RESEARCH METHODOLOGY DEFINITION ion jertaken in order td - to get additional / ‘Oxford Dictionary). information INTRODUCTION TO RESEARCH * Research is a systematic quest for undiscovered truth. a * Research is an innovative way of thinking. ; Amended plan Takeseco action ste !.1 Introduction to research * Research is the way to solve the problems to decrease human suffering and improve knowledge. In scientific terms Research is a systematic, data based, « and scientific inquiry into a specific p undertaken with the objective of + esearch can be divided into two major answers/solutions to it (Fig.1.1). Sasic research when some new ae knowledge/technology is generated to deal anata _ h gs gy is g The main ingredients of researc yl with health problems. out sity to eno sone 4 2. Applied research is necessary to identify * Objectivity priority problems and to design and evaluate policies and programs that will * Positivity of purpose " deliver the greatest health benefit, making * Precision and validity optimal use of’ available resources and * Honesty and rigor knowledge. * Reproducibility To achieve health for all, necessary planning * Reliability requires detailed and accurate information/ pee situation analysis regarding needs, priorities, Logical reasoning tions, cost _ effectiveness, resources, opt y . * Simplicity in explanation sustainability and impact (Fig.1.2)- _il Scanned with CamScannerrent roup tion other deas, hical rcher matic rather uding lected values, social ¢ Trustworthiness ¢ Participants + Qualitative sub-sections of proposal Qualitative researchers typically rely on the following methods for gathering information: 1. Participant observation 2. Non-participant observation Field notes HY Reflexive journals Structured interview Semi-structured interview ao 7. Unstructured interview 8. Analysis of documents and materials 9. Review of historical records The ways of participating and observing can - vary widely from setting to setting. Participant observation is a strategy of reflexive learning, nota single method of observing, In participant” observation researchers become members of 2 culture, group, or setting, and adopt roles © conform to that setting. The aim is for the: To aa odoin il Scanned with CamScannerAqey ou yeousneis SATOH PSCT (uoneioumua) sx AUeU MOLT Aaaims ‘Suouttiadxy among aanenuend J@mens goes aapal & an A ES youeasas aanaupab jo JasuemES Geaace y domes jemuru Si G] lommeg aus 0} Z3pio ur “HOmMIMSuE amp o1 08 isnur seypiresor FE HOME Pe SQAfOAUT 1 We St YITesssr aanmgeel BP 9669 °ON :TTE (QI “Yozeasar seoLuras yppeay pure qafest] UT Spo s SOHSNPOHUT UY -Yoear OULD spoyseut I9y10 sued amp Surypsesy (S661) SAEW D ANPHEA yeoneio2y fy aanonpuy (uonedtfIsse[>) ZX ST IeU AL MOIAIOIUI ‘UOHPAIOSGC) uonoy sanenyendO qpsur saneupenb ue adog wbueng suydaes Surmoseay uonsend spoman A yoreasas aaneinuenb pure saneqjenb usaamaq aueIey IG Scanned with CamScannerSELECTING A RESEARCH TOPIC is w Scanned with CamScanner oy 1 4 Criteria for selecting a research pic ® OS Relevance Innovation Feasibility Acceptability Cost-effectiveness Ethical consideration Evaluation Relevance How big is the problem? How important is it to look for rel solutions to it?Objectives are detined as: an communicated by a statement descrip plan of the researcher in clear, Measyy terms. Importance of research objectives; e Brings focus to the study e Avoids collection of unnecessary data ¢ Determines an appropriate study des ¢ Helps determine analysis plan The objective shold be *S MART” eS: Specific M: Measureable A: Achievable R: Reproducible T: Time bound Scanned with CamScannerstudies are discussed here. 1. Cross-sectional studies Case-control studies Cohort studies CROSS-SECTIONAL STUDIES Cross-sectional sui Cross sectional studies aim at quantifying the distribution of certain variables in a study population at a point of time. They may cover, for example: * Physical characteristics of people, materials, or the environment, as in prevalence surveys ¢ Evaluation of coverage of immunization etc. The knowledge, attitudes, beliefs, and opinions of people, that may help to explain that behaviour (KAP studies), or events that occurred in the population These studies quantify the burden of disease in a given population and are useful for hypothesis generation (Fig.3.1). Cross-sectional surveys cover a sample of the population. If a cross-sectional study covers the total population, it is called a census, The outcome measure of a cross sectional focus TSR Nv among sts The level 5 knowledg§ in two grcs = The stat3 class resus compared” Example 2 To compare m aged 10-16 y survey on mz the following ds iv 4. The perc in a certai The age certain pa Socioecoi demograt availabilit The knoy influence_(gast9 quopeaaad) asvostp au3 Jo _pgoueape UI Sastd “9°! 