Pregnancy Recruitment for Population Research: the National Children's Study Vanguard Experience in W ayne C ounty, M ichigan

Background To obtain a probability sample of pregnancies, the N ational C hildren's S tudy conducted door‐to‐door recruitment in randomly selected neighbourhoods in randomly selected counties in 2009–10. In 2011, an experiment was conducted in 10 US counties, in which the two‐stage geographic sample was maintained, but participants were recruited in prenatal care provider offices. We describe our experience recruiting pregnant women this way in W ayne C ounty, M ichigan, a county where geographically eligible women attended 147 prenatal care settings, and comprised just 2% of total county pregnancies. Methods After screening for address eligibility in prenatal care offices, we used a three‐part recruitment process: (1) providers obtained permission for us to contact eligible patients, (2) clinical research staff described the study to women in clinical settings, and (3) survey research staff visited the home to consent and interview eligible women. Results We screened 34 065 addresses in 67 provider settings to find 215 eligible women. Providers obtained permission for research contact from 81.4% of eligible women, of whom 92.5% agreed to a home visit. All home‐visited women consented, giving a net enrolment of 75%. From birth certificates, we estimate that 30% of eligible county pregnancies were enrolled, reaching 40–50% in the final recruitment months. Conclusions We recruited a high fraction of pregnancies identified in a broad cross‐section of provider offices. Nonetheless, because of time and resource constraints, we could enrol only a fraction of geographically eligible pregnancies. Our experience suggests that the probability sampling of pregnancies for research could be more efficiently achieved through sampling of providers rather than households.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/97525/1/ppe12047.pd

Early influences on cardiovascular and renal development

The hypothesis that a developmental component plays a role in subsequent disease initially arose from epidemiological studies relating birth size to both risk factors for cardiovascular disease and actual cardiovascular disease prevalence in later life. The findings that small size at birth is associated with an increased risk of cardiovascular disease have led to concerns about the effect size and the causality of the associations. However, recent studies have overcome most methodological flaws and suggested small effect sizes for these associations for the individual, but an potential important effect size on a population level. Various mechanisms underlying these associations have been hypothesized, including fetal undernutrition, genetic susceptibility and postnatal accelerated growth. The specific adverse exposures in fetal and early postnatal life leading to cardiovascular disease in adult life are not yet fully understood. Current studies suggest that both environmental and genetic factors in various periods of life may underlie the complex associations of fetal growth retardation and low birth weight with cardiovascular disease in later life. To estimate the population effect size and to identify the underlying mechanisms, well-designed epidemiological studies are needed. This review is focused on specific adverse fetal exposures, cardiovascular adaptations and perspectives for new studies. Copyrigh

HUMeral Shaft Fractures: MEasuring Recovery after Operative versus Non-operative Treatment (HUMMER): A multicenter comparative observational study

Background: Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery. Methods/design. The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective. Discussion. Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. Trial registration. The trial is registered at the Netherlands Trial Register (NTR3617)

Maternal Dietary Patterns During Pregnancy and Child Autism-Related Traits in the Environmental Influences on Child Health Outcomes Consortium

We examined relationships between prenatal dietary patterns and child autism-related outcomes, including parent-reported clinician diagnoses of autism spectrum disorder (ASD) and Social Responsiveness Scale (SRS-2) scores, in up to 6084 participants (with analytic samples ranging from 1671 to 4128 participants) from 14 cohorts in the Environmental Influences on Child Health Outcomes (ECHO) consortium. Associations between quartiles of the Healthy Eating Index (HEI-2015), the Alternative Healthy Eating Index modified for Pregnancy (AHEI-P), and the Empirical Dietary Inflammatory Pattern (EDIP), calculated based on reported prenatal diet, and outcomes were examined using crude and multivariable regression (quantile for SRS scores and logistic for diagnosis). In adjusted models, the higher quartile of prenatal HEI score was associated with lower SRS scores (Q4 vs. Q1 β for median quantile = -3.41 95% CI = -5.15, -1.26). A similar association was observed for the AHEI-P score when adjusting for total calories (Q4 vs. Q1 β = -2.52 95% -4.59, -0.45). There were no significant associations of prenatal diet with ASD diagnosis. Findings from this large U.S.-based study do not suggest strong associations between prenatal dietary patterns and ASD-related outcomes, although subtle associations with broader traits suggest the need to further consider how prenatal diet may relate to ASD-related phenotypes

Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN):study protocol for a randomized controlled trial

