This document provides an overview of research methodology in medical research. It discusses what research is, types of research including conventional and unconventional, and the objectives of research. The basis of research methodology in medical research is explained, noting that medicine is inherently experimental. The steps in medical research are outlined, including identifying the problem, formulating research questions, study design and methodology, data collection and analysis. Common research study designs like case reports, case series, cohort studies, randomized clinical trials and meta-analyses are described.
In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.
Retrospective vs Prospective Study: Advantages, Types and Differences.
https://www.cognibrain.com/retrospective-vs-prospective-study-advantages-types-and-differences/
This is a simple and general presentation about the health research which is prepared to present within staffs of Naulo Ghumti Nepal especially for EIHS staffs, objective if this presentation is to orient staffs about research.
Study designs, Epidemiological study design, Types of studiesDr Lipilekha Patnaik
Study design, Epidemiological study designA study design is a specific plan or protocol
for conducting the study, which allows the investigator to translate the conceptual hypothesis into an operational one.
CRIS LUTHER's RESEARCH METHODOLOGIES COMPILATIONcrisluther
RESEARCH METHODOLOGIES
by Cris Luther, B.S.N.,R.N.
This material is a compilation of various information on generally acceptable knowledge, concepts, principles, theories and practices in RESEARCH. It adapts contents from various publicly acknowledged publications, authors, theorists, authorities and practitioners whose works are commonly utilized in the academe and practice, and are frequently-tested competencies locally and abroad.
The works of these authors, theorists, authorities and practitioners are indispensable in learning research methodologies as they are indispensable in the completeness of this compilation.
Care has been taken to confirm accuracy of the information presented and describes generally accepted practices. However the student who prepared this material is not responsible for errors or omissions or for any consequences from application of the information in this compilation.
The primary goal of the student is to familiarize concepts in the subject RESEARCH METHODOLOGIES based on the COURSE OUTLINE provided by his Graduate School Professor DR. HELEN B. AGGABAO. It is not intended for commercial publication and resources were acquired legally.
It is his great pleasure that this compilation be reproduced for reference of other students aiming to thoroughly understand RESEARCH METHODOLOGIES.
In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.
Retrospective vs Prospective Study: Advantages, Types and Differences.
https://www.cognibrain.com/retrospective-vs-prospective-study-advantages-types-and-differences/
This is a simple and general presentation about the health research which is prepared to present within staffs of Naulo Ghumti Nepal especially for EIHS staffs, objective if this presentation is to orient staffs about research.
Study designs, Epidemiological study design, Types of studiesDr Lipilekha Patnaik
Study design, Epidemiological study designA study design is a specific plan or protocol
for conducting the study, which allows the investigator to translate the conceptual hypothesis into an operational one.
CRIS LUTHER's RESEARCH METHODOLOGIES COMPILATIONcrisluther
RESEARCH METHODOLOGIES
by Cris Luther, B.S.N.,R.N.
This material is a compilation of various information on generally acceptable knowledge, concepts, principles, theories and practices in RESEARCH. It adapts contents from various publicly acknowledged publications, authors, theorists, authorities and practitioners whose works are commonly utilized in the academe and practice, and are frequently-tested competencies locally and abroad.
The works of these authors, theorists, authorities and practitioners are indispensable in learning research methodologies as they are indispensable in the completeness of this compilation.
Care has been taken to confirm accuracy of the information presented and describes generally accepted practices. However the student who prepared this material is not responsible for errors or omissions or for any consequences from application of the information in this compilation.
The primary goal of the student is to familiarize concepts in the subject RESEARCH METHODOLOGIES based on the COURSE OUTLINE provided by his Graduate School Professor DR. HELEN B. AGGABAO. It is not intended for commercial publication and resources were acquired legally.
It is his great pleasure that this compilation be reproduced for reference of other students aiming to thoroughly understand RESEARCH METHODOLOGIES.
Research Methodology_UNIT_I_General Research Methodology M. Pharm (IIIrd Sem.)Prachi Pandey
General Research Methodology: Research, objective, requirements, practical
difficulties, review of literature, study design, types of studies, strategies to eliminate
errors/bias, controls, randomization, crossover design, placebo, blinding techniques.
