This document provides an overview of research methodology. It discusses different types of health research including biomedical, clinical, epidemiological, and health systems research. It also covers research design approaches such as exploratory studies, descriptive studies including case studies and surveys, analytical studies including case-control studies, and experimental designs like randomized controlled trials. Key aspects of the research process are explained such as developing objectives, variables, hypotheses, literature reviews, and ethical considerations. Criteria for selecting good research topics and writing references are also presented.
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.
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.
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.
Cross over design, Placebo and blinding techniques Dinesh Gangoda
A crossover design is a modified randomized block design in which each block receives more than one treatment at different dosing periods.
A block can be a patient or a group of patients.
Patients in each block receive different sequences of treatments.
A crossover design is called a complete crossover design if each sequence contains all treatments under investigation.
A placebo is a dummy medicine containing no active substance.
This substance has no therapeutic effect, used as a control in testing new drugs.
Latin- ‘ I shall please’
Freshers in clinical research and regulatory affairs must go through this presentation. It will help you to understand the basis of clinical trial design as per European guidelines, which is the most preferred reference guideline. Initially, I also faced many problems to understand this concept. A student who is studying a clinical research diploma can also use this presentation for their basic understanding.
Randomization is the process by which allocation of subjects to treatment groups is done by chance, without the ability to predict who is in what group. It is done in clinical trials. This presentation describes the methods of randmization used in clinical trials.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
Medical Research: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
-Research
Research is an art of scientific investigation.
It is regarded as a systematic efforts to gain new knowledge.
The dictionary meaning of research is “a careful investigation or enquiry especially through search for new facts in any branch of knowledge”.
-Nature of Research
-Objectives of Research
-Types of Research
-Research Process
-Significance of Research
-Criteria for Good Research
-Limitations of Research
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.
Cross over design, Placebo and blinding techniques Dinesh Gangoda
A crossover design is a modified randomized block design in which each block receives more than one treatment at different dosing periods.
A block can be a patient or a group of patients.
Patients in each block receive different sequences of treatments.
A crossover design is called a complete crossover design if each sequence contains all treatments under investigation.
A placebo is a dummy medicine containing no active substance.
This substance has no therapeutic effect, used as a control in testing new drugs.
Latin- ‘ I shall please’
Freshers in clinical research and regulatory affairs must go through this presentation. It will help you to understand the basis of clinical trial design as per European guidelines, which is the most preferred reference guideline. Initially, I also faced many problems to understand this concept. A student who is studying a clinical research diploma can also use this presentation for their basic understanding.
Randomization is the process by which allocation of subjects to treatment groups is done by chance, without the ability to predict who is in what group. It is done in clinical trials. This presentation describes the methods of randmization used in clinical trials.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
Medical Research: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
-Research
Research is an art of scientific investigation.
It is regarded as a systematic efforts to gain new knowledge.
The dictionary meaning of research is “a careful investigation or enquiry especially through search for new facts in any branch of knowledge”.
-Nature of Research
-Objectives of Research
-Types of Research
-Research Process
-Significance of Research
-Criteria for Good Research
-Limitations of Research
For this assignment you willwrite a paper using TOPIC 1 QUANTITAT.docxtemplestewart19
For this assignment you willwrite a paper using TOPIC 1: QUANTITATIVERESEARCH &TOPIC 2:QUALITATIVE RESEARCH. Do not worry about the word count as this is not part of the grading criteria for this assignment. Below is a template of how the paper should be setup. This paper will be in APA format. In the template below I am providing a sample of the headers that should be used in APA format to organize your paper. I would highly recommend using them in your paper.
The introduction should introduce the paper. The intro would also include your thesis statement. The thesis tells the reader what will be discussed in the rest of the paper. This section should be in first paragraphs.
