HI 224 Chapter 12

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Calculating and Reporting
Healthcare Statistics, Sixth Edition
Chapter 12:
Basic Research Principles

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Learning Objectives
• Compare and contrast quantitative research and qualitative
research
• Distinguish among the types of research, research methods,
samples, data collection techniques, and data interpretation
issues
• Determine the steps in the research process
• Explain the role of the Institutional Review Board in
research in healthcare facilities
• Comply with ethical guidelines in the use of statistics
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Research
• Research
• The search toward the solution of problem
• Calls attention to theories that may be helpful in
predicting future experiences
• Performed in many arenas and may be done in a variety
of ways
• Health research covers the wide gamut of laboratory
research, clinical trials and public health issues

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Research (continued)
• Two types of research
• Basic research
• The investigator is not concerned with the immediate
applicability of his or her results but rather tries to look for
understanding of natural processes
• Applied research
• The investigator has some kind of application in mind and
wishes to solve a problem or in some way contribute to society

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Research Methodology
• The study of different types of research methods
• Two overarching approaches to research:
quantitative approach and qualitative approach

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Research Methodology (continued)
• Qualitative Research
• Describes events, persons, and so forth without the use of
numerical data
• Consists of interviews, observations, and written documents
• These may be used individually or in combination

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Research Methodology (continued)
• Quantitative Research
• Uses numbers to describe the study including some
comparisons of the population and statistical analysis to
describe the results
• Consists of observations, experiments, and surveys

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Research Process
• Six major steps
• Defining the problem
• Reviewing the literature
• Designing the research
• Collecting the data
• Analyzing the data
• Drawing conclusions

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Problem Definition
• Forming a question regarding a topic you would like
to study
• The most important thing is to be clear about is
what you want to study
• Often an analysis of historical data, or secondary
information, has gone into the problem definition
• Looking at the past to see what has been done before
• Prevents “reinventing the wheel”
• In previous research, the investigator may have made
recommendations for future studies

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Problem Definition (continued)
• Problems may also be broken down into sub-
problems or smaller problems
• May also define the scope of the study— who or
what will be included in the study

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Literature Review
• An investigation of all the information about a topic
• Three reasons for literature review
• Has research already been done to answer your
question?
• Are there any data sources you can use in your study?
• May help you make your hypothesis more specific
• Sources of previous work
• Journals, books, position papers, conference
presentations, videos, interviews, and online
subscription services

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Research Design and Data Collection
Techniques
• Several types of research design
• Exploratory
• Historical
• Conclusive
• Includes descriptive and causal
• Correlational
• Evaluation
• Experimental and quasi-experimental

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Research Design and Data Collection
Techniques (continued)
• Exploratory research
• Undertaken because a problem is not very clearly
defined
• Allows the researcher to study the problem and gather
information about the problem
• May generate a hypothesis

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Research Design and Data Collection
Techniques (continued)
• Generally informal and relies on literature review and
informal discussions with others in order to find out
more about a problem
• This type of research may not help you answer your
problem but rather may provide you with some insights
to the problem

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Research Design and Data Collection
Techniques (continued)
• Historical research
• Involves investigation and analysis of events of the past
• This type of research does not focus solely on the past,
but it also allows the researcher to apply a previous
researcher’s experiences and conclusions from their
study into current professional practice

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Research Design and Data Collection
Techniques (continued)
• Conclusive research
• Performed in order to come to some sort of conclusion or help
in decision making
• May be done using primary research
• Data collected specifically for your study; or
• Secondary research
• Includes a literature review to see if previous studies can be used
to answer your question
• May also include summaries of past works

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Research Design and Data Collection
Techniques (continued)
• Conclusive research
• There are two types of conclusive research:
• Descriptive research
• Causal research

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Research Design and Data Collection
Techniques
• Conclusive research
• Descriptive research (also called statistical research)
• Provides data about the population you are studying, including
the frequency that something occurs
• The two most common collection techniques of descriptive
research are observations and surveys

