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PURPOSE: Scaphoid non-union treatment remains nonconsensual and is based on vascularized or non-vascularized bone grafting. This study aimed to evaluate with a long follow-up the functional, clinical, and radiological outcomes, reported complications and reoperations and studied non-union treatment prognostic factors. METHODS: Patients who had undergone bone graft surgery for scaphoid non-union were retrospectively reviewed. The evaluated outcomes were pain, qDASH, PRWE and MWS scores, active range of motion, grip strength, union rate, scapholunate angle, carpal height, and presence of arthrosis. Complications and reinterventions were also reported. RESULTS: This study included 60 scaphoid non-union treatments with a mean follow-up of 7.7 (1.5-20.3) years. Twenty (33.3%) non-unions were located at the proximal pole, including 6 (10%) with preoperative avascular necrosis (AVN). Union occurred in 51 patients (85%). The functional, clinical, and radiological results were good. The complication rate was 21.3% and the reintervention rate was 16.7%. Subgroup union rate analysis found no difference if the non-union is localized in the proximal pole or if there is AVN. CONCLUSION: With a representative sample of the population and a long follow-up, we have found a good union rate, clinical and functional results regardless of the treatment method chosen. Scaphoid non-union treatment is still controversial and more studies are needed to accurate indications of each graft according to the patient and non-union characteristics. LEVEL OF EVIDENCE IV: Retrospective cohort study.
Subject(s)
Fractures, Ununited , Scaphoid Bone , Humans , Retrospective Studies , Fractures, Ununited/diagnostic imaging , Fractures, Ununited/surgery , Scaphoid Bone/diagnostic imaging , Scaphoid Bone/surgery , Radiography , Upper ExtremityABSTRACT
Despite a global decrease, gastric cancer (GC) incidence appears to be increasing recently in young, particularly female, patients. The causal mechanism for this "new" type of GC is unknown, but a role for autoimmunity is suggested. A cascade of gastric precancerous lesions, beginning with chronic atrophic gastritis (CAG), precedes GC. To test the possible existence of autoimmunity in patients with CAG, we aimed to analyze the prevalence of several autoantibodies in patients with CAG as compared to control patients. Sera of 355 patients included in our previous prospective, multicenter study were tested for 19 autoantibodies (anti-nuclear antibodies, ANA, anti-parietal cell antibody, APCA, anti-intrinsic factor antibody, AIFA, and 16 myositis-associated antibodies). The results were compared between CAG patients (n = 154), including autoimmune gastritis patients (AIG, n = 45), non-autoimmune gastritis patients (NAIG, n = 109), and control patients (n = 201). ANA positivity was significantly higher in AIG than in NAIG or control patients (46.7%, 29%, and 27%, respectively, p = 0.04). Female gender was positively associated with ANA positivity (OR 0.51 (0.31-0.81), p = 0.005), while age and H. pylori infection status were not. Myositis-associated antibodies were found in 8.9% of AIG, 5.5% of NAIG, and 4.4% of control patients, without significant differences among the groups (p = 0.8). Higher APCA and AIFA positivity was confirmed in AIG, and was not associated with H. pylori infection, age, or gender in the multivariate analysis. ANA antibodies are significantly more prevalent in AIG than in control patients, but the clinical significance of this finding remains to be established. H. pylori infection does not affect autoantibody seropositivity (ANA, APCA, AIFA). The positivity of myositis-associated antibodies is not increased in patients with CAG as compared to control patients. Overall, our results do not support an overrepresentation of common autoantibodies in patients with CAG.
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BACKGROUND: Dyspnea is a common but non-specific symptom of asthma, which in particular may be related to anxiety and hyperventilation syndrome, two frequent comorbidities of asthma. METHODS: We conducted a prospective multicentric cohort study in dyspneic asthmatic adults. Dyspnea was assessed using the Multidimensional Dyspnea Profile questionnaire. We described the sensory (QS) and affective (A2) domains of dyspnea and investigated the effect of poor asthma control, hyperventilation and anxiety on each dimension at baseline and after 6 months. RESULTS: We included 142 patients (65.5% women, age: 52 years). Dyspnea was severe and predominated on its sensory domain (median QS: 27/50; A2: 15/50). Uncontrolled asthma (ACQ≥1.5), hyperventilation symptoms (Nijmegen≥23) and anxiety (HAD-A≥10) were present in 75%, 45.7% and 39% of cases, respectively. Hyperventilation symptoms were associated with higher QS and A2 scores: QS at 28.4(10.7) vs. 21.7(12.8) (p = 0.001) and A2 at 24(14) vs. 11.3(11) (p < 0.001) in patients with vs. without hyperventilation symptoms. Anxiety was only associated with increased A2 (27(12.3) vs. 10.9(11), p < 0.001). At 6 months, QS and A2 decreased of 7 and 3 points, respectively, in relation with changes in ACQ-6 and Nijmegen scores as well as the HAD-A score for A2. CONCLUSION: In breathless asthmatics, dyspnea is severe and worsened but differentially modulated by hyperventilation symptoms and anxiety. A multidimensional phenotyping of dyspnea in asthmatics could be useful to understand its origins and personalize treatment.
