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Introduction: 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., Methods: 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., Results: 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)., Conclusion: Although both strategies had similar coverage levels, the campaign-mode strategy was associated with considerable operational needs that could significantly impact the immunization program., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: SSC has since left the US CDC and is currently an employee of Sanofi Vaccines, Lyon, France., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

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.

According to Chapter 1.4 of the World Organisation for Animal Health (WOAH) Aquatic Animal Health Code, an entire country or zone can be classified as free of a disease only if there is compelling evidence that all susceptible populations within the country or zone are free. However, the methods for achieving freedom are not prescribed in the WOAH standards and guidelines. Within this context, this paper describes a novel methodology to determine if surveillance results can be extrapolated from a study population to a target population. A framework of six criteria was developed to standardize a method for extrapolating surveillance results to other susceptible populations that have not been sampled. Criteria 1 assesses the internal validity for the freedom claim on the source population. Criteria 2 assesses which other susceptible populations have a non-negligible probability of exposure. Criteria 3 assesses whether the risk of infection upon exposure of the source population is the same or greater than each of the other susceptible populations. Finally, Criteria 4, 5 and 6 assess if the other susceptible populations would transmit the infection to the source population or if they have the same exposure pathways as the source population. We illustrate the use of this novel methodology using two hypothetical case scenarios. The presented methodology has the advantage of being applicable either retrospectively or prospectively. When applied retrospectively, it can be used to assess if the surveillance results of the source population can be extrapolated to the target population. When applied prospectively it can be used to design a more efficient surveillance system by selecting source populations from which it is easier to extrapolate surveillance results to the rest of the target population. Conclusions drawn using this methodology depend on the validity of the assumptions made when working through the methodology. We therefore recommend cautious application of the criteria and thorough review of all assumptions., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Crown Copyright © 2023. Published by Elsevier B.V. All rights reserved.)

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.

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., (© 2023. The Author(s).)

The treatment of malignant tumors has entered the era of immunotherapy, and immune checkpoint inhibitors (ICIs) have brought significant benefits to patients. However, some patients are required to discontinue treatment with ICIs owing to factors such as disease progression and intolerable side effects. Faced with limited subsequent treatment options and complex medical needs, we searched PubMed, Embase, Cochrane library, and the NIH clinical trials database and found that ICI rechallenge could be a relevant clinical strategy. The factors that could affect the rechallenge efficacy include the patients' characteristics, therapeutic strategy selection, and the timing of treatment. Multiple factors are used to identify target population, of which clinical features and PD-L1 expression are more potential. Both single ICI rechallenge and combination therapy may have survival benefits. Patients who have tolerated initial immunotherapy well could undergo ICI rechallenge, while patients who have experienced grade 3 or higher immune-related adverse events should be carefully assessed prior to rechallenge. Interventions and the interval between two courses of ICI will clearly have an impact on the efficacy of subsequent treatment. Preliminary data evaluation supports further investigation on ICI rechallenge to identify the factors that could contribute to its efficacy., Competing Interests: Competing Interests: The authors have declared that no competing interest exists., (© The author(s).)

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., (© 2022 John Wiley & Sons Ltd.)

Strengthening the city-hospital network is intended to improve the response to the needs of people who move back and forth through the healthcare system. Édouard Habib, Director of the Fédération régionale des dispositifs de ressources et d'appui à la coordination des parcours de santé d'Île-de-France, and Marie-Dominique Lussier, a geriatrician and expert in the field of health care pathways, discussed ways to achieve this goal. In particular, they specified that it was important to think in terms of target populations, to consider networking as a meta-organization capable of adapting to changing needs, and to transform digital tools into vectors for this networking., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Purpose: 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., Results: 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 (414) were interviewed; of them 74 percent (307) provided DOBs within the eligible period. Parents of the remaining eligible girls (543) were interviewed; 55 percent (297) 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., Conclusion: 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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021. Published by Elsevier Ltd.)

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.

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., (© 2021. The Author(s).)

