Proposal development
GUIDELINES FOR PROPOSAL DEVELOPMENT
Title page
Table of contents
Abstract
Chapter One: Introduction
Background Information
Problem Statement
Justification
Objectives
Research Question(s)
Hypothesis
Chapter Two: Literature Review
Chapter Three: Materials and Methods
Time Frame
Budget
• References Staszewski S. N., Miller V. A., Savin C. A., Schelcht C., Gute P. T., Hill A. and Phillips A. T. (1999).
CHAPTER ONE
1.0 Introduction
1.1 Background information
1.2
1.3 Objective
CHAPTER TWO
2.0 Literature review,
2.1 United Nations Programme on HIV/AIDS (UNAIDS) launched the “90–
90–90” targets
2.1.1 first line, second line and third line ART regimens.
Background section
• This is not an open-ended literature review. Review the most
relevant literature only.
• Focus on studies that highlight the big picture, and the gap in
knowledge. Be concise!
PROBLEM STATEMENT
• In order for the reader to understand the problem or need, they first need
to know what the ideal situation would look like. Think for a moment, if

your problem or need did NOT exist, what would the situation be like 
Describe this for the reader e.g. low or no cancer cases
• Obviously the current situation is not ideal. Now that you have defined the
ideal for the reader, you can let them know what the problem or need
is.eg cancer cases numerous
• Explain the consequences of not correcting this situation. If you did not
undertake this research and the situation remained uncorrected, what
would be the negative results? Eg impact of rising cancer cases
JUSTIFICATION OF THE STUDY
• SIGNIFICANCE OF THE STUDY/RATIONALE
• When drafting your rationale, start by introducing and describing what
other scholars have written on in your field of study.
• Next, include a discussion of where the gaps in your field's knowledge are
after you've explained the work of previous literature and earlier research.
• Finally, use these to identify future research issues that need to be
addressed and explain why it's important.
• Focus on biomedical, public health, and translational impact
Disease statistics: special demographics (e.g. pediatrics, elderly, pregnant
women, high risk groups, etc)
RESEARCH QUESTIONS
• CONVERT YOUR OBJECTIVES TO QUESTIONS
LITERATURE REVIEW
• Is a critical and in depth evaluation of previous research.
• It is a summary and synopsis of a particular area of
research, allowing anybody reading them to research,
allowing anybody reading them to establish why you are
pursing this particular research
Research aim/General Objective
To assess medication adherence and lifestyle factors among hypertension
patients in Garissa County
What is the state of medication adherence and lifestyle factors among..?
Specific objectives
1.To assess dietary habits among hypertension patients of Garissa
RQ. What are the dietary habits among hypertension patients att…….?
2. To assess physical fitness habits among hypertension patients
RQ. What are the physical fitness habits among hypertension…………?
3. To assess medical adherence practices among
RQ. What are the medical adherence practices……………..?
4. To determine predictors of medicine adherence among
• Research questions
*What are the antibiotic susceptibility patterns of M. tb from
asymptomatic and symptomatic patients attending Mbagathi ?
*What are the factors contributing to the transmission of TB among ?
*What are the knowledge and awareness levels of mycobacterium TB
among people attending for health care services at the hospital and
the surrounding community?
Tips in writing literature review
• Begin with an introduction and end with a summary.
• Use headings and sub-headings.
• Connect between topic and sub-topics.
• Use direct quotations INFREQUENTLY.
• Always cite the sources.
• Include your own knowledge.
• Summarizes each subtopic.
• A transition paragraph from one subtopic to another is
useful.
CONCEPTUAL FRAMEWORK
1.Definition of Conceptual Framework A conceptual
framework represents the researcher’s synthesis of
literature on how to explain a phenomenon. It maps out the
actions required in the course of the study given his
previous knowledge of other researchers’ point of view and
his observations on the subject of research.
2.In other words, the conceptual framework is the
researcher’s understanding of how the particular variables
in his study connect with each other. Thus, it identifies the
variables required in the research investigation. It is the
researcher’s “map” in pursuing the investigation.