PICOT Statement
Revise the PICOT statement you wrote - PICOT Statements: (1). Changes in leisure time physical activity preference and development of hypertension were significantly correlated, especially among urban Chinese. Hypertension prevention programs may identify the groups at elevated risk by examining levels and changes of LTPA preferences. (2). Hypertension is a major health concern that leads to many complications besides the heart attack, heart failure and other related issues. Therefore, this study will help in studying the Systolic Blood Pressure Intervention Trial (SPRINT) so as to arrive at the solutions. The study will aim at answering the question, how to treat to lower systolic blood pressure. (3). There are several reasons that contributed to non-adherence to treatment in hypertensive patients. Diversity of these reasons is an indication that design and implementation of different kinds of interventions are required in order to increase the patients' awareness, empower them and encourage self-efficacy.” Based on these provide justification of the problem and supporting evidence from multiple resources to justify why this is a problem. This section should be 1-2 paragraphs.
Research Critiques
Use the research critiques to complete this assignment that has both qualitative and quantitative.
Qualitative Studies
Background of the study. Answer the following questions in narrative form regarding the qualitative studies in this section.
· Identify the clinical problem and research problem that led to the study. What was not known about the clinical problem that, if understood, could be used to improve health care delivery or patient outcomes? This gap in knowledge is the research problem.
· How did the author establish the significance of the study? In other words, why should the reader care about this study? Look for statements about human suffering, costs of treatment, or the number of people affected by the clinical problem.
· Identify the purpose of the study. An author may clearly state the purpose of the study or may describe the purpose as the study goals, objectives, or aims.
· List research questions that the study was designed to answer. If the author does not explicitly provide the questions, attempt to infer the questions from the answers.
.
RESEARCH METHODOLOGY FOR UNDERGRADUATES.pptxROBIN VAVACHAN
Embarking on the journey of research as undergraduates is both exciting and challenging. This presentation introduces the fundamental principles of research methodology, offering a roadmap for undergraduates to navigate the complexities of academic inquiry.
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
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.
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.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
2. Research
Research is “the systematic collection,
analysis and interpretation of data to
answer a certain question or to solve
a problem”
3. Purposes of Research
Research serves two Purposes :1- Generates new knowledge and
technologies to deal with major
health problems“ basic research”
2- Identifies priority problems ,
evaluates polices and programs
“applied research”
4. The importance of Research
Why do we carry out research ?
It is generally recognized that there
is a wide gap between data available,
and data needed for management ,
planning and decision making, so
research is needed to bridge this gap
6. Classification of health research
Bio medial research
Clinical research
Epidemiological research
Health system research
7. Bio medical research-1
Bio Medical research focuses on the
individual
It concentrates on how the body
works i.e. Biological process , body
structure and functions , and the
pathological mechanisms occurring
within the body
8. Clinical research
Clinical research focuses on the
individual. It deals with the response
of the body to various preventive ,
diagnostic or therapeutic interventions
Example: The efficacy of long acting penicillin
on tuberculous patients
9. :-Epidemiological research
Epidemiological research focuses on
the population , and considers the
frequency , distribution and
determinants of diseases
Example:Epidemiology of malaria in Khartoum
state
Pattern of health problems in under
five children in Omdorman area .
10. .( Health system research (H.S.R
Health system research focuses on
how well is the health system
functioning , such as cost and quality
of health services etc
Health system research aims to
provide information which improve
the health system.
11. Types of Health system research
Operational research
Health policy research
12. Operational research
Operational research is the process
of identifying and solving health
program problems. It is designed to
improve effectiveness and quality of
health services delivered by health
providers , and the availability ,
accessibility and acceptability of
health services delivered .
14. CRITERIA OF
A RESEARCH TOPIC
Percived discrepancy between what is-1
existing and what is expected
A question why this discrepancy- 2
exists
More than one answer to the question- 3
is expected
15. CRITERIA FOR SELECTION
A RESEARCH TOPIC
The problem selected for the research
should fulfill the following criteria:
1. RELIVANCE:-THE PROBLEM SHOULD BE
AN IMPORTANT HEALTH PROBLEM.
2. APPLICABLE:THE PROBLEM SHOULD
HAVE SOME CHANCE OF BEING SOLVED.
3. FEASIBILITY: THE RESEARCH SHOULD
BE FEASIBLE WITHIN THE AVAILABLE
RESOURCES.
