its conclusion?

Yes. They were accounted for right from the beginning up to the very end of the trial. Throughout the trial period, the researchers kept on accounting for the changes in the participants. Although the beginning of recruitment, there were many participants, the number declined towards the end because there are some participants who, despite their eligibility, never took part in the trial as anticipated (Christmals & Gross, 2017). Hence, by noticing and reporting such changes, it is crystal clear that the researchers were aware of the participants and could account for them at all times.

1. Were patients, health workers and study personnel ‘blind’ to treatment?

            Yes. The health workers and the study personnel were blinded to the treatment because the researchers made them blind throughout the trial period.

1. Were the groups similar at the start of the trail?

Yes. There was similarity in the group at the beginning of the trial.

1. Aside from the experimental intervention, were the group’s traded equally?

A thorough analysis of the trial reveals that all the groups were equally traded because it was necessary for ensuring that the trial was a success.  

1. How large was the treatment effect?

The treatment effect was fairly large and appropriate for the trial because it would help in achieving the set objectives.

1. How precise was the estimate of the treatment effect?

The estimate was fairly large enough to allow for the generalisation of the findings.

1. Can the results be applied to the local population or in your context?

Yes. The results of the trial can be applied to other contexts other than the one that was under study. It can help in addressing the health needs of other populations within my locality or any other place because the trial was effectively done by adhering to all the applicable standards.

1. were all clinically important outcome considered?

Yes. All the clinically important outcomes were considered in the trial. That is why the trial produced reliable and valid findings.

1. Are the benefits worth the harms and costs?

The benefits of the trial are better than the costs incurred or the harms experienced. That is why the implications of the trial can be applied in different contexts.

Interventions

The rigor was properly reported because, in the report, there was a comprehensive coverage of all the activities that were conducted during the trial. One of the most important aspects of the trial that were captured in the rigor is the introduction and background information. Here, a comprehensive analysis of the research question and objectives are provided (Agarwal et al., 2016). At the same time, it captured information on the background knowledge that the readers should know about the research and the research topic. The inclusion of such information was a good idea because it availed all that everyone needed to know about the essence of the trial.

The rigor was also properly done because it contains information on the research methodology. Apart from telling the readers about the reasons for the study, it went ahead and provided objective, accurate, and crucial information on the sample size, its selection, the inclusion criteria, the randomization process, intervention, data collection, and analysis. These are essential information that should be availed to the readers since they need to know how exactly the study was conducted. Lastly, the other aspect of the rigor that makes it appropriate for the trial is that it discusses the findings of the study. Its analysis of the findings, discussion and interpretation is worthy because explains all that should be known about the trial.

References

Agarwal, A., Raad, D., Kairouz, V., Fudyma, J., Curtis, A. B., Schünemann, H. J., & Akl, E.

(2016). The effect of a monetary incentive for administrative assistants on the survey response rate: a randomized controlled trial. BMC medical research methodology, 16(1), 94.

Christmals, C. D., & Gross, J. J. (2017). An integrative literature review framework for  postgraduate nursing research reviews. European Journal of Research in Medical Sciences Vol, 5(1).

Creswell, J. W., & Clark, V. L. P. (2017). Designing and conducting mixed methods research. New York: Sage publications.

Ledford, J. R., & Gast, D. L. (2018). Single case research methodology: Applications in special education and behavioral sciences. New York: Routledge.

Lewis, S. (2015). Qualitative inquiry and research design: Choosing among five approaches.

Health promotion practice, 16(4), 473-475.

Mackey, A., & Gass, S. M. (2015). Second language research: Methodology and design.

New York: Routledge.

Middleton, S., McElduff, P., Ward, J., Grimshaw, J. M., Dale, S., D’Este, C., … & Evans, M.

(2011). Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. The Lancet, 378(9804), 1699-1706.

Nieswiadomy, R. M., & Bailey, C. (2017). Foundations of nursing research. New York:Pearson.