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📚 Research Methodology & Article Writing - Easy Notes

(Based on CPSP Research Evaluation Unit Reading Material)

📌 CHAPTER 1: Introduction to Research

Research = A systematic, scientific process of collecting, analyzing, and interpreting data to find solutions to a problem.

Types of Research

TypeWhat it doesExample
QuantitativeCollects measurable data using closed-ended questions; uses statisticsSurvey asking "Rate your pain 1-10"
QualitativeExplores the why behind things through interviews, focus groupsAsking doctors "Why do patients skip follow-ups?"
Mixed MethodsCombines bothStudy using a survey + in-depth patient interviews

Key Terms

  • Research Objective - What the researcher clearly intends to find out. (e.g., "To determine the prevalence of diabetes in adults aged 40-60 in Karachi")
  • Rationale - Why this study? What gap does it fill? What was wrong or missing in previous studies?
  • Operational Definition - Exactly how you will measure your variables. (e.g., "Hypertension = BP ≥140/90 on two separate readings")
  • Literature Search - Systematically searching journals, conference papers, and databases to understand what's already known before starting your research.

📌 CHAPTER 2: Types of Study Designs

Think of study designs as your "plan of attack" for answering a research question.

1. Descriptive Studies (Describe what's happening - no hypothesis)

DesignDescriptionExample
Case Report1 unusual/rare caseA single patient with a never-seen-before drug reaction
Case SeriesSeveral similar unusual cases5 patients who all developed the same rare syndrome
Cross-SectionalSnapshot of a population at one point in time (= prevalence study)Survey 1,000 people today to check who has obesity
Clinical AuditReviews current practice against set standards to improve careChecking if 95% of heart attack patients received aspirin within 1 hour
LongitudinalFollows the same people over yearsTracking 500 children from birth to age 18

2. Analytical Studies (Test a hypothesis - always have 2+ groups)

Observational (researcher watches, doesn't intervene)

DesignDirectionExample
Cohort (Prospective)Exposure → follow forward → OutcomeFollow smokers & non-smokers for 20 years to see who gets lung cancer
Cohort (Retrospective)Look backward using old recordsUse hospital records: who was exposed to asbestos, did they get mesothelioma?
Case-ControlStart from Outcome → look back at ExposureTake 100 lung cancer patients (cases) + 100 healthy people (controls) → compare their smoking history
Memory trick: Cohort = forward in time (cause → effect). Case-Control = backward (effect → cause).

Experimental (researcher assigns exposure)

DesignDescriptionExample
RCTRandomly assign participants to treatment or control groupRandomly give half the patients Drug A, half a placebo; see who gets better
Non-randomized (Quasi-experimental)Participants choose or are assigned without random chancePatients who volunteer for a new diet program vs. those who don't
Preventive TrialTest ways to prevent diseaseTesting a new vaccine on healthy people
Therapeutic TrialTest new treatments for existing diseaseTesting a new chemo drug on cancer patients

Blinding Types

TypeWho is Blind?
Single-blindParticipant only
Double-blindParticipant + Researcher
Triple-blindParticipant + Researcher + Data Analyst
Why blind? To prevent bias in results. (e.g., if you know you're getting the real drug, your pain might "feel better" due to psychology - the placebo effect)
Placebo = An inactive substance (like a sugar pill) given to the control group so they don't know they're not getting the real treatment.

📌 CHAPTER 3: Sampling

What is a Sample?

A sample is a smaller group taken from the full population. We study the sample to make conclusions about the whole population.
Example: Instead of testing all 200 million Pakistanis, you test 400 people representing the whole country.

