Question

processes for finding and evaluating research

(dnp program)

what are the processes for finding and evaluating research. the research process should intergrate sound theoretical and scientific results.

Answer 1

A research project generally comprises four key components: (1) writing a protocol, (2) performing experiments, (3) tabulating and analyzing data, and (4) writing a thesis or manuscript for publication.

Fundamentals in the research process

A protocol, whether experimental or clinical, serves as a navigator that evolves from a basic outline of the study plan to become a qualified research or grant proposal. It provides the structural support for the research. Dr. G. Jagadeesh (US FDA), the first speaker of the session, spoke on ‘Fundamentals in research process and cornerstones of a research project.’ He discussed at length the developmental and structural processes in preparing a research protocol. A systematic and step-by-step approach is necessary in planning a study. Without a well-designed protocol, there would be a little chance for successful completion of a research project or an experiment.

Research topic The first and the foremost difficult task in research is to identify a topic for investigation. The research topic is the keystone of the entire scientific enterprise. It begins the project, drives the entire study, and is crucial for moving the project forward. It dictates the remaining elements of the study [Table 1] and thus, it should not be too narrow or too broad or unfocused. Because of these potential pitfalls, it is essential that a good or novel scientific idea be based on a sound concept. Creativity, critical thinking, and logic are required to generate new concepts and ideas in solving a research problem. Creativity involves critical thinking and is associated with generating many ideas. Critical thinking is analytical, judgmental, and involves evaluating choices before making a decision.[4] Thus, critical thinking is convergent type thinking that narrows and refines those divergent ideas and finally settles to one idea for an in-depth study. The idea on which a research project is built should be novel, appropriate to achieve within the existing conditions, and useful to the society at large. Therefore, creativity and critical thinking assist biomedical scientists in research that results in funding support, novel discovery, and publication.[1,4]

Table 1

Table 1

Elements of a study protocol

Research question The next most crucial aspect of a study protocol is identifying a research question. It should be a thought-provoking question. The question sets the framework. It emerges from the title, findings/results, and problems observed in previous studies. Thus, mastering the literature, attendance at conferences, and discussion in journal clubs/seminars are sources for developing research questions. Consider the following example in developing related research questions from the research topic.

Topic

Hepatoprotective activity of Terminalia arjuna and Apium graveolens on paracetamol-induced liver damage in albino rats.

Research questions

How is paracetamol metabolized in the body? Does it involve P450 enzymes? How does paracetamol cause liver injury? What are the mechanisms by which drugs can alleviate liver damage? What biochemical parameters are indicative of liver injury? What major endogenous inflammatory molecules are involved in paracetamol-induced liver damage?

Objective A research question is broken down into more precise objectives. The objectives lead to more precise methods and definition of key terms. The objectives should be SMART-Specific, Measurable, Achievable, Realistic, Time-framed,[10] and should cover the entire breadth of the project. The objectives are sometimes organized into hierarchies: Primary, secondary, and exploratory; or simply general and specific. Study the following example:

Primary objective

To evaluate the safety and tolerability of single oral doses of compound X in normal volunteers.

Secondary objective

To assess the pharmacokinetic profile of compound X following single oral doses.

Exploratory objective

To evaluate the incidence of peripheral edema reported as an adverse event.

Hypothesis The objectives and research questions are then formulated into a workable or testable hypothesis. The latter forces us to think carefully about what comparisons will be needed to answer the research question, and establishes the format for applying statistical tests to interpret the results. The hypothesis should link a process to an existing or postulated biologic pathway. A hypothesis is written in a form that can yield measurable results. Studies that utilize statistics to compare groups of data should have a hypothesis. Consider the following example:

The hepatoprotective activity of Terminalia arjuna is superior to that of Apium graveolens against paracetamol-induced liver damage in albino rats.

All biological research, including discovery science, is hypothesis-driven. However, not all studies need be conducted with a hypothesis. For example, descriptive studies (e.g., describing characteristics of a plant, or a chemical compound) do not need a hypothesis.[1]

Relevance of the study Another important section to be included in the protocol is ‘significance of the study.’ Its purpose is to justify the need for the research that is being proposed (e.g., development of a vaccine for a disease). In summary, the proposed study should demonstrate that it represents an advancement in understanding and that the eventual results will be meaningful, contribute to the field, and possibly even impact society.