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BACKGROUND: Serum pepsinogen (PG) testing is recommended by the European guidelines for diagnosis of chronic atrophic gastritis (CAG). However, wide variations in diagnostic performances are observed, due to the differences in the extent of gastric atrophy, and possibly in its origin (Helicobacter pylori-, autoimmune (AIG)). AIM: To analyze the diagnostic performances of PGs testing according to these different parameters, using enzyme-linked-immunosorbent serologic assay (ELISA) and chemiluminescent immunoassay (CLEIA). METHODS: Serum samples from patients having undergone gastroscopy with biopsies in five French centers were collected prospectively. Sensitivity (Se), specificity (Sp), and Area Under Curve were analyzed according to the extent and origin of CAG. RESULTS: Overall, 344 patients (156 males [45%]; mean age 58.8 [±14.2] years) were included, among whom 44 had AIG. Diagnostic performances of PG I for the detection of corpus CAG were excellent, with Se and Sp of 92.7% and 99.1% for ELISA and 90.5% and 98.2% for CLEIA, respectively. For AIG, corresponding values were 97.7% and 97.4% for ELISA, and 95.6% and 97.1% for CLEIA. In multivariate analysis, PG levels were associated with the auto-immune origin (p<0.001) but not with the extent of the atrophic gastritis. CONCLUSIONS: Pepsinogens are highly efficient for the diagnosis of corpus-limited CAG and allow to discriminate AIG from H. pylori-induced gastritis.
Subject(s)
Gastritis, Atrophic , Helicobacter Infections , Helicobacter pylori , Male , Humans , Middle Aged , Gastritis, Atrophic/pathology , Prospective Studies , Pepsinogen A , Gastroscopy , Helicobacter Infections/diagnosis , Helicobacter Infections/complications , GastrinsABSTRACT
STUDY OBJECTIVE: To compare the surgical outcomes of hysterectomy by vaginal natural orifice transluminal endoscopic surgery (vNOTES) for patients with body mass index (BMI) <30 and BMI ≥30. DESIGN: A retrospective cohort study. SETTING: A French teaching hospital. PATIENTS: All patients who underwent a vNOTES hysterectomy from February 2020 to January 2022 were included (N = 200). The vNOTES approach was chosen for all patients requiring a hysterectomy, unless the procedure was for endometriosis or cancer (except grade 1 endometrioid adenocarcinoma). INTERVENTIONS: Patients were categorized into 2 groups based on their BMI (<30 or ≥30 kg/m2). The population characteristics, surgical outcomes, and hospitalization outcomes were compared. The main outcome was the intraoperative conversion rate. Secondary end points were blood loss, operative time, perioperative and postoperative complications, and same-day surgery management. MEASUREMENTS AND MAIN RESULTS: A total of 146 patients were included in the BMI <30 group, and 54 patients in the BMI ≥30 group. There was no statistical difference between obese and nonobese patients concerning intraoperative conversion (p = .150), with 4 cases occurring in the BMI <30 group (2.74%) and 4 occurring in the BMI ≥30 group (7.41%). Operative times were longer in obese patients (115.93 min [±55.28] vs 79.78 min [±40.38], p <.001). There was no significant difference in blood loss (p = .337) or perioperative and postoperative complications (p = .346 and p = .612, respectively). The ability to complete the surgery as a same-day procedure was no different between obese and nonobese patients (p = .150). CONCLUSION: The results concerning intraoperative conversion and perioperative and postoperative complications show that vNOTES hysterectomies seem to be feasible for obese patients. When same-day surgery was decided before surgery, no more obese than nonobese patients were converted to conventional hospitalization. Further studies are needed to confirm these observations.
