Critical Appraisal of a Randomised Control Trial

This article provides a critical appraisal of a randomised control trial that compares the effectiveness of nurse practitioner services with standard medical care in emergency departments. The study involved 260 patients with pain complaints who were randomly assigned to either group. The article discusses the study design, patient selection, treatment methods, and outcomes. The results show that nurse practitioner services can improve the quality of care provided to patients in emergency departments.

Running Head: RANDOMISED CONTROL TRIAL 1
Critical appraisal of a Randomised Control Trial

RANDOMISED CONTROL TRIAL 2
2. Was the assignment of patients to treatments Randomized?
The control trial had been randomized to have the comparison of medical care and NP
services in the emergency department. The randomized technique had been used so that the
authors can get the benefit of reaching multiple patients of various background (Flick, 2015). Ali
et al., (2016) used a similar technique to produce appropriate and accurate results for the benefit
of the diabetic patients. The authors choose the patients with pain to have them assigned to either
NP or ED medical care. These patients were allocated to groups handled by the officers and staff
members with the help of nurses. About 260 patients were randomly chosen for this aspect. The
patients were further divided where 128 were given standard care while the remaining received
NP care facilities. Among these, two were excluded because of having incomplete consent
forms. The study was conducted based on the statements of the National statement concerning
human research.
Other than that, the approval from the patients regarding the trial had been critical for the
authors. The patient’s approval can lead the study toward the collection of answers appropriately
without any fear of being rejected by the authority. Backhouse et al., (2017) did the study in
which the authors identified the potential of getting approval from the patients before their
involvement in the study. The result of the study was improved because of the utilization of such
techniques. Therefore, the author took written consent from the patients before imitating the trial.
The random number generator system had been utilized to select the patients randomly that was
complaining about pain. The random number generator can help the authors in collecting the
individuals randomly from the database of the hospitals (Ali et al., 2016). However, the staff
members involved and the patients had been aware of the study fully. Other than that, the

RANDOMISED CONTROL TRIAL 3
members were not made aware of the possible results that can be obtained by this study until its
end. It was done to obtain accuracy until the climax.
3. Were all of the patients who entered the trial properly accounted for at its conclusion?
At first, about 265 patients were selected randomly for the study, being eligible for the
research. Almost five of the individual patients rejected their will to participate in the study. The
authors assigned 260 to either group randomly for further analysis to ensure better results.
However, the authors observed that two of the individual patients failed to provide perfect
consent forms and they were excluded from the study. The incomplete consent forms indicated
the poor observation and decision-making skills of the individual patients, which could have
created a problem for obtaining appropriate answers. Colligan et al., (2011) stated that the
utilization of completed consent forms is appropriate for a study concerned with healthcare
services since it is directly related to patient health. The study had been observed to be
completed by ensuring that the investigators get appropriate answers. The most critical aspect
had been the consent of the patients. The authors had taken their permission to perform the task
after the selection of the individuals dealing with pain within the hospital. The individual patients
involved in the study had given their consent except the two that submitted incomplete forms.
After that, the individual patients were separated into two groups providing either NP or
ED care. These groups were selected to initially carry out the procedure of the study to get
appropriate answers for the research questions. The division of the individual participants had
been based on the desire of the authors to provide equal opportunity — the rate of accuracy of
answers increases when the participants are satisfied. Since the equality factor can ultimately
satisfy them, the authors ensured the process had been followed effectively. Elliott et al., (2017)

RANDOMISED CONTROL TRIAL 4
used a similar technique in dividing patients into different groups using the randomizing
technique. In result, the authors observed appropriate answers to the research questions
concerning the healthcare services. Similarly, these individual patients were divided into groups
of 128 and 130 people to receive different kind of treatments individually.
4. Were the groups similar at the start of the trial?
The groups involved in the study concerning the patients and the members were certainly
not aware of the outcomes of the trial. The treating staff members and other aspects were not
certainly aware of the outcomes that had been obtained by this study. However, the treating staff
and the individual members were aware of the facilities and study altogether. It was done to stop
the rise of any ethical issues in the study that could have created several hindrances in the
research (Jennings et al., 2015). They were provided with all the information about the study
beforehand that helped in getting desired outcomes. Furthermore, the patients contained nearly
similar gender about 57% men and 43% women that were involved in the study that ensured the
higher growth of the research.
Division of individuals in the separate groups had been critical for this study since it
ensured that the patients and staff would effectively involve in the study altogether. The authors
desired to have an analysis of the obtained results before opening the outcomes in public. It was
because the outcomes, being complex in nature, can confuse the minds of readers without giving
the proper interpretation. Provision of incomplete results would certainly not have done
something good for the development of the hospitals and the individuals as well as it was done in
the study of Hanna et al., (2018). The authors provided answers concerned with Dementia Cases
appropriately. Such factors forced the authors to make sure that the results were first analyzed

