ObjectiveTo investigate the clinical characteristics of epileptics with pregnancy and then provide reference for standardized management of epileptics with pregnancy. MethodsFrom June 2012 to June 2021, epileptics with pregnancy who delivered in Jinan Central Hospital were selected as the research subjects. The clinical data such as the application of Antiseizure medications (ASMs) during pregnancy, seizure frequency, pregnancy outcomes, delivery ways, offspring feeding ways and the incidence of complications were investigated and analyzed. ResultsAmong 36 epileptics with pregnancy, 20 cases (55.56%) were treated with ASMs alone, 5 cases (13.88%) were treated with combined medication, and 11 cases (30.56%) were treated without ASMs during pregnancy. 15 cases (41.67%) adhered to systematic application of ASMs, 17 cases (47.22%) did not adhere to systematic application of ASMs, and 4 cases (11.11%) had unknown medication history. The frequency of seizures increased in 5 cases, decreased in 7 cases and unchanged in 24 cases during pregnancy. Pregnancy outcomes: full-term delivery in 33 cases (91.67%), preterm delivery in 1 case (2.78%) and abortion in 2 cases (5.56%). Delivery mode: cesarean section in 31 cases (91.18%), vaginal delivery in 3 cases (8.82%). After delivery, 4 cases (11.76%) were fed with milk powder and 30 cases (88.24%) were breast-fed. Complications: There were 6 cases complicated with anemia (16.67%), 5 cases complicated with gestational hypertension (13.89%), 3 cases complicated with gestational diabetes (8.33%), 4 cases complicated with premature rupture of membranes (11.11%), 2 cases complicated with fetal growth restriction (5.56%), 2 cases complicated with oligohydramnios (5.56%), 3 cases complicated with fetal distress (8.33%) and 3 cases complicated with neonatal asphyxia (8.33%). ConclusionsThe proportion of epileptics with pregnancy who were systematically treated with ASMs was low and the seizures were poorly controlled. There is a lack of standardized management for such patients in clinical practice.
Digital health technology implementation has grown rapidly in recent years. To standardize the quality of digital health implementation research and increase the transparency and integrity of reporting, Perrin published iCHECK-DH: guidelines and checklist for the reporting on digital health implementations in 2023. This article interprets the contents of the list with a view to improving the reporting quality of digital implementation studies to develop more effective digital health interventions and achieve better health outcomes.
Objective To evaluate the early clinical outcomes of the Renatus? balloon-expandable valve in the treatment of severe aortic stenosis. MethodsFrom November 2021 to April 2022, a total of 38 patients who received Renatus? balloon-expandable valve for severe aortic stenosis in Guangdong Provincial People's Hospital were included. There were 22 males and 16 females, with an average age of 73.7±5.3 years. Mean aortic gradient and peak aortic jet velocity at baseline, post-procedure, and follow-up were compared. Clinical outcomes including all-cause mortality, perivalvular leakage, serious adverse cardiovascular events and the occurrence of permanent pacemaker implantation were assessed. ResultsAll patients completed the procedure successfully without conversion to thoracotomy or perioperative death. The post-implant mean aortic pressure gradient was decreased from 41.5 (27.8, 58.8) mm Hg to 6.0 (3.0, 8.0) mm Hg, and the peak aortic jet velocity was also decreased from 4.1±0.9 m/s to 1.7±0.4 m/s (P<0.001). Pacemakers were required in 2 (5.3%) patients. The median follow-up time was 27.5 (23.0, 87.5) d, with a follow-up rate of 100.0%. The mean aortic gradient was 8.0 (7.0, 10.8) mm Hg and peak aortic jet velocity was 2.0±0.3 m/s, showing significant improvement compared with those in the preoperative period (P<0.001). No severe aortic regurgitation or paravalvular leak was observed. There was no serious cardiovascular adverse event or reoperative event during the study period. ConclusionTranscatheter aortic valve replacement with the domestic Renatus? balloon-expandable valve system is a safe and effective procedure for selected patients with severe aortic stenosis who are at high risk or not candidates for surgical aortic valve replacement.
