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Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy.

Background Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statisti

DPYD Genotyping in Patients Who Have Planned Cancer Treatment With Fluoropyrimidines: A Health Technology Assessment.

BACKGROUND: Fluoropyrimidine drugs (such as 5-fluorouracil and capecitabine) are used to treat different types of cancer. However, these drugs may cause severe toxicity in about 10% to 40% of patients. A deficiency in the dihydropyrimidine dehydrogenase (DPD) enzyme, encoded by the DPYD gene, increases the risk of severe toxicity. DPYD genotyping aims to identify variants that lead to DPD deficiency and may help to identify people who are at higher risk of developing severe toxicity, allowing their treatment to be modified before it begins. Recommendations for fluoropyrimidine treatment modifi

A prospective, multicenter, population-based study of BRAF mutational analysis for Lynch syndrome screening.

BACKGROUND & AIMS: Mismatch repair (MMR) deficiencies are the hallmark of tumors arising in Lynch syndrome, however, in approximately 15% of sporadic colorectal cancers (CRC) these deficiencies most often are associated with somatic methylation of the MMR gene MLH1. Recently, an oncogenic mutation in the BRAF gene has been involved in sporadic CRC showing MMR deficiencies as a result of MLH1 promoter methylation. The aim of this study was to evaluate the contribution of BRAF V600E mutation analysis in the identification of MSH2/MLH1 gene mutation carriers in newly diagnosed CRC patients. METH

Risk assessments and structured care interventions for prevention of foot ulceration in diabetes: development and validation of a prognostic model.

BACKGROUND: Diabetes-related foot ulcers give rise to considerable morbidity, generate a high monetary cost for health and social care services and precede the majority of diabetes-related lower extremity amputations. There are many clinical prediction rules in existence to assess risk of foot ulceration but few have been subject to validation. OBJECTIVES: Our objectives were to produce an evidence-based clinical pathway for risk assessment and management of the foot in people with diabetes mellitus to estimate cost-effective monitoring intervals and to perform cost-effectiveness analyses and

Public preferences and decision-making for mpox vaccination in the African region: a multinational discrete choice experiment.

INTRODUCTION: After the WHO prequalified the first vaccine against mpox, we aimed to identify the influence of vaccine attributes on mpox vaccination preferences among the African adults. METHODS: A discrete choice experiment was conducted among 1832 African adults across six countries. Respondents answered eight questions, each requiring them to choose between two hypothetical vaccines, with variations in distance from home to vaccination facilities, cost, effectiveness, duration of the protective effect, supply and side effects. A mixed logit model was employed to estimate vaccination prefe

Facilitators and barriers to participation and scale-up of a non-specialist delivered psychological intervention for adolescents in low-resourced settings: a process evaluation.

Globally, the number of refugees and displaced individuals has surpassed 100 million for the first time in history. Refugees are more likely than non-refugee populations to experience psychological distress and develop mental disorders. Early Adolescent Skills for Emotion (EASE), developed by the World Health Organization, is a potentially scalable task-sharing intervention targeting symptoms of internalizing disorders such as depression and anxiety for 10-15 years old and their caregiver. Prior to this study a randomized controlled trial in Amman, Jordan was conducted showing effectiveness of

Прогнозирующие факторы развития инвалидности в множестве склерозов в реальной жизни: определение FSEP-высокой категории (OFSEP-HD) во Франции.

ЦЕЛЬ: Определение прогнозируемых факторов инвалидности при множественном склерозе (МС), т.е.1) выявлять факторы, определяющие динамику развития инвалидности;2) изучение эффективности методов лечения с целью видоизменения заболеваний (ДМТ);3) объединить детерминанты и ДРТ для создания ориентированных на пациента средств прогнозирования и ()4) проводить экономический анализ. УЧАСТНИКИ: Лица, зарегистрированные во Французской базе данных Французской обсерватории по склерозам в плаке (OFSEP), были включены в эту группу лиц с высоким определением FOSEP, если они имели диагноз MS, ≥15 :: возраст и у

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… Economic analysis plan Two types of economic analysis will be conducted: (1) a cost-of-illness analysis for identifying the current cost burden to society, together with the identification of the main cost drivers and (2) a cost-effectiveness analysis for exploring the efficiency of recent DMT treatments …

Technology-enabled anticipatory guidance and peer support in empowering parents to prevent early childhood caries: a randomized controlled trial.

