A CAP for Effectiveness of Enhanced Communication Therapy
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DownloadA CAP for Effectiveness of Enhanced Communication Therapy in the First Four Months for Aphasia and Dysarthria: A Randomized Controlled Trial
A Study on the Effectiveness of Communication Therapy in Patients of Stroke suffering from Aphasia and Dysarthria using Randomized Controlled Trials
In summary, the study showed there were similar outcomes between the group that received social interaction (control) and the group that received therapy from a speech-language therapist. Whereas in a within-group analysis, the therapy groups enhanced functional communication gains were similar. According to the Level of Evidence, the systematic review article is the strongest. However, this particular article is a randomized control trial design that characterized it as a Level 2 (Step 2).
Citation/s:Brown, A., Hesketh, A., Patchick, E., Young, A., Davies, L., Vail, A., Long, A., Watkins, C., Wilkinson, M., Pearl, G., Ralph, M., Tyrrell, P. Effectiveness of enhanced communication therapy in the first four months after stroke for aphasia and dysarthria: A randomized controlled trial. British Medical Journal, 2012:345:e4407. doi:10.1136/bmj.e4407
Portney, L., Watkins, M., (2009). Foundations of clinical research: Applications to practice. (3rd edition). New Jersey: Prentice Hall.
Lead author’s name and fax: Audrey Brown [email protected]
Three-part Clinical Question: Will the patients in the first four months after stroke for aphasia and dysarthria have enhanced communications using the ACT Now (Assessing Communication in the North West) compared to social interaction
P: 4 months after stroke, aphasic, dyarthric, admitted to hospital with stroke,
I: ACT Now (Assessing Communication in the North West)
C: Social contact (without communication therapy)
O: Enhanced communication therapy after six months.
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Search Terms: MeSH terms: aphasia, stroke, enhanced communication therapy Publication type: Randomized controlled trial
The Study:Double-blinded Single-blinded concealed randomized controlled trial with intention-to-treat.
The Study Patients: Adults with stroke, aphasia, and dysarthria. Considered by speech and language therapists to benefit from intervention. Excluded: living outside the area, Non-English speaker, Speech-Pathologist deemed unsuitable (i.e, end of life care, dementia, subarachnoid hemorrhage, terminal disease), patients unable to complete eligibility screen after 3 attempts, and patients whose communication problems resolved.
Control group (N = 85; 72 analyzed): The frequency and amount of social contact offered by employed visitors (not therapists or volunteers). A short manual developed for allowing everyday activities mostly led by participants. Patients in the control group received employed visitors. The visits ranged from a variety of non-scripted social interactions mostly led by the patients. The contacts between patients and therapists were monitored and studied by a part-time monitor.
Experimental group (N = 85; 81 analyzed): 3 contacts per week for 16 weeks. Start, duration, and frequency of therapy varied within and between participants that were determined by SLP and participants. There were six specific core components of intervention manual developed. The manual included six core components in the therapy: Assessment, information provision, provision of communications materials, carer contact, indirect contact, direct contact. Dates of start, duration, and frequency of therapies changed given that variations in the patients’ attendance to the therapies. However, due to the nature of the study, this variations did not affect the outcome
The Evidence:
Outcome Time to Outcome CER EER RRR ARR NNT
95% Confidence Intervals: Measure Control Group Experimental Group Difference 95% CI
Mean SD Mean SD TOM 3.0 1.6 3.3 1.4 -0.300 -0.78 – 0.18
Non-Event Outcomes Time to outcome/s Control group Experimental group P-value
TOM 6 months 3.0 (1.6) 3.3 (1.4) 0.27
Comments:
Threats to validity of the article can be assessed based on the conclusion drawn by the authors and the method that the authors used to select the participants as well as the variables in the study. In the findings section of the study, the author concludes that communication therapy adds no benefit beyond the everyday communication within the duration of four months after the stroke. This is a generalized conclusion given that the number of participants chosen was only comprised of elderly adults of the mean age of 70 years. The validity would be guaranteed by making using of a diverse population consisting of both young and old. Essentially, stroke does not only affect adults in their 70s. It also affects them in their 30s, 40s, 50s, and 60s. If all these age groups were included in the study, it would express minimal bias. These are the unprotected threats in the article that tend to weaken the evidence presented by the authors. However, the use of random allocation makes the study within the group selected, more conclusive. In the same way, given the samples were taken and the criteria of exclusion employed, the test shows powerful signs of validity. The demographics are balanced, and the sign of not focusing on racial or ethnicity-based groups helps considering the test a global analysis.
