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PHC215
By Dr. Khaled Ouanes Ph.D.
E-mail: k.ouanes@seu.edu.sa
Twitter: @khaled_ouanes
INTRODUCTION TO
HEALTHCARE RESEARCH
METHODS
Secondary Studies:
Existing Data Sets
Overview
Secondary analysis: the researcher
conducting the statistical analysis has not had
(and does not have) any contact with the
individuals whose data are being examined.
Sources:
 publicly available individual-level or population-level data
 privately held survey data
 clinical records
Publicly Available Data
Sharing data is a cost-efficient way to
extract as much information as possible out
of data sets.
For example, the U.S. Centers for Disease
Control and Prevention (CDC) provides, on
its website, data from several nationwide
cross-sectional studies:
 National Health and Nutrition Examination Survey (NHANES)
 National Health Interview Survey (NHIS)
 Behavioral Risk Factor Surveillance System (BRFSS)
Advantages
 Researchers may be able to download an entire
cleaned data set (and supporting documentation)
immediately and at no cost directly from the
website of the sponsoring organization.
 Secondary analysis is an excellent option for
researchers with strong statistical skills but limited
time and/or data collection resources.
Limitations
 The analyst is limited to exploring only the topics
included in the original survey.
 The analyst has to trust that the data were collected
using valid and standardized methods.
 It may be difficult to find someone who can answer
questions about the data collection process.
 There is a risk of duplicating the analysis that
someone else has done or is doing.
Private Data
 Individual researchers and research teams, such as
those at universities or university hospitals, may have
data available that have not yet been analyzed.
 The original researcher – the one who collected the
data – may be open to a new researcher taking the
lead on analyzing that portion of the data set and
writing up the results for possible publication.
 Limitation: Patient records are often incomplete.
Clinical Records
 Clinical records are a common source of data for
case series.
 Individuals working in clinical settings commonly
have access to patient records for research
purposes, provided that the research project
receives all required approvals and will not violate
any law (such as HIPAA) or policy.
Ethics Committee Review
 Additional approval by an ethics committee at
the institution where the secondary analysis will be
conducted is usually not required for anonymized
publicly available data.
 Secondary analysis of private data or hospital
records almost always requires review by a
research ethics committee.
Tertiary Studies:
Systematic Reviews &
Meta-Analyses
Overview
 A systematic review is the careful compilation and
summary of all publications relevant to a particular
research topic.
 A meta-analysis creates a summary statistic (a pooled
statistic) for the results of systematically identified
articles.
Systematic Review Process
Search Strategy
 After identifying a well-defined study question, the
next critical step in a systematic review or meta-
analysis is to select appropriate databases, search
terms, and search limiters.
 Once a system for identifying eligible articles is in
place, abstract databases are systematically
searched for articles that meet all the inclusion
criteria.
Systematic Search
Strategy & Counts
to Report
Data Extraction
Once all eligible articles are identified, the content of
these articles is extracted into data extraction tables
that list descriptive characteristics like:
 The study location and study years
 The study design
 The study population and sample size
 The key findings of interest
 The strengths and limitations of the study
Data Extraction
 A data extraction table allows for easy compilation
and comparison of observations relevant to the
study question.
 Studies that find no statistically significant results for
an item of interest are just as valuable as those that
find a significant association.
 Publication bias occurs when articles with
statistically significant results are more likely to be
published that those with null results.
Meta-Analysis
 A meta-analysis pools the results of several studies
identified during a systematic review to create one
summary statistic.
 Only similar statistics from similar studies can be
pooled.
 Before pooling the data, the researcher must show
that the results of the studies are comparable.
 A specialized computer software program can be
used to estimate the value of the pooled statistic and
its confidence interval.
 The contribution of each study to the pooled estimate
is usually weighted based on the sample size of the
included studies.
 The contributing studies and the summary measure are
often displayed using a forest plot.
Meta-Analysis
Example of a Forest Plot graphical
display
Threats to the validity of a meta-analysis:
 Poor quality of included studies: The selection criteria
used during the systematic review process can
eliminate any studies of questionable validity.
 Publication bias: The possibility of publication bias can
be examined using a funnel plot.
Meta-Analysis
Example of a Funnel Plot graphical
display
PHC215
By Dr. Khaled Ouanes Ph.D.
