Noncomparative Cohort Study Research Articles

Multidisciplinary medication review during older patient hospitalization according to STOPP/START criteria reduces potentially inappropriate prescriptions: MoPIM cohort study

PurposeMultimorbidity and polypharmacy in older adults converts the detection and adequacy of potentially inappropriate drug prescriptions (PIDP) in a healthcare priority. The objectives of this study are to describe the clinical decisions taken after the identification of PIDP by clinical pharmacists, using STOPP/START criteria, and to evaluate the degree of accomplishment of these decisions.MethodsMulticenter, prospective, non-comparative cohort study in patients aged 65 and older, hospitalized because of an exacerbation of their chronic conditions. Each possible PIDP was manually identified by the clinical pharmacist at admission and an initial decision was taken by a multidisciplinary clinical committee. At discharge, criteria were re-applied and final decisions recorded.ResultsFrom all patients (n = 674), 493 (73.1%) presented at least one STOPP criteria at admission, significantly reduced up to 258 (38.3%) at discharge. A similar trend was observed for START criteria (36.7% vs. 15.7%). Regarding the top 10 most prevalent STOPP criteria, the clinical committee initially agreed to withdraw 257 (34.2%) prescriptions and to modify 93 (12.4%) prescriptions. However, the evaluation of final clinical decisions revealed that 503 (67.0%) of those STOPP criteria were ultimately amended. For the top 10 START criteria associated PIDP, the committee decided to initiate 149 (51.7%) prescriptions, while a total of 198 (68.8%) were finally introduced at discharge.ConclusionsThe clinical committee, through a pharmacotherapy review, succeeded in identifying and reducing the degree of prescription inadequacy, for both STOPP and START criteria, in older patients with high degree of multimorbidity and polypharmacy.Trial RegistrationNCT02830425.

Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis

ObjectiveTo assess the effects of COVID-19 vaccines in women before or during pregnancy on SARS-CoV-2 infection-related, pregnancy, offspring and reactogenicity outcomes.DesignSystematic review and meta-analysis.Data sourcesMajor databases between December 2019 and...

Real-world outcomes associated with afatinib use in patients with solid tumors harboring NRG1 gene fusions

ObjectivesNeuregulin-1 (NRG1) fusions may drive oncogenesis via constitutive activation of ErbB signaling. Hence, NRG1 fusion-driven tumors may be susceptible to ErbB-targeted therapy. Afatinib (irreversible pan-ErbB inhibitor) has demonstrated activity in individual patients with NRG1 fusion-positive solid tumors. This study collected real-world data on demographics, clinical characteristics, and clinical outcomes in this patient population. Materials and MethodsIn this retrospective, multicenter, non-comparative cohort study, physicians in the US-based Cardinal Health Oncology Provider Extended Network collected data from medical records of patients with NRG1 fusion-positive solid tumors who received afatinib (afatinib cohort) or other systemic therapies (non-afatinib cohort) in any therapy line. Objectives included demographics, clinical characteristics, and outcomes (overall response rate [ORR], progression-free survival [PFS], and overall survival [OS]). ResultsPatients (N = 110) with a variety of solid tumor types were included; 72 received afatinib, 38 other therapies. In the afatinib cohort, 70.8 % of patients received afatinib as second-line treatment and Eastern Cooperative Oncology Group performance status (ECOG PS) was 2–4 in 69.4 % at baseline. In the non-afatinib cohort, 94.7 % of patients received systemic therapy as first-line treatment and ECOG PS was 2–4 in 31.6 % at baseline. In the afatinib cohort, ORR was 37.5 % overall (43.8 % when received as first-line therapy); median PFS and OS were 5.5 and 7.2 months, respectively. In the non-afatinib cohort, ORR was 76.3 %; median PFS and OS were 12.9 and 22.6 months, respectively. ConclusionThis study provides real-world data on the characteristics of patients with NRG1 fusion-positive solid tumors treated with afatinib or other therapies; durable responses were observed in both groups. However, there were imbalances between the cohorts, and the study was not designed to compare outcomes. Further prospective/retrospective trials are required.

