Dr Tarek Amin

Professor of Public Health

Cairo University
amin55@myway.com
 II-Introduction/background




 Why this topic is important from the global context
What is known about in terms of:
Global Burden, morbidity, mortality, costs and preventability

Local

On the country level what is the situation and what attributes are there
Findings of the previous research and their limitations

Significance of your research

The problem statement
Rationale
Focal
You approach how will be different, overcoming the previous flaws
Your findings will serve in decreasing morbidity, mortality, costs, provide baseline data etc.,
Remember not to use ―I, our, we‖ use ―The
study‖, not ―My research‖!!!!
 Significance of your study (rationale)
• It makes the purpose worth pursuing. The significance of the study answers
the questions:
Why is your study important?
To whom is it important?
What benefit(s) will occur if your study is done?
Your study should have a value not only to yourself but also to the community
the respondents, has an impact on your field of specialization and you
should mention the sectors that will be benefited by your studies.
Guidance in explaining the importance of the study.
• The rationale, timeliness, and/or relevance of the study
• Possible solutions to existing problems or improvement to unsatisfactory
conditions.
• Who are to be benefited and how they are going to be benefited.
• Possible implications.
 Rationale

۞It makes clear how the findings of the proposed study

will help
o In resolving uncertainties,
o In leading to new scientific understanding and
o In influencing clinical and public health policy.

