Category Archives: Research design

Data collection, Disseminating findings, Literature review, Magnet New Knowledge_Research, nursing research, nursing science, Qualitative research, quantitative research, reading research, Reliability & validity, research, Research design, research methods, Research student, Resident research project

Essentials for Clinical Researchers

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[note: bonus 20% book discount from publisher. See below flyer]

My 2025 book, Doing Research, is a user-friendly guide, not a comprehensive text. Chapter 1 gives a dozen tips to get started, Chapter 2 defines research, and Chapters 3-9 focus on planning. The remaining Chapters 10-12 guide you through challenges of conducting a study, getting answers from the data, and sharing with others what you learned. Italicized key terms are defined in the glossary, and a bibliography lists additional resources.

authorship, Case study, Clinical significance, Conferences, content analysis, Correlation research, Data, Data collection, Descriptive research, Disseminating findings, Ethics, Evidence hierarchy, Historical research, hypothesis, Literature review, Meta-analysis, Methodologic research, Methods, mixed methods, Narrative research, non-experimental research, nonrandom trials, nursing research, Observational research, Outcome measurement, Paradigm, PICO, pilot study, Poster presentation, Prospective design, Publication, Publishing, Qualitative research, quality improvement, quantitative research, quasi-experimental, Questionnaires, RCT, reading research, Reliability & validity, research, Research design, research methods, Resident research project, statistical significance, Writing

New book: “Doing Research: A Practical Guide”

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Author: Martha “Marty” E. Farrar Highfield

NOW AVAILABLE ELECTRONICALLY & SOON IN PRINT.

CHECK OUT: https://link.springer.com/book/10.1007/978-3-031-79044-7

This book provides a step-by-step summary of how to do clinical research. It explains what research is and isn’t, where to begin and end, and the meaning of key terms. A project planning worksheet is included and can be used as readers work their way through the book in developing a research protocol. The purpose of this book is to empower curious clinicians who want data-based answers.

Doing Research is a concise, user-friendly guide to conducting research, rather than a comprehensive research text. The book contains 12 main chapters followed by the protocol worksheet. Chapter 1 offers a dozen tips to get started, Chapter 2 defines research, and Chapters 3-9 focus on planning. Chapters 10-12 then guide readers through challenges of conducting a study, getting answers from the data, and disseminating results. Useful key points, tips, and alerts are strewn throughout the book to advise and encourage readers.

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New Book Strives to Make the Difficult Simple

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Doing Research: A practical guide for health professionals, a new book by Martha E. Farrar Highfield is in press Springer Nature. Release date Feb 1, 2025 (preorder available).

Practical, brief, and affordable, Doing Research is for residents, nurses, chaplains, and other clinicians.

Written in informal, friendly style, this book makes the difficult simple.

The purpose of Doing Research is to empower curious clinicians to conduct research alongside a mentor, even when they lack prior research experience or formal training.

Doing Research presents practical steps for conducting a study from beginning to end. It begins with “a dozen tips” to get started, then moves to study planning, conduct, and dissemination of results. A worksheet to write your research plan (protocol) is included. Research terms and process are explained, including what research is and is not. Tips & Alerts provide a “reassuring voice,” as well as alerting readers to common missteps.

Methods, non-experimental research, nursing research, Observational research, quantitative research, research, Research design, research methods

Primer on Design: Part 3 – Mixing UP Methods

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QUICK REVIEW: Research design is the overall plan for a study. And…there are 2 main types of design: 1) Non-experiments in which the researcher observes and documents what exists,

and 2) Experiments when the researcher tries out an intervention and measures outcomes.

NEW INFO: Two non-experimental research designs that are often confused with one another are: 1) cohort studies & 2) case studies. Epidemiologists often use these designs to study large populations.

In a cohort study, a group of participants, who were exposed to a presumed cause of disease or injury, are followed into the future (prospectively) to identify emerging health issues. Researchers may also look at their past (retrospectively) to determine the amount of exposure that is related to health outcomes.

In contrast, in a case controlled study, participants with a disease or condition (cases) and others without it (controls) are followed retrospectively to compare their exposure to a presumed cause.

EXAMPLES?

