| Abstract |
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Short description
of 100-250 words |
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Follows a structured
format and includes at least the following |
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Objectives
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Methods
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Results
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Conclusions
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The abstract accurately reflects
the contents of the paper and there are no discrepancies |
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| Introduction |
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Author(s) clearly
reviewed fundamental literature related to topic being addressed |
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Appropriate clinical
literature
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Appropriate compliance
literature
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Appropriate health
economic literature
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Other ________________
(specify)
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Objective of study
clearly stated |
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Compliance is primary
outcome of study |
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If not, how is compliance
being used?_______________________
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| Objectives and
Definitions |
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The objective(s) of the
study been clearly stated and can be readily identified as one of the
following: |
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Exploratory
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Descriptive
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Analytical
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There is an explicit
definition of the compliance variable and the definition used is based
on a published, accepted definition |
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Compliance the primary
“outcome” of interest |
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OR |
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Compliance is being used
as an explanatory or control variable to explain variance in another
outcome |
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| Design and
Methods |
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Design |
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The design is clearly
stated |
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The design matches
the objectives |
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Data Sources |
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All of the data sources have been
described adequately |
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The timeframe for data
has been clearly stated |
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The methods for sampling
the population are well described |
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The data have been
appropriately “cleaned” (i.e., erroneous data were fixed or removed)
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There is evidence for the
reliability/accuracy of the data |
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Inclusion /
Exclusion Criteria |
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The inclusion and
exclusion criteria for the study are clearly stated. |
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The rationale for these
criteria is described |
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The method by which the
researchers verified subjects meeting the inclusion/exclusion criteria
are stated and appropriate |
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Continuous eligibility
for drug benefit during study period was verified |
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Patients had sufficient
data to make a valid estimate of compliance |
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For studies of patients
who are newly initiated on a drug regimen, there was an examination of
data from a sufficient pre-enrollment period to ensure that the
subject was truly naïve to the drug |
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The duration of study
period appropriate to the objectives of the study |
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The duration of study
period appropriate to the objectives of the study |
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There is evidence for
protecting the confidentiality of subjects. |
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The matching process, if
appropriate to the study design, is well described |
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Matching strategy
minimizes the potential for bias
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Propensity scores used to
control for selection bias
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Measurement of
Compliance |
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The methods for
calculating the compliance variable are clearly described |
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The measurement matches
the operational definition provided earlier |
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Do the objectives
indicate that study is to measure adherence but persistence is
actually calculated?
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Standard methods are used for
calculating compliance (see below) |
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- Continuous measure of
medication availability (CMA) / Medication possession ratio
(MPR)
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provide
formulae
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The researchers explained
how they handled values greater than 1
- Were the values retained
or converted to 1?
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- List different formulae
for gaps
- The researchers explained
how they handled negative gap values
- Were the values retained
or converted to 0 (no gap)?
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Others? Proportion of
Days Covered (PDC)?
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If an atypical method is
used for calculating compliance, the rationale/formula for the new
method is provided |
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The researchers provided
an appropriate explanation for how patients who switched drugs within,
or between, therapeutic classes were handled |
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If multiple medications were included
within a single compliance estimate, the researchers provided a
rationale and/or a formula for this variable |
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- The average of the
MPR/Gap across the different medications was used
- The analysis controlled
for the influence of how many medications were combined into a single
variable
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- Was another variable
created to indicate whether the patient was on 1 drug for diabetes
versus multiple drugs for diabetes?
- Is there a logical
argument for combining the MPRs? It may be more appropriate to combine
the MPRs for drugs that treat the same condition (e.g., combining the
MPR for 2 drugs for diabetes) as opposed to combining the MPRs for
drugs used for different conditions.
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Statistical
Analyses |
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In general, the
use of continuous data for measurement of compliance is encouraged.
When continuous data are converted to categorical data (e.g.,
compliance vs. non-compliance) there is a loss of statistical power
due to a decrease in the number of degrees of freedom. However, for
some statistical analyses, it may be appropriate to use categorical
data (e.g., logistic regression). If continuous data are converted
to categorical data, the rationale for selection of cutpoints should
be provided and consistent with existing evidence for compliance in
the selected population (e.g., cutpoint of 95% may be most appropriate
for antiretrovirals, but 80% may be appropriate for hypertension). |
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The tests appropriate
given the objectives, design and the nature of the data |
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- For a list of
parametric and non-parametric tests, see the glossary.
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Appropriate adjustments
for multiple comparisons conducted |
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Appropriate adjustments
were made to the analyses if the data were not normally distributed |
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Power and/or sample size
calculations presented and appropriate |
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There was an attempt to
control for selection bias (e.g., propensity scoring) |
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If the researcher is
evaluating an association between adherence and another variable, the
researcher should attempt to control for other variables that may
confound the association being studied. |
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| Presentation
and Discussion of Findings |
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Results |
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The distribution of the
compliance variable is presented |
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Test-statistics and
confidence intervals appropriately presented in addition to p-values |
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The number of subjects
clearly identified in tables and graphs |
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Graphs were constructed
with an appropriate scale |
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Discussion/Conclusion |
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The limitations
appropriately noted as well as the implications of the limitations are
discussed |
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The influence of the
decision to retain values or cap values is discussed.
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Power and sample size
limitations addressed
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The findings of this
study placed in the context of our existing knowledge of the subject |
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- Appropriate comparison of
the current findings to that of similar studies
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The findings and
conclusions are related to the objectives of the study |
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Disclosure of
potential conflicts of interest |
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Potential conflicts of
interest are disclosed |