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Introduction
• The World Health Organization attributes 4.9 million deaths a year to tobacco use, a figure expected to rise to
>10 million by year 2030, if the current trend continues [1]. Almost 70% of these premature deaths will be in
the developing countries, one third of which will be among children [2], making tobacco use a global epidemic.
Despite the fact that the main burden of this epidemic is in the developing countries, most of the related
research and management efforts are addressed by, and toward the developed nations [3]. These efforts also
tend to focus on the most prevalent methods of tobacco use in these countries, namely cigarettes and smokeless
tobacco, and in most instances do not consider those prevalent in developing countries such as WP [4], despite
the fact that as many as 100 million people use this method for tobacco smoking [5]. Waterpipe,
―Shisha,‖―Maassel,‖―Hookha,‖ or ―Nargilha‖ smoking has gained popularity in most countries of the Middle East
and is a common practice in the Arabian peninsula, Turkey, India, Pakistan, Bangladesh, and China [6],
especially attracting the younger population. Factors that promote WP popularity may include its social
acceptance as part of cultural heritage, easy availability, attractive designs, and the availability of flavored
aromatic tobacco called ―Muassel‖ [7]. In some Arab countries, WP (Shisha) smoking is considered less of a
social stigma than cigarette smoking, and is also associated with less gender differentiation [8–10]. In Syria,
among university students, it was found that at least 62.6% of men and 29.8% of women had smoked WP at
least once [9]. In Kuwait, a survey among public employees found that 57% of men and 69% of women had
used WP at least once [11]. In many European countries and the USA, there has been an upsurge in WP use
over the past several years .It is anticipated that this popular form of smoking may become more prevalent due
to globalization and immigration to these countries [12]. WP is perceived by many adolescents, the general
public, and even some health professionals as being less dangerous than cigarette smoking [7]. The basis for this
assumption includes points like—nicotine content of WP is lower than that of cigarettes; water filters out all
noxious chemicals, including carbon monoxide, tar, and nicotine; it is less irritating and thus less harmful to the
throat and respiratory system; and Muassel ―Narghile‖ tobacco contains fruit, making it a healthy choice [13].
Although individuals of college age seem to be the group most vulnerable to WP use, secondary school students
are also susceptible due to the increasing popularity of this form of tobacco [14, 15], which is primarily social in
nature. To address the gap in the current literature on prevalence and possible determinants of WP smoking
among Saudi adolescents, we specifically hypothesized that males and older adolescents are more likely to
smoke WP than females and younger adolescents, respectively. We also predicted that WP smoking among
close relatives and friends, and current cigarette smoking increases the likelihood of being a current WP user.
Additionally, we predicted that adolescents who believe that WP smoking is a socially acceptable behavior, as a
means to socialize, and those having anxiety symptoms are more likely to use WP. The objectives of this study
were to define the prevalence, and pattern of WP smoking among secondary school adolescents in Al Hassa,
KSA. Second- arily, we aimed to assess their mental health status, health- related knowledge and attitudes
toward WP smoking, and to determine the possible psychosocial predictors for adoption of WP smoking.
• Background
Osteoporosis (OP) is a non-communicable global epidemic characterized by deterioration in the micro-
architecture of bone tissue that leads to increased bone frailty and suscep- tibility to fragility (low
trauma) fractures [1, 2]. With ageing societies and changing disease patterns worldwide, human, social,
and economic costs of OP will continue to rise [3]. Osteoporotic fractures accounted for 0.83 % of the
world- wide disability caused by non-communicable diseases [2, 4], globally, approximately 200 million
women are affected by OP, and in the developed countries one in three women and one in five men
over the age of 50 years will sustain an OP-related fracture [4]. Of particular concern are increasing
numbers of hip fractures which is estimated to increase to 2.6 and 4.5 million by year2025 and 2050,
respectively [5], with expected increase in their accompanying toll in terms of morbidity, mortality,
and economic burden in an era of limited health care resources [6, 7]. The burden of OP- related
fractures is less well-studied in the developing countries [8]. In the Middle East, information about OP
prevalence and OP-related fracture rates is sparse. In Iran, it was estimated that two million people are
at risk of OP- related fractures [9]. In Saudi Arabia, Ardawi et al. reported a prevalence of OP among
Saudis aged 20 to 79 years to be 44.5 % [10]. Data on fracture rates are also limited in this part of the
world. Baddourah et al. found that lifetime risk for all fractures to be 9.3 and 16.7 % in males and
females, respectively [11], a figure which is higher than other Asian countries, but less than that found
in Europe. Early OP detection is advocated in numerous clinical guidelines, aim- ing at early
management and reducing the later impact of this avoidable disease [12, 13]. Many factors hinder early
detection of OP with inability to avert OP-related fractures. First, the limited awareness by physicians
and the public of the overall fracture burden of OP on society, how to effec- tively predict fracture
events and when to initiate therapeutic interventions for prevention of OP-related fractures, is a major
contributory factor for the occurrence of OP-related fractures [14]. Secondly, early detection of OP
remains largely opportunistic, and its confirmation is dependent on clinician referral for objective
assessment of bone health [15], and finally, the absence of effective diagnostic tools to assist physicians
especially at primary level in identifying individuals at risk for developing OP and OP-associated
fractures [16]. In Saudi Arabia, there is no screening pro- gram for early detection of OP. Furthermore,
studies about OP screening and its possible influencing factors at primary level do not exist. This study
aimed at estimating the 10- years probability of OP-related fractures and identifies those in need of OP
treatment among Saudi adults attending primary care centers (PHCs) in Al Hassa, Saudi Arabia, using
FRAX® calculator and also to determine the possible factors that influence OP screening among them.
• Introduction Sickle cell disease (SCD) is a group of inherited red blood cell disorders characterized by the presence of abnormal hemoglobin. The clinical
manifestations are diverse and may include vaso-occlusive, hematological and infectious crises [1,2]. SCD is present throughout Saudi Arabia; particularly
common in the eastern and southern provinces: Qatif (eastern region) 17.0 %, Gizan (southern region), 10.3%, Ula (Northern region) 8.1 % and Mecca
(western region) 2.5 % [3]. Increased life expectancy due to recent medical advances has increased the need to understand more fully the quality of life
(QoL) in patients with SCD and factors predicting disease adaptation [4,5]. QoL measures are used not only to assess the psychosocial impact of the disease
but also in evaluating the efficacy of medical care [6-9] and it is the goal of health care providers to enhance treatment outcome and restore comfort and
well-being of their patients [10]. In particular, health related quality of life (HRQoL) assessments in adolescents with chronic disease condition facilitate
doctor–patient communication, they point to areas where patients may experience serious problems, they can be used as diagnostic tools for problem-
oriented follow–up care, and the data are strong predictors of survival [11]. Previous research indicated that patients with SCD experienced a lower
