RESEARCH METHODOLOGY DR. NIRAJ KUMAR ASSOCIATE PROFESSOR PHYSIOTHERAPY DEPT. SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES
Clinical research is a structured process of investigating facts and theories. It is a method of answering the questions in a systematic and objective way to examine clinical conditions and outcomes.
Experimental research (Gold standard research) Pretest-posttest designs Post test only designs Complex variations (several independent variable)
Experimental research Quasi experimental designs Sequential clinical trials Single case experimental designs
Non-Experimental research Descriptive or Exploratory
Descriptive research Systematically describe and interpret conditions or relationships that already exist. Involves questionnaires, , interviews or direct observation Correlational research Used to examine the extent to which variation in one variable corresponds with variation in one or more other factors .
Epidemiology Concerned with the risk of disease or disability associated with specific exposures. Surveys Experimental studies Correlational studies
Evaluation research An objective and empirical assessment of the success of a program or policy in meeting its goal and objectives. Used to assist Decision making Determining if a clinical program should be implemented, continued, or modified
Methodological research Involves the development and validation of measurement tools used in practice and clinical research.
Purpose of a research design Provide information regarding: What is the study? Why is the study being carried out? Where will the study be carried out? How will the study be carried out? What will be the processes and tasks involved? What will be the data? How will the data be collected? What methods of sampling will be used? and How will the analysis be done?
Functions of the research design Provide a plan to undertake systematic study and help to provide procedures to undertake the research work; and Ensure objective, valid, and economic undertaking of the study.
Types of research design Factors Nature of investigation, Data collection methods, Number of contacts made with the subjects, and the Period of reference
Nature of Investigation Exploratory Descriptive Experimental Semi or Quasi- experimental Non- experimental and Field research.
Data Collection Methods Survey Case studies and Content analysis
Definitions of Study Design Case–control study Retrospective comparison of exposures of persons with disease (cases) with those of persons without the disease (controls). ( Harm/Etiology) (EBM Toolkit, 2008) Case–series Report of a number of cases of disease. (Harm/Etiology) (EBM Toolkit, 2008) Cohort study A study that begins with the gathering of two matched groups (the cohorts), one which has been exposed to a prognostic factor, risk factor, or intervention and one which has not. The groups are then followed forward in time (prospective) to measure the development of different outcomes. In a retrospective cohort study, cohorts are identified at a point of time in the past and information is collected on their subsequent outcomes. ( Diagnosis, Harm/Etiology, Prognosis, Therapy) (EBM Toolkit, 2008) Meta–analysis Broad term that includes reports that collect and synthesize data from individual studies to provide new information. (McKibbon, 2009) 3/27/2019 15
The research plan
Title Concise and informative Has an independent variable, dependent variable and the sample.
Abstract Should be in one page It includes A brief description of the method Procedures Methods for data analysis The proposed duration of the study and overall projected costs may be stated
Statement of the research problem Rationale and justification for the study Why the study was needed? Significance of the study What is the use?
Statement of the purpose of the study Specific aims or objectives Help the researcher guide the discussion of results when the study is completed (comparative, correlational , reliability of an instrument and the relationships) Research hypotheses or guiding questions Positive or negative
Aim to map, to develop, to design, to track, to generate, to theorize, to build … Sometimes ‘to investigate, to understand, and to explore… to synthesize, to catalogue, to challenge, to critically interrogate …
Objectives There are usually more than one, are the specific steps you will take to achieve your aim.
Objectives Objectives are often expressed through active sentences. So, objectives often start something like In order to achieve this aim, I will … collect, construct, produce, test, trial, measure, document, pilot, deconstruct, analyse … The list of objectives spells out what you actually and really will do to get to the point of it all. Objectives have to be practical, do-able and achievable .
Background of the study Topics for review of literature related to Theory and supportive rational Related studies Methods Previous work by the investigator that supports the project
Method Subjects : Characteristics, sampling method, plans for recruitment Materials: instrumentation, plans to establish reliability and validity Procedures Study design Details of test and treatment administration Data collection methods Timetable and organizational chart Data management and analysis
Literature cited References should be in any one of the format Vancouver Harvard
Sampling
Population The larger group to which research results are generalized is called a population. Defined aggregate of Objects Persons Places Organizations, animals, days etc.
Sample Through a process of sampling, a researcher chooses a subgroup of the population, called a sample. It serves as the reference group for drawing conclusions about the population.
Target population Target or reference population: to study the overall group of people OA Learning disability Gait dysfunction in hemiplegia
Sampling techniques
Simple random sampling In clinical studies List the available population Chit method (equal size and shape) Tables of random numbers
Systematic sampling Lists arranged alphabetically or in some other ordered fashion. 100 / 1000
Convenience Other name: accidental sample Most common form Chosen according to the availability of the patient. Disadvantage: bias of self selection
Normality test Less than 50 (<50) Shapiro – Wilk test If the significance value is greater than 0.05 More than 50 (>50) Kolmogorov – Smirnov test KS Test If the significance value is greater than 0.05
Parametric (Normal distribution) Parametric – paired t test (pre-post design), Repeated measures Anova – (Pre-Post-Follow up) Independent t test – individual comparison of 2 data (between group) One way Anova – to comparison of all 3 group Pearson correlation – validity. Nonparametric (Non normal distribution) Non- parametric - Wilcoxon (pre-post design) Friedman test (Pre-Post-Follow up) Mann Whitney – individual comparison of 2 data (between group) Krusskal Wallis - to comparison of all 3 group Spearman rank correlation coefficient
Presentation of the research
Visual presentation Avoid confusing slides 4 types of slides may be presented Words or phrases (text) Photographs Graphs Tables
Words and Phrases Title Purpose Important background material Hypothesis Description of subjects and study protocol Summary of results and Conclusion
Abstract should contain Overview and purpose of the study General description of methods Highlights of results Statement of significance of results General conclusion
Abstract Abstract summarizes The purpose of the study Number and type of subjects The basic procedures used Summary of the results And the major conclusion Must be concise Word limits 100
Introduction Statement of the problem Clinical relevance Review of literature Rationale and theoretical framework Specific purpose and hypotheses (or guiding questions)
Introduction should contain The 1 st one or two paragraphs of the introduction should have a clear understanding of the problem being studied. The introduction should end with a statement of the specific purpose of the study
Methodology should contain No. of subjects Selection criteria Informed consent Approved by the appropriate committees. Description of equipment Data collection procedures
Results should contain Should contain only a report of results Significant test and its probability. Tables and figures Statements to support or reject hypotheses
Discussion should contain Reflects the researcher‘s interpretation of the results in terms of the purpose of the study and the outside world. The should comment on Importance of the result Limitation of the study Suggestion for future research And clinical implications
Conclusion A brief restatement of the purpose of the study and its principal findings. Author states the deductions made from the results. Phrases like “the results of this study indicates” and “this study demonstrates” serve to link the summary of results and the meaning of those results.