Objective To evaluate the reporting quality and influencing factors of patient-reported outcome (PRO) data in randomized controlled trials (RCTs) of lung cancer. Methods RCTs of lung cancer with PRO as either primary or secondary endpoints were searched from PubMed, EMbase, Medline, CNKI, Wanfang Data, and VIP databases between January 1, 2010 and April 20, 2024. Reporting quality of included RCTs were assessed based on the CONSORT-PRO extension. Descriptive statistics and bivariate regression analysis were used to describe the reporting quality and analyze the factors influencing the reporting quality. Results A total of 740 articles were retrieved. After screening, 53 eligible RCTs of lung cancer with 22 780 patients were included. The patients were mainly with non-small cell lung cancer (84.91%), with the median sample size of the included studies was 364.0 (160.5, 599.5) patients. The primary PRO tool used was the EORTC QLQ-C30 (60.38%). There were 52 (98.11%) studies whose PRO measured the domain of "symptom management of cough, dyspnea, fatigue, pain, etc.", and 45 (84.91%) studies measured "health-related quality of life". Multicenter studies accounted for 84.91%, and randomized non-blind trials accounted for 62.26%. PRO was used as the primary endpoint in 33.96% of the studies and as secondary endpoints in 66.04%. The reliability and validity of the PRO tools were explicitly mentioned in 11.32% and 7.55% of the studies, respectively. The average completeness of reporting according to the CONSORT-PRO guidelines was 60.00%, ranging from 25.00% to 93.00%. The main factors affecting the completeness of CONSORT-PRO reporting included sample size and publication year. For every increment in sample size, the completeness of reporting increased by 27.5% (SE=0.00, t=2.040, P=0.046). Additionally, studies published after 2018 had a 67.2% higher completeness of reporting compared to those published in or before 2018 (SE=17.8, t=–3.273, P=0.006). Conclusion The study reveals that the overall reporting quality of PRO in lung cancer RCTs is poor. Particularly, the reporting of PRO measures reliability and validity, PRO assumptions, applicability, and handling of missing data need further improvement. Future research should emphasize comprehensive adherence to the CONSORT-PRO guidelines.
Objective To evaluate the risk factors affecting the prognosis in patients with myasthenia gravis after thymeetomy. Methods Therapeutic effects were evaluated with Relative Counting Method in 136 cases with myasthenia gravis who receivingthymectomy. Six clinical factors including sex, age, preoperative course, et al. were converted into quantitative parameters and used for analysis. Cumulative logit model for ordinal response was employed to investigate the therapeutic effects of various factors. Results Sex, age and preoperative course exerted significant effects on postoperative prognosis in patients with myasthenia gravis, while clinical subtype, pathological changes and preoperative administration of cholinesterase inhibitors had no significant impact on therapeutic effects. Conclusion Some factors may lead to the remission and improvement in postoperative patients with myasthenia gravis, therefore, they should be included for the evaluation of prognosis. Early diagnosis and early thymeetomy may improve the therapeutic effects and shorten the duration of amelioration.
Objective To evaluate the visual function before and after photodynamic therapy(PDT) in patients with subfoveal choroidal neovascularization ( CNV) caused by age-related macular degeneration (AMD). Methods Twenty-five consecutive patients (34 eyes) treated with PDT (verteporfin) for subfoveal CNV in age-related macular degeneration diagnosed by fluorescein angiography (FFA), indocyanine green angiography (ICGA) and optical coherence tomography (OCT). Visual function including best corrected visual acuity, contrast sensitivity frequency, binocular function, confusion, stereo-vision, color vision, metamorphopsis and central scotoma were examed before photodynamic therapy and 1 week, 1 month, 3 month after photodynamic therapy. The follow-up time varied from 3 months to 2 years (mean 7.6 months). Results The changes of visual function at the 3rd month after photodynamic therapy revealed improving in 13 eyes (38.24%), without any change in 17 eyes (50.00%), and decreasing in 6 eyes (17.65%). Visual acuity with logMRA improved after photodynamic therapy, but without statistic difference. All spatial contrast sensitivity improved. Contrast sensitivity for spatial frequencies 5 cycles per degree (cpd) was better after photodynamic therapy with significant difference (P=0.045).Binocular function, fusion function, stereo function and color vision were slightly improved without statistic difference. Conclusion Damage of visual function in macular degeneration is many-sided. The treatment of PDT for exudative AMD can improve part visual function. (Chin J Ocul Fundus Dis，2004，20：289-291)