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Disadvantage: The rel a result of th may increase or decrease as bias. Bias due to confounding: This can be. removed by matching. ] Memory or recall bias: Cases, better recal their past history. Selection bias: Cases and controls may not be representatives of cases and controls # the general population. Berksonian bias: This is caused by diftere? rates of admission to hospitals for peor! with different diseases. a Interviewer’s bias: When the intervieV re Scanned with CamScannerKeseat frrwethodalyy andl basic biostatistes fal factary 10 MOL 1 Odds rations and their srnorn trsk Lac hors tO 11! anuibutable y0% Cls cardial vad then population cere calculated factors (ndependent variables) ih ite tisk saoking (ods hye case control study wete N7 for current rs never, PAR 35.7% for ), raised Apo lowest quintile, ratio 2 current and former re never ApoAL ratio (3.25 for top rs \ PAR 49.2% for top four quintiles rs lowest quintile), history of hypertension (1.91, PAR 17.9%), dliabetes (2.87, PAR 9.9%), abclonnmal obesity (112 for top es fowest tertile and 1.62 for middle es lowest tertile, PAR 20.1% for top two tertiles rs lowest terule), prychosoctal ctors (2.67, PAR 32.5%), daily consumption Of fruits and vegetables (0.70, PAR 13.7% for Jack of daily consumption), regular alcohol consumption (0.91, PAR 6.7%), and regular physical activity (0.86, PAR 12.2%), were II significantly related to acute: myocardial infarction (p<0.0001 for all risk factors and =0,03 for alcohol). The noted in men and women, old and young, and in all regions of the world. Collectively, these nine risk factors accounted for 90% of the PAR in men and 94% in women: ¢ associations were Interpretation Abnormal lipids, smoking, hypertension, diabetes, abdominal obesity, psychosocial factors, consumption of fruits, vegetables, and alcohol, and regular physical activity account for most of the risk of myocardial infarction worldwide in both sexes and at all ages in all regions. This finding suggested hat approaches to prevention can be based on similar principles worldwide and have the Potential to prevent most premature eases of inyocardial infarction. ire In a cohort study, a group of individuals q in exposed to a risk factor (study group) compared with « group of individuals " texposed to the risk factor (control group), Fevearcher follows both groups over time ang compares the occurrence of the problem ty he or she expects to be related to the risk fac © two groups to determine wheth -r proportion of those with the risk cted. in th prea are indeed af JA well known example of a cohort st is the Framingham Study of smokers nonsmokers that was conducted to determi the importance of smoking as a risk factor f developing lung cancer. A study may start with one large cohort. the cohort is selected, the researchers then determine who is exposed to the factor (e.g. smoking) and who is not, follow the two groups over time to determil whether the two groups develop lung can‘ IFit is not possible to select a cohort and dis it into a study group and a control group, cohorts may be chosen, one in which the factor is present (study group) and one i which it is absent (control group). In al oth respects the two groups should be as similar possible. The control group should be select at the same time as the study group and should be followed with the same intensity Example 1 Researchers were suspecting that banie were suffering from coronary heart di (CHD). Now they wanted to be sure abe the hypothesis that banking is a risk factor 7% heart discase, First they selected 100 ban and then 100 controls who were not bat matched on the basis of age and sex and risk factors. They followed this group ofP to sce how many got CHD. They found Out of 100 bankers 60 developed CHD 3% the control group, 30 developed CHD.iew over a number of years movement. Loss to fol because f pop, How up is tor may be basical lly differen, St than the compa a ison group, INTERVENTIONAL OR EXPERIMENTAL STUDIES In intervention studies, the