CD4+ T cell count ≥ 300 cells/mm
Body Mass Index 20-29 kg/m
Adapted with permission:(Cummings, 2013)
The inclusion criteria describe the study participants that fulfill the needs of the clinical research question. Commonly used elements for the inclusion criteria include demographic characteristics, clinical attributes, geographic factors, and temporal considerations ( Panacek & Thompson, 2007 ) ( Hulley et al., 2013 ). Defining the inclusion criteria helps to maintain a degree of homogeneity among the accessible population and narrows the available pool of eligible study participants that reflect the study question ( Panacek & Thompson, 2007 ). The inclusion criteria should also address the capacity of the participant to understand the study goals, the study requirements (i.e., attending study visits, completing questionnaires, blood draws, taking study medications), and the potential risks associated with joining a study.
For example, the study exploring the efficacy of over-the-counter fish oil supplementation among HIV+ individuals with high triglyceride considers an age limitation since fish oil can reduce the CD4+ level, and advanced ages are associated with the accelerated loss of the CD4+ level. A triglyceride parameter (fasting serum triglyceride levels between 150-500 mg/dl) is also required to capture participants with the condition, yet limits those with extremely elevated levels and likely eligible for prescription fish-oil treatment. Additionally, parameters for the CD4+ level (CD4+ T cell count ≥ 300 cells/mm 3 ) is necessary to ensure the participants' immune systems are stable. Travel to the study sight is another vital consideration. Geographic limitations are essential if virtual study visits (i.e., web-based interventions) are not possible, and face-to-face interactions are necessary. Using geographic boundaries may reduce missed study visits due to the distance of the study sight from participants' homes. An example of a temporal characteristic using the sample study is the requirement to wait for a minimum of six months or more after starting a new HIV drug regimen. The waiting period reduces the likelihood that the elevated triglyceride level was a temporary elevation and returns to normal levels once the proper dosage achieved.
The informed consent process is the final consideration for the inclusion criteria. A future article in this series will discuss the ethics, including concerns relating to the potential for coercion or undue influence, and the ability of the study participant to provide verbal and written consent.
The exclusion criteria contain the characteristics of the potential study participant who meet the inclusion criteria but have conditions that could affect the outcome of the study in terms of the success or the increased risks of possible adverse effects ( Patino & Ferreira, 2018 ). Therefore, the exclusion criteria is a mechanism to reduce potential study risks and reduce potential confounding variables ( Panacek & Thompson, 2007 ). Confounding variables may affect the outcome of interest (dependent variable), as in the sample study, the triglyceride level is the dependent variable. Therefore, potential participants using fish oil are not eligible to join.
In formulating the exclusion criteria, Hulley and colleagues (2013) recommend considering factors that increase the likelihood of loss to follow-up, the inability to provide necessary data, and the high risk of possible adverse effects related to co-morbidities or current treatments.
In continuing the HIV and high triglyceride example, participants actively abusing alcohol and illicit substances are not eligible to join this study. The chronic use of some substances can lead to changes in the brain and linked with the development of mental health issues such as paranoia, hallucinations, and other problems (National Institute on Drug Abuse (NIDA) ( NIDA, 2017 )). The use of illicit substances can potentially limit a participant's ability to comprehend and comply with the study requirements. The use of a measurement tool that examines attention, recall, and calculation and excluding participants who score below a required screening threshold (less than 23 on the Mini-Mental State Examination ( Folstein et al., 1975 )) is one method to screen for cognitive impairment and hopefully increase the likelihood for obtaining the required data. Participants with diabetes mellitus are excluded from the study to prevent possible adverse effects since fish oil can raise blood glucose levels and not safe for such participants.
For a new clinical research study, reviewing published studies with similar study participants and objectives can assist in formulating the eligibility criteria. Examine the approaches used in such investigations. Assess the data on the retention of the participants and evaluate the reasons for lost-to-follow-up. Much can be learned from the experiences of previously conducted studies to assess if methods were successful and allow investigators to apply useful strategies to their new study.