Purpose: The lowered LDL-C treatment goal of the 2019 European Society of Cardiology dyslipidemia guidelines results in a significant increase in the projected need for cost-intensive proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Addition of bempedoic acid (BA) to established oral lipid-lowering medication (LLM) has the potential to enable affordable LDL-C goal attainment, particularly in patients with statin intolerance (SI). The goal of this study was to quantify the target populations for BA and PCSK9 inhibitors as well as the related treatment costs to achieve the LDL-C goal of <55 mg/dL and a ≥50% reduction assuming the addition of BA to LLM., Methods: This study included 1922 patients with coronary artery disease (CAD) from the contemporary observational cohort study INTERCATH. A Monte Carlo simulation incorporating an algorithm adding sequentially a statin, ezetimibe, optionally BA, and a PCSK9 inhibitor was applied to achieve the LDL-C treatment goal, with consideration of both partial and total SI. Two scenarios were simulated for both a moderate (2% full and 10% partial) and a high (12% full) rate of SI: (1) without BA; and (2) with BA., Findings: Patients' mean age was 69.3 years, and the median baseline LDL-C level was 86.0 mg/dL. The need for a PCSK9 inhibitor would be 41.4% for a moderate rate of SI and 46.1% for a high rate of SI. Addition of BA would: (1) reduce the need for a PCSK9 inhibitor to 25.3% and 29.4%, thus lowering the annual overall treatment cost incurred through PCSK9 inhibitor ± BA per 1 million patients with CAD by 13.3% and 10.5%; (2) lower the cost per prevented event in the entire cohort (-5.0% and -6.3%), although at the price of fewer prevented events (-8.7% and -4.5%); and (3) reduce the cost per prevented event (-6.8% for both rates of SI) while preventing more events (7.6% and 6.9%) in the subpopulation of patients with full SI., Implications: Use of BA is projected to reduce the need for PCSK9 inhibitors as well as the treatment cost for add-on LLM. The subpopulation of patients with full SI might profit particularly., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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.

