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Research is either discovery of new facts, enunciation of new principles, or fresh interpretation of the known facts or principles. It is an attempt to reveal to the world something that was either never thought of, or was in the domain of the conjectures—at best being looked at with suspicion. It is a systematic investigation to develop or contribute to generalizable knowledge. Research is a step in relentless search for truth – it is an organized and systematic way of finding better answers to questions. The basic function of research is to answer why and how of a phenomenon, but searching answers to what, when, how much, etc., is also part of research endeavors. All these questions have relevance to any discipline but medicine seems to have special appetite for such enquiries. The goal of medical research is to improve health, and the purpose is to learn how systems in human body work, why we get sick, and how to get back to health and stay fit. It is a systematic process to better determine etiology, patho-physiology, diagnosis, therapy and prognosis. Research is the very foundation of improved medical care. It can also provide evidence for policies and decisions on health development. Sometimes an established regimen is used in a new setting or on a new kind of subjects to test its applicability to the new environment. This kind of confirmatory work is not hardcore research but is accepted for postgraduate thesis because the objective is training.
Much of human biology is still speculative, and its interaction with environment is intricate. Thus medical science has enormous potential for useful research. At the same time it has its own risks as well. This is illustrated by the reports questioning established modalities. Tamoxifen, a selective estrogen modifying agent and a popular breast cancer therapy for women, was found to carry an increased risk of endometrial cancer. Menopausal women who took estrogen for long time were also found to be at higher risk of getting ovarian cancer. Arthroscopic surgery for osteoarthritis of knee was found an unhelpful procedure. These are not isolated examples. There are many instances when established medical practices were overturned. Some recent advances have indeed been bivalent—potentially useful as well as potentially harmful. Medicine is a delicate science. It is concerned with vitalities of life such as health, disease, and death. Thus, it brooks no error. Ironically, no theories are available that can make it infallible. There are no lemmas and no theorems. It must depend on evidence provided by observations and experience. Medicine is largely an inductive science and has very little space, if any, for deductive methods. If a treatment regimen has worked in Mr. Somebody and nine others of his clan, there is a high likelihood that it would work in the eleventh also of that type. The past experience and present evidence provide an insight in to the future. Areas tackled in the most fundamental parts of medical research include cellular and molecular biology, medical genetics, immunology, neuroscience and psychology. Researchers, mainly in universities or government-funded research institutes, aim to establish an understanding of the cellular, molecular and physiological mechanisms underpinning human health and disease. Since many organisms share a common evolutionary history with humans and hence common features and systems, the basic end of medical research these days shades into basic biology.
Science is known to be a systematic study that follows a pattern and produces testable results. Thus scientific research must follow a step-by-step pathway that foster clarity and avoids the problem of multiplicity. These steps are much more elaborate for research in medicine than for other disciplines because of enormous uncertainties inherent in medical field and the implication is human health. Jenicek (2006) has provided a layout of modern argument in medical research. This involves processes that go on from what is in your mind to searching external evidence (e.g., literature) for or against, making a qualified claim, then conducting the study, leading to the results with limitations such as probabilities and applicability. Because of empirical base, investigations are sin-qua-non for a primary medical research. An outline of the pre-investigation, investigation and post-investigation steps is given next.
PREINVESTIGATION STEPS: However odd it may sound, the preparation and plan for the investigation would be more critical than possibly the actual investigation. Pre-investigation steps are as follows.
IDENTIFY THE PROBLEM: The first step in research is to identify a problem area to work on. One paradigm is that, notwithstanding knowledge explosion in the past century, the unknown segment of the universe is much larger than the known segment. An alert researcher will find a large number of issues floating around. For selection, match the research area to (i) relevance and applicability for improving health in one way or the other, (ii) interest and expertise of you and your collaborators, and (iii) the feasibility of completing the work with available resources, time, subjects, tools, etc. These three aspects should considerably narrow down the problem area. If the situation permits, select a topic that is in debate or meets a current demand. Choose a topic that is in need of development, verification or refutation. It must be well-defined and focused. It should fit your caliber and should be ethically sound. For postgraduate work, it is advisable to consider several topics and choose the one that looks promising. Don‘t feel shy if it does not work out. Convert the problem to specific questions that require answer. The question must pass the ―so what? test. Even when this is done with apparently sufficient specificity, the course of the investigation may reveal that those questions were not so specific after all. Further steps as given below may help to attain focus and clarity. A good research question is backed up by theoretical considerations. If you are investigating the role of a particular type of diet in esophagus cancer, it is helpful to consider why that type of diet can alter the risk of this cancer. Biological plausibility gives a definite edge. Nevertheless, associations may exist for which sufficient causative mechanism is not understood – perhaps it emerges later on. Research on such poorly understood pulsations too are perfectly valid problems.