HRQoL compared to the general adult's population [12] Dampier et al [13] found that children with SCD as well as their parents scored significantly lower
on several HRQoL domains including; general physical, motor and independent daily functioning. Trzepacz et al [14] identified deteriorations in social and
school competence for children with SCD, compared to healthy peers, but they did not find an association with disease severity as measured by sickle cell
genotype. A number of disease-related factors have been found to affect HRQoL in pediatric SCD. Several studies that examined the influence of various
determinants including the role of socio- demographics, disease severity and the presence of complications on HRQoL in SCD patients were carried out in
the developed countries [12,13,15,16] while in the developing countries similar studies do not exist. Furthermore, adolescent health is a relatively
unexplored component of public health in many developing countries [17,18]. Researches on chronic diseases have indicated that HRQoL varies according
to socio-demographic characteristics such as income level, educational status, ethnicity, occupational status, age, and gender, with the disadvantaged groups
typically reporting lower HRQoL. This association has been reported for many chronic conditions including cancer [19], HIV infection [20], renal disease
[21], and sickle cell disease [15]. Also, studies involving healthy populations have indicated that there is an inverse association between children‘s HRQoL
and family variables such as low parental education, socio-economic status (SES) [22-24] with low family income contributing to caregiver distress in
families of children with chronic conditions [25]. Also, Simon et al [26] reported that HRQoL is poorest for children and youth in lower socioeconomic
status groups, those with access barriers, adolescents compared with children, and individuals with medical conditions. Studies on the relationship of
socio-economic variables and the HRQoL in patients with SCD revealed conflicting results. Van den Tweel et al [27] indicated that children of parents with
low educational level perceived a significantly better HRQoL. This phenomenon is difficult to explain, since previous research mainly pointed out that high
quality of life scores were related to high parental education, or that education had no effect at all [11,28]. Also, previous research has shown that children
with low socioeconomic status (SES) functioned worse than children from middle SES backgrounds [29]. Limitations in HRQoL have been documented
consistently for youth with SCD, [15,30,31] particularly as children move into adolescence and young adulthood [32,33]. Sickle cell pain, a common
manifestation that is recurrent, acute, and unpredictable, may be the most important disease complication associated with deterioration in physical and
psychosocial domains of HRQoL [15,34,35]. Palermo et al [32] reported that sickle cell complications (including pain), in addition to child age and gender,
are central to physical but not psychosocial HRQoL in their sample of adolescents with SCD. Yet, Panepinto and colleagues [36] found that only pain, no
other SCD complications, was associated with the deterioration in the physical domain of HRQoL but not the psychosocial. Although pain and other sickle
cell complications show an association with decrements in engagement in physical activities and in physical domains of HRQoL, documentation of a
significant association of pain with psychosocial domains of HRQoL are not consistent [37]. Recently, Brandow et al. [38] examined HRQoL in children with
SCD specifically in relation to painful events at presentation to the emergency room and seven days post- discharge. They found that painful events
diminished all domains of HRQoL and that these domains improve after the pain resolves. If these variables (socio-demographic and disease related
complications) are crucial in determining HRQoL among adolescent patients with SCD, by controlling of these factors, we may better support them with
successful transition to adulthood and with less burden on healthcare services [39]. We specifically hypothesized that adolescents with SCD would have
decreased mean scores along the different subscales of the HRQoL measure compared to adolescents without SCD. We also predicted that certain
demographic factors (increasing age, gender, low socio-economic status) would be related to HRQoL with males and adolescents from lower SES
backgrounds reporting lower quality of life. Additionally, we predicted that adolescents with SCD who experienced disease-related complications, frequent
pain episodes, and greater health care utilization would report lower quality of life than adolescents with SCD who did not report these factors. The
objective of this study were to assess the impairment of the different domains of HRQoL among Saudi adolescents with SCD compared to healthy peers and
to define the relationship between socio- demographic variables, the presence of diseases related complications with the degree of impairment in HRQoL.
• Introduction
Training in research is an important part of medical education. The attitudes of undergraduate medical students towards
research might be influenced by a number of factors such as previous training and skills in research [1], motivated
faculty staff [2] and motivational rewarding environment at the institution [3]. It is essential to inculcate critical
thinking and reasoning skills and to develop positive attitudes towards scientific research amongst medical students from
the beginning of their carrier [1, 3]. Studies have shown that early involvement in research promotes a tendency to
continue the same in later stages of the medical profession [4, 5]. Several studies [1, 4-7] have assessed attitudes towards
research and knowledge about scientific research amongst medical students in developed and developing countries.
Khan et al., [1] in their cross- sectional study conducted among a group of Pakistani medical students reported moderate
level of knowledge towards health research where about 80% of their students were falling in the middle two quartiles
of the knowledge score.
Similar trends were demonstrated by the students on the attitude score. Vodopivec et al. [6] who conducted a study with
similar questionnaire among first year Croatian medical students found a similar mean knowledge but much lower
attitude scores. They have explained their lower scores as to better represent the baseline effect of secondary and high
school education on knowledge and attitudes for research of students. Burgoyne et al., [2] found that the majority of
Irish medical undergraduate students are motivated to pursue research. Graduate entrants and male students appear to
be the most confident regarding their research skills competencies. Furthermore studies that tackled potential barriers
for research conduction among under and post graduate medical students are scarce [2, 8, 9] Heavy workload, financial
difficulty and poor guidance and support from the medical school were their main barriers mentioned among
undergraduate medical students in Ireland [2] while among junior medical faculty a lack of research training was only
barrier to have statistically significant difference between those involved in research versus not. This barrier was also
reported in a study done earlier in Pakistan. [9, 10] To the best of our knowledge, none of studies that assess the
knowledge, attitudes and the perceived barriers towards research among undergraduate medical students have been
carried out in any country of Arab gulf region.
The objective of this study was thus to assess the level of knowledge about and attitudes towards and the perceived barriers
among medical students to participate in scientific research activities in medical schools at three universities, one each in
Saudi Arabia, Bahrain and Kuwait.
 How to determine research priorities?
(Importance/Significance)
I- How frequent is the condition relative to other
conditions?
Prevalence
As a cause of death
II- What is the degree of disability or dysfunction due to
the condition?
III- Are there cost-effective means to cure, control, or
prevent such condition?