Innovative Curriculum to Train Medical Students on Lateral Canthotomy and Cantholysis.

Orbital compartment syndrome (OCS) is an ocular emergency requiring prompt decompression with a lateral canthotomy and cantholysis (LCC) within 2 hours. This study evaluates the feasibility and effectiveness of a standardized LCC curriculum to train medical students to identify and treat OCS. This was a prospective, non-randomized, non-comparative cohort study of 39 novice first-year medical students with no prior LCC training who underwent a standardized LCC curriculum incorporating both didactic and hands-on procedural training. Didactic knowledge of orbital anatomy and OCS was evaluated with written pre- and post-knowledge testing. Expert performance criteria were determined by expert consensus based on the performance of three oculoplastic surgeons and were defined as correctly performing all 12 critical checklist steps of an LCC within 3 minutes twice consecutively on a Sonalyst LCC training system eye model. Utilizing the principles of mastery learning, participants learned how to perform an LCC in a classroom environment and were evaluated on a final test of proficiency in a training lane designed to simulate an austere military environment. Participants required a median of 3.0 practice iterations to achieve expert performance in the classroom environment. During the testing phase, all participants correctly identified the eye with OCS, and 77% (n = 30) of learners successfully performed an LCC at the expert level within their first attempt. The median completion time of those who passed on their first testing was 130 seconds. The mean LCC knowledge test scores significantly improved from 48.7% to 71.2% (P < .001). This study successfully developed a standardized LCC curriculum utilizing the principles of hands-on mastery learning to train novice learners to perform an LCC efficiently and effectively.

Early and long-term results of surgical treatment of popliteal artery aneurysms using a heparin-bonded expanded polytetrafluorethilene graft.

The aim of the present study was to assess early and long-term results of open surgical interventions for popliteal artery aneurysms (PAAs) with the use of heparin-bonded expanded polytetrafluorethylene (HePTFE) in a single center, retrospective, non-comparative cohort study. A retrospective analysis of a prospectively maintained dataset, including 207 open interventions for PAAs between 2002 and 2022, was performed and 170 procedures carried on with the use of a HePTFE graft were found. Perioperative results were analyzed in terms of mortality, graft thrombosis and amputation rates. Follow-up results were analyzed in terms of survival, primary and secondary patency, freedom from amputation, freedom from reintervention with life-table analysis and Kaplan Meier curves. Follow-up results were considered as primary outcomes, whereas perioperative results were considered as secondary outcomes. In 82 interventions (48%) the PAA was asymptomatic. In 140 cases a medial approach was used, while in 30 cases a posterior approach was preferred. The level of the distal anastomosis was the p3 tract of the popliteal artery in 89% of the cases. One perioperative death occurred; early thromboses occurred in eight cases and the overall perioperative amputation rate was 2.8%. The median duration of follow-up was 48 months (range 1-251). Estimated survival rate at 10 years was 55% (standard error, SE, 0.065). The 10-year rates of primary and secondary patency and freedom from amputation were 40.8% (SE 0.06), 47.6% (SE 0.065) and 93.4% (SE 0.04), respectively. The estimated freedom from reintervention rate at 10 years was 57% (SE 0.05). The results of this large monocentric experience showed that open surgical repair of PAAs with HePTFE is a safe procedure, with low rates of perioperative complications, and excellent results in the long-term setting.

Short-Term Outcomes of Faricimab in Patients with Neovascular Age-Related Macular Degeneration on Prior Anti-VEGF Therapy

