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Most prior work in quantitative approaches to generalizability and transportability emphasizes extending causal effect estimates from randomized trials to target populations. Extending findings from observational studies is also of scientific interest, and identifiability assumptions and estimation methods differ from randomized settings when there is selection on both the exposure and exposure--outcome mediators in combination with exposure--outcome confounders (and both confounders and mediators can modify exposure--outcome effects). We argue that this causal structure is common in observational studies, particularly in the field of life course epidemiology, for example, when extending estimates of the effect of an early-life exposure on a later-life outcome from a cohort enrolled in midlife or late life. We describe identifiability assumptions and identification using observed data in such settings, highlighting differences from work extending findings from randomized trials. We describe statistical methods, including weighting, outcome modeling, and doubly robust approaches, to estimate potential outcome means and average treatment effects in the target population and illustrate performance of the methods in a simulation study. We show that in the presence of selection into the study sample on both exposure and confounders, estimators must be able to address confounding in the target population. When there is also selection on mediators of the exposure--outcome relationship, estimators need to be able to use different sets of variables to account for selection (including the mediator), and confounding. We discuss conceptual implications of our results as well as highlight unresolved practical questions for applied work to extend findings from observational studies to target populations. [ABSTRACT FROM AUTHOR]

Inverse probability weighting (IPW) is frequently used to reduce or minimize the observed confounding in observational studies. IPW creates a pseudo-sample by weighting each individual by the inverse of the conditional probability of receiving the treatment level that he/she has actually received. In the pseudo-sample there is no variation among the multiple individuals generated by weighting the same individual in the original sample. This would reduce the variability of the data and therefore bias the variance estimate in the target population. Conventional variance estimation methods for IPW estimators generally ignore this underestimation and tend to produce biased estimates of variance. We here propose a more reasonable method that incorporates this source of variability by using parametric bootstrapping based on intra-stratum variability estimates. This approach firstly uses propensity score stratification and intra-stratum standard deviation to approximate the variability among multiple individuals generated based on a single individual whose propensity score falls within the corresponding stratum. The parametric bootstrapping is then used to incorporate the target variability by re-generating outcomes after adding a random error term to the original data. The performance of the proposed method is compared with three existing methods including the naïve model-based variance estimator, the nonparametric bootstrap variance estimator, and the robust variance estimator in the simulation section. An example of patients with sarcopenia is used to illustrate the implementation of the proposed approach. According to the results, the proposed approach has desirable statistical properties and can be easily implemented using the provided R code. [ABSTRACT FROM AUTHOR]

Background: In the presence of effect measure modification, estimates of treatment effects from randomized controlled trials may not be valid in clinical practice settings. The development and application of quantitative approaches for extending treatment effects from trials to clinical practice settings is an active area of research. Methods: In this article, we provide researchers with a practical roadmap and four visualizations to assist in variable selection for models to extend treatment effects observed in trials to clinical practice settings and to assess model specification and performance. We apply this roadmap and visualizations to an example extending the effects of adjuvant chemotherapy (5-fluorouracil vs. plus oxaliplatin) for colon cancer from a trial population to a population of individuals treated in community oncology practices in the United States. Results: The first visualization screens for potential effect measure modifiers to include in models extending trial treatment effects to clinical practice populations. The second visualization displays a measure of covariate overlap between the clinical practice populations and the trial population. The third and fourth visualizations highlight considerations for model specification and influential observations. The conceptual roadmap describes how the output from the visualizations helps interrogate the assumptions required to extend treatment effects from trials to target populations. Conclusions: The roadmap and visualizations can inform practical decisions required for quantitatively extending treatment effects from trials to clinical practice settings. [ABSTRACT FROM AUTHOR]

The positivity assumption is crucial when drawing causal inferences from observational studies, but it is often overlooked in practice. A violation of positivity occurs when the sample contains a subgroup of individuals with an extreme relative frequency of experiencing one of the levels of exposure. To correctly estimate the causal effect, we must identify such individuals. For this purpose, we suggest a regression tree-based algorithm.

Background: The counterfactual definition of confounding is often explained in the context of exchangeability between the exposed and unexposed groups. One recent approach is to examine whether the measures of association (eg, associational risk difference) are exchangeable when exposure status is flipped in the population of interest. We discuss the meaning and utility of this approach, showing their relationships with the concept of confounding in the counterfactual framework. Methods: Three hypothetical cohort studies are used, in which the target population is the total population. After providing an overview of the notions of confounding in distribution and in measure, we discuss the approach from the perspective of exchangeability of measures of association (eg, factual associational risk difference vs counterfactual associational risk difference). Results: In general, if the measures of association are non-exchangeable when exposure status is flipped, confounding in distribution is always present, although confounding in measure may or may not be present. Even if the measures of association are exchangeable when exposure status is flipped, there could be confounding both in distribution and in measure. When we use risk difference or risk ratio as a measure of interest and the exposure prevalence in the population is 0.5, testing the exchangeability of measures of association is equivalent to testing the absence of confounding in the corresponding measures. Conclusion: The approach based on exchangeability of measures of association essentially does not provide a definition of confounding in the counterfactual framework. Subtly differing notions of confounding should be distinguished carefully.