How to formulate a researchable question based on picos - PubricaPubrica
Unanswered questions in current clinical practice and interactions dictating alternate treatments will lead to the formulation of a clinical research question. It would help researchers by giving them step-by-step instructions about how to formulate a research question.
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Intended Learning Outcomes of this presentation are the following:
1. To enumerate methods that can be used to identify gaps in literature in perioperative nursing care in a culturally diverse healthcare;
2. To identify hierarchy of reseach designs and evaluate levels of evidence in nursing research; and
3. To appreciate the role of nursing research in producing evidences that support knowledge translation in perioperative nursing practice.
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Research design and methodology | Research design and methodology | Research ...Pubrica
A scientific approach in research refers to a systematic review and objective methodology employed to investigate phenomena, gather data, and derive conclusions. It involves the application of rigorous scientific research methods and principles to ensure the findings' validity, reliability, and replicability.
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RESEARCH METHODOLOGY
- INTRODUCTION
- OBJECTIVE
- TYPES OF RESEARCH
- RESEARCH PROCESS
- RESEARCH PROBLEM
- BROAD LITERATURE SURVEY
- HYPOTHESIS FORMULATION
- RESEARCH DESIGN
- SAMPLING
- COLLECTION OF DATA
- ANALYSIS OF DATA
- HYPOTHESIS TESTING
- PREPARATION OF REPORT
- CRITERIA OF GOOD RESEARCH
- PROBLEM ENCOUNTERED BY RESEARCHER IN INDIA
- REFERENCES
EVIDENCE –BASED PRACTICES 1
Evidence-Based Practices
Stephanie Petit-homme
Miami Regional University
Professor: Garcia Mercedes
07/05/2021
Evidence-Based Practices to Guide Clinical Practices
In other terms recognized as evidence-based medication, evidence-based scientific practice is elucidated as the careful, obvious, and judicious use of the best indication in creating results for the outstanding care of separate patients. It helps those who brand the choices to device best healthcare practices while drawing the roadmaps for the health system. In clinical trials, the integration of the EBCP entails clinical respiratory medicine considers two fundamental principles. For example, the principle is the hierarchy of the evidence and the art of clinical decision-making.
The interrelationship between the theory, research, and EBP
The relationship between the theory, research, and the EBP supports the three recognition programs. They still relate in terms of the magnet model component of modern knowledge, innovation, and advancement. They describe in a way in which they lead to the promotion of quality in a setting that makes supports professional practices. Second, there is the identification of excellence in giving nursing services to sick people or the people who stay around. For instance, the model, which is other terms the magnet theory, has got five components ( Reddy, 2018).
The first constituent includes transformational management; the additional is structural authorization. The third one is archetypal specialized practices, new information, invention, and upgrading. Lastly, in the model, there are the empirical quality outcomes. For the achievement of the aims of the goals that have been set, there is a need to make sure that the theory, current knowledge innovation, and the improvements and the components that are found in view all the nurses who are located in the levels of the healthcare company need to get involved.
The research has its primary purpose for the help of coming up with knowledge or the validation done for the knowledge that has always been there from before based on the theory. There is systematic, scientific questioning in the research to give the answers to some of the specific questions. It can use the test hypotheses and the rigorous method, the primary purpose of the study being for investigation knowing of the new things and the exploration. There is a need to understand the philosophy of science.
Second, on the EBP, there is no development of the new knowledge or even the learning being validated. The primary purpose of the EBP is to translate the evidence and then apply it to medical executive. It uses the indication available to brand patient-care choices. The EBP goes yonder the exploration as fine as the persevering penchants and ideals. The EBP retains into deliberation that the best indication is for the opinion leaders and the experts. Even though there is the existence of definitiv ...
Basic introduction to patient counselling for the clinical pharmacy services. Educating the patient on their disease, medication and lifestyle for better patient care and quicker recovery.
This slide contains in-dept knowledge about prescribing in geriatric patients. Steps how to overcome polypharmacy and how to increase medication adherence in geriatrics. It also tells about geriatrics care. Examples of case studies are also included.
A complete drug profile of Tacrolimus an immunosuppressant used for organ transplant. It consist of PK/PD, MOA, Indication & Uses, Contraindications, Warnings & Precautions, Drug-interaction, Doses & Administration, Dosage forms, Chemical Formula, Side-Effects, Adverse Drug Reactions, Therapeutic Drug Monitoring (TDM).
