Is it feasible to nest a Trial within a Cohort Study (TwiCS) to evaluate an early years parenting programme? A Born in Bradford's Better Start study protocol.

BACKGROUND: Evaluating the effectiveness of early years parenting interventions provides evidence to improve the development and wellbeing of children. This protocol paper describes a study to explore the feasibility of evaluating the Incredible Years Toddler early life intervention programme, which is offered to parents of 1-3-year-olds via the Better Start Bradford programme. The study aims to use a Trial within a Cohort Study (TwiCS) design that randomly selects individuals participating in a cohort to be offered an intervention. The TwiCS information and consent process is person-centred and aims to replicate real-world practice whereby only those who are offered the intervention are given information about the intervention. The cohort is the Born in Bradford's Better Start (BiBBS) cohort, an interventional birth cohort recruiting expectant parents in three areas of Bradford, UK. The study will assess the feasibility of TwiCS procedures, staged consent, and intervention take-up. METHODS: We will conduct a feasibility TwiCS to test study procedures. We aim to establish the following: (1) whether TwiCS methodology can be implemented to create control and intervention arms, whilst documenting any incidences of contamination within the cohort; (2) whether satisfactory rates of intervention uptake are achieved among participants allocated to the intervention; and (3) whether satisfactory rates of retention of participants in the intervention can be achieved. A Red Amber Green (RAG) rating system has been applied to support the feasibility assessment of each objective: to be rated red (not achieved), amber (partly achieved), and green (achieved). Eligible participants in the BiBBS cohort will be individually randomised 1:1 to the intervention or control arms, with stratification by child age (1 or 2 years old at the time of randomisation) and ethnicity (White British, South Asian, or other). BiBBS researchers will seek consent from participants randomised to the intervention to pass their contact details onto Incredible Years' delivery agents. DISCUSSION: This feasibility study will inform the utility of the TwiCs approach within an experimental birth cohort to evaluate interventions for infants, toddlers, and their families. TRIAL REGISTRATION: The study was prospectively registered on ISRCTN (ISRCTN16150114).

Combined associations of vitamin D and cognitive function with all-cause mortality among older adults in Chinese longevity areas: A prospective cohort study.

Objectives: While both vitamin D deficiency and cognitive impairment have individually been linked to a greater risk of all-cause mortality, the combined effects of these two different conditions have not previously been explored in this context. We aimed to investigate the combined impact of vitamin D concentration and cognitive impairment on all-cause mortality in older adults. Methods: The analyzed data were collected from community-dwelling adults ≥65 years of age that were enrolled in the Chinese Longitudinal Healthy Longevity Survey (n = 1,673). The Mini-Mental Status Examination (MMSE) was used to assess cognitive function, while the plasma 25-hydroxyvitamin D [25(OH)D] test was used to assess vitamin D status. The associations between vitamin D concentration, cognitive function, and all-cause mortality were assessed with Cox proportional hazards models. We used restricted cubic splines to examine the dose-response relationship between vitamin D and the risk of all-cause mortality and used joint effect testing to explore interactions between vitamin D concentration and cognitive function. Results: During a mean (SD) follow-up of 3.8 (1.9) years, 899 (53.7%) deaths occurred. A negative dose-response relationship was observed between 25(OH)D concentration and cognition impairment at baseline, as well as the odds of all-cause mortality during follow-up. Similarly, cognitive impairment was significantly related to all-cause mortality risk (HR 1.81, 95% CI: 1.54 to 2.12). The combined analyses showed positive associations, with the highest mortality risk observed in older adults with both low vitamin D and cognitive impairment (HR 3.04, 95% CI: 2.40 to 3.86). Moreover, the interaction between 25(OH)D concentration and cognitive function was found to be significant in relation to the risk of mortality (p for interaction <0.001). Conclusion: Lower plasma 25(OH)D and cognitive impairment were, respectively, associated with increased all-cause mortality risks. The 25(OH)D concentration and cognitive impairment exhibited a combined additive effect on all-cause mortality among older Chinese adults.

EMDR for symptoms of depression, stress and burnout in health care workers exposed to COVID-19 (HARD): A study protocol for a trial within a cohort study.