ObjectiveTo evaluate the efficacy and safety of reduced-dose intravitreal ganciclovir for the treatment of acquired immunodeficiency syndrome (AIDS) patients with cytomegalovirus retinitis (CMVR).MethodsA prospective observational cohort study observed 15 AIDS patients (28 eyes) who suffered from CMVR onset between January 2016 and December 2018 at Nanning Aier Eye Hospital. Among this 28 eyes, BCVA of 6 eyes (21.4%) were between moving hand to counting finger, 15 eyes (53.6%) were between 0.02 to 0.1 and 7 eyes were better than 0.1 (25.0%). All eyes received intravitreal injection 0.1 ml of ganciclovir at 4 mg/ml (contain ganciclovir 0.4 mg). The induction regimen was twice weekly for 2 weeks and a maintenance period of the same dose weekly. The mean number of injections was 7.1±1.7 times. For hospitalized patients who had no contraindicated received a 14-day twice daily intravenous ganciclovir (IVG) 5.0 mg/kg·d until complete resolution of CMVR. All patients were divided into intravitreal ganciclovir (IVTG) group and IVTG+IVG group according to different treatment plans, which were 5 cases with 8 eyes and 10 cases with 20 eyes, respectively. The follow-up was more than 6 months. BCVA, complete resolution or stable of the lesion and complications were observed.ResultsSix months later, 20 eyes (71.4%) had a obvious reduced or disappeared of the anterior chamber and vitreous inflammation, and the retinal lesions became stable or complete resolution. 24 eyes showed improvements of BCVA and 4 eyes showed stable. 2 eyes (7.1%) presented with BCVA ≤ counting finger, 7 eyes (25.0%) were 0.02 - 0.1 and 19 eyes were ≥ 0.1 (67.9%). Compared with before treatment, the ratio of BCVA that less than or equal to counting finger and between 0.02 to 0.1 decreased (21.4% vs 7.1% and 53.6% vs 25.0%, respectively), but the ratio of BCVA better than 0.1 increased (25.0% vs 67.9%). When IVTG+IVG group was compared with IVTG group, the average time-to-resolution of CMVR were 83.2±25.2 and 85.3±24.4 days respectively. There was no significant difference in resolution times (Z=0.17, P=0.87). The ratio of retinal lesions became stable or complete resolution were 75.0% (15 eyes) and 62.5% (5 eyes), there was no evident difference in time-to-resolution between the two groups (F=0.42, P=0.51). No recurrence was seen during the follow-up period. In cases of unilateral CMVR, there were no patients with a second eye involvement during the follow-up period. No endophthalmitis, vitreous hemorrhage, retinal detachment were found in our study.ConclusionReduced-dose intravitreal ganciclovir is a safe and effective treatment option for CMVR.
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.
Objective To observe the changes of anatomic structure and visual function after surgery in highly myopia patients with macular hole and retinal detachment (MHRD). Methods Twentyfive patients (25 eyes) with MHRD who underwent vitreous and internal membrane peeling surgery combined with silicone oil tamponade, were enrolled in this study. All the patients had undergone the examinations of logarithm of minimal angle of resolution (logMAR) visual acuity, optical coherence tomography (OCT), MP-1 microperimetry and multifocal electroretinogram (mf-ERG) before and three months after surgery. The visual acuity, structure of macular hole and macula, fixation point, mean sensitivity (MS) within 10° of macular area and four quadrants including supertemporal, supernasal, intranasal and infratemporal, average response densities of N1 and P1 waves at all 6 rings before and after surgery were observed. Results Three months after surgery, the logMAR visual acuity improved (t=8.265， P＜0.05). Twentyfour eyes (96%) were anatomically reattached, one eye (4%) was not anatomically reattached completely. The results of MP-1 microperimetry showed that foveal fixation was found in two eyes (8%), weak foveal fixation was found in four eyes (16%), paracentral fixation was found in 19 eyes (76%). There were four eyes (16%) with stable fixation, nine eyes (36%) with relatively unstable fixation and 12 eyes (48%) with unstable fixation. The MS value within 10° of macular area was 9.031±4.245 dB. The MS value difference among four quadrants was statistically significant (F=7.40，P=0.015). The mf-ERG results showed that the average response densities of N1 and P1 waves at all 6 rings were increased (P＜0.05). Conclusion The macular hole heals, retina remains reattached, visual acuity, and fixation are improved in the most of MHRD eyes after surgery.
