THE JOINT PROGRAM OF FAMILY MEDICINE IN MAKKAH

TITLE

A well-constructed study title is important as it is the first opportunity to attract

the attention of the reader. The study title should be descriptive, although
clearly and concisely indicating the subject of inquiry. Having a refined
research question can assist in constructing a title. This will ensure that your
study title reflects (if appropriate) the patient population, intervention (e.g.
medicinal product or device), comparator (e.g. another intervention, placebo
or usual care) and outcome. You might also consider incorporating the design
type (e.g. a randomized controlled study, case-control study, or retrospective
cohort study) as is recommended to improve the reporting of health research.
However, your initial title will only be a working title that would usually be
revised as your study becomes more refined. The title should also include the
area and time of the study.

Researcher:

Supervisor:

Advisor:

Statistical Advisor:

A research Proposal submitted in partial fulfilment of the requirements

of the Saudi Board of Family Medicine
 Table of Contents
Page
Table of Contents…………………..……………………… ii
List of Abbreviations……………………………………….. iii
1 INTRODUCTION ………………………………………………………… 1
1.1 Background…………………………………………………..
1.2 Rationale………………………………………………………
1.3 Aim……………………………………………………………..
1.4 Objectives…………………………………………………….
2. METHODOLOGY ……………………………………………………….
2.1 Study Design……………………………………………..
2.2 Study Area………………………………………………..
2.3 Study Population……………………………………….
2.4 Inclusion Criteria…………………………………………
2.5 Exclusion Criteria………………………………………..
2.6 Sample size……………………………………………..
2.7 Sampling technique…………………………………….
2.8 Data collection tool (instrument)…………………….
2.9 Data Collection technique……………………………..
2.10 Variables…………………………………………………
2.10 a. Dependent……………………………………………
2.10 b. Independent…………………………………………
2.11 Data entry and analysis………………………………………
2.12 Pilot study/pretesting…………………………………………
2.13 Ethical considerations ………………………………………….
2.14 Relevance and expectations……………………………………
2.15 Limitations……………………………………………………….
2.16 Budget ……………………………………………………………..
3. REFERENCES……………………………………………………….
4. Annexes……………………………………………………………...
LIST OF ABBREVIATIONS
1. INTRODUCTION
The introduction is a very brief overview of study. The introduction should be
concise but sufficient to orientate the reader to the main purpose of the study,
how it will be conducted and its expected benefits.

1.1BACKGROUND

The most important aspect of a research proposal is the clarity of the research
problem.
This is an opportunity to convince the reader (or reviewer) of why the study
needs to be done (and deserves funding or ethical approval). Keep this brief.

The literature review can be either included within this section or a

separate section. The following key points may be used as a guide:

 Conduct a comprehensive literature search (Medline, Cochrane,

Embase and other databases relevant to your area of study).
 Discuss the importance of the topic (public health and/or clinical
importance and impact on individuals/community; incidence,
prevalence, mortality and morbidity).
 Critically appraise the relevant literature and discuss the state of
current knowledge on the topic (including deficiencies in
knowledge or gaps that make the study worth doing).
 Indicate how the research question has emerged and fits logically
with the above.
 Outline your approach to address the research question.
 Explain how your study will contribute to existing research and
benefit other individuals or the wider community.
Theliterature review should logically lead to the statement of the aims of the
proposed project.

1.2 RATIONALE

In this section, you should state reasons of conducting this research:

Why this topic? Importance, seriousness, commonness, previous studies.
Why this population? Is it common in this population? Captive population.
Why this location? Community based, easily accessible, place for the
researcher, most appropriate for the condition studied …..etc.
Why you? Personal interest, personal or family history, commonly seen.

1.3AIM(S) OF THE STUDY

Your aim(s) should arise from your literature review and state what the study
hopes to accomplish.

1.4 OBJECTIVES

Your focused research question needs to be further refined into one or more
study objectives. The study objective(s) should be single and quantifiable
statement(s) that will allow you to answer your research question. Each
Objective should be SMART: (Specific, Measurable, Achievable, Realistic
&Time limited)

e.g. The objective of this study is to determine if socioeconomic status is

associated with excess childhood asthma in Jeddah, during the study period.