• Isolate the important variables. Identify the specific
variables described in the literature and figure out how
these are related.
Major epidemiologic study designs
Study site
* Why is the site suitable for carrying out this study?
* What resources does it have that increase likelihood of study success?
•Study subjects: who & how
* Selection criteria (validity vs efficiency) -
Inclusion criteria (be specific)
* Demographic
* Clinical
* Geographic
* Temporal
* Environmental
Exclusion criteria (be parsimonious)
* Follow up
* Ability to provide good data
* Low risk for side effects
* Unethical to withhold treatment
Sampling method/recruitment plan: describe sequence of events that will take place
Sample size estimation
• Use appropriate formula or sample size table to estimate the sample size.
• Sample size for prevalence studies formula
Sample size calculation ctd’
• Sample size is a research term used for defining the number of individuals
included in a research study to represent a population.
• The sample size references the total number of respondents included in a
study, and the number is often broken down into sub-groups by
demographics such as age, gender, and location so that the total sample
achieves represents the entire population.
•
Determining the appropriate sample size is one of the most important factors
in statistical analysis.
If the sample size is too small, it will not yield valid results or adequately
represent the realities of the population being studied.
• On the other hand, while larger sample sizes yield smaller margins of error
and are more representative, a sample size that is too large may significantly
increase the cost and time taken to conduct the research.
Data collection
* The questionnaire needs to be in a language that
can be understood by the data collectors and
participants
* Decide a priori which measurements are important
* Set operational definitions i.e. the rules &
procedures for making the measurements (SOPs)
* The variables must be defined in terms of events
that are observable by the senses and therefore
measurable.
* Should ensure the highest precision & accuracy
Lab techniques
• These should be:
* sensitive enough to detect differences in the characteristic under measurement
* specific thus representing only the characteristic of interest
* appropriate to the objectives of the study
* able to provide an adequate distribution of responses in the study population to avoid
clustering
* objective by reducing observer involvement & increasing structure and precision of the data
instrument
•Data Management
* Data management ≠ data entry
* Must be able to enter, retrieve and update data
* Easily
* Reliably
* Accurately
* Have a plan that ensures data accuracy, integrity and safety.
•Data analysis
* It is much more than saying that you will use a certain analysis software to analyze your
data.
• o determine the prevalence of Chlamydia trachomatis among asymptomatic pregnant females
attending the antenatal clinic at Jaramogi Oginga Odinga Teaching and Referral Hospital in
Kisumu County.
• Specific objectives
• To assess the demographic characteristics (age, marital status, educational level) of
asymptomatic pregnant females attending the antenatal clinic.
• To explore the risk factors associated with Chlamydia trachomatis infection in asymptomatic
pregnant females.
• To assess the knowledge and awareness of Chlamydia trachomatis infection among
asymptomatic pregnant females.
• To determine the antibiotic susceptibility pattern of Chlamydia trachomatis isolates among
asymptomatic pregnant females.
•
Data analysis
* Never design a study without first knowing how you plan
to analyze the data!
* Choose the most appropriate analytical approach for
meeting your study objectives.
* A data processing and analysis plan:
* will provide you with better insight into the feasibility of
the analysis to be performed as well as the resources that
are required.
* provides an important review of the appropriateness of the
data collection tools for collecting the data you need.
Data analysis - quantitative example
• Final analysis of clinical and laboratory data will be
performed using SPSS and Stata statistical programs.
Paired T-tests and McNemar’s chi-square test will be used
to compare numeric and nominal variables, respectively, in
analyzing baseline characteristics (such as age, education
level, marital status, parity) of women in the two arms to
rule out bias in the selection process. If the randomization
procedure was effective, it is expected that approximately
5% of the characteristics will show differences with P-
values <0.05, and approximately 1% with P<0.01.
