Diploma in Midwifery
Methodology
Table of Contents
CHAPTER THREE:
Note: This chapter is crucial, often the longest, and heavily assessed. Pay close attention to the details within.
3.1 Introduction
This section provides an overview of the methodological approach employed in the study. It outlines the specific procedures, techniques, and strategies that will be used to gather and analyze data. In essence, this chapter details how the research will be conducted, ensuring that the findings are both valid and reliable. It acts as a roadmap for the entire research process.
3.2 Study Design and Rationale
The study design defines the overall structure and strategy of the research, encompassing the methods, approaches and justifications for choosing a particular design. It clarifies the framework for the data collection, sampling process and the analysis procedures. There are various types of study designs, each appropriate for different research questions:
Quantitative designs focus on numerical data and statistical analysis to identify patterns and relationships.
Qualitative designs explore in-depth, non-numerical data to understand experiences, perspectives and meanings.
Mixed methods designs combine both quantitative and qualitative approaches to provide a more comprehensive understanding of the research problem.
It’s important to choose the most suitable design for your research and clearly justify your decision by specifying why a particular design has been selected and explaining its suitability for the research question.
Example:
“This study will employ a cross-sectional descriptive design because it aims to assess [the specific outcome] at one point in time. This design is appropriate as it allows for the examination of the prevalence and distribution of [variables of interest] within the study population.”
3.3 Study Setting and Rationale
This section identifies the specific location or environment where the research will be conducted. The description of the study setting should include important contextual information about the area and the research site. Crucially, this section also provides a justification why this particular setting was chosen, for example:
Accessibility: Is the setting easily accessible and convenient for data collection?
Relevance: Does the setting contain the characteristics or population of interest to the study?
Feasibility: Does the setting enable the researcher to efficiently and ethically carry out the study.
Example:
“This study will take place at the Maternal Health Clinic of [Hospital Name] located in [Location details]. This setting was chosen because it serves a high volume of pregnant women who meet the specific criteria of our research and it has readily accessible records essential for the study”.
3.4 Study Population
The study population represents the entire group of individuals or entities to which the research findings are intended to be generalized. It is the entire collection of potential participants that a researcher is interested in studying. It’s important to clearly define the characteristics of the target population, the inclusion criteria and the justifications for it.
Example:
“The study population will consist of all adults diagnosed with Type 2 Diabetes attending the outpatient clinic at [Hospital Name] between [Specific dates]. This population was selected as it provides a relevant and accessible group of individuals for studying the impact of [specific factor].”
3.4.1 Sample Size Determination
This section describes the process used to determine the number of participants needed for the study. This is a crucial step for ensuring statistical power and validity. The sample size should be large enough to allow the researcher to obtain reliable and generalizable results. To calculate the sample size, various methods can be applied including formulas or online calculators.
3.4.2 Sampling Procedure
This section describes the method used to select participants from the study population. It should include the explanation for choosing the chosen sampling method. It should also describe the steps involved in selecting the sample and the justifications for choosing that approach.
Probability sampling methods (e.g., simple random sampling, stratified sampling) ensure every member of the population has a known chance of being included.
Non-probability sampling methods (e.g., convenience sampling, purposive sampling) are used when probability sampling is not feasible or when specific groups are needed.
3.4.3 Inclusion Criteria
These are the specific characteristics a potential participant must have to be included in the study. The criteria should be clearly defined and justified based on the research objectives. Such characteristics could include age, gender, diagnosis, or any other parameters relevant to the research.
Example:
“Participants will be included in the study if they are adults over the age of 18 years, have a confirmed diagnosis of [Disease/Condition], and have been receiving treatment at the specified clinic for at least six months.”
3.5 Definition of Variables
This section clearly defines all variables under investigation, specifying how each will be measured. A variable is a characteristic or attribute that can vary among individuals or entities. Variables should be defined both conceptually (theoretical meaning) and operationally (how they will be measured practically).
Example:
“The dependent variable in this study is [Specific outcome], which will be operationally defined as [Specific measurements or indicator]. The independent variables include [Specific factors] , which will be measured using [Instruments or scales].”
3.6 Research Instruments
This section identifies and describes the tools used to collect data. Research instruments can include:
Questionnaires: Sets of questions administered to participants.
Interviews: Structured or unstructured conversations with participants.