Subject(s)
Laparoscopy , Natural Orifice Endoscopic Surgery , Female , Humans , Retrospective Studies , Hysterectomy/methods , Natural Orifice Endoscopic Surgery/methods , Obesity/complications , Laparoscopy/methods , Postoperative Complications/epidemiology , Postoperative Complications/etiologyABSTRACT
BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence. METHODS: Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals. DISCUSSION: Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients' physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05025826. First published on August 27, 2021.
Subject(s)
Antineoplastic Agents , Gastrointestinal Neoplasms , Peripheral Nervous System Diseases , Humans , Oxaliplatin/adverse effects , Phycocyanin/adverse effects , Gastrointestinal Neoplasms/drug therapy , Peripheral Nervous System Diseases/chemically induced , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
Background and aims: This research aimed to characterize social information processing abilities in a population of regular nondisordered poker players compared to controls. Methods: Participants completed the Posner cueing paradigm task including social cues (faces) to assess attention allocation towards social stimuli, including the effect of the presentation time (subliminal vs supraliminal) and of the emotion displayed. The study included two groups of participants: 30 regular nondisordered poker players (those who played at least three times a week in Texas Hold'em poker games for at least three months) and 30 control participants (those who did not gamble or gambled less than once a month, whatever the game). Results: The group of regular nondisordered poker players displayed an enhancement of the inhibition of return during the Posner cueing task. This means that in valid trials, they took longer to respond to the already processed localization in supraliminal conditions compared to controls. However, our results did not evidence any particular engagement or disengagement attention abilities toward specific types of emotion. Discussion and Conclusions: These results suggest that regular nondisordered poker players displayed social information processing abilities, which may be due to the importance to efficiently process social information that can serve as tells in live poker. The observed enhancement of the inhibition of return may permit poker players to not process a localization that has already processed to save attentional resources. Further research regarding the establishment of the IOR in other forms of gambling and with non-social cues needs to be performed.
Subject(s)
Cues , Gambling , Humans , Gambling/psychology , EmotionsABSTRACT
INTRODUCTION: Haemolysis and inflammation contribute to cardiac surgery-associated acute kidney injury (CS-AKI). We aimed to assess the performance of plasma haemolysis index (HI) and interleukine-6 (IL-6) for the prediction of all-stage CS-AKI. We also assessed their ability to predict moderate-to-severe CS-AKI and to discriminate persistent from transient CS-AKI. METHODS: Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) were prospectively included. Haemolysis index and IL-6 were measured immediately after the end of CPB and 6 hours later. Correction for haemodilution relied upon changes in albuminaemia. Persistent CS-AKI was defined as a steady/increasing CS-AKI stage between the 48th and the 60th postoperative hour as compared with the worst stage observed within the 48 first hours. RESULTS: Among 82 patients, CS-AKI occurred in 37 (45%) patients. Postoperative HI and IL-6 were positively correlated to the duration of CPB (r ≤ 0.51, p ≤ 0.0003). Whether we considered isolated measurements of HI or IL-6, their indexation to haemodilution or not, their kinetics and/or their combination, the prediction of all stage CS-AKI was inaccurate (area under the receiver operating characteristic curve [AUCROC]≤ 0.68) whereas moderate-to-severe CS-AKI (6 patients only) was predicted with an honourable performance (AUCROC = 0.77 [95%CI 0.67;0.86] and 0.87 [95%CI 0.77;0.93] for HI and IL-6, respectively). The persistent/transient nature of CS-AKI was inaccurately predicted (AUCROC ≤ 0.68). CONCLUSIONS: In a population in which most CS-AKI cases were mild, although they frequently (41%) persisted >48 hours, CS-AKI was inaccurately predicted by HI and/or IL-6. A better performance for moderate-to-severe CS-AKI prediction is likely. These preliminary findings are yet to be validated.