Contains fulltext : 239066.pdf (Publisher’s version ) (Open Access)BACKGROUND: Approximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26-34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking. METHODS: The "Pancreatic Locally Advanced Unresectable Cancer Ablation" (PELICAN) trial is an international multicenter superiority RCT, initiated by the Dutch Pancreatic Cancer Group (DPCG). All patients with LAPC according to DPCG criteria, who start with FOLFIRINOX or (nab-paclitaxel/)gemcitabine, are screened for eligibility. Restaging is performed after completion of four cycles of FOLFIRINOX or two cycles of (nab-paclitaxel/)gemcitabine (i.e., 2 months of treatment), and the results are assessed within a nationwide online expert panel. Eligible patients with RECIST stable disease or objective response, in whom resection is not feasible, are randomized to RFA followed by chemotherapy or chemotherapy alone. In total, 228 patients will be included in 16 centers in The Netherlands and four other European centers. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, RECIST response, CA 19.9 and CEA response, toxicity, quality of life, pain, costs, and immunomodulatory effects of RFA. DISCUSSION: The PELICAN RCT aims to assess whether the combination of chemotherapy and RFA improves the overall survival when compared to chemotherapy alone, in patients with LAPC with no progression of disease following 2 months of systemic treatment. TRIAL REGISTRATION: Dutch Trial Registry NL4997 . Registered on December 29, 2015. ClinicalTrials.gov NCT03690323 . Retrospectively registered on October 1, 2018

Major dietary patterns and cardiovascular risk factors among young Brazilian adults

Purpose: Diet is one of the most important modifiable risk factors for cardiovascular diseases. The scientific literature has consistently shown the effects of certain diets on health; however, given the variety of cultures and dietary habits across the world, it is likely that much remains to be learned about dietary patterns and health outcomes. We assessed the associations between main dietary patterns and cardiovascular risk factors among 4,202 young Brazilian adults in a cross-sectional analysis. Methods: In a principle components analysis, two main dietary patterns were identified: common Brazilian and processed food. As outcomes, we examined body mass index (BMI), waist circumference (WC), systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol, HDL cholesterol (HDL-c), and LDL cholesterol (LDL-c). Means, crude, and adjusted β coefficients and 95% CIs were estimated according to quintiles of dietary patterns. Results: Common Brazilian scores were inversely associated with BMI, WC, LDL-c, HDL-c, and total cholesterol values among men. Among women, inverse association trends were observed with SBP, DBP, LDL-c, HDL-c, and total cholesterol. The processed food pattern was positively associated with LDL-c, HDL-c, total cholesterol, BMI, and WC values among the men. Among the women, the processed food pattern was not significantly associated with cardiovascular risk factors. Conclusions: In conclusion, our findings confirm that diet has an important role on health during early adulthood. The common Brazilian pattern showed generally healthier trends regarding CVD risk factors, but the ultimate effects on risk of risk of disease are unclear because of the inverse relation with HDL-c levels

Nationwide implementation of the international multidisciplinary best-practice for locally advanced pancreatic cancer (PREOPANC-4):study protocol

Background: The introduction of (m)FOLFIRINOX and gemcitabine-nab-paclitaxel has changed the perspective for patients with locally advanced pancreatic cancer (LAPC). Consequently, in experienced centres 23% of patients with LAPC undergo a resection with 5-year overall survival (OS) rates of up to 25%. In the Netherlands, the nationwide resection rate for LAPC remains low at 8%. The PREOPANC-4 program aims for a nationwide implementation of the international multidisciplinary best-practice to improve patient outcome. Methods: Nationwide program implementing the international multidisciplinary best-practice for LAPC. In the training phase, multidisciplinary and surgical webinars are given by 4 international experts, leading to a clinical protocol, followed by surgical off-site and on-site proctoring sessions. In the implementation phase, the clinical protocol will be implemented in all centres, including a nationwide expert panel (2022–2024). Healthcare professionals will be trained in shared decision-making. Consecutive patients diagnosed with pathology-proven LAPC (i.e., arterial involvement &gt; 90° and/or portomesenteric venous &gt; 270° involvement or occlusion [DPCG criteria]) are eligible. Primary outcomes are median and 5-year OS from diagnosis, resection rate, in-hospital/30-day mortality and major morbidity (i.e., Clavien-Dindo grade ≥ IIIa), and radical resection (R0) rate. Secondary outcomes include quality of life, functioning, side effects, and patients’ healthcare satisfaction in all included patients. Outcomes will be compared with patients with borderline resectable pancreatic cancer (BRPC) treated with neoadjuvant FOLFIRINOX in the PREOPANC-2 trial (EudraCT: 2017–002036-17) and a historical cohort of patients with LAPC from the PACAP registry (NCT03513705). The existing prospective LAPC Registry and PACAP PROMs (NCT03513705) will be used for data collection. In qualitative interviews, treatment preferences, values, and experiences of LAPC patients, their relatives, and healthcare professionals will be assessed for the development of shared decision-making supportive tools. It is hypothesized that the program will double the nationwide LAPC resection rate to 16% with major morbidity &lt; 50% and mortality ≤ 5%, and OS following resection similar to that observed in patients with BRPC. Discussion: The PREOPANC-4 program aims to safely implement the international multidisciplinary best-practice for LAPC leading to benchmark outcomes for both short-term morbidity, mortality, and OS. Trial registration: PREOPANC-4 program was registered at ClinicalTrials.gov (NCT05524090) on September 1, 2022.</p