INTRODUCTION: Dental caries is one of the most prevalent chronic diseases of childhood. Early childhood caries (ECC), defined as onset of dental caries before 6 years of age, is preventable and reversible in the early stages with proper interventions. The purpose of the study is to assess the clinical effectiveness and cost-effectiveness of technology-enabled anticipatory guidance and peer support in empowering parents to establish good diets, feeding and oral hygiene practices to prevent ECC. METHODS AND ANALYSIS: Mother-child dyads will be recruited from pre-natal clinics and post-natal war

Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated self-care rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial.

INTRODUCTION: The Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) trial is part of a research programme designed to develop and evaluate a health professional facilitated, home-based, self-help rehabilitation intervention to improve self-care and health-related quality of life in people with heart failure and their caregivers. The trial will assess the clinical effectiveness and cost-effectiveness of the REACH-HF intervention in patients with systolic heart failure and impact on the outcomes of their caregivers. METHODS AND ANALYSIS: A parallel two group randomised controlled tr

Routine blood cultures in the management of pyelonephritis in pregnancy for improving outcomes.

BACKGROUND: Pyelonephritis is a type of urinary tract infection (UTI) that affects the upper urinary tract and kidneys, and is one of the most common conditions for hospitalisation among pregnant women, aside from delivery. Samples of urine and blood are obtained and used for cultures as part of the diagnosis and management of the condition. Acute pyelonephritis requires hospitalisation with intravenous administration of antimicrobial agents. Several studies have questioned the necessity of obtaining blood cultures in addition to urine cultures, citing cost and questioning whether blood testin

A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening older women for the prevention of fractures: rationale, design and methods for the SCOOP study.

SCOOP is a UK seven-centre, pragmatic, randomised controlled trial with 5-year follow-up, including 11,580 women aged 70 to 85 years, to assess the effectiveness and cost-effectiveness of a community-based screening programme to reduce fractures. It utilises the FRAX algorithm and DXA to assess the 10-year probability of fracture. Introduction Osteoporotic, or low-trauma, fractures present a considerable burden to the National Health Service and have major adverse effects on quality of life, disability and mortality for the individual. Methods Given the availability of efficacious treatments a

Function after spinal treatment, exercise and rehabilitation (FASTER): improving the functional outcome of spinal surgery.

BACKGROUND: The life-time incidence of low back pain is high and diagnoses of spinal stenosis and disc prolapse are increasing. Consequently, there is a steady rise in surgical interventions for these conditions. Current evidence suggests that while the success of surgery is incomplete, it is superior to conservative interventions. A recent survey indicates that there are large differences in the type and intensity of rehabilitation, if any, provided after spinal surgery as well as in the restrictions and advice given to patients in the post-operative period. This trial will test the hypothesi

[A proposal for the rational use of the PET in oncology].

OBJECTIVE: This study aims to develop a Clinical Practice Guide for the rational use of the Positron Emission Tomography (PET) in Oncology, that makes it possible to approach the real existence of demand in the public health care service of Andalucía, by limiting the clinical indications, using criteria based on the existence of sufficient scientific evidence on the effectiveness and clinical impact of PET. METHOD: The consensus technique was used to elaborate the Guide, gathering a group of nuclear medicine experts. Prior to this a systematic research of the scientific literature was carried

Cost-effectiveness of MR Imaging-guided Strategies for Detection of Prostate Cancer in Biopsy-Naive Men.

