Submissions

Author Guidelines

FORMAT OF A SYNOPSIS / PROPOSAL

TITLE:

The title should reflect the problem under study as well as the objectives of the study. Length of title should not exceed 150 characters. The preferable length is less than 50 words.

INTRODUCTION: Has 3 parts to it, usually written as separate paragraphs:

1. Identification and Statement of the problem under study (the topic chosen is presented as a problem on which research has to be conducted in order to find a solution). Also briefly describe the epidemiology, morbidity and mortality figures associated with the problem.
2. Research Strategy undertaken by researchers so far. Obviously the problem has been perceived by other people around the world and they have also conducted research on it. Write in your own words the findings of other researchers and their successes or failures in finding solutions to the problem. This part has to be written after conducting a thorough and relevant literature search and providing appropriate references as and where needed. The literature search should be from current research, meaning that the references are one year old or at most 5 years old.
3. Rationale of your study: State why you have decided to undertake research on this problem; what was it that posed as the motivation to conduct your study; what aspect of the problem or disease would you like to study and why? Rationale is usually in keeping with research work conducted so far, so that areas where researchers still continue to have problems are selected and their rationale provided; areas or aspects of the problem that have been successfully resolved are not considered research topics (reinventing the wheel).

OBJECTIVE(S) OF THE STUDY:           

Write in serial fashion (1, 2, 3, ..) two or three achievable objectives. Objectives are the practical or concrete steps that you will undertake to make the aim of your study achievable. Objectives are written in ‘action verbs’ in the ‘to do…’ format, e.g.,

The objectives of this study are:

1. To determine …..
2. To compare….
3. To correlate…   etc.

HYPOTHESIS:

Hypothesis is a statement wherein you take a position regarding the possible outcome of your research, as you are also an experienced researcher in the field and can make a ‘calculated guess’. Generally there are two types of hypotheses: a) The Null Hypothesis, where you make a statement in support of an existing situation or make a statement of no difference from an expected outcome, e.g., ‘the audit will reveal that proper guidelines were followed’, or ‘the audit will reveal that that there were no significant differences in the policy of the hospital and internationally recommended guidelines’. b) The Alternate Hypothesis, where you make a statement opposing the existing state or state that a true difference does exist between expected and obtained outcomes, e.g. ‘the audit is expected to reveal that proper guidelines were not followed’ or ‘the audit will reveal significant differences in policy and practice from internationally recommended guidelines’.

Usually a research study will be based on the alternate hypothesis, because this perceived change from some expected situation is what prompted you to do research in the first place.

OPERATIONAL DEFINITIONS:

Operational definitions are definitions of technical terms as you have intended them to be used in you study, e.g., Anemia in your patients could be defined as ‘clinically evident by inspection of fingernails, mucous membranes or inner margins of eyelids’ or as ‘hemoglobin measurement in g/dl of less than 10 g/dl’ or ‘hemoglobin measurement in g/dl of less than 12 g/dl’, etc. You are free to use standard definitions of technical terms or even make you own definitions which you will use throughout your study.

METHODOLOGY:

Here you provide serially in a checklist fashion, the various steps you will undertake to provide the materials for your study and the methods by which you will conduct your research work. The following checklist is a recommended sequence:

1. Setting: State the place where your research work will be undertaken. This may be a hospital and / or its department(s) or the community or both. Also mention some facilities of the setting that will help your research, e.g., number of beds (patients per month), surgical or medical facilities, researchers / supervisors, equipment, standard labs, etc. The setting usually indicates the place(s) from where you will collect your data and/or carry out your lab work; in case these are separate places, mention both, e.g., data would be collected from patients of medical/surgical wards of a hospital, while the lab work would be conducted in the clinical pathology laboratories of the hospital.
2. Duration: The expected duration of your research study and why this duration is required (number of patients, hospital tests, data collection and analysis, report writing, etc.). You may like to prepare a detailed time table (Gantt Chart) of your activities on a weekly or monthly basis, outlining targets that you expect to achieve per week or month for the entire duration of you study. This will help to organize and allot your work to fellow researchers and give you a basis for monitoring the progress of your research per week or month, so you can make changes, if needed in the pace of work or other parameters. You may, in lieu of a detailed time table, give a brief outline, e.g., literature search – two weeks, making a Performa and pre-testing it – two weeks, getting lab supplies and setting up tests – one month, data collection – 6 months, data entry and analysis on computer – two weeks, writing a thesis – one month, thus giving as total duration of approximately ten months.
3. Study design: Every study has a predetermined design; the broad classification is based on whether an intervention is performed or not. Thus there are Non-Interventional / Observational studies and Interventional studies.

• Observational studies are further classified into:

1. Descriptive studies: Here the study is concerned merely with describing the findings.

1. Case Reports: where rare conditions or unusual presentations of common conditions are reported.
2. Case series: where a series of cases suffering from the same condition are reported as a series.