Defining the eligibility criteria requires a delicate balance between restrictive and less restrictive. A restrictive criterion can make participant recruitment and enrollment more difficult since the study requirements can reduce the eligible participant pool. Additionally, the restrictive criteria might impact the time-frame to complete the study, as well as the workforce needed to recruit and to enroll study participants, requiring more time and staff to complete. On the other hand, a less stringent eligibility criterion is often easier to recruit and to enroll participants and can increase the generalizability of a study, but can leave it open to more confounding variables and a heterogeneous participant pool ( Gallin et al., 2018 ).
During the development of the eligibility criteria, review the Code of Federal Regulations (CFR) 45 , which focuses on the protection of human subjects. Since institutional review board (IRB) approval is mandatory for all clinical research studies, IRBs will assess study protocols to ensure it meets the CFR 45 requirements before approving. CFR 45 focuses on the unbiased selection of study participants centered around gender, race, ethnicity, religion, nationality, and other factors ( Gallin et al., 2018 ). CFR 45 stipulates that all eligible study participants are considered unless there is a compelling safety or scientific rationale for excluding them ( Gallin et al., 2018 ). For example, a prostate cancer study can reasonably exclude women since the disease under study is gender-specific. A case to prohibit pregnant women might involve studies with known risks to maternal and fetal health.
In writing the eligibility criteria, use bullets or a numbered list ( Gallin et al., 2018 ). This format makes it easier for IRB review and implementation. A printed or an electronic version of the eligibility criteria placed near the telephone, computer, or participant screening area can provide an excellent guide for study team members to review the study criteria and reduce the chances for incorrectly enrolling ineligible participants.
Formulating the recruitment process occurs after the development of the eligibility criteria. The study protocol provides the details of the procedures the research team undergoes to recruit and to enroll study participants. In designing the recruitment plan, consider the anticipated participant accrual rate, which includes the number of participants enrolled per month/year and how long it will take to complete the recruitment goals. Additionally, other critical components of the recruitment process include the identification and the recruitment of participants, and the methods to advertise the study and the evaluation of the recruitment plan ( Gallin et al., 2018 ; University of Rochester, 2018 ).
Describing the specifics of how and where to obtain eligible study participants are also essential components of the study recruitment section. Details include the methods to approach the participants and the setting (i.e., clinic setting, research site). For example, in recruiting for the HIV+ adults with high triglycerides, flyers, and brochures were developed and sent to local HIV clinics in the New York City (NYC) area to promote the availability of the study. Potential participants called the research center to inquire about the HIV study; hence the participants initiated the process to join the research study.
Recruitment materials should include the title of the protocol, IRB study number, the sponsoring institution, contact information, purpose of the research (i.e., HIV+ adults with high triglycerides) and indicate whether compensation for time and effort is given to the study participants ( University of Rochester, 2018 ; Gallin et al., 2018 ). All methods to advertise or promote the study requires IRB approval before implementation. Some examples of recruitment materials include the telephone script used to discuss the study, and flyers, posters, postcards, newspaper advertisements, press releases, website advertisements, electronic mailings and social media blogs, and tweets ( Gelinas et al., 2017 ; University of Rochester, 2018 ). Each IRB may require specific information for recruitment materials to obtain approval.
Most institutions publish their IRB requirements online; therefore, to ensure a smoother review process, read the guidelines associated with each IRB institution. Participant recruitment is often one of the most challenging aspects of conducting clinical research. Delays in participant enrollment account for up to 60% ( Gelinas et al., 2017 ) of issues encountered in clinical research; therefore, a well-thought-out and feasible recruitment plan is vital.
The development of the eligibility criteria is a complex process that can affect participant recruitment, enrollment, and study completion. Reviewing the literature for research studies similar to the proposed target population is an excellent method to identify appropriate eligibility criteria. Developing a feasible recruitment plan in terms of selecting the suitable participant pool and approaches to recruit and enroll the eligible participants is at the cornerstone for implementing a successful study.