Observations: Systematic recording of behaviors or events.
Medical records: Patient data or lab results.
Each instrument should be explained in detail, stating its purpose, design, and evidence of its validity and reliability (if available). Justifications for each instrument should also be included.
3.7 Data Collection Procedure
This section provides a step-by-step description of how the data will be collected. This includes how the participants were recruited, how the instruments were administered, and any specific protocols or timelines followed. It must be detailed enough to allow for replication by other researchers.
3.7.1 Data Management
This section describes how the collected data will be handled. This usually includes:
Data Storage: outlining methods for securely storing data, ensuring confidentiality.
Data Cleaning: detailing procedures for ensuring data accuracy by addressing errors or inconsistencies.
Data coding and Entry: Explaining how data is formatted for analysis.
3.7.2 Data Analysis
This section explains how the collected data will be analyzed, including the techniques and statistical software used. It should also specify how the analyzed data will be presented.
3.8 Ethical Considerations
This section describes the ethical measures taken to protect the participants in the study. This should include explaining:
Informed Consent: How consent will be obtained, ensuring participants are fully informed about the study and its risks.
Confidentiality: How participants’ data will be kept private and secure.
Anonymity: How participants’ identities will be protected.
Risks and Benefits: Description of any potential risks or benefits for study participants.
Approval: Ethical clearance process for the study, often from an institutional review board
3.9 Limitations of the Study
This section acknowledges potential limitations of the research, such as sampling biases, data collection constraints, or generalizability issues. Acknowledging these limitations shows an honest assessment of the research.
3.10 Dissemination of Results
This section describes how the study findings will be shared, for example through:
Publications: Submitting research articles to journals.
Conferences: Presenting research at academic meetings.
Reports: Sharing findings with stakeholders and the community.
By outlining these dissemination plans, the researcher demonstrates the commitment to making the research findings accessible and useful for future research and practice.
Probability Sampling Techniques:
Simple Random Sampling: Every individual in the population has an equal chance of being chosen. This is often achieved through random number generators.
Systematic Sampling: Participants are selected at regular intervals from a list (e.g., every 5th person). The starting point is chosen randomly, then we proceed systematically.
Stratified Sampling: The population is divided into subgroups (strata) based on relevant characteristics (e.g., age, gender), and a random sample is then taken from each stratum, ensuring representation of all groups.
Cluster Sampling: The total population is divided into clusters and a random sample of clusters is selected. All units within the selected clusters are included in the sample.
Non-Probability Sampling Techniques:
Convenience Sampling: Participants are selected based on their accessibility and availability, such as individuals who are easy to reach or readily available.
Purposive/Judgmental Sampling: Researchers choose participants based on specific knowledge or traits, useful for selecting individuals who possess specific expertise.
Snowball Sampling: Initial participants refer other potential participants who meet the study criteria, often used when reaching the target population is difficult.
Quota Sampling: Researchers select participants until predefined quotas are met (e.g., a specific number of men and women). This aims to achieve representation of certain characteristics in the sample.
How Subjects Will Be Selected:
Clearly explain the process of participant selection, specifying the method you have chosen. For example, you might state that: “A proportionate quota sampling method will be utilized to ensure the inclusion of representative clients from each of the different first-line ART regimens. This involves determining the proportion of patients on each regimen within the total clinic population and sampling accordingly to ensure our study sample is reflective of the proportions in the clinical setting”
Rationale for Procedure:
Provide a clear explanation of why you chose a particular sampling method, supporting your choice with a justification or explanation, that is suited to the research question, population and resources. For example, you might state: “Proportionate quota sampling was chosen as it ensures the sample is representative of the diverse groups of first-line ART regimen users at the clinic, and allows for analysis across different treatments while maintaining a manageable sample size”
This section details the specific characteristics that prospective participants must possess to be included in the study. It explicitly defines who is eligible and who is not eligible. Participants that are not eligible will be excluded from the study.
Inclusion Criteria: These are specific criteria or qualifications that individuals must meet in order to be included in the study. The criteria should be measurable, observable, or documented. These criteria might encompass demographics, health conditions, or treatment histories.
Example:
For example, you might specify: “Participants eligible for this study must be clients currently receiving a first-line ART regimen for at least three years and must be actively attending the ART clinic at Kayunga Hospital during the period of data collection. Additionally, participants must be 18 years of age or older, which aligns with the legal age of consent as defined by the Ugandan constitution”.
