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The critical steps for successful research: The research proposal and scientific writing

The critical steps for successful research: The research proposal and scientific writing Report The critical steps for successful research: The research proposal and scientific writing th (A report on the pre‑conference workshop held in conjunction with the 64 annual conference of the Indian Pharmaceutical Congress‑2012) 1 2 Pitchai Balakumar, Mohammed Naseeruddin Inamdar , Gowraganahalli Jagadeesh Pharmacology Unit, Faculty of Pharmacy, AIMST University, Semeling, 08100 Bedong. Kedah Darul Aman, Malaysia, Department of Pharmacology, Al‑Ameen College of Pharmacy, Bengaluru, Karnataka, India Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, USA ABSTRACT An interactive workshop on ‘The Critical Steps for Successful Research: The Research Proposal and th Scientific Writing’ was conducted in conjunction with the 64 Annual Conference of the Indian Pharmaceutical Congress-2012 at Chennai, India. In essence, research is performed to enlighten our understanding of a contemporary issue relevant to the needs of society. To accomplish this, a researcher begins search for a novel topic based on purpose, creativity, critical thinking, and logic. This leads to the fundamental pieces of the research endeavor: Question, objective, hypothesis, experimental tools to test the hypothesis, methodology, and data analysis. When correctly performed, research should produce new knowledge. The four cornerstones of good research are the well-formulated protocol or proposal that is well executed, analyzed, discussed and concluded. This recent workshop educated researchers in the critical steps involved in the development of a scientific idea to its successful execution and eventual publication. Key words: Research protocol, scientific writing, creativity, publication ethics, of society. Hence, the primary objective of research is to INTRODUCTION produce new knowledge. Research is both theoretical and Creativity and critical thinking are of particular importance in empirical. It is theoretical because the starting point of scientific scientific research. Basically, research is original investigation research is the conceptualization of a research topic and undertaken to gain knowledge and understand concepts in major development of a research question and hypothesis. Research is subject areas of specialization, and includes the generation empirical (practical) because all of the planned studies involve of ideas and information leading to new or substantially a series of observations, measurements, and analyses of data improved scientific insights with relevance to the needs [1‑9] that are all based on proper experimental design. Access this article online The subject of this report is to inform readers of the proceedings Quick Response Code: th from a recent workshop organized by the 64 Annual conference Website: www.jpharmacol.com of the ‘Indian Pharmaceutical Congress’ at SRM University, Chennai, India, from 05 to 06 December 2012. The objectives of the workshop titled ‘The Critical Steps for Successful Research: DOI: 10.4103/0976-500X.110895 The Research Proposal and Scientific Writing,’ were to assist participants in developing a strong fundamental understanding Address for correspondence: Gowraganahalli Jagadeesh, Division of Cardiovascular and Renal Products, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22, Rm 4128, Silver Spring, MD 20993-0002, USA. E-mail: [email protected] 130 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 Balakumar, et al.: Basic concepts of research and publication of how best to develop a research or study protocol, and a well‑designed protocol, there would be a little chance for communicate those research findings in a conference setting successful completion of a research project or an experiment. or scientific journal. Completing any research project requires Research topic meticulous planning, experimental design and execution, and The first and the foremost difficult task in research is to identify compilation and publication of findings in the form of a research a topic for investigation. The research topic is the keystone paper. All of these are often unfamiliar to naïve researchers; of the entire scientific enterprise. It begins the project, drives thus, the purpose of this workshop was to teach participants to the entire study, and is crucial for moving the project forward. master the critical steps involved in the development of an idea It dictates the remaining elements of the study [Table 1] and to its execution and eventual publication of the results (See the thus, it should not be too narrow or too broad or unfocused. last section for a list of learning objectives). Because of these potential pitfalls, it is essential that a good or novel scientific idea be based on a sound concept. Creativity, THE STRUCTURE OF THE WORKSHOP critical thinking, and logic are required to generate new concepts and ideas in solving a research problem. Creativity The two‑day workshop was formatted to include key lectures involves critical thinking and is associated with generating and interactive breakout sessions that focused on protocol many ideas. Critical thinking is analytical, judgmental, and development in six subject areas of the pharmaceutical [4] involves evaluating choices before making a decision. Thus, sciences. This was followed by sessions on scientific writing. critical thinking is convergent type thinking that narrows and DAY 1 taught the basic concepts of scientific research, refines those divergent ideas and finally settles to one idea for including: (1) how to formulate a topic for research and to an in‑depth study. The idea on which a research project is built describe the what, why, and how of the protocol, (2) biomedical should be novel, appropriate to achieve within the existing literature search and review, (3) study designs, statistical conditions, and useful to the society at large. Therefore, concepts, and result analyses, and (4) publication ethics. DAY 2 creativity and critical thinking assist biomedical scientists in educated the attendees on the basic elements and logistics of research that results in funding support, novel discovery, and writing a scientific paper and thesis, and preparation of poster [1,4] publication. as well as oral presentations. Research question The final phase of the workshop was the ‘Panel Discussion,’ The next most crucial aspect of a study protocol is identifying including ‘Feedback/Comments’ by participants. There a research question. It should be a thoughtp ‑ rovoking question. were thirteen distinguished speakers from India and abroad. The question sets the framework. It emerges from the title, Approximately 120 post‑graduate and pre‑doctoral students, findings/results, and problems observed in previous studies. young faculty members, and scientists representing industries Thus, mastering the literature, attendance at conferences, and attended the workshop from different parts of the country. All discussion in journal clubs/seminars are sources for developing participants received a printed copy of the workshop manual research questions. Consider the following example in and supporting materials on statistical analyses of data. developing related research questions from the research topic. • Topic THE BASIC CONCEPTS OF RESEARCH: THE Hepatoprotective activity of Terminalia arjuna and Apium KEY TO GETTING STARTED IN RESEARCH graveolens on paracetamol‑induced liver damage in albino rats. A research project generally comprises four key components: (1) writing a protocol, (2) performing experiments, (3) tabulating Table 1: Elements of a study protocol and analyzing data, and (4) writing a thesis or manuscript for Element Purpose publication. Research topic* Keystone of the study. Begins, drives, and ends the study Fundamentals in the research process Research Relationship between two or more variables is A protocol, whether experimental or clinical, serves as a question* phrased as a question navigator that evolves from a basic outline of the study plan to Objective* Researchable issue. Developed logically from a become a qualified research or grant proposal. It provides the description of the topic structural support for the research. Dr. G. Jagadeesh (US FDA), Hypothesis* Relationship phrased as a declarative statement, needs statistical testing the first speaker of the session, spoke on ‘Fundamentals in Significance of Why is the research question important? What research process and cornerstones of a research project.’ the study are the implications of the study? He discussed at length the developmental and structural Experimental Materials and methods, subjects, variables, processes in preparing a research protocol. A systematic and design statistics step‑by‑step approach is necessary in planning a study. Without *Considered cornerstones of a research project Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 131 Balakumar, et al.: Basic concepts of research and publication • Research questions vaccine for a disease). In summary, the proposed study should How is paracetamol metabolized in the body? Does demonstrate that it represents an advancement in understanding it involve P450 enzymes? How does paracetamol and that the eventual results will be meaningful, contribute to the field, and possibly even impact society. cause liver injury? What are the mechanisms by which drugs can alleviate liver damage? What biochemical Biomedical literature parameters are indicative of liver injury? What major A literature search may be defined as the process of examining endogenous inflammatory molecules are involved in published sources of information on a research or review topic, paracetamol‑induced liver damage? thesis, grant application, chemical, drug, disease, or clinical trial, etc. The quantity of information available in print or Objective electronically (e.g., the internet) is immense and growing A research question is broken down into more precise objectives. The objectives lead to more precise methods and definition with time. A researcher should be familiar with the right kinds of databases and search engines to extract the needed of key terms. The objectives should be SMART‑ Specific, [10] [3,6] information. Measurable, Achievable, Realistic, Time‑framed , and should cover the entire breadth of the project. The objectives Dr. P. Balakumar (Institute of Pharmacy, Rajendra Institute of are sometimes organized into hierarchies: Primary, secondary, Technology and Sciences, Sirsa, Haryana; currently, Faculty and exploratory; or simply general and specific. Study the of Pharmacy, AIMST University, Malaysia) spoke on following example: ‘Biomedical literature: Searching, reviewing and referencing.’ He schematically explained the basis of scientific literature, designing • Primary objective a literature review, and searching literature. After an introduction To evaluate the safety and tolerability of single oral doses to the genesis and diverse sources of scientific literature searches, of compound X in normal volunteers. the use of PubMed, one of the premier databases used for • Secondary objective biomedical literature searches world‑wide, was illustrated with To assess the pharmacokinetic profile of compound X examples and screenshots. Several companion databases and following single oral doses. search engines are also used for finding information related • Exploratory objective to health sciences, and they include Embase, Web of Science, To evaluate the incidence of peripheral edema reported as SciFinder, The Cochrane Library, International Pharmaceutical an adverse event. [3] Abstracts, Scopus, and Google Scholar. Literature searches Hypothesis using alternative interfaces for PubMed such as GoPubMed, The objectives and research questions are then formulated into Quertle, PubFocus, Pubget, and BibliMed were discussed. The a workable or testable hypothesis. The latter forces us to think participants were additionally informed of databases on chemistry, carefully about what comparisons will be needed to answer drugs and drug targets, clinical trials, toxicology, and laboratory [3] the research question, and establishes the format for applying animals (reviewed in ref ). statistical tests to interpret the results. The hypothesis should Referencing and bibliography are essential in scientific writing link a process to an existing or postulated biologic pathway. [7] and publication. Referencing systems are broadly classified A hypothesis is written in a form that can yield measurable into two major types, such as Parenthetical and Notation results. Studies that utilize statistics to compare groups of data systems. Parenthetical referencing is also known as Harvard should have a hypothesis. Consider the following example: style of referencing, while Vancouver referencing style and • The hepatoprotective activity of Terminalia arjuna ‘Footnote’ or ‘Endnote’ are placed under Notation referencing is superior to that of Apium graveolens against systems. The participants were educated on each referencing system with examples. paracetamol‑induced liver damage in albino rats. Bibliography management All biological research, including discovery science, Dr. Raj Rajasekaran (University of California at San Diego, is hypothesis–driven. However, not all studies need be CA, USA) enlightened the audience on ‘bibliography conducted with a hypothesis. For example, descriptive management’ using reference management software programs studies (e.g., describing characteristics of a plant, or a chemical ® ® ® [1] such as Reference Manager , Endnote , and Zotero for compound) do not need a hypothesis. creating and formatting bibliographies while writing a Relevance of the study manuscript for publication. The discussion focused on the use Another important section to be included in the protocol is of bibliography management software in avoiding common ‘Significance of the study.’ Its purpose is to justify the need mistakes such as incomplete references. Important steps in for the research that is being proposed (e.g., development of a bibliography management, such as creating reference libraries/ 132 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 Balakumar, et al.: Basic concepts of research and publication databases, searching for references using PubMed/Google Table 2: Elements of a research protocol scholar, selecting and transferring selected references into a Title (short and effective) library, inserting citations into a research article and formatting Introduction (should answer ‘what’ and ‘why’ of the proposal (should list research questions, objectives of the study); bibliographies, were presented. A demonstration of Zotero®, this should be followed by (a separate paragraph) ‘the central a freely available reference management program, included hypothesis that would be tested ’ the salient features of the software, adding references from Review of literature (existing knowledge in the area of work, the PubMed using PubMed ID, inserting citations and formatting rationale for the proposed project, and the gaps that the project is intended to fill). The review should be logically organized and using different styles. should include a discussion of major variables that are measured in the research Writing experimental protocols Significance of research (what is expected from the work, why the The workshop systematically instructed the participants expected outcomes are potentially important in advancing the field, study impact) in writing ‘experimental protocols’ in six disciplines Plan of study (how the research will be carried out/work plan with of Pharmaceutical Sciences.: (1) Pharmaceutical timeline) Chemistry (presented by Dr. P. V. Bharatam, NIPER, Mohali, General methodology (based on the plan of study). List each Punjab); (2) Pharmacology (presented by Dr. G. Jagadeesh and method separately and give the chemicals/instruments you intend Dr. P. Balakumar); (3) Pharmaceutics (presented by Dr. Jayant to use in each case References (Bibliography). Follow a proper style, be consistent, Khandare, Piramal Life Sciences, Mumbai); (4) Pharmacy and no mix and match Practice (presented by Dr. Shobha Hiremath, Al‑Ameen College of Pharmacy, Bengaluru); (5) Pharmacognosy and Statistics CD, compiled by Dr. Raveendran, was distributed to Phytochemistry (presented by Dr. Salma Khanam, Al‑Ameen the participants before the session began and was demonstrated College of Pharmacy, Bengaluru); and (6) Pharmaceutical live. Both speakers worked on a variety of problems that Analysis (presented by Dr. Saranjit Singh, NIPER, Mohali, Punjab). The purpose of the research plan is to describe involved both clinical and experimental data. They discussed through examples the experimental designs encountered in the what (Specific Aims/Objectives), why (Background and a variety of studies and statistical analyses performed for Significance), and how (Design and Methods) of the proposal. different types of data. For the benefit of readers, we have The research plan should answer the following questions: (a) what summarized statistical tests applied frequently for different do you intend to do; (b) what has already been done in general, experimental designs and post‑hoc tests [Figure 1]. and what have other researchers done in the field; (c) why is Research and publication ethics this worth doing; (d) how is it innovative; (e) what will this The legitimate pursuit of scientific creativity is unfortunately new work add to existing knowledge; and (f) how will the being marred by a simultaneous increase in scientific research be accomplished? misconduct. A disproportionate share of allegations involves In general, the format used by the faculty in all subjects is scientists of many countries, and even from respected shown in Table 2. laboratories. Misconduct destroys faith in science and scientists and creates a hierarchy of fraudsters. Investigating misconduct Biostatistics also steals valuable time and resources. In spite of these facts, Biostatistics is a key component of biomedical research. most researchers are not aware of publication ethics. Highly reputed journals like The Lancet, BMJ, Journal of the American Medical Association, and many other biomedical Day 1 of the workshop ended with a presentation on ‘research journals include biostatisticians on their editorial board or and publication ethics’ by Dr. M. K. Unnikrishnan (College reviewers list. This indicates that a great importance is given of Pharmaceutical Sciences, Manipal University, Manipal). for learning and correctly employing appropriate statistical He spoke on the essentials of publication ethics that methods in biomedical research. The post‑lunch session on included plagiarism (attempting to take credit of the work day 1 of the workshop was largely committed to discussion on of others), self‑plagiarism (multiple publications by an ‘Basic biostatistics.’ Dr. R. Raveendran (JIPMER, Puducherry) author on the same content of work with slightly different and Dr. Avijit Hazra (PGIMER, Kolkata) reviewed, in wordings), falsification (manipulation of research data parallel sessions, descriptive statistics, probability concepts, and processes and omitting critical data or results), gift sample size calculation, choosing a statistical test, confidence authorship (guest authorship), ghostwriting (someone other intervals, hypothesis testing and ‘P’ values, parametric than the named author (s) makes a major contribution), salami and non‑parametric statistical tests, including analysis of publishing (publishing many papers, with minor differences, variance (ANOVA), t tests, Chi‑square test, type I and type II from the same study), and sabotage (distracting the errors, correlation and regression, and summary statistics. research works of others to halt their research completion). This was followed by a practice and demonstration session. Additionally, Dr. Unnikrishnan pointed out the ‘Ingelfinger Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 133 Balakumar, et al.: Basic concepts of research and publication Statistical design Comparison of Comparison of two groups three or more groups Paired groups Matched groups Unmatched groups Unpaired groups Normal Non-normal Normal Normal Non-normal Normal Non-normal Non-normal Distribution- Distribution- Distribution- Distribution- Distribution- Distribution- Distribution- Distribution- Parametric Nonparametric Parametric Parametric Nonparametric Parametric Nonparametric Nonparametric Paired- Wilcoxon Unpaired- Mann- Repeated