Five meal patterns are differently associated with nutrient intakes, lifestyle factors and energy misreporting in a sub-sample of the Malmö Diet and Cancer cohort

OBJECTIVE: Examine how meal patterns are associated with nutrient intakes, lifestyle and socioeconomic factors, and energy misreporting. DESIGN: A cross-sectional study within the Malmö Diet and Cancer (MDC) cohort. Participants reported on the overall types and frequency of meals consumed, and completed a modified dietary history, a lifestyle and socioeconomic questionnaire, and anthropometric measurements. Based on the reported intake of six different meal types, meal pattern groups were distinguished using Ward's cluster analysis. Associations between meal patterns and nutrient intakes, anthropometric, lifestyle and socioeconomic variables were examined using the chi(2)-method and analysis of variance. SUBJECTS: A sub-sample of the MDC study cohort (n=28,098), consisting of 1,355 men and 1,654 women. RESULTS: Cluster analysis identified five groups of subjects with different meal patterns in both men and women. These meal pattern groups differed regarding nutrient intakes, lifestyle and socioeconomic factors. Subjects reporting frequent coffee meals were more likely to report an 'unhealthy' lifestyle, e.g. smoking, high alcohol consumption and low physical activity, while those with a fruit pattern reported a more 'healthy' lifestyle. Women were more likely to underreport their energy intake than men, and the degree of underreporting varied between the meal pattern groups. CONCLUSIONS: The meal pattern groups showed significant differences in dietary quality and socioeconomic and lifestyle variables. This supports previous research suggesting that diet is part of a multifaceted phenomenon. Incorporation of aspects on how foods are combined and eaten into public health advices might improve their efficiency

Prognostic value of histopathologic traits independent of stromal tumor-infiltrating lymphocyte levels in chemotherapy-naïve patients with triple-negative breast cancer

Background: In the absence of prognostic biomarkers, most patients with early-stage triple-negative breast cancer (eTNBC) are treated with combination chemotherapy. The identification of biomarkers to select patients for whom treatment de-escalation or escalation could be considered remains an unmet need. We evaluated the prognostic value of histopathologic traits in a unique cohort of young, (neo)adjuvant chemotherapy-naïve patients with early-stage (stage I or II), node-negative TNBC and long-term follow-up, in relation to stromal tumor-infiltrating lymphocytes (sTILs) for which the prognostic value was recently reported. Materials and methods: We studied all 485 patients with node-negative eTNBC from the population-based PARADIGM cohort which selected women aged &lt;40 years diagnosed between 1989 and 2000. None of the patients had received (neo)adjuvant chemotherapy according to standard practice at the time. Associations between histopathologic traits and breast cancer-specific survival (BCSS) were analyzed with Cox proportional hazard models. Results: With a median follow-up of 20.0 years, an independent prognostic value for BCSS was observed for lymphovascular invasion (LVI) [adjusted (adj.) hazard ratio (HR) 2.35, 95% confidence interval (CI) 1.49-3.69], fibrotic focus (adj. HR 1.61, 95% CI 1.09-2.37) and sTILs (per 10% increment adj. HR 0.75, 95% CI 0.69-0.82). In the sTILs &lt;30% subgroup, the presence of LVI resulted in a higher cumulative incidence of breast cancer death (at 20 years, 58%; 95% CI 41% to 72%) compared with when LVI was absent (at 20 years, 32%; 95% CI 26% to 39%). In the ≥75% sTILs subgroup, the presence of LVI might be associated with poor survival (HR 11.45, 95% CI 0.71-182.36, two deaths). We confirm the lack of prognostic value of androgen receptor expression and human epidermal growth factor receptor 2 -low status. Conclusions: sTILs, LVI and fibrotic focus provide independent prognostic information in young women with node-negative eTNBC. Our results are of importance for the selection of patients for de-escalation and escalation trials.</p