Background: Modifiable lifestyle risk factors (modRF) of coronary artery disease (CAD) are associated with increased inflammation represented by elevated C-reactive protein (CRP) levels. Lifestyle changes may influence the inflammatory burden in patients with CAD, relevantly modifying the target population for emerging anti-inflammatory compounds., Aims: The aims of this study were to analyse the association of modRF and CRP levels in CAD patients, and to define a potential target population for anti-inflammatory treatment with and without the optimisation of modRF., Methods: We included all patients with angiographically documented CAD from the observational cohort study INTERCATH. Patients with recent myocardial infarction, malignancy, infectious disease, and pre-existing immunosuppressive medication including a history of solid organ transplantation were excluded. Overweight (body mass index (BMI) ≥ 25 kg/m2), smoking, lack of physical activity (PA; <1.5 h/week), and poor diet (≤12 points of an established Mediterranean diet score (MDS), range 0-28 points) were considered as modRF. CRP was measured by a high-sensitivity assay (hsCRP) at baseline. We performed multivariable linear regressions with log-transformed hsCRP as the dependent variable. Based on these associations, we calculated potential hsCRP levels for each patient, assuming optimisation of the individual modRF., Results: Of 1014 patients, 737 (73%) were male, the mean age was 69 years, and 483 (48%) had an hsCRP ≥ 2 mg/l. ModRF were significantly overrepresented in patients with hsCRP ≥ 2 mg/l compared to patients with an hsCRP < 2 mg/l (BMI ≥ 25 kg/m2: 76% vs 61%; PA < 1.5 h/week: 69% vs 57%; MDS ≤ 12: 46% vs 37%; smoking: 61% vs 54%; p < 0.05 for all). hsCRP increased with the incremental number of modRF present (median hsCRP values for N = 0, 1, 2, 3, and 4 modRF: 1.1, 1.0, 1.6, 2.4, 2.8 mg/l, p < 0.001). Multivariable linear regression adjusting for age, sex, intake of lipid-lowering medication, and diabetes mellitus revealed independent associations between log-transformed hsCRP and all modRF (BMI ≥ 25 kg/m2: exp(ß) = 1.55, p < 0.001; PA < 1.5 h/week: exp(ß) = 1.33, p < 0.001; MDS ≤ 12: exp(ß) = 1.18, p = 0.018; smoking: exp(ß) = 1.18, p = 0.019). Individual recalculation of hsCRP levels assuming optimisation of modRF identified 183 out of 483 (38%) patients with hsCRP ≥ 2 mg/l who could achieve an hsCRP < 2 mg/l via lifestyle changes., Conclusion: modRF are strongly and independently associated with CRP levels in patients with CAD. A relevant portion of CAD patients with high inflammatory burden could achieve an hsCRP < 2 mg/l by lifestyle changes alone. This should be considered both in view of the cost and side-effects of pharmacological anti-inflammatory treatment and for the design of future clinical trials in this field., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The recently updated European Society of Cardiology (ESC) dyslipidaemia guidelines recommend a lower low-density lipoprotein cholesterol (LDL-C) goal of <55 mg/dL for patients with atherosclerotic cardiovascular disease (ASCVD), with a concomitant Class IA upgrade for proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) for patients not reaching their LDL-C goal under conventional lipid-lowering therapy., Aims: We aim to quantify the need for PCSK9i and the related costs to achieve the revised LDL-C goal in ASCVD patients compared to former ESC recommendations, in particular the risk-based 2017 ESC consensus update., Methods and Results: We included patients with ASCVD from an observational cohort study ongoing since 2015. A Monte Carlo simulation incorporating a treatment algorithm adding sequentially a statin, ezetimibe, and a PCSK9i was applied with consideration of partial and total statin intolerance. The need for PCSK9i was calculated for three different ESC recommendations (2019 guidelines, 2016 guidelines, 2017 consensus update). Preventable events and treatment costs due to PCSK9i were calculated for a range of annual event rates from 2% to 8% and annual treatment costs of ca. 6050 €. We included 1780 patients (mean age 69.5 years). Median LDL-C at baseline was 85.0 mg/dL, with 61% of patients taking lipid-lowering medication. The need for PCSK9i was simulated to be 42.0% (ESC 2019), 31.9% (ESC 2016), and 5.0% (ESC 2017). The LDL-C goals were achieved in 97.9%, 99.1%, and 60.9% of patients, respectively. Annual treatment cost for PCSK9i per 1 000 000 ASCVD patients would be 2.54 billion € (ESC 2019) compared to 0.30 billion € (ESC 2017). Costs per prevented event due to PCSK9i initiation differed widely, e.g. 887 000 € for an event rate of 3% and a treatment goal of <55 mg/dL compared to 205 000 € for an event rate of 7% and risk-based use of PCSK9i., Conclusion: The revised LDL-C treatment goals increase the projected need for PCSK9i with a substantial increase in associated treatment cost. An allocation strategy based on residual LDL-C and clinical or angiographic risk factors leads to a more tailored target population for PCSK9i with a reasonable benefit/cost ratio., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

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.

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., (© 2020 John Wiley & Sons Ltd.)

Purpose of Review: "Target bias" is the difference between an estimate of association from a study sample and the causal effect in the target population of interest. It is the sum of internal and external bias. Given the extensive literature on internal validity, here, we review threats and methods to improve external validity., Recent Findings: External bias may arise when the distribution of modifiers of the effect of treatment differs between the study sample and the target population. Methods including those based on modeling the outcome, modeling sample membership, and doubly robust methods are available, assuming data on the target population is available., Summary: The relevance of information for making policy decisions is dependent on both the actions that were studied and the sample in which they were evaluated. Combining methods for addressing internal and external validity can improve the policy relevance of study results.

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.

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.

Background: Tuberculosis (TB) is a critical global public threat, and limited epidemiology studies have been performed to explore the efficacy of active TB screening., Methods: 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., Results: 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., Conclusions: 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., (Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Population Health Intervention Research (PHIR) is an expanding field that explores the health effects of population-level interventions conducted within and outside of the health sector. Simulation modeling-the use of mathematical models to predict health outcomes in populations given a set of specified inputs-is a useful, yet underutilized tool for PHIR. It can be employed at several phases of the research process: (1) planning and designing PHIR studies; (2) implementation; and (3) knowledge translation of findings across settings and populations. Using the example of community-wide, built environment interventions for the prevention of type 2 diabetes, we demonstrate how simulation models can be a powerful technique for chronic disease prevention research within PHIR. With increasingly available data on chronic disease risk factors and outcomes, the use of simulation modeling in PHIR for chronic disease prevention is anticipated to grow. There is a continued need to ensure models are appropriately validated and researchers should be cautious in their interpretation of model outputs given the uncertainties that are inherent with simulation modeling approaches. However, given the complexity of disease pathways and methodological challenges of PHIR studies, simulation models can be a valuable tool for researchers studying population interventions that hold the potential to improve health and reduce health inequities.

