Allocation Concealment in Randomized Trials: Defending against Deciphering - Research Paper Example

Quantitative Research Report Appraisal and Critique Introduction Model for Critique Research critique is an important tool of evidence-based learning. This critique shall use the CONSORT research criteria. This criterion has been used to evaluate randomized controlled trials allowing readers to assess the design, conduct, analysis, and interpretation of the study, and to evaluate the validity of the results (Consort, 2012). This tool is often used in order to standardize and improve randomized controlled trials (Ioannidis et. al., 2004). Other research critique tools are available depending on the research, academic institutions, as well as the research institutions carrying out the critique. The CASP or the Critical Appraisal Skills Program uses a range of tools in order to assess various studies and reviews (Ingram, 2007). The Sonama State University uses the critical research tools recommended by Polit, Beck, and Hungler in order to evaluate research studies and assess their applicability to the actual clinical practice (Ingram, 2007). Journal This paper seeks to evaluate whether paracetamol plus ibuprofen are superior to each drug given alone for longer time without fever and for the relief of fever with discomfort among febrile children being managed at home. It was carried out as a randomized controlled trial covering children with fever aged 6 months to 6 years. This journal was published in the UK and information from this journal will affect my decision on the use of ibuprofen and/or paracetamol for febrile children. Since this is a peer-reviewed journal and ranks high in the evidence ranking, I would be convinced to apply its recommendations in my clinical practice. Authors Two of the researchers are involved in the Academe, lecturing in primary health research, one is involved in children’s nursing, another lectures in health economics, one is a professor in primary care health services research, and two are trial coordinators. They are all experts in the field based on their academic and research qualifications as indicated in the research. The University of Bristol is considered a public research university and has been long considered in the world’s top 30 based on the QS World University Ranking. The information about the authors will affect my decision in considering the application of this research in practice lending credibility to the results and their recommendations for the practice. Title /Abstract/ Background / Aims A good title is specific, concise, and informative (Center for Research of Writing Resources, 2006). The study was identified as a quantitative research from the title itself where the author specified it to be a randomized controlled trial. Randomized controlled trials are considered as quantitative researches which are comparative and controlled experiments (MedicineNet.com, 2012). This is a structured abstract as it separately specifies the details for each portion of the study-from the purpose to the conclusion (University of Nebraska, n.d). The study concluded that in order to maximize time for children without fever, ibuprofen must be used first and benefits of using paracetamol with ibuprofen can be evaluated after 24 hours. Background and Objectives A good abstract is one which presents the most important elements of the study, using simple and concise words in about 250 words or less (Sant, 2004). The key points of the background include: due to lack of evidence on the use of paracetamol and ibuprofen on febrile children, it should not be used; and unmanaged fever can cause discomfort and anxiety on children. This study was important because of the need to establish whether or not immediately resorting to combined ibuprofen and paracetamol can be beneficial for the minimization of symptoms for febrile children. Methods The trial design was described as a randomized controlled trial which was community based, blinded, three-arm, and controlled. The inclusion criteria referred to children aged 6 months to 6 years with fever at least 37.8 degrees Celsius to 41.0 degrees Celsius having illnesses which could be managed at home. Children who required hospital interventions were not included, as well as those who were dehydrated, had allergies, had neurological, cardiac, or pulmonary diseases, or those who had liver or renal disease. Interventions Children were to be given paracetamol every 4-6 hours and ibuprofen every 6-8 hours with parents, nurses, and investigators blinded to the treatment administered. The children were followed up at 24 and 48 hours and at day 5. Outcomes Primary outcomes referred to time where the child was without fever in the first four hours from the first dose and the children reported as being normal