Research Design

Prof Meera K Pillai

Research Design


Research design of a study sets out a clear sketch of strategies to be adopted by the researcher to gather evidence which are accurate and can be interpreted. Selection of research design is important as it affects generalizeability , value & predictability of the study.

    

A research design is a blue print which is conceptualized by the researcher for carrying out the study . A design must spell out the following What is the investigator studying Why is the study being done Where will the study be done What is the type of data needed What is the sampling design going to be

  

What is the period of study What are the plan for analyzing the data In a nutshell research design must clearly state the research problem, procedures & techniques for data gathering, the population under study, & data processing & analyzing methods Purpose of a design It is like a well thought about plan

 

It spells out the plan for inquiry A good plan will maximize the objectivity of the study A well planned design helps the researcher to review the plan critically before the actual study is done

Concepts
Manipulation - Manipulation is the treatment or intervention done to the dependent variable to study the effect  Control - control is the ability to direct or manipulate the factors to achieve desired outcome eg in a study on the effect of pre operative teaching on post operative health behavior of patients the following may be controlled by the researcher


Duration of teaching, teaching method , content, and the teacher, the environment where the teaching takes place, type of surgery, number of days prior the teaching is done Characteristics of subjects like age, diagnosis, sex may also be controlled Control is very essential in experimental & quasi experimental study

Greater the control better the validity of study findings  Randomization - randomization includes two processes - random selection of subjects from target population - random assignment of subjects for intervention - In both cases it is done to ensure that the characteristics of the subjects are distributed or spread across in a non systematic way. - In this way the sample will be representative without any bias


 

Random selection:- random selection refers to selection:process of randomly selecting research subject from a target population for the study This ensures the representativeness of the sample and finding can be generalized Random assignment:- random assignment assignment:means allocating subjects or clients to intervention & control conditions in a non systematic way. Eg. Coin toss, random drawing

Probability:Probability:- probability refers to relative causality. An intervention or cause may not yield specific effect each time that particular intervention is done This means that a particular intervention will probably result in the specific effect. Using a probability orientation , researchers design studies to examine the probability that a given effect will occur under a defined set of circumstances.

 

 

Bias:Bias:- Bias means a slant or deviation from what is true or expected. Bias distorts the findings As the studies are conducted to study the real or true phenomenon or effect, researchers try to avoid bias Many factors related to research can be biased These can be attitude of the researcher , components in the environment , instrument, design, data collection method, statistics used.

Research Designs
 

 

Research Designs are mainly quantitative & Qualitative Quantitative designs are non experimental & experimental design Quantitative design:- Non Experimental design:Non experimental designs do not use any intervention or manipulation but study the phenomenon as it exists in nature

 

Non experimental designs are descriptive studies which try to describe a phenomenon. It is comparatively weak design but used when very little is known about a topic or to explore a research question. Descriptive designs are simple descriptive survey, comparative descriptive survey design, developmental survey designs, Descriptive co rrelational studies , retrospective design, path analysis design , predictive co relatonal designs,

Descriptive designs
    

Goal of descriptive design is to describe phenomena as it exists Descriptive survey design involves describing & documenting the world as it currently exists. Objective give as complete a description as possible No manipulation is done & no relationship is determined In simple descriptive survey the variables of importance are identified & frequency of occurrence of these variables are ascertained.

Descriptive co relational designs try to describe relationship among variables rather than to infer cause & effect relationship  Eg A study on relationship among spiritual well being, sleep, quality & health status in HIV infected men and women. Univariate Descriptive studies  Descriptive studies that study the frequency of occurrence of a behavior or condition than relationship.


 

Univariate studies do not focus on one variable Eg a univariate study may describe womens experience, frequency of symptoms during menopause. But known as univariate because the primary purpose is to describe the status of each variable. Descriptive studies like prevalence study, incidence studies are used in epidemiology

  

Prevalence studies are to determine prevalence rate of disease at a particular point in time. They make use of cross sectional design Formula is Number of cases with condition at a given point in time by Number in the population at risk multiplied by Number of people for whom the rate has to be established. Incidence studies are done to measure the frequency of developing new cases.

It is much faster & less expensive. Disadvantage is that information obtained is limited Can not use to infer causality or the extent of relationship between variables Comparative descriptive design comparative descriptive survey design tries to compare between two or more groups Information is obtained on each group & using statistical analysis , the difference is studied.