Timeline
Month 1 Month 2 Month 3 Month 4 Month 5
-Proposal
devt
-Ethical
approval
seeking
Field site
preparation
-Recruitment
-Recruitment
-Follow-up
-Laboratory
assays for
Aims 1, 2,
and 3
-Recruitment
-Follow-up
-Laboratory
assays for
Aims 1, 2,
and 3
-Data
analysis -Final project
preparation
-Final
research
findings
presentation
Ethical considerations
* Human subjects involvement/ characteristics of study
population
* Recruitment of participants and consent process
* Potential risks
* Potential benefits and importance of knowledge to be
gained
* Inclusion of vulnerable populations: women, children,
minorities, incarcerated individuals
Budget
* Explore costs of items and services
* Write detailed budget justification-for funding proposals
* Enumerate visits
* List all tests (if any) at each visit
* Determine costs for assays – check and double check the math
* Be realistic with estimates and take exchange rate and inflation into consideration
* Determine personnel needs
* Estimate percent effort
* Determine salaries, including benefits
* Beware that this section will change
* Determine equipment and supplies needs
* Computers, printers, audio recording devices
* Any large items needed for the study e.g. vehicle, lab equipment, generator.
• Contingency funds
• FACTORS CONTRIBUTING TO NON ADHERENCE TO TREATMENT
AMONG TB PATIENTS IN PORT- VICTORIA SUBCOUNTY HOSPITAL
• MAIN OBJECTIVE
• To determine factors contributing to non-adherence to medication
among TB patients attending Port Victoria Subcounty Hospital
• Specific
• 1. To determine level of Comprehensive knowledge about tuberculosis among TB patients
• 2. To determine transport barriers to health facility among TB patients attending
• 3. To determine frequency of side effects of anti TB
• Viral load suppression rates among adolescents attending CCC clinic at
Emuhaya sub county hospital
• Main Objective
• To determine viral load suppression rates among adolescents
attending CCC clinic at Emuhaya sub county hospital
• Specific objective
• To determine demographic features and clinical history of adolsc
• To determine effect of length on ART on viral suppression
• To determine effect of psychocial support on

Research proposal development and research

  • 1.
  • 2.
    GUIDELINES FOR PROPOSALDEVELOPMENT Title page Table of contents Abstract Chapter One: Introduction Background Information Problem Statement Justification Objectives Research Question(s) Hypothesis Chapter Two: Literature Review Chapter Three: Materials and Methods Time Frame Budget • References Staszewski S. N., Miller V. A., Savin C. A., Schelcht C., Gute P. T., Hill A. and Phillips A. T. (1999).
  • 3.
    CHAPTER ONE 1.0 Introduction 1.1Background information 1.2 1.3 Objective CHAPTER TWO 2.0 Literature review, 2.1 United Nations Programme on HIV/AIDS (UNAIDS) launched the “90– 90–90” targets 2.1.1 first line, second line and third line ART regimens.
  • 4.
    Background section • Thisis not an open-ended literature review. Review the most relevant literature only. • Focus on studies that highlight the big picture, and the gap in knowledge. Be concise!
  • 5.
    PROBLEM STATEMENT • Inorder for the reader to understand the problem or need, they first need to know what the ideal situation would look like. Think for a moment, if  your problem or need did NOT exist, what would the situation be like  Describe this for the reader e.g. low or no cancer cases • Obviously the current situation is not ideal. Now that you have defined the ideal for the reader, you can let them know what the problem or need is.eg cancer cases numerous • Explain the consequences of not correcting this situation. If you did not undertake this research and the situation remained uncorrected, what would be the negative results? Eg impact of rising cancer cases
  • 6.
    JUSTIFICATION OF THESTUDY • SIGNIFICANCE OF THE STUDY/RATIONALE • When drafting your rationale, start by introducing and describing what other scholars have written on in your field of study. • Next, include a discussion of where the gaps in your field's knowledge are after you've explained the work of previous literature and earlier research. • Finally, use these to identify future research issues that need to be addressed and explain why it's important. • Focus on biomedical, public health, and translational impact Disease statistics: special demographics (e.g. pediatrics, elderly, pregnant women, high risk groups, etc)
  • 7.
