Research Design and Analysis

A Primer for the Non-Statistician

Leslie D. Rosenstein

• Publisher: Wiley
• Year: 2019
• Print ISBN: 9781119563594
• eBook ISBN: 9781119563617
• Edition: 1
• Topic: Social Sciences
• Subtopic: Sociology
• Index: Social Sciences

A concise, straightforward overview of research design and analysis, helping readers form a general basis for designing and conducting research

The practice of designing and analyzing research continues to evolve with advances in technology that enable greater technical analysis of data—strengthening the ability of researchers to study the interventions and relationships of factors and assisting consumers of research to understand and evaluate research reports. Research Design and Analysis is an accessible, wide-ranging overview of how to design, conduct, analyze, interpret, and present research. This book helps those in the sciences conduct their own research without requiring expertise in statistics and related fields and enables informed reading of published research.

Requiring no background in statistics, this book reviews the purpose, ethics, and rules of research, explains the fundamentals of research design and validity, and describes how to select and employ appropriate statistical techniques and reporting methods. Readers gain knowledge central to various research scenarios, from sifting through reports of meta-analyses and preparing a research paper for submission to a peer-reviewed journal to discussing, evaluating, and communicating research results. This book:

• Provides end-to-end guidance on the entire research design and analysis process
• Teaches readers how to both conduct their own research and evaluate the research of others
• Offers a clear, concise introduction to fundamental topics ideal for both reference and general education functions
• Presents information derived from the author's experience teaching the subject in real-world classroom settings
• Includes a full array of learning tools including tables, examples, additional resource suggestions, complete references, and appendices that cover statistical analysis software and data sets

Research Design and Analysis: A Primer for the Non-Statistician is a valuable source of information for students and trainees in medical and allied health professions, journalism, education, and those interested in reading and comprehending research literature.

Section 1
The Purpose, Ethics, and Rules of Research

1
The Purpose and Ethics of Research

1.1 The Purpose and Risks of Research

Why do we do research? There are many reasons: to answer a question, to advance understanding of a topic, to evaluate interventions, to predict behavior, to understand differences between groups, and so forth. When we conduct research, we usually start with an inquiry based on theory. We then develop hypotheses. Hypotheses are testable questions or predictions, which are ideally based on theory or pre‐existing knowledge about a topic.

Is there ever a time when research should not be conducted? Yes! Logistically, some research ideas may not have benefits that outweigh the costs of conducting the research. These cost considerations include fiscal costs, time, and effort. But there are also ethical considerations in determining whether research should be conducted and how it is conducted.

In terms of the whether, one might ask if there are any potential harms of the research. Consideration of the issue of potential harm typically refers to the harm that may be incurred by the participants or subjects in the process of conducting the research, but harm can also theoretically result from the findings or the knowledge gained by the research. For instance, what if you want to know whether a necessary, life‐saving treatment causes long‐term cognitive impairments? One might argue that there is no point in “proving” the adverse effects of the treatment if the treatment is required for survival and there are no alternative options. On the other hand, perhaps patients deserve to be fully informed of the potential side effects before deciding whether to pursue treatment versus opting for fate. Perhaps, too, an understanding of negative side effects could lead to the development of strategies and interventions to minimize or reverse them.

As another example, many researchers may be interested in knowing the negative consequences of a certain type and severity of injury. If one stops there in the research, that is, if the research concludes following documentation of the negative impacts of an event or injury, then the research has possibly not improved the human state. However, if used as a starting point, the findings from a line of research investigating those consequences could provide very important information, particularly if it opens the door to further investigations into the mechanisms of those consequences as well as future interventions to address them. In other words, if the next step is taken toward understanding the mechanisms that trigger those sequelae, that understanding can then be used to theorize about and then test potential therapeutic strategies.

The second set of ethical considerations referred to earlier pertains to the how research is conducted. If not carefully planned, research, particularly at the data‐collection stage, can cause harm to the participating humans or animal subjects. Even when experimentation is carefully planned, harm may be inevitable. Harm can occur physically and/or psychologically through injury, misinformation, or misunderstanding.

At times, scientists may face a dilemma in asking whether their research will have more harm than benefit. There may be no clearly right or wrong answer to that question, but it is one that scientists should consider before pursuing a line of research. Ultimately, a researcher wants to be aware of all possible outcomes and impacts that their research may have, not just in the process of conducting the research but also in the process of sharing their results.

Regarding the potential harm to human participants and animal subjects in the process of experimentation, society is replete with examples of individuals and animals being injured physically and/or psychologically by scientific inquiries. This history and the rules and guidelines that have stemmed from attempts to prevent future harm are reviewed next.

1.2 History of Harm to Humans

I am hesitant to introduce the darker side of research in this primer that is, otherwise, intended to be a light overview of research methods. However, understanding harm inflicted on innocent individuals in the name of research throughout recent history puts into perspective the institutional research requirements most of us face when undertaking a new investigation. At times, working through the process of an Institutional Review Board (IRB; which I will discuss in Section 1.6) can be tedious and even frustrating. However, IRB members and other regulators are not trying to make research life difficult. While it does at times seem like we have to overcome irrelevant obstacles, these entities are tasked with the noble and critical goal of preventing a repeating of history. The following pages, therefore, are intended to provide perspective by reminding us of what has come before.

Cruelty inflicted on humans in experimentation actually dates back at least several centuries. In recorded history, convicted criminals were used in studies of human anatomy as far back as the fourth to third century BCE (see Franco (2013), for a review and discussion). Specifically, ancient Greek scientists performed vivisections and dissections on convicted criminals.