Sampling Techniques

1. Probability Sampling (everyone has an equal chance - statistically valid)

TechniqueHow it worksExample
Simple RandomUse a lottery or random number tableDraw 100 names from a list of 1,000 patients
SystematicPick every K-th person (K = population ÷ sample size)If K=10, pick patient #10, #20, #30...
StratifiedDivide into groups (strata), then randomly sample each50 men + 50 women, or by age group
ClusterDivide area into clusters; randomly pick clustersRandomly select 5 hospitals out of 20, then study all patients in those 5

2. Non-Probability Sampling (not statistically ideal, but practical)

TechniqueHow it worksExample
ConvenienceTake whoever is easily availableSurvey patients waiting in your clinic today
ConsecutiveTake every patient meeting criteria over a set time - best non-probability methodEnroll every diabetic patient admitted in 6 months
SnowballExisting participants recruit othersRecruit drug users; each refers others in their network
PurposiveSelect specific targets based on knowledgeInterview only senior surgeons about a rare procedure

📌 CHAPTER 4: Variables, Data & Presentation

Variables

  • Dependent Variable = The OUTCOME you're measuring. (e.g., blood sugar level, death, recovery)
  • Independent Variable = The CAUSE or EXPOSURE you think influences the outcome. (e.g., diet, smoking, drug type)
Example: Studying if smoking causes lung cancer → Smoking = independent variable; Lung cancer = dependent variable.

Types of Data

DATA
├── QUALITATIVE (categories)
│   ├── Nominal - No order (e.g., blood group: A, B, O, AB; gender: M/F)
│   └── Ordinal - Has order but no fixed distance (e.g., cancer stage I, II, III, IV; pain scale: mild/moderate/severe)
│
└── QUANTITATIVE (numbers)
    ├── Discrete - Whole numbers only (e.g., number of children: 0, 1, 2, 3)
    └── Continuous - Any value, including decimals (e.g., weight: 65.4 kg, height: 170.2 cm)

How to Present Data

Data TypeBest Presentation
Qualitative (categories)Frequency table, Pie chart, Bar chart
Quantitative (numbers)Histogram (like bar chart but no gaps between bars)
Pie chart example: 60% of patients are male, 40% female - shown as slices of a circle. Histogram example: Distribution of patient ages - shows if data is normally distributed.

📌 CHAPTER 5: Summarization of Data

Measures of Central Tendency (Where is the "middle"?)

MeasureDefinitionExample (data: 2, 3, 3, 5, 7)
MeanSum ÷ number of values(2+3+3+5+7) ÷ 5 = 4
MedianMiddle value after sortingSorted: 2,3,3,5,7 → 3
ModeMost frequent value3 (appears twice)

Measures of Variation (How spread out is the data?)

MeasureDefinitionExample
RangeLargest - Smallest7 - 2 = 5
Variance (S²)Average of squared deviations from meanTells how much values vary
Standard Deviation (SD)Square root of varianceIf mean height = 170 cm, SD = 5 means most people are between 165-175 cm
Key insight: Small SD = data points are close together. Large SD = data is spread widely.

Standard Error & Confidence Interval

  • Sampling Variation - Every sample you take will give slightly different results - this is natural.
  • Standard Error (SE) - Estimates how much your sample mean might differ from the true population mean.
  • Confidence Interval (CI) - A range within which the true value likely falls.
Example: "The mean blood pressure is 130 mmHg (95% CI: 125-135)" means you are 95% sure the true population mean is between 125-135 mmHg.
Normal Distribution (Bell Curve) - Most values cluster around the mean, with fewer values at the extremes (tails).

📌 CHAPTER 6: Estimation & Hypothesis Testing

Hypothesis

  • Null Hypothesis (H₀) = "There is NO difference/relationship." (e.g., "Drug A and Drug B have the same effect")
  • Alternate Hypothesis (H₁) = "There IS a difference/relationship." (e.g., "Drug A is better than Drug B")

P-Value

  • P-value = Probability that your result occurred by chance if H₀ were true.
  • If p ≤ 0.05 → Result is statistically significant → Reject H₀ (accept H₁)
  • If p > 0.05 → Do NOT reject H₀
Example: p = 0.02 means there's only a 2% chance your result was due to chance - so your finding is likely real!

Errors in Hypothesis Testing

ErrorWhat HappenedExample
Type I (Alpha error)You said there's a difference, but there isn'tYou conclude Drug A is better - but it's not
Type II (Beta error)You said there's no difference, but there isYou conclude drugs are equal - but Drug A is actually better
  • Power = Probability of correctly detecting a real difference = 1 - Beta. Higher power = better study.