Subject(s)
Acute Kidney Injury , Cardiac Surgical Procedures , Adult , Humans , Lipocalin-2 , Interleukin-6 , Proto-Oncogene Proteins , Hemolysis , Acute-Phase Proteins , Biomarkers , Predictive Value of Tests , Cardiac Surgical Procedures/adverse effects , Acute Kidney Injury/diagnosis , Acute Kidney Injury/etiology , Cardiopulmonary Bypass/adverse effects , Creatinine , Postoperative ComplicationsABSTRACT
Background: The COVID-19 pandemic has shaken the world by imposing unprecedented health measures, including in the postpartum period. Objectives: We aim to assess the impact of maternal isolation in the immediate postpartum period on the rate of postpartum depression (PPD) in a tertiary center. Study Design: We conducted a prospective cohort study, between 22 April and 29 October 2020, using anonymous questionnaires on 265 participants (129 during lockdown and 135 outside). The Edinburgh Postnatal Depression Scale (EPDS) was used as screening for PPD. We used a univariate logistic regression model to analyze the association between risk factors and PPD. Results: There was no difference between the two groups for PPD assessed by an EPDS score >10.5 on day 30 and/or day 60 (23.1% vs. 29.3%, p = 0.661) but on day 3 it was higher (31% vs. 17.8%, p = 0.015) during the lockdown period and partners were more impacted psychologically (48.3% vs. 10.5%, p < 0.001). Parity ≥1 was a protective factor for PPD (OR = 0.2, 95% CI [0.1−0.6], p = 0.003). Risk factors of PPD were: history of psychological abuses (OR = 6.4, CI 95% [1.1−37.6], p = 0.04), stressful life event (OR = 4.5, CI 95% [1.6−12.6], p = 0.004), and bad birth experience (OR = 5.1, CI 95% [1.4−17.8], p = 0.012). Conclusion: Maternal isolation in the immediate postpartum period is associated with an increased rate of moderate to severe symptoms of postpartum blues. The well-known long-term consequences of PPD must be balanced against the expected benefits of partner's restrictive access to maternity ward.
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BACKGROUND: Analysis of serum biomarkers for the assessment of atrophic gastritis (AG), a gastric precancerous lesion, is of growing interest for identification of patients at increased risk of gastric cancer. The aim was to analyze the diagnostic performance of serum pepsinogen testing using another method, chemiluminescent enzyme immunoassay (CLEIA), as well as of other new potential biomarkers. MATERIAL AND METHODS: The sera of patients considered at increased risk of gastric cancer and undergoing upper endoscopy collected in our previous prospective, multicenter study were tested for pepsinogen I (PGI) and II (PGII), interleukin-6 (IL-6), human epididymal protein 4 (HE-4), adiponectin, ferritin and Krebs von den Lungen (KL-6) using the CLEIA. The diagnostic performance for the detection of AG was calculated by taking histology as the reference. RESULTS: In total, 356 patients (162 men (46%); mean age 58.6 (±14.2) years), including 152 with AG, were included. For the detection of moderate to severe corpus AG, sensitivity and specificity of the pepsinogen I/II ratio were of 75.0% (95%CI 57.8-87.9) and 92.6% (88.2-95.8), respectively. For the detection of moderate to severe antrum AG, sensitivity of IL-6 was of 72.2% (95%CI 46.5-90.3). Combination of pepsinogen I/II ratio or HE-4 showed a sensitivity of 85.2% (95%CI 72.9-93.4) for the detection of moderate to severe AG at any location. CONCLUSION: This study shows that PG testing by CLEIA represents an accurate assay for the detection of corpus AG. Additionally, IL-6 and HE-4 may be of interest for the detection of antrum AG. MINI-ABSTRACT: Pepsinogens testing by chemiluminescent enzyme immunoassay is accurate for the detection of corpus atrophic gastritis. IL-6 and HE-4 maybe of interest for the detection of antrum atrophic gastritis.
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Interpreting observed changes over time in Patient-Reported Outcomes (PRO) measures is still considered a challenge. Indeed, concluding an observed change at group level is statistically significant does not necessarily equate this change is meaningful from the perspective of the patient. To help interpret within and/or between group changes in the measure over time, the estimation of the Minimal Important Difference (MID) of the instrument - the smallest value that patients consider as a perceived change - is useful. In the last 30 years, a plethora of methods and estimators have been proposed to derive this MID value using clinical data from sample of patients. MIDs for hundreds of PROs have been estimated, with frequently a substantial variability in the results depending on the method used. Nonetheless, a rigorous assessment of the statistical performances of numerous proposed methods for estimating MIDs by experimental design such as Monte-Carlo study has never been performed. The purpose of this paper is to thoroughly depict a protocol for a large-scale simulation study designed to investigate the statistical performances, especially bias against a true populational value, of the common proposed estimators for MID. This paper depicts how investigated methods and estimators were retained after the conduct of a systematic review, the design of a conceptual model that formally defines what is the true populational MID value and the translation of the conceptual model into a model allowing the simulation of responses of items to a hypothetical PRO at two times of measurement along with the response to a Patient Global Rating of Change at the second time under the constraint of a known true MID value. A statistical analysis plan is depicted in order to conclude if working hypotheses on what could be appropriate MID estimators will be verified. Strengths, assumptions, and limits of the simulation model are exposed. Finally, we show how this protocol could be the basis for fostering future methodological research on the issue of interpreting changes in PRO measures.
