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1.
Surg Clin North Am ; 104(2): 451-471, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38453313

ABSTRACT

Teaching during a surgical resuscitation can be difficult due to the infrequency of these events. Furthermore, when these events do occur, the trainee can experience cognitive overload and an overwhelming amount of stress, thereby impairing the learning process. The emergent nature of these scenarios can make it difficult for the surgical educator to adequately teach. Repeated exposure through simulation, role play, and "war games" are great adjuncts to teaching and preparation before crisis. However, surgical educators can further enhance the knowledge of their trainees during these scenarios by using tactics such as talking out loud, targeted teaching, and debriefing.


Subject(s)
Learning , Teaching , Humans , Resuscitation/education
2.
Kans J Med ; 16: 228-233, 2023.
Article in English | MEDLINE | ID: mdl-37791032

ABSTRACT

Introduction: The COVID-19 pandemic impacted multiple aspects of surgical education. This survey delineates steps taken by general surgery residency programs to meet changing patient-care needs while continuing to provide adequate education. Methods: A survey was administered to program directors and coordinators of all United States general surgery residency programs to assess the early effects of the pandemic on residents from March 1 through May 31, 2020. Results: Of 303 programs contacted, 132 (43.6%) completed the survey. Residents were asked to work in areas outside of their specialty at 27.3% of programs. Residency curriculum was changed in 35.6% of programs, and 76.5% of programs changed their academic conferences. Resident schedules were altered at a majority of programs to limit resident-patient exposure, increase ICU coverage, or improve resident utilization. Surgical caseloads decreased at 93.8% of programs; 31.8% of those programs reported concerns regarding residents' achieving the minimum case numbers required to graduate. Conclusions: These results provided insight into the restructuring of general surgery residency programs during a pandemic and may be used to establish future pandemic response plans.

4.
Front Endocrinol (Lausanne) ; 14: 1026187, 2023.
Article in English | MEDLINE | ID: mdl-36864831

ABSTRACT

Background: Gene expression (GE) data have shown promise as a novel tool to aid in the diagnosis of childhood growth hormone deficiency (GHD) when comparing GHD children to normal children. The aim of this study was to assess the utility of GE data in the diagnosis of GHD in childhood and adolescence using non-GHD short stature children as a control group. Methods: GE data was obtained from patients undergoing growth hormone stimulation testing. Data were taken for the 271 genes whose expression was utilized in our previous study. The synthetic minority oversampling technique was used to balance the dataset and a random forest algorithm applied to predict GHD status. Results: 24 patients were recruited to the study and eight subsequently diagnosed with GHD. There were no significant differences in gender, age, auxology (height SDS, weight SDS, BMI SDS) or biochemistry (IGF-I SDS, IGFBP-3 SDS) between the GHD and non-GHD subjects. A random forest algorithm gave an AUC of 0.97 (95% CI 0.93 - 1.0) for the diagnosis of GHD. Conclusion: This study demonstrates highly accurate diagnosis of childhood GHD using a combination of GE data and random forest analysis.


Subject(s)
Dwarfism , Growth Hormone , Transcriptome , Adolescent , Child , Humans , Control Groups , Gene Expression Profiling , Growth Hormone/deficiency
6.
Rheumatology (Oxford) ; 62(11): 3601-3609, 2023 11 02.
Article in English | MEDLINE | ID: mdl-36919768