A subset of patients with neovascular age-related macular degeneration (nAMD) experience treatment burden and suboptimal response with anti-VEGF therapy. The aim of this study was to investigate the effect of switching to a novel, bispecific agent, faricimab, in patients with nAMD currently treated with anti-VEGF. Retrospective, noncomparative cohort study. Patients with nAMD previously treated with anti-VEGF and switched to intravitreal faricimab injection (IFI) at the Cleveland Clinic's Cole Eye Institute. Switching and administration schedule of IFI was at the discretion of the clinician. Visual acuity (VA) and macular OCT parameters, including central subfield thickness (CST), maximum pigment epithelial detachment (PED) height, and presence of subretinal (SRF) or intraretinal fluid (IRF), were assessed at baseline (day of first IFI) and after each IFI. Central subfield thickness and presence of IRF or SRF after ≥ 3 IFIs. One hundred twenty-six eyes of 106 patients were included in the analysis with a mean follow-up time of 24.3 ± 5.2 weeks. Before switching to IFI, patients received a mean of either aflibercept (20.0 ± 8.4, mean ± standard deviation), bevacizumab (7 ± 8.9), ranibizumab (1.9 ± 8.5), or brolucizumab (0.3 ± 1.6) injections. The most common agent used before switching to IFI was aflibercept (n= 110, 87%), and the mean treatment interval with any anti-VEGF was 5.6 ± 1.6 weeks before switching. Central subfield thickness was reduced from baseline after the first IFI (266.8 ± 64.7 vs. 249.8 ± 58.6 μm, P= 0.02) and persisted over the 3 IFIs (P= 0.01). Pigment epithelial detachment height was reduced after the third IFI (249.6 ± 179.0 vs. 206.9 ± 130.0 μm, P= 0.01). The mean VA (62.9 vs. 62.7 approximate ETDRS letters, P=0.42) and interval between injections (6.3 vs. 5.7 weeks, P= 0.16) was similar after the third IFI compared withbaseline. Eleven (8.7%) eyes were switched back to their previous anti-VEGF, including 2 (1.6%) eyes from1patient with intraocular inflammation requiring cessation of IFI. There were no other adverse eventsfromswitching. Switching to faricimab resulted in a reduction in mean CST (-11.6 μm, P= 0.01) and PED height (-44.2 μm, P= 0.01) after 3 injections, with stable VA and at a similar treatment interval to prior anti-VEGF therapy. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Validation of the French version of the Non-Arthritic Hip Score (NAHS) in 113 hip arthroscopy procedures

BackgroundThe Non-Arthritic Hip Score (NAHS) used to evaluate the hip in younger patients is a self-administered questionnaire with 20 items in four sections: pain, symptoms, function, and activities. Although used in France, no transcultural version had been validated. The objective of this study was to translate the NAHS into French then assess the validity, reliability, and sensitivity to change of the French-language version (NAHS-Fr) in younger patients with hip conditions other than osteoarthritis. HypothesisThe NAHS-Fr demonstrates good validity and reliability when used in younger French-speaking patients with hip pain. Material and methodsWe conducted a prospective observational study in 105 patients (62 males and 43 females) scheduled for surgery on one or both hips (113 hips in total) to treat cam-type femoro-acetabular impingement or labral lesions. Before and 6 months after surgery, each patient completed the NAHS-Fr and Western Ontario and McMaster Osteoarthritis Index (WOMAC). Statistical tests were done to evaluate validity, reliability, and sensitivity to change, as recommended by the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN). ResultsThe response rate was 100%, confirming that the NAHS-Fr was easy to use. The NAHS-Fr was both valid and reliable. No ceiling or floor effect was detected for the total NAHS-Fr score. All items had Cronbach alpha coefficients greater than 0.8, indicating good internal consistency. External consistency between the NAHS-Fr and WOMAC was negative (–0.676) due to inversely proportional score indexing. Before surgery, the NAHS-Fr and WOMAC scores were strongly and significantly correlated (p<0.0001). The effect size was greater than 0.8, indicating good sensitivity to the change induced by surgery. DiscussionThese results confirm the study hypothesis: the NAHS-Fr has the same good psychometric characteristics as does the original version and versions in other languages. The NAHS-Fr is useful for evaluating younger patients with non-osteoarthritic hip pain and can be used by French-speaking surgeons in everyday clinical practice. Level of evidenceIV, prospective observational non-comparative cohort study.

Immune-Related Disorders Associated With Ménière'sDisease: A Systematic Review and Meta-analysis.