16. CRITERIA FOR SELECTION
A RESEARCH TOPIC
4-Political acceptability
The ultimate goal of a research is to
provide decision – makers and
managers with results , so it is
advisable to choose a topic that has
the interest and support of the
authorities . This will increase the
chance for recommendations to be
implemented .
17. :URGENCY-5
Urgency of results needed
According to the urgency needed
for data , the researcher should
decide what research to be done
.first and which can be done later
18. Ethical acceptability-6
Ethical issues should be considered
when we are trying to choose a
research topic, for we may do harm
on others when we are carrying out
research. Acceptance of research by
the study subjects is important and
taking consents from them is always
.important
19. Avoidance of duplication- 7
Before you decide to conduct a research,
you should find out whether the suggested
topic was investigated before in this area or
another area with similar conditions. If the
topic has been investigated the results
should be reviewed to explore whether
major questions need further investigations,
if not this topic is not suitable for research
and should be discarded.
THE RESEARCH SHOULD BE COST/EFFECTIVE
22. :Definition of the problem
Once the researcher has decided on the
problem of the research, then he needs to
have a definition/description of the problem
written in a concise clear manner. It should contain
information such as:
Background information concerning the health
status of the community.
Basic description of the problem.
Justification.
Mention previous studies
25. Objectives
The goals to be achieved by the
. research project
Why should the Objectives be
? developed
Focus the study (Narrow it down to-1
( essentials
Avoid collection of unnecessary data- 2
Organize the study in clearly defined- 3
parts
26. :Types
General: Identifies in general terms, what is to
be accomplished by the research
project.
Specific: Identifies in details the specific aims of
the research project
27. Example
:General
To study the reasons for low utilization of
MCH Services in Khartoum State –
2006
:Note
Gen. Objective is clearly related to the
.statement of the problem
28. : -Specific
-To determine the level of utilization
of MCH Services in Khartoum State
-To identify whether there are
variations in Utilization of MCH
Services and
- Seasons
- Type of clinics
29. Types of specific objectives
1. Estimation objectives
E.g. To determine incidence rate
2. Association objectives
Aims at Association between the factor of
interest and a particular event
30. ..Types of specific objectives- Cont
Example
To identify whether there is
Association of low utilization of MCH
clinics and mother education
3. Evaluation objectives:
To evaluate the effect of an
investigation
E.g. the effect of H.E. on utilization
of MCH services.
31. Characteristics of specific objectives
1- Simple, clearly stated & covers all the
aspects of the problem
2- Measurable
- Using action verbs: -e.g to identity, to
compare
- Avoiding non-action verbs: e.g. to
describe, to study, to notice…
32. Characteristics of specific objectives.Cont
3- Attainable: Can be achieved
4- Realistic: - Feasible concerning
resources
5- Timely: - To be conducted within
the allowed time frame of the study.
33. Properly formulated specific objectives
: -will help in
1.
2.
3.
Selection of the right type of design
Orientation of data collection
Evaluation of the study.
34. Hypothesis
A hypothesis is 'a prediction of a
relation ship between one or more
factors and the problem under study,
which can be tested.
A hypothesis is a frequent goal in
quantitative research.
E.g.
Consumption of more than 10
cigarettes / day for ten years is
associated with Ca. Bronchus.
36. Review of the available literature
.?Why do we review Lit
Prevents duplication. 1
Assist in refining statement of the. 2
problem
Strengthening the argument of . 3
of a research topicselection
((Justification
It helps to get familiar with various . 4
types of methodology that might be
(used in your study (Design
37. Source of information
Articles
- Books
- Indexes
- Abstracts from journals
International organization
documents
-
e.g. (WHO,UNICEF)
38. .Source of information- cont
- Reports from MOH facilities
- Vital statistics
- Census
- Surveillance system
- Surveys
-Computer search for international
Literature
-Opinions, beliefs of key persons
(Through
interview)
39. ?How to write lit review
Use index cards.Write in your own language-
40. Bias in literature review
-
-
-
The presentation of the available
information in such away that it
reflects opinions or conclusions
that does not represent the real
situation
Restricting references to those
that support the point of view of
the author.