Friedman One-way or Kruskal- t test signed t test Whitney measures test Two-way* Wallis rank test U test ANOVA ANOVA test Tukey's multiple range test, Dunn’s Student- Dunn’s Bonferroni correction test, test Newman-Keuls test test Duncan’s multiple-range test, Dunnett's test * Two-way ANOVA allows to compare the effects of two categorical factors (e.g., dose and diet) on one outcome (e.g., blood After the null hypothesis is rejected, for pairwise comparisons of groups pressure). The data must be normally with multiple comparison adjustment, a post-hoc test is selected (based distributed and the samples must be on certain criteria) and the data is analyzed to identify the groups that independent. are significantly different from each other 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 distributions are analyzed using parametric tests, if not; the data are analyzed using non‑parametric tests. The most popularly used Student’s t‑ test compares the means of two populations, data for this test could be paired or unpaired. One‑way analysis of variance (ANOVA) is used to compare the means of three or more independent populations that are normally distributed. Applying t test repeatedly in pair (multiple comparison), to compare the means of more than two populations, will increase the probability of type I error (false positive). In this case, for proper interpretation, we need to adjust the P values. Repeated measures ANOVA is used to compare the population means if more than two observations coming from same subject over time. The null hypothesis is rejected with a ‘P’ value of less than 0.05, and the difference in population means is considered to be statistically significant. Subsequently, appropriate post‑hoc tests are used for pairwise comparisons of population means. Two‑way or three‑way ANOVA are considered if two (diet, dose) or three (diet, dose, strain) independent factors, respectively, are analyzed in an experiment (not described in the Figure). Categorical nominal unmatched variables (counts or frequencies) are analyzed by Chi‑square test (not shown in the Figure) rule’ of stipulating that a scientist must not submit the SCIENTIFIC COMMUNICATION: THE KEY TO same original research in two different journals. He also SUCCESSFUL SELLING OF FINDINGS advised the audience that authorship is not just credit for Research outcomes are measured through quality the work but also responsibility for scientific contents of publications. Scientists must not only ‘do’ science but must a paper. Although some Indian Universities are instituting ‘write’ science. The story of the project must be told in a preventive measures (e.g., use of plagiarism detecting clear, simple language weaving in previous work done in software, Shodhganga digital archiving of doctoral theses), the field, answering the research question, and addressing Dr. Unnikrishnan argued for a great need to sensitize young the hypothesis set forth at the beginning of the study. researchers on the nature and implications of scientific Scientific publication is an organic process of planning, misconduct. Finally, he discussed methods on how editors researching, drafting, revising, and updating the current and peer reviewers should ethically conduct themselves while knowledge for future perspectives. Writing a research paper managing a manuscript for publication. is no easier than the research itself. The lectures of Day 2 134 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 Balakumar, et al.: Basic concepts of research and publication of the workshop dealt with the basic elements and logistics based entirely on these observations. Additionally, how the of writing a scientific paper. results are applied to further research in the field to advance our understanding of research questions was discussed. An overview of paper structure and thesis writing Dr. Amitabh Prakash (Adis, Auckland, New Zealand) spoke Dr. Peush Sahni (All‑India Institute of Medical Sciences, on ‘Learning how to write a good scientific paper.’ His New Delhi) spoke on effectively ‘Structuring the Discussion’ presentation described the essential components of an original for a research paper. The Discussion section deals with a research paper and thesis (e.g., introduction, methods, results, systematic interpretation of study results within the available and discussion [IMRaD]) and provided guidance on the correct knowledge. He said the section should begin with the most order, in which data should appear within these sections. The important point relating to the subject studied, focusing on characteristics of a good abstract and title and the creation of key issues, providing link sentences between paragraphs, and appropriate key words were discussed. Dr. Prakash suggested ensuring the flow of text. Points were made to avoid history, not that the ‘title of a paper’ might perhaps have a chance to make repeat all the results, and provide limitations of the study. The a good impression, and the title might be either indicative (title strengths and novel findings of the study should be provided in that gives the purpose of the study) or declarative (title that the discussion, and it should open avenues for future research gives the study conclusion). He also suggested that an abstract and new questions. The Discussion section should end with a is a succinct summary of a research paper, and it should be conclusion stating the summary of key findings. Dr. Sahni gave specific, clear, and concise, and should have IMRaD structure an example from a published paper for writing a Discussion. in brief, followed by key words. Selection of appropriate In another presentation titled ‘Writing an effective title and the papers to be cited in the reference list was also discussed. abstract,’ Dr. Sahni described the important components of a Various unethical authorships were enumerated, and ‘The good title, such as, it should be simple, concise, informative, International Committee of Medical Journal Editors (ICMJE) interesting and eye‑catching, accurate and specific about the criteria for authorship’ was explained (http://www.icmje. paper’s content, and should state the subject in full indicating org/ethical_1author.html; also see Table 1 in reference #9). study design and animal species. Dr. Sahni explained The session highlighted the need for transparency in medical structured (IMRaD) and unstructured abstracts and discussed publication and provided a clear description of items that a few selected examples with the audience. needed to be included in the ‘Disclosures’ section (e.g., sources of funding for the study and potential conflicts of interest of all Language and style in publication The next lecture of Dr. Amitabh Prakash on ‘Language and authors, etc.) and ‘Acknowledgements’ section (e.g., writing assistance and input from all individuals who did not meet style in scientific writing: Importance of terseness, shortness and clarity in writing’ focused on the actual sentence the authorship criteria). The final part of the presentation was devoted to thesis writing, and Dr. Prakash provided the construction, language, grammar and punctuation in scientific audience with a list of common mistakes that are frequently manuscripts. His presentation emphasized the importance of encountered when writing a manuscript. brevity and clarity in the writing of manuscripts describing biomedical research. Starting with a guide to the appropriate The backbone of a study is description of results through Text, construction of sentences and paragraphs, attendees were Tables, and Figures. Dr. S. B. Deshpande (Institute of Medical given a brief overview of the correct use of punctuation with Sciences, Banaras Hindu University, Varanasi, India) spoke on interactive examples. Dr. Prakash discussed common errors ‘Effective Presentation of Results.’ The Results section deals in grammar and proactively sought audience participation in with the observations made by the authors and thus, is not correcting some examples. Additional discussion was centered hypothetical. This section is subdivided into three segments, on discouraging the use of redundant and expendable words, that is, descriptive form of the Text, providing numerical jargon, and the use of adjectives with incomparable words. data in Tables, and visualizing the observations in Graphs or The session ended with a discussion of words and phrases Figures. All these are arranged in a sequential order to address that are commonly misused (e.g., data vs. datum, affect vs. the question hypothesized in the Introduction. The description effect, among vs. between, dose vs. dosage, and efficacy/ in Text provides clear content of the findings highlighting the efficacious vs. effective/effectiveness) in biomedical research observations. It should not be the repetition of facts in tables or manuscripts. graphs. Tables are used to summarize or emphasize descriptive Working with journals content in the text or to present the numerical data that are unrelated. Illustrations should be used when the evidence The appropriateness in selecting the journal for submission bearing on the conclusions of a paper cannot be adequately and acceptance of the manuscript should be determined by the presented in a written description or in a Table. Tables or experience of an author. The corresponding author must have a Figures should relate to each other logically in sequence and rationale in choosing the appropriate journal, and this depends should be clear by themselves. Furthermore, the discussion is upon the scope of the study and the quality of work performed. Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 135 Balakumar, et al.: Basic concepts of research and publication Dr. Amitabh Prakash spoke on ‘Working with journals: Selecting was provided on the best way to address referee feedback. The a journal, cover letter, peer review process and impact factor’ by session concluded with a discussion of the potential drawbacks instructing the audience in assessing the true value of a journal, of the current peer review system. understanding principles involved in the peer review processes, Poster and oral presentations at conferences providing tips on making an initial approach to the editorial Posters have become an increasingly popular mode of office, and drafting an appropriate cover letter to accompany the presentation at conferences, as it can accommodate more submission. His presentation defined the metrics that are most papers per meeting, has no time constraint, provides a better commonly used to measure journal quality (e.g., impact factor™, presenter‑audience interaction, and allows one to select and Eigenfactor™ score, Article Influence™ score, SCOPUS 2‑year attend papers of interest. In Figure 2, we provide instructions, citation data, SCImago Journal Rank, h‑Index, etc.) and guided design, and layout in preparing a scientific poster. In the attendees on the relative advantages and disadvantages of using each metric. Factors to consider when assessing journal final presentation, Dr. Sahni provided the audience with step‑by‑step instructions on how to write and format quality were discussed, and the audience was educated on the ‘green’ and ‘gold’ open access publication models. Various peer posters for layout, content, font size, color, and graphics. Attendees were given specific guidance on the format of review models (e.g., double‑blind, single‑blind, non‑blind) were described together with the role of the journal editor in assessing text on slides, the use of color, font type and size, and the manuscripts and selecting suitable reviewers. A typical checklist use of illustrations and multimedia effects. Moreover, the sent to referees was shared with the attendees, and clear guidance importance of practical tips while delivering oral or poster Title: Declarative (title that gives the study conclusion) Logo, The title should be large so that the text can be read from a distance of 81 ‑ 0 feet Abstract List of Authors number (Underline the presenting author) Affiliations with contact details (email address) DISCUSSION ABSTRACT RESULTS Provide systematic interpretation of Provide clear content of the findings study results. Bullet INTRODUCTION highlighting the observations. statements are fine. Background Preferably, use Tables and/or Graphs to Rationale clarify and depict the study results. Use Objective CONCLUSION headers, footers and legends. Avoid too Hypothesis, if any Include summary many Tables/Figures. of key findings MATERIALS & METHODS KEY Also include REFERENCES Experimental design & ACKNOWLED‑ Statistics used GEMENTS Presented at the Annual Conference of …....held at….... (place) on …….(date) Figure 2: Guidelines and design to scientific poster presentation. The objective of scientific posters is to present laboratory work in scientific meetings. A poster is an excellent means of communicating scientific work, because it is a graphic representation of data. Posters should have focus points, and the intended message should be clearly conveyed through simple sections: Text, Tables, and Graphs. Posters should be clear, succinct, striking, and eye‑catching. Colors should be used only where necessary. Use one font (Arial or Times New Roman) throughout. Fancy fonts should be avoided. All headings should have font size of 44, and be in bold capital letters. Size of Title may be a bit larger; subheading: Font size of 36, bold and caps. References and Acknowledgments, if any, should have font size of 24. Text should have font size between 24 and 30, in order to be legible from a distance of 3 to 6 feet. Do not use lengthy notes 136 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 Poster size: 1.5 meter length and 1 meter width Balakumar, et al.: Basic concepts of research and publication presentation was provided to the audience, such as speak • Study protocols on different topics in their subject of slowly and clearly, be informative, maintain eye contact, and specialization listen to the questions from judges/audience carefully before • Searching and reviewing the literature • Appropriate statistical analyses in biomedical research coming up with an answer. • Scientific ethics in publication • Writing and understanding the components of a research PANEL DISCUSSION: FEEDBACK AND paper (IMRaD) COMMENTS BY PARTICIPANTS • Recognizing the value of good title, running title, abstract, key words, etc After all the presentations were made, Dr. Jagadeesh began a • Importance of Tables and Figures in the Results section, panel discussion that included all speakers. The discussion was and their importance in describing findings aimed at what we do currently and could do in the future with • Evidence‑based Discussion in a research paper respect to ‘developing a research question and then writing an • Language and style in writing a paper and expert tips on effective thesis proposal/protocol followed by publication.’ getting it published Dr. Jagadeesh asked the following questions to the panelists, • Presentation of research findings at a conference (oral and while receiving questions/suggestions from the participants poster). and panelists. • Does a Post‑Graduate or Ph.D. student receive adequate Overall, the workshop was deemed very helpful to participants. The participants rated the quality of workshop from “satisfied” training, either through an institutional course, a workshop of the present nature, or from the guide? to “very satisfied.” A significant number of participants were of the opinion that the time allotted for each presentation was short • Are these Post‑Graduates self‑taught (like most of us who and thus, be extended from the present two days to four days learnt the hard way)? with adequate time to ask questions. In addition, a ‘hands‑on’ • How are these guides trained? How do we train them to session should be introduced for writing a proposal and become more efficient mentors? manuscript. A large number of attendees expressed their desire • Does a Post‑Graduate or Ph.D. student struggle to find a to attend a similar workshop, if conducted, in the near future. method (s) to carry out studies? To what extent do seniors/ guides help a post graduate overcome technical difficulties? How difficult is it for a student to find chemicals, reagents, ACKNOWLEDGMENT instruments, and technical help in conducting studies? • Analyses of data and interpretation: Most students struggle We gratefully express our gratitude to the Organizing Committee, without adequate guidance. especially Professors K. Chinnasamy, B. G. Shivananda, N. Udupa, • Thesis and publications frequently feature inadequate/ Jerad Suresh, Padma Parekh, A. P. Basavarajappa, Mr. S. V. Veerramani, Mr. J. Jayaseelan, and all volunteers of the SRM University. We thank incorrect statistical analyses and representation of data in Dr. Thomas Papoian (US FDA) for helpful comments on the manuscript. tables/graphs. The student, their guide, and the reviewers all share equal responsibility. Disclaimer • Who initiates and drafts the research paper? The The opinions expressed herein are those of Gowraganahalli Post‑Graduate or their guide? Jagadeesh and do not necessarily reflect those of the US Food • What kind of assistance does a Post‑Graduate get from and Drug Administration the guide in finalizing a paper for publication? • Does the guide insist that each Post‑Graduate thesis yield at least one paper, and each Ph.D. thesis more than two REFERENCES papers, plus a review article? 1. Biomedical Research‑From Ideation to Publication. In: Jagadeesh G, st Murthy S, Gupta YK, Prakash A, editors. 1 ed, Philadelphia: Wolters The panelists and audience expressed a variety of views, but Kluwer Health‑Lippincott Williams and Wilkins: 2010. were unable to arrive at a decisive conclusion. 2. Balakumar P. Letter to the Editor. Biomedical Research‑From Ideation to Publication. In: Jagadeesh G, Murthy S, Gupta YK, Prakash A, editors. st 1 ed, Philadelphia: Wolters Kluwer Health‑Lippincott Williams and Wilkins: 2010. J Nat Sci Biol Med 2012;3:212. WHAT HAVE THE PARTICIPANTS LEARNED? 3. Balakumar P, Marcus SJ, Jagadeesh G. Navigating your way through online resources for biomedical research. RGUHS J Pharm Sci 2012;2:5‑27. At the end of this fast‑moving two‑day workshop, the 4. Reisman F. Creative, critical thinking and logic in research. RGUHS J participants had opportunities in learning the following topics: Pharm Sci 2011;1:97‑102. 5. Bartz CC. Getting Started with Research: Ideas to Research Process. • Sequential steps in developing a study protocol, from RGUHS J Pharm Sci 2011;1:176‑9. choosing a research topic to developing research questions 6. Kuberappa YV, Kumar AH. Knowing the known to understand the and a hypothesis. unknown‑A systematic approach to reviewing the scientific literature. Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 137 Balakumar, et al.: Basic concepts of research and publication st RGUHS J Pharm Sci 2012;2:1‑7. In: Jagadeesh G, Murthy S, Gupta YK, Prakash A, editors. 1 ed, Ch 3. 7. Neville C. Referencing: Principles, Practice and Problems. RGUHS J Philadelphia: Wolters Kluwer Health‑Lippincott Williams and Wilkins; Pharm Sci 2012;2:1‑8. 2010. p. 27‑34. 8. Balakumar P, Murthy S, Jagadeesh G. The basic concepts of scientific research and communication Indian J Pharmacol 2007;39:303‑6. How to cite this article: Balakumar P, Inamdar MN, Jagadeesh G. The 9. Balakumar P, Jagadeesh G. The basic concepts of scientific research and critical steps for successful research: The research proposal and scientific scientific communication. J Pharmacol Pharmacother 2012;3:178‑82. writing. J Pharmacol Pharmacother 2013;4:130-8. 10. Kalmund P. Setting thesis research objectives. M.Sc. programme. Cited Source of Support: Nil, Conflict of Interest: None declared. by Jenicek M. In: Biomedical Research‑From Ideation to Publication. Announcement iPhone App A free application to browse and search the journal’s content is now available for iPhone/iPad. The application provides “Table of Contents” of the latest issues, which are stored on the device for future offline browsing. Internet connection is required to access the back issues and search facility. The application is Compatible with iPhone, iPod touch, and iPad and Requires iOS 3.1 or later. The application can be downloaded from http://itunes.apple.com/us/app/medknow-journals/ id458064375?ls=1&mt=8. For suggestions and comments do write back to us. 138 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Pharmacology and Pharmacotherapeutics SAGE

The critical steps for successful research: The research proposal and scientific writing