ObjectiveTo compare the efficacy and safety of mitral valvuloplasty via minimally invasive approach with those of mitral valvuloplasty via traditional median sternotomy.MethodsA total of 1 221 patients undergoing mitral valvuloplasty from January 2015 to August 2018 in Guangdong Provincial People's Hospital were analyzed retrospectively, including 721 males and 500 females, with an average age of 47.2±15.1 years. According to the different surgical methods, they were divided into a study group (n=654), who received mitral valvuloplasty via the totally thoracoscopic approach, and a control group (n=567), who received mitral valvuloplasty via traditional median sternotomy. Clinical data, surgical results, and perioperative outcomes of the two groups were compared.ResultsThere was no significant difference in preoperative general data between the two groups (P>0.05). Compared with the control group, the study group had longer cardiopulmonary bypass time and aortic cross-clamping time (146.7±42.4 min vs. 122.7±30.6 min, 96.2±32.7 min vs. 78.3±23.8 min, both P=0.000), and shorter total operation time (227.4±55.3 min vs. 238.1±56.4 min, P=0.001). There was no significant difference in the incidence of secondary cross-clamping and mitral valve replacement between the two groups (3.7% vs. 2.6%, P=0.312; 1.7% vs. 1.4%, P=0.690). The blood transfusion rate and the incidence of respiratory tract infection and postoperative poor wound healing were lower (13.0% vs. 24.5%, 2.1% vs. 18.0%, 1.5% vs. 5.3%, all P=0.000) and the postoperative hospital stay was shorter (6.2±4.4 d vs. 11.5±8.8 d, P=0.000) in the study group. There was no significant difference in hospitalization expense between the two groups (95 847.9±31 322.0 yuan vs. 99 673.1±47 930.3 yuan, P=0.149). Within 30 d after surgery, 1 patient died in the study group and 4 patients died in the control group. Before discharge, there were 4 and 5 patients with severe mitral valve regurgitation in the study group and the control group, respectively.ConclusionCompared with mitral valvuloplasty via traditional median sternotomy, minimally invasive mitral valvuloplasty is superior in shortening operation time and postoperative hospital stay, lowering blood transfusion rate, and reducing postoperative complications, which can achieve better clinical outcomes.
Objective To investigate the etiology, symptoms, diagnosis, surgical treatment, and outcomes of acute necrotizing mediastinitis (ANM) in order to guide future diagnosis and treatment of ANM. Methods The clinical data of patients with ANM referred to West China Hospital, Sichuan University from March 2012 to April 2021 were retrospectively analyzed. The etiology, clinical manifestations, demographic characteristics, bacterial culture results, surgical approach and prognostic factors of these patients were summarized. ResultsA total of 176 patients were enrolled in this study. The median age was 60 ( 0-84) years. There were 124 (70.5%) males and 52 (29.5%) females. The most common origin of infection was neck (n=66, 37.5%). The most common symptom was fever (n=85, 48.3%). Streptococcus constellatus represented the most common pathogens in secretion culture. Surgical treatment was administered to 119 (67.6%) patients through different approaches, including 54 (30.7%) patients of cervical approach, 9 (5.1%) patients of thoracotomy, 18 (10.2%) patients of video-assisted thoracoscopic surgery (VATS), 7 (4.0%) patients of cervical combined with thoracotomy, 30 (17.0%) patients of cervical combined with VATS, and 1 (0.6%) patient of subxiphoid approach. Among this cohort, 144 (81.8%) patients were cured, while 32 (18.1%) patients died. Age-adjusted Charlson comorbidity index (OR=2.95, P=0.022), perioperative sepsis (OR=2.84, P=0.024), and non-surgical treatment (OR=2.41, P=0.043) were identified as independent predictors of poor outcomes. Conclusion For patients with corresponding history and manifestations of ANM, it is crucial to go through imaging examination to confirm the presence of an abscess and guide the selection of surgical approach. Once the diagnosis of ANM is made, it is imperative to promptly perform surgical intervention for effective drainage. Our study highlights the significance of age-adjusted Charlson comorbidity index, perioperative sepsis and surgical treatment in predicting patients’ outcomes.