Background: Stressful events during a pandemic are a major cause of serious health problems, such as burnout, depression and posttraumatic stress disorder (PTSD) among health care workers (HCWs). During three years, HCWs, on the frontline to fight the COVID-19 pandemic, have been at an increased risk of high levels of stress, anxiety, depression, burnout and PTSD. Regarding potential psychological interventions, Eye Movement Desensitization & Reprocessing (EMDR) is a structured, strongly recommended therapy based on its well-known efficacy in reducing PTSD symptoms and anxiety.Objectives: This study, designed as a trial within a cohort (TwiC), aims to 1) estimate the prevalence of depression, burnout and PTSD in a sample of HCWs after experiencing the COVID-19 emergency (cohort part) and 2) assess the efficacy and acceptability of 'EMDR + usual care' for HCWs from the cohort who report significant psychological symptoms (trial part).Methods: The study, designed as a TwiC, consists of a prospective cohort study (n = 3000) with an embedded, pragmatic, randomized open-label superiority trial with two groups (n = 900). Participants included in the trial part are HCWs recruited for the cohort with significant symptoms on at least one psychological dimension (depression, burnout, PTSD) at baseline, 3 months or 6 months, determined by using the Patient Health Questionnaire (PHQ-9), Professional Quality of Life (ProQOL) scale, and PTSD Checklist for the DSM-5 (PCL-5). The intervention consists of 12 separate EMDR sessions with a certified therapist. The control group receives usual care. The trial has three primary outcomes: changes in depression, burnout and PTSD scores from randomization to 6 months. All participants are followed up for 12 months.Conclusions: This study provides empirical evidence about the impact of the COVID-19 pandemic and the mental health burden it places on HCWs and assesses the effectiveness of EMDR as a psychological intervention.Trial registration NCT04570202.

Health care workers are at increased risk of stress, anxiety, depression, burnout and PTSD following the COVID-19 pandemic.In this study, the effectiveness of EMDR in reducing depression, burnout and PTSD in health care workers exposed to COVID-19 is investigated.In this study, an original 'trial within a cohort' (TwiC) design that consists of a cohort study with an embedded pragmatic randomized trial is used.The study is fully web-based, including online screening, consent and assessments.

Exploring risk factors of short-term readmission in heart failure patients: A cohort study.

Background: The risk of all-cause mortality in patients with heart failure (HF) has been studied previously. Readmission risk of HF patients was rarely explored. Thus, we aimed to explore early warning factors that may influence short-term readmission of HF patients. Methods: The data of this study came from an HF database in China. It was a retrospective single-center observational study that collected characteristic data on Chinese HF patients by integrating electronic medical records and follow-up outcome data. Eventually, 1,727 patients with HF were finally included in our study. Results: In our study, the proportion of HF patients with New York Heart Association (NYHA) class II, III, and IV HF were 17.20%, 52.69%, and 30.11%, respectively. The proportion of patients with readmission within 6 months and readmission within 3 months was 38.33% and 24.20%, respectively. Multivariate logistic regression showed that NYHA class (p III = 0.028, p IV < 0.001), diabetes (p = 0.002), Cr (p = 0.003), and RDW-SD (p = 0.039) were risk factors for readmission within 6 months of HF patients. NYHA class (p III = 0.038, p IV < 0.001), CCI (p = 0.033), Cr (p = 0.012), UA (p = 0.042), and Na (p = 0.026) were risk factors for readmission within 3 months of HF patients. Conclusions: Our study implied risk factors of short-term readmission risk in patients with HF, which may provide policy guidance for the prognosis of patients with HF.

A novel predictive model of hospital stay for Total Knee Arthroplasty patients.