Routine immunization coverage in Nigeria is suboptimal. In the northwestern state of Sokoto, an independent population-based survey for 2016 found immunization coverage with the third dose of Pentavalent vaccine to be 3%, whereas administrative coverage in 2016 was reported to be 69%. One possibility driving this large discrepancy is that administrative coverage is calculated using an under-estimated target population. Official population projections from the 2006 Census are based on state-specific standard population growth rates. Immunization target population estimates from other sources have not been independently validated. We conducted a micro-census in Magarya ward, Wurno Local Government Area of Sokoto state to obtain an accurate count of the total population living in the ward, and to compare these results with other sources of denominator data. We developed a precise micro-plan using satellite imagery, and used the navigation tool EpiSample v1 in the field to guide teams to each building, without duplications or omissions. The particular characteristics of the selected ward underscore the importance of using standardized shape files to draw precise boundaries for enumeration micro-plans. While the use of this methodology did not resolve the discrepancy between independent and administrative vaccination coverage rates, a simplified application can better define the target population for routine immunization services and estimate the number of children still unprotected from vaccine-preventable diseases., Competing Interests: Conflicts of Interest: The authors declare no conflict of interest.

Results obtained in randomized trials may not easily generalize to target populations. Whereas in randomized trials the treatment assignment mechanism is known, the sampling mechanism by which individuals are selected to participate in the trial is typically not known and assuming random sampling from the target population is often dubious. We consider an inverse probability of sampling weighted (IPSW) estimator for generalizing trial results to a target population. The IPSW estimator is shown to be consistent and asymptotically normal. A consistent sandwich-type variance estimator is derived and simulation results are presented comparing the IPSW estimator to a previously proposed stratified estimator. The methods are then utilized to generalize results from two randomized trials of HIV treatment to all people living with HIV in the United States.

Objective: Predictive statistical models used in population stratification programmes are complex and usually difficult to interpret for primary care professionals. We designed FINGER (Forming and Identifying New Groups of Expected Risks), a new model based on clinical criteria, easy to understand and implement by physicians. Our aim was to assess the ability of FINGER to predict costs and correctly identify patients with high resource use in the following year., Design: Cross-sectional study with a 2-year follow-up., Setting: The Basque National Health System., Participants: All the residents in the Basque Country (Spain) ≥14 years of age covered by the public healthcare service (n=1 946 884)., Methods: We developed an algorithm classifying diagnoses of long-term health problems into 27 chronic disease groups. The database was randomly divided into two data sets. With the calibration sample, we calculated a score for each chronic disease group and other variables (age, sex, inpatient admissions, emergency department visits and chronic dialysis). Each individual obtained a FINGER score for the year by summing their characteristics' scores. With the validation sample, we constructed regression models with the FINGER score for the first 12 months as the only explanatory variable., Results: The annual FINGER scores obtained by patients ranged from 0 to 57 points, with a mean of 2.06. The coefficient of determination for healthcare costs was 0.188 and the area under the receiver operating characteristic curve was 0.838 for identifying patients with high costs (>95th percentile); 0.875 for extremely high costs (>99th percentile); 0.802 for unscheduled admissions; 0.861 for prolonged hospitalisation (>15 days); and 0.896 for death., Conclusion: FINGER presents a predictive power for high risks fairly close to other classification systems. Its simple and transparent architecture allows for immediate calculation by clinicians. Being easy to interpret, it might be considered for implementation in regions involved in population stratification programmes., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: To compare the results of two rounds of colorectal cancer screening in Haining, explore the long-term mechanism and interval time of screening during the prevention and control of colorectal cancer, and establish practical basis for the rational prevention and control strategies. Methods: Between 2007 to 2010 and 2013 to 2015, a total of 80, 000 cases who had completed two rounds of tumor screening were enrolled and analyzed. All cases comes from five towns in Haining. Results: The first round of screening was performed in 80 603 cases and 12.92% ( n =10 417) were identified as high-risk population. Colonoscopy were completed in 7 796 subjects and 22.05%( n =1 719) of them were found at least one neoplastic lesions (polyps, adenoma or carcinoma). The population detection rate of all neoplasia was 21.33 per thousand. The detection rate of advanced neoplasia was 4.58% per colonoscopy and 4.43‰ in the population. A total of 357 advanced neoplasia including 296 advanced adenomas and 61 colorectal cancers were found, 330 of whom were applied to early treatment (92.44%). A total of 89 403 subjects participated the second round of screening. The detection rate of high-risk population in the second round (20.81%) was significantly higher than that in the first round ( P <0.05). A total of 12 917 subjects completed colonoscopy and 31.97% ( n =4 129) of them were found as least one neoplastic lesion. The population detection rate of all neoplasia was 46.18 ‰. Both in the subjects completed colonoscopy and in the screened population, the detection rate of all neoplasia were significantly ( P <0.01) higher than that of the first round. The detection rate of advanced neoplasia ( n =851) in both the subjects completed colonoscopy (6.59‰)and the total screened population (9.52‰) in the second round were also significantly ( P <0.01) higher than that of the first round. The difference of early detection rates for the first (92.44%) and the second (97.53%) round screening were not statistically significant( P >0.05). Conclusions: The main technical indicators of the second round of colorectal cancer screening were significantly better than that of the first round, with significant screening effect. A screening interval of 5 years was suggested for the next round of colorectal cancer screening.