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 Assignment:
State the rationale (significance) for the
proposed study question?

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 III-Setting up research objectives.
Are the goals you set out to attain in your
research, inform the readers of what you want
to achieve .
Extremely important to word them clearly and
specifically.
- Main objectives:
☼ Should describe the main questions to be addressed by the
research without going into details.
☼ Should give a reader a clear idea of the nature of the research that
will be undertaken.
‗ The purpose is to measure the effect of a plasmodium falciparum asexual blood-
stage vaccine in reducing morbidity and mortality due to malaria‘

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 Objectives
• Subobjectives: Tackling only one concept and
could be numbered.
o Main and subobjectives should formulated using
ACTION words (to assess, to measure, to
ascertain, to explore etc., )
o Wording determine your research design
o Objectives should be clear, complete, no place
for ambiguity, difficulty in communication or
reflecting the research idea.
 Objectives ―characteristics‖

Clear Complete Specific Identify the Identify the

+ + Main variables + direction of the
+ to be correlated relationship

Descriptive studies

Correlation studies (experimental and non experimental)

Hypothesis-testing studies
 Why is asthma among children in Istanbul exceptionally
frequent?

The purpose of the study are to determine if the

excess asthma in Istanbul is related to a
combination of genetic predisposition
(estimated by atopy) and socio-economic and/or
indoor air pollution.

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 What are the specific objectives to achieve such type
of study?
I. Identify a suitable source of childhood asthma cases and select
200 cases, following a specific case definition.

II. Identify and select suitable control subjects (individuals without

asthma).

III. Measure indoor particulate exposure on each of 3 randomly

selected days for each participant.

IV. Perform allergy skin test on cases and controls (atopy).

V. Record personal, demographic, and socio-economic information

about cases and control.

VI. Compare risk ratio for atopy, low socio-economic status, and
increased indoor air pollution between cases and controls.
• The objectives of this study were to
determine prevalence and pattern of LTPA
among adult ----, and to define the socio-
demographic determinants that correlate
with being sufficiently active LTPA.
Therefore, the aim of our study was to examine the associations of quantitative and qualitative dietary fat intake, serum estrogen level and obesity

• The objectives of this study were to assess

the risk behavior and knowledge related to
toxoplasmoisis among --- pregnant women
attending primary health care centers (PHCs)
and to determine socio-demographic
characteristics related to risk behavior and
knowledge.
• Therefore, the aim of our study was to
examine the associations of quantitative and
qualitative dietary fat intake, serum estrogen
level and obesity with the risk of breast cancer
in a case-control study among -- females
including newly diagnosed breast cancer
patients.
• The objectives of this study were to deter-
mine alterations of vitamin D and parathyroid
hormone levels and their relationship to
insulin resistance among a sample of healthy
young adult obese versus their controls and to
identify factors that might predict these
alterations.
• The objectives of this study were to assess
medical students' knowledge in clinical years
at K University, about SPs' and to explore their
attitudes toward the current
curricular/training in providing them with
effective knowledge and necessary skills with
regard to SPs.
 Concept, variable, indicator
Concept Variable
Subjective impression Measurable through the degree of
No uniformity in understanding precision varies from scale and from
Can not be measured as such variable to variable (attitudes,
income, objective)
Effectiveness Gender
Satisfaction Attitude
Impact Age
Excellent Weight
High achiever Height
Self esteem
Rich
 Concepts Indicators Variables
Concept Indicators Variables Decision level

Rich Income Income/year 1 if > 100,000

assets Total value of 2 if >2500000
homes, boats,
cars
High academic Average marks/exam % of marks 1 If > 75%
achievement Average marks/practical 2 if > 75%
Aggregate marks 3 if > 80%

Effectiveness of a Number of patients No. serviced Before-after

health program Changes in morbidity No. of illness levels significant
Changes in mortality episode/1000 change
Changes in nutritional status population. Point prevalence
No. of deaths
/diseases.
Changes in
weight
 Types of variables

Causal model Study design Unit of measurement

Active Attribute
Independent Can be manipulated Characteristics
Intervening Changed or controlled Age, gender, genetics
Extraneous
Dependent Quantitative Qualitative

Continuous
Categorical
Constants
Only one value or category
Dichotomous

Polytomies
 Intervening variables
Confounders
A confounding variable is associated with the exposure and it affects the outcome, but it is not an
intermediate link in the chain of causation between exposure and outcome.

