1. Study Population
Describe the specific group of individuals or entities your study will focus on. Include demographic details such as age, gender, health status, or other relevant characteristics. Justify why this population is relevant to your research question.
Example:
“The study population will include adults aged 50 to 75 years diagnosed with chronic obstructive pulmonary disease (COPD) who are receiving treatment at XYZ Clinic. This age group is targeted due to the higher incidence of COPD and its impact on quality of life.”
2. Study Area
Specify the geographic location and/or institutional setting where the study will be conducted. Mention any particular features of this area that make it suitable for your research.
Example:
“The study will be conducted in the urban slum areas of City ABC, where access to healthcare services is limited. This setting is chosen to evaluate the effectiveness of a new mobile health intervention.”
3. Study Design
Outline the type of study design you will use (e.g., cross-sectional, cohort, case-control, randomized controlled trial) and explain why this design is appropriate for addressing your research question.
Example:
“This will be a randomized controlled trial (RCT) to evaluate the efficacy of a new antihypertensive medication. The RCT design is selected to minimize biases and provide high-quality evidence on the medication’s effectiveness.”
4. Study Duration
Detail the timeline of the study, including start and end dates, and any significant phases or milestones.
Example:
“The study will span 18 months, beginning in March 2025 and concluding in September 2026. The duration includes a 6-month recruitment phase followed by a 12-month intervention period and data analysis.”
5. Sample Size
Describe how many participants will be included in the study and the rationale behind this number. Mention any statistical calculations or methods used to determine the sample size.
Example:
“Based on a power analysis, a sample size of 200 participants is required to detect a significant difference in outcomes with 80% power and a 5% significance level. This number accounts for potential dropouts and ensures the study’s robustness.”
6. Inclusion and Exclusion Criteria
Define the criteria for selecting participants for the study and any reasons for excluding certain individuals. This helps in ensuring that the study sample is representative and appropriate for the research objectives.
Example:
“Inclusion criteria: Adults aged 50-75 with a diagnosis of COPD and stable medication regimen. Exclusion criteria: Individuals with comorbidities that could interfere with the study outcomes, such as advanced heart disease or cancer.”
7. Study Procedure
Detail the step-by-step process of how the study will be conducted, including recruitment, intervention (if applicable), and follow-up procedures.
Example:
“Participants will be recruited through clinic referrals and advertisements. After obtaining informed consent, they will be randomly assigned to either the intervention or control group. The intervention group will receive the new medication for 6 months, while the control group will receive a placebo. Follow-up assessments will be conducted at 3 and 6 months.”
8. Data Collection Tools
Specify the tools and methods used to collect data, such as surveys, interviews, laboratory tests, or other instruments. Mention any validated tools or procedures.
Example:
“Data will be collected using a combination of structured questionnaires, physical health assessments, and laboratory tests. The questionnaires have been validated for reliability and validity in similar studies.”
9. Outcome Variables
Identify the primary and secondary outcome variables that the study will measure. Explain how these variables will be assessed and their relevance to the research question.
Example:
“The primary outcome variable is the reduction in systolic blood pressure, measured using an automated blood pressure monitor. Secondary outcomes include changes in cholesterol levels and quality of life, assessed using standardized questionnaires.”
Read Also :-
- The Art of Writing Aims and Objectives in Research
- Crafting the Perfect Research Introduction: A Guide for Medical Researchers
- Mastering Protocol Writing for Medical Research
- The Art of Reviewing Literature
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