based on the discomfort scale at 48 hours. For secondary measures, these referred to time when normal temperature first occurred, to the time where there was no fever for over 24 hours, where there were no fever-related symptoms, and when there were no adverse effects seen. Sample size Power calculation refers to the number of units needed in the sample in order to achieve power or the power needed in order to achieve a specific sample size (SAS Institute, 2004). In this case, the sample size was based on 80% power, two sided, and numbered 180 respondents. Randomization Randomization refers to the process of reducing any semblance of subjectivity in the allotment of treatments to any respondent data (Beri, 2007). This study was randomized where the respondents were allocated to one or three trial arms based on a remote and automated randomization service where subjects were assigned to the following treatment groups: paracetamol plus ibuprofen, paracetamol alone, and ibuprofen alone. The allocation concealment process refers to the efforts made by the researchers in order to keep the clinicians and researchers unaware of the assignments in the intervention process (Schulz & Grimes, 2002). The researchers ensured the concealment process by wrapping and placing the medicines in similar packages. All the parents, research nurses, and investigators were blinded to the treatment allocation with parents receiving two identical medicine bottles with either both active or one containing the active drug and the other bottle with the placebo. Despite blinding processes, the parents were still aware which was paracetamol/placebo and ibuprofen/placebo due to differences in dosing. Statistical Methods Descriptive statistics were used to establish baseline data, comparative analyses was then applied in Stat. 9 based on intention to treat using linear or logistic regression. Initial comparisons were between paracetamol plus ibuprofen and either drug alone, and secondary comparisons later included distinguishing between paracetamol and ibuprofen via Dunnet’s and Tukey’s adjustments based on multiple comparisons. Participant Flow A CONSORT flow diagram is a diagram which represents the progress of the study through the phases of parallel randomized trial two groups from enrolment, intervention allocation, and follow-up to data analysis (CONSORT, 2012). This CONSORT flow chart has been used in the study to prevent the participant flow in the study. Under each treatment, there were 52 randomly assigned and 52 also underwent intended treatment. For those under paracetamol only, 52 were analyzed for primary outcome data, for the ibuprofen only group, there were 51, and for the ibuprofen plus paracetamol group, there were 50 who were analyzed for primary outcome. There were no losses and exclusions after randomization. Recruitment The recruitment and follow up was carried out between January 2005 and May 2007. Once the sample size was reached, the recruitment process was stopped. The trial was ended when all data from recruited subjects were recorded. Ethics Ethics is important in research because it provides a guideline for researchers to responsibly carry out the research process (University of Minnesota, 2003). A clinical trial registry is an official platform which clinical trials are cataloged and registered (WHO, 2012). This research is registered as a current controlled trial under the International Standard Randomized Controlled Trials. Protocol The full trial protocol can be accessed at the International Standard Randomized Controlled Trials under the following registration: ISRCTN26362730. It can also be accessed from the Academic Unit of Primary Health Care, Department of Community Based Medicine, University of Bristol. It was also approved by the Bath research ethics committee and underwent external peer review. Funding The sources of funding included the National Institute for Health Research. Active drugs were purchased from Pfizer and DHP Investigational Medicinal Products, but these companies did not have any role in the design, conduct, and analysis of data. Results Based on the intention to treat, paracetamol with ibuprofen was better than paracetamol because of the less time patients had with fever for the first four hours. Over 24 hours, less time with fever was superior for paracetamol plus ibuprofen to paracetamol and to ibuprofen. Combined therapies cleared fever in about 23 minutes faster than paracetamol alone or ibuprofen alone. Harms The most common harms seen were diarrhea and vomiting which did not differ for each group of respondents. Discussion Strong evidence for faster time of clearance in fever for combined therapies were seen and the use of ibuprofen over paracetamol. This study differed from other studies as it recruited from secondary care (Lal et. al., 