Variables are measurable characteristics that change or have different values for different subjects in a study.
The concept of a variable is that it is something that varies/changes. It’s a value of interest to the researcher, and the researcher investigates the relationship between these variables.
Types of Variables:
Dependent Variable: This is the variable you are measuring and expect to be influenced by other variables.
Independent Variable: This is the variable you manipulate or change to see if it has an impact on the dependent variable.
Intervening Variable: Also called mediating variables, influence the relationship between the dependent and independent variable.
Defining Your Variables:
Clearly define the dependent and independent variables of your study.
Example:
For instance, “The dependent variable of this study is the virological outcome, specifically the level of viral load. Viral load refers to the measured amount of Plasma HIV-1 RNA and is measured in copies per milliliter (copies/ml). A viral load measurement of >5000 copies/ml at 12 months following initiation of antiretroviral treatment will be defined as virological failure, which is in accordance with WHO recommendations for resource-limited countries.”
This section identifies and describes the tools that will be used to gather the necessary data for your research, enabling you to achieve your objectives.
Common Research Instruments:
Questionnaires: Structured sets of questions used to collect data from participants.
Interviews: Conversations with participants to gather in-depth data.
Checklists: Standardized lists used to record the presence or absence of certain characteristics or events.
Standardized Tests: Predesigned assessments with established validity and reliability used to measure a participant’s knowledge, abilities, or other characteristics.
Explanation of Instruments:
Clearly describe the specific instruments you will use to gather data, detailing the tool and how it will be employed for your study.
Example:
For example, “This study will use a questionnaire that incorporates both open and closed-ended questions written in straightforward language. The researchers and their assistants will administer this questionnaire using patient’s files and through direct interviews with clients. The questionnaires will be pre-tested prior to the study to assess for any ambiguity or errors and to enable adjustment and corrections to be made”
Questionnaires:
Questionnaires are a way of gathering data from people by asking questions. The questions can either have predetermined answers or be open ended, it’s a systematic way of getting information from a group of people.
Types of Questionnaire Administration:
Self-Administered: Participants fill out the questionnaires independently.
Researcher-Administered: The researcher reads out questions and records participants responses, in this case, the researchers fill the questionnaires based on responses from participants.
Question Types:
Closed-ended: Participants choose from a list of given answers.
Open-ended: Participants provide their answers in their own words.
Advantages and Disadvantages of Questionnaires
| Self-Administered Questionnaires | Researcher-Administered Questionnaires | |
| Advantages | ||
| Convenience: Participants can complete questionnaires at their own pace. | Clarification: Researchers can clarify questions for better understanding. | |
| Privacy: Respondents may feel more comfortable answering sensitive questions privately. | Improved Response Rates: Higher motivation from researcher interaction can increase response rates. | |
| Time Flexibility: Participants choose when to complete the survey. | Thorough Responses: Allows probing to ensure thorough and accurate answers. | |
| Cost-Effective: Eliminates researcher presence, reducing data collection costs. | Controlled Environment: Researchers can control the survey environment. | |
| Large Sample Size: Suitable for geographically dispersed samples. | Data Quality Control: Offers better control over data quality and completeness. | |
| Reduced Researcher Bias: Participants may provide more candid responses. | Clarify Ambiguity: Ability to probe and clarify ambiguous answers. | |
| Disadvantages | ||
| Non-Response Bias: Response rates may be lower and potentially biased. | Time-Consuming: Researcher presence makes data collection more time-intensive. | |
| Misinterpretation: Participants might misunderstand questions. | Researcher Influence: Presence of a researcher can influence participant responses. | |
| Incomplete Responses: Respondents may skip or provide incomplete answers. | Resource Intensive: Can be costly due to resources needed for administration. | |
| Low Control: Researchers have limited control over the survey environment. | Limited Anonymity: Reduced anonymity might affect the honesty of responses. | |
| Limited Probing: Researchers cannot probe for further clarification. | Geographical Constraints: Participant availability can be limited geographically. |
Interview Guides: Structured or semi-structured frameworks to guide the conversation, ensuring key areas are explored.
Focus Group Discussion Interviews: Group discussions (typically 5-10 participants) to explore shared opinions and generate a deeper understanding of a topic through interaction.