📌 CHAPTER 7: Measures of Disease Frequency

Prevalence vs. Incidence

MeasureWhat it countsFormulaExample
Point PrevalenceExisting cases at one point in timeCurrent cases ÷ Total population at that timeOn Jan 1, 50 out of 1,000 people have TB = 5%
Period PrevalenceCases over a time periodCases during period ÷ Average populationTB cases during all of 2024
IncidenceNEW cases developing in a time periodNew cases ÷ Population at risk20 new TB cases per 1,000 people per year
Memory trick: Prevalence = existing (like a photograph). Incidence = new (like a video recording new events).

📌 CHAPTER 8: Measures of Association

Correlation Coefficient (r)

  • Measures the relationship between two variables
  • Ranges from -1 to +1
  • +1 = perfect positive correlation (both go up together)
  • -1 = perfect negative correlation (one goes up, other goes down)
  • 0 = no relationship

Relative Risk (RR) - Used in Cohort Studies

RR = Incidence in Exposed ÷ Incidence in Unexposed
RR ValueMeaning
RR = 1No association
RR > 1Exposure increases risk
RR < 1Exposure is protective
Example: Smokers develop lung cancer at 15%, non-smokers at 1% → RR = 15/1 = 15 (smokers are 15x more likely to get lung cancer)

Odds Ratio (OR) - Used in Case-Control Studies

OR = (a × d) ÷ (b × c) using a 2×2 table
  • Used when you cannot calculate incidence (because you started with diseased people)
  • Interpretation same as RR: OR > 1 = increased risk

📌 CHAPTER 9: Bias, Confounding & Effect Modification

Bias = Systematic error that distorts your results

TypeWhat it isExample
Selection BiasWrong people enrolledStudying hospital patients to draw conclusions about the general population
Recall BiasPeople remember past exposures differentlyCancer patients remember smoking more clearly than healthy people
Interviewer BiasInterviewer's manner influences answersInterviewer nods when patient says "yes" to symptoms
Lost to Follow-up BiasPatients drop out before study endsSicker patients drop out, making drug look better than it is
How to control bias: Blinding, standardized data collection tools, proper questionnaires, careful choice of study population.

Confounding

A confounder is a third variable that is linked to both the exposure and the outcome, distorting the apparent relationship.
Classic Example: Studies find coffee drinkers get more lung cancer. But coffee drinkers also tend to smoke more. Smoking is the confounder - not the coffee!
Control confounding by:
  • At design stage: Restriction, Matching, Randomization
  • At analysis stage: Stratification, Multivariate Analysis

Effect Modifier

A variable that changes the strength of the relationship between exposure and outcome in different subgroups.
Example: A drug works well in women but not men - gender is an effect modifier.

📌 CHAPTER 10: Sample Size Calculation

Sample size = how many participants you need for your study to be valid and reliable.

What you need to calculate sample size:

Descriptive StudiesAnalytical Studies
Prevalence/mean±SD from previous studiesOutcome magnitude for BOTH groups
Level of significanceLevel of significance
Margin of error (d)Power of the test

Key Terms

  • Significance Level = Risk of a false positive (usually 5% = 0.05)
  • Margin of Error (d) = How much deviation from the true prevalence you can tolerate (e.g., ±5%)
  • Power = Ability to detect a real difference (usually 80-95%). More power = larger sample needed.

📌 CHAPTER 11: Screening Tests

The 2×2 Table

                 Disease +     Disease -
Test Positive  |    a (TP)   |    b (FP)  |
Test Negative  |    c (FN)   |    d (TN)  |
MeasureFormulaMeaning
Sensitivitya ÷ (a+c) × 100How good is the test at finding sick people? (True positive rate)
Specificityd ÷ (b+d) × 100How good is the test at clearing healthy people? (True negative rate)
PPVa ÷ (a+b) × 100If test is positive, what's the chance the person actually has the disease?
NPVd ÷ (c+d) × 100If test is negative, what's the chance the person is truly disease-free?
Example: HIV ELISA has high sensitivity (>99%) - catches almost all HIV+ people. Confirmatory Western Blot has high specificity - rules out false positives.
Memory trick: SN-out (Sensitive test, if Negative → rules OUT disease). SP-in (Specific test, if Positive → rules IN disease).