  1. Martinez-Calderon et al (2017 ) Influence of psychological factors on the prognosis of chronic shoulder pain: protocol for a prospective cohort study. BMJ Open, 7. doi: 10.1136/bmjopen-2016-012822
  2. Smith et al (2019). An outbreak of hepatitis A in Canada: The use of a control bank to conduct a case-control study. Epidemiology & Infection, 147. doi: https://doi.org/10.1017/S0950268819001870

CRITICAL THINKING: Do you work with a group that has an interesting past of exposure to some potential cause of disease or injury? Which of the above designs do you find more appealing and why?

Methods, mixed methods, mixed methods, nursing research, reading research, research, Research design, research methods

The Whole Picture: Mixed Methods Design

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Idea2Mixed methods (MM) research provides a more complete picture of reality by including both complementary quantitative and qualitative data.

A clinical analogy for MM research is asking patients to rate their pain numerically on a 0–10 scale and then to describe the pain character in words.

MM researchers sometimes include both experimental hypotheses and non-experimental research questions in the same study.

writing article

Common MM subtypes are in the below table. In concurrent designs investigators collect all data at the same time, and in sequential designs they collect one type of data before the other. In triangulated MM, data receive equal weight, but in embedded designs, such as a large RCT in which only a small subset of RCT participants are interviewed, the main study data is weighted more heavily. In sequential MM, researchers give more weight to whatever type of data were collected first; for exploratory this is qualitative data and for explanatory it is quantitative data.

FOR MORE INFO: WHAT IS MIXED METHODS RESEARCH? – Dr. John Creswell

MM DESIGNEQUALLY WEIGHTED DATAPRIORITY WEIGHTED DATA
Concurrent data collection:
*Triangulation		All data
*EmbeddedMain study data
Sequential data collection:
*Exploratory		Qualitative data
*ExplanatoryQuantitative data
TYPES OF MM DESIGN: Concurrent & Sequential
Descriptive research, Research design

Primer on Research Design: Part 1-Description

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A research design is the investigator-chosen, overarching study framework that facilitates getting the most accurate answer to a hypothesis or question. Think of research design as similar to the framing of a house during construction. Just as house-framing provides structure and limits to walls, floors, and ceilings, so does a research design provide structure and limits to a host of protocol details.

Tip. The two major categories of research design are: 1) Non-experimental, observation only and 2) Experimental testing of an intervention.

DESCRIPTIVE STUDIES

Non-experimental studies that examine one variable at a time.

When little is known and no theory exists on a topic, descriptive research begins to build theory by identifying and defining key, related concepts (variables). Although a descriptive study may explore several variables, only one of those is measured at a time; there is no examination of relationships between variables. Descriptive studies create a picture of what exists by analyzing quantitative or qualitative

data to answer questions like, “What is [variable x]?” or “How often does it occur?” Examples of such one-variable questions are “What are the experiences of first-time fathers?” or “How many falls occur in the emergency room?” (Variables are in italics.)  The former question produces qualitative data, and the latter, quantitative.

Descriptive results raise important questions for further study, and findings are rarely generalizable. You can see this especially in a descriptive case study: an in-depth exploration of a single event or phenomena that is limited to a particular time and place. Given case study limitations, opinions differ on whether they even qualify as research.

Descriptive research that arises from constructivist or advocacy assumptions merits particular attention. In these designs, researchers collect in-depth qualitative information about only one variable and then critically reflect on that data in order to uncover emerging themes or theories. Often broad data are collected in a natural setting in which researchers exercise little control over other variables. Sample size is not pre-determined, data collection and analysis are concurrent, and the researcher collects and analyzes data until no new ideas emerge (data saturation). The most basic qualitative descriptive method is perhaps content analysis, sometimes called narrative descriptive analysis, in which researchers uncover themes within informant descriptions. Figure 4 identifies major qualitative traditions beyond content analysis and case studies.

Alert! All qualitative studies are descriptive, but not all descriptive studies are qualitative.

