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Uses of the viable validity concept: A systematic scoping review.

Eval Program Plann

February 2025

Bordeaux Population Health Research Center U 1219, Inserm - University of Bordeaux, Case 11, 146 rue Léon Saignat, Bordeaux Cedexx 33076,  France; Bordeaux University Hospital -Saint-André Hospital, 1 rue Jean Burguet, Bordeaux 33000, France. Electronic address:

Objective: The concept of viable validity was first defined in 2010 within the framework of the integrative validity model. The concept has continued to evolve in the intervening years, and the purpose of this systematic scoping review is to describe and analyze the ways in which it has been deployed and appropriated by various research traditions.

Methods: We began by including all articles which cite Chen's original article "The bottom-up approach to integrative validity: a new perspective for program evaluation (Eval Program Plann.

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  • The study aimed to see if adding oral glucocorticoids to immunosuppressive therapy improves skin conditions and safety in patients with early diffuse cutaneous systemic sclerosis (dcSSc).
  • It compared two groups: one receiving glucocorticoids combined with immunosuppression, and the other receiving only immunosuppression, assessing changes in the modified Rodnan skin score (mRSS) over about a year.
  • Results showed no significant difference in skin score improvement between the groups, indicating that low-dose glucocorticoids didn't provide added benefits for skin fibrosis nor raised the risk of scleroderma renal crisis.
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  • Cancer can lead to serious kidney issues in children requiring kidney replacement therapy (KRT), with a study identifying 287 pediatric KRT patients who had a history of cancer.
  • The study showed that those whose cancer caused KRT had a longer wait for kidney transplantation compared to matched controls, with a median time of 2.4 years for cancer patients versus shorter times for controls.
  • While childhood cancer survivors experienced increased mortality rates while on KRT (16% for group 1 and 23% for group 2) compared to controls, their long-term survival rates after kidney transplantation were similar to non-cancer patients.
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  • ARC (Augmented renal clearance) is common in patients with subarachnoid hemorrhage (SaH) in the neuro-ICU, with a prevalence of 82% based on a study of 205 patients.
  • ARC typically begins around 4 days after the hemorrhage and lasts for about 5 days, with younger patients displaying a higher likelihood of experiencing it.
  • Monitoring creatinine clearance daily is important for managing drug dosing effectively in these patients, as ARC can lead to underdosing of medications.
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  • - White matter hyperintensities indicate damage in the brain's white matter, which can lead to brain shrinkage and is linked to dementia; a study of over 51,000 people found that larger volumes of these hyperintensities correspond to thinner brain cortex.
  • - Researchers identified 20 significant genetic loci related to white matter hyperintensities that affect genes involved in brain cell types known to support vascular health and neuronal function; some of these genes play roles in processes like axonal structure and transport within the brain.
  • - The genetic traits tied to white matter issues were linked to cardiovascular health, neurodegeneration markers, and poorer cognitive performance, with a polygenic risk score effectively predicting dementia risk in a separate large
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Objective: Patients with diffuse cutaneous systemic sclerosis (dcSSc) frequently show spontaneous improvement of skin fibrosis. Our aim was to examine whether an improvement in skin fibrosis predicts lower likelihood of visceral organ progression and better survival.

Methods: Patients from the European Scleroderma Trials and Research (EUSTAR) cohort with dcSSc, baseline modified Rodnan skin score (mRSS) ≥7, and valid mRSS at 12±3 months follow up were included.

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Malignant hypertension (MHT) crisis triggers widespread microvascular damage, particularly in the brain. Despite recent MRI evidence highlighting acute cerebral injuries during MHT crises, follow-up data remain scarce. This study seeks to fill this gap by exploring how brain MRI markers evolve following acute MHT crisis management.

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  • Hematological involvement (HI) is a serious condition associated with Langerhans cell histiocytosis (LCH), and is defined by low blood cell counts indicating potential life-threatening complications.
  • A study of 2,313 children with LCH revealed that about 331 developed HI, with a distinction between mild (MHI) and severe HI (SHI), each showing different health outcomes and survival rates over 10 years.
  • Recent advances in treatment have improved mortality rates, particularly with combination therapies and targeted treatments, sparking discussions about refining HI definitions to better inform treatment strategies.
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Reducing the prime cardiopulmonary bypass volume during paediatric cardiac surgery.

Perfusion

November 2024

Department of Cardiovascular Anesthesia and Critical Care, CHU Bordeaux, Bordeaux, France.

Introduction: Despite technological advances, the use of homologous blood to prime the cardiopulmonary bypass (CPB) circuits of infants under 10 kg remains common. However, such rapid massive transfusion may increase post-CPB morbidity.

Method: We retrospectively included consecutive patients weighing 2.

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  • * Of the women surveyed, 63% responded, revealing a postpartum depression prevalence of 16.4% when using a specific scoring scale (EPDS score of 13 or higher), which rose to 23.1% with a slightly lower cutoff (score of 11 or higher).
  • * Key risk factors identified included younger maternal age and being born in a non-European country, highlighting the need for tailored support and interventions for at-risk populations after cesarean delivery.
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Tocolysis and Neurodevelopment of Children Born Very Preterm.

JAMA Netw Open

October 2024

Department of Neonatal Pediatrics, Intensive Care and Neuropediatrics, Rouen University Hospital, Rouen, France.

Importance: Neurodevelopmental outcomes of very preterm children exposed to tocolytics are not well described.

Objective: To investigate whether tocolysis administered after spontaneous preterm labor is associated with neurodevelopmental outcomes at 5.5 years and to assess whether the type of tocolytic drug is associated with neurodevelopmental outcomes among infants exposed.