ABSTRACT

OBJECTIVES: The GO-BACK study was designed to evaluate the efficacy and safety of golimumab (GLM) treatment withdrawal in adults with non-radiographic axial spondyloarthritis (nr-axSpA) who demonstrate inactive disease during a 10-month open-label (OL) GLM run-in. METHODS: Eligible participants received OL GLM in period 1. In period 2, participants who achieved inactive disease were randomized 1:1:1 to receive double-blind (DB) treatment with monthly placebo (PBO, treatment withdrawal) or continued GLM treatment given monthly (GLM QMT) or every 2 months (GLM Q2MT). Participants who did not have a disease flare continued DB treatment for ∼12 months. Participants with a disease flare discontinued DB treatment and resumed monthly OL GLM. Primary endpoint compared the proportion of participants without a disease flare in the continued GLM treatment groups (QMT or Q2MT) vs PBO in a multiplicity-controlled, step-down fashion. Safety follow-up continued for ∼3 months after last treatment. RESULTS: A total of 188 patients, out of the 323 enrolled, were eligible for participation in period 2. Both GLM QMT and GLM Q2MT were superior to treatment withdrawal (PBO) in preventing disease flare (P < 0.001), with a treatment-difference vs PBO of 50.4% and 34.4% for the GLM QMT and GLM Q2MT groups, respectively. The time-to-first flare was significantly longer (log-rank P < 0.0001) with GLM treatment compared with PBO. Of 53 participants (in Q2MT or PBO) who had a confirmed disease flare, 51 (96.2%) attained a clinical response within 3 months of restarting OL GLM. Adverse events were consistent with the known GLM safety profile. CONCLUSION: Among participants with active nr-axSpA who attained inactive disease after 10 months of GLM treatment, continued GLM treatment is well tolerated and provides superior protection against disease flares compared with GLM withdrawal. (EudraCT: 2015-004020-65, registered on 30 March 2022; NCT: 03253796, registered on 18 August 2017.).


Subject(s)
Non-Radiographic Axial Spondyloarthritis , Adult , Humans , Symptom Flare Up , Treatment Outcome , Retreatment , Double-Blind Method
7.
J Oral Maxillofac Surg ; 81(3): 280-286, 2023 03.
Article in English | MEDLINE | ID: mdl-36587932

ABSTRACT

PURPOSE: A recently proposed modification of the sagittal split osteotomy (SSO) of the mandible places the horizontal medial cut 'low and short' of the lingula. The purpose of the study was to answer the following clinical question: Among patients undergoing mandibular setback procedures (≤ 8 mm) via SSO, does the placement of the medial horizontal osteotomy below the lingula (infralingular), when compared to placement above the lingula (supralingular), results in different neurosensory, bite force, and range of motion outcomes? MATERIALS AND METHODS: This was a single-center, double-blind, parallel-group study among patients undergoing mandibular setback by SSO (≤ 8 mm), between January 2021 and September 2022. Patients were randomly allocated in a ratio of 1:1 to the supralingular (control) and the infralingular (study) group. Primary outcome variables included neurosensory disturbance of the inferior alveolar nerve based on clinical neurosensory testing and severity graded using Zuniga and Essick's protocol, bite force, and maximum mouth opening evaluated postoperatively during the first week (T1), first month (T2), and third month (T3) of follow-up. Secondary outcome measures included the incidence of a bad split and distal segment interferences intraoperatively. Association between the variables was assessed using Pearson chi-squared test or Fisher's exact test based on the expected observations. A P value of ≤.05 was considered statistically significant. RESULTS: A total of 29 patients (58 osteotomies) were included in the study. Group 1 consisted of 15 patients (9 females and 6 males) with a mean age of 26.4 years. Group 2 consisted of 14 patients (8 females and 6 males) with a mean age of 25.9 years. Patients with severe neurosensory disturbance of the inferior alveolar nerve were more common in group 2 (n = 15, 53.6%) than group 1 (n = 4, 13.3%) at T1 (P value = .0001) and insignificant between the two groups at T2 (P value = .63) and T3 (P value = .99). Comparison of maximum mouth opening between the two groups at T1 (P value = .535), T2 (P value = .934), and T3 (P value = .703) and bite force at T1 (P = .324), T2 (P = .113), and T3 (P = .811) was not significant. CONCLUSION: Both SSO techniques have similar clinical outcomes among patients having mandibular setbacks (≤ 8 mm) for the variables studied.