Role of PK PD in Antibiotic Stewardship Program with case study. This presentation gives an comprehensive overview about role of PK PD in antibiotic stewardship program.
This presentation describes about the cause, parthenogenesis, risk factors, clinical diagnosis, symptoms, complications and treatment of salpingitis (Hydrosalpinx). This presentation also consist a real case.
This is a real case of Breast Carcinoma. The presentation gives an overview of breast cancer topic with introduction, definition, causes, risk factors, genetic factor and treatment options.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
1. Research Methodology
In Medical Research
Dr Asish Kumar Saha
PharmD Intern
JSS Academy of Higher
Education & Research, Mysuru
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 1
3. Types of Research
❑Conventional research includes descriptive studies and analytical studies.
❑Unconventional research, which is gaining more importance nowadays,
includes operational research, evaluation of health systems, economic studies
(cost benefit, cost-effectiveness, etc.), qualitative research, and research
synthesis (reviews and meta-analysis)
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 3
4. What are the Objectives of Research?
The prime objectives of research are:
1. To discover new facts
2. To verify and test important facts
3. To analyze an event or process or phenomenon to identify the cause and effect
relationship
4. To develop new scientific tools, concepts and theories to solve and understand
scientific and nonscientific problems
5. To find solutions to scientific, nonscientific and social problems
6. To overcome or solve the problems occurring in our every day life
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 4
Laake, P., Benestad, H. and Olsen, B. (2018). Research Methodology in the Medical and Biological Sciences - 1st Edition. [online] Elsevier.com. Available at: https://www.elsevier.com/books/research-methodology-in-the-
medical-and-biological-sciences/laake/978-0-12-373874-5 [Accessed 1 Oct. 2018].
5. Basis of RM In Medical Research
Every patient is different in the way the disease manifests and also in the response to
treatment
❖An effective treatment for 90% of the population may not work for the other 10%.
Thus, medicine is said to be inherently experimental
❖Even the most widely accepted treatments need to be monitored and evaluated to
determine whether they are effective for specific patients or for patients in general.
❖This is one of the functions of medical research
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 5
6. Basis of RM In Medical Research
❑Even the best proven prophylactic, diagnostic, and therapeutic methods must
continuously be challenged through research for their efficacy, accessibility and quality
❑Another function is the development of new treatments, especially new
investigational drugs, medical devices and surgical techniques
❑In other words, the purpose of medical research involving human subjects is to
improve prophylactic, diagnostic and therapeutic procedures and understanding of the
etiology and pathogenesis of disease
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 6
7. Steps in Medical Research
1. Research
2. Identify the problem
3. Formulating a research question
4. Refining the research question: Literature review
5. Formulate hypotheses and research objectives
6. Decide the study population and setting
7. Decide on the study design & methodology
8. Writing the protocol
9. Collecting the data
10. Analyze the data and apply statistical significance
11. Write the report
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 7
Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
8. 1. Identify the problem
❑Interest and expertise:
❖The topic should be interesting to the investigator, funding
agency, and the medical community
❑Relevance and applicability:
❖Research should add new information to the scientific society
or expected result is likely to alter clinical decisions in future
❑Feasibility:
❖Should be feasible in terms of time, manpower and money
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 8
Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
9. 2. Formulating a research question
❑Research question is a formal statement of the goal of the study
❑Foremost among these is whether the question is interesting
❑It is important that the investigator is genuinely curious about the
question being investigated, so that he or she can remain motivated till
the successful completion of the study
❑Curiosity is also an asset in terms of stimulating questions for future
studies
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 9
Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
10. 2. Formulating a research question
❑Next is feasibility
❖The third consideration is the novelty factor, or
the potential of the study to contribute something
new to the knowledge base
❖Related to novelty is the relevance of the
research question.
❑It should add to existing knowledge, guide future
studies, or have implications for education, clinical
practice or health care policy.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 10
Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
11. 2. Formulating a research question
❑Finally, the idea must be ethical
❖Studies that invade people’s privacy or
create possible physical or psychological
risks are ethically unacceptable
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 11
Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
12. A good research question could thus be
described by the acronym
F: Feasible
I: Interesting to the investigator
N: Novel
E: Ethical
R: Relevant
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 12
Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala Lumpur: Institute for Health Systems Research.
