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PHM002 Epidemiology Question: Using the Cochrane Collaboration’s ‘Risk of Bias’ assessment tool construct a written critique of the Randomised Controlled Trial references in the box above. In the write up you should consider including the following points: The public health importance of the subject The appropriateness of the study design Methods of data collection Bias and confounding Validity of results Implications of the study Answer: The Public Health Importance Of The Subject Studies have been carried out on the prevalence of binge drinking among young adults. The study by Tavolacci et al. (2016) reported that approximately 50% of college students were engaged in binge drinking. Binge drinking leads to multiple injuries associated with alcohol consumption and the development of illnesses linked to it (White and Hingson, 2013). Due to the severe effects of binge drinking, several attempts have been made in an effort to try and address the issue. For instance, Brief in-person interventions were proposed by Taggart et al. (2013) tested and found to be effective, even though their impact was minimal compared to the large population that is affected by the problem. Clark and Moss (2010) attributed the ineffectiveness of such programs to the costs incurred in their implementations such as offering continuous one-on-one counseling. Another approach is through the use of automated interventions by use of mobile devices and the internet. Computerized procedures allow standardization of support materials and low stigma with regard to individual reporting. Carey et al. (2012) conducted a study on the effectiveness of using computerized alcohol intervention and found out that they had short-term reductions in alcohol consumption among college students. As a result, more other approaches such as mobile phones were later introduced (Morgenstern, Kuerbis, and Muench, 2014). This approach is deemed useful because the mobile phone is owned by most people and thus can reach a broad population within a short time. Some of the effects of binge drinking include increased aggression, risky sexual behaviour, suicidal behaviour and self-disclosure (White and Hingson, 2013). The study aimed at assessing the efficacy of SMS intervention concerning the duration of its effect. This study is therefore important because it aims at looking for a reliable and effective intervention approach for binge drinking . The Appropriateness Of The Study Design The research used a randomized control trial (RCT). The study aimed at assessing the stability of SMS intervention effects for six months after successful completion of the intervention. The study reports participants to be young adults aged between 18 and 25 years and were reimbursed for their time (US$10). Those that successfully completed the follow-ups were also reimbursed in the following order; three months-$20, six months $30, and nine months $40. The study randomly allocated the subjects to three groups and subjected them to one of three treatments at a ratio of 2:1:1. One group received SMS assessment and feedback (SA+F), the other SMS assessment, and the last one did not receive any SMS (control group). The study used blocks of eight at all the places of recruitment assigned them to each group electronically by using algorithms generated from the computer. Thus the sequence of allocation was adequate leading to a low risk of bias. This also shows that the process was truly random (Roever and Oliveira, 2015). Methods of data collection SMS was sent to the participants in the two experimental groups. The SA+F group received two-way messages on Thursday and Sunday, the SA group only received SMS drinking questions every Sunday, and the control group received none. After six to nine months of registration, the subjects were to complete the surveys in the secured computer. Thus, data were collected using online surveys. Moreover, the study used blocks of eight at all the places of recruitment and assigned them to each group electronically by using algorithms generated from the computer. The participants were also not informed of the groups they were allocated, and the investigators were also not made aware of the treatment allocation. These ensured adequate allocation concealment. This also confirms sufficient blinding of the participants and researchers from the knowledge regarding the interventions (Higgins et al., 2011). The study acknowledges missing outcome data, i.e., measure covariates and assert that it was non-trivial. However, the study minimized any potential bias as a result of this missing data by using multiple imputation procedures (McPherson et al., 2013) such as Poisson distribution model for the frequency of drinking days, and logit distribution model for the number of drinks per day. These measures ensured that the missing outcome data did not have a significant impact on the outcomes. Thus, ensuring that there was no high risk of bias. The study protocol is presented, and the findings can be pre-specified as primary and secondary outcomes. In addition to enumerating the study procedures, the study has provided a CONSORT diagram showing the details of the RCT and possible results. This indicates that the study is free of selective reporting (Cheng et al., 2016). Bias And Confounding Several attempts have been made in the study to minimize bias. The use of the self-guided online system to collect data minimized any possibility of reporting bias (Suffoletto et al., 2015). Furthermore, the author also ensured that only the participants were in the room during the assessment, family and friends were requested to leave.  Another step taken to minimize reporting bias was to find out from the emergency department physicians about their view on the association between the care counter and alcohol.   