In this paper a two-phase compressive sensing (CS) and received signal strength (RSS)-based target localization approach is proposed to improve position accuracy by dealing with the unknown target population and the effect of grid dimensions on position error. In the coarse localization phase, by formulating target localization as a sparse signal recovery problem, grids with recovery vector components greater than a threshold are chosen as the candidate target grids. In the fine localization phase, by partitioning each candidate grid, the target position in a grid is iteratively refined by using the minimum residual error rule and the least-squares technique. When all the candidate target grids are iteratively partitioned and the measurement matrix is updated, the recovery vector is re-estimated. Threshold-based detection is employed again to determine the target grids and hence the target population. As a consequence, both the target population and the position estimation accuracy can be significantly improved. Simulation results demonstrate that the proposed approach achieves the best accuracy among all the algorithms compared.

Objective: Published data about prevalence of distinct risk condictions for pneumococcal disease is scarce. This study investigated the prevalence of distinct risk conditions for pneumococal disease in Catalonian adults and stimated the potential size of target population for pneumococcal vaccination in Catalonia and Spain., Methods: Cross-sectional population-based study that included 2,033,465 individuals older than 49 years-old assigned to the Catalonian Health Institute (Catalonia, Spain) at 01/01/2015. The Catalonian Health Institute Information System for the Development of Research in Primary Care (SIDIAP) was used to identify comorbidities and/or underlying conditions in each subject and establish potential target population for pneumococcal vaccination on the basis of their risk for suffering pneumococcal infections: 1) immunocompromised subjects; 2) immunocompetents subjects with any risk condition; 3) immunocompetents subjects without risk conditions., Results: Of the 2,033,465 study subjects, 1,053,155 (51.8%) had no risk conditions, 649,014 (31.9%) had one risk condition and 331,296 (16.3%) had multiple risk conditions (11.4% in 50-64 years vs 21.2% in people older than 65 years, p smaller than 0.001; 21.8% in men vs 11.6% in women, p smaller than 0.001). Overall, 176,600 (8.7%) and 803,710 (39.5%) were classified in risk stratum 1 and 2, respectively. According to distinct risk strata considered, the target population for pneumococcal vaccination varied between 0.2-1.9 million in Catalonia and 1.5-2.3 million in Spain., Conclusions: In our setting, almost fifty percent of people ≥50 years have at least one risk condition to suffert pneumococcal disease. Adult population susceptible for pneumococal vaccination largely varies depending on the risk stratum considered as targeted people for pneumococcal vaccination.