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Research Design and Data Collection
Techniques (continued)
• Conclusive research
• Causal research: Tries to answer questions about what causes
certain things to occur
• This type of research is difficult because there may always be an
additional cause to consider
• Uses experimentation and simulation as its data collection
methods

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Research Design and Data Collection
Techniques (continued)
• Correlational research
• Studies that try to discover a relationship between variables
• Variable: Anything under study
• The strength of the relationship is measured
• There may be a positive relationship or a negative relationship
between variables
• This type of research only determines if there is a relationship
between two or more variables
• It does not determine the cause of those relationships
• Uses questionnaires, observations and secondary data as its data
collection methods

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Research Design and Data Collection
Techniques (continued)
• Evaluation research
• A process used to determine what has happened during a given
activity
• The purpose of evaluation is to lead to better understanding of
whether a program is effective, whether a policy is working, or
if something that was agreed upon is the most cost-effective
way of doing something

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Research Design and Data Collection
Techniques (continued)
• Experimental and quasi-experimental research
• Entails manipulation of a situation in some way in order to test
a hypothesis
• Certain variables are kept constant and an independent or
experimental variable is manipulated
• Researchers select both independent and dependent variables
• Independent variables are the factors that researchers
manipulate directly
• Dependent variables are the measured variables

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Research Design and Data Collection
Techniques (continued)
• Statement of the hypothesis
• In formal research, a hypothesis is formed
• A statement of the predicted relationship of what the
researcher is studying
• A proposed solution or explanation at which the
researcher has arrived through review of the literature
• It is the tentative answer to a question
• The statement of the hypothesis is important because it allows
the researcher to think about the variables to include in the
study and type of research design to use in the study
• Quasi-experimental research does not use
randomization of participants

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Research Design and Data Collection
Techniques (continued)
• The research tests the hypothesis proving it to be
positive or negative (correct or incorrect)
• If the hypothesis is rejected—that is, incorrect—it does not
necessarily mean that the research is poor, but only that the
results are different from what was expected
• The formulation of the hypothesis in advance of the
data-gathering process is necessary for an unbiased
investigation

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Research Design and Data Collection
Techniques (continued)
• There are two forms of the hypothesis
• The null hypothesis
• This hypothesis states that there is no difference between the
population means or proportions that are being compared; or
that there is no association between the two variables that are
being compared
• For example, in a clinical trial of a new medication, the null
hypothesis is the new medication is no better than the current
medication

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Research Design and Data Collection
Techniques (continued)
• The alternative hypothesis
• This hypothesis is a statement of what the study is set up to
establish
• For example, in our clinical trial of a new medication, the
alternative hypothesis is the new medication is better than the
current medication

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Research Design and Data Collection
Techniques (continued)
• Data collection techniques
• Includes primary data sources
• Data obtained from observations, surveys and interviews
• Includes secondary data sources
• Literature review or summaries of original studies
• Irrespective of the data collection method the research
must be valid and reliable

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Research Design and Data Collection
Techniques (continued)
• Validity
• The degree to which scientific observations measure or record
what they purport to measure
• For example, if you are using a written questionnaire to collect
data, pretest it

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Research Design and Data Collection
Techniques (continued)
• Reliability
• The repeatability, including interpersonal replicability, of
scientific observations
• With reliability, the major question is: Can another researcher
reproduce the study using a similar instrument and get similar
results?
• A study may be reliable but not valid
• That is, the study may be able to be replicated, but still does
not answer the research question

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Research Design and Data Collection
Techniques (continued)
• Depends on the type of research the investigator wishes
to conduct
• For example, if the researchers want to establish a
causal relationship, they should conduct one of the
experimental studies
• If they are breaking new ground in a poorly understood
area of practice, they may want to consider an
exploratory study in a qualitative design

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Research Design and Data Collection
Techniques (continued)
• Surveys
• Gathers data from a relatively large number of cases at a
particular time
• Can include interviews and questionnaire surveys
• The questions should be well thought out to be sure to answer
the question of the research study
• The questions can be restricted/closed ended
• The investigator only wants certain answers
• Provide for unanticipated response by providing an “other”
category that permits respondents to indicate other
thoughts