Box 1. Descriptive Qualitative Designs

DesignFocusDiscipline of Origin
EthnographyUncovers phenomena within a given culture, such as meanings, communications, and mores.Anthropology
Grounded TheoryIdentifies a  basic social problem and the process that participants use to confront it.Sociology
PhenomenologyDocuments the “lived experience” of informants going through a particular event or situation.Psychology
Community participatory actionSeeks positive social change and empowerment of an oppressed community by engaging them in every step of the research process.Marxist political theory
FeministSeeks positive social change and empowerment of women as an oppressed group.Marxist political theory
Descriptive research, Qualitative research, quantitative research, research, Research design

Research: What it is and isn’t

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WHAT RESEARCH IS

Research is using the scientific process to ask and answer questions by examining new or existing data for patterns. The data are measurements of variables of interest. The simplest definition of a variable is that it is something that varies, such as height, income, or country of origin. For example, a researcher might be interested in collecting data on triceps skin fold thickness to assess the nutritional status of preschool children. Skin fold thickness will vary.

Research is often categorized in different ways in terms of: data, design, broad aims, and logic.

Qualitative Data
  • Design. Study design is the overall plan for conducting a research study, and there are three basic designs: descriptive, correlational, and experimental.
    1. Descriptive research attempts to answer the question, “What exists?” It tells us what the situation is, but it cannot explain why things are the way they are. e.g., How much money do nurses make?
    2. Correlational research answers the question: “What is the relationship” between variables (e.g., age and attitudes toward work). It cannot explain why those variables are or are not related. e.g., relationship between nurse caring and patient satisfaction
    3. Experimental research tries to answer “Why” question by examining cause and effect connections. e.g., gum chewing after surgery speeds return of bowel function. Gum chewing is a potential cause or “the why”
  • Aims. Studies, too, may be either applied research or basic research. Applied research is when the overall purpose of the research is to uncover knowledge that may be immediately used in practice (e.g., whether a scheduled postpartum quiet time facilitates breastfeeding). In contrast, basic research is when the new knowledge has no immediate application (e.g., identifying receptors on a cell wall).
  • Logic. Study logic may be inductive or deductive. Inductive reasoning is used in qualitative research; it starts with specific bits of information and moves toward generalizations [e.g., This patient’s pain is reduced after listening to music (specific); that means that music listening reduces all patients pain (general)]. Deductive reasoning is typical of quantitative research; it starts with generalizations and moves toward specifics [e.g., If listening to music relaxes people (general), then it may reduce post-operative pain (specific)]. Of course the logical conclusions in each case should be tested with research!

WHAT RESEARCH IS NOT:

Research as a scientific process is not going to the library or searching online to find information. It is also different from processes of applying research and non-research evidence to practice (called Evidence-Based Practice or EBP). And it is not the same as Quality Improvement (QI). See Two Roads Diverged for a flowchart to help differentiate research, QI and EBP.

experiment, nonrandom trials, quantitative research, RCT, research, Research design, research methods

iS IT 2? OR 3?

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Credible sources often disagree on technicalities. Sometimes this includes classification of research design. Some argue that there are only 2 categories of research design:

  1. True experiments. True experiments have 3 elements: 1) randomization to groups, 2) a control group and an 3) intervention; and
  2. Non-experiments. Non-experiments may have 1 to none of those 3 elements.
Within-subject Control Group

Fundamentally, I agree with the above. But what about designs that include an intervention and a control group, but Not randomization?

Those may be called quasi-experiments; the most often performed quasi-experiment is pre/post testing of a single group. The control group are subjects at baseline and the experimental group are the same subjects after they receive a treatment or intervention. That means the control group is a within-subjects control group (as opposed to between-group control). Quasi-experiments can be used to answer cause-and-effect hypothesis when an experiment may not be feasible or ethical.

One might even argue that a strength of pre/post, quasi-experiments is that we do Not have to Assume that control and experimental groups are equivalent–an assumption we would make about the subjects randomized (randomly assigned) to a control or experimental group. Instead the control and experimental  are exactly equivalent because they are the same persons (barring maturation of subjects and similar threats to validity that are also true of experiments).

I think using the term quasi-experiments makes it clear that persons in the study receive an intervention. Adding “pre/post” means that the

This image has an empty alt attribute; its file name is intervention.jpg
Baseline ->Intervention->Post

researcher is using a single group as their own controls. I prefer to use the term non-experimental to mean a) descriptive studies (ones that just describe the situation) and b) correlation studies (ones without an intervention that look for whether one factor is related to another).

What do you think? 2? or 3?

Data collection, Disseminating findings, Ethics, pilot study, Research design, research methods

Pilot sTUdies: Look before you leap! (a priori vs. posthoc)

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Why does it matter if a study is labeled a “pilot”?