Group differences in the choice of participants are a statistically significant factor that impacts on the results and conclusion of the study. For any study to be reliable and valid, it must consider random randomization samplings of the participants in all dimensions. Taking random samples does not always imply the selection of samples from different localities at random. It also involves the selection of samples of different age groups, races, gender, among other diversity factors. In the current study, the author does not mention any randomization aspect of random sampling of the participants apart from their age and where they were selected. In that sense, it is important to note that randomization of samples is used effectively as a way to correctly remove bias from the research group. The use of a company to provide the study with a randomization service also improves the chance of removing bias in the experiment. Furthermore, by placing the subjects in randomized blocks with other individuals with similar characteristics increases the validity of the test. This contributes to the weakness of the study since it adds more bias to the findings and conclusions drawn. It also undermines the quality of the evidence presented by making the conclusions appear generalized. Although, the use of random sampling would have not changed the outcome of the experiment, taking a broader range of samples could have added depth to the study.
MCID is defined as the smallest change in an outcome measure that is perceived as beneficial by the patient (Portney and Watkins, 2009). The primary result of the study suggests there was an improvement of 0.8 on the TOM scale, which indicates a meaningful gain in functions communication. On the other hand, the subjects in the subgroup analyses the study stated they had no added benefit after completion of the study whether they were in the control or intervention group. The effect size of the differences, in this case (-0.18) is considered weak and not a significant difference between the two groups. It is not clinically meaningful because stroke is a condition that affects people of all ages and not only those in their 70s. At the same time, the article repeatedly shows notable baseline characteristics of the samples used as participants from the randomized controlled trial. The authors have tested the trials to ensure that there is no significant difference between the study groups. Bowen (2012) stated that sensitivity analysis accounted for the eight deaths and 12 declining follow-up in the control group and the four deaths and 3 declining follow-up in the intervention group. Moreover, after four months of treatment patients of both groups report similar communication abilities. The study shows that there are not significant differences among the groups. The only difference is that the experimental group benefit from speech therapy, while the other is just conversing with an untrained assessor.
Considering the width of the confidence interval, a confidence of 95 percent seems exaggerated considering the invalidity nature of the study as far as the choice of participants is concerned. If that trust interval were to stand out rightfully, being a narrow CI, the authors would need to change the topic of the study to reflect specificity the age group used as participants. adequate. Given the standard nature of the statistical measures there is no evidence to doubt the results the test has presented. However, we can see that since the control group results show a lack of interest by the patients, especially the younger and more disabled ones. This can change the results, if not statistically, in terms of effectivity of the treatment and the study. Otherwise, with a generalized conclusion and perspective, a confidence interval of 95 percent is not authentic given that the randomization of the study is in doubt. The authors also claim that the study did not find significant differences between the control and the experimental samples. This is an implication of apparently negative trials and an indication of the bias of the study. An important difference would be possible if the participants were randomly chosen considering all the factors of randomization. Also, although the level of occurrences such as death, repeated stroke, and repeated hospitalization were higher among the control, group, the statistical differences were not greater than the experimental group concerning adverse effects in the treatment. This indicates that therapy might be slightly more useful when treating the aphasia and dysarthria, but treatment did not increase potential adverse effects.
Considering the statistical factors of randomization, control, intervention, and the mean value at 95 percent confidence interval; the study does not demonstrate an adequate statistical power to deem it valid and the evidence provided reliable. Proves to be a reliable source as it offers a thorough and conclusive study on the subject. Statistically, given the fact that that the CI results encompassed 0, this shows that there are is not a significant amount of statistical difference that proves any difference between the two practices
That way, since it did not show a significant difference between the control and the experimental group I would not consider the study relevant for my practice As previously emphasized, randomization is completely lacking in the statistical values, a factor that weakens the evidence given and strengthens the invalidity of the findings and the conclusion. The same is implicated by the negative and the positive trials of the study that produce statistically insignificant values as is indicated in Table 5 in the article. As a result of my clinical review of this study, I would not consider this study clinically relevant for use in my practice.
I work in a hospital setting, and the population is older adults 80-100 years of age. My experience working with this population is that structured Speech-Language Therapy is essential to their recovery of communication and language disorders and social interaction with family and friends is considered a supplement to their therapy not in lieu of structured intervention. Although the subjects for this study were identified while in the hospital, the data was obtained as an out-patient model. Patients acutely diagnosed with stroke are not in the hospital for weeks (unless medically unstable), therefore, this study does not apply to my facility. However, we do encourage the discharge of patients very quickly so as to begin their rehabilitation.
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