COLLECT AND EVALUATE EXISTING INFORMATION: The next step is to collect as much information on the identified problem as possible and evaluate it critically. One major source is the literature. But do not underestimate the potency of other sources. Secondary data might be available in various organizations that can enhance the focus of the problem. Thesis guide and the subject-experts can provide useful insight that they imbibe through years of experience of working in that area. Talk to them without inhibition. Do not think that your limited knowledge will be a hindrance. In fact this limitation is propelling you to explore this problem. Experts might lead to the hitherto unexplored literature and, more importantly, to the work other agencies or institutions are doing in that area. Make sure that a reasonable answer to the proposed question is not already available. The objective of all this exercise should be to identify the specific information gaps, and to examine how the problem fits into the medical jigsaw puzzle. Assess if the problem is really worth pursuing. If none or very little baseline information is available, consider carrying out an exploratory study as a first step.
FORMULATE RESEARCH OBJECTIVES AND HYPOTHESES: Critical evaluation of the literature and other data on the problem will greatly assist in focusing thoughts regarding what exactly to investigate. Translate these to the research objectives. The objectives must match with the perceived utility of the results. For example, for interventions, the objectives could be to find efficacy, effectiveness, affordability, efficiency, safety, acceptability, etc. Clearly identify the specific aspect to concentrate on and formulate the research objectives accordingly. They should be amenable to evaluation, and should be realistic: clearly phrased and stated in logical sequence. The objectives should be consistent with meaningful decisions taken in actual practice. They should not focus on trivial issues that can be addressed without research. Consider whether you expect to come up with entirely novel findings or just confirm previous work that left some doubt, or would address the present conflict. From objectives emanate hypotheses. A hypothesis is a carefully worded statement regarding the anticipated status of a phenomenon. For example, one may hypothesize that recurrence of eclampsia in pregnant women is more common in those that have family history of hypertension. The hypothesis should be biologically plausible and supported by reasoning. It should be restricted to the research under plan. Further details about objectives and hypotheses are described in the next section.
IDENTIFY THE STUDY SUBJECTS: The definition of the subject of study and the target population should be clearly spelt out. Iodine deficiency can be diagnosed either on the basis of the palpable or visible goiter, or now on the basis of urine iodine concentration < 100 g/l. Borderline hypertension may be defined to start from 135/85 mmHg or from 140/90 mmHg. Choose a definition that is consistent with the objectives and justify it. Besides inclusion criteria, the exclusion criteria should also be clearly stated so that the cases are not excluded mid-way through the study. For this, anticipate the type of cases that can become ineligible later on after inclusion. If there are two or more groups, define them.
THINK OF A DESIGN: Now, think of a strategy to get valid and reliable answer to the questions, or to get a solution of the problem. The strategy would be in terms of collection of data in a manner that inspires confidence. This requires identifying all sources of uncertainty, and developing a design that can keep them under control, In effect, this means (i) sample design for survey; (ii) prospective, retrospective or cross-sectional strategy for observational study; (iii) deciding on the specifics of intervention if any; (iv) determining the variables on which the data would be collected: the variables that are valid to provide the correct answer; (v) the mode to obtain valid data on those variables – feasible yet robust methods that can stand scientific scrutiny; (vi) tools for easy recording of information; (vii) the strategy to handle any ethical problem that might arise during the course of that investigation; (viii) the number of cases or subjects that should be included in this kind of investigation; (ix) the method of selection of the subjects of the study; (x) the method of randomization, blinding, matching, etc., and (xi) the method of statistical analysis of data. Most medical professionals do need expert advice from a biostatistician to develop an appropriate design. If needed, catch him at early phase of planning and seek his collaboration for all phases of the study. Do not aim at methodological overkill. Marginally improved results at a substantially higher cost may not be worth.