RANDOMISED CONTROL TRIAL 5
and written before they can even strive to explain them to the patients and the members.
However, it had been observed that the gender differences did not produce any negative
outcome, which has been seen in many cases involving the diversion among sexes (Llewellyn-
Bennett et al., 2018).
6. Aside from the experimental intervention, were the groups treated equally?
It had been observed that the individual groups were treated equally by ensuring that the
authors take permission and consent first. Before even the patients were given consent form, they
were randomly selected without caring for the gender or age factor. Such aspects show that the
authors highly believed in treating individual patients equally. Equal treatment of the patients for
this study can ensure the development of the results as it is evident in the case of Ling & Tzellos
(2018). Only two forms were rejected because the patients had impolitely submitted them. Other
than that, the authors tried to divide the patients truthfully into two distinct groups providing
them with two kinds of treatment methods. However, the author noticed that the 128 individuals
received standard while others were given NP care.
The authors did not care about the division of groups concerning gender because their
focus had been on the treatment rather than the gender or age group. Furthermore, the outcomes
of the research had been equally recorded that enabled the patients to be equally treated while
taking the permission individually.
7. How large was the treatment effect?
Two groups were seen in the study that ensured the development of the entire research. It
had been observed that the authors strived to ensure that the individual patient is treated equally

RANDOMISED CONTROL TRIAL 6
throughout the study (Babbie, 2011). The outcomes had been measured in two forms: primary
and secondary. The primary outcomes provided the information about the baseline of eligible
participants that enabled the researchers to perform the research. It provided the information
about the gender, age, time of presentation, mode of transport, analgesia information, and other
factors related to the basic treatment. The inclusion of such factors had been observed in many
kinds of literature such as Russell et al., (2016) that promoted the authors to get inspiration from
the same. The second outcome provided information about the patients involving professional
procedure concerning the individual method of care. It involved the utilization of analgesia and
other factors related to timing in each method. The results section showed that the primary factor
had been able to state the relative answers.
The outcomes were able to provide the answers related to the time that was observed
after having the utilization of Analgesia the NP service issues were also realized by having a
careful study of this research along with appropriate methodology. The authors desired to present
the information about the most effective methodology that can be used to treat the patients with
pain.
9. Can the results be applied in your context?
Patients covered by the study involved the utilization of randomized technique in
selecting the individuals from the database. Even though the study had been effectively meant to
provide answers about which treatment technique had been effective, the overall reach of the
authors had only been limited to the individuals with pain complains. It was done because the
individual authors desired to include one context of disease at a time. The inclusion of several
fields of diseases could have created problems of getting accurate answers (Snellman, Jonsson &

RANDOMISED CONTROL TRIAL 7
Wikblad, 2012). However, the study could have involved other individuals having the provision
of similar groups such that the study can be performed to ensure the effect of the individual
method over the patients altogether. For this, the individual patients having other factors and
issues should be involved.
In real life instance, the patients involving many issues are selected by the professionals
to provide effective services. At such instance, the individual patients will be given appropriate
treatment that can ensure their benefit. Certainly, it means that the patients covered by the trial
had been limited and the real-life instance will be involving more and varieties of individuals
having issues other than just the pain. It would ensure that the hospitals or clinics can promote
the betterment of the patients (Russell et al., 2016).
11. Are the benefits worth the harms and costs?
The benefits of treatment method provided in the study had been involved in ensuring the
betterment of the patients. It certainly means that the individual hospitals have had been involved
in the provision of better facilities to the patients if the study is used as another method or
learning procedure. The outcomes provided assurance about the enhancement of the patient care
quality and effective method or facilities concerning nurse practitioner service. The efforts done
by the individual authors can give the readers the benefit of effective treatment methods that can
increase the treatment quality in the hospitals (Szanton et al., 2014).
The results involve the service innovation from the side of the patient that can add value
to the quality service given to them. Furthermore, increased health quality can provide enhanced
demand for the services among the patients that can also improve the financial status. The
patients are supposed to be given effective care that can be evidence-based (Szanton et al., 2014).