13. An useful format to use in the development of
a specific research question is the PICO format
❑Format the population (P) of interest the intervention (I) being studied,
the comparison (C) group (the intervention being compared) and the
outcome of interest (O)
❑Often timing (T) is added to PICO, indicating the time frame in which the
study will be completed
❑In patients with pneumonia (P) whether treatment with X (I) compared
to Y (C) reduces the number of days of hospital stay (O)
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 13
14. 3. Refining the research question:
Literature review
Once the problem or question is specified, the next step is to collect as much
related information as possible
❑Literature review will help to determine
❑To what extent the issue or research question has been previously researched,
❑To identify the past relevant studies as well as methods used,
❑To refine the research question and
❑Also to put the project and methodology into A relevant context
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 14
Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala Lumpur: Institute for Health Systems Research.
15. 4. Formulate hypotheses and research
objectives
The research hypothesis is developed from the research question
❑For example, in the research study comparing treatment X versus treatment Y
in patients with pneumonia, the experimental group would be treatment X and
the control/ conventional group would be treatment Y
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 15
Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala Lumpur: Institute for Health Systems Research.
16. 4. Formulate hypotheses and research
objectives
❑The investigative team would first
state a research hypothesis.
❑This could be expressed as a single
outcome, e.g., treatment X leads to
improved functional outcome
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 16
Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala Lumpur: Institute for Health Systems Research.
17. 5. Decide the study population and
setting
The definition of the subject of study and the target population should be clearly spelt
out
❖The inclusion and exclusion criteria should be decided in the beginning itself
❖Sample size is very important
❖The smaller the sample, the more will be the uncertainty
❖Sample size should be chosen in such a way that the finding in the study accurately
reflects what is going on in the population
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
18. 5. Decide the study population and
setting
❑A well designed study, poorly analyzed, can be rescued by re analysis but a
❑Poorly designed study is beyond the redemption of even sophisticated
statistics
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
19. 5. Decide the study population and
setting
❑To get valid and reliable answer to the questions, appropriate research design
and method is a prerequisite
❖Study design is the frame work in which investigation is planned and carried
out
❖Selection of design is necessarily based on type of research question
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
20. 6. Research designs
Observational
Studies in which subjects are observed-includes:
❖Case study/case series
❖Case-Control
❖Cross Sectional
❖Cohort/Longitudinal
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
21. 6. Research designs
Experimental
Studies in which the effect of an intervention is observed
❖Controlled trials
❖Diagnostic Test
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
23. 1. Case Reports
2. Case Series
3. Analyses of Secular Trends
4. Case – Control Studies
5. Cohort Studies
6. Randomized Clinical Trials
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
24. Case Reports
• Are simply reports of events observed in single patients.
• Useful for raising hypotheses about drug effects. Leads to the drug test with more
rigorous study design.
• Very rare to use to make a statement of causation.
• Exception to this is when the outcome is very rare and so characteristic that one knows
that it is due to the exposure.
• Is accepted when challenge situation is very fatal.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
25. Case Series
• Collections of patients, all of whom have a single exposure, whose clinical outcomes are
then evaluated and described.
• Alternatively case series can be collection of patients with a single outcome, looking at
their antecedent exposure.
• Useful for quantifying the incidence of an adverse reaction or whether occurs in larger
population.
• Just provides clinical descriptions of a disease or of patients who receive an exposure.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
26. Analyses of Secular Trends
• Called as ecological studies.
• Examines trends in an exposure that is a presumed cause and trends in a disease that is a
presumed effect and test whether the trends coincide.
• Vital statistics and record linkage are often used in these studies.
• Useful for rapidly providing evidence for or against a hypothesis.
• Unable to control confounding variables. E.g. lung cancer might be the cause of cigarettes
but chance of occupational hazards can still not be ruled out
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
27. Case – Control Studies
• Compare cases with the disease to controls without the disease, looking for differences in
exposure.
• Multiple possible causes of a single disease can be studied.
• Helps in studying relatively rare disease requires smaller sample size.
• Informations are generally obtained retrospectively from the medical records, by interviews or
questionnaires.