Aims: Cardiopoietic 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 Results: This 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., Conclusion: The 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., (© The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Biostatisticians recognize the importance of precise definitions of technical terms in randomized controlled clinical trial (RCCT) protocols, statistical analysis plans, and so on, in part because definitions are a foundation for subsequent actions. Imprecise definitions can be a source of controversies about appropriate statistical methods, interpretation of results, and extrapolations to larger populations. This paper presents precise definitions of some familiar terms and definitions of some new terms, some perhaps controversial. The glossary contains definitions that can be copied into a protocol, statistical analysis plan, or similar document and customized. The definitions were motivated and illustrated in the context of a longitudinal RCCT in which some randomized enrollees are non-adherent, receive a corrupted treatment, or withdraw prematurely. The definitions can be adapted for use in a much wider set of RCCTs. New terms can be used in place of controversial terms, for example, subject. We define terms specifying a person's progress through RCCT phases and that precisely define the RCCT's phases and milestones. We define terms that distinguish between subsets of an RCCT's enrollees and a much larger patient population. 'The intention-to-treat (ITT) principle' has multiple interpretations that can be distilled to the definitions of the 'ITT analysis set of randomized enrollees'. Most differences among interpretations of 'the' ITT principle stem from an RCCT's primary objective (mainly efficacy versus effectiveness). Four different 'authoritative' definitions of ITT analysis set of randomized enrollees illustrate the variety of interpretations. We propose a separate specification of the analysis set of data that will be used in a specific analysis. Copyright © 2016 John Wiley & Sons, Ltd., (Copyright © 2016 John Wiley & Sons, Ltd.)

Purpose: Causal effects in epidemiology are almost invariably studied by considering disease incidence even when prevalence data are used to estimate the causal effect. For example, if certain conditions are met, a prevalence odds ratio can provide a valid estimate of an incidence rate ratio. Our purpose and main result are conditions that assure causal effects on prevalence can be estimated in cross-sectional studies, even when the prevalence odds ratio does not estimate incidence., Methods: Using a general causal effect definition in a multivariate counterfactual framework, we define causal contrasts that compare prevalences among survivors from a target population had all been exposed at baseline with that prevalence had all been unexposed. Although prevalence is a measure reflecting a moment in time, we consider the time sequence to study causal effects., Results: Effects defined using a contrast of counterfactual prevalences can be estimated in an experiment and, with conditions provided, in cross-sectional studies. Proper interpretation of the effect includes recognition that the target is the baseline population, defined at the age or time of exposure., Conclusions: Prevalences are widely reported, readily available measures for assessing disabilities and disease burden. Effects on prevalence are estimable in cross-sectional studies but only if appropriate conditions hold., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The clinical utility of microbiome biomarkers depends on the reliable and reproducible nature of comparative results. Underappreciation of the variation associated with common demographic, health, and behavioral factors may confound associations of interest and generate false positives. Here, we present the Midwestern Reference Panel (MWRP), a resource for comparative gut microbiome studies conducted in the Midwestern United States. We analyzed the relationships between demographic and health behavior-related factors and the microbiota in this cohort, and estimated their effect sizes. Most variables investigated were associated with the gut microbiota. Specifically, body mass index (BMI), race, sex, and alcohol use were significantly associated with microbial β-diversity (P < 0.05, unweighted UniFrac). BMI, race and alcohol use were also significantly associated with microbial α-diversity (P < 0.05, species richness). Tobacco use showed a trend toward association with the microbiota (P < 0.1, unweighted UniFrac). The effect sizes of the associations, as quantified by adjusted R(2) values based on unweighted UniFrac distances, were small (< 1% for all variables), indicating that these factors explain only a small percentage of overall microbiota variability. Nevertheless, the significant associations between these variables and the gut microbiota suggest that they could still be potential confounders in comparative studies and that controlling for these variables in study design, which is the main objective of the MWRP, is important for increasing reproducibility in comparative microbiome studies.