Biomedical literature

A literature search may be defined as the process of examining published sources of information on a research or review topic, thesis, grant application, chemical, drug, disease, or clinical trial, etc. The quantity of information available in print or electronically (e.g., the internet) is immense and growing with time. A researcher should be familiar with the right kinds of databases and search engines to extract the needed information.[3,6]

Dr. P. Balakumar (Institute of Pharmacy, Rajendra Institute of Technology and Sciences, Sirsa, Haryana; currently, Faculty of Pharmacy, AIMST University, Malaysia) spoke on ‘Biomedical literature: Searching, reviewing and referencing.’ He schematically explained the basis of scientific literature, designing a literature review, and searching literature. After an introduction to the genesis and diverse sources of scientific literature searches, the use of PubMed, one of the premier databases used for biomedical literature searches world-wide, was illustrated with examples and screenshots. Several companion databases and search engines are also used for finding information related to health sciences, and they include Embase, Web of Science, SciFinder, The Cochrane Library, International Pharmaceutical Abstracts, Scopus, and Google Scholar.[3] Literature searches using alternative interfaces for PubMed such as GoPubMed, Quertle, PubFocus, Pubget, and BibliMed were discussed. The participants were additionally informed of databases on chemistry, drugs and drug targets, clinical trials, toxicology, and laboratory animals (reviewed in ref[3]).

Referencing and bibliography are essential in scientific writing and publication.[7] Referencing systems are broadly classified into two major types, such as Parenthetical and Notation systems. Parenthetical referencing is also known as Harvard style of referencing, while Vancouver referencing style and ‘Footnote’ or ‘Endnote’ are placed under Notation referencing systems. The participants were educated on each referencing system with examples.

Bibliography management

Dr. Raj Rajasekaran (University of California at San Diego, CA, USA) enlightened the audience on ‘bibliography management’ using reference management software programs such as Reference Manager®, Endnote®, and Zotero® for creating and formatting bibliographies while writing a manuscript for publication. The discussion focused on the use of bibliography management software in avoiding common mistakes such as incomplete references. Important steps in bibliography management, such as creating reference libraries/databases, searching for references using PubMed/Google scholar, selecting and transferring selected references into a library, inserting citations into a research article and formatting bibliographies, were presented. A demonstration of Zotero®, a freely available reference management program, included the salient features of the software, adding references from PubMed using PubMed ID, inserting citations and formatting using different styles.

Writing experimental protocols

The workshop systematically instructed the participants in writing ‘experimental protocols’ in six disciplines of Pharmaceutical Sciences.: (1) Pharmaceutical Chemistry (presented by Dr. P. V. Bharatam, NIPER, Mohali, Punjab); (2) Pharmacology (presented by Dr. G. Jagadeesh and Dr. P. Balakumar); (3) Pharmaceutics (presented by Dr. Jayant Khandare, Piramal Life Sciences, Mumbai); (4) Pharmacy Practice (presented by Dr. Shobha Hiremath, Al-Ameen College of Pharmacy, Bengaluru); (5) Pharmacognosy and Phytochemistry (presented by Dr. Salma Khanam, Al-Ameen College of Pharmacy, Bengaluru); and (6) Pharmaceutical Analysis (presented by Dr. Saranjit Singh, NIPER, Mohali, Punjab). The purpose of the research plan is to describe the what (Specific Aims/Objectives), why (Background and Significance), and how (Design and Methods) of the proposal.

The research plan should answer the following questions: (a) what do you intend to do; (b) what has already been done in general, and what have other researchers done in the field; (c) why is this worth doing; (d) how is it innovative; (e) what will this new work add to existing knowledge; and (f) how will the research be accomplished?

In general, the format used by the faculty in all subjects is shown in Table 2.