Subject(s)
Patient Reported Outcome Measures , Quality of Life , Humans , Research Design , Systematic Reviews as TopicABSTRACT
INTRODUCTION: The breech presentation represents 4,7% of deliveries at term. There is a method of external cephalic version (ECV) performed from 36 weeks of gestation. French guidelines for the clinical practice of ECV were published in 2020. OBJECTIVE: To evaluate the national practices of ECV in French maternity units, especially on the use of tocolysis, 1 year after publication of the French clinical recommendations guidelines by the French national college of obstetricians and gynecologists (CNGOF). METHODS: Data self-reported for this national descriptive study were collected from March to May 2021 by an online questionnaire distributed to all French maternities. The 25 items of the questionnaire collected information of maternity units, the general practice of ECV, use or not of tocolysis for ECV attempt and the relevance of a prospective study. RESULTS: Of the 517 French maternity units, 150 (29%) responded to the online survey. 95,3% systematically performed ECV. A Kleihauer test was routinely performed in 71 units (49.7%). A tocolysis was associated with ECV attempt in 52.4% of cases. The drugs used were intravenous atosiban (30,7%), mainly in levels 2b and 3 maternity units, intravenous salbutamol (24%), other mode of administration of salbutamol (14,7%) and oral nifedipine (22,6%) mainly in levels 1 and 2a maternity units. Adverse effects were described in 20%, mainly with the use of salbutamol (73,3%). CONCLUSIONS: 52.4% of the French maternity units surveyed used tocolysis for the ECV attempt, although it is systematically recommended. The choice of tocolytic drug differed according to the maternity units.
Subject(s)
Breech Presentation/therapy , Version, Fetal/methods , Breech Presentation/physiopathology , Female , France , Humans , Obstetrics and Gynecology Department, Hospital/organization & administration , Obstetrics and Gynecology Department, Hospital/statistics & numerical data , Pregnancy , Prospective Studies , Surveys and Questionnaires , Tocolytic Agents/administration & dosage , Version, Fetal/standards , Version, Fetal/statistics & numerical dataABSTRACT
OBJECTIVES: To assess the impact of expanded criteria donors (ECD) on urinary complications in kidney transplantation. PATIENTS AND METHODS: The UriNary Complications Of Renal Transplant (UNyCORT) is a cohort study based on the French prospective Données Informatisées et VAlidées en Transplantation/Computerized and VAlidated Data in Transplantation (DIVAT) cohort. Data were extracted between 1 January 2002 and 1 January 2018 with 1-year minimum follow-up, in relation to 44 pre- and postoperative variables. ECD status was included according to United Network for Organ Sharing (UNOS) definition. The primary outcome of the UNyCORT study was the association between the donor's ECD/standard criteria donors (SCD) status and urinary complications at 1 year in uni- and multivariate analysis. Sub-group analysis, stratified analysis on ECD/SCD donor's status and transplant failure analysis were then conducted. RESULTS: Between 1 January 2002 and 1 January 2018, 10 279 kidney transplants in adult recipients were recorded within the DIVAT network. A total of 8559 (83.4%) donors were deceased donors and 1699 (16.6%) were living donors (LD). Among donation after circulatory death (DCD) donors, 224 (2.85%) were uncontrolled DCD and 93 (1.09%) were controlled DCD donors. A total of 3617 (43.9%) deceased donors were ECD. The overall urological complication rate was 16.26%. The donor's ECD status was significantly associated with an increased risk of urological complications at 1 year in multivariate analysis (odds ratio: 1.50, 95% CI 1.31-1.71; P < 0.001) and especially with stenosis and ureteric fistulae at 1 year. There is no association with LD, uncontrolled and controlled DCD. The placement of an endo-ureteric stent was beneficial in preventing urinary complications in all donors and particularly in ECD donors. CONCLUSION: The donor's ECD status is associated with a higher likelihood of stenosis and ureteric fistulae at 1 year. Recipients of grafts from ECD donors should probably be considered for closer urological monitoring and systematic preventive measures.
