Introduction
Polycystic ovarian syndrome (PCOS) is one of the common conditions of the endocrine system that affects females of the reproductive system. The condition is caused by hormonal imbalance, particularly the female sex hormones; this imbalance prevents the development and release of female mature eggs, without which fertilization cannot occur (Joham et al, 2015). There is a need to conduct more research on this condition to help create awareness and formulate policies necessary to regulate it. In order to understand the link between this condition and fertility there must be a study design formulated to clearly show whether the condition is associated with infertility or not. Therefore, this paper underscores a critical discussion on the methods and study design to determine the link between PCOS and fertility.
Study population
This study, to begin with, will target adult female between the ages of 18 to 30. The females are the target population for this study because Polycystic ovary syndrome is solely associated with the female population and not the male (Joham et al, 2015). Female population of age 18 to 30 will be the ones involved in the study because this is the age where most women are believed to conceive. The study population will cut across all ethnic and social boundaries to be as inclusive as possible.
Inclusion criteria
The study will include patient who have been previously diagnosed with PCOS or those who have symptoms associated with the condition. Awareness creation will be conducted after which the subjects in this case, the patients will be allowed to consent to be art of this study. Moreover, any patient who falls within the mentioned specification but refuses to consent to being one of the study participants will be excluded from the study (Gignac & Szodorai, 2016). This will help confine the study to those patients who either have the symptoms, for example irregular periods, have consented to the study or those confirmed to have the condition hence making the study as objective as possible. The data containing the names of the case group will be obtained from local hospitals; the hospitals that will be included in the study will be randomly selected using random selection software with the target number being six (6). These hospitals must be evenly distributed across the area of study.
Sample Size DeterminationAdequate sample size shall be determined according to Pourhoseingholi, Vahedi and Rahimzadar (2013) on cross-sectional studies.
n=z2p1-pd2Where n is the sample size,
z is the statistic corresponding to level of confidence,
p is expected outcome (that can be obtained from same studies or a pilot study conducted by the researchers), and
d is precision (corresponding to effect size).
The level of confidence aimed is 95%.
Assumed p is 10%
Precision of 15%
Study design
Case control study design will be used in this study. The study design compares patients who have an outcome of interest/the disease of interest, named cases with patients who do not have the disease or outcome of interest (controls). The study design then looks back retrospectively to compare how frequently the exposure to a risk factor is present in each group to determine the relationship between the risk factor and the disease (Tetnowski, 2015). Case control study is mainly observational because no intervention is attempted nor is any attempt made to interfere with the course of the disease. The study is mainly designed to estimate odds with its goal being to retrospectively determine the exposure to the risk factor of interest from each of the two groups of individuals: cases and controls (Limmanthurotsakul, et al., 2016).
In order to understand the relationship between PCOS and fertility, two distinct groups will be involved in the study. The first group will be women between the age of 18 to 30 who have been confirmed to have PCOS or who show any symptom of the disease. The second group will be women of the same age bracket who neither shows symptoms for the disease nor have been diagnosed with PCOS. Individuals in the two groups under investigation must have attempted or desire to conceive (Tetnowski, 2015).
Case control study will allow clear observation of the relationship between PCOS and fertility after comparing the data obtained from those women that have the condition and those that do not. The data containing individuals diagnosed with PCOS will be obtained from a referral hospital database after acquisition of ethical clearance from the relevant government body as well as the institution; this will make it easy to approach and include this patient in the study. The study will be conducted with the help of hospital staff mainly nurses who have interacted with these patients in order to make them feel more comfortable participating in the study. The control group will conduct random selection and approach the sampled group to consent to the study.
Sampling procedure
Sampling is the process of taking a portion of a population and considering it as a representation of the entire population. Any study conducted on the sample population inferred or generalized to the larger population (Chaudhuri, 2016). The respondents will be selected using a register fed into an excel run random number generator. Stratified sampling techniques will then be used to divide the samples into manageable groups to make it easier to study. Non-probability sampling approach will also be used since the population of the target groups is large and therefore a representative sample is convenient, and the population of interest relatively homogeneous therefore any kind of sample chosen could well represent the entire population.