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Research Design and Data Collection
Techniques (continued)
• Surveys
• Questionnaire surveys
• The questions can be unrestricted (open ended)
• This allows the participant to express a response in his or
her own words
• These questionnaires can be difficult to tabulate; however,
they are easier to write

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Research Design and Data Collection
Techniques (continued)
• Observation
• Instead of asking a participant questions, the investigator
observes the participant
• Non-participant observation, the examiner is a neutral observer
who does not interact with the participants
• Participant observation, the researcher may also participate in
the actions being observed; however, they try to maintain their
objectivity

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Research Design and Data Collection
Techniques (continued)
• Observation
• Ethnography or naturalistic inquiry
• The researcher observes, listens to, and sometimes converses
with the subjects in as free and natural an atmosphere as
possible
• The assumption is that the most important behavior of
individuals in groups is a dynamic process of complex interactions
and consists of more than a set of facts, statistics, or even
discrete incidents
• A position of neutrality is important in this type of research

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Research Design and Data Collection
Techniques (continued)
• Experimental study
• This provides a logical, systematic way to answer the question,
“If this is done under carefully controlled conditions, what will
happen?”
• Experimentation is a sophisticated technique for collection of
data

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Research Design and Data Collection
Techniques (continued)
• Selecting an instrument
• The instrument, also called a tool, is a consistent way to
collect data
• There are many different types of instruments to use
• Should fit the purpose of the research
• Researchers should not develop an instrument until they
have established that one does not already exist
• If you decide to develop your own instrument take your
time in developing the questions
• It would be too costly and time consuming to have to repeat a
survey because you neglected a question or two

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Research Design and Data Collection
Techniques (continued)
• Samples
• The selection of subjects for the study
• For example, if your study concerns health information
departments in the United States, you could study every
health information department in the United States
(including all of the population is referred to as a census)
• That would not be very practical and could be very costly and
time consuming
• The next best thing is a sample
• When chosen correctly samples are considered to be
representative of the population

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Research Design and Data Collection
Techniques (continued)
• Types of samples
• Two types of sampling techniques
• Probability sampling
• Nonprobability sampling

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Research Design and Data Collection
Techniques (continued)
• Probability samples
• Simple random sample
• Consists of individuals from the population chosen in such a
way that every individual has an equal chance of being selected
• The simplest way to select a sample is to place names in a hat
(the population) and draw out a handful (the sample)
• Statistics books also include a table of random numbers that
can be used for the selection of random samples

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Research Design and Data Collection
Techniques (continued)
• Systematic random sampling
• A systematic pattern is used with random sampling
• For example, let’s say you are choosing a list of
discharged patients from the last month, you choose the
first patient randomly, then choose every fifth patient (or
whatever number you choose) thereafter
• In this sample the choice of the first patient determines
the others

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Research Design and Data Collection
Techniques (continued)
• Stratified random sampling (SRS)
• First divide the population into groups of similar individuals,
called strata
• Then choose a separate SRS in each stratum and combine
these SRSs to form the full sample
• For example, you may want to choose a selection by gender, by
patients with private insurance and those without or
separating hospitals by bed size

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Research Design and Data Collection
Techniques (continued)
• Cluster sampling
• The population is selected from groups or clusters
• For example, let’s say, your study includes health information
practitioners working in large cities
• We would choose the cities (the cluster) first
• Then we would randomly choose the health information
practitioners
• This is called two-stage cluster sampling

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Research Design and Data Collection
Techniques (continued)
• Non-probability samples—Almost all qualitative
research methods rely on this type of sampling
• Judgment sampling
• The researcher relies on his or her own judgment to select the
subjects
• For example, let’s say, you are performing a study on
transcription departments in acute care hospitals that use an
incentive plan to pay employees
• There are a number of large hospitals as well as small and
medium sized hospitals using an incentive plan
• In a judgment sampling, the researcher decides which hospitals
to use in the groups