1. Comparative studies: whenever there are two groups or data sets, which have to be compared to arrive at some meaningful conclusion. Comparisons can be made among any two groups selected by the researcher. All comparative studies also require analysis of the comparisons by using tests of significance to see if the perceived differences are true differences or merely due to a chance array of data.
2. Analytic studies: Here the data is subjected to specific analyses meant to determine a cause-effect relationship. Such studies are used to see if the disease (effect) is related to a possible risk factor (cause). The strength of association of such cause-effect relationships are measured or quantified by applying relevant formulae. There are two subtypes depending on the direction of inquiry:

1. Case-Control studies: Here the two groups are cases (patients) of a disease, and a (preferably matching) group of people without the disease as the control group. The case-control ratio should be kept as at least 1:1 but may be increased to 1:4, if needed, to make inferences more valid. Both groups are studied for exposure to the risk factor being studied and the direction of inquiry is into the past history of exposure (or retrospective in direction) to the risk factor for both cases and controls. An example is to have cases of lung cancer probed about their exposure to cigarette smoking; the same is done for controls. Comparison is then made of the relative frequencies of such exposures in both groups and by applying the formula for Odds Ratio (O.R.), the risk of exposure is quantified, e.g., lung cancer patients have a 4-fold increased risk of exposure (if O.R. is 4), hence they are 4-times more likely to get the disease.
2. Cohort studies: A cohort is defined as a group of people with some common factor in them which is being studied. In analytic studies, the cohort represents a group of people with a common risk factor being studied, e.g., cigarette smokers. A control group is also selected, as before, of people without the risk factor, i.e., non-smokers. As there is no disease in either group at the start of the study, both groups are studied for the occurrence of the disease under study, i.e., lung cancer in this study. Thus the incidence of lung cancer in both the cohort and the control group is recorded for the duration of the study; as disease may occur years after exposure, these studies tend to be of long duration and oriented prospectively in time. The ratio of the incidence of disease in both groups, when calculated by formula, gives the Relative Risk (R.R.) of the occurrence of the disease due to the risk factor. Thus we can say that smokers have a 10-fold increased likelihood (if R.R. is 10) of getting lung cancer as compared to non-smokers.

1. Cross Sectional studies (Surveys): These are studies where a cross section of the population is sampled either at one point in time (say, on one day) or over a time period (weeks, months or years). They are also called prevalence studies, as they are most often used to provide prevalence data. Such studies are conducted whenever a rough idea is to be made about some condition for which data are collected during the study.

• Interventional (or Experimental) studies must have the following three requirements to be called as interventional studies:
  1. Presence of two groups, here called the Test and Placebo groups.
  2. Assignment of subjects to the groups by Random Allocation.
  3. An Intervention.

If any one of these three conditions is not present, the study is called a Quasi-Experimental study.

Usually in interventional studies, matching and blinding (single, double or triple) is applied to increase validity of results. Random allocation to the two groups can done by simple lottery method or using the Random Numbers Table or by computer.

1. Population and Sample: Simply this means your study subjects or patients. However population here refers to the group or subgroup of people from whom your sample is actually taken, e.g., ‘all male diabetics attending the OPD during the study period’ or ‘all diabetics admitted to the ward during the study period’ or ‘all blood samples processed by the lab for cardiac enzymes during the study period’ etc. You thus make a statement, ‘the sample will be taken from …… (the population)’.
2. Sample size: The number of people from whom you will collect your data. You may select any sample you think appropriate or calculate a minimum sample size by using formulas; however for most studies using people, a random sample of over 30 is considered suitable; a sample over 120 suffices for most inferences as well. For non-random samples, the rule is that the larger the sample size, the better the study. You may select all the patients that you come across during the study period, and give an expected sample size, based on your experience of how many people will be visiting you with the condition under study during the study duration.
3. Sampling Technique: This refers to how you will actually select your sample, viz., which people will become a part of your sample from whom you will actually collect data? How do you know which people to select and which to not select? Why should you select the ones you selected and not select the ones you did not select? Although inclusion and exclusion criteria are commonly used for selection of non-random samples, it does nothing to improve statistical validity. The only statistically valid sampling technique is random sampling, based on the lottery method; currently, you can also use a Random Numbers Table or ask the computer to generate a random sample for you of the desired sample size from a computer database of patient records or lab tests. Mention whether you are generating a random or a non-random sample. If you are using the data of all patients or lab records during the study period, then you need not mention a sampling technique as you are studying the entire population and not a sample.
4. Selection criteria: Here you describe both inclusion and exclusion criteria for your subjects. If there are two groups, these criteria must be made for both groups. Exclusion criteria apply to subjects selected after using inclusion criteria, so that some of the included patients will be excluded if certain conditions are found in them which are likely to affect the study results by introducing bias. Such conditions are called confounders, and are defined best in analytic studies, where a confounder is a factor that has effects on both the cause and the effect, so that a pure cause-effect relationship cannot be established unless the confounder is removed by exclusion of subjects that have them.

DATA COLLECTION PROCEDURE:

Describe how data will be collected from each subject; in other words what procedures each subject will undergo in order to collect required data. In case of lab records, it is enough to state that data would be obtained from a lab databank (registers or computerized). Data would be collected as variables of a pre-designed Performa (which will be attached as annex A).

DATA ANALYSIS:

Mention data entry into a computer program after collection on Performa or from a register, e.g., data would be entered into SPSS version 10 for analysis. Describe the main variables that would be used for calculations and analysis. Describe calculations that would be done, including formulae where needed. Describe any tests of significance that would be applied to compare different variables; also provide the appropriate p value that denotes significance.

References:

List all relevant references according to the Vancouver Style using a reference manager like Mendeley, End Note, etc. In text citation shall be superscript.

Annexures:

Annexure 1 usually contains the Performa. Annexure 2 shall have the Informed Consent Form in English and local language. Other annexes may be made to provide any detailed methods (e.g., lab procedure methodology, details of operative procedures, etc.) that cannot be included in the main text.

Templates

ASRB GC Proposal Presentation
Undertaking
Letter from supervisor
Format of synopsis/proposal

Following are the Submission Sections