Research Instruments
Questionnaires and interviews will be the two main research instruments, which will be used to collect data during this study. Questionnaires are basically a collection of written questions to which the respondents are required to respond to (Leutner,et al, 2017). Data will be collected through self-administered semi-structured questionnaires. A semi-structured questionnaire is convenient since respondents get an opportunity to seek clarifications on issues not well understood.
Research assistants will be used to help in data collection.
The form of the questionnaire will be standard to all respondents because:
- It will facilitate the process of getting the responses from different people/respondents but to the same set of questions.
- Standardized procedures enable the completion of data collection in good time and the collection of accurate data for the analysis.
- Standardized data collection procedure also helps achieve speed and accuracy in handling the data especially in analysis as opposed to collecting data in whatever form chosen.
- The questionnaire items are developed from a review of the available literature.
- It will be pre-tested outside the study area to ensure that any omissions and/or mistakes made in the preparation are corrected early enough. The questionnaire also provides spaces for writing answers to the questions as appended.
Validity of the Instruments
Validity of the questionnaire will be established in two ways in order to determine the accuracy of the instrument. Content validity: The Supervisor will be given the questionnaire to go through and make suggestions on the adjustments to be made. Face validity: This will be done by piloting the questionnaire to randomly selected individuals and officers within the hospital to find out the questions interpretations and perceptions.Questionnaire AdministrationResearch assistants will carry out the administration of the questionnaire to the sampled population. Research supervisors and a quality control assistant will oversee the quality of their work. There will also be 15 key informant interviews on the various stakeholder persons including medical doctors, nurses, as well as medical research scientists. This will help gather professional input on the possible outcome of the study. Their opinions will play a key role in putting the data obtained into understandable information that can help in policy formulation. Two sets of questionnaires will be formulated with one used to obtain data from the case group and the other used to obtain data from the control group. The two data sets will then be compared to find out if there exist any relationship between PCOS and infertility.
Data Analysis and Presentation
Descriptive data analysis will be used in the analysis of the data obtained. This includes proportions, means, percentages and cross tabulation of data of the various groups that will be interviewed to provide a deeper understanding of the data (Taylor & Bonsall, 2017). Correlation analysis will also be used to help determine the relationship between the variables. The five point like type of profile will be used in the study to test for any differences between various groups of respondents. Since the study is descriptive in nature, this approach is deemed appropriate
During data preparation, the data will be edited, coded, and tabulated using the SPSS software. This stage is important since it helps eliminate the errors in the data and simplifies the handling of the actual analysis step. In the interpretation stage, data will be compared and related to the study objectives, hypotheses and to other existing information in the area of study.
Conclusion
In conclusion, the condition is common among women of the reproductive age and affects approximately 5 to 10% of young women. Some of the symptoms of PCOS include; abnormal hair growth, irregular periods, ovaries containing multiple small cysts and acne. Research shows that 2.2 to 26.7 percent of young women between the ages of 15 to 44 have PCOS; many of these women do not even know that they are suffering from the condition. Therefore, a research design such as this need to be implemented to manage the condition.
References
Chaudhuri, A. (2016). Randomized response and indirect questioning techniques in surveys. Chapman and Hall/CRC.
Gignac, G. E., & Szodorai, E. T. (2016). Effect size guidelines for individual differences researchers. Personality and individual differences, 102, 74-78.
Joham, A. E., Teede, H. J., Ranasinha, S., Zoungas, S., & Boyle, J. (2015). Prevalence of infertility and use of fertility treatment in women with polycystic ovary syndrome: data from a large community-based cohort study. Journal of women's health, 24(4), 299-307.
Leutner, D., Fleischer, J., Grunkorn, J., & Klieme, E. (Eds.). (2017). Competence assessment in education: Research, models and instruments. Springer.
Taylor, M. A., & Bonsall, P. W. (2017). Understanding traffic systems: data analysis and presentation. Routledge.
Tetnowski, J. (2015). Qualitative case study research design. Perspectives on Fluency and Fluency Disorders, 25(1), 39-45.
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