Subject(s)
Kidney Transplantation , Tissue and Organ Procurement , Adult , Cohort Studies , Constriction, Pathologic/etiology , Graft Survival , Humans , Kidney , Kidney Transplantation/adverse effects , Living Donors , Prospective Studies , Retrospective Studies , Tissue Donors , Treatment OutcomeABSTRACT
BACKGROUND: For the detection of cardiac surgery-associated acute kidney injury (CS-AKI), the performance of urine tissue inhibitor of metalloproteinase 2 insulin-like growth factor-binding protein 7 (TIMP2 IGFBP7) has never been compared with that of very early changes in plasma creatinine (∆pCr). We hypothesized that, in the context of perioperative haemodilution, lack of postoperative decrease in pCr would be of honourable performance for the detection of CS-AKI. We therefore aimed at comparing these biomarkers and their kinetics (primary objective). As secondary objectives, we assessed plasma neutrophil gelatinase-associated lipocalin (pNGAL), cystatin C (pCysC) and urea (pUrea). We also determined the ability of these biomarkers to early discriminate persistent from transient CS-AKI. METHODS: Patients over 75 years-old undergoing aortic valve replacement with cardiopulmonary bypass (CPB) were included in this prospective observational study. Biomarkers were measured before/after CPB and at the sixth postoperative hour (H6). RESULTS: In 65 patients, CS-AKI occurred in 27 (42%). ∆pCr from post-CPB to H6 (∆pCrpostCPB-H6): outperformed TIMP2 IGFBP7 at H6 and its intra- or postoperative changes: area under the receiver operating characteristic curve (AUCROC) of 0.84 [95%CI:0.73-0.92] vs. ≤0.67 [95%CI:0.54-0.78], p ≤ 0.03. The AUCROC of pNGAL, pCysC and pUrea did not exceed 0.72 [95%CI:0.59-0.83]. Indexing biomarkers levels for blood or urine dilution did not improve their performance. Combining TIMP2 IGFBP7 and ∆pCrpostCPB-H6 was of no evident added value over considering ∆pCrpostCPB-H6 alone. For the early recognition of persistent CS-AKI, no biomarker outperformed ∆pCrpostCPB-H6 (AUCROC = 0.69 [95%CI:0.48-0.85]). CONCLUSIONS: In this hypothesis-generating study mostly testing early detection of mild CS-AKI, there was no evident added value of the tested modern biomarkers over early minimal postoperative changes in pCr: despite the common perioperative hemodilution in the setting of cardiac surgery, if pCr failed to decline within the 6 h after CPB, the development of CS-AKI was likely. Confirmatory studies with more severe forms of CS-AKI are required.
Subject(s)
Acute Kidney Injury/diagnosis , Cardiopulmonary Bypass/adverse effects , Heart Valve Prosthesis Implantation/adverse effects , Insulin-Like Growth Factor Binding Proteins/urine , Tissue Inhibitor of Metalloproteinase-2/urine , Acute Kidney Injury/etiology , Aged , Aged, 80 and over , Aortic Valve/surgery , Biomarkers/analysis , Early Diagnosis , Female , Humans , Male , Pilot Projects , Prospective Studies , Sensitivity and SpecificityABSTRACT
BACKGROUND: Endometrial cancer is the most common pelvic gynecological cancer in France. The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies. The treatment is very codified and consists of a surgical intervention for anatomopathological analysis. The latter is frequently reassuring. These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery. This study aims to explore the sensitivity of an innovative marker: Human Epididymis 4 (HE4) in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings. METHODS: This is a prospective multicenter diagnostic study with three centers involved. Inclusion criteria are any patient with post-menopausal bleeding who is to undergo hysteroscopy, endometrial biopsy, or endometrial resection. In accordance with the recommendations for the management of post-menopausal bleedings, the medical conduct consists of performing a clinical examination, an ultrasound and, in general, even in case of paraclinical examination reassuring, an anatomopathological analysis. This pathological analysis can be obtained in several ways: biopsy, hysteroscopy-curettage (which is the most frequently performed surgery), and hysterectomy. Our protocol consists of taking a blood sample from each woman who will undergo one of the interventions mentioned above. The dosage of HE4 and CA125 requires the withdrawal of an additional heparinized tube during the preoperative assessment usually performed. This research is therefore classified as non-interventional. The primary outcome is to evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer. The secondary outcomes are other parameters (specificity, VPP, VPN) of HE4, Evaluating the diagnostic capabilities of the CA125 marker alone and associated with HE4, as well as those of the REM and REM-B algorithms. We aim to include 100 patients over a period of one year in three centers. DISCUSSION: As of now, there is no biological marker used in routine practice in the diagnosis of endometrial cancer. The ultimate goal of HE4 in endometrial cancer is to avoid surgery for those who are identified as non-sick. This study is the precursor of others for use in routine practice, HE4 would represent a great help to diagnosis if our study demonstrates it as reliable in the management of these patients and avoid many unnecessary and risky surgeries.