This manuscript is supported in part by grant # UL1TR001866 from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program.
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In this paper the concepts of general, target and accessible population are explained in response to misconceptions and controversies associated with them, and the fact that the relationships between them have not been explained in the context of qualitative enquiry in any formal study. These concepts are discussed in this study based on a general scenario. We basically attempt to explain the importance of specifying the general, target and accessible populations in a qualitative study when the study population is large. The study depicts how the research goal, contexts and assumptions can dictate the content and concentration of the target and accessible population in qualitative inquiry. It also poses the sampling implications of our explanations and highlights the stages and levels of what we refer to as population refinement.
Asiamah Nestor , Henry Kofi Mensah
Current Research in Psychology
Henry Kofi Mensah
The Qualitative Report
Ahmed Agyapong
Rural and Community Banks (RCBs) were set up to provide banking services by way of funds mobilization and offering of credit to cottage industry operators, farmers, fishermen, and regular salaried employees. These banks are not obliged to undertake Corporate Social Responsibility (CSR) activities but are expected by some stakeholders such as citizens in the community to devote part of their profits to meet social developmental activities. This study examines the CSR practices among RCBs in Ghana by adopting a mixed method approach. A combination of Focus Group Discussions (FGDs) and crosssectional survey was employed to gather detailed information from 86 respondents who are associated with the selected RCBs. Data collected from Focus Group Discussions (FGDs) and annual reports were analyzed using content analysis and presented in themes and models. Using the binomial test and descriptive statistics, questionnaire responses were analyzed and presented. We found that among RCBs, CSR ...
Arts and Design Studies
Jacqui Kisato
Fredrick Aila
Kenya Vision 2030 envisions provision of globally competitive quality education, training and research to citizens. Despite public universities' contribution to this mandate, stakeholders such as World Bank, Commission for University Education, employers and scholars fault the quality and relevance of some academic programmes. The decline in quality is attributed to increased workload, reduced rigour in recruitment and promotion criteria, inability to attract and retain quality staff, and lecturers' alleged incompetence. Previous studies relating human resource planning (HRP) practices to employee performance (EP) do not use descriptors of HRP like business plans, scenario planning, demand and supply forecasting, forecasting future requirements and action planning in entirety in addition to exhibiting mixed findings. This study intended to establish influence of HRP on lecturers' performance in Kenyan public universities. It is anchored on Simon's Decision Making Theory and supported by Barney's Resource Based View; Adam Smith's Human Capital Theory; and Herzberg's Two-Factor Theory and implemented using descriptive cross-sectional survey research design. Target population comprised 1,653 lecturers in 14 chartered public universities established between 2009 and 2019. Multi-stage purposeful sampling technique was adopted to finally take a census of 158 academic heads of departments (lecturers) from 13 out of the 14 universities, having used 20 in piloting. Public universities account for 72% of the total university teaching staff hence the interest. Primary data were collected using semi-structured questionnaires while secondary data obtained from relevant secondary sources. Cronbach's alpha coefficient was used to examine the internal consistency at 0.796 (SD= 0.067). While content validity was ascertained by reviewing literature within the domain of study concepts and corroborated by a panel of experts, Pearson's r was used to measure construct validity. Data were analyzed using Pearson's r and regression analysis. The correlation between human resource planning (HRP) practice and lecturers' performance was established to be positive and significant (r=.528, p=.000) HRP practice accounted for 38.0% (Adjusted R 2 =.380) of the variation in the lecturers' performance in Kenyan public universities implying that it can predict their performance. The findings are useful to the management of public universities, HRM practitioners, researchers, organizational behaviourists and theorists.
kofi sobre frimpong
Johnson Kassah
The purpose of this study was to investigate the difficulties tutors face when using the traditional demonstration method of teaching for vocational skills delivery especially in large class sizes. The study also aimed to modernise the demonstration method for effective vocational skills delivery in Ghana tertiary institutions. The study employed Solomon four quasi-experimental research design. The study targeted tutors and students offering textiles related (fabric and leather decoration) component of vocational skills programme in Ghana Colleges of Education. Purposive and simple random sampling techniques were used. The sample size for the study was 322 (320 students & tutors). The instruments used for data collection were interview guide, observation and skills achievement tests. The study revealed that tutors faced a lot of difficulties when using the traditional demonstration method of teaching for skills delivery in large vocational skills classes. The study also found that t...