Drawing far reach conclusions from
shaky or Preliminary results
41. Ethical considerations in lit.
Review
Bias- Careless presentation and
interpretation of data
Put researcher on the wrong way
- Loss of resources.
- Wrong decisions
42. How to write References
:From journals/ 1
Author (s). Article. Journal. Year;
Volume: Pages
(Author : Surname followed by initials)
43. How to write References
From a book/ 2
Author. Title of the book. Edition. Place:
.Publisher, Year: Pages
From a chapter in a book/ 3
Author (s). Chapter title, In: Editors of the
book. Edition. Title of the book. Place.
Publisher, Year: Pages
46. Study Variables
A variable is a characteristic of a
person, object or phenomenon that
can take different values and can be
.measured
47. Classification of Variables
: Numerical
Expressed in numbers, E.g. Weight,
height, Distance between homes and
…clinic etc
:Categorical
. Expressed in categories: E.g
...colors, ranks etc
48. Classification of Variables
1- Numerical variables: a- Discrete: - E.g. Episodes of
diarrhea, schist. eggs.
b- Continuous: - E.g. Weight, Height
2- Categorical variables: a- Ordinal: E.g. Doctors, soldier
ranksb- Nominal: E.g. colors, sex
49. Types of variables
: Dependant variable 1
.Use to measure the problem
: Independent variable2
cause or influence the problem
-: Confounding variables 3
Variables associated with the problem
.and its possible causes
51. : -Confounding variables
- May affect results (Bias)
- Must be considered
particularly in case -control
studies( matching)
52. ?How to write variables
Expressed in a neutral way
Factor
long waiting time
Absence of drugs
Variables
- Waiting time- Drug availability-
53. Operationalization of variables
Determine whether the variables are
measurable or need appropriate
indicators E.g. Level of Knowledge,
Nutritional status Weight/ age
,Weight/ height etc... (Standard
(growth curve
57. Exploratory study
It is a small - scale study of relatively short
duration, which is carried out when little is
known about a situation or a problem
Exploratory studies problem is not as may
be descriptive and/ analytical. If the
problem is not well defined , it is always
.advisable to do an exploratory study
58. Exploratory study
:Example
One community with high and
another with low participation in
health activities, to identify the
factors that contribute to community
.participation
61. Case studies
A case study describes in depth
the characteristics of one or
limited number of cases in its
natural environment
62. Case studies
A case may be a patient, a health…centre, a village etc
Can provide useful insight into theproblem e.g. a new disease
Common in clinical medicine, socialsciences, management and
..administration etc
Associated with qualitative data andpresentation is in a narrative way
-
63. Case studies
:Features
Should be well planned and data will be collected thorough predetermined
questions
Should be flexible to deal with unexpected situations
66. SURVEYS
Use :
1. To collect information on
demographic characteristics.
Age, sex, education etc…
2. To study characteristics on
health related variables. E.g.
MMR, incidence rate, etc….
3.To study attitudes, opinions and
beliefs
67. SURVEYS
Surveys answer the following questions:
- WHEN IS THE DISEASE OCCURRING?
(TIME DISTRIBUTION)
- WHERE IS THE DISEASE OCCURRING?
(PLACE DISTRIBUTION)
- WHO IS AFFECTED? (PERSON
DISTRIBUTION)
68. PROCEDURE
Define the problem under- 1
study
2- DEFINE THE POPULATION
UNDER THE STUDY.
3- DESCRIBE THE DISEASE BY
TIME, PERSON AND PLACE.
4- MEASUREMENT OF THE
DISEASE.
5- COMPARING WITH KNOWN
INDICES.
6- FORMULATION OF AN
.AETIOLOGICAL HYPOTHESIS
69. CROSS SECTIONAL STUDY
PREVALENCE RATE STUDY
THE RELATIONSHIP BETWEEN
THE DISEASE & OTHER
VARIABLES OF INTEREST AS
THEY EXIST AT ONE PARTICULAR
POINT OF TIME
70. CROSS SECTIONAL STUDY OF
HYPERTENSION
1.