Subject(s)
Mandible , Trigeminal Nerve Injuries , Male , Female , Humans , Adult , Mandible/surgery , Osteotomy , Osteotomy, Sagittal Split Ramus/methods , Mandibular Nerve , Trigeminal Nerve Injuries/etiology
8.
J Pharm Pract ; 36(2): 468-471, 2023 Apr.
Article in English | MEDLINE | ID: mdl-34569328

ABSTRACT

The growing use of oral factor Xa (FXa) inhibitors in patients with chronic kidney disease (CKD), particularly the recent increased use of apixaban in patients with end-stage renal disease (ESRD), has created a new dilemma in the already controversial topic of oral FXa inhibitor reversal. With the limited availability of anti-Xa levels specific to oral FXa inhibitors and even scarcer availability of reversal data for patients on these agents with ESRD, ensuring adequate reversal is currently often solely guided by repeat imaging and changes in clinical status. Low molecular weight heparin (LMWH) anti-Xa levels have been used as a more commonly accessible test to guide the need for and efficacy of reversal of oral FXa inhibitors in patients with normal renal function. However, evidence supporting this technique is again lacking in patients with renal dysfunction. This case report focuses on the use of LMWH anti-Xa levels to guide reversal of apixaban in a patient with ESRD on hemodialysis and correlation of those levels to the patient's clinical status.


Subject(s)
Heparin, Low-Molecular-Weight , Kidney Failure, Chronic , Humans , Factor Xa Inhibitors/adverse effects , Pyridones/adverse effects , Renal Dialysis , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/therapy , Anticoagulants
9.
J Clin Endocrinol Metab ; 108(4): 1007-1017, 2023 03 10.
Article in English | MEDLINE | ID: mdl-36355576

ABSTRACT

The first step in the evaluation of the short child is to decide whether growth parameters in the context of the history are abnormal or a variant of normal. If growth is considered abnormal, system and hormonal tests are likely to be required, followed by more directed testing, such as skeletal survey and/or genetic screening with karyotype or microarray. In a small percentage of short children in whom a diagnosis has not been reached, this will need to be followed by detailed genetic analysis; currently, exome sequencing using targeted panels relevant to the phenotype is the commonly used test. Clinical scenarios are presented that illustrate how such genetic testing can be used to establish a molecular diagnosis, and how that diagnosis contributes to the management of the short child. New genetic causes for short stature are being recognized on a frequent basis, while the clinical spectrum for known genes is being extended. We recommend that an international repository for short stature conditions is established for new findings to aid dissemination of knowledge, but also to help in the definition of the clinical spectrum both for new and established conditions.


Subject(s)
Dwarfism , Genetic Testing , Humans , Dwarfism/diagnosis , Dwarfism/genetics , Phenotype , Exome Sequencing , Karyotype
10.
Transplantation ; 106(10): 2000-2005, 2022 10 01.
Article in English | MEDLINE | ID: mdl-35642977

ABSTRACT

BACKGROUND: Mortality from cirrhosis is increasing and is the highest among young adults with alcohol-associated liver disease (ALD). The aim of this study was to describe rates of liver transplant (LT) waitlisting stratified by age, sex, and cirrhosis etiology. METHODS: Retrospective population-based study from 2003 to 2018 using the Scientific Registry of Transplant Recipients database. Adults newly registered on the LT waitlist were included, and age at listing was dichotomized to ±40 y. Annual standardized incidence proportions of LT waitlisting by age group, sex, and etiology were calculated using census data. Changes in annual rates were described with Poisson regression. RESULTS: A total of 209 399 unique individuals were included, 10 326 (5%) <40 y at listing. In those <40 y of age, listing increased most for ALD (4-fold increase) followed by nonalcoholic fatty liver disease (NAFLD; 2-fold increase). Compared to young adult males, young females were more likely to be listed for ALD and less likely to be listed for NAFLD. In those ≥40 y of age, listings increased most for ALD (2-fold increase) and NAFLD (2-fold increase). Hepatitis C virus increased from 2003 to 2013 and declined post-2014 in the ≥40-y age group. CONCLUSIONS: LT waitlisting is increasing substantially in young Americans, driven primarily by ALD. These data support ongoing efforts to identify adolescents and young adults with early stages of ALD where interventions can be implemented to prevent the development of cirrhosis and liver-related complications.


