1. Was the assignment of patients to treatments randomised?
2. Were all of the patients who entered the trial properly accounted for at its conclusion?
3. Were the groups similar at the start of the trial?
4. Aside from the experimental intervention, were the groups treated equally?
5. How large was the treatment effect?
6. Can the results be applied in your context? (or to the local population?)
7. Are the benefits worth the harms and costs?
Was the assignment of patients to treatments randomised?
1. The second question of the assessment tool focuses entirely on the discussing the randomization for the sample selection and intervention delivery. Randomized control trials are the types of clinical trials where all of the participants of the study have the equal chance to get selected in the intervention group or control group (Broekhuizen et al. 2015). The randomization allows the data collected to be extremely authentic and devoid of bias. In this case, Jennings et al. (2015) in this article have successfully incorporated the aspects of randomization in the sample selection and intervention delivery. Elaborating more, the patients presenting with pain were randomly assigned to either receive the standard ED medical care or NP care. This has allowed the participants to be completely unaware of the interventions that were being provided to the participants, which in turn improved the impact of the outcome. Hence, in this case, the authors have successfully followed the randomization criteria effectively. Similarly, it can be considered that the allocation sequence was successfully concealed for this assignment.
2. The third question refers to the continuity of the article and as per the article, it can be easily stated that the patients have been involved in the process throughout the study. Along with that the patients were accounted for the completion of the study as well, and the follow up was carried out regularly till the compketion of the study (Jennings et al. 2015). Moreover, the study was not stopped or discontinued under any circumstances during the study. Now coming to the second element that this particular question is attempting to address, the patients were analysed effectively in the groups that they were assigned to as well. It is crucial for the researchers to analyse the patients in the groups that have been assigned to the particular group to ensure authentic data collection and correct or successful interpretation of the outcome of the intervention.
3. A crucial aspect associated with carrying out a randomized controlled trial design of the research study is ensuring that each participants in the different groups are treated similarly (Claydon 2015). It ensures that impact of the intervention outcome is understood effectively and successfully. In this case, the authors in the research study have taken additional care to ensure that all of the participants have been treated similarly. Elaborating further, in this case the participants were all treated similarly at the start of the trial, and the patients were more or less the same for both the intervention and the control group. As per the study, the population selection had been done from the same cohort which also further confirms the care has been taken by the authors to ensure that population is as similar as possible. The baseline data also insthat the confounders of age and sex of the participants had been noted, analysed and adjusted in the study as well. Hence, the authors have taken the most of the needed measures to ensure that the selection of the participants for the study had been as similar as possible so as to ensure most optimal outcome identification and interpretation (Jennings et al. 2015). Hence, undoubtedly the authors of the research study are needed to be recommended for the efforts taken to ensure efficacy of the research design and staying the most true to the research design selected.
Were all of the patients who entered the trial properly accounted for at its conclusion?
4. One of the most impactful factors that has the potential to destroy the success of the research study is the presence of bias. As discussed by Hróbjartsson et al. (2014), the presence of bias, regardless of the type of bias, has the potential to affect the outcome of the study and alter the data findings delimiting the scope and impact of the research study completely. Hence, it is crucial for the research studies to eliminate bias as much as possible while designing and carrying out the research study to ensure that the outcomes are not affected in a manner and the research carried out is successful. One very impactful and effective method of ensuring that bias is reduced as much as possible is to treat both the control and intervention group in all the factors other than the intervention itself. In this case however, the authors have failed to ensure that both the control and intervention group has not been treated similarly. For instance, it has to be mentioned in this context that the control group was managed by the medical officers long with the assistance provided by the registered nurses, and the medical officers included 17 emergency medicine registrars, each with a minimum of 3 years of postgraduate training, undertaking advanced training toward fellowship of the Australasian College for Emergency Medicine. On the other hand, the intervention or the treatment group had been managed by the NPs or the nurse practitioners. Now, although it is unclear the exact changes that this difference can make on the outcome, it needs to be acknowledged that the Nurse practitioners have the potential to provide autonomous, comprehensive care. Although, similarly it has to be acknowledged that the assistance of registered nurse was provided to the NPs as well when required. Although the lack of similar treatment being given to both the control and the treatment group can have a huge risk of acting as a bias and affecting the outcome of the study, which is undoubtedly a considerable con of the study design (Jennings et al. 2015).