SHORT ANSWER: …Because a pilot is about testing research methods,….not about answering research questions.

If a project has “pilot” in the title, then you as a reader should expect a study that examines whether certain research methods work (methodologic research). Methods include things like timing of data collection, sampling strategies, length of questionnaire, and so on. Pilots suggest what methods will effectively to answer researchers’ questions. Advance prep in methods makes for a smooth research landing.

Small sample = Pilot? A PILOT is related to study goals and design–not sample size. Of course pilots typically have small samples, but a small sample does not a pilot study make. Sometimes journals may tempt a researcher to call their study a pilot because of small samples. Don’t go there. Doing so means after-the-fact, posthoc changes that were Not the original, a priori goals and design.

Practical problems? If researchers label a study a “pilot” after it is completed (post hoc), they raise practical & ethical issues. At a practical level, researchers must create feasibility questions & answers. (See NIH.) The authors should drop data analysis that answers their original research questions.

Ethics? This ethically requires researchers 1) to say they planned something that they didn’t or 2) to take additional action. Additional action may be complete transparency about the change and seeking modification to original human subjects’ committee approvals. An example of one human subjects issue is that you informed your subjects that their data would answer a particular research question, and now you want to use their data to answer something else–methods questions!

Options? You can just learn from your small study and go for a bigger one, including improving methods. Some journals will consider publication of innovative studies even when small.

Look first, then leap: Better to look a priori, before leaping. If you think you might have trouble with your methods, design a pilot. If you made the unpleasant discovery that your methods didn’t work as you hoped, you can 1) disseminate your results anyway or 2) rethink ethical and practical issues.

Who’s with me? The National Institutes of Health agree: https://nccih.nih.gov/grants/whatnccihfunds/pilot_studies . NIH notes that common misuses of “pilots” are determining safety, efficacy of intervention, and effect size.

Who disagrees? McGrath argues that clinical pilots MAY test safety and efficacy, as well as feasibility. (See McGrath, J. M. (2013). Not all studies with small samples are pilot studies, Journal of Perinatal & Neonatal Nursing, 27(4): 281-283. doi: 10.1097/01.JPN.0000437186.01731.bc )

Data collection, Evidence based nursing, evidence based practice, Methodologic research, Methods, research, Research design, research methods

Trial Balloons & Pilot Studies

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A pilot study is to research what a trial balloon is to politics. 

In politics, a trial balloon is communicating a law or policy idea via media to see how the intended audience reacts to it.  A trial balloon does not answer the question, “Would this policy (or law) work?” Instead a trial balloon answers questions like “Which people hate the idea of the policy/law–even if it would work?” or “What problems might enacting it create?” In other words, a trial balloon answers questions that a politician wants to know BEFORE implementing a policy so that the policy or law can be tweaked to be successfully put in place.

meeting2

In research, a pilot study is sort of like a trial balloon. It is “a small-scale test of the methods and procedures” of a planned full-scale study (Porta, Dictionary of Epidemiology, 5th edition, 2008). A pilot study answers questions that we want to know BEFORE doing a larger study, so that we can tweak the study plan and have a successful full-scale research project. A pilot study does NOT answer research questions or hypotheses, such as “Does this intervention work?”  Instead a pilot study answers the question “Are these research procedures workable?”

A pilot study asks & answers: “Can I recruit my target population? Can the treatments be delivered per protocol? Are study conditions acceptable to participants?” and so on.   A pilot study should have specific measurable benchmarks for feasibility testing. For example if the pilot is finding out whether subjects will adhere to the study, then adherence might be defined as  “70 percent of participants in each [group] will attend at least 8 of 12 scheduled group sessions.”  Sample size is based on practical criteria such as  budget, participant flow, and the number needed to answer feasibility questions (ie. questions about whether the study is workable).

A pilot study does NOT:  Test hypotheses (even preliminarily); Use inferential statistics; Assess safety of a treatment; Estimate effect size; Demonstrate safety of an intervention.

A pilot study is not just a small study.

Next blog: Why this matters!!

For more info read the source of all quotes in this blog: Pilot Studies: Common Uses and Misuses @ https://nccih.nih.gov/grants/whatnccihfunds/pilot_studies