To analyze evidence supporting an association between immune-related diseases and Ménière's disease (MD) since it has long been thought to be related to autoimmune disorders and allergies. We retrieved records from Pubmed, Web of Science, Scopus, and Cochrane Library to identify studies published between January 2002 and October 2022. Articles were independently assessed by 2 reviewers and verified by a third reviewer. Published cross-sectional studies, cohort/longitudinal studies, case series, and noncomparative cohort studies were considered eligible for inclusion. We conducted a systematic review and meta-analysis according to a registered protocol on the International Prospective Register of Systematic Reviews and Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Selected studies were classified into 2 groups: epidemiological and genetic association studies. Relative frequencies and odds ratios (ORs) for each autoinflammatory/autoimmune disease or genetic marker reported to be associated with MD. Fifteen studies from 6 countries met our inclusion criteria. Nine are epidemiological studies and 6 are genetic association studies. The epidemiological studies were used to perform 3 different meta-analyses. Airway allergic disease and autoimmune thyroid disease showed a significant association with MD (OR = 2.27 [2.08-2.48] and OR = 1.35 [1.25-1.46]); while rheumatoid arthritis did not (OR = 0.63 [0.28-1.41]). Other comorbidities also showed a significant association with MD like chronic obstructive pulmonary disease, vitiligo, fibromyalgia, arthritis, and psoriasis. Epidemiological evidence supports an association between MD and immune-related disorders in European and Asian populations, with population-specific effects. The evaluation of thyroid diseases, airway allergic diseases, and other inflammatory diseases should be implemented in the clinical management of MD patients.

Genetic analysis of allogenic donor cells after successful allo-limbal epithelial transplantation in simple and cultivated limbal epithelial transplantation procedures

This non-comparative cohort study investigated long-term donor cell survival after allogenic simple/cultivated limbal epithelial transplantations (allo-SLET/allo-CLET, respectively) by genetic analysis. Transplanted corneal epithelial cells, which underwent impression cytology and/or corneal-button biopsy, were examined for personal identities of autosomal short-tandem repeats; the percentages of donor cells were calculated based on matching recipient or donor buccal-DNA references. Twelve patients were included; 4 underwent allo-CLET, 8 underwent allo-SLET. Eight patients (67%) had total limbal stem cell deficiency (LSCD). Genetic analysis was performed postoperatively (mean, 55.3 months). Donor cells were detected in 4 of 12 patients (25%), all of whom underwent allo-SLET; 1 patient had a donor genotype and 3 patients had a mixed donor/recipient genotype. The longest time of donor cell detection was 30 months. Seven patients (58%) used systemic immunosuppressives at the time of genetic analysis (mean use, 22.5 months). Allogenic donor cells survived in both procedures for the long term postoperatively, which encourages the long-term use of systemic immunosuppressives. Donor cells may not be the only factor in graft survival, in that most successful cases had a recipient profile. Their presence for a specific time may promote niches for the patients’ own cells to repopulate, especially for partial LSCD.

Implications of cage impactions in single-level OLIF treatment of degenerative spondylolisthesis

IntroductionCage impactions (CI) of Oblique Lumbar Interbody Fusion (OLIF) appear to be a frequent mechanical complication with a potential functional impact. ObjectivesTo determine the rate of CI occurrence, their risk factors and clinical implications in the case of combined single-level arthrodesis. MethodA retrospective analysis of prospectively collected data was performed. All our patients with degenerative spondylolisthesis initially underwent OLIF combined with pedicle screw fixation (PSF). Intraoperative control with an image intensifier and a standard radiograph in the immediate postoperative period made it possible to assess the occurrence of CI, depending on the position of the implant. Secondary subsidence was sought on the standing radiological examination using EOS biplanar radiography during follow-up. The pelvic parameters were analyzed, as well as the occurrence of bone fusion. The clinical evaluation was made at≥1 year, by the Oswestry Disability Index (ODI), the walking distance (WD) and the Visual Analogue Scale (VAS). ResultsIn all, 130 patients out of the 131 included were analyzed. A CI occurred in 25.3% (n=33) of cases and of these, 94% (n=32) occurred intraoperatively. Postmenopausal women had more CI with an odds ratio (OR) of 5.8 (P=0.034). The “CI” group had a 9.5% lower ODI score than the “non-CI” group (P=0.0040), but both provided excellent ODI gains of 30.8±16 and 32.9±15.5% (P<0.0001). An “anterior” position of the implant allowed a greater gain in lumbar lordosis (P<0.001) but was associated with greater CI occurrence (P<0.001), with an OR of 6.75 (P=0.0018). ConclusionThe occurrence of intraoperative cage impaction is a frequent event when performing OLIF. Postmenopausal women have an approximately 6 times greater risk of impaction than men, and patients with an “anterior” implant placement have a 7 times greater risk than with central placement. The negative impact of cage impactions on the clinical score (ODI) was significant after one year of follow-up. Level of evidenceIV, non-comparative cohort study.