ObjectiveTo investigate the clinical settings, antibiotic susceptibilities, management and outcomes of streptococcal endophthalmitis. MethodsA retrospective observational case series study. Fifty six eyes of 56 patients diagnosed with streptococcal endophthalmitis in Eye & ENT Hospital, Fudan University from 2012 to 2022 were collected. The treatment followed the general principles of relevant guidelines, including pars plana vitrectomy (PPV), vitreous injection of antibiotics (IVI), vitreous injection of glucocorticoids and systemic application of antibiotics. The follow-up time was (11.9±17.0) months. Patients' clinical characteristics, pathogenic distribution and antibiotic susceptibilities, treatment and outcomes in their medical records were retrospectively collected and analyzed. ResultsAll 56 patients had monocular onset, including 39 (69.6%, 39/56) males and 17 (30.4%, 17/56) females, 26 (46.4%, 26/56) with left eyes involved and 30 (53.6%, 30/56) with right eyes involved. Their average age was (25.0±24.4) years. Ocular trauma was the leading cause of streptococcal endophthalmitis (73.2%, 41/56), followed by ophthalmic surgery (23.2%, 13/56) and endogenous infection (3.6%, 2/56). The streptococcal species included Streptococcus viridans (50.0%, 28/56), Streptococcus pneumoniae (18/56, 32.1%) and β-hemolytic Streptococcus (17.9%, 10/56). The susceptibility rates of Streptococcus to penicillin, cefatriaxone, vancomycin and levofloxacin were 66.0%, 57.1%, 94.1% and 92.4%, respectively. Patients received PPV+IVI and IVI as initial treatment were 49 eyes (87.5%, 49/56) and 7 eyes (12.5%, 7/56), respectively. Vitreous injection of glucocorticoids were performed in 17 eyes (30.4%, 17/56); and systemic antibiotics were applied in 52 cases (92.9%, 52/56). At the final follow-up, 47 eyes were recorded with visual acuity. Twenty (35.7%, 20/56) had best corrected visual acuity (BCVA)≥0.05 and 27 (48.2%, 27/56) had BCVA ＜0.05, of which 1 (1.8%, 1/56) had an eyeball enucleation. The etiology of endophthalmitis, streptococcal species, initial treatment with PPV, vitreous injection of glucocorticoids, and systemic antibiotics did not significantly affect patients' visual outcomes (P＞0.05). Timely visit to the hospital after the onset of symptoms (≤3 days) was significantly associated with achieving a final BCVA above 0.05 (P=0.025). ConclusionsOcular trauma was the primary cause of streptococcal endophthalmitis. Streptococcus viridans is the most common pathogenic bacterium. Streptococci had high susceptibility to vancomycin, but patients' visual outcomes were poor.
ObjectiveTo evaluate the reliability,validity and feasibility of a patient-reported outcomes (PRO) scale in the subjects with respiratory failure.
Methods364 patients with chronic respiratory failure and 97 healthy subjects were face-to-face interviewed by well-trained investigators,and the data of respiratory failure -PRO instrument were collected. The psychometric performance such as reliability,validity,responsiveness and clinical feasibility in the respiratory failure -PRO instrument was evaluated.
ResultsThe Cronbach's alpha coefficient of the respiratory failure -PRO instrument and each dimension were greater than 0.7. Factor analysis showed that the instrument had good construct validity. The scores of each of the facets and total scores between the patients and the healthy subjects were different. The recovery rate and the efficient rate of the questionnaire were more than 95%,and the time required to complete a questionnaire was within 15 minutes,indicating that the scale had a high clinical feasibility.