Subject(s)
Liver Diseases, Alcoholic , Liver Transplantation , Non-alcoholic Fatty Liver Disease , Adolescent , Female , Humans , Liver Cirrhosis/epidemiology , Liver Diseases, Alcoholic/epidemiology , Liver Diseases, Alcoholic/surgery , Liver Transplantation/adverse effects , Male , Non-alcoholic Fatty Liver Disease/epidemiology , Non-alcoholic Fatty Liver Disease/surgery , Retrospective Studies , United States/epidemiology , Young Adult
11.
Eur J Gastroenterol Hepatol ; 34(6): 646-654, 2022 06 01.
Article in English | MEDLINE | ID: mdl-35412484

ABSTRACT

BACKGROUND: In PURSUIT, golimumab (GLM) was efficacious in patients with moderate-to-severe ulcerative colitis (UC). We assessed whether remote monitoring of combined patient-reported Mayo stool frequency and rectal bleeding scores is an effective real-world outcome measure for assessing maintenance of GLM-induced clinical response. METHODS: This was a 54-week prospective, observational cohort study conducted at 43 European outpatient clinics in adults with moderate-to-severe UC who were biologic naïve or had received a maximum of one other biological therapy. Patients were treated according to European GLM UC label/local practice. Clinical response (based on partial or full Mayo score) was assessed at week 6, 10, or 14 of induction, depending on local practice. Investigators remotely monitored scores every 4 weeks. The primary endpoint was the proportion of induction responders in patient-reported continuous clinical response (pCCR) at week 54, defined as absence of UC flare based on combined patient-reported Mayo stool frequency and rectal bleeding scores every 4 weeks and full or partial Mayo score. A key secondary endpoint was the proportion of induction responders in clinical remission at week 54. RESULTS: Among 109 patients, 37 (34.0%) received at least two GLM induction doses and completed induction in clinical response (induction responders). At week 54, 15/37 (40.5%) induction responders were in pCCR, and 21/37 (56.8%) were in clinical remission. CONCLUSION: In daily clinical practice, regular remote monitoring of combined patient-reported Mayo stool frequency and rectal bleeding scores appears to be a meaningful real-world outcome measure for monitoring maintenance of GLM-induced clinical response in UC.


Subject(s)
Colitis, Ulcerative , Adult , Antibodies, Monoclonal , Colitis, Ulcerative/chemically induced , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/drug therapy , Gastrointestinal Hemorrhage , Humans , Patient Reported Outcome Measures , Prospective Studies , Remission Induction , Severity of Illness Index , Treatment Outcome
12.
Vet Sci ; 9(1)2022 Jan 01.
Article in English | MEDLINE | ID: mdl-35051100

ABSTRACT

Persistent stifle instability is a recognized complication following tibial tuberosity advancement techniques (TTAT). The aim of this study is to report the feasibility and outcome of tibial plateau leveling techniques (TPLT) to treat dogs with persistent lameness, suspected to be secondary to persistent stifle instability, following (TTAT). Medical records of dogs presented for persistent lameness after TTAT were reviewed. Preoperative data included orthopedic examination, lameness score and radiographs. Inclusion criteria included performance of a surgery to address persistent lameness and suspected instability. Short-term follow up data included orthopedic examination and radiographs of the stifle. Long-term follow up was based on postoperative Liverpool Osteoarthritis in Dogs (LOAD) questionnaire. Seven dogs were included in the study. Mean subjective preoperative lameness score was 3 ± 1.53. Mean preoperative patellar ligament angle relative to the tibial plateau (PLATP) was 94° and mean tibial plateau angle (TPA) was 28°. Six dogs had tibial plateau leveling osteotomy and one had modified cranial closing wedge ostectomy. Mean postoperative PLATP was 79° and mean TPA was 5°. Mean subjective lameness score at follow up was 0.57 ± 0.49. Minor complications were present in 2 dogs and major complication in 1 dog. Mean LOAD questionnaire score was 6.6/52. TPLT can be performed after TTAT and may improve clinical function and stability in these cases in which persistent instability is suspected.