2.
3.
4.
5.
MEASURE THE B.P. AMONG THE
STUDY POPULATION
(PREVALENCE.)
COLLECT DATA ON AGE, SEX,
SOCIAL CLASS , OCCUPATION
etc...
DETERMINE HOW
HYPERTENSION IS RELATED TO
THESE VARIABLES
Compare with findings of others
Draw hypothesis
71. LONGITUDINAL STUDY DESIGNS
OBSERVATIONS ARE REPEATED IN
THE SAME POPULATION OVER A
PROLONGED PERIOD OF TIME
THESE ARE USEFUL IN:
STUDY THE NATURAL HISTORY OF
THE DISEASE.
IDENTIFY THE RISK FACTORS.
DETERMINE THE INCIDENCE RATE.
73. Case Control study
In Case Control Study, the investigator
compare one group among which a
problem present, with another group
(control) where the problem is absent
74. Common features
1.
2.
3.
Both exposure and outcome have
occurred before the start of the
study
Study proceeds back from effect to
cause
Presence of a control group
76. Selection of cases
It involves two specifications:
1. Diagnostic criteria:
Specific diagnostic criteria of the
disease, its staging are to be
stated clearly.
2. Eligibility criteria:
Criteria to determine who is
allowed to be included in the
study. E.g. Only newly diagnosed
cases rather than old ones
77. Sources of cases and controls
:Cases
-
Patients
General population
:Controls
-
Patients
Relatives
Neighbor hood
General population
78. Matching
Is the process by which controls are to
be similar to the study group
:Types
Individual matching
Group matching
79. :Analysis
1.
2.
The exposure rate among both the
cases and the controls.
Odds ratio: This ratio can be used
to estimate the relative risk as the
incidence rate can not be determined
in case-control study design.
Thus the case control study is
always suggestive of the etiological
association between two variables
80. Case control study of smoking and Ca. lung
Cases
status
smoking
Yes
No
Total
(a
c
Controls Total
)33 (b
(
)55
a+
(d
)27
c
)2
35
(a + c)
82
(b + d)
(b
)88
)29
(+ d
117
(a+b+c+d)
81.
The exposure rate among cases=
a ÷ a+c = 33÷35= 0.94x100=94%.
The exposure rate among the
controls= b÷ b+ d=55 ÷82=
0.67x100=67%.
Odds ratio= a/c÷ b/d = a/c x d/
b=891÷110=8.1
82. INTERPRETATION
From the exposure rates among the
cases & controls: Chi square test has
to be used to confirm that there is
statistical difference between the two
values.
If the odds ratio is found to be
greater than one it means that there
is a positive etiological association.
84. Cohort study
A longitudinal a study in which a
group of individuals are followed up
for some time.
A cohort is a group of persons who
share common characteristics or
experience within a defined time.
85. Features
The cohort is identified before the
appearance of the investigated
disease
The study groups are observed over
a period of time
The study proceeds from cause to
effect
Note: The incidence rate can be measured
86. :Indications of cohort study
1.
2.
3.
When there is strong suspicion of
association between exposure and
disease
When exposure is rare but the
incidence is high among the exposed
When the attrition of study
population can be minimized
87. Types of Cohort studies
:Historical Cohort studyStarts from a point in the past to now
:Prospective Cohort studyStarts from now and study goes on to the
future
Retrospective Prospective Cohort:study
Starts from the past, passing through now
and proceeds to the future
88. Elements of a cohort study
:Selection of a study group -1
From:- a. a general population or
b. Special group (Such as doctors, drivers etc.. or
(exposure group
:Obtaining data on exposure- 2
…By review of records , medical examination, interview etc
;Selection of a comparison group- 3
Internal comparisons: According to exposure levelExternal comparisons: From out side the study group-
89. .Elements of a cohort study- cont
:Follow up- 4
By: a. Periodic medical examination
b. Review of records
c. Review of death certificates
d. Mailed questionnaires
…e. Telephone calls etc
:Analysis- 5
a. Incidence rate
b. Relative risk
91. Attributable risk
This is the difference in incidence of
disease or death between exposed &
non-exposed group. It is expressed as
a percentage.