Objective: This study aimed to explore the main risk factors affecting Total Knee Arthroplasty (TKA) patients and develop a predictive nomogram of hospital stay. Methods: In total, 2,622 patients undergoing TKA in Singapore were included in this retrospective cohort study. Hospital extension was defined based on the 75% quartile (Q3) of hospital stay. We randomly divided all patients into two groups using a 7:3 ratio of training and validation groups. We performed univariate analyses of the training group, in which variables with P-values < 0.05 were included and then subjected to multivariate analysis. The multivariable logistic regression analysis was applied to build a predicting nomogram, using variable P-values < 0.01. To evaluate the prediction ability of the model, we calculated the C-index. The ROC, Calibration, and DCA curves were drawn to assess the model. Finally, we verified the accuracy of the model using the validation group and by also using the C-index. The ROC curve, Calibration curve, and DCA curve were then applied to evaluate the model in the validation group. Results: The final study included 2,266 patients. The 75% quartile (Q3) of hospital stay was six days. In total, 457 (20.17%) patients had hospital extensions. There were 1,588 patients in the training group and 678 patients in the validation group. Age, Hb, D.M., Operation Duration, Procedure Description, Day of Operation, Repeat Operation, and Blood Transfusion were used to build the prediction model. The C-index was 0.680 (95% CI: 0.734-0.626) in the training group and 0.710 (95% CI: 0.742-0.678) for the validation set. The calibration curve and DCA indicated that the hospital stay extension model showed good performance in the training and validation groups. Conclusion: To identify patients' risk factors early, medical teams need to plan a patient's rehabilitation path as a whole. Its advantages lie in better resource allocation, maximizing medical resources, improving the functional recovery of patients, and reducing the overall cost of hospital stay and surgery, and will help clinicians in the future.

Association of Blood Lead Levels with the Risk of Depressive Symptoms in the Elderly Chinese Population: Baseline Data of a Cohort Study.

Previous studies have reported an association between blood lead (BPb) levels and depressive symptoms in adults. However, the relationship between BPb levels and depression remains unclear in the old population. Our purpose was to investigate the association of BPb levels with depression among the old population. Data were gathered from 994 elderly persons in the Cohort Study of Elderly Health and Environmental Controllable Factors, which was created in Anhui, China. BPb was measured by inductively coupled plasma mass spectrometry. Our subjects were divided into four groups according to BPb quartiles. Multivariate logistic regressions were used to assess the association between BPb levels and depression. The median (25th-75th) BPb level was 26.94 µg/L (20.34 µg/L-36.13 µg/L). BPb levels in participants with depression were higher than those in participants without depression. The prevalence of depression was 27.64%. After multivariate adjustment for confounding factors, participants with BPb level in the highest quartile had 2.03 times higher risk of depression compared with those in the lowest quartile. In rural areas, the risk of depression in higher BPb quartile was higher than that in the lowest quartile. These findings suggest that higher BPb level was associated with increased odds of depression in the old population. This association was obvious among older people living in rural areas.

Identification and follow-up of pregnant women with platelet-type human platelet antigen (HPA)-1bb alloimmunized with fetal HPA-1a.

INTRODUCTION: Pregnant women negative for human platelet antigen 1a (HPA-1a) are at risk of alloimmunization with fetal HPA-1a antigen inherited from the father, and their offspring may develop fetal and neonatal alloimmune thrombocytopenia (FNAIT). The aim of this study was to analyze the frequency of HPA-1a alloimmunization in pregnant Polish women, the feasibility of using maternal platelets for intrauterine transfusions in women subjected to diagnostic fetal blood sampling (FBS) and to discuss potential consequences of alloimmunization. MATERIAL AND METHODS: Fifteen thousand two hundred and four pregnant women were typed for HPA-1a; HPA-1a negative were screened for anti-HPA-1a. Alloimmunized women received specialist perinatology care; some of them were subjected to FBS, followed by transfusion of HPA-1a negative platelet concentrates (PC) prepared from maternal blood. RESULTS: Three hundred seventy-three (2.5%) women were HPA-1a negative, and 32 (8.6%) tested positively for anti-HPA-1a. Antibodies were detected in 22 women during pregnancy. Diagnostic FBS followed by PC transfusion was performed in 14 woman, who were platelet donors for their 16 unborn babies. Blood donations were tolerated well by the patients, and also intrauterine platelet transfusions were uneventful. Pharmacotherapy with intravenous immunoglobulins was implemented in 11/22 patients. CONCLUSIONS: HPA-1a negative women (ca. 2.5% of all pregnant patients) are at risk of alloimmunization with HPA-1a antigen and developing FNAIT. Alloimmunized women can be donors of platelets for their offspring providing removal of antibodies from PC. Owing to potential complications, special care should be taken if an alloimmunized woman was qualified as a blood or stem cell recipient.