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Chronic histiocytic intervillositis of unknown origin (CHI) is a rare placental disorder associated with adverse pregnancy outcomes, frequent recurrence, and a lack of effective preventive strategies. Recent insights indicate a potential link between CHI-associated inflammatory lesions and the inflammasome pathway, suggesting innovative therapeutic avenues. Here we show a potential role of the inflammasome pathway in CHI through comprehensive transcriptomic analysis of grade 2 or 3 histopathologic CHI samples, paired with placental controls.

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  • Endovascular interventions using Luminor, a nanotechnology-based drug-coated balloon (DCB), have shown effectiveness in treating femoropopliteal lesions, with a large-scale study called the LUMIFOLLOW registry evaluating its real-world performance after it succeeded in prior trials like Effpac.
  • The LUMIFOLLOW study involved 542 patients with various comorbidities and lesion types, focusing on safety and efficacy, with primary endpoints including freedom from major complications and target lesion revascularization.
  • Results indicated a high procedural success rate of 99.4%, although some patients required stenting and there were minor adverse events, suggesting the treatment is generally effective but may need further assessment in complicated
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Objectives: Resective surgery is a potential therapeutic option for select patients with intractable focal epilepsy. However, the presence of ictal onset zones within or surrounding highly functional brain areas presents a surgical challenge, leading to poor seizure and functional outcomes. This report describes our experiences with awake mapping-tailored resection of epileptogenic areas involving eloquent cortices and evaluates their feasibility, tolerance, limitations, and significance.

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Background And Aims: We aimed to evaluate the feasibility, safety and efficacy of endoscopic submucosal dissection for recurrent rectal neoplastic lesions after transanal microsurgery of superficial rectal neoplasms.

Methods: Multicenter retrospective study.

Main Outcomes: recurrence at first endoscopic follow-up, En bloc, R0 and curative resections.

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  • The study aims to determine how rod characteristics, screw density, and cages affect mechanical complications in spinal surgeries compared to patient-related factors and alignment in adult spinal deformity cases.
  • Data from 302 patients was analyzed using different statistical models to measure outcomes like pseudarthrosis and screw loosening and understand the impact of surgical techniques versus patient demographics.
  • Key findings include that using four rods reduces the risk of pseudarthrosis, postoperative malalignment significantly increases the risk of complications, and high screw density leads to a lower risk of screw loosening, while age has a secondary impact on outcomes.
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Background: Tranexamic acid is a recommended treatment for women with a clinical diagnosis of postpartum haemorrhage, but whether it can prevent bleeding is unclear. We conducted a systematic review and individual patient data (IPD) meta-analysis of randomised controlled trials to assess the effects of tranexamic acid in women giving birth.

Methods: In this systematic review and IPD meta-analysis, we searched the WHO International Clinical Trials Registry Platform from database inception to Aug 4, 2024 for randomised trials that assessed the effects of tranexamic acid in women giving birth.

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: Prolonged remission on low-dose glucocorticoids (GC) is a main goal in patients with systemic lupus erythematosus (SLE). The aim of this study is to assess whether GC ≤ 5 mg/d increases the risk of damage accrual in patients with SLE in prolonged remission. : Observational study of routine clinical care data of the inception Lupus Cruces-Bordeaux cohort.

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  • * Postoperative PF occurred in 14.4% of patients, with the majority classified as grade B or C; however, the 5-year overall survival rate was slightly higher in the PF group (45.3%) compared to the non-PF group (37.0%), though not statistically significant.
  • * In contrast, the 5-year recurrence-free survival was significantly better in patients with postoperative PF (43.7%) compared to those without it
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  • Avelumab is a treatment approved for patients with advanced urothelial carcinoma (aUC) who did not experience disease progression after platinum-based chemotherapy, based on findings from the JAVELIN Bladder 100 trial.
  • The AVENANCE study included 595 patients and assessed the effectiveness and safety of avelumab as a maintenance therapy, revealing a median overall survival of 21.3 months.
  • The results demonstrated that avelumab is effective in this patient population, reinforcing its role in managing aUC in real-world settings.
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Introduction: Systemic Lupus Erythematosus (SLE) can be diagnosed using the 2012 criteria of the Systemic Lupus International Collaborating Clinics (SLICC) and, more recently, the 2019 criteria of the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR). Hematological involvement is scored differently by these classifications. Our objective was to compare both criteria in a cohort of children with autoimmune cytopenia (AIC)-associated SLE.

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  • The study aimed to compare the antibody response to SARS-CoV-2 in patients with inflammatory rheumatic diseases and healthy individuals.
  • Researchers screened unvaccinated patients with conditions like rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis in France, and matched them with seropositive healthcare workers as controls.
  • Results showed no significant difference in antibody levels between both groups, with a trend indicating that patients with severe COVID-19 symptoms had higher antibody titres; treatments like glucocorticoids seemed linked to lower antibody responses.
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The Banff classification is regularly updated to integrate recent advances in the characterization of kidney allograft rejection, gathering novel diagnostic, prognostic, and theragnostic data into a diagnostic and pathogenesis-based framework. Despite ongoing research on noninvasive biomarkers of kidney rejection, the Banff classification remains, to date, biopsy-centered, primarily relying on a semiquantitative histological scoring system that overall lacks reproducibility and granularity. Besides, the ability of histopathological injuries and transcriptomics analyses from bulk tissue to accurately infer the pathogenesis of rejection is questioned.

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