E-mail: k.ouanes@seu.edu.sa
Twitter: @khaled_ouanes
HEALTHCARE RESEARCH METHODS
Based on the textbook of introduction to health research methods – K.H. Jacobsen

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Introduction to Healthcare Research Methods

  • 1. PHC215 By Dr. Khaled Ouanes Ph.D. E-mail: k.ouanes@seu.edu.sa Twitter: @khaled_ouanes INTRODUCTION TO HEALTHCARE RESEARCH METHODS
  • 3. Overview Secondary analysis: the researcher conducting the statistical analysis has not had (and does not have) any contact with the individuals whose data are being examined. Sources:  publicly available individual-level or population-level data  privately held survey data  clinical records
  • 4. Publicly Available Data Sharing data is a cost-efficient way to extract as much information as possible out of data sets. For example, the U.S. Centers for Disease Control and Prevention (CDC) provides, on its website, data from several nationwide cross-sectional studies:  National Health and Nutrition Examination Survey (NHANES)  National Health Interview Survey (NHIS)  Behavioral Risk Factor Surveillance System (BRFSS)
  • 5. Advantages  Researchers may be able to download an entire cleaned data set (and supporting documentation) immediately and at no cost directly from the website of the sponsoring organization.  Secondary analysis is an excellent option for researchers with strong statistical skills but limited time and/or data collection resources.
  • 6. Limitations  The analyst is limited to exploring only the topics included in the original survey.  The analyst has to trust that the data were collected using valid and standardized methods.  It may be difficult to find someone who can answer questions about the data collection process.  There is a risk of duplicating the analysis that someone else has done or is doing.
  • 7. Private Data  Individual researchers and research teams, such as those at universities or university hospitals, may have data available that have not yet been analyzed.  The original researcher – the one who collected the data – may be open to a new researcher taking the lead on analyzing that portion of the data set and writing up the results for possible publication.  Limitation: Patient records are often incomplete.
  • 8. Clinical Records  Clinical records are a common source of data for case series.  Individuals working in clinical settings commonly have access to patient records for research purposes, provided that the research project receives all required approvals and will not violate any law (such as HIPAA) or policy.
  • 9. Ethics Committee Review  Additional approval by an ethics committee at the institution where the secondary analysis will be conducted is usually not required for anonymized publicly available data.  Secondary analysis of private data or hospital records almost always requires review by a research ethics committee.
  • 11. Overview  A systematic review is the careful compilation and summary of all publications relevant to a particular research topic.  A meta-analysis creates a summary statistic (a pooled statistic) for the results of systematically identified articles.
  • 13. Search Strategy  After identifying a well-defined study question, the next critical step in a systematic review or meta- analysis is to select appropriate databases, search terms, and search limiters.  Once a system for identifying eligible articles is in place, abstract databases are systematically searched for articles that meet all the inclusion criteria.
  • 14. Systematic Search Strategy & Counts to Report
  • 15. Data Extraction Once all eligible articles are identified, the content of these articles is extracted into data extraction tables that list descriptive characteristics like:  The study location and study years  The study design  The study population and sample size  The key findings of interest  The strengths and limitations of the study
  • 16. Data Extraction  A data extraction table allows for easy compilation and comparison of observations relevant to the study question.  Studies that find no statistically significant results for an item of interest are just as valuable as those that find a significant association.  Publication bias occurs when articles with statistically significant results are more likely to be published that those with null results.
  • 17. Meta-Analysis  A meta-analysis pools the results of several studies identified during a systematic review to create one summary statistic.  Only similar statistics from similar studies can be pooled.  Before pooling the data, the researcher must show that the results of the studies are comparable.
  • 18.  A specialized computer software program can be used to estimate the value of the pooled statistic and its confidence interval.  The contribution of each study to the pooled estimate is usually weighted based on the sample size of the included studies.  The contributing studies and the summary measure are often displayed using a forest plot. Meta-Analysis
  • 19. Example of a Forest Plot graphical display
  • 20. Threats to the validity of a meta-analysis:  Poor quality of included studies: The selection criteria used during the systematic review process can eliminate any studies of questionable validity.  Publication bias: The possibility of publication bias can be examined using a funnel plot. Meta-Analysis
  • 21. Example of a Funnel Plot graphical display
  • 22. PHC215 By Dr. Khaled Ouanes Ph.D. E-mail: k.ouanes@seu.edu.sa Twitter: @khaled_ouanes HEALTHCARE RESEARCH METHODS Based on the textbook of introduction to health research methods – K.H. Jacobsen