2. METHODOLOGY (MATERIALS AND METHODS)

2.1 Study Design
Examples include: Cross-sectional, analytic, case-control (retrospective) or
cohort (prospective or historical). Interventional including randomized control
trial (RCT), non-randomized or quasi-randomized controlled trials, community
trials, Pre-Post Interventional studies assessing the effect of interventions
(educational, therapeutic…etc.) on a specific population. A Systematic
review, with or without a meta-analysis. These are based on primary health
care attendants, primary school children, hospital department,
community…..etc.

2.2 Study Population

Examples include: Patients attending primary health care or hospital
departments; Students, teachers or employee at a given institution or school.

ELIGIBILITY CRITERIA

Inclusion and exclusion criteria are standards that you have set determining
whether a person may or may not be allowed to enter your study. They are
used to identify appropriate participants and to ensure their safety.

a. Inclusion criteria
Inclusion criteria are the ‘characteristics’ that clearly describe the study
population that are required for a subject to be included in the study. The
criteria may be based on factors such as age, gender, the type and stage of a
disease, previous treatment history, and co-morbid medical conditions. They
may state appropriate criteria for admitting special ‘at-risk’ populations such
as women of reproductive age, children or patients with disease.

b. Exclusion criteria

Provide details of participants that will be considered ineligible to participate

and justification for their exclusion. These criteria are not always clinical in
nature, aiming principally to accommodate participants in a safe and ethical
manner. Criteria may include:

- circumstances that interfere with the participant’s ability to give

informed consent (diminished understanding or comprehension or
language),
- contraindications to the study treatment(s)/procedure(s),
- taking certain concomitant medication(s),
- conditions that interfere with a patient's ability to comply with all
treatment(s)/procedure(s).

2.3 Study Area

The city: description of the location, the importance and major characteristics
of the city (Holy city of Makkah Al-Mokarramah, commercial city of Jeddah).
The services: major governmental services; such as Health, Education,
Electricity, Municipality, Transportation,

The study location: details of the study location: if in health sector, how
many hospitals and primary health care centers (urban & rural). Then, the
details of the department services, reflecting the area of the data collection.

2.4 Sample size

(by epiInfo, http://www.raosoft.com/samplesize.html or other programs)

The goal of sample size estimation is to calculate an appropriate number of

subjects for a given study design.
Mother population: the total population of interest.

The prevalence of the problem (for cross sectional studies): consider

local, national or international. If not possible consider 50% to obtain the
largest sample size.

Confidence level: 90 – 99% (95%).

Error: 1- 10% (5%) or the worse acceptable; (the prevalence ± the error).

For Interventional studies: For interventional studies: The null hypothesis is

set up to be rejected, thus if we want to compare two interventions, the null
hypothesis will be “there is no difference” versus the alternative hypothesis of
“there is a difference”. Thus the sample size should large enough to be able to
detect the hypothesized difference or no difference (in non-inferiority trials).

2.5 Sampling technique

For cross sectional studies:
Simple random: an equal chance to each subject to appear in each draw,
using random number generator (http://www.random.org) or random
number tables or random number calculators.
Systematic random: deciding the factorial by dividing the total population by
the required sample size; (300 / 50 = 6). The index case out of 6 should be
decided randomly; (http://www.random.org).
Proportional sampling: maintain the proportion of the mother population in
the sample; (male & female, multi stage at schools, level, classes and
students.
Cluster sampling: List all the clusters in the population, and from the list,
select the clusters – usually with simple random sampling (SRS) strategy. All
units (elements) in the sampled clusters are selected for the survey.
Stratified sampling: the division of a population into smaller groups known
as strata. The strata are formed based on members' shared attributes or
characteristics. A random sample from each stratum is taken in a number
proportional to the stratum's size when compared to the population. These
subsets of the strata are then pooled to form a random sample.
For Interventional studies:
RCTs: Simple random allocation using a specific program. Or semi or quasi
random allocation (e.g. odds and even numbers or patients on alternate
days…etc,).

2.6 Data collection tool (instrument)

Questionnaire: (Self-administered vs interview questionnaire).