RANDOMISED CONTROL TRIAL 8
The results show that the patients can be given effective and quality care by ensuring better
treatment. Certainly, this study can be worth the harm and costs provided by the study. The
efforts of the individual authors are also certainly effective if the patients are given better
facilities in the future.
References
Ali, S. M., Giordano, R., Lakhani, S., & Walker, D. M. (2016). A review of randomized
controlled trials of medical record powered clinical decision support system to improve
quality of diabetes care. International journal of medical informatics, 87, 91-100.
Babbie, E. R. (2011). Introduction to social research. Wadsworth Cengage learning.
Backhouse, A., Ukoumunne, O. C., Richards, D. A., McCabe, R., Watkins, R., & Dickens, C.
(2017). The effectiveness of community-based coordinating interventions in dementia care:
a meta-analysis and subgroup analysis of intervention components. BMC health services
research, 17(1), 717.
Colligan, M., Collins, C., Foley, B., Jones, P., Miles, J. and Zeng, I., (2011). Emergency nurse
practitioners: do they provide an effective service in managing minor injuries, compared to
emergency medicine registrars?. Ethnicity, 68(59), pp.0-03.
Elliott, L. S., Henderson, J. C., Neradilek, M. B., Moyer, N. A., Ashcraft, K. C., & Thirumaran,
R. K. (2017). Clinical impact of pharmacogenetic profiling with a clinical decision support
tool in polypharmacy home health patients: A prospective pilot randomized controlled
trial. PloS one, 12(2), e0170905.

RANDOMISED CONTROL TRIAL 9
Flick, U. (2015). Introducing research methodology: A beginner's guide to doing a research
project. Sage.
Jennings, N., Gardner, G., O'reilly, G., & Mitra, B. (2015). Evaluating emergency nurse
practitioner service effectiveness on achieving timely analgesia: a pragmatic randomized
controlled trial. Academic Emergency Medicine, 22(6), 676-684.
Hanna, M. L., Kim, D., Albrecht, J., & Perfetto, E. M. (2018). A Method to Use Administrative
Claims to Categorize Dementia Cases by Subtype. Value in Health, 21, S230.
Llewellyn-Bennett, R., Edwards, D., Roberts, N., Hainsworth, A. H., Bulbulia, R., & Bowman,
L. (2018). Post-trial follow-up methodology in large randomised controlled trials: a
systematic review. Trials, 19(1), 298.
Ling, T., & Tzellos, S. (2018). Analyzing Prescription Data to Target Hard-To-Identify Patient
Populations for Clinical Trials: A Case Study in Narcolepsy. Value in Health, 21, S230-
S231.
Russell, C. L., Moore, S., Hathaway, D., Cheng, A. L., Chen, G., & Goggin, K. (2016). MAGIC
study: aims, design and methods using SystemCHANGE™ to improve
immunosuppressive medication adherence in adult kidney transplant recipients. BMC
nephrology, 17(1), 84.
Snellman, I., Jonsson, B., & Wikblad, K. (2012). Validation and Test–Retest Reliability of a
Health Measure, Health as Ability of Acting, Based on the Welfare Theory of
Health. Evaluation & the health professions, 35(1), 87-103.

RANDOMISED CONTROL TRIAL
10
Szanton, S. L., Wolff, J. W., Leff, B., Thorpe, R. J., Tanner, E. K., Boyd, C., ... & Gitlin, L. N.
(2014). CAPABLE trial: a randomized controlled trial of nurse, occupational therapist and
handyman to reduce disability among older adults: rationale and design. Contemporary
clinical trials, 38(1), 102-112.