Journal of Global Responsibility
Purpose This study aims to assess health workers’ level of emotional intelligence (EI) in Accra North and recommend a simple but robust statistical technique for compulsorily validating EI measurement scales. Design/methodology/approach The researchers used a self-reported questionnaire to collect data from 1,049 randomly selected health workers. Two non-nested models, BNK MODEL and CMODEL, were compared to see which of them better fits the study population and yields a better level of EI. The one-sample and independent-samples t-tests, exploratory factor analysis and confirmatory factor analysis were used to present results. Findings The study found that health workers were appreciably emotionally intelligent for both models at the 5 per cent significance level. However, EI was higher for the CMODEL. The CMODEL also better fits the study population (χ2 = 132.2, p = 0.487, Akaike information criterion = 124.932) and thus better underlies EI in it. This study recommends proper valida...
American Journal of Sociological Research
Peter M. Samburu , Peter M. Samburu
In a rapidly evolving settlement, finding an ideal location which satisfies all the factors an entrepreneur would consider in locating an economic enterprise isn't an easy resolve. A business owner would like to have guarantee of maximum returns considering various factors and therefore, the analogy of comparative advantage comes to play. The study explores aspects of building typology and its impact on the location of economic enterprises in Obunga Informal Settlement in Kisumu city. It was guided by the systems theory, cross-sectional survey research design, multi-stage and stratified sampling techniques. The target population comprised of 211 economic enterprise owners (operators) which included 106 operators of retail shops, 39 operators of M-pesas, 30 operators of food kiosks and 36 operators of barbershops and salons. The corresponding sample size included 176 economic enterprise operators which included 80 operators of retail shops, 36 operators of M-pesas, 28 operators of food kiosks and 32 operators of barbershops and salons. A multilinear analysis results were presented using a model summary table, analysis of variance (ANOVA) regression model was used to test the corresponding hypothesis. Findings indicated a significant relationship between aspects of building typology and location of economic enterprises (F=10.824, critical value=2.094, α=0.05). This relationship was contributed by: house rent (β=-0.435, p=0.00), construction materials (β=-0.239, p=0.021), cost of building construction (β=-0.209, p=0.049), tenure status (β=-0.96, p=0.375), room size (β=-0.104, p=0.339), building accessibility (β=-0.129, p=0.270) and access to basic amenities (β=-0.07, p=0.095). The study concluded that the investigated aspects of building typology serves a key role in determining the location and resulting spatial pattern of economic establishments. The study recommends recognition of informal settlement's economic enterprises for spatial planning in respect to the various aspects of building typologies.
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Addictive Behaviors Reports
Noor Azimah Muhammad
Acta Commercii
Renitha Rampersad
Frank Frimpong Opuni
Prof. Frank F . Opuni , Henry Kofi Mensah
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Inny N , Reginald Legoabe
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The University of Wisconsin - Milwaukee, ProQuest Dissertations Publishing
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Introduction. Research methodology relies heavily on the precise definition and differentiation between the. population under study and the target population, as these concepts serve as the ...
Council for Medical Schemes, Policy Research a nd Monitoring, South Africa. The importance of differentiating between the population and. target population in research cannot be overemphasised as ...
Furthermore, the article briefly discusses the implications of misidentifying the target population, including flawed research outcomes, biased results, and ineffective interventions or policies.
Defining the Target Population in Clinical Studies The target population in clinical studies is a defined group of individuals or subjects who meet specific criteria for inclusion in the research [1-5]. Defining the target population requires careful consideration of various factors, including demographic
This paper thoroughly explores the foundational principles governing population and target population concepts within research methodology. It delves into the essential roles these concepts play in shaping the design and influencing the interpretation of research studies. Through an exhaustive analysis, it meticulously outlines the nuances that ...