2000) and it also evaluated impact of single doses (Erlewyn-Lajeunesse et. al., 2006) and it did not apply thermometry. As a nurse, I understood from the study that my role was to monitor the patient during the administration of each drug noting any adverse effects and signs which may indicate the stoppage of the drug. Limitations Since, there was no placebo, only group data can only relate to decisions on the use of antipyretics. Also, the sample did not gain sufficient power to establish differences in discomfort, and the auxiliary temperature of 37.8 degrees Celsius may not always denote fever. The success of blinding was also based on 48 hours nurse visits where parents were asked to guess which drug was active. Finally, based on issues with recruitment, the sample may not be representative of the general population. Generalisability Due to the limited population, the results may not be applicable to a larger population. Moreover, based on issues in external validity and applicability, the trial findings cannot be applied to a larger population. Interpretation The interpretation is consistent with the results, and is based on benefits and harms while also considering other relevant evidence from the existing literature to the current study results. References Most of the references are recent; however, some are already beyond acceptable current dates as they are more than 10 years old from the time the research was carried out. Most of the studies have been peer-reviewed studies in credible journals. The literature review is comprehensive as it was able to search through various databases with the use of keywords related to the current topic (Polit et. al., 2001). Conclusion The authors concluded that doctors, nurses, pharmacists, and parents who want to use medicines to manage children with fever must first opt for ibuprofen first and then consider ibuprofen plus paracetamol only after 24 hours has passed. This was high quality research because the topic is relevant and the randomized processes were applied in order to ensure that the respondents were given equal chance to be part of any intervention (Polit et. al., 2001). It is also high quality research because its limitations were specified by the researchers, the methods are replicable, and the conclusions were logical (Polit et. al., 2001). This could be used in research as it can guide nurses, doctors, and parents on what medicine to best give their feverish child. It can also be used in the practice in terms of ensuring the effective reduction of fever and anxiety among febrile children. Finally, it can help future researchers on options they can consider for other related studies. References Beri, G. C. (2007). Marketing research. UK: Tata McGraw-Hill Education. Center for Research of Writing Resources. (2006). Writing an effective title-how to write a research paper: an Editage series. UK: Cactus Communications. CONSORT. (2010). Flow diagram. Retrieved 14 July 2012 from http://www.consort-statement.org/consort-statement/flow-diagram0/ Erlewyn-Lajeunesse, MDS, et al. (2006). Randomized controlled trial of combined paracetamol and ibuprofen for fever. Arch Dis Child, 91:414-6. Ingram, R. (2007). Critiquing research. Retrieved 14 July 2012 from http://www.attu70.dsl.pipex.com/student/critintro.htm Ioannidis, J., Evans, S., Gotzsche, P., O’Neill, R., and Altman, D. (2004). Better reporting of harms in randomized trials: An extension of the consort statement. Ann Intern Med, 141: 781-788. Lal A., Gomber S., Talukdar B. (2000). Antipyretic effects of nimesulide, paracetamol and ibuprofen-paracetamol. Indian J Pediatr, 67:865-70. MedicineNet.com (2012). Definition of randomized controlled trial. Retrieved 14 July 2012 from http://www.medterms.com/script/main/art.asp?articlekey=39532 Polit, D. F., Beck, C. T., and Hungler, B. P. (2001). Essentials of nursing research methods, appraisal, and utilization. (5th Ed.). Philadelphia: Lippincott. Sant, T. (2004). Persuasive business proposals: Writing to win more customers, clients, and contracts. UK: AMACOM Div American Mgmt Assn. SAS Institute. (2004). Getting started with the SAS power and sample size application. California: SAS Institute. Schulz, K., and Grimes, D. (2002). Allocation concealment in randomized trials: Defending against deciphering. Lancet, 359(9306):614-8. University of Minnesota (2003). A guide to research ethics. Retrieved 14 July 2012 from http://www.ahc.umn.edu/img/assets/26104/Research_Ethics.pdf University of Nebraska. (2012). Guidelines for a structured abstract. Retrieved 14 July 2012 from http://gpvec.unl.edu/files/Epi/GuideForStructuredAbstracts.pdf World Health Organization (2012). Working group on best practice for clinical trials registers (BPG). Retrieved 14 July 2012 from http://www.who.int/ictrp/network/bpg/en/index.html Read More