Abstract Backgrounds Meta-analyses can be a powerful tool but need to calibrate potential unrepresentativeness of the included trials to a target population. Estimating target population average treatment effects (TATE) in meta-analyses is important to understand how treatments perform in well-defined target populations. This study estimated TATE of paliperidone palmitate in patients with schizophrenia using meta-analysis with individual patient trial data and target population data. Methods We conducted a meta-analysis with data from four randomized clinical trials and target population data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study. Efficacy was measured using the Positive and Negative Syndrome Scale (PANSS). Weights to equate the trial participants and target population were calculated by comparing baseline characteristics between the trials and CATIE. A calibrated weighted meta-analysis with random effects was performed to estimate the TATE of paliperidone compared to placebo. Results A total of 1,738 patients were included in the meta-analysis along with 1,458 patients in CATIE. After weighting, the covariate distributions of the trial participants and target population were similar. Compared to placebo, paliperidone palmitate was associated with a significant reduction of the PANSS total score under both unweighted (mean difference 9.07 [4.43, 13.71]) and calibrated weighted (mean difference 6.15 [2.22, 10.08]) meta-analysis. Conclusions The effect of paliperidone palmitate compared with placebo is slightly smaller in the target population than that estimated directly from the unweighted meta-analysis. Representativeness of samples of trials included in a meta-analysis to a target population should be assessed and incorporated properly to obtain the most reliable evidence of treatment effects in target populations.

Backgrounds: Meta-analyses can be a powerful tool but need to calibrate potential unrepresentativeness of the included trials to a target population. Estimating target population average treatment effects (TATE) in meta-analyses is important to understand how treatments perform in well-defined target populations. This study estimated TATE of paliperidone palmitate in patients with schizophrenia using meta-analysis with individual patient trial data and target population data. Methods: We conducted a meta-analysis with data from four randomized clinical trials and target population data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study. Efficacy was measured using the Positive and Negative Syndrome Scale (PANSS). Weights to equate the trial participants and target population were calculated by comparing baseline characteristics between the trials and CATIE. A calibrated weighted meta-analysis with random effects was performed to estimate the TATE of paliperidone compared to placebo. Results: A total of 1,738 patients were included in the meta-analysis along with 1,458 patients in CATIE. After weighting, the covariate distributions of the trial participants and target population were similar. Compared to placebo, paliperidone palmitate was associated with a significant reduction of the PANSS total score under both unweighted (mean difference 9.07 [4.43, 13.71]) and calibrated weighted (mean difference 6.15 [2.22, 10.08]) meta-analysis. Conclusions: The effect of paliperidone palmitate compared with placebo is slightly smaller in the target population than that estimated directly from the unweighted meta-analysis. Representativeness of samples of trials included in a meta-analysis to a target population should be assessed and incorporated properly to obtain the most reliable evidence of treatment effects in target populations. [ABSTRACT FROM AUTHOR]

Purpose: To conceptualize a particular target population and estimand for multi‐site pharmacoepidemiologic studies within data networks and to analytically examine sample‐standardization as a meta‐analytic method compared with inverse‐variance weighted meta‐analyses. Methods: The target population of interest is all and only all individuals from the data‐contributing sites. Standardization, a general conditioning technique frequently employed for confounding control, was adopted to estimate the network‐wide causal treatment effect. Specifically, the proposed sample‐standardization yields a meta‐analysis estimator, that is, a weighted summation of site‐specific results, where the weight for a site is the proportion of its size in the entire network. This sample‐standardization estimator was evaluated analytically in comparison to estimators from inverse‐variance weighted fixed‐effect and random‐effects meta‐analyses in terms of statistical consistency. Results: A proof is reported to justify the consistency of the sample‐standardization estimator with and without treatment effect heterogeneity by site. Both inverse‐variance weighted fixed‐effect and random‐effects meta‐analyses were found to generally result in inconsistent estimators in the presence of treatment effect heterogeneity by site for this particular target population and estimand. Conclusions: Sample‐standardization is a valid approach to generate causal inference in multi‐site studies when the target population comprises all and only all individuals within the network, even in the presence of heterogeneity of treatment effect by site. Multi‐site studies should clearly specify the target population and estimand to help select the most appropriate meta‐analytic methods. [ABSTRACT FROM AUTHOR]