Table 2

Table 2

Elements of a research protocol

Biostatistics

Biostatistics is a key component of biomedical research. Highly reputed journals like The Lancet, BMJ, Journal of the American Medical Association, and many other biomedical journals include biostatisticians on their editorial board or reviewers list. This indicates that a great importance is given for learning and correctly employing appropriate statistical methods in biomedical research. The post-lunch session on day 1 of the workshop was largely committed to discussion on ‘Basic biostatistics.’ Dr. R. Raveendran (JIPMER, Puducherry) and Dr. Avijit Hazra (PGIMER, Kolkata) reviewed, in parallel sessions, descriptive statistics, probability concepts, sample size calculation, choosing a statistical test, confidence intervals, hypothesis testing and ‘P’ values, parametric and non-parametric statistical tests, including analysis of variance (ANOVA), t tests, Chi-square test, type I and type II errors, correlation and regression, and summary statistics. This was followed by a practice and demonstration session. Statistics CD, compiled by Dr. Raveendran, was distributed to the participants before the session began and was demonstrated live. Both speakers worked on a variety of problems that involved both clinical and experimental data. They discussed through examples the experimental designs encountered in a variety of studies and statistical analyses performed for different types of data. For the benefit of readers, we have summarized statistical tests applied frequently for different experimental designs and post-hoc tests [Figure 1].

Figure 1

Figure 1

Conceptual framework for statistical analyses of data. Of the two kinds of variables, qualitative (categorical) and quantitative (numerical), qualitative variables (nominal or ordinal) are not normally distributed. Numerical data that come from normal ...

Research and publication ethics

The legitimate pursuit of scientific creativity is unfortunately being marred by a simultaneous increase in scientific misconduct. A disproportionate share of allegations involves scientists of many countries, and even from respected laboratories. Misconduct destroys faith in science and scientists and creates a hierarchy of fraudsters. Investigating misconduct also steals valuable time and resources. In spite of these facts, most researchers are not aware of publication ethics.

Day 1 of the workshop ended with a presentation on ‘research and publication ethics’ by Dr. M. K. Unnikrishnan (College of Pharmaceutical Sciences, Manipal University, Manipal). He spoke on the essentials of publication ethics that included plagiarism (attempting to take credit of the work of others), self-plagiarism (multiple publications by an author on the same content of work with slightly different wordings), falsification (manipulation of research data and processes and omitting critical data or results), gift authorship (guest authorship), ghostwriting (someone other than the named author (s) makes a major contribution), salami publishing (publishing many papers, with minor differences, from the same study), and sabotage (distracting the research works of others to halt their research completion). Additionally, Dr. Unnikrishnan pointed out the ‘Ingelfinger rule’ of stipulating that a scientist must not submit the same original research in two different journals. He also advised the audience that authorship is not just credit for the work but also responsibility for scientific contents of a paper. Although some Indian Universities are instituting preventive measures (e.g., use of plagiarism detecting software, Shodhganga digital archiving of doctoral theses), Dr. Unnikrishnan argued for a great need to sensitize young researchers on the nature and implications of scientific misconduct. Finally, he discussed methods on how editors and peer reviewers should ethically conduct themselves while managing a manuscript for publication.

SCIENTIFIC COMMUNICATION: THE KEY TO SUCCESSFUL SELLING OF FINDINGS

Research outcomes are measured through quality publications. Scientists must not only ‘do’ science but must ‘write’ science. The story of the project must be told in a clear, simple language weaving in previous work done in the field, answering the research question, and addressing the hypothesis set forth at the beginning of the study. Scientific publication is an organic process of planning, researching, drafting, revising, and updating the current knowledge for future perspectives. Writing a research paper is no easier than the research itself. The lectures of Day 2 of the workshop dealt with the basic elements and logistics of writing a scientific paper.

An overview of paper structure and thesis writing

Dr. Amitabh Prakash (Adis, Auckland, New Zealand) spoke on ‘Learning how to write a good scientific paper.’ His presentation described the essential components of an original research paper and thesis (e.g., introduction, methods, results, and discussion [IMRaD]) and provided guidance on the correct order, in which data should appear within these sections. The characteristics of a good abstract and title and the creation of appropriate key words were discussed. Dr. Prakash suggested that the ‘title of a paper’ might perhaps have a chance to make a good impression, and the title might be either indicative (title that gives the purpose of the study) or declarative (title that gives the study conclusion). He also suggested that an abstract is a succinct summary of a research paper, and it should be specific, clear, and concise, and should have IMRaD structure in brief, followed by key words. Selection of appropriate papers to be cited in the reference list was also discussed.

PLEASE DO LIKE??