Real-World Evidence BRIDGE: A Tool to Connect Protocol With Code Programming.

Objective: To enhance documentation on programming decisions in Real World Evidence (RWE) studies.

Materials And Methods: We analyzed several statistical analysis plans (SAP) within the Vaccine Monitoring Collaboration for Europe (VAC4EU) to identify study design sections and specifications for programming RWE studies. We designed a machine-readable metadata schema containing study sections, codelists, and time anchoring definitions specified in the SAPs with adaptability and user-friendliness.

Estimating uncertainty when providing individual cardiovascular risk predictions: a Bayesian survival analysis.

Background: Cardiovascular disease (CVD) risk scores provide point estimates of individual risk without uncertainty quantification. The objective of the current study was to demonstrate the feasibility and clinical utility of calculating uncertainty surrounding individual CVD-risk predictions using Bayesian methods.

Study Design And Setting: Individuals with established atherosclerotic CVD were included from the Utrecht Cardiovascular Cohort-Secondary Manifestations of ARTerial disease (UCC-SMART).

Healthy ageing in a multi-ethnic population: A descriptive cross-sectional analysis from the HELIUS study.

Objective: We investigated ethnic health disparities in the Healthy Life in an Urban Setting multi-ethnic cohort using the multidimensional Healthy Ageing Score.

Study Design: We conducted a cross-sectional analysis of the study baseline data (2011-2015) collected through questionnaires/physical examinations for 17,091 participants (54.8 % women, mean (SD) age = 44.

Impact of antenatal care on severe maternal and neonatal outcomes in pregnancies complicated by preeclampsia and eclampsia in Ghana.

Objectives: To explore how specific measures of antenatal care utilization are associated with outcomes in pregnancies complicated by preeclampsia and eclampsia in Ghana.

Study Design: Participants were adult pregnant women with preeclampsia or eclampsia at a tertiary hospital in Ghana. Antenatal care utilization measures included timing of first visit, total visits, facility and provider type, and referral status.

From Surviving Cancer to Getting on With Life: Adult Testicular Germ Cell Tumor Survivors' Perspectives on Transition From Follow-Up Care to Long-Term Survivorship.

With an increasing incidence and a high cure rate, a growing number of testicular germ cell tumor (TGCT) survivors require specialized follow-up care. However, knowledge of these patients' needs is lacking, leaving TGCT survivors with unmet care needs at risk of symptom burden when transitioning to long-term survivorship. This grounded theory study aimed to understand the perspectives of TGCT survivors' transition from follow-up care to long-term survivorship.

Comparison of likelihood penalization and variance decomposition approaches for clinical prediction models: A simulation study.

Logistic regression is one of the most commonly used approaches to develop clinical risk prediction models. Developers of such models often rely on approaches that aim to minimize the risk of overfitting and improve predictive performance of the logistic model, such as through likelihood penalization and variance decomposition techniques. We present an extensive simulation study that compares the out-of-sample predictive performance of risk prediction models derived using the elastic net, with Lasso and ridge as special cases, and variance decomposition techniques, namely, incomplete principal component regression and incomplete partial least squares regression.

Prevention and Screening for Cardiometabolic Disease Following Hypertensive Disorders in Pregnancy in Low-Resource Settings: A Systematic Review and Delphi Study.

Hypertensive disorders in pregnancy (HDP) and cardiometabolic and kidney diseases are rising in low- and middle-income countries (LMICs). While HDP are risk factors for cardiometabolic and kidney diseases, cost-effective, scalable strategies for screening and prevention in women with a history of HDP are lacking. Existing guidelines and recommendations require adaptation to LMIC settings.

Concepts and definitions of healthy ageing: a systematic review and synthesis of theoretical models.

Background: Healthy ageing (HA) has been defined using multiple approaches. We aim to produce a comprehensive overview and analysis of the theoretical models underpinning this concept and its associated normative terms and definitions.

Methods: We conducted a systematic review of peer-reviewed HA models in Embase.

Pre-diagnostic clinical features and blood tests in patients with colorectal cancer: a retrospective linked-data study.

Background: The majority of colorectal cancer is diagnosed in patients following symptomatic presentation in the UK.

Aim: To identify windows of opportunity for timely investigations or referrals in patients presenting with colon and rectal cancer-relevant symptoms or abnormal blood tests.

Design And Setting: A retrospective cohort study was undertaken using linked primary care and cancer registry data for patients with colorectal cancer diagnosed in England between 2012 and 2015.

Geriatric Falls: A Registry-Based Study in the Netherlands.

Background: Falls in people 65 years and older evaluated in the emergency department are increasing. Of all unintentional injury-related deaths among older people, 55% are due to falls. The impact of falls, especially concerning Dutch older people with the highest proportion of living independently worldwide, is unclear.

Cost-Effectiveness of a Multidisciplinary Lifestyle-Enhancing Treatment for Inpatients With Severe Mental Illness: The MULTI Study V.

Economic evaluations of lifestyle interventions for people with mental illness are needed to inform policymakers and managers about implementing such interventions and corresponding reforms in routine mental healthcare. We aimed to evaluate changes in healthcare costs 18 months after the implementation of a multidisciplinary lifestyle-enhancing treatment for inpatients with severe mental illness (MULTI) versus treatment as usual (TAU). In a cohort study ( = 114; 65 MULTI, 49 TAU), we retrospectively retrieved cost data in Euros on all patient sessions, ward stay, medication use, and hospital referrals in the quarter year at the start of MULTI (Q1 2014) and after its evaluation (Q3 2015).

Prediction models for living organ transplantation are poorly developed, reported, and validated: a systematic review.

Objective: To identify and critically appraise risk prediction models for living donor solid organ transplant counselling.