In 2016, the Kenya National Immunization Technical Advisory Group requested additional programmatic and cost effectiveness data to inform the choice of strategy for a national influenza vaccination program among children aged 6–23 months of age. In response, we conducted an influenza vaccine demonstration project to compare the performance of a year-round versus campaign-mode vaccination strategy. Findings from this demonstration project will help identify essential learning lessons for a national program. We compared two vaccine delivery strategies: (i) a year-round vaccination strategy where influenza vaccines were administered throughout the year at health facilities. This strategy was implemented in Njoro sub-county in Nakuru (November 2019 to October 2021) and Jomvu sub-county in Mombasa (December 2019 to October 2021), (ii) a campaign-mode vaccination strategy where vaccines were available at health facilities over four months. This strategy was implemented in Nakuru North sub-county in Nakuru (June to September 2021) and Likoni sub-county in Mombasa (July to October 2021). We assessed differences in coverage, dropout rates, vaccine wastage, and operational needs. We observed similar performance between strategies in coverage of the first dose of influenza vaccine (year-round strategy 59.7 %, campaign strategy 63.2 %). The coverage obtained in the year-round sub-counties was similar (Njoro 57.4 %; Jomvu 63.1 %); however, more marked differences between campaign sub-counties were observed (Nakuru North 73.4 %; Likoni 55.2 %). The campaign-mode strategy exceeded the cold chain capacity of participating health facilities, requiring thrice monthly instead of once monthly deliveries, and was associated with a two-fold increase in workload compared to the year-round strategy (168 vaccines administered per day in the campaign strategy versus 83 vaccines administered per day in the year-round strategy). Although both strategies had similar coverage levels, the campaign-mode strategy was associated with considerable operational needs that could significantly impact the immunization program. [ABSTRACT FROM AUTHOR]

Some research on the population in a European country, referred to as the target population, may not provide a sufficient sample size and require pooling multiple national data sources. The researcher can access multiple national data sources one at a time but cannot access them simultaneously at an individual patient level, because of regulation requirements on data sharing. We propose a strategy that enables the combination of information from multiple data sources when IPD are not simultaneously accessible to researchers. This strategy starts with a protocol for extracting information consistently from all data sources. It uses the matching adjusted indirect comparison (MAIC) approach to derive the weights to align the means of the identified covariates of each data source to those of a target study population. The final analysis will be a meta-analysis on the weight adjusted estimates of treatment effect from individual data sources. [ABSTRACT FROM AUTHOR]

Duality of human nature has often been the centre of numerous works of art. However, what has been relatively hidden is the underlying duality in the makers. Starting from Greek philosopher Aretaeus of Cappadocia's notes which mention mania and melancholia as two manifestations of the same ailment in the 1st century B.C (Angst & Marneros, 2001). However, the modern conceptualization of bipolarity as a disorder was done by Emil Kraepelin (Bar & Ebert, 2010), and named it "manic-depressive insanity". One of the seminal works about the link of bipolar disorder, the manic phase to be more precise; was written by Lloyd-Evans et al. (2006) that has partly inspired this undertaking. There is a persevering belief in western communities that creativity and the manic phases of bipolar disorder are somehow linked. That has been investigated in this paper. While there are some beneficial effects of unfiltered stimuli entering brain during the manic phase on creativity, no definite causal relation between bipolar disorder and creativity has been found. [ABSTRACT FROM AUTHOR]

Abstract Background China is facing substantial risks of imported coronavirus disease 2019 (COVID-19) cases and a domestic resurgence in the long run, and COVID-19 vaccination is expected to be the long-lasting solution to end the pandemic. We aim to estimate the size of the target population for COVID-19 vaccination at the provincial level in the mainland of China, and summarize the current progress of vaccination programs, which could support local governments in the timely determination and adjustment of vaccination policies and promotional measures. Methods We conducted a descriptive study of the entire population in the mainland of China, between December 2020 and August 2021. By extracting provincial-stratified data from publicly available sources, we estimated the size of priority target groups for vaccination programs, and further characterized the ongoing vaccination program at the provincial level, including the total doses administered, the coverage rate, and the vaccination capacity needed to achieve the target coverage of 80% by the end of 2021. We used R (version 4.1.0) to complete the descriptive statistics. Results The size of the target population shows large differences among provinces, ranging from 3.4 million to 108.4 million. As of 31 August, 2021, the speed of vaccine roll-out differs considerably as well, with the highest coverage occurring in Beijing and Shanghai, where 88.5% and 79.1% of the population has been fully vaccinated, respectively. In 22 of 31 provincial-level administrative divisions (PLADs), more than 70% of the population was administered at least one dose by August. With the current vaccination capacity, the target of 80% coverage could be achieved by 2021 in 28 PLADs. Conclusions Disparities exist in the target population size and vaccination progress across provinces in the mainland of China. China has made great strides in the vaccination speed since roll-out, and could basically achieve the targeted vaccine coverage. Graphic Abstract

Methods based on propensity score (PS) have become increasingly popular as a tool for causal inference. A better understanding of the relative advantages and disadvantages of the alternative analytic approaches can contribute to the optimal choice and use of a specific PS method over other methods. In this article, we provide an accessible overview of causal inference from observational data and two major PS-based methods (matching and inverse probability weighting), focusing on the underlying assumptions and decision-making processes. We then discuss common pitfalls and tips for applying the PS methods to empirical research and compare the conventional multivariable outcome regression and the two alternative PS-based methods (ie, matching and inverse probability weighting) and discuss their similarities and differences. Although we note subtle differences in causal identification assumptions, we highlight that the methods are distinct primarily in terms of the statistical modeling assumptions involved and the target population for which exposure effects are being estimated.

AimsCardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort.Methods and resultsThis multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370 mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death.ConclusionThe primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.

Malawi introduced the human papillomavirus (HPV) vaccine nationwide in January 2019, with a target population of nine-year-old girls. Early in rollout, some health facilities reported stockouts, raising questions about the accuracy of the age eligibility of girls registered during the initial population mapping exercise. Mapping results showed that the estimated number of nine-year-old girls registered for vaccination was significantly higher than National Statistical Office (NSO) estimates, resulting in questions about enumeration of the target population. Consequently, the Ministry of Health of Malawi's Expanded Programme on Immunization (MOH-EPI) and immunization partners conducted a post-introduction data verification exercise to validate the eligibility of girls registered during mapping. Data were collected by immunization partners and representatives from national, zonal, and district levels. Dates of birth (DOB) were validated in HPV vaccine mapping registers and compared with information obtained from individual registered girls during school visits and their parents during home visits. HPV vaccine mapping registers were reviewed, showing that 76 percent of girls (n = 957) had DOBs within the vaccination eligibility range. A subset of the 957 girls (4 1 4) were interviewed; of them 74 percent (3 0 7) provided DOBs within the eligible period. Parents of the remaining eligible girls (5 4 3) were interviewed; 55 percent (2 9 7) of them, provided DOBs that were within the eligible period, indicating that, when using parents as an information source, 45 percent of the girls were outside the target age group. The eligibility verification exercise reviewed the accuracy of the mapping exercise and provided lessons for future target setting. Findings validate using NSO population estimates for target setting, incorporating the identification and registration of girls for HPV vaccination into RI microplanning headcounts, and verifying with parents the age and eligibility of girls registered before HPV vaccination is conducted. [ABSTRACT FROM AUTHOR]

BACKGROUND: Level I trauma centers must conduct injury prevention activities within their communities, despite limited resources available to them. To direct resources where they are most needed, injury prevention personnel at our trauma center use a novel method employing standard computer software. Although this method can be applied toward any injury population and prevention program, the example of targeting elderly falls prevention with A Matter of Balance classes is provided. OBJECTIVE: To share an innovative, yet efficient, technique to direct injury prevention efforts using Microsoft Excel map charts. METHODS: Using fictitious trauma registry data, an elderly falls rate is computed for each zip code. The top falls areas are then compared visually with areas where A Matter of Balance classes were conducted using Microsoft Excel map charts. RESULTS: Disparate areas of outreach, as well as areas where resources are inefficiently utilized, present in a manner that is easily recognized and communicated. CONCLUSION: Microsoft Excel map charts provide an effective and efficient means of displaying areas of greatest need, assessing disparities between those needs and outreach efforts that were conducted, and communicating with leadership. [ABSTRACT FROM AUTHOR]

Abstract Background All countries are facing decisions about which population groups to prioritize for access to COVID-19 vaccination after the first vaccine products have been licensed, at which time supply shortages are inevitable. Our objective is to define the key target populations, their size, and priority for a COVID-19 vaccination program in the context of China. Methods On the basis of utilitarian and egalitarian principles, we define and estimate the size of tiered target population groups for a phased introduction of COVID-19 vaccination, considering evolving goals as vaccine supplies increase, detailed information on the risk of illness and transmission, and past experience with vaccination during the 2009 influenza pandemic. Using publicly available data, we estimated the size of target population groups, and the number of days needed to vaccinate 70% of the target population. Sensitivity analyses considered higher vaccine coverages and scaled up vaccine delivery relative to the 2009 pandemic. Results Essential workers, including staff in the healthcare, law enforcement, security, nursing homes, social welfare institutes, community services, energy, food and transportation sectors, and overseas workers/students (49.7 million) could be prioritized for vaccination to maintain essential services in the early phase of a vaccination program. Subsequently, older adults, individuals with underlying health conditions and pregnant women (563.6 million) could be targeted for vaccination to reduce the number of individuals with severe COVID-19 outcomes, including hospitalizations, critical care admissions, and deaths. In later stages, the vaccination program could be further extended to target adults without underlying health conditions and children (784.8 million), in order to reduce symptomatic infections and/or to stop virus transmission. Given 10 million doses administered per day, and a two-dose vaccination schedule, it would take 1 week to vaccinate essential workers but likely up to 7 months to vaccinate 70% of the overall population. Conclusions The proposed framework is general but could assist Chinese policy-makers in the design of a vaccination program. Additionally, this exercise could be generalized to inform other national and regional strategies for use of COVID-19 vaccines, especially in low- and middle-income countries.