13.
J Orthod ; 49(3): 316-323, 2022 09.
Article in English | MEDLINE | ID: mdl-34479470

ABSTRACT

BACKGROUND AND AIM: The coronavirus disease 2019 (COVID-19) has brought new challenges to every specialty and orthodontics is no exception. Currently, there seems no way other than to mitigate the risk and proceed with routine orthodontic treatment. The aim of the present study was to conduct a qualitative inquiry into the coping strategies, perceptions and anticipations of orthodontic patients and the challenges faced by orthodontists. METHODS: An in-depth telephone interview of 30 patients and/or their parents and orthodontists belonging to an Academic-based Residency Program and Private Practice was conducted regarding the challenges, opportunities and futuristic ways of coping with COVID-19. Inputs were recorded, transcripts were prepared and anonymised, and a thematic analysis was performed. RESULTS: Six themes and several sub-themes emerged from the detailed interviews and their transcripts. The initial fearful situation due to COVID-19 has gradually transformed into a certain 'new normal' in the lives of patients and caregivers, explaining why patients started seeking orthodontic treatment as usual or even preferring to begin treatment during this period. Orthodontists in the midst of uncertainty are delivering quality care and expecting future innovations and changes to combat such pandemics. CONCLUSION: Humans can adapt to any crisis that runs over a period of time. The new insights obtained will help to plan treatment and set up practice to cope with pandemics and crises that can affect orthodontic treatment in the future.


Subject(s)
COVID-19 , Orthodontics , Humans , Orthodontists , Pandemics , Patient Care
14.
Rheumatology (Oxford) ; 61(2): 617-627, 2022 02 02.
Article in English | MEDLINE | ID: mdl-33878154

ABSTRACT

OBJECTIVES: We report the open-label extension (OLE) of the GO-AHEAD study evaluating the long-term efficacy and safety of golimumab (GLM) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). METHODS: Patients [both GLM- and placebo (PBO)-treated in the double-blind phase] received GLM 50 mg every 4 weeks during the OLE (36-week treatment; additional 8-week safety follow-up; GLM/GLM and PBO/GLM groups). All patients who entered and received ≥1 dose of study treatment in the OLE were included in the efficacy and safety analyses. The primary efficacy evaluations were the proportions of patients achieving 20% and 40% improvement in the ASAS criteria (ASAS20 and ASAS40, respectively). Responders' analyses were calculated using a non-responder imputation approach. RESULTS: Of 198 patients randomised, 189/198 (95.5%) entered the OLE; 174/198 patients (87.9%) completed all visits. Although the proportion of responders increased from week 16 to week 52 in the OLE in both GLM/GLM and PBO/GLM groups, the GLM/GLM group had a higher proportion of responders than the PBO/GLM group throughout the OLE from week 16 to week 52 (ASAS20: 71.1% to 83.9% vs 40.0% to 75.0%, respectively; ASAS40: 56.7% to 76.3% vs 23.0% to 59.4%, respectively; ASAS partial remission: 33.0% to 53.8% and 18.0% to 45.8%). In the OLE, the overall incidence of AEs was lower in the GLM/GLM vs PBO/GLM groups (41.9% and 54.2%). CONCLUSIONS: Sustained improvement in clinical efficacy was observed at 52 weeks in patients with nr-axSpA following GLM treatment. GLM was well tolerated and provided substantial long-term benefits to patients with nr-axSpA. TRIAL REGISTRATION: NCT01453725; United States National Library of Medicine clinical trials database; www.clinicaltrials.gov.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Axial Spondyloarthritis/drug therapy , Double-Blind Method , Humans , Treatment Outcome , Tumor Necrosis Factor Inhibitors/therapeutic use
15.
J Oral Biol Craniofac Res ; 12(1): 45-48, 2022.
Article in English | MEDLINE | ID: mdl-34697583

ABSTRACT

Our aim was to observe if there was any appreciable difference in the etiology and pattern of maxillofacial fractures during the pre-COVID-19 and COVID-19 periods in Central Kerala, South India. This retrospective study was conducted with data over a period of two years from the central database registry of our hospital. Age, sex, etiology, date of injury, and site of facial fractures were recorded and compared between both the time periods. Increase in facial fractures due to fall at home (p value < 0.01) and decrease in mass casualty cases (p value < 0.01) were observed during the COVID-19 period. Pedestrians involved were significantly more in the pre-COVID-19 period (p value < 0.01) and heavy vehicle accidents producing facial fractures were significantly more in the COVID-19 period (p value < 0.01). Frontal bone (p value = 0.008), nasal bone (p value < 0.001) and zygomatico-maxillary complex fractures (p value < 0.001) occurred significantly more in the COVID-19 time period whereas naso-orbito-ethmoidal (p value = 0.003), mandibular (p value = 0.011) and dentoalveolar fractures (p value < 0.001) were seen significantly more in the pre-COVID-19 period. There was decrease in the total number of maxillofacial cases during the COVID-19 period. However, this was not significant when only the number of facial fractures were compared between the two periods. This study provided an insight on the differences in etiology and pattern of maxillofacial fractures during the pre-COVID-19 and COVID-19 periods. Road traffic accidents involving two wheelers predominate during the COVID-19 period also, prompting further critical exploration of the reasons behind this finding.