    RESEARCH QUESTIONS • CONVERTYOUR OBJECTIVES TO QUESTIONS LITERATURE REVIEW • Is a critical and in depth evaluation of previous research. • It is a summary and synopsis of a particular area of research, allowing anybody reading them to research, allowing anybody reading them to establish why you are pursing this particular research
  • 8.
    Research aim/General Objective Toassess medication adherence and lifestyle factors among hypertension patients in Garissa County What is the state of medication adherence and lifestyle factors among..? Specific objectives 1.To assess dietary habits among hypertension patients of Garissa RQ. What are the dietary habits among hypertension patients att…….? 2. To assess physical fitness habits among hypertension patients RQ. What are the physical fitness habits among hypertension…………? 3. To assess medical adherence practices among RQ. What are the medical adherence practices……………..? 4. To determine predictors of medicine adherence among
  • 9.
    • Research questions *Whatare the antibiotic susceptibility patterns of M. tb from asymptomatic and symptomatic patients attending Mbagathi ? *What are the factors contributing to the transmission of TB among ? *What are the knowledge and awareness levels of mycobacterium TB among people attending for health care services at the hospital and the surrounding community?
  • 11.
    Tips in writingliterature review • Begin with an introduction and end with a summary. • Use headings and sub-headings. • Connect between topic and sub-topics. • Use direct quotations INFREQUENTLY. • Always cite the sources. • Include your own knowledge. • Summarizes each subtopic. • A transition paragraph from one subtopic to another is useful.
  • 12.
    CONCEPTUAL FRAMEWORK 1.Definition ofConceptual Framework A conceptual framework represents the researcher’s synthesis of literature on how to explain a phenomenon. It maps out the actions required in the course of the study given his previous knowledge of other researchers’ point of view and his observations on the subject of research. 2.In other words, the conceptual framework is the researcher’s understanding of how the particular variables in his study connect with each other. Thus, it identifies the variables required in the research investigation. It is the researcher’s “map” in pursuing the investigation.
  • 13.
    • Isolate theimportant variables. Identify the specific variables described in the literature and figure out how these are related.
  • 14.
  • 15.
    Study site * Whyis the site suitable for carrying out this study? * What resources does it have that increase likelihood of study success? •Study subjects: who & how * Selection criteria (validity vs efficiency) - Inclusion criteria (be specific) * Demographic * Clinical * Geographic * Temporal * Environmental Exclusion criteria (be parsimonious) * Follow up * Ability to provide good data * Low risk for side effects * Unethical to withhold treatment Sampling method/recruitment plan: describe sequence of events that will take place
  • 16.
    Sample size estimation •Use appropriate formula or sample size table to estimate the sample size. • Sample size for prevalence studies formula
  • 17.
    Sample size calculationctd’ • Sample size is a research term used for defining the number of individuals included in a research study to represent a population. • The sample size references the total number of respondents included in a study, and the number is often broken down into sub-groups by demographics such as age, gender, and location so that the total sample achieves represents the entire population. • Determining the appropriate sample size is one of the most important factors in statistical analysis. If the sample size is too small, it will not yield valid results or adequately represent the realities of the population being studied. • On the other hand, while larger sample sizes yield smaller margins of error and are more representative, a sample size that is too large may significantly increase the cost and time taken to conduct the research.
  • 18.
    Data collection * Thequestionnaire needs to be in a language that can be understood by the data collectors and participants * Decide a priori which measurements are important * Set operational definitions i.e. the rules & procedures for making the measurements (SOPs) * The variables must be defined in terms of events that are observable by the senses and therefore measurable. * Should ensure the highest precision & accuracy
  • 19.