Study sample has to be as similar as possible in all variable except variable under study For this random sampling & when possible stratified random to be used comparative design provides detailed descriptive information on several groups. Weakness is its inability to determine degree of association

Developmental Survey design

 

 

This design is used when the researcher wants to examine the way variables change over time Two main types of developmental survey designs are longitudinal surveys & cross sectional Longitudinal survey designs can collect data at several points of time. Common designs are trend studies, cohort studies, panel studies

 

In trend studies samples from general population are selected at specified time intervals. In each interval new subjects are selected In cohort studies different subjects are also selected at specified time intervals but these are drawn from previously identified groups within the population. Panel studies refers to measurement of the same subjects at specified intervals

  

Cross sectional survey collect data from a cross section of the population Here data can be obtained from the selected subjects at one point in time. Other method in cross sectional studies is to obtain data from individuals at a fixed event during life such as death or birth. Advantages in trend studies are their use in studying amount of change that has occurred

Cohort studies have the advantage of studying segment of population for change over a period of time. Panel studies can give details about specific subjects on areas under study over a period of time. Advantage of cross sectional studies are they are fast, cost effective, easy to conduct. Provide information for health care planning

Disadvantages of longitudinal studies are the long process, time , expense, loss of subjects, Difficulty in cross sectional studies is difficulty in determining what contributed to the difference in data Another disadvantage is when a section of population is studied at the same time , difference may be attributed to generational difference between groups rather than changes occurred over time

Co relational studies
 

 

Ex post facto are referred to as Co relational studies . In ex post facto ( After the fact) no manipulation is done because the event has already occurred This type of study is done to study the existing relationship between variables When there is a corelation change in one variable corresponds to change in the other.

 

But co relation does not indicate causation Some of the ex post facto designs are descriptive co relational, retrospective studies, prospective studies, path analysis & predictive designs. Descriptive co relational studies researcher describes the relationship between variables Subjects are not randomly assigned for any treatment

 

No control group & no manipulation of independent variables Researcher identifies the variables of interests ans selects appropriate means to measure them Questionnaire, interview techniques are used Attempts to find co relation between variables statistically Advantages are less expensive, done quickly

Can be done as a preliminary study for further research  Dis advantage is it can not study causation Retrospective designs:designs: Here study is done to see what happened or what in the past is associated with this effect.  Epidemiological studies use this design  In retrospective studies subjects are chosen based on a particular effect in which the researcher is interested  Data can also be taken from archives or medical or nursing records.


     

Studies with retrospective designs links an existing phenomenon with that occurred in the past Here the antecedents of a present outcome is searched from past evidence Case control studies were done to study the link between cigarette smoking & lung cancer. Here the researchers studied cases (people with lung cancer )and control were people who did not have the disease. Researcher searched for variation in behavior or conditions in both the groups Hence in a retrospective study the researcher starts with the dependent variable and attempts to study the corelation with one or more antecedent independent variable.

Eg a case control design to compare infants who died of sudden infant death syndrome with controls that did not All retrospective studies do not use case control methods A retrospective study can be done to identify factors that could be used to predict the length of time new mothers breast fed their infants

Prospective non experimental design

      

This is also called a cohort design as it is studied prospectively Starts with a presumed cause and the presumed effect is followed up in time. Here hypothesis can be incidence of rubella during pregnancy is related to infant abnormality Here the study begins with pregnant women with some mother who had rubella infection. They will be followed up to see the congenital abnormalities in the new born. Prospective studies are more expensive Require larger samples

In a good prospective study, researchers take steps to conform that all subjects are free from the effect at the time the independent variable is measured Eg. In a prospective smoking/lung cancer studies, lung cancer may be present initially but not yet diagnosed Some prospective studies are explorative

Researcher tries to measure a wide range of possible causes at on point in time. Path Analysis  Path analysis involves testing of hypothesis of causal chain among a set of independent, mediating & dependant variable, using sophisticated statistical methods.


Experimental design


In experimental studies researchers are active not passive observers Pure observation of a phenomenon is valuable but because of complexities occurring in nature it is difficult to understand the relationship Hence laboratory condition under controlled situation was used to study the effect or causal relationship by physical scientists.

  

Pure experimental studies use randomized controlled trials Controlled experiments are standards for reliable evidence about cause & effect relationship True experimental designs are characterized by:by:- manipulation :- some intervention is done to the subjects - Control_ introduces control over Control_ experimental situation

Randomization:Randomization:- Researcher randomly assigns subjects to experimental or control group Design features  Manipulation:- the experimenter manipulates the Manipulation:independent variable by giving some treatment to some subjects & withholding from other by trying other treatments.  Deciding on the condition under which the


the study is done or control Control group: Control group refers to subjects whose response to the dependent variable is used to evaluate the response of the treatment group.  In some studies control group do not get any treatment .In others it can get a pseudo intervention eg. Placebo. Sometimes there can be placebo effect.