Purpose: To identify the influence of gender stereotypes on eating habits among Costa Rican adolescents., Design: Qualitative, descriptive research was used in this study., Setting: Adolescents and parents were recruited from socioeconomically diverse populations in rural and urban areas of San José, Costa Rica., Subjects: Subjects were 92 adolescents (14 to 17 years old) and 48 parents., Methods: Focus group data were transcribed and entered into the qualitative data analysis software Atlas.ti version 5.0. Analyses were grounded on the social cognitive theory., Results: Five themes emerged from the focus group discussions: (1) Costa Rican adolescents associate the consumption of moderate quantities of healthy foods with femininity and male homosexuality. (2) The consumption of hearty portions of nonhealthy foods was associated with masculinity and male heterosexuality. (3) There is an emerging view that it is acceptable for heterosexual male adolescents to take care of their bodies through healthy eating. (4) Body care among female adolescents is an element of femininity and body image. (5) Parents reinforce their daughters' persistent concern with weight control because they perceive it as feminine behavior., Conclusion: Health promoters should be aware of the existing and changing food stereotypes around gender as an avenue for the promotion of healthy eating.

Purpose: To evaluate the interactions of risk factors and identify their most powerful discrimination pathway for the occurrence of low back pain (LBP)., Design: A cross-sectional study., Setting: Taiwan., Subjects: Taiwanese population of 30 to 64 years old., Measures: A self-reported question, "Have you experienced LBP within the last 3 months?" was used to evaluate LBP. The study variables included demographics (age, gender, occupation, education level, marital status, and household income), biometric health measures (bone mineral density and body mass index), dietary habits (weekly milk, coffee, tea, and soybean consumption), and other lifestyle factors (smoking habits, alcohol consumption, betel nut chewing, body weight control, exercise regularity, and stress management)., Analysis: Logistic regression and classification tree analyses., Results: A total of 969 Taiwanese participants were analyzed. Primary logistic regression analysis identified three critical risk factors (gender, bone mineral density, and exercise regularity) for the occurrence of LBP. By classification tree analysis, demographic factors, dietary habits, and lifestyle factors had modifying effects on LBP., Conclusions: Various factors contribute to the risk of LBP. Interactions between risk factors should be considered when developing future strategies for the prevention and management of LBP.

Background: We review three common methods to estimate predicted probabilities following confounder-adjusted logistic regression: marginal standardization (predicted probabilities summed to a weighted average reflecting the confounder distribution in the target population); prediction at the modes (conditional predicted probabilities calculated by setting each confounder to its modal value); and prediction at the means (predicted probabilities calculated by setting each confounder to its mean value). That each method corresponds to a different target population is underappreciated in practice. Specifically, prediction at the means is often incorrectly interpreted as estimating average probabilities for the overall study population, and furthermore yields nonsensical estimates in the presence of dichotomous confounders. Default commands in popular statistical software packages often lead to inadvertent misapplication of prediction at the means., Methods: Using an applied example, we demonstrate discrepancies in predicted probabilities across these methods, discuss implications for interpretation and provide syntax for SAS and Stata., Results: Marginal standardization allows inference to the total population from which data are drawn. Prediction at the modes or means allows inference only to the relevant stratum of observations. With dichotomous confounders, prediction at the means corresponds to a stratum that does not include any real-life observations., Conclusions: Marginal standardization is the appropriate method when making inference to the overall population. Other methods should be used with caution, and prediction at the means should not be used with binary confounders. Stata, but not SAS, incorporates simple methods for marginal standardization., (© The Author 2014; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.)

The development of anti-staphylococcal vaccines is nowadays a priority to prevent surgical site infections (SSI). The objective of the present study was to identify a potential target population by assessing surveillance data on surgery patients for possible anti-staphylococcal vaccine administration. Individuals at high risk of SSI by Staphylococcus aureus (SA) were targeted by the French SSI Surveillance Network in south-eastern France between 2008 and 2011. Among 238,470 patients, those undergoing primary total hip replacement appeared to be an interesting and healthy enough population for anti-staphylococcal vaccine testing. These male patients, subjected to multiple procedures and with American Society of Anesthesiologists score>2, had a probability of SA SSI about 21 times higher than females with no severe systemic disease and no multiple procedures. Our study indicates that surveillance data on SSI might be an interesting epidemiological source for planning vaccine trials to prevent nosocomial infections.

