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Then we propose a decision framework for key decision points that lead to different QED options. We conclude with a brief discussion of incorporating additional design elements to capture the full range of relevant implementation outcomes in order to maximize external validity. The nonrandomized control group design is a good choice for certain populations of people where randomization could be unsettling. However, in a nonrandomized control group design, the absence of randomization could result in tainted posttest data. Internal validity is the degree to which the exposure to treatment causes a change in the specified experimental settings. Maturation and history can threaten the internal validity of a randomized control group design.
Are the Average-Based and the Individual-Based Approaches Related?
The demographic information of a participant was only filled in during the post-test test of the last case, and the analysis considered participants who finished all four VP cases. Each case was assessed depending on the answers to the paper case, where 0 was the minimum score, and 15 was the maximum score per paper case. After data collection, all answer sheets from the participants were made into an extra copy to allow the awarding of scores by two different nurses per paper case. Since all questions were open-ended, interpreting the answers differently was possible.
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Pregnant women from three local churches were recruited by active church health teams (CHTs) in three respective communities in Enugu State, Southeast Nigeria. In 2013, the HBI was deployed in 40 communities in Enugu, where our team has a history of working with religious leaders [23, 26]. Some authors suggest this should occur before marriage [13, 14] but others noted that the importance of pre-marital knowledge is invalidated by the observation that some intending couples do not implement the knowledge during marriage [15]. Considering this challenge, some authors have advocated that this should be done during adolescence to provide information early enough to make marital/procreation decisions [16].
An Introduction to the Hypergeometric Distribution
In the pre-test phase, a participant answered questions about non-communicable disease cases before using the VP case on a tablet. The questions of each disease case were on four separate pages, and a participant was given the next page after he/she had submitted the previous one and was not allowed to go back and change their previous answers. After completing the paper-based questionnaire, participants were provided with a tablet running Android and equipped with internet access for their CPD. The correct answers to the paper cases were not revealed to the participating nurses.
Limitations of the separate-sample pretest-posttest design:
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Responding to questions about their current lifestyle might prompt participants to decrease their caloric intake or increase their physical activity, irrespective of the intervention. For this reason, utilizing the Solomon four-group pretest-posttest design may be an optimal choice in order to avoid the interaction of pretesting and treatment. A thorough analysis of the data will provide insight into the validity of the study. The pretest-posttest control group design, also called the pretest-posttest randomized experimental design, is a type of experiment where participants get randomly assigned to either receive an intervention (the treatment group) or not (the control group).
Feasible when random assignment of participants is considered unethical
On the day of the baby shower, the CHTs convened the pregnant women for the program. Using the education guide, educational sessions at each of the three churches were delivered by a team led by either a hematologist or a program manager. All team leads have experience in running over 100 baby showers for funded research studies between 2013 and 2019 [27, 28, 31, 32]. The education session with questions and answers lasted approximately 30–45 min. In addition, during the baby showers the CHTs took basic health measurements including height, weight, and blood pressure. Hb genotype screening was conducted using HemoTypeSC™ rapid test with on-the-spot results delivered to the participants.
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As well, when a complex intervention is related to a policy or guideline shift and implementation requires logistical adjustments (such as phased roll-outs to embed the intervention or to train staff), QEDs more truly mimic real world constraints. As a result, capturing processes of implementation are critical as they can describe important variation in uptake, informing interpretation of the findings for external validity. However, QEDs are often conducted by teams with strong interests in adapting the intervention or ‘learning by doing’, which can limit interpretation of findings if not planned into the design. As done in the study by Bailet et al (3), the investigators refined intervention, based on year 1 data, and then applied in years 2–3, at this later time collecting additional data on training and measurement fidelity. This phasing aspect of implementation generates a tension between protocolizing interventions and adapting them as they go along. When this is the case, additional designs for the intervention roll-out, such as adaptive or hybrid designs can also be considered.
QEDs test causal hypotheses but, in lieu of fully randomized assignment of the intervention, seek to define a comparison group or time period that reflects the counter-factual (i.e., outcomes if the intervention had not been implemented) (43). QEDs seek to identify a comparison group or time period that is as similar as possible to the treatment group or time period in terms of baseline (pre-intervention) characteristics. QEDs can include partial randomization such as in stepped wedge designs (SWD) when there is pre-determined (and non-random) stratification of sites, but the order in which sites within each strata receive the intervention is assigned randomly. For example, strata that are determined by size or perceived ease of implementation may be assigned to receive the intervention first. However, within those strata the specific sites themselves are randomly selected to receive the intervention across the time intervals included in the study). In all cases, the key threat to internal validity of QEDs is a lack of similarity between the comparison and intervention groups or time periods due to differences in characteristics of the people, sites, or time periods involved.