ConclusionThe respiratory failure -PRO instrument has good reliability,validity,responsiveness and clinical feasibility.
Objective To evaluate the effectiveness of tendon insertion medialized repair in treatment of large-to-massive rotator cuff tears (L/MRCT). Methods The clinical and imaging data of 46 L/MRCT patients who underwent arthroscopic insertion medialized repair between October 2015 and June 2019 were retrospectively analyzed. There were 26 males and 20 females with an average age of 57.7 years (range, 40-75 years). There were 20 cases of large rotator cuff tears and 26 cases of massive rotator cuff tears. Preoperative imaging evaluation included fatty infiltration (Goutallier grade), tendon retraction (modified Patte grade), supraspinatus tangent sign, acromiohumeral distance (AHD), and postoperative medializaiton length and tendon integrity. The clinical outcome was evaluated by visual analogue scale (VAS) score, American Society for Shoulder and Elbow Surgery (ASES) score, shoulder range of motion (including anteflexion and elevation, lateral external, and internal rotation) and anteflexion and elevation muscle strength before and after operation. The patients were divided into two groups (the intact tendon group and the re-teared group) according to the integrity of the tendon after operation. According to the medializaiton length, the patients were divided into group A (medialization length ≤10 mm) and group B (medialization length >10 mm). The clinical function and imaging indexes of the patients were compared. Results All patients were followed up 24-56 months, with an average of 31.8 months. At 1 year after operation, MRI showed that the medializaiton length of supraspinatus tendon was 5-15 mm, with an average of 10.26 mm, 33 cases in group A and 13 cases in group B. Eleven cases (23.91%) had re-teared, including 5 cases (45.45%) of Sugaya type Ⅳ and 6 cases (54.55%) of Sugaya type Ⅴ. At last follow-up, the VAS score, ASES score, shoulder anteflexion and elevation range of motion, lateral external rotation range of motion, and anteflexion and elevation muscle strength significantly improved when compared with those before operation (P<0.05); there was no significant difference in internal rotation range of motion between pre- and post-operation (P>0.05). The Goutallier grade and modified Patte grade of supraspinatus muscle in the re-teared group were significantly higher than those in the intact tendon group, and the AHD was significantly lower than that in the intact tendon group (P<0.05). There was no significant difference in other baseline data between the two groups (P>0.05). Except that the ASES score of the intact tendon group was significantly higher than that of the re-teared group (P<0.05), there was no significant difference in the other postoperative clinical functional indicators between the two groups (P>0.05). There was no significant difference in the incidence of re-tear, VAS score, ASES score, range of motion of shoulder joint, and anteflexion and elevation muscle strength between group A and group B (P>0.05). ConclusionTendon insertion medialized repair may be useful in cases with L/MRCT, and shows good postoperative shoulder function. Neither tendon integrity nor medialization length shows apparent correlations with postoperative shoulder function.
Sample size, mean and standard deviation are necessary when conducting meta-analysis for continuous outcomes. Advanced methods of data extraction were needed if the mean and the standard deviation couldn’t be obtained from a literature directly. Eight methods were introduced and two examples were given to illustrate how to apply the methods.
In the clinical evidence-based decision-making process, factors including benefits and harms, evidence certainty, cost and feasibility of interventions should be considered based on the best evidence. The development of decision threshold of effect size (DTES) for patient health outcomes can help stakeholders understand the benefits and harms of interventions, assess evidence certainty, and interpret research results. Based on international experience, the MERGE Working Group through group discussions, semi-structured interviews, expert consensus, and pilot application developed a set of 8-step guidelines for the development of DTES for health outcomes. These steps included necessity assessment, formation of working groups, selection of patient important outcomes, creation of scenarios based on the best evidence, design of expert consultation questionnaires, analysis of expert consultation results, face-to-face expert consensus, dissemination of the application and reevaluation. The DTES guideline development is intended to provide methodological guidance for stakeholders to develop DTES for health outcome indicators in different domains.
