Background: Cluster randomized control trials (cRCTs) are useful for asking about system-level interventions compared to other types of clinical research design, however they present unique challenges with conduct and delivery. Numerous cRCTs in hospitals have encountered challenges and time delays in enrolling hospitals and launching the trials which contributes to research waste. While each cRCT has unique barriers and enablers to their conduct, it is important to understand and explore these factors at the general level of the cRCT itself. Previous literature has documented factors associated with successful cRCTs, however, these studies focused primarily on the statistical aspect, while neglecting to evaluate the delivery of the trial. Objectives: The goal of this dissertation was to explore barriers and enablers to conducting cRCTs in hospitals, and to identify potential strategies that facilitate their delivery. This research was conducted to identify evidence and generate guidance for researchers aiming to conduct these trials. Specifically, the objectives were: 1) To explore the current knowledge and evidence surrounding the implementation of cRCTs in hospitals; 2) To explore from the perspective of the coordinating site, what influenced the delivery and hospital engagement of an ongoing cRCT, and what challenges were encountered; 3) To identify strategies to facilitate delivery of cRCTs in hospitals; 4) To systematically review reported recruitment strategies of healthcare facilities in cRCTs. Methods: The dissertation employed multiple research methods. To address the first objective, a scoping review was performed of current literature related to hospitals in cRCTs. The second objective was addressed with a qualitative case study. Semi-structured interviews were carried out with six key members of the team to understand their perceptions of the delivery of the trial. For the third objective, a tool matching two implementation concepts (the Consolidated Framework for Implementation Research (CFIR)- Expert Recommendations for Implementing Change (ERIC) matching tool) was used to identify strategies targeted to address barriers and enablers to cRCT conduct identified in the first two studies. Lastly, a systematic review was performed to address the fourth objective, to identify reported strategies used for hospital engagement in cRCTs. The thesis was guided and analyzed using an over-arching implementation framework, CFIR, and an implementation strategies list, the ERIC compilation. This was done to allow comparability and synthesis of results between methodologies from the dissertation, and between the results from the studies and previous literature. Results: Several key CFIR domains were identified in the literature in the scoping review that were determined to being influential for conducting the cRCTs in hospitals: the adaptability to tailor the trial to each site; the engagement of opinion leaders, champions and formally appointed implementation leaders in the cRCT process as facilitators to conducting the trial; the lack of a site perceiving a relative priority for the trial or tension for change for the clinical field presenting barriers to conducting the cRCT; and limited available resources can present barriers to conducting the cRCT. The qualitative case study identified similar CFIR domains and constructs as potentially influential for cRCT conduct, including the emphasis on adaptability of trial, the importance of tension for change in the sites for accepting inclusion in the trial, the availability of resources, and the engagement of leaders. The CFIR-ERIC matching study identified strategies that may be used to overcome barriers and target enablers for cRCT delivery from CFIR domains and constructs identified in the first two studies. A list of strategies was generated, ranked by the number of many determinants for which the strategy was listed as a Level 1 strategy, then by how many determinants for which the strategy was listed as a Level 2 strategy. The top ERIC strategies that were endorsed as a Level 1 strategy for any or multiple CFIR domains were: 1) Identify and prepare champions, 2) Conduct local needs assessment, 3) Conduct educational meetings, 4) Inform local opinion leaders, 5) Build a coalition, 6) Promote adaptability, 7) Develop a formal implementation blueprint, 8) Involve patients/consumers and family members, 9) Obtain and use patients/consumers and family feedback, 10) Develop educational materials, 11) Promote network weaving, 12) Distribute educational materials, 13) Access new funding, and 14) Develop academic partnerships. The systematic review identified literature reporting on the recruitment of healthcare facility sites into cRCTs. Numerous strategies for cRCT site recruitment were identified, and these were coded to the ERIC compilation. Strategies that were commonly cited were: involve executive boards, promote network weaving, conduct educational meetings, inform local opinion leaders, and centralize technical assistance. Conclusions: The results from the dissertation can contribute to the knowledge for facilitating cRCT delivery in hospitals while recognizing the critical limitations in the studies. Key concepts and strategies to facilitate the conduct and delivery of cRCTs in hospitals were identified. Future research should aim to empirically evaluate the identified strategies. Researchers should aim to address the reporting gap for cRCT delivery identified by this dissertation.