Objective: Poor eating habits are a key priority on the European public health agenda due to their large health and economic implications. Healthy eating interventions may be more effective if consumers perceive their eating habits as a more serious personal health risk. This study investigates European consumers' perceived seriousness of their eating habits, its determinants and relative importance among other potential personal health risks including weight, stress and pollution., Method: A quantitative survey was conducted during Spring 2011 among samples representative for age, gender and region in five European countries (n=3003)., Results: Participants were neutral towards the seriousness of their eating habits for personal health. Eating habits were ranked third after stress and weight. Gender, age, country, health motive, body mass index, and subjective health status were important determinants of the perceived seriousness of their eating habits, whereas perceived financial condition, smoking and education were insignificant., Conclusion: Eating habits were perceived more seriously by women, Italians, obese, and younger individuals with stronger health motives and fair subjective health status. Nevertheless, other health risks were often considered more important than eating habits. More or specific efforts are required to increase Europeans' awareness of the seriousness of their eating habits for personal health., (© 2013.)

Several papers have been published recently in the Journal addressing "best practices" for survey research manuscripts. This paper explores in more detail the effects of the target population size on sample size determination, probability sampling versus census approaches, and response rates and the relationship to potential nonresponse bias. Survey research is a complex methodology requiring expertise in the planning, execution, and analytic stages.

A common assumption is that outreach-based HIV counseling and testing services reach a clientele with a higher HIV seroprevalence than clinic-based counseling and testing. To examine this assumption, we analyzed Wisconsin's anonymous counseling and testing client records for 62,299 contacts (testing episodes) from 1992 to 1995. Bivariate analysis of counseling and testing service setting (outreach-based or clinic-based) and HIV test results suggested that outreach contacts were 23% (odds ratio [OR], 1.23; 95% confidence interval [95% CI], 1.0-1.5) more likely to test HIV-seropositive than clinic-based contacts. Relations between HIV test outcome and variables for client age, race, gender, previous testing history, mode of risk exposure, and region, as well as service setting, were examined by logistic regression. An inverted relation between service setting and seropositivity (OR, 0.65; 95% CI, 0.5-0.8) indicated that, within some subpopulations, outreach contacts were significantly less likely to test HIV-positive than clinic-based contacts. Analysis of interactions among the covariates identified race as a critical codeterminant in the relation between service setting and test outcome. These results support retargeting outreach services to enhance their overall effectiveness. Specific recommendations include the need for aggressive strategies to better "market" HIV counseling and testing to nonwhite populations, and to focus resources more selectively on gay/bisexual men of all races.

As part of the evaluation of a community-level HIV prevention program for women, this study examined predictors of exposure to print media and community outreach and assessed the relationship between exposure to the intervention and condom use behavior. Data from interviews with 479 women randomly selected from the intervention community in 1995 and 1996 were examined. Analysis of demographic and risk characteristics were conducted to identify predictors of exposure to the project's HIV prevention messages. Additionally, logistic regression analyses were conducted to examine the effects of intervention exposure on condom use, controlling for factors related to exposure. The results revealed that the print media campaign reached the largest number of women. However, women at highest risk did not have high rates of exposure to print media, but had greater exposure to outreach. Exposure to print media had an effect on increased communication with a main partner about condom use, but was not significantly related to condom use last time had sex. There were no significant main effects for exposure to outreach on condom use behavior. An important finding of this analysis was that each intervention strategy was successful in reaching a different portion of the target population and that exposure had differential effects on the condom use behavior of particular segments of the target population.

Context: Traditional methods of identifying areas in need of adolescent pregnancy prevention programs may miss small localities with high levels of adolescent childbearing., Methods: Birthrates for 15-17-year-olds were computed for all California zip codes, and the zip codes with birthrates in the 75th percentile were identified. Panels of local experts in adolescent pregnancy reviewed these "hot spots" for accuracy and grouped them into potential project areas, based on their demographics, geography and political infrastructure., Results: In all, 415 zip codes exceeded the 75th-percentile cut-off point of 62.8 births per 1,000, and 210 of them differed significantly from the state average of 44.5 per 1,000 for 15-17-year-olds. While all had high adolescent birthrates, they varied greatly in racial and ethnic mix, poverty and educational attainment, and certain perinatal measures such as inadequate prenatal care and repeat pregnancy., Conclusions: The use of zip code-level data holds promise for more effective program planning and intervention.