Also known as observation forms, these tools allow researchers to record specific behaviors, events, or conditions.
Researchers use checklists to note whether a specific action or event occurred. often followed by rating scales, or scoring.
These are tools designed to assess abilities or knowledge in a consistent, objective way, using the same criteria for all participants.
Example, IQ tests or cognitive assessments of children to measure overall cognitive abilities.
This section details the practical steps involved in gathering data from participants using your selected tools.
It should explain how each tool will be used to collect the necessary information and must be appropriate to your research design and approach.
For Example: It may describe how ethical approvals were obtained, how participants were recruited, and how consent was secured prior to the commencement of data collection activities.
This focuses on the processes of ensuring data quality and accuracy before analysis.
Data cleaning involves checking for errors, inconsistencies, and missing information to ensure the data is reliable.
Explanation must describe how you will protect and manage your data before entry into analysis software.
For example: describes the steps taken to ensure data completeness, security, and how it will be stored before entry into a statistical software package.
This outlines the methods used to transform collected data into meaningful findings.
It involves analyzing clean data to identify patterns, trends, and relationships, which are interpreted to answer research questions or test hypotheses.
The section should explain how the data will be analyzed to generate findings.
For example: Describes the statistical software, specific analyses to be performed, and how the findings will be presented (e.g., tables, charts, graphs).
This section addresses the protection of human subjects in research.
It should include informed consent, confidentiality, privacy, and oversight from ethics committees.
Explains the measures taken to uphold ethical guidelines and protect the rights and well-being of research participants.
For Example: describes the process of obtaining ethical approval from relevant committees and seeking permission from institutions before conducting the research.
This highlights potential challenges or constraints that might impact the study’s validity or generalizability.
Acknowledging limitations demonstrates the researcher’s awareness of potential biases or weaknesses in the study.
It will explain how these constraints were addressed.
For Example: The researcher identifies time constraints as a potential challenge and details the use of a time table as a solution.
This outlines how the research findings will be shared with relevant audiences.
It emphasizes the importance of sharing research results to contribute to the body of knowledge.
It can include reports, journals, conferences etc.
For Example: The researcher may have detailed which organizations will receive a copy of the final research report.
This section contains all sources cited, used, or referred to in the research proposal.
It’s essential to ensure accuracy and consistency in the referencing style. (APA style is preferred)
It should include a complete list of all citations made in the text.
A sample list of properly formatted references should be provided.
This is where you place supplementary material relevant to the research proposal.
It may include budget, work plan, consent forms, data collection tools, or other necessary documents.
These provide additional context and detail not included in the main body of the proposal.
Informed consent is the voluntary agreement given by a participant to take part in research after being fully informed about the study. This means participants understand the research’s purpose, procedures, potential risks, and benefits, and agree to participate freely, with full awareness of the consequences.
A consent form serves as documented proof that the informed consent process has occurred, demonstrating that the participant has been made aware of, and agrees to, all aspects of the study.
A consent form should include the following elements to ensure that participants are fully informed and have given valid consent:
Study Purpose: A clear and concise explanation of the research’s purpose, including the study’s title, and what the research intends to achieve.
Procedures and Time Commitment: A detailed description of the procedures participants will undergo during the study. It should specify what is involved in each step, and how much time each will take.
Potential Risks, Side Effects, or Discomfort: An explanation of any possible risks, side effects, or discomfort participants might experience during the study, ensuring the are aware of all potential negative aspects.
Potential Benefits: An outline of any benefits participants may expect to gain from their involvement in the research.
Voluntary Participation and Right to Withdraw: A declaration stating that the participant’s involvement is entirely voluntary. It should explicitly mention the right to withdraw from the study at any time without negative consequences.
Right to Ask Questions: A confirmation that participants are allowed to ask any questions they have about the study at any point in time.
Confidentiality Measures: An explanation of the measures in place to protect participant confidentiality, such as how personal data will be stored and used.
Data Usage Post-Study: An explanation of how the collected data will be used after the conclusion of the study.
Copy of Consent Form: Confirmation that the participant will receive a copy of the signed and dated consent form for their records.
Investigator Information: The full name and contact details of the lead researchers.
Statement of Consent: A clear “statement of consent” section that the participant can agree to by signing the form, including their printed name and signature.
Person Obtaining Consent: Identification and signature of the person who obtained consent from the participant.
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