It measures the impact that removal
of a certain factor will have on the
incidence of the disease.
93. Analysis
Incidence rate of Ca lung
among smokers=
a/a+b=70/7000= 10/1000
Incidence rate of Ca lung
among non-smokers=
c/c+d= 3/3000= 1/1000
94. Analysis
Relative risk=
Incidence of disease among exposed:
incidence among non-exposed
10/1000
1/1oo0.
Attributable risk= Incidence rate
among exposed-incidence rate
among non-exposed/incidence rate
among exposed= 10-1x100=90%.
96. EXPERIMENTAL STUDY DESIGNS
In experimental studies the researcher
manipulates a situation and measures
its effect after that
:Type
Randomized control trials- 1
Non-randomized trials- 2
98. RANDOMIZED CONTROLLED TRIALS
Those trials are used for assessment
of methods of treatment and
prevention.
They include:
- intervention
- control groups and
- randomization
99. Features of Randomized control trials
:Manipulation- 1
The researcher does some intervention (Example provision of
.new drug) to one of the study groups
:Control- 2
The researcher introduces one or more control groups to
compare with the experimental group
:Randomization- 3
Each subject have an equal chance of being
allocated to either of the two groups( study and
(comparison groups
100. :-steps
1. Drawing a protocol.
2. Selecting comparison &
experimental groups
.Randomization. 3
4. Manipulation (intervention).
5. Follow up.
6. Assessment of the outcome.
101. THE PROTOCL
One of the essential features of the
randomized trials.
The protocol specifies:
1. The objectives.
2. The questions to be answered.
3. The selection criteria.
4. The sample size.
5. The procedures of allocation of the
subjects into experimental and
control groups.
102. . …THE PROTOCL- cont
6. The treatment applied: How,
what dose etc...
7. The details of the scientific
techniques and investigations.
:Note
Once the protocol has been evolved, it
should be strictly adhered to through out
the study.
103. RANDOMIZATION
Randomization is the statistical
procedure by which the
participants are allocated into
groups usually called study &
control groups to receive or not
to receive intervention or
therapeutic procedure .
Randomization aims at making
the groups comparable and
eliminate bias.
104. RANDOMIZATION
Randomization ensures that the
investigator has no control over the
allocation of the participants to either the
study or control group, thus eliminating
the selection bias.
Every individual has an equal chance of
being allocated into either group.
Randomization is best done by using
statistical random table.
105. MANIPULATION
Manipulation or intervention is usually
done by application or withdrawal of the
suspected factor e.g. drugs, vaccine or
dietary factor.
This manipulation creates an independent
variable (drug, vaccine or new procedure)
which effect is then determined by the
measurement of the final outcome which
constitutes the dependent variable e.g.
incidence of disease, recovery.
106. FOLLOW UP
This includes examination of the
study & control groups subjects at
defined intervals of time in standard
manner under the same conditions in
the same time frame till the final
assessment.
The main difficulties encountered in
the follow up process include:
Attrition from:- death, migration,
displacement and loss of interest etc
107. ASSESSMENT
The final assessment of the trial is carried in terms of:
Positive results:
These include the benefits of the experimental study
such as reduced incidence of the disease or severity
of the disease, cost of health services or other
appropriate outcome.
Negative results:
These include the severity & frequency of sideeffects and complications.
The incidence of positive/negative results is
compared in both groups and the differences are
tested statistically.
109. a. QUASI-EXPERIMENTAL STUDY DESIGNS
At least one of the characteristics of the true
experiment is missing (RANDOMIZATION OR
CONTROL GROUP)
QUASI-EXPERIMENTAL STUDY DESIGNS
ALWAYS INCLUDES MANIPULATION
( INTERVENTION)
110. Non-randomized trials. 2
b. Before and after study:
- Includes intervention
- No control group
- No randomization
- Observation before and after the
intervention
- Test ( analysis)
111. Bias in experimental studies
Bias is the systematic difference between
observed results and the actual results.
