In this essay, a study of randomized control trial study is criticized. The study evaluated the effectiveness of the nursing practitioners in giving analgesics within time among the patients having severe pain.
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Running head:CRITICAL APPRAISAL OF ARTICLE Critical Appraisal of Article Name of the Student Name of the University Author Note
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1CRITICAL APPRAISAL OF ARTICLE In this essay, a study of randomized control trial study is criticized.The study by Jennings et al. (2015) is critically appraised using the tool named CASP.The study evaluated the effectiveness of the nursing practitioners in giving analgesics within time among the patients having severe pain. The following sections addresses various part of the article critically. 2. Yes, the assignment of the patients to treatments was randomized and it was a pragmatic randomized controlled study. The study was carried out according to the National Statement on Ethical conduct in human research. The allocation sequence was not concealed as the allocation sequence was generated by the computer randomly with the generation of the number (Ilic and Maloney 2014). The patients and the treatment staff were aware of the treatment allocation. However, the treatment outcome was not revealed to the treatment staff. In addition to this, the primary investigator was not aware of the allocation of the patients for analyzing the results of the study. The randomized selection method makes the study very much unbiased in terms of sampling method (Dziura et al. 2013). The most common randomized selection method can be conducted through using computer software programs. The process of allocation conceal refers to the technique of reserving the random allocation sequence without having the knowledge of the treatment thatwillbereceivedbythepatients.However,incaseofnotmaintainingthe concealment, the chances of the biased treatment is very much high ( Hayes and Moulton 2017). 3. No, the trial was not stopped early. The trial process was completed properly according to the timeline. The patients were assigned randomly to the either group that is control group or intervention group. 2 patients were excluded from this study they had not completedtheconsentformproperly.Theremaining258patientswereanalyzed according the group they were assigned. In randomized controlled study, the sample size
2CRITICAL APPRAISAL OF ARTICLE was divided randomly in two different groups. It is very importanttomaintainthatthe twogroupsaretreatedequally.Bydoingthis,theresearchersaretryingtoreducethebias andas well it will become very easy for them to observe the effect of the predefined treatment. This equal treatment to both of the group, will allow the researcher to be unbiased in nature (Chow et al. 2017). One of the most important advantages of the randomized control study is that there is a direct cause and effect relationship without any bias or with very minimal bias (Speith et al. 2016). RCT is counted as one of the most reliable method of scientific evidence and it can influence the study as it helps to reduce the bias in the selection process of the sample population (Chow et al. 2017). However, it is evident that, RCT is not a very easy process and it is very much important to report RCT in a high quality. In addition to this, the researcher should design a RCT study by maintaining the various ethical issues as well. In case of working with human subjects maintenance of ethical issues is very much important. Although, RCT is very much advantageous, it has a few drawbacks. As a part of the disadvantages, it can be said that, RCT is a time bound and expensive process. In addition to this, the chosen subject population may not be the representative of the whole population (Yunus and Karim 2015). 5. No, the groups were not similar at the start of the study. Firstly, 2 patients were excluded at the beginning of the study as they had not completed the consent form properly. As a result, the sample size of the two groups were not same. The groups who were receiving the Standard ED medical led care had the population size of 128 patients and the other group who were receiving the NP care had the sample size of 130 patients. Among the total sample population men were more in number than that of the women. The number of men was 147 that 57% of total population and the rest 435 was female in sample in this study. In addition to this, both of the group had not have the same number of population of a
3CRITICAL APPRAISAL OF ARTICLE particular age. There was no information related to the social class of the patients. Sample size is very much important in statistical analysis of any study and it the sample size is directly affecting the result of the study (Chow et al. 2017). The imbalance in the sample size is very much common in case of RCT and this imbalance is planned sometimes. However, in many cases the imbalance may occur due to missing out of data for technical problems. Due to the drop out of patients, there may be cases imbalance in the data (Vanhove2018).According to Philips and Kimmelman (2014), the unequal sample group size may be scientifically advantageous. In their study, they also mentioned that, unequal sample size may help the researcher in case of those studies that are costly. The second justification is not applicable for the studies that are sham comparators or placebo in nature. The requirement ofextrasafety information may also support the unequal sample group size of the subject population. Gender bias is very common in a randomized control study as the gender bias may hamper the generalization of the study result. However, in some cases it may happen that gender bias is needed such as excluding of pregnant woman is justified in spite of it is a biased practice (Blackwell 2018). 