📌 CHAPTER 12: Questionnaire Development

Types of Questions

TypeDescriptionExample
Closed-endedPre-set answer choices; used in quantitative research"Do you smoke? Yes / No"
Open-endedFree-text answers; used in qualitative research"Describe your pain experience"

Likert Scale

Used to measure abstract concepts like quality of life, satisfaction, or attitudes.
Example: "The doctor explained my condition clearly." Strongly Agree | Agree | Neutral | Disagree | Strongly Disagree

📌 CHAPTER 13: Bioethics

The 4 Core Principles

PrincipleMeaningExample
AutonomyRespect patient's right to decidePatient refuses surgery - you must respect that
BeneficenceDo good for the patientGiving pain relief to a suffering patient
Non-maleficenceDo no harmAvoiding unnecessary surgery
JusticeFairness in resource distributionEqual ICU access during a pandemic

Ethical Considerations in Research

  • Informed Consent - Participants must know the purpose, risks, and benefits before agreeing
  • No Plagiarism - Give credit, cite sources properly
  • Conflict of Interest - Disclose any financial or personal ties to the research
  • Data Confidentiality - Keep participant data secure
  • Animal Welfare - Follow ethical guidelines when using animals

Consequences of Unethical Research

  • Retraction of published papers
  • Loss of credibility and public trust
  • Legal action and professional penalties
  • Inability to replicate findings

📌 CHAPTER 14: Publishing Original Research

IMRaD Structure (The Standard Format)

SectionWhat to Include
IntroductionBackground, rationale, research objective
MethodsStudy design, ethics approval, population, data collection, analysis plan
ResultsPresent findings using tables and figures
and DiscussionInterpret results, compare with past studies, state limitations
+ ConclusionSummary and implications

Key Qualities of a Good Research Article

  • Novelty - New findings, not published before
  • Scientific Rigor - Clear hypothesis, valid methods
  • Ethical Approval - Mandatory for human/animal studies (ERC/IRB)
  • Reproducibility - Methods described in enough detail for others to replicate

Reporting Guidelines by Study Design

Study TypeGuideline
RCTCONSORT
Cohort/Case-Control/Cross-sectionalSTROBE
Systematic Review/Meta-analysisPRISMA
Qualitative studiesCOREQ
Diagnostic accuracySTARD
Case reportsCARE
Animal studiesARRIVE

Publishing Process (Step-by-Step)

  1. Develop a clear research question
  2. Get Ethics Committee (ERC/IRB) approval
  3. Register the trial (if it's a clinical trial)
  4. Follow the relevant guideline (CONSORT, STROBE, etc.)
  5. Get synopsis approved by REU (CPSP)
  6. Conduct the study
  7. Write with clarity and scientific integrity
  8. Submit to a peer-reviewed, indexed journal (as per HEC/CPSP criteria)

🧠 Quick Summary Table

ChapterCore ConceptOne-line Memory Aid
1Research typesQuant = numbers; Qual = why; Mixed = both
2Study designsDescriptive = describe; Analytical = test; Experimental = intervene
3SamplingProbability = equal chance; Non-probability = convenient
4Variables & dataDependent = outcome; Independent = cause
5Data summaryMean/Median/Mode = center; SD = spread
6Hypothesis testingp < 0.05 = significant; Type I = false alarm; Type II = missed call
7Disease frequencyPrevalence = existing; Incidence = new
8AssociationRR for cohort; OR for case-control
9Bias & confoundingBias = error; Confounder = hidden 3rd variable
10Sample sizeNeed significance level + power + expected prevalence
11ScreeningSensitivity = find sick; Specificity = clear healthy
12QuestionnaireClosed = quantitative; Open = qualitative; Likert = scale
13BioethicsAutonomy, Beneficence, Non-maleficence, Justice
14Article writingIMRaD format + right reporting guideline
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