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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