The study has described all measures to ensure that there is a low risk of performance bias. For instance, the study has provided distinct differences between the study groups in addition to blinding of participants and researchers about the knowledge of the intervention.  The subjects made aware of the groups they were allocated and the investigators were also blinded of the treatment allocation. The blinding of study subjects and researchers also minimized attrition bias. The Validity Of The Results The study can be said to be valid because of multiple reasons. The study has endeavored to minimize and address all types of bias in the study. For instance, reporting bias, performance bias, and attrition bias have been discussed in the research. According to Rothwell (2009), the external validity of RCTs can be achieved by ensuring that the setting of the trial is described. The study was web-based but still limited its participants to those found in Pittsburgh. Participant selection has also been described in details, i.e., the inclusion and exclusion criteria, the period for the intervention, and the random allocation ratio of the participants to the groups. Rothwell (2009) observes that external validity in RCT is increased when there are in-depth descriptions of the characteristics of the randomized patients. The research provides the characteristics of the participants regarding their baseline characteristics. Internal validity of the research has also been achieved. Savovi? et al. (2014) elucidate that the Cochrane assessment tool is a most appropriate critical tool for internal validity of RCTs. Based on the above critical analysis of the study using the Cochrane tool, it can be deduced that the internal validity of the study was achieved. For instance, there is a ‘yes’ response to all elements of the Cochrane tool Implications Of The Study The study found out that the use of an intervention that is computerized and with interactive text message led to sustained reductions in the consumption of alcohol among college students. The findings of this study have implications for different relevant institutions. Studies have indicated that almost 50% of college students are alcoholic (Tavolacci et al., 2016) despite the numerous interventions that have been implemented to help curb the situation. The management of both public and private colleges can adopt this intervention to address the issue of binge drinking among college students. Moreover, this approach is likely to be cost effective because it uses mobile devices that can reach a large population. Studies have also linked high usage of mobile devices to youths. Hence the intervention will be much appropriate for institutions of higher learning. The ministry of education can also adopt this approach in ensuring that binge drinking among youths is minimized. For instance, the government can implement the automated text message- intervention in rehabilitation centers as a way of helping those addicted to alcohol drinking.  Additionally, this study acts as a basis for further research on the most appropriate interventions for alcohol consumption among the young and old adults. References: Carey, K.B., Scott-Sheldon, L.A., Elliott, J.C., Garey, L. and Carey, M.P., 2012. Face-to-face versus computer-delivered alcohol interventions for college drinkers: A meta-analytic review, 1998 to 2010. Clinical psychology review, 32(8), pp.690-703. Cheng, A., Kessler, D., Mackinnon, R., Chang, T.P., Nadkarni, V.M., Hunt, E.A., Duval-Arnould, J., Lin, Y., Cook, D.A., Pusic, M. and Hui, J., 2016. Reporting guidelines for health care simulation research: extensions to the CONSORT and STROBE statements. Advances in Simulation, 1(1), p.25. Clark, D.B. and Moss, H.B., 2010. Providing alcohol-related screening and brief interventions to adolescents through health care systems: obstacles and solutions. PLoS medicine, 7(3), p.e1000214. Higgins, J.P., Altman, D.G., Gøtzsche, P.C., Jüni, P., Moher, D., Oxman, A.D., Savovi?, J., Schulz, K.F., Weeks, L. and Sterne, J.A., 2011. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. Bmj, 343, p.d5928. McPherson, S., Barbosa?Leiker, C., McDonell, M., Howell, D. and Roll, J., 2013. Longitudinal missing data strategies for substance use clinical trials using generalized estimating equations: an example with a buprenorphine trial. Human Psychopharmacology: Clinical and Experimental, 28(5), pp.506-515. Morgenstern, J., Kuerbis, A. and Muench, F., 2014. Ecological momentary assessment and alcohol use disorder treatment. Alcohol research: current reviews, 36(1), p.101. Roever, L. and Oliveira, B.F.G., 2015. Critical Appraisal of Randomised Controlled Trials. Evidence Based Medicine and Practice, 1, p.2. Rothwell, P.M., 2009. Commentary: External validity of results of randomized trials: disentangling a complex concept. International journal of epidemiology, 39(1), pp.94-96. Savovi?, J., Weeks, L., Sterne, J.A., Turner, L., Altman, D.G., Moher, D. and Higgins, J.P., 2014. Evaluation of the Cochrane Collaboration’s tool for assessing the risk of bias in randomized trials: focus groups, online survey, proposed recommendations and their implementation. Systematic reviews, 3(1), p.37. Suffoletto, B., Kristan, J., Chung, T., Jeong, K., Fabio, A., Monti, P. and Clark, D.B., 2015. An interactive text message intervention to reduce binge drinking in young adults: A randomized controlled trial with 9-month outcomes. PloS one, 10(11), p.e0142877. Taggart, I.H., Ranney, M.L., Howland, J. and Mello, M.J., 2013. A systematic review of emergency department interventions for college drinkers. The Journal of emergency medicine, 45(6), pp.962-968. Tavolacci, M.P., Boerg, E., Richard, L., Meyrignac, G., Dechelotte, P. and Ladner, J., 2016. Prevalence of binge drinking and associated behaviours among 3286 college students in France. BMC public health, 16(1), p.178. White, A. and Hingson, R., 2013. The burden of alcohol use: excessive alcohol consumption and related consequences among college students. Alcohol research: current reviews.

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