manipulates a situation by his/her and measures the effec Usually (but not ak compared, one in takes place (c.g. treatment with a new d and another group that remains “unto (eg treatment with a standard drug), ‘There are two types of intervention studies: | five? . own d Experimental studies j sure : j ckat * Quasi-experimental studies rthe inga Experimental studies 4 Fees Experimental design is the only type of study ve design that can actually prove causation. In ). nirol_ allocated to at east two groups. One group sive subjected to an intervention or experimed case- while the other group(s) is not. The out sriate of the interver is measured by comp and the two groups. The experimental studi other also called Randomized controlled recall (RCT), : Pat The classical experimental study desig three characteristics; ‘than * Randomization: the researcher © care to randomly assign subjects cither control or experimen “Random” does not mean “at scientific process. Control: the researcher introduces | Scanned with CamScanner of more control group(s) t6 compare with the experimental group. + Manipulation: the researcher something differenvadditional group of subjects in the stud Schematic diagram of experimental study In a quasi-experimental study, at least one haracteristic of a true experiment is missing, her randomization or the use of a separate rol group. However, a quasi-experimental study always includes manipulation of an variable that serves as the does x anew see Most of the quasi-experimental studies uses ‘two (or more) groups, one of, which serves a control group in which no intervention takes place. Both groups are observed before as well as after the intervention, to test if the intervention has made any difference. The subjects in the two groups (study and control groups) have not been randomly assigned. Examples 1 Person-by-treatment designs are the most common type of a quasi experiment design. In this design, the experimenter ‘measures atleast one independent variable. Along with measuring one variable, the 3. @perimenter will also manipulate a different independent variable. Because ‘here is manipulating and measuring of different independent vatiables, the Tesearch is mostly done I nee £2 make sure that the experimenter has SunPlete control over the manipulations that are ing done to the study. An cxamy ple of this type of design was Reformed at the university of notre dame. ‘The study was conducted to see if beingee mation that will ) be used safely. fter the drug or |. These studies ug or treatment their effect in ny side effects sc. na set of rules | describes what ate in the trial; res, medications, ‘the study. While re scen regularly itor their health ind effectiveness ¢n_a clinical trial the randomized | groups must be ept the one being bility on factors influence on the face, Or severity , for these factors. viduals for factors 3 — Study designs Single blinding: When the person receiving treatment or intervention (subject) is unaware of the treatment group. Double blinding: When the — subject and person noting the outcome measure (researcher) are unaware of the treatment group. Triple blinding. When the subject, researcher and person doing analysis (statistician) are unaware of the treatment group. Classification of clinical trial falls into big groups: I. Controlled trials 1. Parallel or concurrent controls a. Randomized b. Not randomized 2. Sequential controls a. Self-control b. Crossover 3. External controls II. Studies with no controls Controlled trials are studies in which the experimental drug or procedure is compared with another drug or procedure as usually previously accepted or placebo treatment. Wis ccide ed ale. Lela a oases Scanned with CamScanner7 hat occur during the time period, divided by the total f population who were at the risk of same period of time. rate is a Tate computed over all ls in a given entire population, regardless of differences caused by a gender, race, etc. Rates that are computed within relatively small, well-defined subgroups are called specific rates. Mortality rate calculated for individual age groups are known as age-specific death rates; for individual sex groups mortality rate; for cause groups — caus specific mortality rate. The number of persons who develop a disease during the specified time period teed by the number of people who were at risk for the same period of time. mene and prevalence are the main used to oan, morbidity and are commonly many med uate the population health status in Y medical and epidemiological researches. case fans ie ave occurr ing the specified Who Eee divided by the number of people © at risk for the same period of time. with a gi _ i with a given disease ata given point in Vi peed by the population at risk for that t that time, time gi Uiscace Scanned with CamScannersoftwares. 