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Research Design and Data Collection
Techniques (continued)
• Quota sampling
• The population is first divided as in stratified sampling
• Then the researcher uses his or her own judgment to select the
number of subjects based on a specified proportion
• Using our example of HIM departments using an EHR
• If there are 100 hospitals in your state, and 50 are using an EHR
and 50 are not, you may choose to perform your study on 20 of
the hospitals as that would be 20 percent of the total population
of hospitals in your state

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Research Design and Data Collection
Techniques (continued)
• Convenience sampling
• The selection is based on availability of the subjects
• Using our example above, you might decide to use only the
hospitals in your city or within a certain driving distance in
order to expedite the study
• Not clear if this type of sample is representative of the
population
• However, you may be able to get some insights about the
question you are trying to answer

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Research Design and Data Collection
Techniques (continued)
• Snowball sampling
• Used when characteristics needed to be possessed by
participants are difficult to find
• Using our earlier example, if you wanted to study only those
departments using a particular type of software and could not
get that information from the vendor, you might have to rely on
HIM professionals to refer you to others they know are using
the same software
• You would need to find the initial contact and then rely on the
participant to direct you to subsequent participants

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Research Design and Data Collection
Techniques (continued)
• Sample size
• The ideal sample is large enough to serve as an
adequate representation of the population about which
the researcher wishes to generalize and small enough to
be selected economically
• In terms of subject availability, expense in both time and
money, and complexity of data analysis
• The larger the sample, the smaller the magnitude of
sampling error
• Survey studies ordinarily have a larger sample size then
experimental studies

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Research Design and Data Collection
Techniques (continued)
• If you mail questionnaires, your response rate could be a
low as 20 percent to 30 percent, so a large initial sample
is recommended
• If you are planning to have subgroups from your
population, start out with a large group to make sure
you have enough participants for the subgroups
• Subject availability and costs are legitimate
considerations in determining a sample size

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Research Design and Data Collection
Techniques (continued)
• Analyzing the data
• The investigator tries to determine what the data
disclose
• There are a variety of statistics used to analyze data
• Most investigators use a variety of techniques to describe the
data
• Two types of statistical applications are relevant to most
studies
• Descriptive
• Inferential

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Research Design and Data Collection
Techniques (continued)
• Descriptive statistics
• These are statistics that describe the data
• Includes measures of central tendency and measures of
variation
• Inferential statistics
• These statistics allow the researchers to make inferences about
the population characteristics (parameters) from the sample’s
characteristics
• t tests and analysis of variance are examples

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Research Design and Data Collection
Techniques (continued)
• Drawing conclusions
• Any conclusions should be related to the hypothesis, or
if using the qualitative approach, then the problem
identified
• Results for each hypothesis should be described
• Any limitations that the researcher discovered during
data analysis should be reported
• For example, our study of HIM departments studied one city—
this may be a limiting factor
• New hypotheses may be proposed if the data do not support
the original hypotheses
• Researchers usually include tables and graphs in this section of
the research report to clarify the data

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Research Design and Data Collection
Techniques (continued)
• Research always raises new questions about what to
study
• These become suggestions for future research
• The researcher should always include conclusions about
whether or not this problem is better understood or
perhaps even resolved from the research

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Data Interpretation Issues
• Misleading presentation of numbers
• The easiest way to fabricate data is to simply make up
the numbers
• Another way to mislead people is to give
misinformation—that is to make a claim that is
contradicted by the available statistics information
• Check the facts before asserting the information

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Data Interpretation Issues (continued)
• Ignoring the baseline
• Another common error that occurs is to compare raw
numbers without adjusting the baseline
• Selection bias
• Statistical errors can also occur when a sample used in
research does not represent the population
• Graphical misrepresentation
• Graphs can be manipulated to emphasize different
points

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Data Interpretation Issues (continued)
• Sabotage
• One researcher may try to sabotage a colleague’s work
• Using questionable practices when reporting the
data to improve the outcome

