CHAPTER 1

Research Process: Overview

To do successful research, you don't need to know everything;you just need to know of one thing that isn't known.

—Arthur Schawlow

Highlights: notion of scientific research, research questions and hypotheses; purpose of researchand research objectives; outcome and independent variables; clinical versus population medicine/health; epidemiologic methods

INTRODUCTION

Scientific research is a systematic, controlled, empirical, and critical investigation of naturalphenomena guided by theories and hypotheses about the presumed relations among them.Consequently, research implies an organized and systematic way of finding solutions toquestions. This attempt requires that solutions to the postulated questions be approachedwhen it is feasible, interesting, novel, ethical, and relevant. Clinical research thus involvesthree basic elements:

1. conceptualization,

2. design process, and

3. statistical inference.

As will be discussed further in this text, fundamental thinking in clinical research involvesthese elements:

a) biologic relevance,

b) clinical importance, and

c) statistical stability.

The statistical inference allows conclusions to be drawn from data because the entire populationis never studied. The combination of this tripartite approach to evidence discovery from thedata remains the cornerstone of valid and reliable results from clinical studies and theircautious interpretation in the attempt to improve patient care.

Conducting research involves planning, and that requires the measurement and quantification ofthe variables in the study, careful administration of well-designed instruments, data collection,appropriate analysis, and the interpretation of results. Depending on the research question andthe type of design, this process could be very time-consuming and complex. For example, inclinical trials, an elaborate protocol for participants' enrollment, randomization, and treatmentadministration are used to ensure appropriate documentation of events during the trial.

The materials in this chapter will enable readers to understand research conceptualizationand the distinction between clinical, population medicine and epidemiology as well as theirimplications in epidemiologic/population-based, clinical and biomedical research. Thischapter, as a brief overview of research processes, focuses on the description of terms appliedin research conceptualization and provides practical examples—process of research conduct,research objectives, purpose of research, research questions, hypotheses, and the descriptionof clinical and population medicine within a research context.

STRUCTURE AND FUNCTION OF RESEARCH

Conducting research involves several processes:

(a) A well-defined problem statement, research questions, purposes, and potential benefits ofthe study to science, society, and humanity

For example, one may formulate a research question around the effectiveness of treatmentin improving some pathologic conditions—does cervical spine surgery stabilize the spine inchildren with skeletal dysplasia (SKD)? Clinicians and biomedical researchers should realizethat research questions are not study topics, since such topics are generally broad and researchquestions must be very specific. Specifically, research questions should be formulated in sucha way that they can be answered by observable evidence. Therefore, unless the research forthe question is feasible, it cannot answer the question posed in a measurable manner.

(b) Identification of the theory and assumptions and a search of background literature toaddress the magnitude of the problem

Such a literature review is aimed at identifying what has been done in terms of previousresearch, the gap in literature, and what the proposed study intends to add or contribute to theexisting body of knowledge in the field. It is a common mistake made by novice researchers toavoid the intensive literature review of the subject of their interest until the research questionand study designs are formulated. We caution against such an approach since there is apossibility that such questions have already been answered. It may lead to a study that is notnovel and hence will have very little to offer to science in medicine.

(c) Measurement of variables and statement of researchable hypotheses

Research is basically an exercise with measurement, which is always subject to errors. Goodresearch aims therefore at minimizing measurement error, thus reducing variability in whatis being measured.

(d) Identification of the appropriate study design and methodology to fit the research questionor hypothesis

For example, in the previously mentioned illustration with cervical spine surgery and SKD,the selected design may be the one that involves the administration of surgery to all patientswith SKD, which makes it a...