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OBJECTIVE: The aim of this study was to compare the quality of life (mental health) and voice in patients with or without permanent hypoparathyroidism after total thyroidectomy. SUMMARY BACKGROUND DATA: Permanent hypoparathyroidism is an underestimated complication of thyroid surgery owing to suppression of parathormone secretion. Few studies have evaluated the consequences of hypoparathyroidism on quality of life and none has studied its effects on voice. METHODS: The QoL-hypopara study (ClinicalTrial.gov NCT04053647) was a national observational study. Adult thyroidectomized patients were included between January and June 2020. A serum parathormone level <15 pg/mL >6âmonths after surgery defined permanent hypoparathyroidism. Patients answered the MOS-36-item short-form health (SF-36), the Voice Handicap Index (VHI) surveys, and a list of questions regarding their symptoms. RESULTS: A total of 141 patients were included, 45 with permanent hypoparathyroidism. The median period between thyroid surgery and the questionnaire was 6 (Q1-Q3 4-11) and 4 (4-5) years in hypoparathyroid patients and controls respectively. Hypoparathyroid patients presented a reduced median mental score ratio (SF-36) [0.88 (Q1-Q3 0.63-1.01) vs 1.04 (0.82-1.13), P = 0.003] and a lower voice quality (incidence rate ratio for total VHI 1.83-fold higher, P < 0.001). In multivariable analysis, hypoparathyroidism [-0.17 (95% confidence interval -0.28 to -0.07), P = 0.002], but not age, female sex, thyroid cancer, or abnormal TSH level, was associated with the reduced mental score ratio. Myalgia, joint pain, paresthesia, tetany, anxiety attack, and exhaustion were the most common symptoms among hypoparathyroid patients (>50%). CONCLUSIONS: Hypoparathyroid patients present significantly impaired quality of life, lower voice quality, and frequent symptoms. These results reinforce the importance of preventing this complication.
Subject(s)
Hypoparathyroidism/etiology , Mental Health , Quality of Life , Thyroidectomy/adverse effects , Voice/physiology , Diagnostic Self Evaluation , Female , Humans , Hypoparathyroidism/epidemiology , Hypoparathyroidism/physiopathology , Male , Middle Aged , Retrospective Studies , Self-AssessmentABSTRACT
INTRODUCTION: Endometrial cancer, one of the most frequent pelvic gynecologic cancer worldwide, currently has no biomarker used to assess it in daily practice. Nonetheless, human epididymis 4 (HE4) appears to offer the best prospects, alone or combined with CA125. This study sought to systematically review the work on HE4 from the first publications in 2008 until now. MATERIAL AND METHODS: Two independent reviewers searched the PubMed database with the terms "HE4â³, "endometrial cancer", "endometrial carcinoma", and HE4 or human epididymis protein 4. Only original clinical research articles and meta-analyses, published in English, were included, with literature reviews and case reports excluded. RESULTS: Studies were organized into 3 categories: diagnosis, prognosis, and recurrence/survival. Overall we identified 117 articles dealing with HE4 and endometrial cancer and selected 52 relevant texts: 46 articles, 6 meta-analyses. The sensitivity of HE4 for the diagnosis of endometrial cancer varied from 44.2% to 91% and its specificity from 65.5 to 100%, versus 24.1 to 71.5% and from 65.6 to 100% for CA125. Two meta-analyses of their combination produced areas under the curve (AUC): 0.83 and 0.86. Two available algorithms - the REM (risk of endometrial malignancy) and REM-B (risk of endometrial malignancy associated with BMI) scores - require more study. HE4 is also strongly associated with prognostic factors such as myometrial invasion, tumor grade, FIGO stage, and lymph node involvement. It also predicts recurrence and can serve as a monitoring tool, as reported by a 2018 meta-analysis with a hazard ratio of 2.15 (P < 0.001). CONCLUSION: HE4, alone or associated with CA125, appears to be an important tool in the management of endometrial cancer, initially for diagnosis, but for assessing prognosis and survival. Other prospective and multicenter studies are necessary to confirm these hopes and be able to recommend the use of HE4 in regular practice.