• Limitations are validity of retrospective information and selection of control is challenging
task. Inappropriate control selection can lead to incorrect conclusion.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
28. Cohort Studies
• Identify subsets of a defined population and followed them over time, looking for differences
in their outcome.
• Used to compare exposed patients to unexposed patients, can also be used to compare one
exposure to another or when multiple outcomes from single exposure is to be studied.
• Either done prospectively or retrospectively.
• More reliable causal association.
• But requires large sample size (even for an uncommon outcome) and can require prolonged
time period to study delayed outcomes.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
29. Differences between Cohort study and
Case – Control study
Case – Control Studies
Disease
Cohort
studies
Factor
Present
(Cases)
Absent
(Controls)
Present
(Exposed)
Absent
(Unexposed)
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical
research handbook. Kuala Lumpur: Institute for Health
Systems Research.
30. Randomized Clinical Trials
• An experimental study – the investigator controls the therapy that is to be received by
each participant.
• Major strength is the randomization.
• Problems might include the ethical issues and are expensive. They are not of big
importance after marketing.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
31. Meta-Analysis Studies
DEFINITION
Meta-analysis has been defined as the statistical analysis of a collection of analytical results for the
purpose of integrating the findings
USE OF META-ANALYSIS ?
Identify sources of variation among study findings
To provide an overall measure of effect as a summary of those findings
Meta-analysis is most often used to assess the clinical effectiveness of healthcare interventions;
it does this by combining data from two or more randomized control trials.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
32. Meta-Analysis Studies
Meta-analysis of trials provides a precise estimate of treatment effect, giving due
weight to the size of the different studies included.
Important: Studies chosen for inclusion in a meta-analysis must be sufficiently
similar in a number of characteristics in order to accurately combine their results.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
33. Where does meta analyses fit in the
research process ?
❑The graphical elements of the meta-analysis, such as the forest plot, provide a mechanism for
presenting the data clearly, and for capturing the attention of the reviewers.
❑Some funding agencies now require a meta-analysis of existing research as part of the grant
application to fund new research.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
34. Evidence Based Medicine
EBM is an approach to medical practice that uses the results
of patient care research and other available objective
evidence as a component of clinical decision making.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
36. Need for Evidence based medicine
1) Daunting number of diseases.
2) Availability of broad number of therapeutic options
3) To Keep ourselves updated in the field of expertise.
4) Addition in number of information sources.
5) To remain competent throughout the careers.
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
37. 7. Writing the protocol
❑All the efforts put into preceding steps culminates into the draft of the
research protocol that incorporates all the information regarding the research in
a concise manner
❑The protocol should contain background information on the study, objectives,
ethical aspects, study design, study procedures, method of assessment, statistics
and evaluation, administrative issues and references
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
38. 7. Writing the protocol
❑Once the protocol is ready, approval from the Ethics committee
should be obtained before the start of the study
❑Along with the protocol, the informed consent form and other
documents required should also be submitted to Ethics committee
for approval
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
39. 8. Collecting the data
❑Once the protocol is finalized, the data should be collected
❑The data forms should be legibly filled, and they should be fully completed
❑Ethical issues must be taken care of from the beginning to the end of study
❑In drug trials care must be taken to document the details of adverse events if any
❑Proper documentation through out the study is important to ensure credibility of
data
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
40. 9. Analyze the data and apply statistical
significance
❑The data should be scrutinized for internal consistency and external
validity
❖Data should be analyzed using the already decided data
management plan
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
41. 10. Write the report
❑The report should be sufficiently detailed that can remove any doubt a reader
might have about any aspect of the results
❑It should be properly worded, should be adequately illustrated by charts or
diagrams or tables which enhance the clarity
❑All the limitations need to be described openly
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Singh, A., Bakar, A. and Sararaks, S. (2008). The medical research handbook. Kuala
Lumpur: Institute for Health Systems Research.
