Critical Appraisal of a clinical trial

Critical Appraisal of a clinical trial

• Answer all 11 questions below. Write your answers in complete sentences
and construct your arguments clearly. At least one mark for each question
is awarded for the structure of the response, no simply for mentioning the
right answer. Do not simply give a yes or no answer but explain with
detailed reference to the texts. Equally, do not get caught up in elaborate
tangents that do not directly answer the question.
• In answering each question make sure you understand the terminology
being discussed and answer the question being asked. If you mix up
selection bias with information bias, or randomization with allocation, you
are unlikely to get awarded any marks.
• There are plenty of resources available on eLearning for you to clarify
these definitions and procedures. Chapter 16 in the Prince textbook is the
best starting point, and other readings provided on eLearning will point you
towards more detailed aspects of critical appraisal. In particular, the
document by Moher et al., (2010) gives the full CONSORT ‘gold
standards’ and has text boxes throughout with excellent elaborations of
terminology.
• Don’t just try to dream up fanciful possibilities that may have interfered
with each study. Evaluate the merits as well as the failings of the each
study according to the core principles you have learned. Note the aspects
you have confidence in and those that require more information or further
investigation.
• Format your answers in a single word document following the submission
instructions on page 9 of the unit of study outline. References to external
sources should not be required, but should be done in APA or Harvard
style according to standard academic writing practice.
BMRI5020 Page 2 of 3
CRITICAL APPRAISAL QUESTIONS:
1. Does the study by Talwar et al., (2006) present a compelling rationale for
the trial and a clearly testable hypothesis? Bear in mind the length of the
introduction might be restricted by publication limits of the journal itself. (5
marks)
2. The British study by Talwar and colleagues follows from an earlier study
conducted in a Hong Kong clinic (Yang et al., 1998). Apart from possible
racial differences between participants, what similarities or differences
might exist in the samples recruited by each study? (8 marks)
3. Compared to the Yang study, what strengths does the Talwar study have
terms of subject recruitment and exclusion and the way this was reported?
(5 marks)
4. How well does the Talwar study meet the CONSORT guidelines with
respect to providing information about proper randomization? Comment
also on the comparability of the treatment and control subject groups at
the start of the study. What evidence is there that this may have
confounded the findings of the study? (8 marks)
5. Discuss the attempts of the Talwar and colleagues to address expectation
bias and their effectiveness in reporting this process. How does the Yang
study compare in this respect? (9 marks)
6. In the Talwar study, were subjects and controls handled in a comparable
way throughout the study? Are there ways in which their differential
treatment may have introduced bias or confounding into the findings? And
how vulnerable is the study to the introduction of attrition bias? (8 marks)
7. Comment on the effect of treatment on the primary outcome measure in
the Talwar study. What statistical information gives you confidence that the
findings are reported with sufficient information to compare them
objectively? (4 marks)
8. Comment on the effect of treatment on the subscales of the PANSS test.
Are these results to be predicted from the findings of the earlier Yang
study? The Yang study shows a strong treatment effect on the SANS
scale. What are three reasons such an outcome might be expected? (8
marks
BMRI5020 Page 3 of 3
9. Did the Talwar study have adequate power to see an effect if there was
one? Does the Yang study differ in this respect? What other differences in
the conduct of the intervention used could explain the comparatively large
treatment effect in the Yang (1998) study? (9 marks)
10. Which of the two studies provides the most compelling findings with
regards to quality of evidence? What more might need do be done to
consolidate the internal validity of any such investigations in future? (6
marks)
11. Comment on the clinical significance of the two studies. What do they
mean for applicable treatment for acute-care sufferers of schizophrenia?
What is the generalizability of the findings to other settings? Do these
findings support use of music practice by individuals in their own homes?
Could music therapy replace the use of neuroleptic medications? What
other questions remain about the music therapy as an intervention?

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