The research evaluates for the first time the process of vaccination against Covid-19 in Imereti region, its quantitative characteristics and coverage rates in accordance with the place of residence and age groups, both in regional and district contexts. The data have been compared with the indicators from other regions and data available at the national level. Vaccination rates have also been assessed in terms of the compliance with each vaccine registered in the country according to the dose frequency. Problem areas have been identified where the number of vaccination is much lower. Assessment of vaccination against Covid-19 by age showed that in the Imereti region, as well as at the national level, the highest number of vaccinations from the target population are given above the age of 60 years, which is mainly due to an intervention (monetary incentive). [ABSTRACT FROM AUTHOR]

This study evaluated the impact of subgroup weighting for equating through a common‐item anchor. We used data from a single test form to create two research forms for which the equating relationship was known. The results showed that equating was most accurate when the new form and reference form samples were weighted to be similar to the target population. When the target population was a combination of the two equating samples and one sample was weighted to be similar to the other, the equating was less accurate but still much more accurate than equating with unweighted samples. Report Number: RR‐21‐02 [ABSTRACT FROM AUTHOR]

Abstract Background For several years mobile X-ray equipment has been routinely used for imaging in patients too unwell within the hospital, when transportation to the radiology department was inadvisable. Now, mobile X-ray examinations are also used outside the hospital. The literature describes that fragile patients may benefit from mobile X-ray, but we need to provide insights into the breadth, depth and gaps in a body of literature. Methods The scoping review was performed by searching PubMed, Cinahl, Embase, EconLit and Health Technology Assessment. English-, Danish-, Norwegian-, German-, Italian-, French- and Swedish-language studies, published 1.1.2009–1.5.2020 about mobile X-ray outside the hospital were included. Participants were patients examined using mobile X-ray as the intervention. PRISMA was used when eligible to build up the review. To extract data from the selected articles, we used a structured summary table. Results We included 12 studies in this scoping review. The results were divided into four topics:1. Target population 2. Population health 3. Experience of care and 4. Cost effectiveness. The main findings are that target population could be larger for instance including hospice patients for palliative care, group dwelling for people with intellectual disabilities, or psychiatric patients, population health may be improved, image quality seems to be good and mobile X-ray may be cost effective. Limitations of language, databases and grey literature may have resulted in studies being missed. Conclusions Mobile X-ray may be used outside hospital. There seems to be potential benefits to both patients and health care staff. Based on the published studies it is not possible to draw a final conclusion if mobile X-ray examination is a relevant diagnostic offer and for whom. Further studies are needed to assess the feasibility of use in fragile patients, also regarding staff, relatives and societal consequences and therefore the topic mobile X-ray needs more research.

Background: China is facing substantial risks of imported coronavirus disease 2019 (COVID-19) cases and a domestic resurgence in the long run, and COVID-19 vaccination is expected to be the long-lasting solution to end the pandemic. We aim to estimate the size of the target population for COVID-19 vaccination at the provincial level in the mainland of China, and summarize the current progress of vaccination programs, which could support local governments in the timely determination and adjustment of vaccination policies and promotional measures. Methods: We conducted a descriptive study of the entire population in the mainland of China, between December 2020 and August 2021. By extracting provincial-stratified data from publicly available sources, we estimated the size of priority target groups for vaccination programs, and further characterized the ongoing vaccination program at the provincial level, including the total doses administered, the coverage rate, and the vaccination capacity needed to achieve the target coverage of 80% by the end of 2021. We used R (version 4.1.0) to complete the descriptive statistics. Results: The size of the target population shows large differences among provinces, ranging from 3.4 million to 108.4 million. As of 31 August, 2021, the speed of vaccine roll-out differs considerably as well, with the highest coverage occurring in Beijing and Shanghai, where 88.5% and 79.1% of the population has been fully vaccinated, respectively. In 22 of 31 provincial-level administrative divisions (PLADs), more than 70% of the population was administered at least one dose by August. With the current vaccination capacity, the target of 80% coverage could be achieved by 2021 in 28 PLADs. Conclusions: Disparities exist in the target population size and vaccination progress across provinces in the mainland of China. China has made great strides in the vaccination speed since roll-out, and could basically achieve the targeted vaccine coverage. [ABSTRACT FROM AUTHOR]