Smoking Cancer
Assumed cause Assumed effect
Independent variable Affect the relationship Dependent variable

Age of the person

Extent of smoking
Duration of smoking
Exercise
Extraneous variables
Modulate the cause-effect relationship
 Hypotheses and Underlying
Principles
Dr. Tarek Tawfik

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 Hypothesis definition
A hypothesis is written in such a way that it can be proven or
disproved by valid and reliable data-it is in order to obtain these data
that we perform our study. Grinnel 1988:200.

Hypothesis has certain characteristics:

1. It is a tentative proposition ―hunch‖
2. Its validity is unknown.
3. In most cases, it specifies a relationship between two or more
variables.

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 Functions of hypothesis
 Formulation of a hypothesis provides a study with focus
―specific aspects of a research problem to investigate‖
 What data are necessary to collect to test the hypothesis.
 Enables you to specifically conclude what is true or what is
false.

Process of testing a hypothesis

Phase I Phase II Phase III

Formulate your Collect the Analyze data

required To draw conclusions
Hunch or
data About the hunch-true/false
assumption

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 Characteristics of a good hypothesis
Simple, Specific, Stated in advance (3Ss)

A-Simple versus complex

Contains one predictor and one outcome variable;
(a sedentary lifestyle is associated with an increased risk of
proteinuria in patients with diabetes).

A complex hypotheses contains more than one

predictor;
(a sedentary lifestyle and alcohol consumption are associated
with increased risk of proteinuria in patients with diabetes).

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 Simple hypotheses
Or more than one outcome variable;
(alcohol consumption is associated with an increased risk of
proteinuria and neuropathy in patients with diabetes).

Complex hypotheses can be readily tested with a

single statistical tests and can be easily approached by
breaking them into two or more simple hypotheses.

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 Simple hypotheses
(smoking cigarettes, cigars, or a pipe is
associated with an increased risk of
proteinuria in patients with diabetes).

What type of hypotheses is this?

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 B-Specific versus Vague

 A specific hypothesis leaves no ambiguity about the subjects,

the variables, or about how the test of statistical significance
will be applied.
 it uses concise operational definitions that summarize the
nature and source of the subjects and how variables will be
measured;
(a history of using tricyclic antidepressant medications, as
measured by review of pharmacy records, is more common in
patients hospitalized with an admission diagnosis of
myocardial infarction at Longview Hospital in the past year
than in control hospitalized for pneumonia).

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 Specific versus Vague
 It is often obvious from the research hypothesis
whether the predictor variable and the outcome
variable are dichotomous, continuous, or
categorical.
(alcohol consumption (in mg/day) is associated with an
increased risk of proteinuria (> 30 mg/dL) in patients with
diabetes).

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 C-In Advance versus After-the-Fact

 The hypothesis should be stated in writing at the

outset of the study.
 A single pre-tested hypothesis creates a stronger basis
for interpreting the study results than several
hypotheses that emerge as a result of data inspection.
 Hypotheses that are formulated after data examination
are a form of multiple hypothesis testing that often
leads to over-interpreting the importance of the
findings.

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 Types of hypothesis

Alternate hypothesis Research hypothesis

Hypothesis Hypothesis Hypothesis

of difference of point- of association
Null hypothesis prevalence

Hypothesis
of no difference
“null hypothesis”
 Types of hypothesis ―examples‖
There is no significant difference in the proportion of
male and female smokers in the study population.
Hypothesis is ?
A greater proportion of females than males are smokers
in the study population. Hypothesis is ?
A total of 60% of females and 30% of males in the study
population are smokers. Hypothesis is ?
There are twice as many female smokers as male
smokers in the study population. Hypothesis is ?

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• To address the existing gap in the literature on
smoking among adolescents we have tested the
following hypotheses: First, older male adolescents
are more likely to smoke tobacco than younger and
female adolescents. Second, smoking among close
relatives (environmental tobacco exposure) and
friends (peer pressure) would increase the likelihood
(risk) of being current smoker. Finally, certain
motives (socializing, imitation, outing, rather than
relieve of stress and pleasure) and the presence of
depressive and/or anxiety disorders may represent
potential predictors for the current smoking status
among adolescents.