What question did the study ask?
Rosen et al. (2017) sought to study whether the use of telephone care management (TCM) to usual outpatient mental health care had any positive effect as pertains to attendance to treatment, compliance to medication, and clinical outcomes of veterans suffering from post-traumatic stress disorder (PTSD).
Was the assignment of patients to treatments randomized appropriately? How does randomization affect bias in this study?
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The study relied on the Efron randomization technique. Zhao, Weng, Wu and Palesch (2011) discussed the technique stating that the main purpose of randomization is to avoid any kind of bias. The Efron randomization method, also called the biased coin deign, uses a biased probability to reduce imbalance and an equal probability is used. In the study in question, Rosen et al. (2017) assigned participants to treatments but with a focus on balancing the treatment. The randomization here affects selective bias which results from researchers categorizing participants into particular groups and deciding who should be in treatment or control group. Thus, using the Efron randomization technique, Rosen et al. (2017) sought to balance the allocation of participants to the treatment and control interventions.
Were the groups similar/equivalent at the start of the trial? How does similarity of groups affect bias in this study?
The groups were not equivalent at the start of the trial when it comes to the number of participants. At the onset, there were 365 participants where 191 were enrolled in TCM intervention, while 165 were enrolled in usual care (Rosen et al., 2017). However, the researchers were keen to ensure that the sample had similar features. For instance, stratification was used whereby factors such as gender and the region a participant served (Iraq or Afghanistan) were considered. The rationale of having such kind of similarity was to avoid a situation whereby it is not clear to attribute the factors leading to results acquired. Having dissimilar features or qualities would mean that the outcome of patients would not be solely due to the inclusion or exclusion of TCM as an intervention. Hence, Rosen et al. (2017) were rather critical about the similarity of features among the participants where one was in the intervention or control group.
Were the groups treated equally, aside from the differences associated with the allocated treatment? How does this approach affect bias in this study?
The groups were treated equally apart from the differences associated with the allocation of treatment. In a randomized trial, the researchers should ensure that regardless of treatment approach used for either group, they should receive equal treatment. The main idea is to avoid any kind of bias which would undermine the validity of the study itself (Zhao, Weng, Wu & Palesch, 2011). Therefore, in the case in question, Rosen et al. (2017) conducted surveys at four and 12-month follow-ups using the Dillman method for all participants. The rationale behind exposing participants to equal treatment is to ensure that no other factor affects the target of the study in question. In this case, the focus was on determining the effects of TCM intervention. Therefore, it would be appropriate to have both treatment and control groups go through the same procedure and differ only in the nature of intervention used.
Were all subjects enrolled in the trial accounted for in considering the sample and data analysis? How does the presence or absence of these strategies affect bias in this study?
All the subjects enrolled in the trial were accounted for. There were 356 participants all of whom were included in the study. Rosen et al. (2017) ensured that they acquired data from the participants enrolled accounting for sampling and data analysis. The rationale for including sampling and data analysis all subjects were included which means that data acquired was recorded based on the experiences of the participants with the different interventions they were exposed to. The 195 participants were exposed to TCM intervention while 165 were exposed to usual care. Doing so affects bias in that in the event that some of the participants experience non-study-related events, it becomes easy to determine which individuals had results contrary to what was expected. For instance, Rosen et al. (2017) reported various non-study-related events such as hospitalization for alcohol withdrawal, car accidents and other medical reasons. Sampling and data analysis allowed the researchers to determine if such events affected the anticipated outcome. In this case, bias was avoided as the researchers did not have to allocate results amidst influence from non-study-related events.
To what extent was “blinding” used in the study? How does the presence or absence of blinding affect bias in this study?
The study did not use the concept of “blinding”. The concept of blinding entails a situation whereby the researcher decides to mask the information about a test from the participant. The idea is to reduce or eliminate bias until after the outcome of the trial is known (Probst et al., 2016). The absence of blinding in the study does not seem to have had any effect on bias as the respondents are made aware of the treatment approach to be used. The only difference is the use of the telephone as a follow-up technique in addition to usual care. In this case, allowing participants to know what intervention method they would be enrolled in helped them determine whether they would want to participate or not. Thus, it was imperative that participants are assigned to a treatment method they are comfortable with.
Critique the reliability and validity reporting for the instruments used in the study. Discuss how the data analysis was appropriate to report the strength of the findings for an RCT.
The study does not provide clear discussion about the reliability and validity reporting instruments. However, the telephone care managers were tasked with using a semi-scripted protocol to access participants’ treatment attendance, medication compliance, and side effects, severity of symptoms, self-efficacy, suicidality, substance, and risk for violence (Rosen, et al., 2017). Basing in information gathered, the data analysis focused on whether, for instance, the use of telephone care managers helped participants experienced improved clinical outcomes. For the study in question, the protocol that the telephone care managers followed was both reliable and valid as it inclined to the main purpose of the research itself.
External Validity
What is the overall strength, quality, and consistency of the evidence provided by the findings of this study?
One of the major strengths of the study was that it the participants had similar characteristics such as being veterans and having been in either Iraq or Afghanistan, as well as being categorized based on gender. The quality of the study is evident in that the researchers used a random approach when assigning participants to different interventions. In this case, they avoided being biased in determining who was enrolled in which intervention method. However, the consistence of the evidence generated was affected due to the occurrence of non-study-related events. Some participants suffered car accidences, others withdrawal, while some even died. Such outcomes undermine the consistency of evidence gathered making it hard for researchers to explain the results in terms of what they imply for the use of TCM among PTSD patients.
How generalizable are the findings of this study? How generalizable are the findings to your patients?
Are my patients so different from those in the study that the results cannot apply? A major outcome of the study was that there was no considerable effect in terms of patient improvement upon exposure to TCM. The authors explained that they did not experience the anticipated result that TCM promotes better medical compliance, or improved outcomes in patients. Rosen et al. (2017) found that TCM enhanced management of treatment but that the outcomes depended on the effectiveness of the treatment that patients received. Therefore, following from the said conclusion, application of TCM would have the same outcome as in the study.
Is the treatment feasible in my setting? The treatment is feasible in my setting as most of my patients are referred to a psychiatrist. However, it is not clear whether the effects would the same as those found in the study.
Will the potential benefit(s) of treatment outweigh the potential harm(s) of treatment for my patients? Based on the study findings, TCM did not improve patient outcomes but did promote treatment management. Therefore, the idea is to ensure that after the treatment has been managed, the patients are exposed to more effective intervention methods. Doing so will complement the use of TCM. As is at the moment, the results of the study are not as expansive as one would wish when it comes to applying to external contexts.
References
Probst, P., Grummich, K., Heger, P., Zaschke, S., Knebel, P., Ulrich, A., … Diener, M. K. (2016). Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study. Systematic reviews , 5 , 48. doi:10.1186/s13643-016-0226-4
Rosen, C. S., Azevedo, K. J., Tiet, Q. Q., Greene, C. J., Wood, A. E., Calhoun, P., . . . Schnurr, P. P. (2017). An RCT of Effects of Telephone Care Management on Treatment Adherence and Clinical Outcomes Among Veterans With PTSD. Psychiatric Services,68 (2), 151-158. doi:10.1176/appi.ps.201600069
Zhao, W., Weng, Y., Wu, Q., & Palesch, Y. (2011). Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness. Pharmaceutical statistics , 11 (1), 39–48. doi:10.1002/pst.493