Minimal research has assessed the policy process of developing solar programs at the state level, and no research yet has investigated how these policies characterize and engage with the target populations they are designed to benefit. Grounded in Schneider and Ingram's social construction framework (SCF) and applying computational methods (i.e., text analysis and machine learning), this research examines how low-income households are socially constructed in policy provisions, how their social construction has been reinforced through public participation, and how to classify low-income households among target populations. Based on the case of Massachusetts, this research analyzes the 2020 Solar Massachusetts Renewable Target (SMART) Emergency Regulation as well as its public comments. We find that low-income households constitute a visible target group of this program and their characterizations as “deserving policy benefits” are positively constructed by policy makers. Furthermore, the conveyed messages and attitudes regarding the assigned benefits to low-income households have been reinforced through public participation. Despite this advantageous positive construction, low-income households have less political power (i.e., measured by topic prevalence in the public comments) than other target groups such as large corporations (e.g., solar developers or solar installers) and less ability to participate or be represented in the policy process, making their voices less likely to be heard by policy makers. With positive social construction but weaker political power, low-income households fall into the category of “dependents” instead of “advantaged,” which may engender undesirable policy outcomes minimizing the intended long-term benefits of the policies to low-income households. This research reveals procedural injustices in energy policies and highlights the importance of more inclusive policy-making process, while also offering a novel theoretical lens to understand the rationale and dynamics of developing solar statutes targeting low-income households.

Aim/Purpose The purpose of this article is to present clear definitions of the population structures essential to research, to provide examples of how these structures are described within research, and to propose a basic structure that novice researchers may use to ensure a clearly and completely defined population of interest and sample from which they will collect data. Background Novice researchers, especially doctoral students, experience challenges when describing and distinguishing between populations and samples. Clearly defining and describing research structural elements, to include populations and the sample, provides needed scaffolding to doctoral students. Methodology The systematic review of 65 empirical research articles and research texts provided peer-reviewed support for presenting consistent population- and samplerelated definitions and exemplars. Contribution This article provides clear definitions of the population structures essential to research, with examples of how these structures, beginning with the unit of analysis, are described within research. With this defined, we examine the population subsets and what characterizes them. The proposed writing structure provides doctoral students a model for developing the relevant population and sample descriptions in their dissertations and other research. Findings The article describes that although many definitions and uses are relatively consistent within the literature, there are epistemological differences between research designs that do not allow for a one-size-fits-all definition for all terms. We provide methods for defining populations and the sample, selecting a sample from the population, and the arguments for and against each of the methods. Recommendations for Practitioners Social science research faculty seek structured ways in which to present key research elements to doctoral students and to provide a model by which they may write the dissertation. The article offers contemporary examples from the peerreviewed literature to support these aims. Recommendations for Researchers Novice researchers may wish to use the recommended framework within this article when developing the relevant section of the dissertation. Doing so provides an itemized checklist of writing descriptions, ensuring a more complete and comprehensive description of the study population and sample. Impact on Society The scientific method provides a consistent methodological approach to researching and presenting research. By reemphasizing the definitions and applications of populations and samples in research, and by providing a writing structure that doctoral students may model in their own writing, the article supports doctoral students' growth and development in using the scientific method. Future Research Future researchers may wish to further advance novice researcher knowledge in developing models to guide dissertation writing. Future studies may focus on other essential areas of research, including studies about recruitment methods and attrition strategies, data collection procedures, and overall research alignment. Additionally, future researchers may wish to consider evaluating doctoral student foundational knowledge about populations and samples as part of the research process. [ABSTRACT FROM AUTHOR]

Purpose Diffuse large B‐cell lymphoma (DLBCL) is an aggressive lymphoma often refractory to currently available treatments (immuno‐chemotherapy/autologous‐stem‐cell‐transplantation‐ASCT). Recently, new cell therapies have been approved for patients failing two conventional treatments, CAR‐T (Chimeric‐Antigen‐Receptor‐T‐cell), committing payers in planning and implementing their use. We aim to define, using Real World Data (RWD), a reproducible procedure that allows identification of CAR‐T target population for DLBCL. Methods: Through the linking of electronic healthcare datasets (EHD), we identified patients with non‐Hodgkin's Lymphoma (NHL), resident in Lazio region (2010–2015), aged ≥20 years. DLBCL patients were followed using pathological anatomy (PA) reports, up to 3 years. To be defined as relapsed after two treatment lines, patients must have had new chemotherapy and/or NHL hospitalization after ASCT or at the end of the second chemotherapy. The incident rate of second relapse (R2‐rate) was extended to the population without PA reports. Result: NHL incident patients were 7384, 68% presented a PA report and, 29% of these had DLBCL codes. Patients who relapsed after two treatment lines were 47 (39%) in the subgroup of patients who received ASCT and 138 (41%) in that with second chemotherapy treatment. Patients in the two subgroups were very different in terms of age and comorbidity. The annual incident number of DLBCL was estimated to be 329 which multiplied by R2‐rate (13.7%) gives 45 patients per year eligible for CAR‐T. Discussion: This study shows how RWD allows the identification of a target population with new advanced therapies. This approach is rigorous, transparent and verifiable over time. [ABSTRACT FROM AUTHOR]

