By Dr Hidayathulla Shaikh

 At the end of the lecture student should be able to -  mention steps in methodology of a study  Discuss steps in methodology of a study  Explain plan of action  Enumerate blinding trials.

 Designing the suitable methodology of an experiment in an institution (hospital or Lab) or for an inquiry in the field needs very logical and systematic planning.  Guidelines are required to answer questions pertaining to the purpose, scope, objectives, methodology, results and practical applicability of the proposed research.  Experts from other fields concerned for research should be consulted or involved in planning or conduction of research study.

1) Definition of the Problem  Define the problem you want to study such as smoking and oral cancer, cholesterol and coronary heart disease, oral hygiene and dental caries etc. 2) Aims and Objectives  Define aims and objectives of the study, state whether nature of the problem has to be studied or solution of the problem to be found by different methods.  Ex – a) comparing efficacy of two lines of treatment  Ex – b) warning public against smoking  Ex – c) modifying measures to control malaria. etc

3) Review of Literature  Critically review the literature on the problem under study, find if any such work has been done before by others.  If so, than clarify if you want to confirm the findings, challenge the conclusion, or extend the work further.  Ex – a) density of microflora is higher at night, but you want to know which part of night.  Ex – b) untoward or toxic reactions of some medications and so on.

4) Hypothesis  State your hypothesis after the problem and purpose are clear and literature on the previous works is reviewed.  You have to precisely start with an assumption positive or negative, such as  Ex – a) iron by injection is not more effective than by mouth.  Ex – b) chewing tobacco cause more damage to oral tissues than smoking, and so on…

5) Plan of Action  Prepare an overall plan or design of the investigation for studying the problem and meeting the objectives, the plan should specify 5a) Defining the population under study  It may be country, state, city, village, families or specific group of population as per income, age, occupation etc.  Define clearly who are to be included and who are to be excluded.

5b) Selection of samples  Samples should be of sufficient size (large for field research), and represent the population under study. 5c) Specifying the nature of study  State which type of study you are doing – Descriptive, Analytical or Experimental study and specify its sub type clearly.  Here in order to reduce bias in study design blinding is done, it can be of 3 types

i) Single blind trial – here the study is planned in such a way that participants do not know whether they belong to study group or control group. ii) Double blind trial – here neither the investigator nor the participant is aware of the group allotted and treatment received. iii) Triple blind trial – in this type the participant, investigator and the person analyzing the data are un aware of their group to which they belong.

5d) Ruling out the Observer and Instrument error  The investigator has to be trained, errors in taking readings/recording data should be minimized.  Instruments like weighing machines, sphygmomanometer, thermometer ect should be checked before the use. 5e) Recording Data  For recording data, a standard proforma, format or questionnaire has to be prepared and presented in few cases.  Investigators have to be trained in filling these proforma.

5e) Work Schedule  Prepare work schedule for data collection by estimating work expected per hour/day /week/month and per worker or per team.  This should be done by pilot survey (initial survey with small sample)

6) Presentation of Data  Compile all data and verify their accuracy and adequacy before processing further.  Classify as per age, gender, class, profession and other desired characteristics.  Prepare frequency tables and diagrams using statistical analysis.

7) Conclusions  Draw unbiased conclusions and see if the hypothesis is established.  Re check the whole plan before making logical recommendations.  Prepare your reports as an article for publication in the scientific journals.