5. The effectiveness of the results of the study can be understood effectively by the outcomes measured and the extent of how the outcome affected the participants. In this case the primary outcome measure had been the proportion of patients receiving analgesia within 30 minutes from being seen by care group (Jennings et al. 2015). Similarly, the secondary outcome measure had been the time to analgesia from presentation and documentation of and changes in pain scores; which indicates each outcome had results. Judging the treatment effect of the outcome as evidenced by the results or data findings of the research study, there had been a huge difference of 17.6 minute between in the control and the treatment group. Elaborating further, the mean time from being seen to analgesia was 25.4 minutes for NP care and 43.0 minutes for standard care. Hence, from the data, it is clear that there is a statistically significant difference in the care service and effectiveness of the treatment in case of the trained nurse practitioners as evidenced by the p value and differences in the median change of pain scores between the two (Jennings et al. 2015). Hence, the treatment effectiveness was comparatively high for the intervention being tested which was evidenced by the nurse practitioner’s service effectiveness higher for achieving timely analgesia for emergency department patients and reliving the pain.
6. Research studies are conducted to discover the effectiveness of a particular intervention so that it can be applied to the local context (Bondemark and Ruf 2015). Hence ensuring transferability and generalizability of the data findings is a very important responsibility that the researchers must not ignore. Although it has to be mentioned that this study covered a large demographic background of participants, which makes its findings viable and applicable to other patients. However, it has to be mentioned that the primary or target population of ED environment and there are certain limitations which are pertaining to the ED environment of care delivery, as discussed by the authors in the study itself, generalizability of the results of the research study to other ED settings can be limited due to different patient census and staffing models, hence it requires further investigation. Hence, it can be mentioned the authors have not been successful in making the study optimally transferrable to any local setting or population context (Jennings et al. 2015).
7. The relevance of a research study is also needed to be critically analysed by comparing and contrasting the benefits with any possible harms (Twisk et al. 2018). It has to be mentioned in this context that there are no considerable harms associated with the intervention that is being implemented. Although, the only possible drawback of the intervention that is being tested in research study refers to the costs associated with employing a large staff of nurse practitioners for pain management in the ED department. Although, developing a cost effective solution to any challenge is one of the outcomes of a randomized clinical trial, in this case the difference had been daunting in the performance effectiveness and treatment effect in reducing the pain score (Jennings et al. 2015). Hence, even though the costs of recruiting trained nurse practitioners will have an impact on the budget allocation of the facilities, the benefits in terms of patient satisfaction, care outcome and in turn good brand image of the facility can potentially outweigh the possible cons.
Bondemark, L. and Ruf, S., 2015. Randomized controlled trial: the gold standard or an unobtainable fallacy?. European journal of orthodontics, 37(5), pp.457-461.
Broekhuizen, K., Pothof, A., de Craen, A.J. and Mooijaart, S.P., 2015. Characteristics of randomized controlled trials designed for elderly: a systematic review. PloS one, 10(5), p.e0126709.
Claydon, L.S., 2015. Rigour in quantitative research. Nursing Standard (2014+), 29(47), p.43.
Hróbjartsson, A., Emanuelsson, F., Skou Thomsen, A.S., Hilden, J. and Brorson, S., 2014. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies. International journal of epidemiology, 43(4), pp.1272-1283.
Jennings, N., Gardner, G., O'reilly, G. and Mitra, B., 2015. Evaluating emergency nurse practitioner service effectiveness on achieving timely analgesia: a pragmatic randomized controlled trial. Academic Emergency Medicine, 22(6), pp.676-684.
Twisk, J., Bosman, L., Hoekstra, T., Rijnhart, J., Welten, M. and Heymans, M., 2018. Different ways to estimate treatment effects in randomised controlled trials. Contemporary clinical trials communications, 10, pp.80-85.
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