Objectives: Dossiers submitted for early benefit assessments in Germany also provide information on the precise determination of the target population (patients eligible for a drug). The situation is complex for non-small-cell lung cancer (NSCLC) due to highly specific therapeutic indications. Our aim was to compare the different methodological steps applied to determine the target population in dossiers on drugs for NSCLC. Methods: We analysed NSCLC dossiers assessed by the German Institute for Quality and Efficiency in Health Care (IQWiG) between 01.01.2011 and 31.12.2017. Methodological details regarding the determination of the target population were extracted and compared. Results: We analysed 23 NSCLC dossiers. In all dossiers, the target population was determined using the number of all patients with lung cancer as the basis for calculations. This patient population was further reduced in several successive steps by assuming proportions of patients with a specific characteristic (e.g. disease stage). The most important calculation steps were patients with NSCLC (n = 23 dossiers), with a specific disease stage (n = 23), with a specific tumour mutation (n = 14), with a specific tumour histology (n = 7), without prior treatment (n = 15), with pretreatment in second or further treatment lines (n = 17), and/or with specific pretreatments (n = 9). The proportions of patients determined within the same calculation step varied considerably between dossiers. Discussion: The calculation methods applied and the target population sizes reported in NSCLC dossiers vary considerably. A consensus with regard to the databases and calculation methods used to determine the target population in NSCLC would be helpful to reduce variations. [ABSTRACT FROM AUTHOR]

In this paper we have compiled and summarized the steps which manufacturers and clinical investigators need to undertake to perform a target population definition during the Health technology assessment process of medical device, namely external cardio stimulator (pacemaker). Based on available data using top-down approach we have defined target population for external cardiostimulator and estimated, that the size of the target population for external pacing will not exceed 16000 patients per year in the Czech Republic and is of comparable size with other states in the region. [ABSTRACT FROM AUTHOR]

This research examines if there is any relationship between restricted maternal right and infant death in Rimin Gado. The town consist of 14 wards which were all selected, houses were combined into a continuous list and systematic sampling technique was used, with a sampling ratio of 1:2 (an interval of every second house). 511 women respondents were drawn on the basis of availability. The target population were married women who must have given birth at least once. The units of analysis were married women, married men, Wanzamai and traditional birth attendants. The research was anchored on social action theory. The research's critical variable is maternal right. The type of data collected were both quantitative (questionnaire) and qualitative. Simple frequency, percentage table cross tabulation and correlation in SPSS version 16.0 were used to test the hypotheses. Findings revealed that there is no direct link between maternal right and infant deaths. [ABSTRACT FROM AUTHOR]

Orthpoxvirus infection can spread more easily in a population with a waning immunity with the subsequent emergence/re-emergence of the viruses pertaining to this genus. In the last two decades, several cases of Orthopoxvirus, and in particular Cowpoxvirus infections in humans were reported in different parts of the world, possibly due to the suspension of smallpox vaccinations. To date, in Italy, few investigations were conducted on the presence of these infections, and because of this a serosurvey was carried out to evaluate Cowpoxvirus infection in feline colonies situated in the province of Rome, since these are also susceptible to other zoonotic viruses belonging to Orthopoxvirus, and from which humans may contract the infection. The sample design was set at an expected minimum seroprevalence of 7.5%, a 5% standard error and 95% confidence level. In parallel, a serological investigation was conducted using convenience sampling in domestic, exotic and wild susceptible animals of the Latium and Tuscany Regions, which are areas in the jurisdiction of the Istituto Zooprofilattico Sperimentale del Lazio e della Toscana, coordinating this study. The serological methods employed were indirect immunofluorescence for 36 sera of nonhuman primate and virus neutralization for 1198 sera of different species. All the 1234 sera examined were negative for the presence of antibodies against Cowpoxvirus, indicating its limited circulation in the areas of investigation. The methodology applied for the serosurveillance could be adopted in the case of outbreaks of this infection and for the evaluation of the spread of this infection in the area of interest, to obtain essential information crucial for animal and public health policies according to the One Health concept.

• Our evidence has shown that active case-finding of tuberculosis might be effective in high prevalence area with a low economic level, particularly among the elderly and people with a history of TB. • New rapid diagnosis technology should be considered to decrease the TB prevalence in people with a history of TB. • ACF screening could identify more active TB cases than PCF by a TB surveillance system in high prevalence area with underdeveloped economics. Tuberculosis (TB) is a critical global public threat, and limited epidemiology studies have been performed to explore the efficacy of active TB screening. Three sites located in eastern China were chosen in 2013, and three rounds of systematic screenings were performed in permanent residents aged older than 15 years. The TB incidence showed a downtrend after several rounds of active screening at the three sites, and a significant change was observed at site A in the overall population. In the target population at sites A and B, both the elderly and people with a history of TB had a remarkable decline through the first or second round of screening. The implementation of active case-finding identified 2.36 [1.47,3.81] (2013 vs. 2012) and 1.49 [1.1,2.03] (2013–2015 vs. 2010–2012) more potential cases than the passive case-finding by the surveillance system at site A. Active case-finding of tuberculosis might be effective in high prevalence area with a low economic level, particularly among the elderly and people with a history of TB. Additionally, new rapid diagnosis technology should be considered to decrease the prevalence among people with a history of TB. Ultimately, active screening identified more active TB cases than passive case-finding, particularly in high prevalence area with underdeveloped economics. [ABSTRACT FROM AUTHOR]