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0976-500X
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10.4103/0976-500x.110895
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Report The critical steps for successful research: The research proposal and scientific writing th (A report on the pre‑conference workshop held in conjunction with the 64 annual conference of the Indian Pharmaceutical Congress‑2012) 1 2 Pitchai Balakumar, Mohammed Naseeruddin Inamdar , Gowraganahalli Jagadeesh Pharmacology Unit, Faculty of Pharmacy, AIMST University, Semeling, 08100 Bedong. Kedah Darul Aman, Malaysia, Department of Pharmacology, Al‑Ameen College of Pharmacy, Bengaluru, Karnataka, India Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, USA ABSTRACT An interactive workshop on ‘The Critical Steps for Successful Research: The Research Proposal and th Scientific Writing’ was conducted in conjunction with the 64 Annual Conference of the Indian Pharmaceutical Congress-2012 at Chennai, India. In essence, research is performed to enlighten our understanding of a contemporary issue relevant to the needs of society. To accomplish this, a researcher begins search for a novel topic based on purpose, creativity, critical thinking, and logic. This leads to the fundamental pieces of the research endeavor: Question, objective, hypothesis, experimental tools to test the hypothesis, methodology, and data analysis. When correctly performed, research should produce new knowledge. The four cornerstones of good research are the well-formulated protocol or proposal that is well executed, analyzed, discussed and concluded. This recent workshop educated researchers in the critical steps involved in the development of a scientific idea to its successful execution and eventual publication. Key words: Research protocol, scientific writing, creativity, publication ethics, of society. Hence, the primary objective of research is to INTRODUCTION produce new knowledge. Research is both theoretical and Creativity and critical thinking are of particular importance in empirical. It is theoretical because the starting point of scientific scientific research. Basically, research is original investigation research is the conceptualization of a research topic and undertaken to gain knowledge and understand concepts in major development of a research question and hypothesis. Research is subject areas of specialization, and includes the generation empirical (practical) because all of the planned studies involve of ideas and information leading to new or substantially a series of observations, measurements, and analyses of data improved scientific insights with relevance to the needs [1‑9] that are all based on proper experimental design. Access this article online The subject of this report is to inform readers of the proceedings Quick Response Code: th from a recent workshop organized by the 64 Annual conference Website: www.jpharmacol.com of the ‘Indian Pharmaceutical Congress’ at SRM University, Chennai, India, from 05 to 06 December 2012. The objectives of the workshop titled ‘The Critical Steps for Successful Research: DOI: 10.4103/0976-500X.110895 The Research Proposal and Scientific Writing,’ were to assist participants in developing a strong fundamental understanding Address for correspondence: Gowraganahalli Jagadeesh, Division of Cardiovascular and Renal Products, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22, Rm 4128, Silver Spring, MD 20993-0002, USA. E-mail: [email protected] 130 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 Balakumar, et al.: Basic concepts of research and publication of how best to develop a research or study protocol, and a well‑designed protocol, there would be a little chance for communicate those research findings in a conference setting successful completion of a research project or an experiment. or scientific journal. Completing any research project requires Research topic meticulous planning, experimental design and execution, and The first and the foremost difficult task in research is to identify compilation and publication of findings in the form of a research a topic for investigation. The research topic is the keystone paper. All of these are often unfamiliar to naïve researchers; of the entire scientific enterprise. It begins the project, drives thus, the purpose of this workshop was to teach participants to the entire study, and is crucial for moving the project forward. master the critical steps involved in the development of an idea It dictates the remaining elements of the study [Table 1] and to its execution and eventual publication of the results (See the thus, it should not be too narrow or too broad or unfocused. last section for a list of learning objectives). Because of these potential pitfalls, it is essential that a good or novel scientific idea be based on a sound concept. Creativity, THE STRUCTURE OF THE WORKSHOP critical thinking, and logic are required to generate new concepts and ideas in solving a research problem. Creativity The two‑day workshop was formatted to include key lectures involves critical thinking and is associated with generating and interactive breakout sessions that focused on protocol many ideas. Critical thinking is analytical, judgmental, and development in six subject areas of the pharmaceutical [4] involves evaluating choices before making a decision. Thus, sciences. This was followed by sessions on scientific writing. critical thinking is convergent type thinking that narrows and DAY 1 taught the basic concepts of scientific research, refines those divergent ideas and finally settles to one idea for including: (1) how to formulate a topic for research and to an in‑depth study. The idea on which a research project is built describe the what, why, and how of the protocol, (2) biomedical should be novel, appropriate to achieve within the existing literature search and review, (3) study designs, statistical conditions, and useful to the society at large. Therefore, concepts, and result analyses, and (4) publication ethics. DAY 2 creativity and critical thinking assist biomedical scientists in educated the attendees on the basic elements and logistics of research that results in funding support, novel discovery, and writing a scientific paper and thesis, and preparation of poster [1,4] publication. as well as oral presentations. Research question The final phase of the workshop was the ‘Panel Discussion,’ The next most crucial aspect of a study protocol is identifying including ‘Feedback/Comments’ by participants. There a research question. It should be a thoughtp ‑ rovoking question. were thirteen distinguished speakers from India and abroad. The question sets the framework. It emerges from the title, Approximately 120 post‑graduate and pre‑doctoral students, findings/results, and problems observed in previous studies. young faculty members, and scientists representing industries Thus, mastering the literature, attendance at conferences, and attended the workshop from different parts of the country. All discussion in journal clubs/seminars are sources for developing participants received a printed copy of the workshop manual research questions. Consider the following example in and supporting materials on statistical analyses of data. developing related research questions from the research topic. • Topic THE BASIC CONCEPTS OF RESEARCH: THE Hepatoprotective activity of Terminalia arjuna and Apium KEY TO GETTING STARTED IN RESEARCH graveolens on paracetamol‑induced liver damage in albino rats. A research project generally comprises four key components: (1) writing a protocol, (2) performing experiments, (3) tabulating Table 1: Elements of a study protocol and analyzing data, and (4) writing a thesis or manuscript for Element Purpose publication. Research topic* Keystone of the study. Begins, drives, and ends the study Fundamentals in the research process Research Relationship between two or more variables is A protocol, whether experimental or clinical, serves as a question* phrased as a question navigator that evolves from a basic outline of the study plan to Objective* Researchable issue. Developed logically from a become a qualified research or grant proposal. It provides the description of the topic structural support for the research. Dr. G. Jagadeesh (US FDA), Hypothesis* Relationship phrased as a declarative statement, needs statistical testing the first speaker of the session, spoke on ‘Fundamentals in Significance of Why is the research question important? What research process and cornerstones of a research project.’ the study are the implications of the study? He discussed at length the developmental and structural Experimental Materials and methods, subjects, variables, processes in preparing a research protocol. A systematic and design statistics step‑by‑step approach is necessary in planning a study. Without *Considered cornerstones of a research project Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 131 Balakumar, et al.: Basic concepts of research and publication • Research questions vaccine for a disease). In summary, the proposed study should How is paracetamol metabolized in the body? Does demonstrate that it represents an advancement in understanding it involve P450 enzymes? How does paracetamol and that the eventual results will be meaningful, contribute to the field, and possibly even impact society. cause liver injury? What are the mechanisms by which drugs can alleviate liver damage? What biochemical Biomedical literature parameters are indicative of liver injury? What major A literature search may be defined as the process of examining endogenous inflammatory molecules are involved in published sources of information on a research or review topic, paracetamol‑induced liver damage? thesis, grant application, chemical, drug, disease, or clinical trial, etc. The quantity of information available in print or Objective electronically (e.g., the internet) is immense and growing A research question is broken down into more precise objectives. The objectives lead to more precise methods and definition with time. A researcher should be familiar with the right kinds of databases and search engines to extract the needed of key terms. The objectives should be SMART‑ Specific, [10] [3,6] information. Measurable, Achievable, Realistic, Time‑framed , and should cover the entire breadth of the project. The objectives Dr. P. Balakumar (Institute of Pharmacy, Rajendra Institute of are sometimes organized into hierarchies: Primary, secondary, Technology and Sciences, Sirsa, Haryana; currently, Faculty and exploratory; or simply general and specific. Study the of Pharmacy, AIMST University, Malaysia) spoke on following example: ‘Biomedical literature: Searching, reviewing and referencing.’ He schematically explained the basis of scientific literature, designing • Primary objective a literature review, and searching literature. After an introduction To evaluate the safety and tolerability of single oral doses to the genesis and diverse sources of scientific literature searches, of compound X in normal volunteers. the use of PubMed, one of the premier databases used for • Secondary objective biomedical literature searches world‑wide, was illustrated with To assess the pharmacokinetic profile of compound X examples and screenshots. Several companion databases and following single oral doses. search engines are also used for finding information related • Exploratory objective to health sciences, and they include Embase, Web of Science, To evaluate the incidence of peripheral edema reported as SciFinder, The Cochrane Library, International Pharmaceutical an adverse event. [3] Abstracts, Scopus, and Google Scholar. Literature searches Hypothesis using alternative interfaces for PubMed such as GoPubMed, The objectives and research questions are then formulated into Quertle, PubFocus, Pubget, and BibliMed were discussed. The a workable or testable hypothesis. The latter forces us to think participants were additionally informed of databases on chemistry, carefully about what comparisons will be needed to answer drugs and drug targets, clinical trials, toxicology, and laboratory [3] the research question, and establishes the format for applying animals (reviewed in ref ). statistical tests to interpret the results. The hypothesis should Referencing and bibliography are essential in scientific writing link a process to an existing or postulated biologic pathway. [7] and publication. Referencing systems are broadly classified A hypothesis is written in a form that can yield measurable into two major types, such as Parenthetical and Notation results. Studies that utilize statistics to compare groups of data systems. Parenthetical referencing is also known as Harvard should have a hypothesis. Consider the following example: style of referencing, while Vancouver referencing style and • The hepatoprotective activity of Terminalia arjuna ‘Footnote’ or ‘Endnote’ are placed under Notation referencing is superior to that of Apium graveolens against systems. The participants were educated on each referencing system with examples. paracetamol‑induced liver damage in albino rats. Bibliography management All biological research, including discovery science, Dr. Raj Rajasekaran (University of California at San Diego, is hypothesis–driven. However, not all studies need be CA, USA) enlightened the audience on ‘bibliography conducted with a hypothesis. For example, descriptive management’ using reference management software programs studies (e.g., describing characteristics of a plant, or a chemical ® ® ® [1] such as Reference Manager , Endnote , and Zotero for compound) do not need a hypothesis. creating and formatting bibliographies while writing a Relevance of the study manuscript for publication. The discussion focused on the use Another important section to be included in the protocol is of bibliography management software in avoiding common ‘Significance of the study.’ Its purpose is to justify the need mistakes such as incomplete references. Important steps in for the research that is being proposed (e.g., development of a bibliography management, such as creating reference libraries/ 132 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 Balakumar, et al.: Basic concepts of research and publication databases, searching for references using PubMed/Google Table 2: Elements of a research protocol scholar, selecting and transferring selected references into a Title (short and effective) library, inserting citations into a research article and formatting Introduction (should answer ‘what’ and ‘why’ of the proposal (should list research questions, objectives of the study); bibliographies, were presented. A demonstration of Zotero®, this should be followed by (a separate paragraph) ‘the central a freely available reference management program, included hypothesis that would be tested ’ the salient features of the software, adding references from Review of literature (existing knowledge in the area of work, the PubMed using PubMed ID, inserting citations and formatting rationale for the proposed project, and the gaps that the project is intended to fill). The review should be logically organized and using different styles. should include a discussion of major variables that are measured in the research Writing experimental protocols Significance of research (what is expected from the work, why the The workshop systematically instructed the participants expected outcomes are potentially important in advancing the field, study impact) in writing ‘experimental protocols’ in six disciplines Plan of study (how the research will be carried out/work plan with of Pharmaceutical Sciences.: (1) Pharmaceutical timeline) Chemistry (presented by Dr. P. V. Bharatam, NIPER, Mohali, General methodology (based on the plan of study). List each Punjab); (2) Pharmacology (presented by Dr. G. Jagadeesh and method separately and give the chemicals/instruments you intend Dr. P. Balakumar); (3) Pharmaceutics (presented by Dr. Jayant to use in each case References (Bibliography). Follow a proper style, be consistent, Khandare, Piramal Life Sciences, Mumbai); (4) Pharmacy and no mix and match Practice (presented by Dr. Shobha Hiremath, Al‑Ameen College of Pharmacy, Bengaluru); (5) Pharmacognosy and Statistics CD, compiled by Dr. Raveendran, was distributed to Phytochemistry (presented by Dr. Salma Khanam, Al‑Ameen the participants before the session began and was demonstrated College of Pharmacy, Bengaluru); and (6) Pharmaceutical live. Both speakers worked on a variety of problems that Analysis (presented by Dr. Saranjit Singh, NIPER, Mohali, Punjab). The purpose of the research plan is to describe involved both clinical and experimental data. They discussed through examples the experimental designs encountered in the what (Specific Aims/Objectives), why (Background and a variety of studies and statistical analyses performed for Significance), and how (Design and Methods) of the proposal. different types of data. For the benefit of readers, we have The research plan should answer the following questions: (a) what summarized statistical tests applied frequently for different do you intend to do; (b) what has already been done in general, experimental designs and post‑hoc tests [Figure 1]. and what have other researchers done in the field; (c) why is Research and publication ethics this worth doing; (d) how is it innovative; (e) what will this The legitimate pursuit of scientific creativity is unfortunately new work add to existing knowledge; and (f) how will the being marred by a simultaneous increase in scientific research be accomplished? misconduct. A disproportionate share of allegations involves In general, the format used by the faculty in all subjects is scientists of many countries, and even from respected shown in Table 2. laboratories. Misconduct destroys faith in science and scientists and creates a hierarchy of fraudsters. Investigating misconduct Biostatistics also steals valuable time and resources. In spite of these facts, Biostatistics is a key component of biomedical research. most researchers are not aware of publication ethics. Highly reputed journals like The Lancet, BMJ, Journal of the American Medical Association, and many other biomedical Day 1 of the workshop ended with a presentation on ‘research journals include biostatisticians on their editorial board or and publication ethics’ by Dr. M. K. Unnikrishnan (College reviewers list. This indicates that a great importance is given of Pharmaceutical Sciences, Manipal University, Manipal). for learning and correctly employing appropriate statistical He spoke on the essentials of publication ethics that methods in biomedical research. The post‑lunch session on included plagiarism (attempting to take credit of the work day 1 of the workshop was largely committed to discussion on of others), self‑plagiarism (multiple publications by an ‘Basic biostatistics.’ Dr. R. Raveendran (JIPMER, Puducherry) author on the same content of work with slightly different and Dr. Avijit Hazra (PGIMER, Kolkata) reviewed, in wordings), falsification (manipulation of research data parallel sessions, descriptive statistics, probability concepts, and processes and omitting critical data or results), gift sample size calculation, choosing a statistical test, confidence authorship (guest authorship), ghostwriting (someone other intervals, hypothesis testing and ‘P’ values, parametric than the named author (s) makes a major contribution), salami and non‑parametric statistical tests, including analysis of publishing (publishing many papers, with minor differences, variance (ANOVA), t tests, Chi‑square test, type I and type II from the same study), and sabotage (distracting the errors, correlation and regression, and summary statistics. research works of others to halt their research completion). This was followed by a practice and demonstration session. Additionally, Dr. Unnikrishnan pointed out the ‘Ingelfinger Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 133 Balakumar, et al.: Basic concepts of research and publication Statistical design Comparison of Comparison of two groups three or more groups Paired groups Matched groups Unmatched groups Unpaired groups Normal Non-normal Normal Normal Non-normal Normal Non-normal Non-normal Distribution- Distribution- Distribution- Distribution- Distribution- Distribution- Distribution- Distribution- Parametric Nonparametric Parametric Parametric Nonparametric Parametric Nonparametric Nonparametric Paired- Wilcoxon Unpaired- Mann- Repeated Friedman One-way or Kruskal- t test signed t test Whitney measures