In nursing studies withholding care may not be ethically possible or correct Difference intensity of treatment to experiment & control group especially in study dealing with dose response effects. Wait list control- here with delayed treatment , controlcontrol group gets the full treatment.

Basic experimental design  After only design or post test only design  Eg study the effect of massage on pain levels of elderly home residents  Data on dependent variable is collected only once  Another basic design is before after design or a pre test post test design

Experimental design


 

In the pretest post control design subjects are randomly assigned to either control or experimental group Each group is observed (pre test) One group receives treatment other group does not Both group are observed again (post test) to determine the effect

R O1 X O2 R O1 X O2 (R(R- randomization, O ,Observation X treatment  Advantages are the control will minimise threat to internal validity  Again quality of control depends on how the researcher structures the environment  These include history, maturation selection


 

  

Only difference between experimental & control group should be treatment Whatever extraneous influence that happens between pre & post test must happen for both groups. Then threat of history can be reduced. Random assignment & selection can reduce the bias Disadvantage is that results can be generalized to similar groups Possibility that mortality may affect one group than the other

Post test only control group design



   

R X O R O Weak design no pretest is done Useful in situations where pre test is not possible Randomization does provide some control Without pretest the strength & direction of the response can not be determined

Solomon four group design

   

Complex & combination of pretest post test control group design Here there are two control groups & two experimental group Subjects are randomly assigned to one of the group With randomization of a large enough number of subjects groups can be considered equivalent at the onset of the study

Here the purpose of more groups is to have more control over extraneous variables Sometimes act of pre testing itself can influence the out come Eg when studying subjects for presence of anxiety , this itself can make some of them aware of their problem and there may be some motivation to get better. To avoid such influences Solomon four group designs can be used

 

Pre test & post tests are carried out for one control group & one experimental group For other two groups only post test Intervention is carried out only for experimental groups & no intervention for control groups Exp 1 R O1 X O2 Control1 R O1 O2 Exp2 R X O2 Contrl2 R O2

 

Very strong design & increases the internal validity Effects of history & maturation is controlled for by the pre tested group The groups without the pretest control for the effect of testing

 

Non pre tested control group allows the researcher to assess the effect of maturation without treatment Main disadvantage is the resources needed large number of subjects are required for this design When more than one researcher is involved bias may be there in the observation

Factorial Design


Factorial design is used when the researcher wants to study the effect of more than one independent variable or intervention These multiple independent variable are called factors which has to be tested To study the effect of two types of stimulation of varying degrees on premature infants development

Auditory stimulation have more beneficial effect than tactile effect or vice versa Does the duration of stimulation affect the development Is auditory stimulation most effective when combined with a particular dose & tactile stimulation most effective when combined with a different dose.

The third aspect shows the strength of factorial design Here we can assess not only the main effects but also the combined effects In factorial design subjects are assigned at random to combination of conditions In the above example premature infants will be assigned randomly to one of six cells

    

Cells are treatment conditions represented as boxes in schematic diagram Type of stimulation is factor A Amount of daily exposure is B This is a typical 2 x 3 factorial design i.e two levels in factor A & three levels in factor B Designs with more than three factors are rare . Usually these studies can be done with three or more independent variables

Factorial design schematic diagram

Type of stimulation

Auditory A1
Daily exposure

Tactile A2 A2 B1 A2 B2 A3 B3

15 Min B1 30 min B2 45min B3

A1 B1 A1 B2 A1 B3

Randomized Block design

 

This is a design similar to factorial design Here also there are two independent variables The difference is that one factor is not experimentally manipulated and the second factor is a stratifying variable

In the eg used for factorial design if we have to compare the effects of tactile versus auditory stimulation for male versus female premature infants , stratification on gender will be done before randomization This can be structured as a 2 X 2 experiment with type of experiment as one factor & gender as the other factor

The variable gender, which we cannot manipulate is the blocking or stratifying variable here subjects can not be assigned to one of four cells as in factorial design But male & female subjects are randomly assigned to the two stimulation method

The design can use more than one blocking design As a thumb rule minimum of 20 subjects per cell is required to achieve stability within cells. A minimum of 80 subjects will be needed for 2x2 design

Cross over Design



Cross over design exposes the same group of subjects to different treatment. This type of within subjects design has the advantage of ensuring highest possible equivalence among subjects exposed to different conditions Group being compared are equal with respect to age, weight, health

If there are 3 conditions the subjects will be randomly assigned to particular order of treatment ie. Some group will be receiving tactile stimulation first, others will be getting auditory stimulation first When there are three or more conditions to which each subjects will be exposed , the procedure of counterbalancing can be used to rule out ordering defect

A BC A C B B C A B A C C A B C B A Cross over design are very powerful but not appropriate for drug studies There can be carry over effect