24 ~~ / ras _cantrol and cohort studies can ee < se oeea% Cl, and 80% power of ‘ ¢ 2000 software. The sample of experimental studies can be 159% Cl and effect size by software available Raoso' Steps in hypothesis testing & ) Formulate a Hypothesis. Specify the level of significance. Select the appropriate statistical test. Compute the value of the statistical test. Compute the value of p. ee Accept or reject Hypothesis. Hypothesis testin: Null vs. Alternative hypothesis. Null hypothesis is any hypothesis which red with CamScannersSITYIO YIIEOSE1 AP ee ¢ ‘Apnas siprydds aodaysnp ays pue N au) Jo [eE s10190p 2t8 jou souls gouryoduut ut 09 pawusogtt Jo 3daou05 pue sseunyyntL ‘Aarusip 0} 3811 oy) oAeY Quened oy Supeen uosiod ay) pur) quoned oy, [—Aesid ‘yuauneen WY $393 OYM JO worsi9ap ayy pue ‘seommoser yIeoy 921eS jo uonNNqLsip stp suia9u0—eonsnf - wurey OU Op, ‘IsiTj[—eoueoTya[euuON] ‘yuaned oy) Jo ISo19IUT 4S9q OY UT goe pinoys rsuonnovsd y—eoues]youag sei Sr9quisin Jo squdad [voTIOIsIy pasvozout sey 39s ay, —Asouoy ‘JUDUNLID IBY} BsOOY) IO asnjor 02 14811 ay) sey qoned oY, [—Awouojny ‘OL G tore SUOISSNOSIp soya [eotpetu on Afdde Apuouro0s aevya sanpea sy3 JO XIS SOTYIO [LITpoul UT sonyeA “SONSST YOIVISAI Jeortype UO sisQueslos pure sAotpoue 1 Jo} uoVkonps sayo AyenunUOS Scanned with CamScanner—_. ber of te my ‘t and with of my 2 a my tions agues s of ics OF n my t for tion, Consent for mi Informed Consent is involving human subjects essential for research Informed consent should include: Description of the nature of the research SS. Statement that the research is voluntary and participants can withdraw at any time Identification of risks and benefits Description of how confidentiality will be ————EEE rotected Description of compensation at info researchers will Description of wh share with participants ation of who is responsible for teeny ‘with contact information ae research r edical rocedures stan curgery | Scanned with CamScanneral appraisal is the procedure of warily thodicall research nine its reliability. It is an orderly used to recognize the strong points tions of a research article in order © the worth and validity of research © most critical elements of a tisal are an assessment of the fhe study design for the rescarch 1 thorough review of the key investigating, ue thethods- cal elements of this design. Other issues th’ 59 should be judged include the appropris'« 1-8 of the statistical methods used and th equent explanation, possible conflicts of interest and the significance of the research to one’s own practice. 1. Isthe study question! pertinent? Does the study contribute to éxisting) 3. What type of SQHFEHYGaestion) is being asked? Ws che SPASBHTSRable for che tescarch question? 5 Did the Sources of bias? Were there 7, aa study vest a Hepes? deal with the major viations from the 5. Were che ISRCANEHIBEs carried out properly? 9. Do the dataljiglifehe eOnelusions? 10. Are there any cOiifliets OPimterest? Is the study’s research question pertinent? 0 The first query about any published research article is to determine its relevance to one’s own field of work/proposed research question. Despite using rigorous methodology, a study is of modest value if it does not focus on an important topic and adds to the existing body of literature on the subject. The assessment of whether the research question is relevant is inevitably based on subjective opinion, as what might be crucial to some will be irrelevant to. others. Nonetheless, the first question to ask of any research article is whether its topic is relevant to one’s own field of work Does the study contribute to existing knowledge? Scientific-research endeavor is often likened to ‘standing on the shoulders of giants’, because new ideas and knowledge are developed on the basis of previous work, Seminal research papers that make a substantive new contribution to knowledge are a relative. rarity, but research that makes an incremental advance can also be of value. 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