No description available.

Thesis (Ph.D. (English))--North-West University, Potchefstroom Campus, 2007.

There are few instructional tasks more important than teaching children to read. The consequences of low achievement in reading are costly both to individuals and society. Low achievement in literacy correlates with high rates of school drop-out, poverty, and underemployment. The far-reaching effects of literacy achievement have heightened the interest of educators and non-educators alike in the teaching of reading. Successful efforts to improve reading achievement emphasise identification and implementation of evidence-based practices that promote high rates of achievement when used in classrooms by teachers with diverse instructional styles with children who have diverse instructional needs and interests. Being able to recognise what characterises rigorous evidence-based reading instruction is essential to choosing the right reading curriculum (i.e., what method or approach). It will be necessary to ensure that general classroom reading instruction is of universally high quality and that practitioners are prepared to effectively implement validated reading interventions. When educators are not familiar with research methodologies and findings, national and provincial departments of education may find themselves implementing fads or incomplete findings. The choice of method of instruction is very often based on empirical research studies. The selection of statistical procedures is an integral part of the research process. Statistical significance testing is a prominent feature of data analysis in language learning studies and also specifically, reading instruction studies. For many years, methodologists have debated what statistical significance testing means and how it should be used in the interpretation of substantive results. Researchers have long placed a premium on the use of statistical significance testing. However, criticisms of the statistical significance testing procedure are prevalent and occur across many scientific disciplines. Critics of statistical significance tests have made several suggestions, with the underlying theme being for researchers to examine and interpret their data carefully and thoroughly, rather than relying solely upon p values in determining which results are important enough to examine further and report in journals. Specific suggestions include the use of effect sizes, confidence intervals, and power. The purpose of this study was to: determine what the state of affairs is with regard to statistical significance testing in reading instruction research, with specific reference to post-1999 literature (post-I999 literature was selected because of the specific request, made by Wilkinson and the Task Force on Statistical Inference in 1999, to include the reporting of effect sizes in empirical research studies); determine what the criticisms as well as the defences are that have been offered for statistical significance testing; determine what the alternatives or supplements are to statistical significance testing in reading instruction research; To provide a framework for the most effective and appropriate selection, use and representation of statistical significance testing in the reading instruction research field. A comprehensive survey on the use of statistical significance testing, as manifested in randomly selected journals, was undertaken. Six journals (i.e., System, Language Learning and Technology, The Reading Matrix, Scientific Studies of Reading, Teaching English as a Second or Foreign Language (TESL-EJ); South African Journal for Language Teaching) regularly including articles related to reading instruction research and publishing articles reporting statistical analyses, were reviewed and analysed. All articles in these journals from 2000-2005, employing statistical analyses were reviewed and analysed. The data was analysed by means of descriptive statistics (i.e., frequency counts and percentages). Qualitative reporting was also utilized. A review of six readily accessible (online) journals publishing research on reading instruction indicated that researchers/authors rely very heavily on statistical significance testing and very seldom, if ever, report effect size/effect magnitude or confidence interval measures when documenting their results. A review of the literature indicates that null hypothesis significance testing has been and is a controversial method of extracting information from experimental data and of guiding the formation of scientific conclusions. Several alternatives or complements to null hypothesis significance testing, namely effect sizes, confidence intervals and power analysis have been suggested. The following central theoretical statement was formulated for this study: Statistical significance tests should be supplemented with accurate reports of effect size, power analyses and confidence intervals in reading research studies. In addition, quantitative studies, utilising statistics as stated in the previous sentence, should be supplemented with qualitative studies in order to obtain a more comprehensive picture of reading instruction research. Research indicates that no single study ever establishes a programme or practice as effective; moreover it is the convergence of evidence from a variety of study designs that is ultimately scientifically convincing. When evaluating studies and claims of evidence, educators must not determine whether the study is quantitative or qualitative in nature, but rather if the study meets the standards of scientific research. The proposed framework presented in this study consists of three main parts, namely, part one focuses on the study's description of the intervention and the random assignment process, part two focuses on the study's collection of data and part three focuses on the study's reporting of results, specifically the statistical reporting of the results. / Thesis (Ph.D. (English))--North-West University, Potchefstroom Campus, 2007.