Objective To identify the postoperative function and short-term outcome of Global Modular Replacement System (GMRS) for reconstruction of defect after removal of tumor so as to supply information for cl inical appl ication. Methods Between March 2007 and May 2009, 30 l imb-salvage cases reconstructed with GMRS were retrospectively reviewed, including 18 males and 12 females with a median age of 25 years (range, 11-57 years). The preoperative diagnoses were osteosarcoma in 15 cases, mal ignant fibro-histiocytoma in 4, giant cell tumor in 3, chondrosarcoma in 2, and Ewing’s sarcoma and angiosarcoma in 1 respectively. The duration of symptom ranged from 1 to 15 months with an average of 5.6 months. There were 4 revision cases at mean time of 3.4 years after index surgeries. The locations were the proximal femur in 3 cases, distal femur in 22 cases, and proximal tibia in 5 cases. According to Enneking stage, 2 cases were rated as stage IB, 1 as stage IIA, and 27 as stage IIB. Four cases were compl icated by pathologic fracture. Results The average operation time was 165 minutes (range, 120-240 minutes); the mean blood loss was 448.3 mL (range, 100-1 500 mL); and the mean resection length was 14.1 cm (range, 7.5-22.5 cm). All the wounds healed by first intention. All 30 patients were followed up 10-35 months (22.3 months on average). Local recurrence occurred in 2 cases (6.7%) at 5 and 14 months respectively and distal metastasis occurred in 5 cases (16.7%) at 4-12 months (7.3 months on average) postoperatively. One patient died of multiple lung metastases at 10 months postoperatively. Twenty-nine patients survived at last follow-up, including 25 cases of tumor-free survival and 4 cases of tumor bearing survival. Aseptic loosening occurred in 2 cases (6.7%) at 1.5 years and 2 years postoperatively respectively. Deep infection occurred in 1 case (3.3%) at 1 year postoperatively. At last follow-up, the Musculoskeletal Tumor Society (MSTS) 93 scores were 4.6% ± 0.7% for pain, 3.7% ± 0.9% for function, 3.2% ± 1.3% for satisfactory degree, 4.3% ± 0.9% for orthesis, 3.7% ± 0.7% for walking, 3.3% ± 1.0% for gait; total score was 75.9% ± 14.2%. The Toronto Extremity Salvage Score (TESS) score was 87.0 ± 7.0. Conclusion Reconstruction for defect after removal of tumor with GMRS has satisfactory short-term outcome with good function recovery and low compl ication rate.
Objective To explore the impact of gender difference in 90-day outcomes after mechanical thrombectomy for acute cerebral infarction. Methods A prospective registration, observational, and retrospective analysis study was carried out. Patients with acute cerebral infarction who were admitted to the Department of Neurology of the First Affiliated Hospital of Chengdu Medical College and the Department of Neurology of Nanjing First Hospital between June 2015 and June 2019 were collected. Patients were divided into two groups based on gender. The detailed demographic, laboratory examination, imaging examination and clinical data were collected. Then, the data were analyzed using univariate and multivariate logistic regression analyses. Results A total of 298 patients were included. Among them, there were 185 males and 113 females. The differences in age, smoking, atrial fibrillation, using antiplatelet drugs before stroke, TOAST classification, and involved cerebrovascular sites between the two groups were statistically significant (P<0.05), and there was no statistically significant difference in other baseline data between the two groups (P>0.05). The results of univariate logistic regression analysis showed that the rate of 90-day favourable outcome of female patients was lower than that of male patients [odds ratio (OR)=0.462, 95% confidence interval (CI) (0.275, 0.775), P=0.030]. The results of multivariate logistic regression analysis showed that, after adjusting for confounding factors, there was no independent correlation between gender and the 90-day favourable outcome of patients with acute cerebral infarction who underwent mechanical thrombectomy [OR=1.511, 95% CI (0.745, 3.066), P=0.253]. Conclusion The gender has no significant effect on the 90-day favourable outcome of acute cerebral infarction patients treated with mechanical thrombectomy.
Objective To investigate the clinical efficacy of minimally invasive mitral valvuloplasty (MVP) in the treatment of infective endocarditis (IE) with mitral regurgitation (MR). Methods A retrospective analysis was conducted on the clinical data of patients who underwent MVP for IE with MR in the Department of Cardiovascular Surgery at Zhongshan Hospital, Fudan University from January 2016 to December 2020. Patients were divided into two groups based on the surgical incision: those with a right mini-thoracotomy were classified as a minimally invasive surgery (MIS) group, and those with a median sternotomy were classified as a median sternotomy (MS) group. All patients had isolated mitral valve involvement. Perioperative data were analyzed, and mid- to long-term outcomes were compared between the two groups. Results A total of 86 patients were included, with 40 in the MIS group (22 males and 18 females, with a mean age of 39±15 years ranging from 8 to 71 years) and 46 in the MS group (27 males and 19 females, with a mean age of 49±16 years ranging from 14 to 71 years). The patients in the MIS group were relatively younger (P=0.004) with better preoperative cardiac function (P=0.004). There was no statistical difference in preoperative fever, gender, or comorbidities between the two groups (P>0.05). The MIS group had shorter postoperative ventilation times, less postoperative 24-hour drainage, less blood transfusion, and shorter total hospital stays compared to the MS group (P=0.001, 0.018, 0.005, 0.005). There was no statistical difference in cardiopulmonary bypass times or ICU stays between the two groups (P>0.05). The perioperative complication rates and mortality rates were not significantly different between the two groups (P>0.05). Follow-up was conducted for 11-92 months, with a mean duration of 49±19 months and an overall follow-up rate of 91.6%. During the follow-up, 3 patients in each group required reoperation for mitral valve issues, with no statistical difference in incidence (7.5% vs. 6.5%, P=0.691). There were no warfarin-related complications, recurrences, or deaths in either group during follow-up. Multivariate regression analysis identified age, preoperative cardiac function, and surgeon experience as influencing factors for the choice of surgical approach. Conclusion Minimally invasive MVP for IE with MR is relatively safe in the perioperative period and shows significant efficacy, with clear mid- to long-term outcomes. It is recommended for younger patients with better preoperative cardiac function and when performed by surgeons with extensive experience in mitral valvuloplasty.