16.
Vet Rec ; 189(8): e505, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34018608

ABSTRACT

PURPOSE: MRI is becoming increasingly available within the veterinary profession, and eyes are frequently included as part of a cranial study. The advantages of volumetric imaging are numerous, when compared to traditional two-dimensional imaging, and could be utilised within the veterinary setting. This report describing the normal MRI appearance of the canine eye, aimed to establish a standard reference range on a T1w volumetric acquisition. METHOD: This study retrospectively assessed 62 eyes from 31 dogs that had undergone MRI at the Small Animal Hospital, Langford Vets, University of Bristol between 2016 and 2018 using a standardised MRI protocol. Dogs were excluded if they had presented with any reported ocular or orbital abnormalities. Measurements were performed from the 3D T1w volumetric sequence by a single observer using a previously published technique. RESULTS: Mean axial globe length was 2.13 cm and equatorial width 2.16 cm. Mean anteroposterior depth of the anterior chamber was 0.40 cm and 0.97 cm for the vitreous chamber. The mean anteroposterior and equatorial distance of the lens was 0.75 cm and 1.15 cm, respectively. Mean optic nerve width was 0.15 cm, and the mean width of the entire optic nerve sheath was 0.43 cm. Statistically significant relationships were noted between age and axial globe length and both lens dimensions. Highly significant relationships were noted between all variables, except lens dimensions and body weight Conclusion: This study provides reference values to assist in the interpretation of ocular structures during MRI on a T1w volumetric acquisition.


Subject(s)
Eye , Magnetic Resonance Imaging , Animals , Dogs , Eye/diagnostic imaging , Magnetic Resonance Imaging/veterinary , Reference Values , Retrospective Studies
17.
Am J Health Syst Pharm ; 78(15): 1382-1384, 2021 07 22.
Article in English | MEDLINE | ID: mdl-33895798

ABSTRACT

PURPOSE: This case report describes utilization of thromboelastography (TEG) in the setting of an acute major bleed in a patient on dabigatran who had concomitant acute kidney injury. SUMMARY: An 80-year-old female presented to the emergency department after a fall with complaints of pain in her knee, shoulder, and hip. Her medical history was significant for coronary artery disease, for which she took clopidogrel 75 mg daily, and atrial fibrillation, for which she took dabigatran 150 mg twice daily. The physical exam was remarkable for pain within the shoulder, hip, and knee, which had swelling and ecchymosis that extended into the right thigh. Given the possibility of compartment syndrome with multiple possible etiologies of coagulopathy, TEG and computed tomography angiography (CTa) of the right lower extremity were performed. The initial TEG showed prolonged R time and activated clotting time, indicating clotting factor dysfunction with no additional coagulopathy noted, including antiplatelet effects. On the basis of the TEG and CTa findings, it was decided to reverse dabigatran with 5 grams of idarucizumab. Approximately 1 hour after administration of idarucizumab, the patient was taken to interventional radiology where a limited angiogram of the right lower extremity showed no active extravasation. Because of the patient's renal dysfunction and the possibility of rebound hypercoaguability, repeat TEG tests were ordered at 4 and 8 hours after the initial reversal to ensure clearance of idarucizumab-dabigatran complexes. The repeat TEG values showed complete reversal of the initial coagulopathy noted. During the admission, the patient required no blood transfusions or surgical interventions and all her initial laboratory results improved. CONCLUSION: Serial TEG testing was successful at managing multiple coagulopathies in a patient at risk for trauma-induced compartment syndrome.