There are few instructional tasks more important than teaching children to read. The consequences of low achievement in reading are costly both to individuals and society. Low achievement in literacy correlates with high rates of school drop-out, poverty, and underemployment. The far-reaching effects of literacy achievement have heightened the interest of educators and non-educators alike in the teaching of reading. Successful efforts to improve reading achievement emphasise identification and implementation of evidence-based practices that promote high rates of achievement when used in classrooms by teachers with diverse instructional styles with children who have diverse instructional needs and interests. Being able to recognise what characterises rigorous evidence-based reading instruction is essential to choosing the right reading curriculum (i.e., what method or approach). It will be necessary to ensure that general classroom reading instruction is of universally high quality and that practitioners are prepared to effectively implement validated reading interventions. When educators are not familiar with research methodologies and findings, national and provincial departments of education may find themselves implementing fads or incomplete findings. The choice of method of instruction is very often based on empirical research studies. The selection of statistical procedures is an integral part of the research process. Statistical significance testing is a prominent feature of data analysis in language learning studies and also specifically, reading instruction studies. For many years, methodologists have debated what statistical significance testing means and how it should be used in the interpretation of substantive results. Researchers have long placed a premium on the use of statistical significance testing. However, criticisms of the statistical significance testing procedure are prevalent and occur across many scientific disciplines. Critics of statistical significance tests have made several suggestions, with the underlying theme being for researchers to examine and interpret their data carefully and thoroughly, rather than relying solely upon p values in determining which results are important enough to examine further and report in journals. Specific suggestions include the use of effect sizes, confidence intervals, and power. The purpose of this study was to: determine what the state of affairs is with regard to statistical significance testing in reading instruction research, with specific reference to post-1999 literature (post-I999 literature was selected because of the specific request, made by Wilkinson and the Task Force on Statistical Inference in 1999, to include the reporting of effect sizes in empirical research studies); determine what the criticisms as well as the defences are that have been offered for statistical significance testing; determine what the alternatives or supplements are to statistical significance testing in reading instruction research; To provide a framework for the most effective and appropriate selection, use and representation of statistical significance testing in the reading instruction research field. A comprehensive survey on the use of statistical significance testing, as manifested in randomly selected journals, was undertaken. Six journals (i.e., System, Language Learning and Technology, The Reading Matrix, Scientific Studies of Reading, Teaching English as a Second or Foreign Language (TESL-EJ); South African Journal for Language Teaching) regularly including articles related to reading instruction research and publishing articles reporting statistical analyses, were reviewed and analysed. All articles in these journals from 2000-2005, employing statistical analyses were reviewed and analysed. The data was analysed by means of descriptive statistics (i.e., frequency counts and percentages). Qualitative reporting was also utilized. A review of six readily accessible (online) journals publishing research on reading instruction indicated that researchers/authors rely very heavily on statistical significance testing and very seldom, if ever, report effect size/effect magnitude or confidence interval measures when documenting their results. A review of the literature indicates that null hypothesis significance testing has been and is a controversial method of extracting information from experimental data and of guiding the formation of scientific conclusions. Several alternatives or complements to null hypothesis significance testing, namely effect sizes, confidence intervals and power analysis have been suggested. The following central theoretical statement was formulated for this study: Statistical significance tests should be supplemented with accurate reports of effect size, power analyses and confidence intervals in reading research studies. In addition, quantitative studies, utilising statistics as stated in the previous sentence, should be supplemented with qualitative studies in order to obtain a more comprehensive picture of reading instruction research. Research indicates that no single study ever establishes a programme or practice as effective; moreover it is the convergence of evidence from a variety of study designs that is ultimately scientifically convincing. When evaluating studies and claims of evidence, educators must not determine whether the study is quantitative or qualitative in nature, but rather if the study meets the standards of scientific research. The proposed framework presented in this study consists of three main parts, namely, part one focuses on the study's description of the intervention and the random assignment process, part two focuses on the study's collection of data and part three focuses on the study's reporting of results, specifically the statistical reporting of the results. / Thesis (Ph.D. (English))--North-West University, Potchefstroom Campus, 2007.

No description available.