Sources of bias:
1. Participant’s bias:
The participants report subjectively that they
feel better or improved if they knew that
they were receiving new treatment.
112. . ..BIAS – cont
2.Observer’s bias:
The influence of the investigator measuring
the outcome of the trial if he knew
beforehand the particular procedure to
which the patient has been subjected.
113. ?How to reduce the sources of bias
1. Randomization.
2. Blinding.
Blinding is carried in three ways:
1. Single blind trial: The trial is so planned
that the participant is not aware whether he
belongs to the study or control group.
2. Double blind trial: The trial is so planned
that nether the doctor nor the participant is
aware of the group allocation and treatment
received.
114. How to reduce the sources of bias?
…Cont
3. Triple-blind trial:
The trial is so planned that the
participant, the investigator& the
person analyzing the data are all
blind.
This is the ideal but double-blinding is the
most commonly used.
117. Sampling
A sample is a selection of a
number of study units from a
defined study population
118. Questions to be asked
-
Study population:Population from whom the sample is to be taken
-
Sample frame:
A list of all units of study population from which the
sample is to be drawn
-
Sample size
Method of selection of the sample
Note
The sample should be representative, i.e. it should
carry the characteristics of the study population
120. Probability sample- 1
It is a random selection procedures
that every unit of the study
population has an equal chance of
being selected in the sample
122. Probability sampling- 1
1. Simple random sampling
1.
2.
3.
Give number to all the subjects
(List)
Determine the sample size
Select the sample using;
- A lottery or
- A table of random selection
123. Probability sampling - 1
2. Systematic random sampling
Used when there is a sample frame e.g. a
class, doctors in a hospital etc
:Steps
Determine the sample frame Determine the sample size Determine the interval Sample frame/ Sample size =
Note
First unit should be taken randomly
124. Probability sampling- 1
3. Stratified sampling
Used when the characteristics are not
equally distributed in the population
and the researcher is interested in
these characteristics to appear in the
analysis
.E.g
..Age, sex, religions etc
125. Probability sampling- 1
4. Multistage sampling
Used when the population is divided into subgroups
e.g. In a study of HIV/AIDS prevalence in the Sudan,
:the sample may be taken as follows
Take three states out of the 25 states Take two localities from each selected state Take towns and villages from each selected locality Take individuals from each town and village locality
Note
Multistage sampling usually involves more than one methods
126. Probability sampling- 1
5. Cluster sampling
Cluster sampling is the selection of study
.groups instead of individuals
Used when there is no complete sampling
frame, or there is some logistic difficulties
e.g. the population is composed of a large
. number of scattered villages
Note
Multistage sampling usually involves more than one
method
127. Advantages of multistage and cluster
sampling
A sampling frame is not required
The sample is easy to select
Disadvantage of cluster sampling:
-The sample may not be representative
Note:
Take more clusters and so big sample to
avoid this problem
128. Bias in sampling
1.
2.
3.
4.
Improper sampling procedure
Study of registered patients only
studying volunteers only
Tarmac bias: Study accessible
areas only
130. Non-probability sampling- 2
1. Convenience sample
-
Samples in which randomization is absent,
and so subjects have no equal chances of
being selected.
- For convenience, only those units which are
accessible at the time are taken.
- Used when there is no sample frame
- Many clinical based studies are from this type.
Problem:
Not representative
131. Non-probability sampling- 2
2. Quota sample
The population is divided into
categories and a quota is to be
surveyed from each category
:Problem
Not representative
132. Non-probability sampling- 2
3. Purposive sample
The researcher selects specific subjects in
the population and includes them in the
sample
:Problem
Not representative
133. Sample size
:For descriptive study
2
2
n= z . p q/ d
n = Sample size
z = Standard normal deviate = 1.96
p = Proportion of the characteristic
under study estimated in the target
population
q = 1-p
d = Error allowed = 0.05