Subject(s)
Acute Kidney Injury , Atrial Fibrillation , Acute Kidney Injury/diagnosis , Acute Kidney Injury/drug therapy , Aged, 80 and over , Dabigatran/adverse effects , Female , Hemorrhage , Humans , Thrombelastography
19.
Inflamm Bowel Dis ; 27(12): 1963-1967, 2021 11 15.
Article in English | MEDLINE | ID: mdl-33577644

ABSTRACT

BACKGROUND: This analysis of the Observational Postmarketing Ulcerative Colitis Study examined incidence rates of colectomy in patients with ulcerative colitis who received originator infliximab (IFX) or conventional therapies (ConvRx) as per their treating physician. METHODS: Cox proportional hazards models compared time to colectomy for both treatment groups. A secondary analysis examined colectomy incidence rates based on IFX exposure timing (defined by a 90-day window after the last IFX dose date). RESULTS: Of 2239 patients with data, 1059 enrolled in IFX and 1180 enrolled in ConvRx (including 296 patients who switched to IFX). Patients in the IFX group had more severe disease at baseline vs the ConvRx group (percentage with baseline partial Mayo score 7-9: 46.0% vs 30.5%, respectively). During 5 years of follow-up, 271 patients (12.1% of enrolled patients) had colectomy. Enrollment in the IFX group was associated with a higher risk of colectomy (hazard ratio = 3.12; 95% confidence interval, 2.25-4.34; P < 0.001) compared with enrollment in the ConvRx group. A total of 174 colectomies occurred in the IFX group, but 97 of these colectomies occurred ≥90 days after the last IFX dose date. CONCLUSIONS: Colectomy was reported at a higher rate in the IFX group than in the ConvRx group, although patients in the IFX group had more severe disease at baseline and most of the colectomies occurred after patients had been off of IFX for ≥90 days.


Subject(s)
Colectomy/statistics & numerical data , Colitis, Ulcerative , Gastrointestinal Agents , Infliximab , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/epidemiology , Colitis, Ulcerative/surgery , Gastrointestinal Agents/adverse effects , Humans , Incidence , Infliximab/adverse effects , Retrospective Studies , Treatment Outcome
20.
Radiat Oncol J ; 38(2): 109-118, 2020 Jun.
Article in English | MEDLINE | ID: mdl-33012154

ABSTRACT

PURPOSE: Hypofractionated radiotherapy (RT) is becoming a new standard in postoperative treatment of patients with early stage breast cancer after breast conservation surgery. However, data on hypofractionation in patients with advanced stage disease who undergo mastectomy followed by local and regional nodal irradiation (RNI) is lacking. In this retrospective study, we report late-term effects of 3 weeks post-mastectomy hypofractionated local and RNI with two-dimensional (2D) technique in patients with stage II and III breast cancer. METHODS: Between January 1990 and December 2007, 1,770 women with breast cancer who were given radical treatment with mastectomy, systemic therapy and RT at least 10 years ago were included. RT dose was 35 Gy/15 fractions/3 weeks to chest wall by two tangential fields and 40 Gy in same fractions to supraclavicular fossa (SCF) and internal mammary nodes (IMNs). SCF and IMNs dose was prescribed at dmax and 3 cm depth, respectively. Chemotherapy and hormonal therapy was given in 64% and 74% patients, respectively. Late-term toxicities were assessed with the Radiation Therapy Oncology Group (RTOG) scores and LENT-SOMA scales (the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales). RESULTS: Mean age was 48 years (range, 19 to 75 years). Median follow-up was 12 years (range, 10 to 27 years). Moderate/marked arm/shoulder pain was reported by 254 (14.3%) patients. Moderate/marked shoulder stiffness was reported by 219 (12.3%) patients. Moderate/marked arm edema was seen in 131 (7.4%) patients. Brachial plexopathy was not seen in any patient. Rib fractures were noted in 6 (0.3%) patients. Late cardiac and lung toxicity was seen in 29 (1.6%) and 23 (1.3%) patients, respectively. Second malignancy developed in 105 (5.9%) patients. CONCLUSION: RNI with 40 Gy/15 fractions/3 weeks hypofractionation with 2D technique seems safe and comparable to historical data of conventional fractionation (ClinicalTrial.gov Registration No. XXXX).

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