HIM discussion (health information management)

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Calculating and Reporting Healthcare Statistics, Fifth Edition, Revised Reprint

Chapter 12: Basic Research Principles

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

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

Research Methodology

The study of different types of research methods

Two overarching approaches to research: quantitative approach and qualitative approach

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

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

Research Process

Six major steps

Defining the problem

Reviewing the literature

Designing the research

Collecting the data

Analyzing the data

Drawing conclusions

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

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

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

Research Design and Data Collection Techniques

Several types of research design

Exploratory

Historical

Conclusive

Includes descriptive and causal

Correlational

Evaluation

Experimental and quasi-experimental

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

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

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

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

Research Design and Data Collection Techniques (continued)

Conclusive research

There are two types of conclusive research:

Descriptive research

Causal research

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

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

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

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

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

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

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

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

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

Research Design and Data Collection Techniques (continued)

Data collection techniques

Includes primary research

Data obtained from observations, surveys and interviews

Includes secondary research

Literature review or summaries of original studies

Irrespective of the data collection method the research must be valid and reliable

Research Design and Data Collection Techniques (continued)

Validity

The degree to which scientific observations actually measure or record what they purport to measure

For example, if you are using a written questionnaire to collect data, pretest it

Research Design and Data Collection Techniques (continued)

Reliability

The repeatability, including interperson 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

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

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

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

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

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

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

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

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

Research Design and Data Collection Techniques (continued)

Types of samples

Two types of sampling techniques

Probability sampling

Nonprobability sampling

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

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

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

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

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

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

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 really representative of the population

However, you may be able to get some insights about the question you are trying to answer

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

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

Research Design and Data Collection Techniques (continued)

If you mail questionnaires, your response rate could be a low as 20 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

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

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

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

E.g., 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

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

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

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

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

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

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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (continued)

The Privacy Rule protects the privacy of individually identifiable information while ensuring that researchers continue to have access to the medical 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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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

Introduction to Institutional Review Boards (IRB) (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