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San Francisco State University

We termed them the average-based change approach (ABC) and the individual-based change approach (IBC). The aim of ABC is to evaluate whether a group, as a whole, experienced a reliable change. In turn, the goal of IBC is to identify specific individuals who showed change. To assess ABC, researchers often use a statistic that describes the center of the distributions (often, the pre and post means), by using null hypothesis tests and effect size measures (c.f., Cohen, 1988; Fritz et al., 2012; Grissom and Kim, 2012; Pek and Flora, 2018).
A convenience sample of 90 pregnant women who indicated interest in the HBI were invited to participate in this study. The inclusion criteria were women aged 15–49 years in their second or third trimester of pregnancy who attended the selected churches [31], and had working contact phone numbers. For all conditions in both designs, the properties of the generated samples corresponded to those imposed in the simulation. We report the results regarding SID only; those based on the RCI are similar. You collect your participants and give them a series of tests that will measure their judgment and general knowledge. For example, you may look at their ability to discern when it would be a good time to pull out into traffic as a measure of judgment.
This can be challenging as there may not be adequate information available to determine how ‘equivalent’ the comparison group is regarding relevant covariates. The quadratic and cubic functions achieved a slightly better fit than the linear function, but only with negative skewness; the logistic and linear functions achieved similar fit. As in the single group design, the linear function was deemed preferable because it is the most parsimonious, with only minimal loss of fit. To identify which individual scores showed a reliable change (i.e., which cases fell above a certain cutoff after being standardized) and then calculate the percentage of individual changes for each sample, we decided to use two individual change indices. We chose two indices that have shown lowest false negative rates (see Ferrer and Pardo, 2014). As an example, a study in Greece looked at the effect of providing meals in schools on household food security.[6] The 51 schools in this study were randomly allocated to provide or not provide a healthy meal every day to students; schools in both the groups provided an educational intervention.
Briefly, during worship, the priest invited all the pregnant women and their male partners for prayers for healthy pregnancy and safe delivery. The priest provided information on HBI and notified the pregnant women that the baby shower will be held during the week. All the pregnant women who indicated interest were given information about the program and their questions answered by the CHT. The CHTs then confirmed eligibility for the study by asking the qualifying questions in the inclusion criteria. The study was explained to the potential participants in English and Igbo (the local Nigerian language). Written informed consent was obtained from those willing to participate in the study prior to completing the study survey forms.
Health education sessions offered in a community setting may be an effective means to increase knowledge of SCD and NBS [11]. Another rationale for using online training through VP cases for CPD at health centers is the transition from communicable to non-communicable diseases as the predominant health concern [2]. Infectious diseases, such as malaria in endemic regions, often have well-defined protocols for their screening and management. However, establishing clear screening protocols for every non-communicable disease at the health center level can be challenging. In such a scenario, VP cases can facilitate nurses at this level of care to engage with a variety of non-communicable disease cases, thereby enhancing their clinical reasoning skills in terms of timely diagnosis, management, or appropriate referrals. Furthermore, VP cases are provided in the form of online CPD, which offers a number of advantages over physical CPD.
This course is intended for experienced software developers who wish to expand and refine their knowledge of advanced object-oriented design. The participant started with the first page and was given the next page after he/she had submitted the previous page. The participants were not allowed to go back and change answers on the previous page(s). The research team and experts also developed a list of possible answers to each question asked, used for the subsequent correction of the paper cases. EE, EF, and AP analyzed the data and interpreted the results, organized the article structure and drafted the manuscript critically revised the manuscript.
Traditional RCTs strongly prioritize internal validity over external validity by employing strict eligibility criteria and rigorous data collection methods. Pre-post studies are valuable tools for evaluating how interventions affect outcomes over time, and can be applied across many different clinical research settings. They are generally less costly and simpler to implement than RCTs, and can also be feasible with relatively smaller sample sizes. Further, pre post studies have other unique benefits that make them preferable in certain circumstances. This study aimed to determine the feasibility of using CPD through VP cases to improve nurses' clinical reasoning in primary health care.
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