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Data Interpretation Issues (continued)
• Importance of data validation
• When a statistical report is received, the HIM
professional should examine it carefully to determine if
the data are correct

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Introduction to Institutional Review Boards
(IRB)
• Responsible for reviewing all research projects for
approval
• Ensure steps are taken by the researcher to protect
the rights and welfare of participants
• Review research procedures before the study is
started and perform periodic reviews during the
study

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Introduction to IRBs (continued)
• Benefits and risks
• A benefit may be specific to the individual subject or to
others that may result from the research
• Risks are concerned with the probability or extent of
harm to the research subject
• Extent of harm may be a statement that indicates minor
problems such as itchiness as a result of the treatment, or it
may be a major effect of treatment such as liver failure that
may result in death

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Introduction to IRBs (continued)
• They may approve, revise, or deny research
requests
• Any research on humans must be taken with care
to ensure that subjects are not abused in any way
• It may be necessary for you to ask participants to
sign a statement that they understand what will be
asked of them
• The researcher must protect the privacy of any
research participants

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Introduction to IRBs (continued)
• Required in healthcare organizations that conduct
research on human subjects
• A committee whose primary responsibility is to
protect the rights and welfare of research subjects
• Professionals who serve on IRBs have extensive
education and experience in clinical research
• Most of these individuals have medical and/or doctoral
or other advanced degrees

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Introduction to IRBs (continued)
• Also called
• Independent Ethics Committee
• Human Subjects Committees
• The IRB functions as a kind of ethics committee
that focuses on what is right or wrong and what is
undesirable in order to protect the rights and
welfare of anyone participating in the research
study

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Introduction to IRBs (continued)
• Because human subjects are involved, researchers
are required to follow certain ethical principles that
guide researcher behavior, morality, and character
traits
• Research ethics provide
• A structure for analysis and decision making
• Support and reminders for researchers to protect human
subjects
• Workable definitions of benefits and risks

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Introduction to IRBs (continued)
• Responsible for reviewing the research procedures
before the study is started and may require
periodic reviews during the study
• They may approve, revise, or deny requests for
research in their facility
• Any research on humans must be done carefully to
ensure that subjects are not abused in any way

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Introduction to IRBs (continued)
• The researcher must obtain permission from the
IRB before any research study is started and
prepare a plan for the research
• The researcher must have thought through the research
very carefully
• Prepared any questionnaires
• Decided how to select a sample and how to collect data
• Prepare the documentation necessary for the IRB, including
informed consent forms for the subjects

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Introduction to IRBs (continued)
• Subjects must give an informed consent
• Informed consent is a person’s voluntary agreement to
participate in research or to undergo a diagnostic,
therapeutic, or preventive procedure
• It is based on adequate knowledge and an understanding of
relevant information provided by the investigators
• In giving informed consent, subjects do not waive any of their
legal rights nor do they release the investigator, sponsor, or
institution from liability for negligence

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Introduction to IRBs (continued)
• Required federal regulations
• A statement that the study involves research, the
purpose of the research, the expected time frame of
subject participation, a description of the procedures to
be followed, and the identification of procedures that
are experimental
• A description of reasonably foreseeable risks or
discomforts. The description must be accurate and
reasonable, and subjects must be informed of previously
reported adverse events

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Introduction to IRBs (continued)
• A description of the benefits to the subject or who may
benefit from the research
• A disclosure of any appropriate alternative procedures
or courses of treatment that might be available
• When appropriate, a statement that supportive care with no
additional disease-specific treatment is an alternative

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Introduction to IRBs (continued)
• A statement describing the extent to which
confidentiality of records identifying the subject will be
maintained
• The statement should include full disclosure and description of
approved agencies, such as the FDA, that may have access to
the records
• For research involving more than minimal risk, an
explanation as to whether any compensation or medical
treatments are available if injury occurs, and, if so, what
they consist of or where further information may be
obtained

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Introduction to IRBs (continued)
• An explanation of whom to contact for answers to
pertinent questions about the research and whom to
contact in the event of a research-related injury
• A statement that participation is voluntary, that refusal
to participate will involve no penalty or loss of benefits,
and that the subject may discontinue participation at
any time

