Clinical Trial for Consort Evaluation- myassignmenthelp.com

Question: Discuss about thrClinical Trial for Consort Evaluation. Answer: Introduction The introduction in AlBedah et al, Pg. 504, does not conform to CONSORT Item 2a. The text is free flowing but the scientific background and rationale for the trial has not been established clearly. The introduction discusses the global prevalence rate of lower back pain, with no supporting evidence for their target population. Also, no scientific rationale for the specific issue of PNSLBP has been presented, besides the lack of epidemiological details specific for Saudi Arabia. The authors have mentioned the growing evidence for efficacy of wet cupping techniques but it lacks a plausible explanation, Pg. 505. The introduction lacks justification for conducting the present trial, as it is not clear whether the present trial aims to contribute to the existing pool of knowledge or serve as a pioneer study. The advantages of wet cupping technique have not been mentioned, although it has been said that it is the third most common traditional practice in Saudi Arabia. This further question s the necessity of present trial. The study mentions the aim, but no objectives and hypothesis have been mentioned separately. However, the aim itself mentions the objectives that the study seeks to fulfil. Hence, it can be inferred that AlBedah et al fulfils CONSORT Item 2b. Methods The given methodology, Pg. 505, partially conforms to CONSORT Item 3a. It mentions information on type of trial as parallel, however it does not mention whether the trial aims to establish superiority, inferiority, or equivalence of the intervention. Also, allocation ratio has not been mentioned. The given methodology partially conformed to CONSORT Item 4a regarding the eligibility criteria for participants, Pg. 505. This is because it has been mentioned Men and women age 18 to 60 years who met the de?nition were recruited., however no clear definition has been provided. The eligibility criteria further mentions the exclusion criteria, with no clearly defined inclusion criteria. Interventions, Pg. 505, conformed with CONSORT Item 5, as the authors provided details on how to administer the intervention, providing reference to the previously published intervention procedure. The details regarding the allowed medication were provided besides the forbidden therapeutics. The outcome measures reported in the AlBedah et al, Pg. 505, conforms to CONSORT Item 6a, as the primary and secondary outcome measures have been identified and reported from previously developed and validated scales of measurement. The endpoints for measurement of scores with definition of scales is also mentioned. The sample size determination, Pg. 505, conforms to CONSORT Item 7a, as the authors have mentioned the assumption for deciding the sample size, with due consideration to dropouts. The randomization procedures, Pg. 505, partially conformed to CONSORT Items 8a to 10. The random allocation sequence was generated using sealedenvelope.com, using the block randomization method. The random allocation sequence was implemented using sealed opaque envelopes. However, information regarding who generated sequence, enrolled participants, and assigned participants to interventions was not available. The statistical method section, Pg. 505, conformed to CONSORT Item 12a, as the statistical methods used to compare the intervention and control groups were clearly mentioned by the authors. Results The study results conform to CONSORT Item 13a as the authors have illustrated the flow of participants, Pg. 506, during the different stages of the trial. The study results also conformed to CONSORT Item 13b as the number of participants lost at the different stages of trial after randomization were given with exact reasons. None of the participants were excluded from the trial. The study results conform to CONSORT Item 15, which includes the representation of baseline characteristics of each group in tabular form, Pg. 506. The baseline characteristics in the present study involved age, gender, expectation of prognosis which was enquired before randomization, age of onset of condition, duration of illness, primary and secondary scores. All the values were given in form of mean and standard deviations, with statistical measure of p value. In conformance with CONSORT Item 16, the study results clearly mentioned the number of patients analysed in the given trial, Pg. 505. Out of the eligible 80 patients, allocated in two groups of 40 each in intervention and control groups, 3 patients from intervention and 2 from control groups were lost to follow up. The authors also indicated the reason for their loss, and the data for the remaining participants was analysed. In conformance with CONSORT Item 17a, the study results for each of the primary and secondary outcomes for each of the groups, besides estimated effect size and precision were given, Pg. 507. The outcome measures for two time points of 2 weeks and 4 week besides the p values were given. The authors also mentioned the number of acetaminophen tablets taken by patients in both the groups during the entire 4 week period. However, the results did not conform to CONSORT Item 17b, as the absolute and relative effect sizes for binary outcomes were not reported. Discussion In conformance with CONSORT Item 19, the authors mentioned no adverse effects or unintended effects of the administered intervention. In conformance with CONSORT Item 20, the authors mentioned one limitation of the absence of a placebo control in the trial, Pg. 507. The development of sham cupping devices and more objective pain outcome measures was suggested. However, any other sources of potential bias and imprecision were not reported. With respect to CONSORT Item 21 the generalisability of the results was indicated in applicability of the respective technique in healthcare setting in government hospitals and clinics. Also, the study results indicated efficacy of the technique in reducing pain and improving disability after 2 weeks of usage. Overall the discussion was found to be in partial conformance to the CONSORT Item 22. The interpretation was consistent with results but it could be supplemented with inclusion of findings from primary and outcome measures. The discussion highlights only the benefits of the techniques, which leads to an imbalance between presentation of benefits and harms. References and presentation AlBedah, A., Khalil, M., Elolemy, A., Hussein, A. A., AlQaed, M., Al Mudaiheem, A., Bakrain, M. Y. (2015). The Use of Wet Cupping for Persistent Nonspeci?c Low Back Pain: Randomized Controlled Clinical Trial. The Journal of Alternative and Complementary Medicine, 21, 504508. https://doi.org/10.1089/acm.2015.0065 Mother, D., Schulz, K. ., Altman, D. G., Consort Group. (2001). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.