WRITE THE PROTOCOL: All the hard work put into the preceding steps culminates into the draft of a research protocol. It incorporates all the information regarding the plan of research in a concise manner. Developing a protocol is just about the most important step in conducting a research. For this reason, we are devoting a full section in this chapter on this aspect alone. When the thoughts are put together on a paper, they crystallize and concretize. Since protocol is a written commitment, further deliberations may be needed for example to make the objectives and hypotheses more specific and to justify the strategy to be adopted. Protocol contains much more information. For example, it states the work plan and identifies the resources required for the project, including the time-line. The latter comprises the time point when each step is to be initiated and how much time this will take to complete. Work on two or more steps of research can go together, and this time-line will indicate this overlap also.
DEVELOP THE TOOLS: Tools for medical research are of two types. First is the recording questionnaire, schedule, or proforma that is uniformly followed throughout the investigation. Second are the measurement and investigation tools such as a scoring system and Holter test. Development of tools also encompasses arranging investigations such as for imaging and those to be done in a laboratory. For some this may require procuring kits with the help of external facilities. Arrangements may also have to be made to procure drugs, including life saving drugs, to meet any contingency. Work out the modality for getting help from outside agencies when needed in case of exigency. For a large-scale investigation, instruction manual may be needed. The staff may have to be trained in interview, examination, or laboratory methods so that valid and uniform data are generated.
INVESTIGATION STEPS: Note that preinvestigation steps are complex, and their major component is the thought process. After these steps comes the actual investigation. This also requires some preliminary steps before actually embarking upon the real study.
PRETEST AND DO PILOT STUDY: No matter how thoughtful you have been in developing the tools of the investigation, there is always a need to pretest them for their performance in actual conditions on the same kind of subjects as the main study. Experience suggests that almost invariably some deficiency is detected, and the tools or their implementation are found to require some modification. Thus do not shy away from this exercise. Similarly, a pilot study, which is a small forerunner of the actual investigation, also provides useful inputs regarding changes required in the measurements to be taken, in the interview or examination method, in the laboratory or imaging investigations, in the recording system, etc.
COLLECT THE DATA: Although the objective of this step is collection of the relevant data but it actually entails administering the intervention such as a drug if any, and observing the subjects. As always in a medical setup, the data are obtained by inspecting the records, by conducting interview or physical examination or laboratory/ imaging investigations, or by a combination of these data-eliciting methods. Continuous vigil is maintained to ensure that the data remain of good quality—that is they are correctly obtained for each subject without favor or fervor, and honestly recorded. The methods earlier decided should be strictly followed. If the past history is to be obtained by interview, do not replace it by records available with the patients. The data forms should be legibly filled, and they should be fully completed.
HANDLE THE NONRESPONSE AND ETHICAL ISSUES: In a science such as medicine, it is difficult to complete the investigation in all the planned subjects. Some subjects will invariably drop out during the course of the investigation. Anticipate such non-response and keep it at the minimal level to avoid bias in the results. Make all efforts to extract at least the basic information that can help in adjusting for any bias. Then there are ethical issues that need to be constantly monitored, particularly if the research involves an intervention such as a therapeutic maneuver. Even when informed consent is taken, medical ethics requires that the intervention and data generation or collection should not subjugate the interest of the patient.
SCRUTINISE THE DATA: Despite all the care exercised at the time of taking history of patients, at the time of physical examination, and at the time of laboratory/imaging investigation, errors do occur. Most of these can be detected by scrutinizing the data for internal consistency and external validity. For example, if a patient with hypertension has low cholesterol then sufficient reasons should be available within the record. A woman of age 23 years cannot possibly have six children. Such errors look odd but they are practical occurrences particularly in a large-scale research. Sometimes called data cleaning, this step of scrutiny is considered essential for quality research.
POSTINVESTIGATION STEPS: After the data are collected, which should be adequate in terms of quality and quantity, they need to be exploited to their full potential to draw conclusions. This requires the following steps.