6.The information related to the treatment of the patients other than the experimental interventions are not specified properly in the article. So, this cannot be told. Equal treatment to all of the subject population will help the study result to become more unbiased and as a result the study became very much reliable. However, lack in equal treatment can alter the study result and reduces the reliability of the study result (Schmidt and Hunter 2014). 7.In this study, mainly two outcomes were measure that was primary outcome and secondary outcome. The primary outcome of the study was to measure the proportion of the patients who had received the analgesia treatment within the National target of the Australia that is within 30 minutes. The secondary outcome of this study was to measure the time for
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4CRITICAL APPRAISAL OF ARTICLE administering the analgesia after arriving the emergency department (ED), measuring the changes in the pain score and to record the changes in the pain score of the patients. The primary outcome of the study was clearly specified in this study. In the primary outcome it was found that the a few patients had administered analgesia already in their home and the amount was almost 36%.However, 28 patients had refused to take the analgesia and 65 more patients had also refused to consume analgesic during the care in the ED department. The case of representation was observed in 0.5% of the NP care group and in case of standard care group the amount was almost < 0.1%.The overall number percentage of the patients who received analgesic within 30 minutes of being observed was 49.2% for NP group and in case of standard care group this amount was almost 29.7%. In the secondary outcomes it was found that 64 patients out of 165 patients had received analgesics within the 30 minutes in the NP group and in case of standard care group 38 patients had received the drugs within the time period. By using the Kalpan- Meier analysis it was found that, the documentation rate of first pain score among the standard care group was 71.1% ( n= 91) and in the NP group the pain score documentation rate was 63.1% (n= 82). The p value was 0.17. The documentation of the second pain score documented in 9.3% of standard care patients (n= 12) and among the NP care subjects the documentation rate was almost 13.1 % (n= 17). However, no significant difference was not observed in the median of the pain score among the standard care group ( 0,IQR= -1 to 0; n= 91) and the NP care group ( -0.5, IQR= -3 to 0, n= 82;p=0.13). 9. The results of this study can be applied to the context of the local population as the random sampling method was used for conducting study. Patients, who were admitted to the emergency department, were used as subject population with a very few exclusion and inclusion criteria.
5CRITICAL APPRAISAL OF ARTICLE 11. Yes,thebenefitsworththeharmsandcostsofthestudyasthestudyexaminedthe effectivenessoftheNPserviceontheclinicaloutcomethatisassociatedwiththepatientcare quality (Doyle , Lennox and Bell 2013).Astherewasnopreviouseffectivestudyoneffectiveness ofNP serviceinpainmanagement,thisstudywillhelptodocumenttheeffectiveness.Asthisstudy wasveryfirststudyinassessing thepatientoutcomeintermsofNPservices.Thisstudywouldgive themaximumbenefitastherewasnopreviousstudybasedevidenceforassessingthe effectivenessoftheNPservicesinpainmanagement.
6CRITICAL APPRAISAL OF ARTICLE References Blackwell., 2018. Blackwellpublishing.com. Available at: http://www.blackwellpublishing.com/content/BPL_Images/Content_store/Sample_chapter/ 9781405132664/9781405132664_4_003.pdf [Accessed 26 Dec. 2018]. Chow, S.C., Shao, J., Wang, H. and Lokhnygina, Y., 2017.Sample size calculations in clinical research. Chapman and Hall/ Doyle, C., Lennox, L. and Bell, D., 2013. A systematic review of evidence on the links between patient experience and clinical safety and effectiveness.BMJ open,3(1), p.e001570. Dziura, J.D., Post, L.A., Zhao, Q., Fu, Z. and Peduzzi, P., 2013. Strategies for dealing with missing data in clinical trials: from design to analysis.The Yale journal of biology and medicine,86(3), p.343. Hayes, R.J. and Moulton, L.H., 2017.Cluster randomised trials. Chapman and Hall/CRC. Hey, S.P. and Kimmelman, J., 2014. The questionable use of unequal allocation in confirmatory trials.Neurology,82(1), pp.77-79. Ilic, D. and Maloney, S., 2014. Methods of teaching medical trainees evidence‐based medicine: a systematic review.Medical Education,48(2), pp.124-135. Schmidt, F.L. and Hunter, J.E., 2014.Methods of meta-analysis: Correcting error and bias in research findings. Sage publications. Spieth, P.M., Kubasch, A.S., Penzlin, A.I., Illigens, B.M.W., Barlinn, K. and Siepmann, T., 2016. Randomized controlled trials–a matter of design.Neuropsychiatric disease and treatment,12, p.1341.
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