Probably the most egregious and well‐known modern examples of unethical, horrific research experiments occurred during the reign and terror of the Nazi regime. Weindling, von Villiez, Loewenau, and Farron (2015) provide a systematic accounting of the atrocities inflicted on tens of thousands of adult and child victims from at least 24 countries during that period. There were a particularly large number of victims from Poland, including both Jewish and Catholic citizens. Many, many cases occurred in the context of imprisonment such as in concentration camps, while other cases occurred under coercion and without consent within psychiatric facilities. Many victims died or were killed in the course of experimentation, with some murders occurring in order to study bodies and body parts. Many other victims lived, but were left with serious, often life‐altering injuries.

As outlined by Weindling et al. (2015), the Nazi experimentation began as an undertaking in eugenics. There, the goal of the Nazis was to wipe the land of individuals from different groups, including those of the Jewish faith, individuals identifying as Roma or Sinti, individuals of “mixed race,” individuals with mental illness, and others. Experimentation grew from X‐ray sterilization to also include studies in which victims were infected with diseases in order to test new drugs. Forced infection included diseases such as tetanus, typhoid, and typhus. Twins sometimes served as comparison controls for their victim sibling in these drug studies, and they were also used in gruesome experiments in which perpetrators attempted to conjoin twins surgically. There were experiments assessing the impact of exposure to high altitude/low pressures and/or extreme freezing temperatures. Anthropometric “data” were collected, including in the form of a “Jewish skeleton collection.” In all, with just what is now known through others’ tenacious inspection of records and interviews, there were a great number of atrocities in the name of experimentation committed against innocent, nonconsenting human beings during the reign of the Nazi terror.

At the same time that the Nazis were inflicting atrocities on humans as research guinea pigs, the Japanese Imperial Army and the Japanese Imperial Guard were, likewise, inflicting great harm on prisoners of war in the name of scientific investigation. Those atrocities have only come to be widely known in more recent years, however. Two major components of the wartime experiments occurred at Unit 731 and other prisoner‐of‐war camps in Japanese‐occupied China, and in an American prisoner‐of‐war camp in Japan.

Unit 731 was a prisoner‐of‐war camp in Manchuria where Chinese inmates, both soldiers and locals, were subjected to horrific experiments as described by Herbert Kikoy (2018) and others. As reported by Kikoy, similar experiments were conducted on Russian and other allied war prisoners at nearby camps. The perpetrators horrendously conducted live vivisections and other biological investigations. These included studies of biological weapons for warfare in which bombs were set off to test the ability to spread airborne infection of gangrene and other bacteria. Other similarities with the Nazi experiments were studies evaluating the impact of exposure to extreme temperatures or decompression. The Japanese Imperial scientists led by a surgeon also tested the effects of X‐ray bombardment, starvation, and sleep deprivation in humans. In addition to the live vivisections, they boiled humans alive, and subjected others to centrifuges resulting in unimaginable terror, pain, and death.

In addition to the atrocities performed on the prisoners at Unit 731 and the nearby war camps, the Japanese Imperial research extended to studies of the plague involving the Chinese populace. The perpetrators bred rats that could be infested with fleas infected with the plague. The goal, again, was to develop biological weapons. Those experiments resulted in several outbreaks of the plague according to Kikoy (2018).

Another component of the Imperialists' atrocious research program occurred in Japan at the medical school of Kyushu Imperial University. One experiment involved injecting an anesthetized prisoner with seawater to test whether it could serve as a substitute for sterile saline solution (McCurry, 2015). According to McCurry, based on review of testimony used during war tribunals, organs were removed from prisoners to assess the impact of surgery on organ systems. One prisoner suffered through the experience of having his skull drilled through to test a surgical intervention for the treatment of epilepsy. Corpses of deceased prisoners of war were also preserved in formaldehyde for medical students to use in their studies. These and other details are discussed in a Japanese book written by a physician who was a young medical student at Kyushu Imperial University during this period; his accounts are reviewed, in English, by McCurry (2015) and others (e.g. O'Flynn, 2015).

Sadly, harmful experimentation inflicted on unknowing or unwilling individuals has also occurred outside of the context of war. In the United States, one of the most infamous and shameful of these experiments, originally known as the “Tuskegee Study of Untreated Syphilis in the Negro Male,” was carried out by the United States Public Health Service. That study concluded in 1972 and involved monitoring the natural course of syphilis even after penicillin became the accepted treatment of choice in the 1940s (Centers for Disease Control and Prevention, 2017c).

As chronicled by the National Center for Bioethics in Research and Health Care (Tuskegee University, 2018), 600 men, including 399 who were found to have syphilis and 201 who served as a control group, were recruited into the study beginning in 1932. In exchange for their participation, they were offered, “medical exams, rides to and from the clinics, meals on examination days, free treatment for minor ailments and guarantees that provisions would be made after their deaths in terms of burial stipends paid to their survivors.” The purpose of the study was to learn about the natural course of the disease. When the ...

Table of contents

• Cover
• Table of Contents
• List of Figures
• List of Tables
• Introduction
• Section 1: The Purpose, Ethics, and Rules of Research
• Section 2: Basic Research Designs and Validity
• Section 3: The Nuts and Bolts of Data Analysis
• Section 4: Reporting, Understanding, and Communicating Research Findings
• Appendix A: Data Sets and Databases
• Appendix B: Statistical Analysis Packages
• Appendix C: Helpful Statistics Resources
• Glossary
• References
• Index
• End User License Agreement