Purpose To evaluate the cost-effectiveness of multiparametric diagnostic magnetic resonance (MR) imaging examination followed by MR imaging-guided biopsy strategies in the detection of prostate cancer in biopsy-naive men presenting with clinical suspicion of cancer for the first time. Materials and Methods A decision-analysis model was created for biopsy-naive men who had been recommended for prostate biopsy on the basis of abnormal digital rectal examination results or elevated prostate-specific antigen levels (age groups: 41-50 years, 51-60 years, and 61-70 years). The following three major

The CHIRPY DRAGON intervention in preventing obesity in Chinese primary-school--aged children: A cluster-randomised controlled trial.

BACKGROUND: In countries undergoing rapid economic transition such as China, rates of increase in childhood obesity exceed that in the West. However, prevention trials in these countries are inadequate in both quantity and methodological quality. In high-income countries, recent reviews have demonstrated that school-based prevention interventions are moderately effective but have some methodological limitations. To address these issues, this study evaluated clinical- and cost- effectiveness of the Chinese Primary School Children Physical Activity and Dietary Behaviour Changes Intervention (CHI

Artificial Intelligence-Enabled Electrocardiography Identifies Osteoporosis and has Prognostic Value.

Background: Osteoporosis, a common disease leading to weakened bones and increased fracture risk, often goes undiagnosed until a fracture occurs. Dual-energy X-ray absorptiometry (DXA) is the current gold standard for bone mineral density (BMD) measurement, but it has limitations. Recent studies reported Artificial Intelligence (AI)-enabled Electrocardiography (ECG) for disease screening. We hypothesized that AI ECG could serve as a screening tool for osteoporosis. Objective: This study aimed to develop a deep learning model (DLM) to identify osteoporosis using EKG features and to assess its p

A treatment strategy with nifedipine versus labetalol for women with pregnancy hypertension: study protocol for a randomised controlled trial (Giant PANDA).

BACKGROUND: Approximately one in ten women have high blood pressure during pregnancy. Hypertension is associated with adverse maternal and p … nal age at randomisation categories (11 + 0 to 19 + 6, 20 + 0 to 27 + 6, 28 + 0 to 34 + 6 weeks). A cost-effectiveness analysis using an NHS perspective will be undertaken using a cost-consequence analysis up to postnatal hospital discharge and an extrapolation exercise with a lifetime horizon conditional on the results of the cost-consequence analysis. DISCUSSION: This tri …

Cost-effectiveness of the third-agent class in treatment-naive human immunodeficiency virus-infected patients in Portugal.

INTRODUCTION: Current Portuguese HIV treatment guidelines recommend initiating antiretroviral therapy with a regimen composed of two Nucleos … ption in the Portuguese context. METHODS: We developed a microsimulation discrete events model for cost-effectiveness analysis of HIV treatment, simulating individual paths from ART initiation to death. Four driving forces determine the course of events: CD4+ cell count, viral load, resistance and adherence. Distributions of time to event are conditional to individuals' cha …

Diagnostic criteria for postpartum haemorrhage treatment: a cost-effectiveness study.

BACKGROUND: A threshold of 500 mL or more of blood loss within 24 h of childbirth has conventionally been used to initiate postpartum haemorrhage (PPH) treatment. We assessed the cost-effectiveness of initiating PPH treatment at lower blood loss thresholds, alone and in combination with any abnormal haemodynamic marker (pulse, systolic and diastolic blood pressure, or shock index), compared with the conventional 500 mL or more threshold. METHODS: We developed a decision-tree model to assess the cost per disability-adjusted life-year (DALY) averted from a health-care provider perspective when

The Potential Cost and Cost-Effectiveness Impact of Using a Machine Learning Algorithm for Early Detection of Sepsis in Intensive Care Units in Sweden.

Background: Early diagnosis of sepsis has been shown to reduce treatment delays, increase appropriate care, and reduce mortality. The sepsis machine learning algorithm NAVOY® Sepsis, based on variables routinely collected at intensive care units (ICUs), has shown excellent predictive properties. However, the economic consequences of forecasting the onset of sepsis are unknown. Objectives: The potential cost and cost-effectiveness impact of a machine learning algorithm forecasting the onset of sepsis was estimated in an ICU setting. Methods: A health economic model has been developed to capture