    Lab techniques • Theseshould be: * sensitive enough to detect differences in the characteristic under measurement * specific thus representing only the characteristic of interest * appropriate to the objectives of the study * able to provide an adequate distribution of responses in the study population to avoid clustering * objective by reducing observer involvement & increasing structure and precision of the data instrument •Data Management * Data management ≠ data entry * Must be able to enter, retrieve and update data * Easily * Reliably * Accurately * Have a plan that ensures data accuracy, integrity and safety. •Data analysis * It is much more than saying that you will use a certain analysis software to analyze your data.
  • 20.
    • o determinethe prevalence of Chlamydia trachomatis among asymptomatic pregnant females attending the antenatal clinic at Jaramogi Oginga Odinga Teaching and Referral Hospital in Kisumu County. • Specific objectives • To assess the demographic characteristics (age, marital status, educational level) of asymptomatic pregnant females attending the antenatal clinic. • To explore the risk factors associated with Chlamydia trachomatis infection in asymptomatic pregnant females. • To assess the knowledge and awareness of Chlamydia trachomatis infection among asymptomatic pregnant females. • To determine the antibiotic susceptibility pattern of Chlamydia trachomatis isolates among asymptomatic pregnant females. •
  • 21.
    Data analysis * Neverdesign a study without first knowing how you plan to analyze the data! * Choose the most appropriate analytical approach for meeting your study objectives. * A data processing and analysis plan: * will provide you with better insight into the feasibility of the analysis to be performed as well as the resources that are required. * provides an important review of the appropriateness of the data collection tools for collecting the data you need.
  • 22.
    Data analysis -quantitative example • Final analysis of clinical and laboratory data will be performed using SPSS and Stata statistical programs. Paired T-tests and McNemar’s chi-square test will be used to compare numeric and nominal variables, respectively, in analyzing baseline characteristics (such as age, education level, marital status, parity) of women in the two arms to rule out bias in the selection process. If the randomization procedure was effective, it is expected that approximately 5% of the characteristics will show differences with P- values <0.05, and approximately 1% with P<0.01.
  • 23.
    Timeline Month 1 Month2 Month 3 Month 4 Month 5 -Proposal devt -Ethical approval seeking Field site preparation -Recruitment -Recruitment -Follow-up -Laboratory assays for Aims 1, 2, and 3 -Recruitment -Follow-up -Laboratory assays for Aims 1, 2, and 3 -Data analysis -Final project preparation -Final research findings presentation
  • 24.
    Ethical considerations * Humansubjects involvement/ characteristics of study population * Recruitment of participants and consent process * Potential risks * Potential benefits and importance of knowledge to be gained * Inclusion of vulnerable populations: women, children, minorities, incarcerated individuals
  • 25.
    Budget * Explore costsof items and services * Write detailed budget justification-for funding proposals * Enumerate visits * List all tests (if any) at each visit * Determine costs for assays – check and double check the math * Be realistic with estimates and take exchange rate and inflation into consideration * Determine personnel needs * Estimate percent effort * Determine salaries, including benefits * Beware that this section will change * Determine equipment and supplies needs * Computers, printers, audio recording devices * Any large items needed for the study e.g. vehicle, lab equipment, generator. • Contingency funds
  • 26.
    • FACTORS CONTRIBUTINGTO NON ADHERENCE TO TREATMENT AMONG TB PATIENTS IN PORT- VICTORIA SUBCOUNTY HOSPITAL • MAIN OBJECTIVE • To determine factors contributing to non-adherence to medication among TB patients attending Port Victoria Subcounty Hospital • Specific • 1. To determine level of Comprehensive knowledge about tuberculosis among TB patients • 2. To determine transport barriers to health facility among TB patients attending • 3. To determine frequency of side effects of anti TB
  • 27.
    • Viral loadsuppression rates among adolescents attending CCC clinic at Emuhaya sub county hospital • Main Objective • To determine viral load suppression rates among adolescents attending CCC clinic at Emuhaya sub county hospital • Specific objective • To determine demographic features and clinical history of adolsc • To determine effect of length on ART on viral suppression • To determine effect of psychocial support on