Check list: to collect data from different resources.
Information sheet: suchas school information or performance information
sheets.
Measuring scale: such as height, weight, head circumference and hip-
waste ratio.
Psychiatric scale: such as DSM, GHQ, Rahim scale and Beck depression
inventory.
Others.
VALIDITY OF QUESTIONNAIRES/TOOLS: It is better to use validated tool
(questionnaire) either English or Arabic. However if the tool was constructed
by the investigated it needs to validated ideally by face and content validity by
statistician, or to be tested during the pilot and then validated by 2-3
consultants in the field of specialty.

Translation: translation of an English tool (questionnaire) to Arabic Language

should be translated back to English with a consistency and similarity of
>80% between the two English versions.

2.7 Data Collection technique

A detailed description of the exact method of data collection.

The place, setting, time and the technique of data collection should be
explicitly described. An example ofthe distribution method of the self-
administered questionnaire to emergency physicians: “by submitting it to head
of ER department to be submitted to all ER physicians”. This is different from
meeting these physicians by the investigator in there working hours q8 hourly.
This is also different from sending the questionnaire by mail or by E-mail.

NB. The following are extra items that can be added to help you and the
reviewers clarify the methods:

2.7.1 STUDY PROCEDURES

This section should describe exactly what is going to happen during conduct
of the study. It is preferable to use the active voice and state in the future
tense (e.g. “We will randomly allocate subjects to…”).

2.7.2 STUDY OUTCOMES

a. Primary Outcome

The primary outcome should be the most important and clinically relevant
outcome (e.g. clinical, psychological, economic, or other) of the study. This
isthe measure used to answer your study aim. However, it is also the outcome
used to calculate study sample size and power and test the primary research
hypothesis. Generally, no more than 1-2 primary outcome measures are pre-
specified. Primary outcome measures may be measured in various ways such
as: binary (e.g. caesarean/no caesarean, blood loss ≥500mL/blood loss
<500mL); continuous (e.g. weight - kg, blood loss - mL); ordinal (e.g. pain -
mild, moderate, severe); time to event (e.g. survival), and counts (e.g. number
of infections, number of events occurring).

b. Secondary Outcome(s)
Secondary outcome(s) are measures of additional or less important research
interest. They may include additional clinical, psychological, economic, or
safety outcomes (e.g. treatment related side effects/adverse events).
However, as these endpoints are not used to calculate study power and
sample size it is often not possible to draw robust conclusions from the
results.

2.8 STUDY VARIABLES :

Dependant variable: (the main variable in the study) such as; the condition
of interest i.e diabetes, hypertension, anemia, depression, knowledge,
awareness, control of a disease, level of satisfaction, ….. etc.

Dependant variable can be presented Nominally (anemic vs not anemic) or

anemia by level of hemoglobin or anemia by degree (mild, moderate and
sever)

Independent variables: these include socio demographic variables such as

age, gender, nationality, education, occupation and income. Furthermore,
these may include variables related or claimed to be related or intended to
test their relation to the dependant variables; such as parity with anemia or
breast feeding with enuresis, life style with diabetes or salty food intake with
hypertension.

2.9 DATA ENTRY AND ANALYSIS

Computer programs with versions: (SPSS) statistical program for social

sciences with a version should be specified.

Significance: P –value < 0.05 should be considered for significance.

2.10 PILOT STUDY/PRETESTING

Done on 10% of the sample size only, and among subjects not included within
the actual study. A pilot study should be carried out with the application of the
full methodology and analysis of results. The method, the feasibility, and
duration will be assessed. Necessary changes will be made and described. If
this is not possible, at least pretesting of the study tool should be conducted.
 2.11 ETHICAL CONSIDERATIONS :

 Research committee approval.

 Higher authority approval.
 Local or institutional and departmental approval.
 Written or verbal consents from all participants to be obtained.
 Service to be provided to the participants and or their institution; (H.
education materials, educational sessions and submission of
recommendation).
 Acknowledgments of all supervisors, advisors, helpers, facilitators,
participants and family members indicating their role in the research
process.

2.12 RELEVANCE & EXPECTATIONS :

- What are the possible recommendations from the answer of the

research question?
- What can be added to current literature?
- Importance & impact on the population & the institution.

2.13 . Budget, Fund or Grant:

Usually self-funded, If otherwise declaration of no conflict of interest
might be required.

2.14 . REFERENCES
Use Vancouver style.

3. Annexes