test Two-way* Wallis rank test U test ANOVA ANOVA test Tukey's multiple range test, Dunn’s Student- Dunn’s Bonferroni correction test, test Newman-Keuls test test Duncan’s multiple-range test, Dunnett's test * Two-way ANOVA allows to compare the effects of two categorical factors (e.g., dose and diet) on one outcome (e.g., blood After the null hypothesis is rejected, for pairwise comparisons of groups pressure). The data must be normally with multiple comparison adjustment, a post-hoc test is selected (based distributed and the samples must be on certain criteria) and the data is analyzed to identify the groups that independent. are significantly different from each other 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 distributions are analyzed using parametric tests, if not; the data are analyzed using non‑parametric tests. The most popularly used Student’s t‑ test compares the means of two populations, data for this test could be paired or unpaired. One‑way analysis of variance (ANOVA) is used to compare the means of three or more independent populations that are normally distributed. Applying t test repeatedly in pair (multiple comparison), to compare the means of more than two populations, will increase the probability of type I error (false positive). In this case, for proper interpretation, we need to adjust the P values. Repeated measures ANOVA is used to compare the population means if more than two observations coming from same subject over time. The null hypothesis is rejected with a ‘P’ value of less than 0.05, and the difference in population means is considered to be statistically significant. Subsequently, appropriate post‑hoc tests are used for pairwise comparisons of population means. Two‑way or three‑way ANOVA are considered if two (diet, dose) or three (diet, dose, strain) independent factors, respectively, are analyzed in an experiment (not described in the Figure). Categorical nominal unmatched variables (counts or frequencies) are analyzed by Chi‑square test (not shown in the Figure) rule’ of stipulating that a scientist must not submit the SCIENTIFIC COMMUNICATION: THE KEY TO same original research in two different journals. He also SUCCESSFUL SELLING OF FINDINGS advised the audience that authorship is not just credit for Research outcomes are measured through quality the work but also responsibility for scientific contents of publications. Scientists must not only ‘do’ science but must a paper. Although some Indian Universities are instituting ‘write’ science. The story of the project must be told in a preventive measures (e.g., use of plagiarism detecting clear, simple language weaving in previous work done in software, Shodhganga digital archiving of doctoral theses), the field, answering the research question, and addressing Dr. Unnikrishnan argued for a great need to sensitize young the hypothesis set forth at the beginning of the study. researchers on the nature and implications of scientific Scientific publication is an organic process of planning, misconduct. Finally, he discussed methods on how editors researching, drafting, revising, and updating the current and peer reviewers should ethically conduct themselves while knowledge for future perspectives. Writing a research paper managing a manuscript for publication. is no easier than the research itself. The lectures of Day 2 134 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 Balakumar, et al.: Basic concepts of research and publication of the workshop dealt with the basic elements and logistics based entirely on these observations. Additionally, how the of writing a scientific paper. results are applied to further research in the field to advance our understanding of research questions was discussed. An overview of paper structure and thesis writing Dr. Amitabh Prakash (Adis, Auckland, New Zealand) spoke Dr. Peush Sahni (All‑India Institute of Medical Sciences, on ‘Learning how to write a good scientific paper.’ His New Delhi) spoke on effectively ‘Structuring the Discussion’ presentation described the essential components of an original for a research paper. The Discussion section deals with a research paper and thesis (e.g., introduction, methods, results, systematic interpretation of study results within the available and discussion [IMRaD]) and provided guidance on the correct knowledge. He said the section should begin with the most order, in which data should appear within these sections. The important point relating to the subject studied, focusing on characteristics of a good abstract and title and the creation of key issues, providing link sentences between paragraphs, and appropriate key words were discussed. Dr. Prakash suggested ensuring the flow of text. Points were made to avoid history, not that the ‘title of a paper’ might perhaps have a chance to make repeat all the results, and provide limitations of the study. The a good impression, and the title might be either indicative (title strengths and novel findings of the study should be provided in that gives the purpose of the study) or declarative (title that the discussion, and it should open avenues for future research gives the study conclusion). He also suggested that an abstract and new questions. The Discussion section should end with a is a succinct summary of a research paper, and it should be conclusion stating the summary of key findings. Dr. Sahni gave specific, clear, and concise, and should have IMRaD structure an example from a published paper for writing a Discussion. in brief, followed by key words. Selection of appropriate In another presentation titled ‘Writing an effective title and the papers to be cited in the reference list was also discussed. abstract,’ Dr. Sahni described the important components of a Various unethical authorships were enumerated, and ‘The good title, such as, it should be simple, concise, informative, International Committee of Medical Journal Editors (ICMJE) interesting and eye‑catching, accurate and specific about the criteria for authorship’ was explained (http://www.icmje. paper’s content, and should state the subject in full indicating org/ethical_1author.html; also see Table 1 in reference #9). study design and animal species. Dr. Sahni explained The session highlighted the need for transparency in medical structured (IMRaD) and unstructured abstracts and discussed publication and provided a clear description of items that a few selected examples with the audience. needed to be included in the ‘Disclosures’ section (e.g., sources of funding for the study and potential conflicts of interest of all Language and style in publication The next lecture of Dr. Amitabh Prakash on ‘Language and authors, etc.) and ‘Acknowledgements’ section (e.g., writing assistance and input from all individuals who did not meet style in scientific writing: Importance of terseness, shortness and clarity in writing’ focused on the actual sentence the authorship criteria). The final part of the presentation was devoted to thesis writing, and Dr. Prakash provided the construction, language, grammar and punctuation in scientific audience with a list of common mistakes that are frequently manuscripts. His presentation emphasized the importance of encountered when writing a manuscript. brevity and clarity in the writing of manuscripts describing biomedical research. Starting with a guide to the appropriate The backbone of a study is description of results through Text, construction of sentences and paragraphs, attendees were Tables, and Figures. Dr. S. B. Deshpande (Institute of Medical given a brief overview of the correct use of punctuation with Sciences, Banaras Hindu University, Varanasi, India) spoke on interactive examples. Dr. Prakash discussed common errors ‘Effective Presentation of Results.’ The Results section deals in grammar and proactively sought audience participation in with the observations made by the authors and thus, is not correcting some examples. Additional discussion was centered hypothetical. This section is subdivided into three segments, on discouraging the use of redundant and expendable words, that is, descriptive form of the Text, providing numerical jargon, and the use of adjectives with incomparable words. data in Tables, and visualizing the observations in Graphs or The session ended with a discussion of words and phrases Figures. All these are arranged in a sequential order to address that are commonly misused (e.g., data vs. datum, affect vs. the question hypothesized in the Introduction. The description effect, among vs. between, dose vs. dosage, and efficacy/ in Text provides clear content of the findings highlighting the efficacious vs. effective/effectiveness) in biomedical research observations. It should not be the repetition of facts in tables or manuscripts. graphs. Tables are used to summarize or emphasize descriptive Working with journals content in the text or to present the numerical data that are unrelated. Illustrations should be used when the evidence The appropriateness in selecting the journal for submission bearing on the conclusions of a paper cannot be adequately and acceptance of the manuscript should be determined by the presented in a written description or in a Table. Tables or experience of an author. The corresponding author must have a Figures should relate to each other logically in sequence and rationale in choosing the appropriate journal, and this depends should be clear by themselves. Furthermore, the discussion is upon the scope of the study and the quality of work performed. Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 135 Balakumar, et al.: Basic concepts of research and publication Dr. Amitabh Prakash spoke on ‘Working with journals: Selecting was provided on the best way to address referee feedback. The a journal, cover letter, peer review process and impact factor’ by session concluded with a discussion of the potential drawbacks instructing the audience in assessing the true value of a journal, of the current peer review system. understanding principles involved in the peer review processes, Poster and oral presentations at conferences providing tips on making an initial approach to the editorial Posters have become an increasingly popular mode of office, and drafting an appropriate cover letter to accompany the presentation at conferences, as it can accommodate more submission. His presentation defined the metrics that are most papers per meeting, has no time constraint, provides a better commonly used to measure journal quality (e.g., impact factor™, presenter‑audience interaction, and allows one to select and Eigenfactor™ score, Article Influence™ score, SCOPUS 2‑year attend papers of interest. In Figure 2, we provide instructions, citation data, SCImago Journal Rank, h‑Index, etc.) and guided design, and layout in preparing a scientific poster. In the attendees on the relative advantages and disadvantages of using each metric. Factors to consider when assessing journal final presentation, Dr. Sahni provided the audience with step‑by‑step instructions on how to write and format quality were discussed, and the audience was educated on the ‘green’ and ‘gold’ open access publication models. Various peer posters for layout, content, font size, color, and graphics. Attendees were given specific guidance on the format of review models (e.g., double‑blind, single‑blind, non‑blind) were described together with the role of the journal editor in assessing text on slides, the use of color, font type and size, and the manuscripts and selecting suitable reviewers. A typical checklist use of illustrations and multimedia effects. Moreover, the sent to referees was shared with the attendees, and clear guidance importance of practical tips while delivering oral or poster Title: Declarative (title that gives the study conclusion) Logo, The title should be large so that the text can be read from a distance of 81 ‑ 0 feet Abstract List of Authors number (Underline the presenting author) Affiliations with contact details (email address) DISCUSSION ABSTRACT RESULTS Provide systematic interpretation of Provide clear content of the findings study results. Bullet INTRODUCTION highlighting the observations. statements are fine. Background Preferably, use Tables and/or Graphs to Rationale clarify and depict the study results. Use Objective CONCLUSION headers, footers and legends. Avoid too Hypothesis, if any Include summary many Tables/Figures. of key findings MATERIALS & METHODS KEY Also include REFERENCES Experimental design & ACKNOWLED‑ Statistics used GEMENTS Presented at the Annual Conference of …....held at….... (place) on …….(date) Figure 2: Guidelines and design to scientific poster presentation. The objective of scientific posters is to present laboratory work in scientific meetings. A poster is an excellent means of communicating scientific work, because it is a graphic representation of data. Posters should have focus points, and the intended message should be clearly conveyed through simple sections: Text, Tables, and Graphs. Posters should be clear, succinct, striking, and eye‑catching. Colors should be used only where necessary. Use one font (Arial or Times New Roman) throughout. Fancy fonts should be avoided. All headings should have font size of 44, and be in bold capital letters. Size of Title may be a bit larger; subheading: Font size of 36, bold and caps. References and Acknowledgments, if any, should have font size of 24. Text should have font size between 24 and 30, in order to be legible from a distance of 3 to 6 feet. Do not use lengthy notes 136 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 Poster size: 1.5 meter length and 1 meter width Balakumar, et al.: Basic concepts of research and publication presentation was provided to the audience, such as speak • Study protocols on different topics in their subject of slowly and clearly, be informative, maintain eye contact, and specialization listen to the questions from judges/audience carefully before • Searching and reviewing the literature • Appropriate statistical analyses in biomedical research coming up with an answer. • Scientific ethics in publication • Writing and understanding the components of a research PANEL DISCUSSION: FEEDBACK AND paper (IMRaD) COMMENTS BY PARTICIPANTS • Recognizing the value of good title, running title, abstract, key words, etc After all the presentations were made, Dr. Jagadeesh began a • Importance of Tables and Figures in the Results section, panel discussion that included all speakers. The discussion was and their importance in describing findings aimed at what we do currently and could do in the future with • Evidence‑based Discussion in a research paper respect to ‘developing a research question and then writing an • Language and style in writing a paper and expert tips on effective thesis proposal/protocol followed by publication.’ getting it published Dr. Jagadeesh asked the following questions to the panelists, • Presentation of research findings at a conference (oral and while receiving questions/suggestions from the participants poster). and panelists. • Does a Post‑Graduate or Ph.D. student receive adequate Overall, the workshop was deemed very helpful to participants. The participants rated the quality of workshop from “satisfied” training, either through an institutional course, a workshop of the present nature, or from the guide? to “very satisfied.” A significant number of participants were of the opinion that the time allotted for each presentation was short • Are these Post‑Graduates self‑taught (like most of us who and thus, be extended from the present two days to four days learnt the hard way)? with adequate time to ask questions. In addition, a ‘hands‑on’ • How are these guides trained? How do we train them to session should be introduced for writing a proposal and become more efficient mentors? manuscript. A large number of attendees expressed their desire • Does a Post‑Graduate or Ph.D. student struggle to find a to attend a similar workshop, if conducted, in the near future. method (s) to carry out studies? To what extent do seniors/ guides help a post graduate overcome technical difficulties? How difficult is it for a student to find chemicals, reagents, ACKNOWLEDGMENT instruments, and technical help in conducting studies? • Analyses of data and interpretation: Most students struggle We gratefully express our gratitude to the Organizing Committee, without adequate guidance. especially Professors K. Chinnasamy, B. G. Shivananda, N. Udupa, • Thesis and publications frequently feature inadequate/ Jerad Suresh, Padma Parekh, A. P. Basavarajappa, Mr. S. V. Veerramani, Mr. J. Jayaseelan, and all volunteers of the SRM University. We thank incorrect statistical analyses and representation of data in Dr. Thomas Papoian (US FDA) for helpful comments on the manuscript. tables/graphs. The student, their guide, and the reviewers all share equal responsibility. Disclaimer • Who initiates and drafts the research paper? The The opinions expressed herein are those of Gowraganahalli Post‑Graduate or their guide? Jagadeesh and do not necessarily reflect those of the US Food • What kind of assistance does a Post‑Graduate get from and Drug Administration the guide in finalizing a paper for publication? • Does the guide insist that each Post‑Graduate thesis yield at least one paper, and each Ph.D. thesis more than two REFERENCES papers, plus a review article? 1. Biomedical Research‑From Ideation to Publication. In: Jagadeesh G, st Murthy S, Gupta YK, Prakash A, editors. 1 ed, Philadelphia: Wolters The panelists and audience expressed a variety of views, but Kluwer Health‑Lippincott Williams and Wilkins: 2010. were unable to arrive at a decisive conclusion. 2. Balakumar P. Letter to the Editor. Biomedical Research‑From Ideation to Publication. In: Jagadeesh G, Murthy S, Gupta YK, Prakash A, editors. st 1 ed, Philadelphia: Wolters Kluwer Health‑Lippincott Williams and Wilkins: 2010. J Nat Sci Biol Med 2012;3:212. WHAT HAVE THE PARTICIPANTS LEARNED? 3. Balakumar P, Marcus SJ, Jagadeesh G. Navigating your way through online resources for biomedical research. RGUHS J Pharm Sci 2012;2:5‑27. At the end of this fast‑moving two‑day workshop, the 4. Reisman F. Creative, critical thinking and logic in research. RGUHS J participants had opportunities in learning the following topics: Pharm Sci 2011;1:97‑102. 5. Bartz CC. Getting Started with Research: Ideas to Research Process. • Sequential steps in developing a study protocol, from RGUHS J Pharm Sci 2011;1:176‑9. choosing a research topic to developing research questions 6. Kuberappa YV, Kumar AH. Knowing the known to understand the and a hypothesis. unknown‑A systematic approach to reviewing the scientific literature. Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2 137 Balakumar, et al.: Basic concepts of research and publication st RGUHS J Pharm Sci 2012;2:1‑7. In: Jagadeesh G, Murthy S, Gupta YK, Prakash A, editors. 1 ed, Ch 3. 7. Neville C. Referencing: Principles, Practice and Problems. RGUHS J Philadelphia: Wolters Kluwer Health‑Lippincott Williams and Wilkins; Pharm Sci 2012;2:1‑8. 2010. p. 27‑34. 8. Balakumar P, Murthy S, Jagadeesh G. The basic concepts of scientific research and communication Indian J Pharmacol 2007;39:303‑6. How to cite this article: Balakumar P, Inamdar MN, Jagadeesh G. The 9. Balakumar P, Jagadeesh G. The basic concepts of scientific research and critical steps for successful research: The research proposal and scientific scientific communication. J Pharmacol Pharmacother 2012;3:178‑82. writing. J Pharmacol Pharmacother 2013;4:130-8. 10. Kalmund P. Setting thesis research objectives. M.Sc. programme. Cited Source of Support: Nil, Conflict of Interest: None declared. by Jenicek M. In: Biomedical Research‑From Ideation to Publication. Announcement iPhone App A free application to browse and search the journal’s content is now available for iPhone/iPad. The application provides “Table of Contents” of the latest issues, which are stored on the device for future offline browsing. Internet connection is required to access the back issues and search facility. The application is Compatible with iPhone, iPod touch, and iPad and Requires iOS 3.1 or later. The application can be downloaded from http://itunes.apple.com/us/app/medknow-journals/ id458064375?ls=1&mt=8. For suggestions and comments do write back to us. 138 Journal of Pharmacology and Pharmacotherapeutics | April-June 2013 | Vol 4 | Issue 2

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Journal of Pharmacology and PharmacotherapeuticsSAGE

Published: Jun 1, 2013

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