Outcomes of Free Flap Reconstruction for Chronic Venous Ulceration in the Lower Limb: A Systematic Review.

The mainstay of treatment for venous ulceration is conservative wound management and lifelong compression therapy. For patients with recalcitrant ulcers, free flap reconstruction has been proposed as a treatment option to reconstruct the diseased soft tissues as well as the underlying insufficient venous system. This review systematically evaluates the outcomes of free flap reconstruction for chronic venous ulcers in the lower limb. A protocol was developed a priori and registered on the PROSPERO database. A systematic search of literature was performed in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), clinical trials registries, and OpenGrey from inception to April 2020 according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Studies of patients undergoing free tissue transfer reconstruction for chronic venous ulcers in the lower limb were included. A total of 5 noncomparative cohort studies featuring 56 patients with 62 recalcitrant venous ulcers treated with 64 free flaps who had a mean age of 50 years (range, 17-76 years) were included, and a narrative analysis undertaken. Mean defect size following ulcer debridement was 153.3 cm 2 (range, 24-600 cm 2 ). Defects were reconstructed with muscle (n = 39 [60.9%]), fasciocutaneous (n = 23 [35.9%]), and visceral (n = 2 [3.1%]) free flaps, with latissimus dorsi (n = 16, 25%) and rectus abdominis flaps (n = 16, 25%) being the most frequently used. Mean follow-up ranged from 24 to 125 months. Pooled flap survival rate was 95%. No recurrence within the territory of the flap was reported, but there were 20 instances (35.7%) of new ulcers outside of the flap boundaries. There is currently an absence of evidence to support the use of free flap reconstruction for recalcitrant venous ulcers compared with conventional management. Although evidence suggests that it is technically feasible, there is no evidence to suggest it prevents ulceration outside the reconstructed region. Further studies are necessary to evaluate its effectiveness for venous ulcers in the lower limb.

Posterior hinge fixation for the treatment of unstable traumatic sacroiliac joint injuries

IntroductionPosterior hinge fixation (PHF) is a sacroiliac joint fixation method indicated for the surgical treatment of unstable pelvic ring fractures (tile C). HypothesisPHF yields good functional outcomes based on the Majeed score at more than 1 year of follow-up. MethodsA single-center, retrospective study of patients who had a Tile C pelvic ring fracture, who were operated by PHF and who were evaluated at a minimum follow-up of 1 year. The functional outcome was determined using the Majeed score and pain was evaluated by the patients using a visual analog scale (VAS). The preoperative, intraoperative and postoperative data, complications and sequelae were documented. A CT-scan was done at least 1 year after the surgical treatment to determine the SI joint's reduction and fusion. ResultsIncluded were 22 patients (59% men) who had a mean age of 37.3±11.9 years; 21 of these patients were reviewed at a mean of 4.8±4 years. The mean Majeed score at the final assessment was 76.4 points±15.3, with 24% of patients having excellent results (n=5), 53% having good results (n=11), 19% having average results (n=4) and 5% having poor results (n=1). The mean pain level on VAS was 28±23mm. Of the eight surgical site infections, seven occurred in the PHF (88%). CT-scans taken at 1 year postoperative were compared to the preoperative scans. The pelvic opening was reduced by −9±6 (p<0.01), SI diastasis by −11mm±9 (p<0.001), vertical displacement by–7mm±8 (p<0.001), symphysis opening by −15mm±15 (p<0.001), median transverse diameter by −10mm±9 (p<0.001) and bispinal diameter by −5mm±7 (p<0.001). SI fusion was confirmed in 43% of patients (n=9). ConclusionPHF is a surgical instrumentation method that provides satisfactory long-term reduction of Tile C pelvic ring fractures. The clinical outcomes are good or excellent in 77% of cases. The perioperative morbidity is marked by surgical site infections, all of which healed. Level of evidenceIV; retrospective, non-comparative cohort study.