Participants in randomized control trials (RCTs) should be representative of those most likely to experience the disorder of focus, yet reviews of psychology research studies consistently find certain demographic groups are overrepresented at the price of others being unincluded. The present review aimed to characterize the demographic representation of US-based RCTs for gambling disorder and compare findings to the population of individuals most likely to experience the disorder. Thirteen US-based RCTs comprising a total of 2,343 participants were reviewed. We found that although gambling disorder is most prevalent among low SES racial minorities, RCTs are mostly conducted among populations who are white, employed, and have some level of college education. Demographic variables that are related to the likelihood of experiencing gambling disorder are not consistently reported, and there are many groups of individuals who experience gambling disorder that have been virtually left out of all treatment study samples to date. We conclude with recommendations for future gambling focused treatment studies, which are geared towards increasing the convergence between characteristics of participants in RCTs and those who experience gambling disorder in the United States.

No description available.

Vitamin D inadequacy is highly prevalent among pregnant women worldwide. Inadequacy or deficiency of vitamin D can lead to adverse outcomes during pregnancy such as pre-eclampsia, gestational diabetes, and caesarian section. A systematic review and meta-analysis were conducted to examine the effectiveness of vitamin D supplementation on serum vitamin D status during pregnancy in randomized controlled trials (RCTs). A search was conducted in PubMed, Scopus, ProQuest, EBSCO, Cochrane CENTRAL Database of Controlled Clinical Trials, PsycINFO, CINAHL, and Google Scholar, in addition to searching reference lists in published reviews. A comprehensive list of RCTs of vitamin D status and supplemental use in pregnancy was compiled. The random effects model was used to determine a summary effect size using pre/post means and standard deviations of serum vitamin D levels from intervention and control groups. Sixteen RCTs indicated a large effect size (d = .849, 95% CI .607 – 1.001, p < .001). Serum vitamin D concentration at delivery was higher with vitamin D supplementation, and thereby the metabolic outlook was favorable for the mother and newborn. Heterogeneity of the meta-analysis was significant (Q = 344.418, p < .001); the I-squared statistic showed moderate heterogeneity (61.89%), which warranted subgroup analysis to identify possible sources of variation among the studies. Moderators for subgroup analysis included vitamin D dosages, use of a placebo, use of multivitamins in addition to vitamin D, duration of interventions, age, low or adequate baseline vitamin D status, trimester when supplementation was started, country where the RCT was conducted (USA/UK/AUS versus other countries), and blinded versus non-blinded RCTs. Subgroup analysis only demonstrated a significant impact on heterogeneity from the trimester moderator (p < .001). Women who began vitamin D supplementation during the first trimester had a higher effect size and improved vitamin D status compared to those who began supplementation in the second or third trimester. Since pregnant women with vitamin D inadequacy or deficiency are more susceptible to complications, routine examination of vitamin D status should be conducted in pregnant women.

Parent-implemented interventions (PIIs) can be useful in promoting parents’ knowledge of autism spectrum disorder (ASD) and in transferring necessary skills to children with ASD. Individuals with ASD can directly and indirectly benefit from PIIs in terms of academics, ASD symptom severity, behavior improvement, cognition, communication, and social skills. Many studies have explored the efficacy of PIIs; however, they have tended to report mixed effects. Previous meta-analyses and systematic reviews have been characterized by limited search terms and literature search procedures, emphases on published manuscripts, dependency on parent reports, dated findings, and comparisons across of different types of control groups. This study attempts to improve on the methodology of prior meta-analyses and to update findings of the effectiveness of PIIs for children and youth with ASD. We located 1925 studies at initial manuscript search in 9 databases. After additional search from other sources, 43 studies met the inclusion criteria. Studies with same participants were merged that yield 40 records for final data coding. Eligible studies coded in Dyches et al.’s meta-analysis (2018) combined with current data resulted in 53 randomized controlled trials for data analysis. The random effects model meta-analysis found a moderate and statistically significant effect (g = 0.55, 95% CI 0.35 to 0.65, p < 0.00001) on overall weighted effect size across 53 studies included. PIIs can improve child outcomes in positive behavior/social skill (g = 0.603), maladaptive behavior (g = 0.519), adaptive behavior/life skills (g = 0.239), and language/communication (g = 0.545). These findings are inconclusive and should be interpreted with caution, especially adaptive behavior/life skill because only six studies reported outcomes on that variable. No moderating variables were identified in post hoc random effects weighted analyses. Implications for future research are discussed.