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Introduction to IRBs (continued)
• Federal regulations also require that informed
consent be in a language that is understandable to
the subject
• The consent form must be translated into that language
• Subjects who are not literate in their language must have an
interpreter present to explain the study and to translate
questions and answers between subject and investigator

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Introduction to IRBs (continued)
• Privacy considerations
• The Privacy Rule (HIPAA) establishes a category of
protected health information (PHI), which may be used
or disclosed only in certain circumstances or under
certain conditions
• PHI is a subset of what is called individually identifiable health
information
• It includes what healthcare professionals typically regard as a
patient’s PHI
• PHI also includes identifiable health information about subjects
of clinical research

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Introduction to IRBs (continued)
• The Privacy Rule
• Defines how human research subjects are informed of how
their personal medical information will be used or disclosed
• Defines the rights they have to access the information

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Introduction to IRBs (continued)
• The Privacy Rule protects the privacy of individually
identifiable information while ensuring that researchers
continue to have access to the health information they
need to conduct their research
• Investigators are permitted to use and disclose PHI for research
with individual authorization or without individual
authorization under limited circumstances

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Introduction to IRBs (continued)
• A valid Privacy Rule authorization is an individual’s
signed permission allowing a covered entity to use or
disclose the patient’s PHI for the purpose(s) and to the
recipient(s) stated in the authorization
• When an authorization is obtained for biomedical research
purposes, the Privacy Rule requires that it pertain only to a
specific research study, not to future unspecified projects

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Introduction to IRBs (continued)
• The core elements of the Privacy Rule authorization are
• A description of the PHI to be used or disclosed
• The names or other specific identification of the person or
persons authorized to make the requested use or disclosure
• The names or other specific identification of the person or
persons to whom the covered entity may make the requested
use or disclosure

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Introduction to IRBs (continued)
• A description of each purpose of the requested use or
disclosure
• An authorization expiration date or expiration event that
relates to the individual or to the purpose of the use or
disclosure
• The signature of the individual and the date
• If the individual’s legally authorized representative signs the
authorization, a description of his or her authority to act for the
individual also must be provided

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Introduction to IRBs (continued)
• That the individual has the right to revoke the authorization at
any time and must be provided with the procedure for doing so
• Whether treatment, payment, enrollment, or eligibility of
benefits can be contingent upon authorization, including
research-related treatment and consequences of refusing to
sign the authorization, if applicable

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Introduction to IRBs (continued)
• Any potential risk that the PHI will be redisclosed by the
recipient and no longer protected by the Privacy Rule
• The authorization must be written in plain language and
a copy provided to the individual

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Introduction to IRBs (continued)
• Some facilities may also have a Research Protocol
Monitoring Committee
• Reviews any research before and during the study to
ensure that there are no adverse effects on the
participants
• It may even recommend closure of research that is not
meeting safety standards, does not have scientific merit,
or is not meeting the goals of the research

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Introduction to IRBs (continued)
• Ethical guidelines in statistics
• Statistics play an important part in clinical and
healthcare administrative decision-making
• Statistical data collection, calculation, display and
interpretation must be appropriate and accurate
• Follow the edicts of the Institutional Review Board at their
facilities and follow accepted ethical practice

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Introduction to IRBs (continued)
• Ethical guidelines in statistics
• The American Statistical Association has developed
Ethical Guidelines for Statistical Practice
• They advocate for integrity in the professional work
• Their guidelines include
• Present findings and interpretations honestly and objectively
• Avoid untrue, deceptive, or undocumented statements
• Disclose any financial or other interests that may affect, or
appear to affect, their professional statements

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Introduction to IRBs (continued)
• How to develop research skills
• Take at least one course in statistics and research
methodologies
• Begin to read research studies in professional journals to see
how others have performed their research
• Agree to work with a skilled health information researcher on a
study to gain experience
• Learn how to present data effectively both in written form and
verbally