Arthroscopic Synovectomy of the Wrist in Patients With Rheumatoid Arthritis: A Systematic Review of the Current Literature.

Rheumatoid arthritis (RA) of the wrist can lead to loss of wrist function and progressive joint destruction if inadequately treated. Arthroscopic synovectomy of the wrist may prove a valuable treatment for local inflammation. The aim of this study was to perform a systematic review evaluating functional outcomes and pain following arthroscopic synovectomy of the wrist in RA patients. A systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) guidelines. MEDLINE, EMBASE, The Cochrane Library, Web of Science, and Google Scholar were searched for studies describing pain or functional outcomes following arthroscopic synovectomy of the wrist in RA patients (CRD42021270846). Risk of bias was assessed using the Methodological Index for Non-Randomized Studies. Data collection included patient characteristics, pain scores, wrist function questionnaires, secondary surgery, and complications. Six noncomparative cohort studies were included, with a total of 153 arthroscopic synovectomies. Disease duration of RA ranged from 32 to 89 months, and radiographic progression was mild to moderate. The Methodological Index for Non-Randomized Studies scores ranged from 8 to 10 out of 16. Mean follow-up ranged from 21 to 95 months. Improvements were seen in pooled mean visual analog scale pain score (from 7.7 to 2.2, p < 0.05), pooled mean Modified Mayo Wrist Score (from 43.3 to 70.4, p < 0.05), and the Disability of the Arm, Shoulder, and Hand (from 67.5 to 36.5, p < 0.05). Two complications occurred, and 5 patients required secondary surgery. There is limited evidence suggesting that arthroscopic synovectomy of the wrist improves wrist function and pain in patients with RA, with few complications. In centers with arthroscopic expertise, it can be considered as a treatment option.

Posterior vertebral column resection for pediatric rigid spinal deformity

IntroductionSurgery for pediatric spinal deformity may involve vertebral osteotomies in complex cases. Vertebral column resection (VCR) is the most technically demanding procedure, with the severest morbidity. It can use a double anterior and posterior approach (APVCR), though a single posterior approach (PVCR) is gaining in popularity. HypothesisPVCR provides effective correction with acceptable morbidity in children. MethodA single-center retrospective series included spinal deformities treated by PVCR. Surgical data and global pelvic-spinal balance parameters were analyzed. ResultsSixteen PVCRs were performed in 13 patients, with a mean age of 14.1±2.8 years. Mean operative time was 411±54minutes. Mean preoperative rigid principal Cobb angle was 74.3°. Mean correction was 64.3% postoperatively, without significant correction loss at last follow-up. Mean blood loss was 941±221ml. The cell-saver enabled 92.3% autologous transfusions, with 53.4% homologous transfusions. Transient monoplegia and permanent psoas deficit were observed during the postoperative period. Radiologic follow-up found 4 non-unions requiring revision. ConclusionPVCR provided major correction of rigid spinal deformity in children. Complications mainly comprised mechanical or neurological incidents. Level of evidenceIV, non-comparative cohort study.

Prognostic role of intraparotid lymph node metastasis in primary parotid cancer: Systematic review.

The prognostic importance of intraparotid lymph node metastasis (P+) in patients with primary parotid gland carcinoma is unclear. Nineteen retrospective and noncomparative cohort studies, published between 1992 and 2020, met the inclusion criteria and included 2202 patients for this systematic review. The pooled prevalence of the P in adult patients in the unselected studies was 24.10% (95% confidence interval = 17.95-30.25). The number of P+ lymph nodes per patient was counted in only three studies and ranged from 1 to 11. The 5-year recurrence-free survival rate based on Kaplan-Meier analysis varied from 83% to 88% in P- patients compared to 36% to 54% in P+ patients. The average hazard ratio for tumor recurrence in patients with P+ compared to P- was 2.67 ± 0.58. P+ is an independent negative prognostic factor in primary parotid gland cancer and should be included into the treatment planning.