44. The Basics of Ethics in Research
Dishonest, fraudulent, or unethical researchers can circumvent the
scientific method
Notable examples:
1. Nazi Germany Experimentation
- Charges brought against 23 German physicians in the Nuremberg
War Crime Trials for their medical experiments – included:
1. Freezing Experiments
2. Malaria Experiments
3. High-Altitude Experiments
- Led to the development of
Nuremberg Code
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45. The Basics of Ethics in Research
2. The Tuskegee Syphilis Study
Was investigation of long-term effects of untreated
syphilis on AA males in Macon County,AL
Decision was made to do long-term prospective study
and follow long-term effects until death
Participants were never told real nature of study – were
not afforded informed consent
Treatment for syphilis was withheld (even after
discovery of penicillin to treat syphilis) – study
continued for 40 yrs.
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46. Regulation of research and protection of
research participants:
Proponents of situational ethics argue that no general rules can be
applied to all situations – each action is unique
Belmont report – serves as a fundamental document for current
federal regulations for protection of human subjects – 3 principle:
1. Respect for Persons
2. Beneficence
3. Justice
*Code requires that protocols involving human subjects be reviewed by an IRB.
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47. Informed Consent
Inherent to this principle are 4 elements:
1. Subjects are made fully aware of the nature and purpose of the research project
2. Consent is voluntarily given
3. The person involved has the legal capacity to give consent
4. The responsibility for obtaining consent rests with the researcher
* Sometimes, because of the Hawthorne Effect, it may be necessary to use some deception in
telling subjects about the study.
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48. Privacy and Confidentiality
Privacy refers to capacity of individuals to control when and what conditions
others have access to their behaviors, beliefs, and values.
Confidentiality refers to linking information to a person’s identity
◦ CAN YOU THINK OF EXAMPLES WHERE CONFIDENTIALITY WOULD BE IMPOTANT?
Informed consent should indicate how researcher will protect confidentiality of
participants
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49. Privacy and Confidentiality
Some procedures that can ensure confidentiality:
◦ Obtaining anonymous information
◦ Code data so that identifying info is eliminated
◦ Substitute other names
◦ Do not release or report individual data
◦ Limit access that could reveal individual identity
◦ Report data only in group form
◦ Used computerized methods for encrypting data
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50. Six Areas of Scientific Dishonesty
1. Plagiarism—using the ideas, writings, and drawings of others as your
own
2. Fabrication and falsification—making up or altering data
3. Nonpublication of data , also called “cooking data”
4. Faulty data-gathering procedures
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51. Six Areas of Scientific Dishonesty
5. Poor data storage and retention
6. Misleading authorship—who should be an author?
➢Technicians do not necessarily become joint authors.
➢Authorship should involve only those who contribute directly.
➢Discuss authorship before the project!
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52. CONSTITUTION OF IRB
The IRB should consist at least SEVEN members, who collectively have the qualifications and experience to
review and evaluate the science, medical aspects, and ethics of the proposed trial. viz.
1. Chairperson – Appointed (who is from outside the institution)
2. 1-2 basic medical scientists (i.e. Clinical Pharmacologist)
3. 1-2 clinicians from same institute
4. One legal expert
5. One social scientist
6. One philosopher or ethicist
7. One lay person from community
8. Member secretary – Appointed
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Drugs & Cosmetic Act 1940, Schedule Y
53. QUORUM OF IRB
For reviewing and making decision on each protocol the quorum of
IRB should be at least FIVE members with the following
representations:
1. Basic medical scientists (preferably one pharmacologist)
2. Clinicians
3. Legal expert
4. Social scientist / Representative of non-governmental voluntary
agency / Philosopher / Ethicist / Theologian or a similar person
5. Lay person from the community
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Drugs & Cosmetic Act 1940, Schedule Y
54. QUORUM OF IRB
In any case, the IRB must include
1. At least one member whose primary area of interest / specialization is
nonscientific
2. At least one member who is independent of the institution / trial site
3. Besides, there should be appropriate gender representation on the IRB
4. If required, subject experts may be invited to offer their views
5. Further, based on the requirement of research area, e.g. AIDS, genetic
disorders etc. Specific patient groups may also be represented in the
IRB
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 54
Drugs & Cosmetic Act 1940, Schedule Y
55. Conclusion
➢Research is a scientific method used to collect and analyse information to
increase our understanding or solve issue on particular field.
➢The research topic should be Feasible, Interesting, Novel, Ethical and Relevant.
➢The ethical consideration should be taken care of conducting the research.
➢The research result should not be biased, both the negative and positive results
should be reported/published.
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