Study Design And Setting: We systematically reviewed articles describing the development or validation of prognostic risk prediction models about living donor solid organ (kidney and liver) transplantation indexed in Medline until April 4, 2021. Models were eligible if intended to predict, at transplant counselling, any outcome occurring after transplantation or donation in recipients or donors.

Clinical presentation, microbiological aetiology and disease course in patients with flu-like illness: a post hoc analysis of randomised controlled trial data.

Background: There is little evidence about the relationship between aetiology, illness severity, and clinical course of respiratory tract infections (RTIs) in primary care. Understanding these associations would aid in the development of effective management strategies for these infections.

Aim: To investigate whether clinical presentation and illness course differ between RTIs where a viral pathogen was detected and those where a potential bacterial pathogen was found.

The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations.

Clinicians have worked feverishly to treat patients with COVID-19 while also carrying out clinical research studies. We discuss how the clinical research community responded to the pandemic in Europe, what lessons were learned, and provide recommendations for future clinical research response during pandemics. We focused on two platform trials: RECOVERY and REMAP-CAP.

Comparison of (Cost-)Effectiveness of Magnetic Resonance Image-Guided High-Intensity-Focused Ultrasound With Standard (Minimally) Invasive Fibroid Treatments: Protocol for a Multicenter Randomized Controlled Trial (MYCHOICE).

Background: Magnetic resonance image-guided high-intensity-focused ultrasound (MR-HIFU) is a rather new, noninvasive option for the treatment of uterine fibroids. It is safe, effective, and has a very short recovery time. However, a lack of prospectively collected data on long-term (cost-)effectiveness of the MR-HIFU treatment compared with standard uterine fibroid care prevents the MR-HIFU treatment from being reimbursed for this indication.

Persistent Hypertension Up to One Year Postpartum among Women with Hypertensive Disorders in Pregnancy in a Low-Resource Setting: A Prospective Cohort Study.

Background: Hypertensive disorders in pregnancy (HDPs) are associated with lifelong cardiovascular disease risk. Persistent postpartum hypertension in HDPs could suggest progression to chronic hypertension. This phenomenon has not been well examined in low- and middle-income countries (LIMCs), and most previous follow-ups typically last for maximally six weeks postpartum.

Adherence to Guidelines in Postpartum Management of Hypertensive Disorders in Pregnancy in Tertiary Health Facilities in Nigeria: A Multi-centre Study.

Hypertensive disorders in pregnancy (HDPs) are a leading cause of maternal morbidity and mortality. Available guidelines for their postpartum management are expected to be optimally utilized. This study aimed to determine adherence to guidelines in selected Nigerian tertiary hospitals.

Metabolic syndrome following hypertensive disorders in pregnancy in a low-resource setting: A cohort study.

Objectives: Hypertensive disorders in pregnancy (HDPs) are associated with risk of future metabolic syndrome. Despite the huge burden of HDPs in sub-Saharan Africa, this association has not been adequately studied in this population.

Study Design: This was a prospective cohort study on pregnant women recruited between August 2017 - April 2018 and followed up to one year after their deliveries and evaluated for presence of metabolic syndrome at delivery, nine weeks, six months and one year.

Clinical prediction models: diagnosis versus prognosis.

Clinical prediction models play an increasingly important role in contemporary clinical care, by informing healthcare professionals, patients and their relatives about outcome risks, with the aim to facilitate (shared) medical decision making and improve health outcomes. Diagnostic prediction models aim to calculate an individual's risk that a disease is already present, whilst prognostic prediction models aim to calculate the risk of particular heath states occurring in the future. This article serves as a primer for diagnostic and prognostic clinical prediction models, by discussing the basic terminology, some of the inherent challenges, and the need for validation of predictive performance and the evaluation of impact of these models in clinical care.

Derivation and validation of a prognostic model for predicting in-hospital mortality in patients admitted with COVID-19 in Wuhan, China: the PLANS (platelet lymphocyte age neutrophil sex) model.

Background: Previous published prognostic models for COVID-19 patients have been suggested to be prone to bias due to unrepresentativeness of patient population, lack of external validation, inappropriate statistical analyses, or poor reporting. A high-quality and easy-to-use prognostic model to predict in-hospital mortality for COVID-19 patients could support physicians to make better clinical decisions.

Methods: Fine-Gray models were used to derive a prognostic model to predict in-hospital mortality (treating discharged alive from hospital as the competing event) in COVID-19 patients using two retrospective cohorts (n = 1008) in Wuhan, China from January 1 to February 10, 2020.

Foley catheter vs oral misoprostol for induction of labor: individual participant data meta-analysis.

Objective: To compare the effectiveness and safety of Foley catheter and oral misoprostol for induction of labor (IOL).

Methods: The Cochrane Review on Mechanical Methods for Induction of Labour and Ovid MEDLINE, EMBASE via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov and Scopus, from inception to April 2019, were searched for randomized controlled trials (RCTs) comparing Foley catheter to oral misoprostol for IOL in viable singleton gestations.

Screening and patient-tailored care for emotional and cognitive problems compared to care as usual in patients discharged home after ischemic stroke (ECO-stroke): a protocol for a multicenter, patient-blinded, cluster randomized controlled trial.

Background: Ischemic stroke patients with a good outcome in terms of motor functioning and communication are likely to be discharged home without further rehabilitation. A significant number of these patients experience cognitive and emotional problems resulting in lower quality of life and decreased participation in society. This paper presents the protocol of a study examining the clinical effectiveness, cost-effectiveness and implementation of an intervention focused on screening and patient-tailored care for cognitive and emotional problems as compared to usual care in patients discharged home after ischemic stroke.