Phenotypic Characterization of Corneal Epithelium in Long-Term Follow-Up of Patients Post-Autologous Cultivated Oral Mucosal Epithelial Transplantation.

To analyze the phenotype of the corneal epithelium in patients with long-term follow-up who underwent autologous cultivated oral mucosal epithelial transplantation (COMET) using in vivo confocal microscopy (IVCM) and impression cytology with immunofluorescence staining (ICIF). Thirteen eyes from patients with severe limbal stem cell deficiency, who underwent COMET at least 48 months before, were recruited in this noncomparative cohort study. After eye examination, IVCM and ICIF were performed. Clinical manifestations of the cornea were evaluated and compared with epithelial findings detected by IVCM and ICIF [cytokeratin (CK) 3, CK7, and CK12]. Two corneal buttons derived from patients receiving the corneal transplantation post-COMET were sent for immunohistochemistry (CK3, CK6, CK7, CK12, paired box gene 6, p63, zonula occludens-1, and integrin β -1). The mean age of patients was 51.2 ± 20.6 years, and the mean follow-up time since COMET was 78.7 ± 16.3 months. Six of 13 eyes showed clinically successful COMET. In these eyes, IVCM demonstrated predominant cornea-like epithelium and ICIF reported positivity for CK3 and CK12, confirming the presence of oral mucosal and corneal epithelium. Meanwhile, 7 eyes showed total conjunctivalization, corresponding with substantial conjunctival epithelium detected by IVCM and positivity for conjunctival (CK7) and oral mucosal epithelial (CK3) markers detected by ICIF. The immunohistochemistry of corneal buttons stained positive for oral mucosal, corneal epithelial, and stem cell markers (CK3, CK12, and p63). In long-term follow-up of COMET, epithelium of successful patients demonstrated cornea-like phenotype, whereas failed cases revealed mainly conjunctival phenotype. However, there were evidences that oral mucosal epithelial cells remained across the cornea in both successful and failed COMET as detected by IVCM and ICIF.

Способ оценки эффективности лечения урогенитального туберкулеза

Methods for evaluating the efficiency of treatment which were developed for pulmonary tuberculosis (absence of bacterial transmission and closure of cavities) are not suitable for urogenital tuberculosis. To evaluate the use of scoring system for assessing the efficiency of treatment of urogenital tuberculosis. A pilot simple open-label prospective noncomparative cohort study was carried out, which included 15 patients with urogenital tuberculosis. All patients completed the urogenital tuberculosis score upon admission and after 1 month, along with standard clinical, laboratory and X-ray examinations. We developed this score to objectify evaluate the efficiency of antituberculosis therapy and it includes clinical and laboratory manifestations of urogenital tuberculosis. Eleven (73.3%) patients responded well to standard therapy, and 4 (26.7%) required therapy correction. Considering that the correction of therapy was carried out in a timely manner, the final result of the treatment was satisfactory. The efficiency of the proposed score has been demonstrated by clinical results. Using the urogenital tuberculosis score for assessing the results of treatment of urogenital tuberculosis allows timely correction of therapy according to objective criteria.

A 15-year retrospective epidemiologic study of ocular trauma in the north of Portugal.

