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The Standard Appraisal Questions

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What size of effect did the study have the power to detect? ... Chance effects may appear quite large, especially when the sample size is small ... – PowerPoint PPT presentation

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Title: The Standard Appraisal Questions


1
The Standard Appraisal Questions
2
Anatomy of a scholarly journal article
  • Abstract
  • Introduction
  • Methods
  • Results
  • Discussion
  • (conclusion)
  • Designed to answer
  • Is it of interest
  • Why was it done?
  • How was it done?
  • What has it found?
  • What are the implications?
  • What else is of interest?

Adapted from Crombie, 1996
3
Abstract
  • Is it of interest?
  • A summary that presents key points from each of
    the main sections
  • Structured abstract now commonly required vs.
    previously accepted in paragraph form
  • Should give an overview of the article
  • How relevant is the topic to the information
    sought by a reader?
  • Common flaws
  • Not concise, clear or accurate summary
  • Author may put a spin on the abstract that may
    influence novice readers

4
Why was it done? - Introduction
  • Provides the background to the study
  • Review previous work
  • Highlight gaps in current knowledge
  • May explain why gaps are urgent
  • Clinical importance of the topic
  • Usually expressed in epidemiological terms
  • Morbidity, mortality, cost of health services
  • Introduction should wrap-up with a clear
    statement of the studys purpose
  • A hypothesis to be tested or a question to be
    answered
  • If absent, did authors know what they were
    looking for?

5
Are the aims clearly stated?
  • Explanation of why the study was carried out.
  • Did the research tackle an important problem?
  • Clearly stated tightly focused aims
  • Hypothesis specified in advance
  • Well planned study
  • Vs. trawling which could result in spuriously
    significant results

6
How was the study carried out? - Methods
  • Should be thorough enough to reproduce
  • However, often refers to other publications for
    details
  • Who was studied how were they recruited
  • Clinic? Diagnostic criteria? Demographics sought?
  • Information needed for generalization
  • Are data accurate?
  • How were measurements taken?
  • Steps taken to standardize measurements?
  • Scientific quality of questionnaires measuring
    instruments
  • Which statistical methods were used in analysis

7
An essential component of the Methods section
  • If a published study does not disclose the
    details of how they estimated their required
    sample size, including
  • Expected or clinically important difference
    sought
  • Acceptable probability of making a Type I error
  • Desired power to detect a difference if there is
    one
  • And the statistical package or computer program
    used to calculate needed sample size based on the
    above
  • Then, the statistical conclusions can be
    interesting, informative, but not convincing!

8
What has it found? - Results
  • Main findings tables figures, explained in
    text
  • Logical presentation simple observations to
    complex analyses
  • Text should highlight key findings of the data
  • Text will emphasize what authors find important
  • Readers should make up their own minds
  • Do results fulfill the aims of the study
  • What do the findings mean?
  • Reader should find flaws assess their impact
  • Reader should decide what findings really mean

9
Was the sample size justified?
  • Large enough to give accurate picture of whats
    going on
  • Size of the effect being sought
  • How big study must be to detect this effect
  • Small studies may fail to detect clinically
    important effects
  • What size of effect did the study have the power
    to detect?
  • May be calculated after study completion

10
Are measurements likely to be valid reliable?
  • Detailed description of measurement methods
  • Read critically, asking how errors could be
    introduced
  • Were assessments subjective?
  • Did more than one observer assess?
  • Did authors discuss potential measurement errors?
  • Should discuss how reliability validity were
    assessed

11
Were basic data adequately described?
  • Number of subjects and how they were obtained
  • Basic characteristics, mean range
  • What typical measurements look like how they
    vary
  • Important for generalizability comparability
  • Begin with simple analyses, giving main outcomes
    in tables /or figures
  • Complex analyses later, should reconcile

12
Do the numbers add up?
  • Subjects lost to followup or missing data should
    be accounted for
  • If data analyzed in subgroups, all should add up
    to total
  • Discrepancies should be accounted for
  • Small (lt1) discrepancies unlikely to have impact
    on findings

13
Are the statistical methods described?
  • Described in the Methods section, and referenced
  • Address assumptions about data
  • Warning sign large numbers of tests carried out
  • Potential for spurious significance
  • Simple analyses should be compared with more
    complex ones

14
Was the statistical significance assessed?
  • Chance effects may appear quite large, especially
    when the sample size is small
  • P-value lt.05 provides good evidence that the
    result is likely to be real rather than chance
  • Some journals prefer confidence intervals to
    p-values
  • CI shows the range within which the true value
    could lie, with a certain degree of confidence
    (usually 95)
  • A broad range calls into question the effect size

15
What are the implications? - Discussion
  • Can the findings be generalized to other people,
    places times?
  • Subjective authors are not always impartial
  • Implications
  • What is new?
  • What does it mean for health care?
  • Is it relevant to my patients?
  • Author should make comparisons to other studies
    and address discrepancies
  • Conclusions
  • Should findings induce changes in clinical
    practice?
  • Do findings highlight need for further research?

16
What do the main findings mean?
  • Is the effect size clinically significant?
  • Why or why not?
  • Internal consistency may be demonstrated
  • Similar results by age or sex
  • Dose response
  • Supports findings as not chance aberration
  • Reader should consider whether authors
    interpretations make sense
  • Biologic plausibility, timing of events,

17
How are null findings interpreted?
  • Was there lack of effect?... OR
  • Was the study too small to have a reasonable
    chance of detecting anything?
  • Wide confidence interval indicates this
    possibility
  • Lack of evidence of an association is not the
    same as evidence of no association

18
Did untoward events occur during the study?
  • Many problems should have been dealt with in
    feasibility pilot studies
  • Difficulty following research design
  • Loss of subjects to followup
  • Difficult to make measurements on some
    individuals
  • Missing data may allow bias to intrude
  • Midstream changes in design worrisome
  • Data may not be comparable

19
Are important effects overlooked?
  • Reader should look at the results for unexplored
    findings, patterns, etc.
  • Researchers, understandably, may draw attention
    to findings which fit their preconceptions
  • Do they comment on results which do not fit their
    views?

20
How do the results compare with previous reports?
  • Single study seldom provides convincing evidence
  • New findings accepted only with substantial
    body of research
  • Confidence diminishes if other studies fail to
    confirm previous results
  • Findings should be fitted into a balanced
    overview of all reported studies

21
What implications does the study have for your
practice?
  • Should this information lead to changes in the
    management of ones own patients?
  • Risk subjecting patients to useless therapy
  • Risk denying patients access to effective ones
  • Risk causing anxiety by advising them to avoid
    harmful behavior
  • How big was the effect, and is it clinically
    important?
  • Were patients circumstances similar to your
    practice?

22
Overall Questions to Ask
  • Is the study design appropriate to address the
    research question?
  • In the Discussion Section Are the findings...
  • ...consistent with the research question of the
    study?
  • consistent with the results presented?
  • given in the context of current evidence?
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