ANALYSE THE DATA: Analysis of data is an umbrella term that incorporates a large number of mini-steps. First is preparing a master chart by tabulating the data in a manner that all the information on one subject constitutes one record. In an Excel format, this really means that there is only one row of data for each person. Also each field (column in Excel) must contain only one piece of information. If an AIDS patient has chronic peritonitis, toxoplasmosis, and kaposi sarcoma, with codes 7, 12, and 14 respectively, these three should be entered in separate fields, and not as 7,12,14 in one field. Second step in data analysis is exploring the data for their pattern. Not many researchers appreciate the importance of this preliminary step. For example, pattern in geographical plot may reveal hidden mysteries in the medical phenomena you are studying. Outliers may reveal new relationships. Examine whether some selected variables are really following a Gaussian pattern or not. That will decide whether parametric tests of statistical significance should be used or nonparametric tests. For exploring relationship among various measurements, scatter plots can be immensely useful. These will indicate where and what type of relationship should be explored. Third step is to use the data for assessing the parameters of health and disease that were outlined in the protocol. Various indicators and indices of health and disease such as waist-hip ratio and scores may have to be calculated to assess risk factors and outcomes of interest. Fourth step is to summarise the data. This is done in terms of mean, standard deviation, proportion, rate, and more importantly in medicine in term of odds ratio and relative risk. Such summaries tend to delineate the uncertainty levels in the results and help in grasping the essential features of data. This step sets the tone for statistical analysis. The next step is grinding the data through the process of statistical analysis. This involves performing statistical tests to assess the significance of differences, obtaining the structure of relationships such as regression and their significance, assessing trends and agreement, etc. Wise researchers devote sufficient time to the examination of the data and to their analysis. Collecting quality data is important in itself but exploiting it fully is even more important. New results are sometimes missed despite availability of good data because they are not properly exploited.
INTERPRET THE RESULTS: Whereas statistical analysis is mostly computer-based, interpretation of the results requires critical thinking. A series of steps can be suggested. (i) Examine the results in the context of the questions that prompted the research. (ii) Verify that various results are consistent with one-another and a proper explanation is available for the inconsistent ones. (iii) Check that all the potential biases have been either ruled out by design, or the results are properly adjusted for the biases. (iv) Assess the reliability of the results. They must be reproducible. (v) Confirm that a convincing biological explanation is available. (vi) Show by sensitivity analysis and uncertainty analysis that the results are robust to the systematic variations. (vii) Ensure that the final conclusions are indeed a further development and not repeat of previous knowledge. In short, not only that you should be convinced about the correctness of the conclusions but also there should be enough reasons to convince others. Results should not be speculative, instead should be based on evidence as revealed by the data and other facts. If the results are too good to believe, reexamine them.
WRITE AND DISSEMINATE THE REPORT: Report is a generic term that includes a thesis, a dissertation, an article, a paper, and a project report. It should contain all the details in a concise manner. Then disseminate it to the intended audience. Dissemination could be the most fruitful step in a research endeavor. The world is informed about the new conclusions, and a feedback is obtained regarding quality of the conclusions. A clear idea about the users of results will help to decide how to disseminate findings to the stakeholders. The report should be sufficiently detailed that can remove any doubt a reader might have about any aspect of the results. It should be properly worded with a clear demarcation of the evidence-based results from opinions and comments. The report should be adequately illustrated by diagrams to enhance clarity. Numerical results can be summarized in the form of tables. Describe all the limitations candidly. No result has universal applicability, and the scientific community is fully aware of this fact. Thus the limitations should be stated without inhibition. The format of the report is geared to meet the expectation of the audience. A scientific paper would concisely state a particular aspect of the research in a paragraph that would take several pages in a thesis or a dissertation. The language for the press release would be very different than for a scientific paper. A report prepared for a funding agency may have a different focus to fit their requirement.
MONITOR THE REACTIONS: Research is a continuous process. You might want to improve upon by learning from the reactions of the users of the research. For this it is necessary that all such reactions be systematically monitored. It is not uncommon in research journals to publish comments and the author‘s rejoinder. These help to crystallize thoughts, and to improve in a subsequent endeavor. Also monitor whether or not the results are being utilized.
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