Micronutrient intake in advanced age: Te Puawaitanga o Nga Tapuwae Kia ora Tonu, Life and Living in Advanced Age: A Cohort Study in New Zealand (LiLACS NZ).

A high prevalence of undernutrition has previously been reported in indigenous Maori (49 %) and non-Maori (38 %) octogenarians and may be associated with risk of micronutrient deficiencies. We examined vitamin and mineral intakes and the contributing food sources among 216 Maori and 362 non-Maori participating in Life and Living to Advanced age a Cohort Study in New Zealand, using a repeat 24-h multiple-pass recall. More than half of the Maori and non-Maori participants had intakes below the estimated average requirement from food alone for Ca, Mg and Se. Vitamin B6 (Maori women only), folate (women only), vitamin E (Maori women; all men) and Zn (men only) were low in these ethnic and sex subgroups. Women had intakes of higher nutrient density in folate, vitamin C, Ca, Mg, K, vitamin A (non-Maori) and ß-carotene (Maori) compared with men (P<0·05). When controlling for age and physical function, ß-carotene, folate, vitamin C, Ca and Mg were no longer significantly different, but vitamins B2, B12, E and D, Fe, Na, Se and Zn became significantly different for Maori between men and women. When controlling for age and physical function, vitamins A and C and Ca were no longer significantly different, but vitamin B2, Fe, Na and Zn became significantly different for non-Maori between men and women. For those who took nutritional supplements, Maori were less likely to be deficient in food alone intake of vitamin A, folate and Mg, whereas non-Maori were less likely to be deficient in intakes of Mg, K and Zn, but more likely to be deficient in vitamin B12 intake. A lack of harmonisation in nutrient recommendations hinders the interpretation of nutrient adequacy; nonetheless, Ca, Mg and Se are key micronutrients of concern. Milk and cheese were important contributions to Ca intake, whereas bread was a key source of Mg and Se. Examination of dietary intake related to biochemical status and health outcomes will establish the utility of these observations.

Macronutrient intake in advanced age: Te Puawaitanga o Nga Tapuwae Kia ora Tonu, Life and Living in Advanced Age: A Cohort Study in New Zealand (LiLACS NZ).

As part of the 12-month follow-up of the longitudinal cohort study, Life and Living in Advanced Age: A Cohort Study in New Zealand, dietary intake was assessed in 216 Maori and 362 non-Maori octogenarians using repeat 24-h multiple pass recalls. Energy and macronutrient intakes were calculated, and food items reported were allocated to food groups used in the New Zealand Adult Nutrition Survey (NZANS). Intakes were compared with the nutrient reference values (NRV) for Australia and New Zealand. The median BMI was higher for Maori (28·3 kg/m2) than for non-Maori (26·2 kg/m2) P=0·007. For Maori, median energy intake was 7·44 MJ/d for men and 6·06 MJ/d for women with 16·3 % energy derived from protein, 43·3 % from carbohydrate and 38·5 % from fat. Median energy intake was 7·91 and 6·26 MJ/d for non-Maori men and women, respectively, with 15·4 % of energy derived from protein, 45 % from carbohydrate and 36·7 % from fat. For both ethnic groups, bread was the top contributor to energy and carbohydrate intakes. Protein came from beef and veal, fish and seafood, bread, milk and poultry with the order differing by ethnic groups and sex. Fat came mainly from butter and margarine. Energy-adjusted protein was higher for Maori than non-Maori (P=0·049). For both ethnic groups, the median energy levels were similar, percent carbohydrate tended to be lower and percent fat higher compared with adults aged >70 years in NZANS. These unique cross-sectional data address an important gap in our understanding of dietary intake in this growing section of our population and highlight lack of age-appropriate NRV.