The primary objective of this study was to better understand the epidemiological risk factors associated with severe eye injury of patients and the secondary objective was to evaluate functional outcomes of these severe eye injuries. A retrospective, noncomparative cohort study of severe ocular trauma, in patients assessed in an emergency room from January 2004 to December 2018 at Centro Hospitalar Universitário do Porto was performed and statistically analyzed. This study included a total of 751 patients (758 eyes) suffering ocular trauma. Men had a higher rate of ocular trauma than women (81.4% vs 18.6%). The mean age was 48.9 years old. The most common types of injury were rupture (33.8%) and penetrating (20.9%). Work-related accidents were responsible for 19.3% of injuries. Home was the most common location of trauma (46.3%). In 8.8% of trauma the best corrected visual acuity at presentation was superior to 20/40 while in 6.5% of cases no light perception (NLP) was registered. In 44.8% of trauma the best corrected visual acuity at last follow-up visit (BCVAF) was superior to 20/40 while in 15.7% of cases NLP was registered. The epidemiological high-risk factors identified were: adult males, economic crisis, home, blunt objects in man and falls in woman. Future primary prevention should take into account these factors. This study also demonstrated an important visual impairment associated with severe ocular trauma, even with timely surgical treatment, with BCVAF of NLP in 15.7% of cases.

Minimally invasive unilateral lumbar interbody fusion (UNILIF) in over-80-year-olds. Continuous series of 42 patients at 1.4 years’ follow-up

IntroductionIn lumbar stenosis, surgery aims to improve quality of life in increasingly elderly patients. Minimally invasive techniques better suit the requirements of elderly patients with increasing functional demand. HypothesisThe UNILIF unilateral lumbar interbody fusion technique improves functional scores at 1 year in over-80 year-olds, with low morbidity. MethodPatients undergoing minimally invasive decompression with transforaminal lumbar interbody fusion (TLIF) associated to unilateral pedicle screwing for degenerative lumbar stenosis were analyzed at a minimum 1 year's follow-up. SF12, Oswestry Disability Index (ODI) and Quebec scores and sagittal spinopelvic radiographic parameters were assessed at follow-up. Surgical and general complications were also collated. ResultsIn all, 42 patients (64.3% female; mean age, 83.7±2.9 years) were treated by UNILIF at levels L2-L3 (3.8%), L3-L4 (15.4%), L4-L5 (71.2%) and L5-S1 (9.6%). Mean follow-up was 520±226 days (range, 340–1166 days). Mean preoperative SF12 score was 77.5±10.9, with significant improvement at last follow-up: 81.9±138 (p<0.05). Mean preoperative ODI was 44.4%±14.0, with significant improvement at last follow-up: 32.4%±13.3 (p<0.001). Mean preoperative Quebec score was 42.9±19.9, with significant improvement at last follow-up: 28.5±21.9 (p<0.001). Spinopelvic sagittal balance was not affected by the UNILIF procedure. There were no cases of infection or severe general complications during follow-up, although 2 cases of non-union required revision surgery. ConclusionLumbar stenosis surgery by UNILIF improved functional scores at 1 year, with low morbidity. It is a suitable strategy for degenerative lumbar stenosis in elderly patients. Level of evidenceIV, non-comparative cohort study.

Hernia at the stoma site after loop ileostomy reversal

PurposeTo estimate the incidence of and risk factors for stoma site hernia after closure of a temporary diverting ileostomy.MethodIn a non-comparative cohort study, charts (n = 216) and CT-scans (n = 169) from patients who had undergone loop ileostomy closure following low anterior resection for rectal cancer 2010–2015 (mainly open surgery) at three hospitals were evaluated retrospectively. Patients without hernia diagnosis were evaluated cross-sectionally through a questionnaire (n = 158), and patients with symptoms of bulging or pain were contacted and offered a clinical examination or a CT scan including Valsalva maneuver.ResultsIn the chart review, five (2.3%) patients had a diagnosis of incisional hernia at the previous stoma site after 8 months (median). In 12 patients, the CT scan showed a hernia, of which 8 had not been detected previously. The questionnaire was returned by 130 (82%) patients, of which 31% had symptoms of bulging or pain. Less than one in five of patients who reported bulging were diagnosed with hernia, but the absolute majority of the radiologically diagnosed hernias reported symptoms. By combining clinical and radiological diagnosis, the cumulative incidence of hernia was 7.4% during a median follow up time of 30 months. Risk factors for stoma site hernia were male sex and higher BMI.ConclusionHernia at the previous stoma site was underdiagnosed. Less than a third of symptomatic patients had a hernia diagnosis in routine follow up. Randomized studies are needed to evaluate if prophylactic mesh can be used to prevent hernias, especially in patients with risk factors.