La généralisation de la vaccination antigrippale à l'officine est encadrée par des règles précises. Ces modalités, qui régissent les conditions de sa mise en œuvre, visent à garantir une qualité de l'acte à tous les patients sur le territoire. The generalisation of influenza vaccination at pharmacists is governed by specific rules. These methods, which govern the conditions of implementation, aim to guarantee quality of the act to all patients in the region. [ABSTRACT FROM AUTHOR]

The definition of the target population of a public policy or program stands in function of the problem construction, this situation has an implication for the design of a social policy, because it has to take in consideration the inclusion or exclusion of some population group in the relationship with governmental attention. Traditionally, the design of social programs in Mexico has identified the target population through the multidimensional poverty approach; however, the literature evidences the need to give priority attention to vulnerability because this approach considers the poor population and also that which may be facing future changes in the environment. Therefore, the objective of this article is to present the usefulness and scope of the vulnerability approach as an additional option to define the target population in social programs, using as an example the "support to female heads of family" program that is implemented in the state of Jalisco since 2013. [ABSTRACT FROM AUTHOR]

When epidemiologic studies are conducted in a subset of the population, selection bias can threaten the validity of causal inference. This bias can occur whether or not that selected population is the target population and can occur even in the absence of exposure-outcome confounding. However, it is often difficult to quantify the extent of selection bias, and sensitivity analysis can be challenging to undertake and to understand. In this article, we demonstrate that the magnitude of the bias due to selection can be bounded by simple expressions defined by parameters characterizing the relationships between unmeasured factor(s) responsible for the bias and the measured variables. No functional form assumptions are necessary about those unmeasured factors. Using knowledge about the selection mechanism, researchers can account for the possible extent of selection bias by specifying the size of the parameters in the bounds. We also show that the bounds, which differ depending on the target population, result in summary measures that can be used to calculate the minimum magnitude of the parameters required to shift a risk ratio to the null. The summary measure can be used to determine the overall strength of selection that would be necessary to explain away a result. We then show that the bounds and summary measures can be simplified in certain contexts or with certain assumptions. Using examples with varying selection mechanisms, we also demonstrate how researchers can implement these simple sensitivity analyses. See video abstract at, http://links.lww.com/EDE/B535. [ABSTRACT FROM AUTHOR]

This study examines representativeness by compiling a sample of translations for textual analyses and a sample of translators for interviews. The process of achieving representativeness is exemplified by reporting on each case. The investigation is grounded in ongoing research on the strategies of literary translation from English to Czech that combines comparative text analyses and biographical interviews. The research objective is to generalise the strategies to the level of Czech literary translation norms. It is thus necessary to work with samples that are (1) representative to allow for such a level of generalisation and (2) of sizes that enable feasible analyses and interviews (i.e. the samples are not too extensive). The applied methodology pursues the fulfilment of both conditions through the three following steps: (a) Determination of the target population size and calculation of the sample size through statistical methods, (b) creation of a representative sample through probability sampling, analysis, and description, and (c) purposive sampling to obtain samples of texts and translators that represent the research intent. [ABSTRACT FROM AUTHOR]

Background: Case management has focused on care coordination reinforcement for the very frail community-dwelling older people in order to allow them to stay at home as long as possible. However the definition of the target population eligible to have a case manager is not clear. The purpose of this study was to identify predictive factors leading to not living at home over one year in a very frail community dwelling older population. Methods: A secondary analysis from a prospective cohort of 428 very frail older people, aged 65 years and over, living at home in Paris were set up. Patients were assessed using RAI-HC 2.0 (Resident Assessment Instrument -- Home care) tool. Not living at home at one year was identified in relation with admission characteristics using logistic regressions. Results: At baseline, a large majority of the patients lived alone with cognitive impairments and functional limitations. In one year, 48.6% (n = 208) did not live at home anymore. Among them 40.5% were dead, 36% were institutionalized and 23.5% were hospitalized and moved away. Functional disabilities formeal preparation (p = 0.04) and eating (p = 0.08), bladder incontinence (p = 0.07) and prior hospitalization (p = 0.08) increased the risk of not living at home over one year. Cognitive impairment, socio-demographic characteristics and number of home-based services were not related with the primary outcome. Conclusion: Functional limitations and prior hospitalizationswere predictive factors leading to not living at home in a very frail community dwelling older population. Results could help for identifying the population eligible to have a case manager. [ABSTRACT FROM AUTHOR]