This paper thoroughly explores the foundational principles governing population and target population concepts within research methodology. It delves into the essential roles these concepts play in shaping the design and influencing the interpretation of research studies. Through an exhaustive analysis, it meticulously outlines the nuances that differentiate these two concepts, elucidating ...
In research, there are 2 kinds of populations: the target pop-ulation and the accessible population. The accessible popula-tion is exactly what it sounds like, the subset of the target population that we can easily get our hands on to conduct our research. While our target population may be Caucasian females with a GFR of 20 or less who are ...
Selecting the Study Participants. Defining the target population is an essential part of protocol development to ensure that the study participants are well suited to the research question (Hulley et al., 2013). The target population is the entire group of people who share a common condition (disease process) or characteristic the researcher is ...
General Population, Target Population, Accessible Population, Sampling, Population Refinement . In researchers' quest to contribute to academic debate and knowledge, they gather data or information from participants. These participants belong to the research population, which
Distinguishing Between Population and Target Population: A Mini Review. August 2023. Surgery Research Journal 3 (2):1-2. 3 (2):1-2. DOI: 10.33425/2768-0428.1027. Authors: Michael Mncedisi Willie ...
The sampling frame intersects the target population. The sam-ple and sampling frame described extends outside of the target population and population of interest as occa-sionally the sampling frame may include individuals not qualified for the study. Figure 1. The relationship between populations within research.
The target population is the collection of individuals about whom we want to draw conclu-sions (make inferences). The sample (study) popula-tion is the group of individuals chosen for study from an accessible population. The sampling process This aims to yield a population for study that is rep-resentative of the target population, is large enough
OPRE Report # 2021-111. One goal of the evaluation design is to align the target population, the study population, and the analysis sample. The intervention is intended for the target population. The people selected to be in your evaluation are the study population. They either get the intervention or are placed in a group used for comparison.
In research, there are 2 kinds of populations: the target population and the accessible population. The accessible population is exactly what it sounds like, the subset of the target population that we can easily get our hands on to conduct our research. While our target population may be Caucasian females with a GFR of 20 or less who are ...
PDF | In this paper the concepts of general, target and accessible population are explained in response to misconceptions and controversies associated... | Find, read and cite all the research you ...
In research, the population refers to the entire group of individuals, objects, or events that share a common characteristic and are the focus of the study. It represents the complete set of elements that the researcher aims to study and draw conclusions about (Jilcha Sileyew, 2020; Garg, 2016). Defining the
Abstract. This mini review provides a concise examination of the differentiation between the population and the target population in research. It explores the significance of accurately defining ...
An Illustration of the Three Types of Population Population General population Stage - 1 Attribute/characteristic applied Corresponding criteria Health worker A participant must be a health worker with respect to the research goal and context Educational level Target population 2 3 Tenure Access to EI training Population size Hospital A ...
Figure 2: Differentiating between Population, Target/study population and sample- medical scheme example MEDICAL SCHEME TARGET POPULATION EXAMPLE A straightforward medical scheme target population for research is the 4.1 million main members enrolled in the 76 medical schemes that are registered with the Council for Medical Schemes (CMS, 2021).
Target population is population of ultimate clinical interest. But, because of practicalities, entire target population often cannot be studied. Study population is subset of target population that can be studied. Samples are subsets of study populations used in clinical research because often not every member of study population can be measured.
An Illustration of the Three Types of Population Population General population Stage - 1 Target population 2 3 - Attribute/characteristic applied Corresponding criteria Health worker A participant must be a health worker with respect to the research goal and context Educational level Tenure Access to EI training Unwillingness to participate ...
design, population of interest, study setting, recruit ment, and sampling. Study Design. The study design is the use of e vidence-based. procedures, protocols, and guidelines that provide the ...