Subject(s)
Endometrial Neoplasms , Ovarian Neoplasms , Biomarkers, Tumor , CA-125 Antigen , Endometrial Neoplasms/diagnosis , Female , Humans , Neoplasm Recurrence, Local , Prospective Studies , ProteinsABSTRACT
OBJECTIVES: This study aimed to examine the sensitivity of muscle biopsy (MB) in ANCA-associated vasculitis (AAV), identify factors predicting MB positivity and assess the prognostic value of a positive MB. METHODS: We conducted a single-centre retrospective study of AAV with an MB performed at diagnosis. AAV classification [granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA)] followed the European Medicines Agency algorithm. A logistic regression model was used to identify the factors associated with MB positivity. Survival curves were generated using the Kaplan-Meier method. RESULTS: Among 276 AAV patients (1995-2018), 101 had an MB. Seventy-eight patients were included: 33 with GPA, 25 with MPA and 20 with EGPA. MB samples were positive in 45 cases (58%): 17 GPA, 16 MPA and 12 EGPA. Univariate analysis focussed on GPA and MPA, revealed that the MB yield was higher in females [22/31 (71%) vs 11/27 (41%); P = 0.02] and in anti-MPO patients [25/37 (68%) vs 6/19 (32%) for anti-PR3; P = 0.01]. By multivariate analysis, three factors predicted MB positivity: anti-MPO ANCA [odds ratio (OR) 10.67 (CI 2.09, 81.68)], female sex [OR 5.3 (CI 1.16, 32.35)] and neutrophil count [OR 1.33 (CI 1.07, 1.8)]. MB positivity had no impact on relapse, death or end-stage renal disease-free survival. CONCLUSIONS: MB is a safe and efficient diagnostic tool for AAV. Predictors of MB yield include ANCA type, sex and neutrophil count. MB cannot substitute for kidney biopsy when indicated, but should be considered in other cases.
Subject(s)
Algorithms , Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/diagnosis , Biopsy/methods , Muscle, Skeletal/immunology , Neutrophils/pathology , Aged , Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/epidemiology , Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/immunology , Antibodies, Antineutrophil Cytoplasmic/immunology , Female , France/epidemiology , Humans , Incidence , Leukocyte Count , Male , Middle Aged , Muscle, Skeletal/metabolism , Muscle, Skeletal/pathology , Neutrophils/immunology , Prognosis , Recurrence , Retrospective Studies , Sex FactorsABSTRACT
BACKGROUND: Analysis of serum biomarkers for the assessment of atrophic gastritis (AG), considered as gastric precancerous lesion, is of growing interest and recommended by current guidelines. Our aim was to evaluate the diagnostic performance of a panel of biomarkers (GastroPanel®) for the detection of AG in France, a country of a low gastric cancer (GC) incidence. MATERIAL AND METHODS: In this prospective, multicenter, cross-sectional study, consecutive patients considered at increased risk of GC and undergoing upper endoscopy with gastric biopsies were included. Blood samples were collected for the analysis of GastroPanel® (association of Pepsinogens I and II, Gastrin-17, and Helicobacter pylori serology) using ELISA. The results of GastroPanel® were compared to the results of histology considered as the reference. RESULTS: Between 2016 and 2019, 344 patients (148 cases with AG, 196 controls without AG) were included. Sensitivity, specificity, positive, and negative predictive values for the detection of AG by GastroPanel® were of 39.9% (95% CI 31.9; 48.2), 93.4% (95% CI 88.9; 96.4), 81.9 (95% CI 71.1; 90.0), and 67.3 (95% CI 61.4; 72.8), respectively. The sensitivity was significantly higher for the detection of severe AG [60.8% (95% CI 46.1; 74.6) P = .015] and corpus AG [61.0% (95% CI 49.2; 72.0), P = .004]. Diagnostic performances of GastroPanel® tended to be better than those of Pepsinogen I alone, but the difference did not reach statistical significance (P = .068). CONCLUSION: Serum pepsinogen and GastroPanel® tests show promising results for the detection of AG, especially of corpus AG and severe AG, in patients at high risk of GC in France.